SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K
 
 
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 or 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
 
 
Report on Form 6-K dated October 24, 2023
(Commission File No. 1-15024)
 

 
Novartis AG
(Name of Registrant)
 
 
Lichtstrasse 35
4056 Basel
Switzerland
(Address of Principal Executive Offices)
 


 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
 
Form 20-F: x
   
Form 40-F: o
 
 
Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes: o
   
No: x
 

 




SIGNATURES
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
Novartis AG
   
     
Date: October 24, 2023
By:
/s/ PAUL PENEPENT
     
 
Name:
Paul Penepent
 
Title:
Head Financial Reporting and Accounting
       
 

 
 
Ad hoc announcement pursuant to Art. 53 LR

FINANCIAL RESULTS | RÉSULTATS FINANCIERS | FINANZERGEBNISSE
 


Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
https://www.novartis.com
 

Novartis delivers 12% sales and 21% core operating income growth from continuing operations (in cc1). Executes Sandoz spin-off, achieves important innovation milestones, and raises FY 2023 guidance

Transformation into a “pure-play” innovative medicines business is complete, with the spin-off of Sandoz; commentary below is on continuing operations2
Q3 sales grew +12% (cc, +12% USD) with core operating income growing +21% (cc, +17% USD)
o
Growth driven by continued strong performance from Kesimpta (+124% cc), Entresto (+31% cc), Kisqali (+76% cc), Pluvicto (+217% cc) and Scemblix (+157% cc)
Q3 operating income grew +13% (cc, -4% USD) driven by higher sales and lower restructuring charges, partly offset by higher impairments through discontinuation of early stage development projects
Q3 net income grew +37% (cc, +14% USD) mainly due to higher operating income
Q3 free cash flow3 was USD 5.0 billion (+24% USD) driven by higher net cash flows from operating activities
Q3 core EPS grew +29% (cc, +24% USD) to USD 1.74
Strong nine months performance with sales growing +10% (cc, +8% USD) and core operating income growing +19% (cc, +13% USD)
Q3 key innovation milestones, including positive Ph3 data for multiple pipeline assets with blockbuster potential:
o
Cosentyx FDA approval for intravenous formulation in three indications (PsA, AS, nr-axSpA)
o
Demonstrated clinically meaningful and statistically significant Ph3 data for: 1) Pluvicto (mCRPC pre-taxane), 2) iptacopan (IgAN), 3) remibrutinib (CSU), 4) Lutathera (GEP-NETs)
o
Kisqali – Ph3 NATALEE iDFS 500 event analysis complete; file submitted in EU, US submission planned for Q4 2023
Initiated previously announced, up-to USD 15 billion share buyback to be completed by year-end 2025
Full-year 2023 guidance raised for core operating income based on strong momentum4
o
Net sales expected to grow high single digit
o
Core operating income expected to grow mid to high teens (from low double digit to mid teens)

Basel, October 24, 2023 – commenting on the quarter, Vas Narasimhan MD, CEO of Novartis, said: “Novartis delivered a very strong quarter, with double-digit sales and core operating income growth leading to a further upgrade to 2023 guidance. We have successfully executed the spin-off of Sandoz, allowing us to fully focus on high-value innovative medicines. Our growth drivers, including Kesimpta, Entresto, Kisqali and Pluvicto, continue to perform well in the market. Our robust pipeline also continues to deliver, and we have achieved important innovation milestones for Pluvicto, iptacopan, remibrutinib and Lutathera. We are confident in our mid-term growth outlook and remain committed to creating value for our shareholders.”

Key figures1
 
Continuing operations2
 
Q3 2023
Q3 2022
% change
9M 2023
9M 2022
% change
 
USD m
USD m
USD
cc
 
USD m
USD m
USD
cc
Net sales
11 782
10 492
12
12
 
34 017
31 630
8
10
Operating income
1 762
1 826
-4
13
 
7 187
6 191
16
31
Net income
1 513
1 330
14
37
 
5 934
4 734
25
41
EPS (USD)
0.73
0.61
20
45
 
2.84
2.16
31
49
Free cash flow
5 043
4 054
24
 
 
11 019
8 661
27
 
Core operating income
4 405
3 772
17
21
 
12 551
11 149
13
19
Core net income
3 585
3 035
18
23
 
10 320
8 983
15
22
Core EPS (USD)
1.74
1.40
24
29
 
4.95
4.09
21
28
1 Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 48 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2 As defined on page 37 of the Condensed Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities and Discontinued operations include operational results from the Sandoz business. 3 Effective January 1, 2023, Novartis revised its definition of free cash flow, to define free cash flow as net cash flows from operating activities less purchases of property, plant and equipment. To aid in comparability, the prior year free cash flow amounts have been revised to conform with the new free cash flow definition. See page 48 of the Condensed Interim Financial Report. 4 Please see detailed guidance assumptions on page 8.



Strategy update
Our focus
Novartis has completed its transformation into a “pure-play” innovative medicines business, with the successful spin-off of Sandoz. Our focus is now centered on four core therapeutic areas (cardiovascular, renal and metabolic; immunology; neuroscience, and oncology). In each of these areas, we have multiple significant in-market and pipeline assets, all of which address diseases with a high burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy, and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan.

Financials
Following the September 15, 2023, shareholders’ approval of the spin-off of the Sandoz business the Company reported its consolidated financial statements for the current and prior years as “continuing operations” and “discontinued operations.”
Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing corporate activities. Discontinued operations include the Sandoz Division and selected portions of corporate activities attributable to Sandoz’s business, as well as certain expenses related to the spin-off.
With the spin-off of the Sandoz business, Novartis operates as a single global operating segment, being a focused innovative medicines company.
The commentary below focuses on continuing operations. We also provide information on discontinued operations, which mainly includes Sandoz and allocated corporate activities.
Continuing operations
Third quarter
Net sales were USD 11.8 billion (+12%, +12% cc) driven by volume growth of 17 percentage points. Pricing had a negative impact of 1 percentage point and generic competition had a negative impact of 4 percentage points.
Operating income was USD 1.8 billion (-4%, +13% cc), mainly driven by higher sales and lower restructuring charges, partly offset by higher impairments through discontinuation of early stage development projects.
Net income was USD 1.5 billion (+14%, +37% cc), mainly due to higher operating income and lower tax rate driven by non-recurring items. EPS was USD 0.73 (+20%, +45% cc), growing faster than net income, benefiting from lower weighted average number of shares outstanding.
Core operating income was USD 4.4 billion (+17%, +21% cc), mainly driven by higher sales. Core operating income margin was 37.4% of net sales, increasing by 1.4 percentage points (+2.7 percentage points cc).
Core net income was USD 3.6 billion (+18%, +23% cc), mainly due to higher core operating income. Core EPS was USD 1.74 (+24%, +29% cc), growing faster than core net income, benefiting from lower weighted average number of shares outstanding.

Free cash flow amounted to USD 5.0 billion (+24% USD), compared with USD 4.1 billion in the prior year quarter driven by higher net cash flows from operating activities.

Nine months
Net sales were USD 34.0 billion (+8%, +10% cc) driven by volume growth of 16 percentage points. Pricing had a negative impact of 2 percentage points and generic competition had a negative impact of 4 percentage points.

2



Operating income was USD 7.2 billion (+16%, +31% cc), mainly driven by higher sales, other income from legal matters, lower restructuring charges, partly offset by higher impairments through discontinuation of early stage development projects.
Net income was USD 5.9 billion (+25%, +41% cc), mainly due to higher operating income. EPS was USD 2.84 (+31%, +49% cc), growing faster than net income, benefiting from lower weighted average number of shares outstanding.
Core operating income was USD 12.6 billion (+13%, +19% cc), mainly driven by higher sales. Core operating income margin was 36.9% of net sales, increasing by 1.7 percentage points (+2.9 percentage points cc).
Core net income was USD 10.3 billion (+15%, +22% cc), mainly due to higher core operating income. Core EPS was USD 4.95 (+21%, +28% cc), growing faster than core net income, benefiting from lower weighted average number of shares outstanding.

Free cash flow amounted to USD 11.0 billion (+27% USD), compared with USD 8.7 billion in the prior year period driven by higher net cash flows from operating activities.
Discontinued operations
Results for discontinued operations in the third quarter and nine-months 2023 include the results of the Sandoz Division and selected portions of corporate activities attributable to Sandoz business, as well as certain expenses related to the spin-off.

In connection with the Sandoz spin-off on October 4, 2023, the Company will report as part of its Q4 discontinued operations results a one-time non-cash non-taxable IFRS gain of approximately USD 5.9 billion. This IFRS gain represents mainly the excess amount of the IFRS distribution liability, which is the estimated fair value of the Sandoz business distributed to Novartis AG shareholders, over the then carrying value of Sandoz business net assets.

Third quarter
Discontinued operations net sales were USD 2.5 billion (+8%, +6% cc), mainly driven by ex-US growth.

Operating loss amounted to USD 86 million, compared to an operating income of USD 342 million in the previous year. The operating loss in third quarter was driven by the discontinued corporate transaction cost related to spin-off of the Sandoz business, which were core adjustments.

Core operating income was USD 250 million (-51%, -38% cc), mainly driven by lower gross margin and higher SG&A expenses.

Net income from discontinued operations amounted to USD 250 million, compared to USD 245 million in the previous year.

Nine months
Discontinued operations net sales were USD 7.4 billion (+6%, +8% cc), mainly driven by ex-US growth.

Operating income amounted to USD 265 million, compared to USD 1.1 billion in the previous year. The current year period includes the discontinued corporate transaction cost related to spin-off of the Sandoz business, which were core adjustments.

Core operating income was USD 1.2 billion (-20%, -11% cc), mainly driven by higher SG&A expenses and R&D investments.

Net income from discontinued operations amounted to USD 440 million, compared to USD 755 million in the previous year.

3



Total company
Third quarter
Total company net income was USD 1.8 billion, mainly due to higher operating income and lower tax rate driven by non-recurring items compared to USD 1.6 billion in the prior year. EPS increased to USD 0.85 from USD 0.73 in prior year.

Cash flows from operating activities amounted to USD 5.4 billion compared to USD 4.7 billion in the prior year. Free cash flow amounted to USD 5.0 billion compared to USD 4.4 billion in the prior year.

Nine months
Total company net income was USD 6.4 billion, mainly due to higher operating income compared to USD 5.5 billion in the prior year. EPS increased to USD 3.05 from USD 2.50 in prior year.

Cash flows from operating activities amounted to USD 11.9 billion compared to USD 10.1 billion in the prior year. Free cash flow amounted to USD 11.0 billion compared to USD 9.3 billion in the prior year.
Q3 key growth drivers
Underpinning our financial results in the quarter is a continued focus on key growth drivers including:
Kesimpta
(USD 657 million, +124% cc) sales growth was driven by increased demand, strong access and benefitting from a one-time revenue deduction adjustment in Europe
Entresto
(USD 1 485 million, +31% cc) sustained robust demand-led growth, benefitting from the adoption of guideline-directed medical therapy across regions
Kisqali
(USD 562 million, +76% cc) sales grew strongly across all regions, based on increasing recognition of consistent overall survival and quality of life benefits
Pluvicto
(USD 256 million, +217% cc) continued sales growth in the US. Supply now unconstrained, focusing on initiating new patients
Ilaris
(USD 335 million, +24% cc) sales grew across all regions
Scemblix
(USD 106 million, +157% cc) sales grew across all regions, demonstrating the high unmet need in CML
Leqvio
(USD 90 million, +165% cc) launch in the US and other markets ongoing, with focus on patient on-boarding, removing access hurdles and enhancing medical education
Cosentyx
(USD 1 329 million, +4% cc) continued demand growth across key regions, partly offset by US revenue deduction fluctuations across periods. Ex-US sales grew +15% (cc)
Promacta/Revolade
(USD 576 million, +10% cc) grew across all regions, driven by increased use in chronic ITP and severe aplastic anemia
Xolair
(USD 369 million, +13% cc) sales grew across most regions
Jakavi
(USD 427 million, +9% cc) sales grew in Emerging Growth Markets, Europe and Japan, driven by strong demand in both myelofibrosis and polycythemia vera
Tafinlar + Mekinist
(USD 482 million, +8% cc) sales grew in the US and Emerging Growth Markets, driven by demand in BRAF+ adjuvant melanoma and NSCLC indications
Lutathera
(USD 159 million, +19% cc) sales grew mainly in the US, Japan and Europe due to increased demand
Emerging Growth Markets*
Overall, grew +17% (cc). Growth in China (+14% cc, USD 848 million)
*All markets except the US, Canada, Western Europe, Japan, Australia, and New Zealand

4



Net sales of the top 20 products in 2023
 
Q3 2023
% change
9M 2023
% change
 
USD m
USD
cc
USD m
USD
cc
Entresto
1 485
31
31
4 400
31
33
Cosentyx
1 329
4
4
3 677
-1
1
Promacta/Revolade
 576
10
10
1 706
10
12
Kesimpta
- excl. revenue deduction adjust.*
 657
127
87
      124
       86
1 530
      112
       95
      112
       96
Kisqali
 562
72
76
1 470
68
74
Tafinlar + Mekinist
 482
7
8
1 436
10
13
Tasigna
 464
-5
-5
1 402
-3
-1
Jakavi
 427
11
9
1 276
9
11
Lucentis
 363
-20
-22
1 174
-20
-19
Xolair
 369
15
13
1 085
4
6
Sandostatin
 338
15
15
 998
7
8
Ilaris
 335
23
24
 979
18
20
Zolgensma
 308
-3
-2
 928
-13
-11
Gilenya
 270
-47
-48
 771
-54
-53
Pluvicto
 256
220
217
 707
nm
nm
Exforge Group
 187
1
3
 557
-5
-1
Galvus Group
 181
-15
-4
 539
-17
-10
Diovan Group
 153
-4
-1
 466
-9
-4
Lutathera
 159
20
19
 458
34
34
Gleevec/Glivec
 144
-19
-17
 433
-24
-21
Top 20 brands total
9 045
13
13
25 992
9
11
nm= not meaningful
* Sales growth benefiting from a one-time revenue deduction adjustment in Europe

5



R&D update - key developments from the third quarter
New approvals

Leqvio
Approved in China and Japan as the first and only small interfering RNA (siRNA) therapy for LDL-C reduction
Cosentyx
In October, FDA approved the intravenous formulation in three indications: Psoriatic Arthritis, Ankylosing Spondylitis, and non-radiographic axial SpA

Regulatory updates

Kisqali
EU file submission in adjuvant early breast cancer setting; US submission planned for Q4 2023
Adakveo
EC adopts decision endorsing CHMP recommendation to revoke conditional marketing authorization

Results from ongoing trials and other highlights

iptacopan
In October, Ph3 APPLAUSE-IgAN study interim analysis demonstrated clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy. The trial met its pre-specified interim analysis (9 months) primary endpoint, demonstrating superiority vs. placebo in proteinuria reduction, with safety consistent with previously reported data.
Novartis plans to review interim data with regulatory authorities for accelerated approval; study continues with final readout at 24 months
remibrutinib
Ph3 REMIX-1 and REMIX-2 studies met all primary and secondary endpoints, showing fast, clinically meaningful improvements across urticaria disease activity scores. Remibrutinib demonstrated a favorable safety profile with rates of adverse events comparable to placebo and balanced liver function tests across both studies.
Final (52 weeks) readout and submissions to health authorities are expected in 2024. Full data will be presented at upcoming medical meetings
Pluvicto
Ph3 PSMAfore study demonstrated clinically meaningful and statistically significant rPFS benefit in patients with PSMA+ mCRPC in the pre-taxane setting. Per updated analysis presented at ESMO, median rPFS more than doubled compared to ARPI switch. Patients on Pluvicto showed improved quality of life compared to daily oral ARPI, along with improvements in other clinically meaningful efficacy endpoints including PSA response, ORR, DOR and time to symptomatic skeletal event, with favorable safety. Pre-specified crossover-adjusted OS analysis demonstrated a HR of 0.80 (0.48, 1.33); the unadjusted ITT OS analysis was confounded by a high rate of crossover.
Novartis is continuing to collect OS data, regulatory filings are anticipated in 2024
Lutathera
Ph3 NETTER-2 study demonstrated clinically meaningful and statistically significant improvement in PFS (primary endpoint) in patients with newly diagnosed somatostatin receptor (SSTR)-positive, Grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) vs. high-dose long-acting octreotide alone. The trial also met its key secondary endpoint of ORR. No new or unexpected safety findings were observed and data are consistent with the already well-established safety profile of Lutathera.
Data to be presented at an upcoming medical meeting and discussed with regulatory authorities, with submissions to follow
Kisqali
Ph3 NATALEE iDFS 500 event analysis complete. Updated data is consistent with the interim analysis results announced in March 2023 and will be communicated at an upcoming medical meeting.



6



Health-related quality of life (HRQoL) analyses from Ph3 NATALEE trial demonstrated that patients with early breast cancer receiving adjuvant Kisqali plus ET for up to 3 years maintained physical and social functioning; psychological well-being; and overall health scores, compared to baseline. Data was presented at the ESMO Virtual Plenary 2023
Leqvio
Long-term data from Ph3 ORION-8 demonstrated that Leqvio, in addition to statin therapy, provides consistent low-density lipoprotein cholesterol (LDL-C) reduction beyond six years of treatment in patients with atherosclerotic cardiovascular disease (ASCVD), increased risk of ASCVD or heterozygous familial hypercholesterolemia. Efficacy and safety were consistent with previously reported Ph3 results. Data was presented at ESC 2023
GT005
(PPY988)
Development in Geographic Atrophy secondary to dry-Age-related Macular Degeneration discontinued based on benefit-risk assessment. No new safety signals identified. Patients treated will be provided with long term safety follow up
Tislelizumab
Novartis and BeiGene mutually agreed to terminate the collaboration and license agreement for tislelizumab for certain markets. With the termination, BeiGene will re-assume all development and commercialization rights for tislelizumab, and Novartis will manufacture tislelizumab for certain markets. BeiGene will also provide Novartis with ongoing clinical supply of tislelizumab to support its clinical trials
‘Front of Eye’ Assets
Divestment completed of ‘front of eye’ ophthalmology assets to Bausch + Lomb

Capital structure and net debt
Retaining a good balance between investment in the business, a strong capital structure and attractive shareholder returns remains a priority.
During the first nine months of 2023, Novartis repurchased a total of 74.9 million shares for USD 7.2 billion on the SIX Swiss Exchange second trading line. These repurchases included 52.8 million shares (USD 4.9 billion) under the USD 15 billion share buyback (announced in December 2021 and completed in June 2023) and 10.4 million shares (USD 1.1 billion) under the new up-to USD 15 billion share buyback announced in July 2023. In addition, 11.7 million shares (USD 1.2 billion) were repurchased to mitigate dilution related to participation plans of associates. Furthermore, 1.4 million shares (for an equity value of USD 0.1 billion) were repurchased from associates. In the same period, 12.2 million shares (for an equity value of USD 0.8 billion) were delivered as a result of options exercised and share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 64.1 million versus December 31, 2022. These treasury share transactions resulted in an equity decrease of USD 6.5 billion and a net cash outflow of USD 7.3 billion.
As of September 30, 2023, net debt excluding net debt related to discontinued operations increased to USD 10.8 billion compared to USD 7.2 billion total net debt at December 31, 2022. The increase was mainly due to the USD 7.3 billion annual dividend payment, net cash outflow for treasury share transactions of USD 7.3 billion and net M&A / intangible assets transactions of USD 2.9 billion. This increase in net debt was partially offset by USD 11.0 billion free cash flow.
As part of the spin-off, Sandoz incurred total bank debt of approximately USD 3.7 billion and paid approximately USD 3.0 billion in cash, including payment in satisfaction of certain intercompany indebtedness owed by Sandoz and its subsidiaries to Novartis and its affiliates as of September 30, 2023. This reduced the net debt position of Novartis by USD 3.0 billion.
As of Q3 2023, the long-term credit rating for the company is A1 with Moody’s Investors Service and AA- with S&P Global Ratings.


7




2023 outlook raised due to strong momentum                 

Barring unforeseen events; growth vs prior year in cc    Previous Guidance  
Net sales
Expected to grow high single digit
Unchanged
 
  
Core operating income
Expected to grow mid to high teens
(from low double digit to mid teens)
 
 

Key assumptions:
No US Entresto Gx at risk launch in 2023
No Sandostatin LAR generics enter in the US in 2023

Entresto patent update
Novartis has appealed to reverse the negative US District Court decision and to uphold the validity of its combination patent covering Entresto and other combinations of sacubitril and valsartan, which expires in 2025 (with pediatric exclusivity). No generics have tentative or final approval in the US. Any US commercial launch of a generic Entresto product prior to the final outcome of Novartis combination patent appeal, or ongoing litigations involving other patents, may be at risk of later litigation developments.

Foreign exchange impact
If late-October exchange rates prevail for the remainder of 2023, the foreign exchange impact for the year would be negative 2 percentage point on net sales and negative 6 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.


8



Key figures1

Continuing operations2
 
Q3 2023
Q3 2022
% change
   
9M 2023
9M 2022
% change
 
USD m
USD m
USD
cc
 
 
USD m
USD m
USD
cc
Net sales
11 782
10 492
12
12
 
Net sales
34 017
31 630
8
10
Operating income
1 762
1 826
-4
13
 
Operating income
7 187
6 191
16
31
As a % of sales
15.0
17.4
 
 
 
As a % of sales
21.1
19.6
 
 
Net income
1 513
1 330
14
37
 
Net income
5 934
4 734
25
41
EPS (USD)
0.73
0.61
20
45
 
EPS (USD)
2.84
2.16
31
49
Cash flows from
operating activities
5 304
4 275
24
 
 
Cash flows from
operating activities
11 673
9 271
26
 
Non-IFRS measures
         
Non-IFRS measures
       
Free cash flow
5 043
4 054
24
 
 
Free cash flow
11 019
8 661
27
 
Core operating income
4 405
3 772
17
21
 
Core operating income
12 551
11 149
13
19
As a % of sales
37.4
36.0
 
 
 
As a % of sales
36.9
35.2
 
 
Core net income
3 585
3 035
18
23
 
Core net income
10 320
8 983
15
22
Core EPS (USD)
1.74
1.40
24
29
 
Core EPS (USD)
4.95
4.09
21
28
                     
                     
                     
Discontinued operations2
 
Q3 2023
Q3 2022
% change
   
9M 2023
9M 2022
% change
 
USD m
USD m
USD
cc
 
 
USD m
USD m
USD
cc
Net sales
2 476
2 286
8
6
 
Net sales
7 428
6 998
6
8
Operating (loss)/income
-86
342
nm
nm
 
Operating income
265
1 057
-75
-60
As a % of sales
nm
15.0
 
 
 
As a % of sales
3.6
15.1
 
 
Net income
250
245
2
79
 
Net income
440
755
-42
-18
Non-IFRS measures
         
Non-IFRS measures
       
Core operating income
250
510
-51
-38
 
Core operating income
1 185
1 486
-20
-11
As a % of sales
10.1
22.3
 
 
 
As a % of sales
16.0
21.2
 
 
                     
                     
                     
Total company
 
Q3 2023
Q3 2022
% change
   
9M 2023
9M 2022
% change
 
USD m
USD m
USD
cc
 
 
USD m
USD m
USD
cc
Net income
1 763
1 575
12
44
 
Net income
6 374
5 489
16
33
EPS (USD)
0.85
0.73
16
51
 
EPS (USD)
3.05
2.50
22
40
Cash flows from
operating activities
5 378
4 721
14
 
 
Cash flows from
operating activities
11 911
10 125
18
 
Non-IFRS measures
         
Non-IFRS measures
       
Free cash flow
5 043
4 435
14
 
 
Free cash flow
11 038
9 325
18
 
Core net income
3 784
3 419
11
16
 
Core net income
11 209
10 101
11
18
Core EPS (USD)
1.83
1.58
16
22
 
Core EPS (USD)
5.37
4.60
17
24
nm= not meaningful


1 Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 48 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.
2 As defined on page 37 of the Condensed Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities and Discontinued operations include operational results from the Sandoz business.

Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below:
https://ml-eu.globenewswire.com/resource/download/1a97fd38-edbc-49ea-9350-8042dc006c1c/


9



Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “guidance,” “expected,” “momentum,” “continue,” “drivers,” “confident,” “outlook,” “remain,” “committed,” “prioritized,” “prioritizing,” “continued,” “growing,” “growth,” “plans,” “on-track,” “continuing,” “anticipated,” “to follow,” “will,” “outlook,” “may,” “upcoming,” “ongoing,” “focus,” “pipeline,” “potential,” “estimated,” “launch,” “to deliver,” “transformation,” “transformative,” “address,” “planned,” “focusing,” “accelerated,” “long-term,” “innovation,” “priority,” “can,” “awaiting,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding potential future, pending or announced transactions; or regarding potential future sales or earnings of Novartis; or regarding discussions of strategy, priorities, plans, expectations or intentions, including our transformation into a “pure-play” innovative medicines business; or regarding our liquidity or cash flow positions and our ability to meet our ongoing financial obligations and operational needs; or regarding our USD 15 billion share buyback; or regarding our appeal of the negative decision of the US District Court for the District of Delaware on the validity of our patent covering Entresto and combinations of sacubitril and valsartan. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee expected benefits or synergies from the transactions described in this press release will be achieved in the expected timeframe, or at all. In particular, our expectations could be affected by, among other things: liquidity or cash flow disruptions affecting our ability to meet our ongoing financial obligations and to support our ongoing business activities; the impact of a partial or complete failure of the return to normal global healthcare systems including prescription dynamics; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding potential significant breaches of data security or data privacy, or disruptions of our information technology systems; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the development of the products described in this press release; the potential that the benefits and opportunities expected from our planned spin-off of Sandoz may not be realized or may be more difficult or take longer to realize than expected; the uncertainties in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; safety, quality, data integrity, or manufacturing issues; uncertainties involved in the development or adoption of potentially transformational technologies and business models; uncertainties regarding actual or potential legal proceedings, investigations or disputes; our performance on environmental, social and governance measures; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
All product names appearing in italics are trademarks owned by or licensed to Novartis AG and its subsidiaries. BAUSCH + LOMB is a registered trademark of Bausch & Lomb Incorporated.

10


About Novartis
Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.
Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 8:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting https://www.novartis.com/investors/event-calendar.
Detailed financial results accompanying this press release are included in the condensed interim financial report at the link below. Additional information is provided on Novartis divisions and pipeline of selected compounds in late stage development and a copy of today's earnings call presentation can be found at https://www.novartis.com/investors/event-calendar.

Important dates
November 13, 2023 Impact and Health Equity Annual Event
November 28, 2023 R&D Day



11







Novartis Third Quarter and Nine Months 2023 Condensed Interim Financial Report – Supplementary Data

INDEX
Page
COMPANY OPERATING PERFORMANCE REVIEW
Continuing operations
3
Discontinued operations
11
Total Company
11
COMPANY CASH FLOW AND BALANCE SHEET
12
INNOVATION REVIEW
16
CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Consolidated income statements
19
Consolidated statements of comprehensive income
21
Consolidated balance sheets
22
Consolidated statements of changes in equity
23
Consolidated statements of cash flows
25
Notes to condensed interim consolidated financial statements, including update on legal proceedings
27
SUPPLEMENTARY INFORMATION
48
CORE RESULTS
Reconciliation from IFRS results to core results
50
Total Company
51
Discontinued operations
53
FREE CASH FLOW
54
ADDITIONAL INFORMATION
Net debt
57
Share information
57
Effects of currency fluctuations
58
DISCLAIMER
59


2



Company
Key Figures
Third quarter and nine months

(USD millions unless indicated otherwise)
Q3 2023
USD m
Q3 2022
USD m
% change
USD
% change
cc 1
9M 2023
USD m
9M 2022
USD m
% change
USD
% change
cc 1
Net sales from continuing operations
11 782
10 492
12
12
34 017
31 630
8
10
Other revenues
310
291
7
6
867
865
0
0
Cost of goods sold
-3 117
-2 874
-8
-4
-9 450
-8 541
-11
-9
Gross profit
from continuing operations

8 975

7 909

13

15

25 434

23 954

6

10
Selling, general and administration
-3 091
-2 936
-5
-4
-9 073
-9 010
-1
-1
Research and development
-3 925
-2 542
-54
-48
-8 804
-6 956
-27
-25
Other income
224
87
157
143
1 322
541
144
141
Other expense
-421
-692
39
42
-1 692
-2 338
28
29
Operating income
from continuing operations

1 762

1 826

-4

13

7 187

6 191

16

31
% of net sales
15.0
17.4
21.1
19.6
Loss from associated companies
-3
-5
40
46
-7
-8
13
26
Interest expense
-222
-206
-8
-11
-638
-593
-8
-11
Other financial income and expense
15
-28
nm
nm
204
18
nm
nm
Income before taxes
from continuing operations

1 552

1 587

-2

18

6 746

5 608

20

36
Income taxes
-39
-257
85
82
-812
-874
7
-5
Net income from continuing operations
1 513
1 330
14
37
5 934
4 734
25
41
Net income from discontinued operations
250
245
2
79
440
755
-42
-18
Net income
1 763
1 575
12
44
6 374
5 489
16
33
Basic earnings per share from continuing operations (USD)
0.73
0.61
20
45
2.84
2.16
31
49
Basic earnings per share from discontinued operations (USD)
0.12
0.12
0
88
0.21
0.34
-38
-13
Total basic earnings per share (USD)
0.85
0.73
16
51
3.05
2.50
22
40
Net cash flows from operating activities from continuing operations
5 304
4 275
24
11 673
9 271
26
Non-IFRS measures 1
Free cash-flow from continuing operations  2
5 043
4 054
24
11 019
8 661
27
Core operating income from continuing operations
4 405
3 772
17
21
12 551
11 149
13
19
% of net sales
37.4
36.0
36.9
35.2
Core net income from continuing operations
3 585
3 035
18
23
10 320
8 983
15
22
Core basic earnings per share (USD) from continuing operations
1.74
1.40
24
29
4.95
4.09
21
28
 1  Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 48. Unless otherwise noted, all growth rates in this release refer to same period in prior year.
 2  Effective January 1, 2023, Novartis revised its definition of free cash flow, to define free cash flow as net cash flows from operating activities less purchases of property, plant and equipment. To aid in comparability, the prior year free cash flow amounts have been revised to conform with the new free cash flow definition. See page 48 of the Condensed Interim Financial Report.
nm = not meaningful
3

Strategy update
Our focus
Novartis has completed its transformation into a “pure-play” innovative medicines business, with the successful spin-off of Sandoz. Our focus is now centered on four core therapeutic areas (cardiovascular, renal and metabolic; immunology; neuroscience and oncology). In each of these areas, we have multiple significant in-market and pipeline assets, all of which address diseases with a high burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy, and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies– the US, China, Germany and Japan.
Financials
Following the September 15, 2023, shareholders’ approval of the spin-off of the Sandoz business the Company reported its consolidated financial statements for the current and prior years as “continuing operations” and “discontinued operations.”
Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing corporate activities. Discontinued operations include the Sandoz Division and selected portions of corporate activities attributable to Sandoz’s business, as well as certain expenses related to the spin-off.
With the spin-off of the Sandoz business, Novartis operates as a single global operating segment, being a focused innovative medicines company.
The commentary below focuses on continuing operations. We also provide information on discontinued operations, which mainly includes Sandoz and allocated corporate activities.
Third quarter
Net sales
Net sales were USD 11.8 billion (+12%, +12% cc) driven by volume growth of 17 percentage points. Pricing had a negative impact of 1 percentage point and generic competition had a negative impact of 4 percentage points. Sales in the US were USD 4.7 billion (+13%) and in the rest of the world USD 7.1 billion (+12%, +11% cc).
Sales growth was mainly driven by continued strong performance from Kesimpta (USD 657 million, +127%, +124% cc), Entresto (USD 1.5 billion, +31%, +31% cc), Kisqali (USD 562 million, +72%, +76% cc), Pluvicto (USD 256 million, +220%, +217% cc) and Scemblix (USD 106 million, +159%, +157% cc), partly offset by generic competition mainly for Gilenya.
In the US (USD 4.7 billion, +13%), sales growth was mainly driven by Kesimpta, Pluvicto, Kisqali and Entresto, partly offset by the impact of generic competition on Gilenya. In Europe (USD 3.9 billion, +17%, +11% cc), sales growth was driven by Kesimpta, Entresto and Kisqali, partly offset by increased generic competition for Lucentis and Gilenya. Emerging Growth Markets grew +11% (+17% cc), which includes China sales of USD 0.8 billion (+8%, +14% cc).
Operating income
Operating income was USD 1.8 billion (-4%, +13% cc), mainly driven by higher sales and lower restructuring charges, partly offset by higher impairments through discontinuation of early stage development projects. Operating income margin was 15.0% of net sales, decreasing 2.4 percentage points (+0.1 percentage points in cc).
Core adjustments were USD 2.6 billion, mainly due to impairments and amortization compared to USD 1.9 billion in prior year. Core adjustments increased compared to prior year, mainly due to higher impairments, partly offset by lower restructuring charges.
Core operating income was USD 4.4 billion (+17%, +21% cc), mainly driven by higher sales. Core operating income margin was 37.4% of net sales, increasing 1.4 percentage points (+2.7 percentage points cc). Other revenue as a percentage of sales decreased by 0.2 percentage points (cc). Core cost of goods sold as a percentage of sales increased by 0.8 percentage points (cc). Core R&D expenses as a percentage of net sales decreased by 1.7
4

percentage points (cc). Core SG&A expenses as a percentage of net sales decreased by 1.9 percentage points (cc). Core other income and expense as a percentage of net sales increased the margin by 0.1 percentage points (cc).
Interest expense and other financial income/expense
Interest expense amounted to USD 222 million broadly in line with prior year at USD 206 million.
Other financial income and expense amounted to an income of USD 15 million compared to an expense USD 28 million in the prior year, as higher interest income was only partly offset by higher currency losses.
Core other financial income and expense amounted to an income of USD 46 million compared to an expense USD 6 million in the prior year, as higher interest income was only partly offset by higher currency losses.
Income taxes
The tax rate for continuing operations in the third quarter was 2.5% compared to 16.2% in the prior year. The current year rate was favorably impacted by tax benefits from the write-down of investments in subsidiaries, net decreases in uncertain tax positions and the effect of adjusting to the estimated full year tax rate, which was lower than previously estimated. The prior year third quarter tax rate was impacted by the effect of adjusting to the estimated full year tax rate, which was higher than previously estimated. Excluding these impacts the current and prior year quarter rate would have been 14.9% and 15.5% respectively. The decrease from the prior year was mainly the result of a change in profit mix.
The core tax rate for continuing operations (core taxes as a percentage of core income before tax) in the third quarter was 15.2% compared to 14.6% in the prior year. The current and prior year third quarter core tax rate was impacted by the effect of adjusting to the estimated full year core tax rate, which was lower than previously estimated. Excluding these impacts the current and prior year quarter tax rate would have been 15.4%.
Net income, EPS and free cash flow
Net income was USD 1.5 billion (+14%, +37% cc), mainly due to higher operating income and lower tax rate driven by non-recurring items. EPS was USD 0.73 (+20%, +45% cc), growing faster than net income, benefiting from lower weighted average number of shares outstanding.
Core net income was USD 3.6 billion (+18%, +23% cc), mainly due to higher core operating income. Core EPS was USD 1.74 (+24%, +29% cc), growing faster than core net income, benefiting from lower weighted average number of shares outstanding.
Free cash flow amounted to USD 5.0 billion (+24% USD), compared with USD 4.1 billion in the prior year quarter driven by higher net cash flows from operating activities.
Nine months
Net sales
Net sales were USD 34.0 billion (+8%, +10% cc) driven by volume growth of 16 percentage points. Pricing had a negative impact of 2 percentage points and generic competition had a negative impact of 4 percentage points. Sales in the US were USD 13.2 billion (+13%) and in the rest of the world USD 20.8 billion (+5%, +8% cc).
Sales growth was mainly driven by continued strong performance from Entresto (USD 4.4 billion, +31%, +33% cc), Kesimpta (USD 1.5 billion, +112%, +112% cc), Kisqali (USD 1.5 billion, +68%, +74% cc), Pluvicto (USD 707 million) and Scemblix (USD 288 million, +197%, +198% cc), partly offset by generic competition mainly for Gilenya.
In the US (USD 13.2 billion, +13%), sales growth was mainly driven by Pluvicto, Entresto, Kesimpta, Kisqali and Scemblix, partly offset by the impact of generic competition on Gilenya. In Europe (USD 11.3 billion, +5%, +5% cc), sales growth was driven by Kesimpta, Entresto, Kisqali, and Leqvio, partly offset by increased generic competition for Gilenya and Lucentis. Emerging Growth Markets grew +9% (+17% cc), which includes China sales of USD 2.5 billion (+5%, +12% cc).
Operating income
Operating income was USD 7.2 billion (+16%, +31% cc), mainly driven by higher sales, other income from legal matters, lower restructuring charges, partly offset by higher impairments through discontinuation of early stage
5

development projects. Operating income margin was 21.1% of net sales, increasing 1.5 percentage points (+3.6 percentage points in cc).
Core adjustments were USD 5.4 billion, mainly due to amortization and impairments, compared to USD 5.0 billion in prior year. Core adjustments increased compared to prior year, mainly due to higher impairments, partly offset by other income from legal matters and lower restructuring charges.
Core operating income was USD 12.6 billion (+13%, +19% cc), mainly driven by higher sales. Core operating income margin was 36.9% of net sales, increasing 1.7 percentage points (+2.9 percentage points cc). Other revenue as a percentage of sales decreased by 0.2 percentage points (cc). Core cost of goods sold as a percentage of sales increased by 0.3 percentage points (cc). Core R&D expenses as a percentage of net sales decreased by 1.4 percentage points (cc). Core SG&A expenses as a percentage of net sales decreased by 2.2 percentage points (cc). Core other income and expense as a percentage of net sales decreased the margin by 0.2 percentage points (cc).
Interest expense and other financial income/expense
Interest expense amounted to USD 638 million broadly in line with prior year at USD 593 million.
Other financial income and expense amounted to an income of USD 204 million compared to USD 18 million in the prior year, as higher interest income was only partly offset by higher currency losses.
Core other financial income and expense amounted to an income of USD 293 million compared to USD 90 million in the prior year, as higher interest income was only partly offset by higher currency losses.
Income taxes
The tax rate in the first nine months was 12.0% compared to 15.6% in the prior year period. The current year rate was favorably impacted by the effect of non-taxable income recognized related to a legal matter, tax benefits from the write-down of investments in subsidiaries and net decreases in uncertain tax positions. Excluding these impacts, the current year tax rate would have been 15.3% compared to 15.6% in the prior year period. The decrease from the prior year was mainly the result of a change in profit mix.
The core tax rate (core taxes as a percentage of core income before tax) was 15.4% in the first nine months compared to 15.6% in the prior year period. The decrease from the prior year was mainly the result of a change in profit mix.
Net income, EPS and free cash flow
Net income was USD 5.9 billion (+25%, +41% cc), mainly due to higher operating income. EPS was USD 2.84 (+31%, +49% cc), growing faster than net income, benefiting from lower weighted average number of shares outstanding.
Core net income was USD 10.3 billion (+15%, +22% cc), mainly due to higher core operating income. Core EPS was USD 4.95 (+21%, +28% cc), growing faster than core net income, benefiting from lower weighted average number of shares outstanding.
Free cash flow amounted to USD 11.0 billion (+27% USD), compared with USD 8.7 billion in the prior year period driven by higher net cash flows from operating activities.
6

Product commentary (relating to Q3 performance)
Cardiovascular, RENAL and METABOLIC
Q3 2023
Q3 2022
% change
% change
9M 2023
9M 2022
% change
% change
USD m
USD m
USD
cc
USD m
USD m
USD
cc
Cardiovascular, Renal and Metabolic
Entresto
1 485
1 135
31
31
4 400
3 353
31
33
Leqvio
90
34
165
165
232
70
231
231
Total Cardiovascular, Renal and Metabolic
1 575
1 169
35
34
4 632
3 423
35
37
Entresto (USD 1 485 million, +31%, +31% cc) sustained robust demand-led growth. In the US and Europe, Entresto penetration grew through the adoption of guideline-directed medical therapy in heart failure. In China and Japan, Entresto volume growth is fueled by heart failure as well as increased penetration in hypertension. In the US, Novartis is in ANDA litigation with generic manufacturers. Novartis has appealed to reverse the negative US District Court decision and to uphold the validity of its combination patent covering Entresto and other combinations of sacubitril and valsartan, which expires in 2025 (with pediatric exclusivity). No generics have tentative or final approval in the US. Any US commercial launch of a generic Entresto product prior to the final outcome of Novartis combination patent appeal, or ongoing litigations involving other patents, may be at risk of later litigation developments.
Leqvio (USD 90 million, +165%, +165% cc) launch in the US and other markets is ongoing, with focus on patient on-boarding, removing access hurdles and enhancing medical education. In the US, Leqvio is covered at or near label for 76% of patients. More than 55% of Leqvio source of business in the US is now through “Buy and Bill” acquisition mode. FDA expanded the label to include primary hyperlipidemia (patients at increased risk of ASCVD) and removed four adverse reactions from the safety section as well as Limitations of Use. In Q3 2023, Leqvio was approved in China and in Japan and is now approved in 93 countries. Novartis obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.
Immunology
Q3 2023
Q3 2022
% change
% change
9M 2023
9M 2022
% change
% change
USD m
USD m
USD
cc
USD m
USD m
USD
cc
Immunology
Cosentyx
1 329
1 274
4
4
3 677
3 708
-1
1
Xolair 1
369
322
15
13
1 085
1 042
4
6
Ilaris
335
272
23
24
979
832
18
20
Other
1
nm
nm
Total Immunology
2 033
1 868
9
9
5 741
5 583
3
4
 1  Net sales reflect Xolair sales for all indications.
nm = not meaningful
Cosentyx (USD 1 329 million, +4%, +4% cc) continued demand growth across key regions, partly offset by US revenue deduction fluctuations across periods. Ex-US sales grew +15% (cc). Since initial approval in 2015, Cosentyx has shown sustained efficacy and a consistent safety profile treating patients across six systemic inflammatory conditions. In October 2023, FDA has approved Cosentyx intravenous formulation for the treatment of adults with psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Cosentyx hidradenitis suppurativa is now approved in more than 45 countries worldwide, with an FDA decision expected in Q4 2023.
Xolair (USD 369 million, ex-US +15%, +13% cc) sales grew across most regions. Novartis co-promotes Xolair with Genentech in the US and shares a portion of revenue as operating income but does not record any US sales. In September 2023, Novartis received CHMP positive opinion for the six new Xolair product configurations, including auto injectors.
Ilaris (USD 335 million, +23%, +24% cc) sales grew across all regions. Contributors to growth include the Still’s disease indications (SJIA/AOSD) in the US and Europe, as well as strong performance for the Familial Mediterranean Fever (FMF) indication in key markets worldwide.
7

Neuroscience
Q3 2023
Q3 2022
% change
% change
9M 2023
9M 2022
% change
% change
USD m
USD m
USD
cc
USD m
USD m
USD
cc
Neuroscience
Kesimpta
657
289
127
124
1 530
723
112
112
Zolgensma
308
319
-3
-2
928
1 061
-13
-11
Mayzent
103
94
10
9
286
258
11
12
Aimovig
69
50
38
32
197
159
24
24
Other
1
nm
nm
Total Neuroscience
1 137
752
51
50
2 941
2 202
34
35
nm = not meaningful
Kesimpta (USD 657 million, +127%, +124% cc) sales growth was driven by increased demand, strong access, and benefiting from a one-time revenue deduction adjustment in Europe. Kesimpta is a targeted B-cell therapy that can deliver powerful and sustained high efficacy, with a favorable safety and tolerability profile and the flexibility of an at home self-administration for a broad population of RMS patients. Kesimpta is now approved in 87 countries with more than 55,000 patients treated.
Zolgensma (USD 308 million, -3%, -2% cc) sales were broadly in line with previous year. Established markets are treating mainly incident patients. Zolgensma is now approved in 51 countries with more than 3500 patients treated globally through clinical trials, early access programs and in the commercial setting.
Mayzent (USD 103 million, +10%, +9% cc) sales grew mainly in Europe. Sales continued to grow in patients with multiple sclerosis showing signs of progression despite being on other treatments.
Aimovig (USD 69 million, ex-US, ex-Japan +38%, +32% cc) sales grew mainly in Europe. Aimovig is reimbursed in 32 markets and has been prescribed to more than 834,000 patients worldwide. Novartis commercializes Aimovig ex-US, ex-Japan, while Amgen retains all rights in the US and in Japan.
ONCOLOGY
Q3 2023
Q3 2022
% change
% change
9M 2023
9M 2022
% change
% change
USD m
USD m
USD
cc
USD m
USD m
USD
cc
Oncology
Promacta/Revolade
576
523
10
10
1 706
1 548
10
12
Kisqali
562
327
72
76
1 470
874
68
74
Tafinlar + Mekinist 1
482
450
7
8
1 436
1 305
10
13
Tasigna
464
489
-5
-5
1 402
1 448
-3
-1
Jakavi
427
386
11
9
1 276
1 173
9
11
Pluvicto
256
80
220
217
707
92
nm
nm
Lutathera
159
132
20
19
458
343
34
34
Kymriah
124
134
-7
-9
388
397
-2
-1
Piqray/Vijoice
128
103
24
24
374
261
43
44
Votrient
102
118
-14
-14
313
371
-16
-14
Scemblix
106
41
159
157
288
97
197
198
Adakveo
45
50
-10
-11
150
143
5
5
Tabrecta
36
36
0
1
113
97
16
17
Other
1
2
nm
nm
Total Oncology
3 467
2 869
21
21
10 082
8 151
24
26
 1  Majority of sales for Mekinist and Tafinlar are combination, but both can be used as monotherapy.
nm = not meaningful
Promacta/Revolade (USD 576 million, +10%, +10% cc) sales grew across all regions driven by increased use in second-line persistent and chronic immune thrombocytopenia and as first-line and/or second-line treatment for severe aplastic anemia, according to the respective label in the countries.
8

Kisqali (USD 562 million, +72%, +76% cc) sales grew strongly across all regions, based on increasing recognition of its consistently reported overall survival and quality of life benefits in HR+/HER2- advanced breast cancer. Interim iDFS data from the NATALEE trial in early HR+/HER2- breast cancer, were presented at ASCO and submitted to EMA in August 2023. QOL information from this data was recently presented at a virtual ESMO session demonstrating that the addition of Kisqali did not compromise the quality of life of patients with early breast cancer. Submissions to other regulatory authorities are ongoing with major markets expected to be submitted by the end of this year. Novartis is in US ANDA litigation with a generic manufacturer.
Tafinlar + Mekinist (USD 482 million, +7%, +8% cc) sales grew in the US and Emerging Growth Markets, partly offset by decline in Europe, driven by demand in BRAF+ adjuvant melanoma and NSCLC indications, while maintaining demand in the highly competitive BRAF+ metastatic melanoma market. In addition, growth in the US came from the tumor agnostic indication.
Tasigna (USD 464 million, -5%, -5% cc) sales declined across all regions due to various factors including competition.
Jakavi (USD 427 million, ex-US +11%, +9% cc) sales grew in Emerging Growth Markets, Europe and Japan, driven by strong demand in both myelofibrosis and polycythemia vera indications. Incyte retains all rights to ruxolitinib (Jakafi®) in the US.
Pluvicto (USD 256 million, +220%, +217% cc) saw continued sales growth in the US. Pluvicto is the first and only radioligand therapy approved by the FDA for the treatment of adult patients with progressive, PSMA-positive metastatic castration-resistant prostate cancer, who have already been treated with other anticancer treatments (ARPI and taxane-based chemotherapy).
Lutathera (USD 159 million, +20%, +19% cc) sales grew mainly in the US, Japan and Europe due to increased demand. Novartis announced the Phase III NETTER-2 trial with Lutathera met its primary endpoint, showing Lutathera is the first radioligand therapy (RLT) to demonstrate clinically meaningful benefit in a first line setting.
Kymriah (USD 124 million, -7%, -9% cc) sales declined in the US, Emerging Growth Markets and Europe, partly offset by growth in Japan.
Piqray/Vijoice (USD 128 million, +24%, +24% cc) sales grew mainly in the US, Emerging Growth Markets and Europe. In addition to PIK3CA-related overgrowth spectrum (PROS), Piqray is the first and only therapy specifically developed for the approximately 40% of HR+/HER2- advanced breast cancer patients who have a PIK3CA mutation, associated with a worse prognosis.
Votrient (USD 102 million, -14%, -14% cc) sales declined due to increased competition, especially from immune-oncology agents in metastatic renal cell carcinoma.
Scemblix (USD 106 million, +159%, +157% cc) sales grew across all regions, demonstrating the high unmet need for effective and tolerable treatment options for CML patients, who have been treated with 2 or more tyrosine kinase inhibitors, or who have the T315I mutation.
Adakveo (USD 45 million, -10%, -11% cc) sales declined mainly in Emerging Growth Markets and Europe. In August 2023, European Commission endorsed the CHMP’s recommendation to revoke the conditional marketing authorization for Adakveo. Adakveo remains approved for use by the FDA for the reduction in frequency of vaso-occlusive crises (pain crises) in adults and pediatric patients aged 16 years or older with sickle cell disease. Novartis continues to discuss the STAND study results with FDA and other health authorities globally.
Tabrecta (USD 36 million, 0%, +1% cc) sales were stable (cc). Tabrecta is the first therapy approved by the FDA to specifically target metastatic NSCLC with a mutation that leads to MET exon 14 skipping (METex14) in line agnostic setting.
9

Other promoted brands
Q3 2023
Q3 2022
% change
% change
9M 2023
9M 2022
% change
% change
USD m
USD m
USD
cc
USD m
USD m
USD
cc
Other Promoted Brands
Ultibro Group
104
108
-4
-7
332
366
-9
-8
Xiidra
64
109
-41
-41
249
342
-27
-27
Beovu
47
52
-10
-9
151
154
-2
1
Other respiratory
21
19
11
21
69
58
19
27
Total Other Promoted Brands
236
288
-18
-19
801
920
-13
-11
Total Promoted Brands 1
8 448
6 946
22
21
24 197
20 279
19
21
 1  Total Promoted Brands refer to the sum of Total Other Promoted Brands and all Therapeutic Areas brands (Cardiovascular, Renal and Metabolic, Immunology, Neuroscience, and Oncology).
Ultibro Group (USD 104 million, -4%, -7% cc) sales declined mainly in Europe, Japan and Emerging Growth Markets due to various factors including competition. Ultibro Group consists of Ultibro Breezhaler, Seebri Breezhaler and Onbrez Breezhaler.
Xiidra (USD 64 million, -41%, -41% cc) sales declined mostly driven by increase in revenue deductions. In September 2023, Novartis completed the divestment of Xiidra to Bausch + Lomb.
Beovu (USD 47 million, -10%, -9% cc) sales declined in the US and Europe, partly offset by growth in Japan and Emerging Growth Markets.
Established BRANDS
Q3 2023
Q3 2022
% change
% change
9M 2023
9M 2022
% change
% change
USD m
USD m
USD
cc
USD m
USD m
USD
cc
Established Brands
Lucentis
363
455
-20
-22
1 174
1 476
-20
-19
Sandostatin
338
295
15
15
998
933
7
8
Gilenya
270
507
-47
-48
771
1 667
-54
-53
Exforge Group
187
185
1
3
557
584
-5
-1
Galvus Group
181
212
-15
-4
539
650
-17
-10
Diovan Group
153
160
-4
-1
466
510
-9
-4
Gleevec/Glivec
144
178
-19
-17
433
570
-24
-21
Afinitor/Votubia
85
125
-32
-30
311
406
-23
-21
Contract manufacturing 1
471
271
74
60
1 174
879
34
30
Other 2
1 142
1 158
-1
-2
3 397
3 676
-8
-3
Total Established Brands 1, 2
3 334
3 546
-6
-7
9 820
11 351
-13
-11
 1  2022 restated to reflect the transfer of the Sandoz Division’s biotechnology manufacturing services to other companies’ activities to the Innovative Medicines Division that was effective as of January 1, 2023.
 2  2022 restated to reflect the transfer of the Coartem brand from the Sandoz Division to the Innovative Medicines Division that was effective as of January 1, 2023.
Lucentis (USD 363 million, ex-US -20%, -22% cc) sales declined in Europe, Emerging Growth Markets and Japan mainly due to biosimilar competition.
Sandostatin (USD 338 million, +15%, +15% cc) sales grew mainly in the US, benefiting from favorable revenue deduction adjustment and inventory movements compared to the prior year.
Gilenya (USD 270 million, -47%, -48% cc) sales declined due to generic competition across all regions. Novartis is in litigation against a generic manufacturer on the method of treatment patent in the US, and against generic manufacturers on the dosing regimen patent in Europe.
10

Discontinued operations
Results for discontinued operations in the third quarter and nine-months 2023 include the results of the Sandoz Division and selected portions of corporate activities attributable to Sandoz business, as well as certain expenses related to the spin-off.
In connection with the Sandoz spin-off on October 4, 2023, the Company will report as part of its Q4 discontinued operations results a one-time non-cash non-taxable IFRS gain of approximately USD 5.9 billion. This IFRS gain represents mainly the excess amount of the IFRS distribution liability, which is the estimated fair value of the Sandoz business distributed to Novartis AG shareholders, over the then carrying value of Sandoz business net assets.
Third quarter
Discontinued operations net sales were USD 2.5 billion (+8%, +6% cc), mainly driven by ex-US growth.
Operating loss amounted to USD 86 million, compared to an operating income of USD 342 million in the previous year. The operating loss in third quarter was driven by the discontinued corporate transaction cost related to spin-off of the Sandoz business, which were core adjustments.
Core operating income was USD 250 million (-51%, -38% cc), mainly driven by lower gross margin and higher SG&A expenses.
Net income from discontinued operations amounted to USD 250 million, compared to USD 245 million in the previous year.
Nine months
Discontinued operations net sales were USD 7.4 billion (+6%, +8% cc), mainly driven by ex-US growth.
Operating income amounted to USD 265 million, compared to USD 1.1 billion in the previous year. The current year period includes the discontinued corporate transaction cost related to spin-off of the Sandoz business, which were core adjustments.
Core operating income was USD 1.2 billion (-20%, -11% cc), mainly driven by higher SG&A expenses and R&D investments.
Net income from discontinued operations amounted to USD 440 million, compared to USD 755 million in the previous year.
Total company
Third quarter
Total company net income was USD 1.8 billion, mainly due to higher operating income and lower tax rate driven by non-recurring items compared to USD 1.6 billion in the prior year. EPS increased to USD 0.85 from USD 0.73 in prior year.
Cash flows from operating activities amounted to USD 5.4 billion compared to USD 4.7 billion in the prior year. Free cash flow amounted to USD 5.0 billion compared to USD 4.4 billion in the prior year.
Nine months
Total company net income was USD 6.4 billion, mainly due to higher operating income compared to USD 5.5 billion in the prior year. EPS increased to USD 3.05 from USD 2.50 in prior year.
Cash flows from operating activities amounted to USD 11.9 billion compared to USD 10.1 billion in the prior year. Free cash flow amounted to USD 11.0 billion compared to USD 9.3 billion in the prior year.
11

Company Cash Flow and Balance Sheet
Cash Flow
Third quarter
Net cash flows from operating activities from continuing operations amounted to USD 5.3 billion, compared with USD 4.3 billion in the prior year quarter. This increase was mainly driven by higher net income adjusted for non-cash items and other adjustments, including divestment gains, favorable changes in working capital, partly offset by higher income taxes paid.
Net cash flows from operating activities from discontinued operations amounted to USD 74 million, compared with USD 0.4 billion in the prior year quarter. This decrease was mainly driven by lower net income from discontinued operations adjusted for non-cash items and other adjustments, including divestment gains.
Net cash outflows used in investing activities from continuing operations amounted to USD 2.0 billion, compared with USD 5.3 billion net cash inflows in the prior year quarter.
The current year quarter net cash outflows from investing activities from continuing operations were mainly driven by cash outflows of USD 3.4 billion for acquisitions and divestments of businesses, net (including the acquisition of Chinook Therapeutics, Inc. for USD 3.1 billion, net of cash acquired USD 0.1 billion, and the acquisition of DTx Pharma Inc. for USD 0.5 billion, net of cash acquired USD 0.1 billion); USD 0.4 billion for purchases of intangible assets; and USD 0.3 billion for purchases of property, plant and equipment. These cash outflows were partly offset by the proceeds from sale of intangible assets of USD 1.8 billion (including USD 1.75 billion proceeds from the divestment of the ‘front of eye’ ophthalmology assets to Bausch + Lomb); and USD 0.1 billion from the sale of financial assets and property, plant and equipment. Net proceeds from the sale of marketable securities, commodities and time deposits amounted to USD 0.2 billion.
In the prior year quarter, net cash inflows from investing activities from continuing operations of USD 5.3 billion were mainly driven by net proceeds of USD 5.7 billion from the sale of marketable securities, commodities and time deposits. These cash inflows were partly offset by USD 0.5 billion cash outflows for purchases of intangible assets and property, plant and equipment.
Net cash outflows used in investing activities from discontinued operations amounted to USD 0.2 billion, broadly in line with USD 0.1 billion in the prior year quarter.
Net cash outflows used in financing activities from continuing operations amounted to USD 4.3 billion, compared with USD 4.7 billion in the prior year quarter.
The current year quarter net cash outflows used in financing activities from continuing operations were mainly driven by USD 2.2 billion for the repayment of two bonds denominated in euro (notional amounts of EUR 1.25 billion and of EUR 0.75 billion) at maturity; USD 1.6 billion payments for net treasury share transactions; and USD 0.4 billion from the net decrease in current financial debts.
In the prior year quarter, net cash outflows used in financing activities from continuing operations of USD 4.7 billion were mainly driven by USD 2.7 billion for net treasury share transactions; USD 1.5 billion for the repayment of a US dollar bond; USD 0.5 billion net decrease in current financial debts; and USD 0.1 billion payments for lease liabilities.
The current year quarter net cash inflows from financing activities from discontinued operations of USD 3.5 billion were mainly driven by USD 3.5 billion cash inflows from bank borrowings (including the USD 3.3 billion Sandoz business borrowings on September 28, 2023, from a group of banks) in connection with the distribution (spin-off) of the Sandoz business to Novartis AG shareholders (refer to Notes 2, 3 and 12 for further details). Net cash inflows from financing activities from discontinued operations in the prior year quarter were USD 11 million.
Free cash flow from continuing operations amounted to USD 5.0 billion (+24% USD), compared with USD 4.1 billion in the prior year quarter, driven by higher net cash flows from operating activities from continuing operations.
Net cash flows from operating activities for the total company amounted to USD 5.4 billion, compared with USD 4.7 billion in the prior year quarter. Total company free cash flow amounted to USD 5.0 billion, compared with USD 4.4 billion in the prior year quarter.
12

Nine months
Net cash flows from operating activities from continuing operations amounted to USD 11.7 billion, compared with USD 9.3 billion in the prior year period. This increase was mainly driven by higher net income adjusted for non-cash items and other adjustments, including divestment gains, favorable changes in working capital, partly offset by higher payments out of provisions.
Net cash flows from operating activities from discontinued operations amounted to USD 0.2 billion, compared with USD 0.9 billion in the prior year period. This decrease was mainly driven by lower net income from discontinued operations adjusted for non-cash items and other adjustments, including divestment gains.
Net cash inflows from investing activities from continuing operations amounted to USD 7.7 billion, compared with USD 3.2 billion in the prior year period.
The current year period net cash inflows from investing activities from continuing operations were driven by net proceeds of USD 11.1 billion from the sale of marketable securities, commodities and time deposits; USD 2.0 billion from the sale of intangible assets (including USD 1.75 billion cash proceeds from the divestment of the ‘front of eye’ ophthalmology assets to Bausch + Lomb); and USD 0.3 billion from the sale of financial assets and property, plant and equipment. These cash inflows were partly offset by cash outflows of USD 3.6 billion for acquisitions and divestments of businesses, net (including the acquisition of Chinook Therapeutics, Inc. for USD 3.1 billion, net of cash acquired USD 0.1 billion, and the acquisition of DTx Pharma Inc. for USD 0.5 billion, net of cash acquired USD 0.1 billion); USD 1.3 billion for purchases of intangible assets; USD 0.7 billion for purchases of property, plant and equipment; and USD 0.1 billion for purchases of financial assets.
In the prior year period, net cash inflows from investing activities from continuing operations of USD 3.2 billion were mainly driven by net proceeds of USD 5.6 billion from the sale of marketable securities, commodities and time deposits; USD 0.3 billion from the sale of intangible assets, financial assets and property, plant and equipment. These cash inflows were partly offset by USD 1.1 billion for purchases of intangible assets; USD 0.6 billion for purchases of property, plant and equipment; and USD 0.8 billion for acquisitions and divestments of businesses, net (primarily the acquisition of Gyroscope Therapeutics Holdings plc for USD 0.8 billion).
Net cash outflows used in investing activities from discontinued operations amounted to USD 0.3 billion, broadly in line with the prior year period.
Net cash outflows used in financing activities from continuing operations amounted to USD 17.1 billion, compared with USD 16.6 billion in the prior year period.
The current year period net cash outflows used in financing activities from continuing operations were mainly driven by USD 7.3 billion for the dividend payment; USD 7.3 billion for net treasury share transactions; USD 2.2 billion for the repayment of two bonds denominated in euro (notional amounts of EUR 1.25 billion and of EUR 0.75 billion) at maturity, and USD 0.1 billion from the net decrease in current financial debts. Payments of lease liabilities amounted to USD 0.2 billion.
In the prior year period, net cash outflows used in financing activities from continuing operations of USD 16.6 billion were mainly driven by USD 7.5 billion for the dividend payment; USD 7.9 billion for net treasury share transactions; USD 2.5 billion in aggregate for the repayment of two US dollar bonds; and USD 0.2 billion payments for lease liabilities. These cash outflows were partly offset by cash inflows of USD 1.4 billion from the net increase in current financial debts and other net financing cash inflows of USD 0.1 billion.
The current year period net cash inflows from financing activities from discontinued operations of USD 3.4 billion were mainly driven by USD 3.6 billion cash inflows from bank borrowings (including the USD 3.3 billion Sandoz business borrowings on September 28, 2023, from a group of banks) in connection with the distribution (spin-off) of the Sandoz business to Novartis AG shareholders (refer to Notes 2, 3 and 12 for further details). Net cash inflows from financing activities from discontinued operations in the prior year period were USD 14 million.
Free cash flow from continuing operations amounted to USD 11.0 billion (+27% USD), compared with USD 8.7 billion in the prior year period driven by higher net cash flows from operating activities from continuing operations.
Net cash flows from operating activities for the total company amounted to USD 11.9 billion, compared with USD 10.1 billion in the prior year period. Total company free cash flow amounted to USD 11.0 billion, compared with USD 9.3 billion in the prior year period.
13

Balance sheet
There has been a significant change on the September 30, 2023 consolidated balance sheet resulting from the presentation of the Sandoz business as a discontinued operations, following the September 15, 2023 shareholders’ approval to spin-off of Sandoz business through a dividend in kind distribution to the Novartis AG shareholders (for further details see Note 1, Note 2 and Note 3).
The December 31, 2022 consolidated balance sheet includes the assets and liabilities of the Sandoz business. The September 30, 2023 consolidated balance sheet excludes the assets and liabilities of the Sandoz business in the individual lines and presents its total assets in a single line in current assets “Assets related to discontinued operations” and its total liabilities in a single line in current liabilities “Liabilities related to discontinued operations.” The consolidated balance sheet discussion and analysis that follows excludes the impacts of the presentation of the assets and liabilities of the Sandoz business in these respective single lines as current assets and current liabilities, respectively. For details on the assets and liabilities of the Sandoz business at September 30, 2023 see Note 12.
Assets
Total non-current assets of USD 67.0 billion decreased by USD 1.9 billion compared to December 31, 2022, excluding the impact of the presentation of the Sandoz business non-current assets related to discontinued operations.
Intangible assets other than goodwill decreased by USD 3.8 billion mainly due to amortization and impairments and the divestment of the ‘front of eye’ ophthalmology assets, partially offset by the acquisition of Chinook Therapeutics, Inc. and of DTx Pharma Inc., additions, and favorable currency translation adjustments.
Goodwill increased by USD 1.6 billion mainly due to the acquisition of DTx Pharma Inc. and of Chinook Therapeutics, Inc.
Deferred tax assets increased by USD 0.6 billion and property, plant and equipment, right-of-use assets, investments in associated companies, financial assets, and other non-current assets were broadly in line with December 31, 2022.
Total current assets of USD 45.7 billion decreased by USD 4.0 billion compared to December 31, 2022, excluding the impact of the presentation of the Sandoz business non-current assets related to discontinued operations.
Cash and cash equivalents, marketable securities, commodities, time deposits and derivative financial instruments decreased by USD 6.2 billion mainly due to the dividend payment, and net purchases of treasury shares and intangible assets, partially offset by the cash generated through operating activities.
Inventories increased by USD 0.6 billion and trade receivables increased by USD 1.0 billion. Other current assets increased by USD 0.6 billion and income tax receivables were broadly in line with December 31, 2022.
Liabilities
Total non-current liabilities of USD 26.1 billion decreased by USD 2.5 billion compared to December 31, 2022, excluding the impact of the presentation of the Sandoz business non-current liabilities related to discontinued operations.
Non-current financial debts decreased by USD 2.1 billion mainly due to the reclassification of USD 2.1 billion from non-current to current financial debts of a USD denominated bond with notional amount of USD 2.2 billion maturing in 2024.
Non-current lease liabilities, deferred tax liabilities and provisions and other non-current liabilities were broadly in line with December 31, 2022.
Total current liabilities of USD 48.4 billion increased by USD 0.7 billion compared to December 31, 2022 excluding the impact of the presentation of the Sandoz business non-current liabilities related to discontinued operations. This increase was mainly due to recognition of the dividend in kind distribution liability to effect the spin-off of the Sandoz business of USD 14.0 billion (see Note 3).
Current financial debts and derivative financial instruments decreased by USD 0.3 billion, mainly due to the repayment of a 0.5% coupon bond with a notional amount of EUR 750 million and a 0.125% coupon bond with a notional amount
14

of EUR 1.25 billion partly offset by the reclassification of USD 2.1 billion from non-current to current financial debts of a USD denominated bond with notional amount of USD 2.2 billion maturing in 2024.
Provisions and other current liabilities increased by USD 1.4 billion. Trade payables, current income tax liabilities and current lease liabilities were broadly in line with December 31, 2022.
Equity
The Company’s equity decreased by USD 21.2 billion to USD 38.2 billion compared to December 31, 2022.
This decrease was mainly due to the dividend in kind distribution liability of USD 14.0 billion (see Note 3), the cash-dividend payment of USD 7.3 billion and the purchase of treasury shares of USD 7.3 billion. This was partially offset by the net income of USD 6.4 billion, exercise of options and employee transactions of USD 0.2 billion, and equity-based compensation of USD 0.7 billion.
Net debt and debt/equity ratio
The Company’s liquidity amounted to USD 12.7 billion at September 30, 2023, compared to USD 18.9 billion on December 31, 2022. Total non-current and current financial debts, including derivatives, amounted to USD 23.5 billion at September 30, 2023 compared to USD 26.2 billion at December 31, 2022.
The debt/equity ratio were 0.62:1 at September 30, 2023, compared to 0.44:1 at December 31, 2022. As of September 30, 2023 the net debt was USD 10.8 billion, compared to USD 7.2 billion on December 31, 2022.
15

Innovation Review
Novartis continues to focus its R&D portfolio prioritizing high value medicines with transformative potential for patients. We now focus on ~115 projects in clinical development.
Selected Innovative Medicines approvals

Product
Active ingredient/
Descriptor

Indication

Region
Leqvio
inclisiran
Hypercholesterolemia
China, Japan
Cosentyx
secukinumab

Intravenous formulation for psoriatic
arthritis, ankylosing spondylitis,
and non-radiographic axial SpA
US

Jakavi
ruxolitinib
Acute graft-versus-host
disease
Japan

Chronic graft-versus-host
disease
Japan
Selected Innovative Medicines projects awaiting regulatory decisions
Completed submissions
Product
Indication
US
EU
Japan
News update
Kisqali
Hormone receptor-positive /
human epidermal growth factor
receptor 2-negative early
breast cancer (adjuvant)



Q3 2023





– EU filing


LNP023
(iptacopan)
Paroxysmal nocturnal
hemoglobinuria
Q2 2023
Q2 2023
Q3 2023
– Japan filing
Cosentyx
Hidradenitis suppurativa
Q3 2022
Approved
VDT482
(tislelizumab)
2L Esophageal cancer



– Mutual termination of the agreement
with BeiGene, Ltd.
Non-small cell lung
cancer




Selected Innovative Medicines pipeline projects
Compound/
product
Potential indication/
Disease area
First planned
submissions
Current
Phase

News update
Aimovig
Migraine, pediatrics
≥2026
3
AVXS-101
(OAV101)
Spinal muscular atrophy
(IT formulation)
2025
3

Beovu
Diabetic retinopathy
2025
3
CFZ533
(iscalimab)
Sjögren's syndrome
≥2026
2

Coartem
Malaria, uncomplicated (<5 kg patients)

2024

3

– Submission will use the MAGHP procedure
in Switzerland to facilitate rapid approval in
developing countries
Cosentyx
Giant cell arteritis
2025
3
Polymyalgia rheumatica
≥2026
3
Rotator cuff tendinopathy
≥2026
3
EXV811
(atrasentan)
IgA nephropathy
2024
3
– Chinook aquisition
FUB523
(zigakibart)
IgA nephropathy
≥2026
3
– Chinook aquisition
JDQ443
(opnurasib)
Non-small cell lung cancer, 2/3L
2024
3

Non-small cell lung cancer (combos)
≥2026
2
KAE609
(cipargamin)
Malaria, uncomplicated
≥2026
2
Malaria, severe
≥2026
2
KLU156
(ganaplacide
+ lumefantrine)
Malaria, uncomplicated

≥2026

2

– FDA Orphan Drug designation
– FDA Fast Track designation
16

Compound/
product
Potential indication/
Disease area
First planned
submissions
Current
Phase

News update
Leqvio
Secondary prevention of cardiovascular
events in patients with elevated levels of LDL-C
≥2026
3

Primary prevention CVRR
≥2026
3
LNA043
Osteoarthritis
≥2026
2
– FDA Fast Track designation
LNP023
(iptacopan)
IgA nephropathy


2024


3


– EU Orphan Drug designation
– Ph3 APPLAUSE-IgAN study met
its pre-specified interim analysis
primary endpoint
C3 glomerulopathy



2024



3



– EU Orphan Drug designation
– EU PRIME designation
– FDA Rare Pediatric designation
– China Breakthrough Therapy designation
– FDA Breakthrough Therapy designation
IC-MPGN
≥2026
3
Atypical haemolytic uraemic syndrome
≥2026
3
LOU064
(remibrutinib)
Chronic spontaneous urticaria
2024
3
– Ph3 REMIX-1 and REMIX-2 studies
met all primary and secondary endpoints
Multiple sclerosis
≥2026
3
CINDU
≥2026
3
Sjögren's syndrome
≥2026
2
Lutathera
Gastroenteropancreatic
neuroendocrine tumors,
1L in G2/3 tumors
2024

3

– Ph3 NETTER-2 trial met
its primary endpoint
177Lu-NeoB
Multiple solid tumors
≥2026
1
LXE408
Visceral leishmaniasis
≥2026
2
MBG453
(sabatolimab)
Myelodysplastic syndrome
2024
3
– FDA Fast Track designation
– EU Orphan Drug designation
Unfit acute myeloid leukemia
≥2026
2
MIJ821
(onfasprodil)
Depression



2

– Program discontinued following
strategic review, including a benefit risk
assessment of acute MDD with suicidality
Piqray
Ovarian cancer

3
– Program discontinued based on benefit-risk
assessment
Pluvicto
Metastatic castration-resistant
prostate cancer pre-taxane
2024
3
– Novartis is continuing to collect OS data,
regulatory filings are anticipated in 2024
Metastatic hormone sensitive prostate cancer
2024
3
PPY988
(GT005)
Geographic atrophy





2


– Program discontinued based on benefit-risk
assessment. No new safety signals identified.
Patients treated to be provided with long term
safety follow up
QGE031
(ligelizumab)
Food allergy
≥2026
3

Scemblix
1L Chronic myeloid leukemia
2024
3
TQJ230
(pelacarsen)
Secondary prevention of cardiovascular
events in patients with elevated levels
of lipoprotein(a)
2025

3

– FDA Fast Track designation
– China Breakthrough Therapy designation
17

Compound/
product
Potential indication/
Disease area
First planned
submissions
Current
Phase

News update
VAY736
(ianalumab)
Auto-immune hepatitis
≥2026
2

Sjögren’s syndrome
≥2026
3
– FDA Fast Track designation
Lupus nephritis
≥2026
3
Systemic lupus erythematosus
≥2026
3
1L Immune thrombocytopenia
≥2026
3
2L Immune thrombocytopenia
≥2026
3
warm Autoimmune hemolytic anemia
≥2026
3
VDT482
(tislelizumab)
1L Gastric cancer

3
– Mutual termination of the agreement
with BeiGene, Ltd.
1L ESCC
3
Localized ESCC
3
1L Small cell lung cancer
3
1L Urothelial cell carcinoma
3
Adj/Neo adj. NSCLC
3
Xolair
Food allergy
2023
3
XXB750
Hypertension
≥2026
2
YTB323
sr Lupus nephritis /
Systemic lupus erythematosus
≥2026
2

1L High-risk large B-cell lymphoma
≥2026
2
18

Condensed Interim Consolidated Financial Statements

Consolidated income statements
Third quarter (unaudited)
(USD millions unless indicated otherwise)
Note
Q3 2023
Q3 2022
Net sales from continuing operations
10
11 782
10 492
Other revenues
10
310
291
Cost of goods sold
-3 117
-2 874
Gross profit from continuing operations
8 975
7 909
Selling, general and administration
-3 091
-2 936
Research and development
-3 925
-2 542
Other income
224
87
Other expense
-421
-692
Operating income from continuing operations
1 762
1 826
Loss from associated companies
-3
-5
Interest expense
-222
-206
Other financial income and expense
15
-28
Income before taxes from continuing operations
1 552
1 587
Income taxes
-39
-257
Net income from continuing operations
1 513
1 330
Net income from discontinued operations
12
250
245
Net income
1 763
1 575
Attributable to:
   Shareholders of Novartis AG
1 761
1 573
   Non-controlling interests
2
2
Weighted average number of shares outstanding – Basic (million)
2 062
2 167
Basic earnings per share from continuing operations (USD) 1
0.73
0.61
Basic earnings per share from discontinued operations (USD) 1
0.12
0.12
Total basic earnings per share (USD) 1
0.85
0.73
Weighted average number of shares outstanding – Diluted (million)
2 075
2 180
Diluted earnings per share from continuing operations (USD) 1
0.73
0.61
Diluted earnings per share from discontinued operations (USD) 1
0.12
0.11
Total diluted earnings per share (USD) 1
0.85
0.72
 1  Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
19

Consolidated income statements
Nine months to September 30 (unaudited)
(USD millions unless indicated otherwise)
Note
9M 2023
9M 2022
Net sales from continuing operations
10
34 017
31 630
Other revenues
10
867
865
Cost of goods sold
-9 450
-8 541
Gross profit from continuing operations
25 434
23 954
Selling, general and administration
-9 073
-9 010
Research and development
-8 804
-6 956
Other income
1 322
541
Other expense
-1 692
-2 338
Operating income from continuing operations
7 187
6 191
Loss from associated companies
-7
-8
Interest expense
-638
-593
Other financial income and expense
204
18
Income before taxes from continuing operations
6 746
5 608
Income taxes
-812
-874
Net income from continuing operations
5 934
4 734
Net income from discontinued operations
12
440
755
Net income
6 374
5 489
Attributable to:
   Shareholders of Novartis AG
6 370
5 489
   Non-controlling interests
4
0
Weighted average number of shares outstanding – Basic (million)
2 085
2 196
Basic earnings per share from continuing operations (USD) 1
2.84
2.16
Basic earnings per share from discontinued operations (USD) 1
0.21
0.34
Total basic earnings per share (USD) 1
3.05
2.50
Weighted average number of shares outstanding – Diluted (million)
2 098
2 210
Diluted earnings per share from continuing operations (USD) 1
2.83
2.14
Diluted earnings per share from discontinued operations (USD) 1
0.21
0.34
Total diluted earnings per share (USD) 1
3.04
2.48
 1  Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.  
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
20

Consolidated statements of comprehensive income
Third quarter (unaudited)
(USD millions)
Q3 2023
Q3 2022
Net income
1 763
1 575
Other comprehensive income
Items that are or may be recycled into the consolidated income statement from continuing operations
   Net investment hedge, net of taxes
38
36
   Currency translation effects, net of taxes
-389
-631
Total of items that are or may be recycled
-351
-595
Items that will never be recycled into the consolidated income statement from continuing operations
   Actuarial gains/(losses) from defined benefit plans, net of taxes
104
-530
   Fair value adjustments on equity securities, net of taxes
27
40
Total of items that will never be recycled
131
-490
   Other comprehensive income from continuing operations
-220
-1 085
   Other comprehensive income from discontinued operations
-66
-129
Total comprehensive income
1 477
361
Total comprehensive income for the year attributable to:
   Shareholders of Novartis AG
1 476
363
   Non-controlling interests
1
-2
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
Nine months to September 30 (unaudited)
(USD millions)
9M 2023
9M 2022
Net income
6 374
5 489
Other comprehensive income
Items that are or may be recycled into the consolidated income statement from continuing operations
   Net investment hedge, net of taxes
32
84
   Currency translation effects, net of taxes
63
-1 735
Total of items that are or may be recycled
95
-1 651
Items that will never be recycled into the consolidated income statement from continuing operations
   Actuarial gains from defined benefit plans, net of taxes
47
1 741
   Fair value adjustments on equity securities, net of taxes
-19
-281
Total of items that will never be recycled
28
1 460
   Other comprehensive income from continuing operations
123
-191
   Other comprehensive income from discontinued operations
-21
-170
Total comprehensive income
6 476
5 128
Total comprehensive income for the year attributable to:
   Shareholders of Novartis AG
6 472
5 136
   Non-controlling interests
4
-8
    
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
21

Consolidated balance sheets

(USD millions)


Note
Sep 30,
2023
(unaudited)
Dec 31,
2022
(audited)
Assets
Non-current assets
Property, plant and equipment
9 044
10 764
Right-of-use assets
1 300
1 431
Goodwill
23 416
29 301
Intangible assets other than goodwill
26 418
31 644
Investments in associated companies
202
143
Deferred tax assets
3 628
3 739
Financial assets
1 920
2 411
Other non-current assets
1 109
1 110
Total non-current assets
67 037
80 543
Current assets
Inventories
5 610
7 175
Trade receivables
6 819
8 066
Income tax receivables
280
268
Marketable securities, commodities, time deposits and derivative financial instruments
290
11 413
Cash and cash equivalents
12 405
7 517
Other current assets
2 782
2 471
Total current assets related to
continuing operations


28 186

36 910
Assets related to discontinued operations
12
17 474
Total current assets
45 660
36 910
Total assets
112 697
117 453
Equity and liabilities
Equity
Share capital
825
890
Treasury shares
-32
-92
Reserves
37 371
58 544
Equity attributable to Novartis AG shareholders
38 164
59 342
Non-controlling interests
81
81
Total equity
38 245
59 423
Liabilities
Non-current liabilities
Financial debts
18 068
20 244
Lease liabilities
1 453
1 538
Deferred tax liabilities
2 457
2 686
Provisions and other non-current liabilities
4 081
4 906
Total non-current liabilities
26 059
29 374
Current liabilities
Dividend in kind distribution liability
3
13 962
Trade payables
3 870
5 146
Financial debts and derivative financial instruments
5 458
5 931
Lease liabilities
210
251
Current income tax liabilities
2 129
2 533
Provisions and other current liabilities
13 974
14 795
Total current liabilities
related to continuing operations


39 603

28 656
Liabilities related to discontinued operations
12
8 790
Total current liabilities
48 393
28 656
Total liabilities
74 452
58 030
Total equity and liabilities
112 697
117 453
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
22

Consolidated statements of changes in equity
Third quarter (unaudited)
Reserves

(USD millions)





Note




Share
capital




Treasury
shares




Retained
earnings




Total value
adjustments
Issued share
capital and
reserves
attributable
to Novartis
shareholders



Non-
controlling
interests




Total
equity
Total equity at July 1, 2023
842
-52
55 682
-4 625
51 847
84
51 931
Net income
1 761
1 761
2
1 763
Other comprehensive income
-285
-285
-1
-286
Total comprehensive income
1 761
-285
1 476
1
1 477
Dividend in kind
3
-13 962
-13 962
-13 962
Purchase of treasury shares
-6
-1 390
-1 396
-1 396
Reduction of share capital
4.1
-17
26
-9
Exercise of options and employee transactions
4.2
-2
-2
-2
Equity-based compensation
0
221
221
221
Taxes on treasury share transactions
3
3
3
Transaction costs, net of taxes
4.4
-74
-74
-74
Changes in non-controlling interests
-4
-4
Fair value adjustments on financial assets sold
52
-52
Other movements
4.5
51
51
51
Total of other equity movements
-17
20
-15 110
-52
-15 159
-4
-15 163
Total equity at September 30, 2023
825
-32
42 333
-4 962
38 164
81
38 245
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
Reserves

(USD millions)





Note




Share
capital




Treasury
shares




Retained
earnings




Total value
adjustments
Issued share
capital and
reserves
attributable
to Novartis
shareholders



Non-
controlling
interests




Total
equity
Total equity at July 1, 2022
890
-60
65 432
-3 337
62 925
81
63 006
Net income
1 573
1 573
2
1 575
Other comprehensive income
-1 210
-1 210
-4
-1 214
Total comprehensive income
1 573
-1 210
363
-2
361
Purchase of treasury shares
-11
-2 702
-2 713
-2 713
Exercise of options and employee transactions
4.2
-2
-2
-2
Equity-based compensation
1
213
214
214
Taxes on treasury share transactions
1
1
1
Changes in non-controlling interests
-1
-1
Fair value adjustments on financial assets sold
-4
4
Other movements
4.5
32
32
32
Total of other equity movements
-10
-2 462
4
-2 468
-1
-2 469
Total equity at September 30, 2022
890
-70
64 543
-4 543
60 820
78
60 898
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
23

Consolidated statements of changes in equity
Nine months to September 30 (unaudited)
Reserves

(USD millions)





Note




Share
capital




Treasury
shares




Retained
earnings




Total value
adjustments
Issued share
capital and
reserves
attributable
to Novartis
shareholders



Non-
controlling
interests




Total
equity
Total equity at January 1, 2023
890
-92
63 540
-4 996
59 342
81
59 423
Net income
6 370
6 370
4
6 374
Other comprehensive income
102
102
0
102
Total comprehensive income
6 370
102
6 472
4
6 476
Dividends
-7 255
-7 255
-7 255
Dividend in kind
3
-13 962
-13 962
-13 962
Purchase of treasury shares
-41
-7 243
-7 284
-7 284
Reduction of share capital
4.1
-65
94
-29
Exercise of options and employee transactions
4.2
2
149
151
151
Equity-based compensation
5
649
654
654
Taxes on treasury share transactions
11
11
11
Transaction costs, net of taxes
4.4
-74
-74
-74
Changes in non-controlling interests
-4
-4
Value adjustments on financial assets sold
68
-68
Other movements
4.5
109
109
109
Total of other equity movements
-65
60
-27 577
-68
-27 650
-4
-27 654
Total equity at September 30, 2023
825
-32
42 333
-4 962
38 164
81
38 245
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
Reserves

(USD millions)





Note




Share
capital




Treasury
shares




Retained
earnings




Total value
adjustments
Issued share
capital and
reserves
attributable
to Novartis
shareholders



Non-
controlling
interests




Total
equity
Total equity at January 1, 2022
901
-48
70 989
-4 187
67 655
167
67 822
Net income
5 489
5 489
0
5 489
Other comprehensive income
-353
-353
-8
-361
Total comprehensive income
5 489
-353
5 136
-8
5 128
Dividends
-7 506
-7 506
-7 506
Purchase of treasury shares
-44
-8 159
-8 203
-8 203
Reduction of share capital
4.1
-11
15
-4
Exercise of options and employee transactions
4.2
1
88
89
89
Equity-based compensation
6
645
651
651
Shares delivered to Alcon employees
as a result of the Alcon spin-off



0

5


5


5
Taxes on treasury share transactions
12
12
12
Decrease of treasury share repurchase obligation
under a share buyback trading plan

4.3



2 809


2 809


2 809
Changes in non-controlling interests
-81
-81
Fair value adjustments on financial assets sold
3
-3
Other movements
4.5
172
172
172
Total of other equity movements
-11
-22
-11 935
-3
-11 971
-81
-12 052
Total equity at September 30, 2022
890
-70
64 543
-4 543
60 820
78
60 898
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
24

Consolidated statements of cash flows
Third quarter (unaudited)
(USD millions)
Note
Q3 2023
Q3 2022
Net income from continuing operations
1 513
1 330
Adjustments to reconcile net income to net cash flows from operating activities from continuing operations
Reversal of non-cash items and other adjustments from continuing operations
6.1
3 329
2 920
Dividends received from associated companies and others
1
Interest received
109
82
Interest paid
-178
-159
Change in other financial receipts
37
89
Change in other financial payments
-4
19
Income taxes paid
6.2
-426
-260
Net cash flows from operating activities from continuing operations
before working capital and provision changes


4 381

4 021
Payments out of provisions and other net cash movements in non-current liabilities
-255
-193
Change in net current assets and other operating cash flow items
6.3
1 178
447
Net cash flows from operating activities from continuing operations
5 304
4 275
Net cash flows from operating activities from discontinued operations
74
446
Total net cash flows from operating activities
5 378
4 721
Purchases of property, plant and equipment
-261
-221
Proceeds from sale of property, plant and equipment
51
20
Purchases of intangible assets
-422
-251
Proceeds from sale of intangible assets
1 823
3
Purchases of financial assets
-11
-15
Proceeds from sale of financial assets
91
26
Purchases of other non-current assets
-1
Acquisitions and divestments of interests in associated companies, net
-3
-2
Acquisitions and divestments of businesses, net
6.4
-3 443
8
Purchases of marketable securities, commodities and time deposits
-28
-6 693
Proceeds from sale of marketable securities, commodities and time deposits
199
12 435
Net cash flows (used in)/from investing activities from continuing operations
-2 004
5 309
Net cash flows used in investing activities from discontinued operations
-208
-111
Total net cash flows (used in)/from investing activities
-2 212
5 198
Purchases of treasury shares
-1 625
-2 718
Proceeds from exercised options and other treasury share transactions, net
-1
Repayments of the current portion of non-current financial debts
-2 223
-1 500
Change in current financial debts
-418
-499
Payments of lease liabilities
-63
-64
Other financing cash flows, net
24
32
Net cash flows used in financing activities from continuing operations
-4 306
-4 749
Net cash flows from financing activities from discontinued operations
12
3 474
11
Total net cash flows used in financing activities
-832
-4 738
Net change in cash and cash equivalents before effect of exchange rate changes
2 334
5 181
Less cash and cash equivalents from discontinued operations at September 30, 2023
12
-648
Effect of exchange rate changes on cash and cash equivalents
-166
-80
Net change in cash and cash equivalents
1 520
5 101
Cash and cash equivalents at July 1
10 885
3 625
Cash and cash equivalents at September 30
12 405
8 726
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
25

Consolidated statements of cash flows
Nine months to September 30 (unaudited)
(USD millions)
Note
9M 2023
9M 2022
Net income from continuing operations
5 934
4 734
Adjustments to reconcile net income to net cash flows from operating activities from continuing operations
Reversal of non-cash items and other adjustments from continuing operations
6.1
8 578
7 875
Dividends received from associated companies and others
2
1
Interest received
482
119
Interest paid
-513
-455
Other financial receipts
64
89
Other financial payments
-14
-21
Income taxes paid
6.2
-1 694
-1 368
Net cash flows from operating activities from continuing operations
before working capital and provision changes


12 839

10 974
Payments out of provisions and other net cash movements in non-current liabilities
-1 181
-451
Change in net current assets and other operating cash flow items
6.3
15
-1 252
Net cash flows from operating activities from continuing operations
11 673
9 271
Net cash flows from operating activities from discontinued operations
238
854
Total net cash flows from operating activities
11 911
10 125
Purchases of property, plant and equipment
-654
-610
Proceeds from sale of property, plant and equipment
73
56
Purchases of intangible assets
-1 316
-1 131
Proceeds from sale of intangible assets
1 953
170
Purchases of financial assets
-77
-86
Proceeds from sale of financial assets
201
121
Purchases of other non-current assets
-1
Acquisitions and divestments of interests in associated companies, net
-8
-22
Acquisitions and divestments of businesses, net
6.4
-3 550
-833
Purchases of marketable securities, commodities and time deposits
-97
-24 147
Proceeds from sale of marketable securities, commodities and time deposits
11 216
29 706
Net cash flows from investing activities from continuing operations
7 741
3 223
Net cash flows used in investing activities from discontinued operations
-385
-288
Total net cash flows from investing activities
7 356
2 935
Dividends paid to shareholders of Novartis AG
-7 255
-7 506
Purchases of treasury shares
-7 468
-7 974
Proceeds from exercised options and other treasury share transactions, net
158
100
Repayments of the current portion of non-current financial debts
-2 223
-2 575
Change in current financial debts
-128
1 448
Payments of lease liabilities
-194
-198
Other financing cash flows, net
42
123
Net cash flows used in financing activities from continuing operations
-17 068
-16 582
Net cash flows from financing activities from discontinued operations
12
3 397
14
Total net cash flows used in financing activities
-13 671
-16 568
Net change in cash and cash equivalents before effect of exchange rate changes
5 596
-3 508
Less cash and cash equivalents from discontinued operations at September 30, 2023
12
-648
Effect of exchange rate changes on cash and cash equivalents
-60
-173
Net change in cash and cash equivalents
4 888
-3 681
Cash and cash equivalents at January 1
7 517
12 407
Cash and cash equivalents at September 30
12 405
8 726
The accompanying Notes form an integral part of the condensed interim consolidated financial statements
26

 

Notes to the Condensed Interim Consolidated Financial Statements for the three month and nine month period ended September 30, 2023 (unaudited)

1. Basis of preparation
These Condensed Interim Consolidated Financial Statements for the three month and nine month interim period ended September 30, 2023, were prepared in accordance with International Accounting Standard 34 Interim Financial Reporting and accounting policies set out in the 2022 Annual Report published on February 1, 2023.
Following the shareholder approval for the spin-off of our Sandoz business at the Novartis AG 2023 Extraordinary General Meeting held on September 15, 2023, International Financial Reporting Standards (IFRS) require the Sandoz Division and selected portions of corporate activities attributable to Sandoz’s business, as well as certain expenses related to the spin-off (the “Sandoz business”) to be reported as discontinued operations in the consolidated financial statements. As a result, the Sandoz business has been presented as discontinued operations in the consolidated financial statements. This requires the three months and nine months September 30, 2023 consolidated income statement, consolidated statement of comprehensive income and consolidated statement of cash flows to present separately continuing operations from discontinued operations, with comparative amounts in the prior years restated on a consistent basis. On the September 30, 2023, consolidated balance sheet, the Sandoz business discontinued operations assets and liabilities are presented in a single line within current assets (“Assets related to discontinued operations”) and within current liabilities (“Liabilities related to discontinued operations”), respectively, with no restatement of December 31, 2022, consolidated balance sheet required. Refer to Note 2, Note 3, and Note 12 for further information and disclosures.
2. Selected critical accounting policies
The Company’s principal accounting policies are set out in Note 1 to the Consolidated Financial Statements in the 2022 Annual Report and conform with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board.
The preparation of interim financial statements requires management to make certain estimates and assumptions, either at the balance sheet date or during the period, which affect the reported amounts of revenues, expenses, assets, liabilities and contingent amounts.
Estimates are based on historical experience and other assumptions that are considered reasonable under the given circumstances and are regularly monitored. Actual outcomes and results could differ from those estimates and assumptions. Revisions to estimates are recognized in the period in which the estimate is revised.
As disclosed in the 2022 Annual Report, goodwill, and acquired In-Process Research & Development projects are reviewed for impairment at least annually and these, as well as all other investments in intangible assets, are reviewed for impairment whenever an event or decision occurs that raises concern about their balance sheet carrying value. The amount of goodwill and other intangible assets on the Company’s consolidated balance sheet has risen significantly in recent years, primarily from acquisitions. Impairment testing may lead to potentially significant impairment charges in the future that could have a materially adverse impact on the Company’s results of operations and financial condition.
The Novartis AG shareholders’ approval of a special distribution by way of a dividend in kind to effect the spin-off of Sandoz Group AG (the Sandoz business), at the 2023 EGM held on September 15, 2023, required the recognition of a distribution liability at the fair value of the Sandoz business to be distributed to Novartis AG shareholders.
This required the use of valuation techniques for purposes of impairment testing of the Sandoz business net assets to be distributed and for the measurement of the fair value of the distribution liability. These valuations required the use of management assumptions and estimates related to estimating the Sandoz business fair value. These fair value measurements are classified as “Level 3” in the fair value hierarchy. The section “—Impairment of goodwill and intangible assets” in Note 1 to the Consolidated Financial Statements in the Annual Report 2022 provide additional information on key assumptions that are highly sensitive in the estimation of fair values using valuation techniques. Due to these factors and inherent uncertainties in the use of estimates, actual outcomes and results could vary significantly. The section below “Distribution of Sandoz Group AG to Novartis AG shareholders” in this Note 2 and Note 3 provides further information and disclosures.
27

The Company’s activities are not subject to significant seasonal fluctuations.
Non-current assets held for sale or held for distribution to owners
Non-current assets are classified as assets held for sale or related to discontinued operations when their carrying amount is to be recovered principally through a sale transaction or distribution to owners and a sale or distribution to owners is considered highly probable. They are stated at the lower of carrying amount and fair value less costs to sell with any resulting impairment recognized. Assets related to discontinued operations and assets of disposal group held for sale are not depreciated or amortized. The prior-year consolidated balance sheet is not restated.
Distribution of Sandoz Group AG to Novartis AG shareholders
At the 2023 Extraordinary General Meeting (EGM) of Novartis AG shareholders, held on September 15, 2023, the Novartis AG shareholders approved a special distribution by way of a dividend in kind to effect the spin-off of Sandoz Group AG.
The September 15, 2023 shareholder approval for the spin-off required the Sandoz Division and selected portions of corporate activities attributable to Sandoz’s business (the “Sandoz business”) to be reported as discontinued operations.
The shareholder approval to spin off the Sandoz business also required the recognition of a distribution liability at the fair value of the Sandoz business. Novartis policy is to measure the distribution liability at the fair value of the Sandoz business net assets taken as a whole. The distribution liability was recognized through a reduction in retained earnings. It is required to be adjusted at each balance sheet date for changes in its estimated fair value, up to the date of the distribution to shareholders through retained earnings. Any resulting impairment of the business assets to be distributed would have been recognized in the consolidated income statements in “Other expense” of discontinued operations, at the date of initial recognition of the distribution liability or at subsequent dates resulting from changes of the distribution liability valuation.
At the October 4, 2023, distribution settlement date, the resulting gain, which is measured as the excess amount of the distribution liability over the then-carrying value of the net assets of the business distributed, will be recognized in the fourth quarter 2023 on the line “Gain on distribution of Sandoz Group AG to Novartis AG shareholders” within the income statement of discontinued operations.
The recognition of the distribution liability required the use of valuation techniques for purposes of impairment testing of the Sandoz business’ assets to be distributed and for the measurement of the fair value of the distribution liability. These valuations required the use of management assumptions and estimates related to the Sandoz business’ future cash flows, market multiples, opening share price of Sandoz Group AG on the first day of trading its shares on the SIX Swiss Exchange, to estimate day one market value, and control premiums to apply in estimating the Sandoz business fair value. These fair value measurements are classified as “Level 3” in the fair value hierarchy. The section “—Impairment of goodwill and intangible assets” in Note 1 to the Consolidated Financial Statements in the Annual Report 2022 provide additional information on key assumptions that are highly sensitive in the estimation of fair values using valuation techniques.
Transaction costs that are directly attributable to the distribution (spin-off) of Sandoz business to the Novartis AG shareholders by way of a dividend in kind, and that would otherwise have been avoided, are accounted for as a deduction from equity (within retained earnings) at the date of distribution (spin-off). Prior to the recognition of the distribution liability, these costs were recorded as prepaid expenses in the consolidated balance sheet.
For additional disclosures, refer to Note 3 and Note 12.
28

3. Significant transactions
The Company applied the acquisition method of accounting for businesses acquired, and did not elect to apply the optional concentration test to account for acquired business as an asset separately acquired.
Significant transaction closed in October 2023
Spin-off of the Sandoz business through a dividend in kind distribution to Novartis AG shareholders
On July 18, 2023, Novartis announced its Board of Directors had unanimously endorsed the proposed separation of the Sandoz business to create an independent company by way of a spin-off and to seek shareholder approval for the spin-off of the Sandoz business into a separately traded standalone company, following the complete structural separation of the Sandoz business into a standalone company (the Sandoz business or Sandoz Group AG) and subject to satisfaction of certain conditions and Novartis AG shareholders’ approval.
At the 2023 EGM held on September 15, 2023, the Novartis AG shareholders approved a special distribution by way of a dividend in kind to effect the spin-off of Sandoz Group AG, subject to completion of certain conditions precedent to the distribution. Upon shareholder approval, the Sandoz business was reported as discontinued operations and the distribution liability was recognized at its fair value, which exceeded the carrying value of the Sandoz business net assets.
The conditions precedent to the spin-off were met and on October 3, 2023 the spin-off of the Sandoz business was effected by way of a distribution of a dividend in kind of Sandoz Group AG shares to Novartis AG shareholders and ADR (American Depositary Receipt) holders (the Distribution). Through the Distribution, each Novartis AG shareholder received 1 Sandoz Group AG share for every 5 Novartis AG shares / ADRs they held on October 3, 2023, close of business. As of October 4, 2023, the shares of Sandoz Group AG are listed on the SIX Swiss Exchange (SIX) under the symbol “SDZ”.
On September 18, 2023, the Sandoz business entered into financing arrangements with a group of banks under which it borrowed on September 28, 2023 a total amount of USD 3.3 billion. These borrowings consisted of a bridge in EUR (EUR 2.4 billion) and term loans in EUR (EUR 0.2 billion) and USD (USD 0.5 billion). In addition, approximately USD 0.4 billion of borrowings under a number of local bilateral facilities in different countries were raised. This resulted in a total gross debt of USD 3.7 billion. These outstanding borrowings of the Sandoz business legal entities was recognized in the September 30, 2023 consolidated balance sheet within Liabilities related to discontinued operations and within financing activities cash flows from discontinued operations. Prior to the Distribution on October 3, 2023, through a series of intercompany transactions, Sandoz business legal entities paid approximately USD 3.3 billion in cash to Novartis and its affiliates.
At September 30, 2023, the dividend in kind distribution liability to effect the Distribution (spin-off) of the Sandoz business amounted to USD 14.0 billion and was recorded as a reduction to equity (retained earnings). It remained unchanged from its initial recognition and was in excess of the then carrying value of the Sandoz business net assets, which amounted to USD 8.7 billion (see Note 12). At the Distribution on October 3, 2023, the distribution liability was unchanged from September 30, 2023, and was in excess of the Sandoz business net assets.
Certain consolidated foundations own Novartis AG dividend-bearing shares that restrict their availability for use by Novartis. These Novartis AG shares are accounted for as treasury shares. Through the Distribution, these foundations received Sandoz Group AG shares representing an approximate 4.31% equity interest in Sandoz Group AG. Upon the loss of control of Sandoz Group AG through the Distribution on October 3, 2023, the financial investment in Sandoz Group AG will be recognized at its initial fair value based on the opening traded share price of Sandoz Group AG on October 4, 2023 (a Level 1 hierarchy valuation). At initial recognition, on October 4, 2023, the Sandoz Group AG financial investment’s fair value of USD 0.5 billion and will be reported in the fourth quarter 2023 on the consolidated balance sheet as a financial asset. Management has designated this investment at fair value through other comprehensive income.
At September 30, 2023 there was USD 0.3 billion cumulative income included in other comprehensive income relating to discontinued operations.
In the fourth quarter 2023, the Company will recognize a non-taxable, noncash gain as at the Distribution date of the spin-off of the Sandoz business amounting to approximately USD 5.9 billion, comprising the excess amount of the distribution liability over the then carrying value of Sandoz business net assets, the gain on recognition of Sandoz Group AG shares obtained through the consolidated foundation and Distribution related transaction costs.
For additional disclosures on discontinued operations, refer to Note 12.
Significant transactions closed in third quarter 2023
Acquisition of DTx Pharma Inc.
In the second quarter of 2023, Novartis entered into an agreement to acquire DTx Pharma Inc. (DTx), a San-Diego US based, pre-clinical stage biotechnology company focused on leveraging its proprietary FALCON platform to develop siRNA therapies for neuroscience indications. DTx’s lead program, DTx-1252 targets the root cause of CMT1A—the overexpression of PMP22, a protein that causes the myelin sheath that supports and insulates nerves in the peripheral nervous system to function abnormally. The transaction also includes two additional pre-clinical programs for other neuroscience indications. The transaction closed on July 14, 2023.
The purchase price consists of a cash payment of USD 0.6 billion and potential additional milestones up to USD 0.5 billion, which the DTx Pharma Inc. shareholders
29

are eligible to receive upon achievement of specified milestones.
The fair value of the total purchase consideration was USD 0.6 billion. The amount consisted of a cash payment of USD 0.6 billion, the fair value of contingent consideration of USD 29 million, which DTx shareholders are eligible to receive upon achievement of specified milestones. The preliminary purchase price allocation resulted in net identifiable assets of USD 0.4 billion, consisting primarily of intangible assets of USD 0.3 billion and cash of USD 0.1 billion. Goodwill amounted to USD 0.2 billion.
The results of operations since the date of acquisition are not material.
Acquisition of Chinook Therapeutics, Inc.
On June 12, 2023, Novartis entered into an agreement to acquire Chinook Therapeutics, Inc. (Chinook Therapeutics), a Seattle, WA, based clinical stage biopharmaceutical company with two late-stage medicines in development for rare, severe chronic kidney diseases. The acquisition closed on August 11, 2023.
The purchase price consists of a cash payment of USD 3.2 billion and potential additional payments of up to USD 0.3 billion, which Chinook Therapeutics shareholders are eligible to receive upon achievement of specified milestones.
The fair value of the total purchase consideration was USD 3.3 billion. The amount consisted of an upfront cash payment of USD 3.2 billion and the fair value of contingent consideration of USD 0.1 billion, which Chinook Therapeutics shareholders are eligible to receive upon achievement of specified milestones. The preliminary purchase price allocation resulted in net identifiable assets of USD 2.0 billion, consisting of intangible assets of USD 2.1 billion, net deferred tax liabilities of USD 0.4 billion and other net assets of USD 0.3 billion, including cash of USD 0.1 billion. Goodwill amounted to USD 1.3 billion.
The results of operations since the date of acquisition are not material.
Significant transactions in 2022
Acquisition of Gyroscope Therapeutics Holdings plc
On December 22, 2021, Novartis entered into an agreement to acquire all outstanding shares of Gyroscope Therapeutics Holdings plc (Gyroscope), a UK-based ocular gene therapy company. Gyroscope focuses on the discovery and development of gene therapy treatments for retinal indications. The purchase price consisted of a cash payment of USD 0.8 billion, subject to certain customary purchase price adjustments, and potential additional milestone payments of up to USD 0.7 billion, which Gyroscope shareholders are eligible to receive upon achievement of specified milestones. The acquisition closed on February 17, 2022.
The fair value of the total purchase consideration was USD 1.0 billion. The amount consisted of an upfront cash payment of USD 0.8 billion (including customary purchase price adjustments) and the fair value of contingent consideration of USD 0.2 billion, which Gyroscope shareholders are eligible to receive upon achievement of specified milestones. The purchase price allocation resulted in net identifiable assets of USD 0.9 billion, consisting primarily of intangible assets of USD 1.1 billion and net deferred tax liabilities of USD 0.2 billion. Goodwill amounted to USD 0.1 billion.
The 2022 results of operations since the date of acquisition were not material.
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4. Summary of equity attributable to Novartis AG shareholders
Number of outstanding shares (in millions)
Issued share capital and reserves attributable to Novartis AG shareholders (in USD millions)
Note
2023
2022
9M 2023
9M 2022
Balance at beginning of year
2 119.6
2 234.9
59 342
67 655
Shares acquired to be canceled
-74.9
-94.2
-7 150
-8 085
Other share purchases
-1.4
-1.3
-134
-118
Exercise of options and employee transactions
4.2
2.8
1.9
151
89
Equity-based compensation
9.4
9.7
654
651
Shares delivered to Alcon employees as a result of the Alcon spin-off
0.0
5
Taxes on treasury share transactions
11
12
Decrease of treasury share repurchase obligation
under a share buyback trading plan

4.3




2 809
Transaction costs, net of taxes
4.4
-74
Dividends
-7 255
-7 506
Dividend in kind
3
-13 962
Net income of the period attributable to shareholders of Novartis AG
6 370
5 489
Other comprehensive income attributable to shareholders of Novartis AG
102
-353
Other movements
4.5
109
172
Balance at September 30
2 055.5
2 151.0
38 164
60 820
4.1. In 2023 Novartis AG reduced its share capital by canceling the 126 million of shares that were repurchased on the SIX Swiss Exchange second trading line during the previous year.
In addition, in connection with the Distribution (spin-off) of Sandoz business, Novartis AG shareholders approved at the 2023 EGM held on September 15, 2023, a decrease in Novartis AG share capital in the amount of CHF 22.8 million (USD 17.1 million). The capital decrease resulted in a reduction of the nominal value of the Novartis AG shares by CHF 0.01 from CHF 0.50 per share to CHF 0.49 per share.
In 2022 Novartis AG reduced its share capital by canceling 30.7 million of shares that were repurchased on the SIX Swiss Exchange second trading line during the previous year.
4.2. At December 31, 2022, the market maker held 3 million written call options, originally issued as part of the share-based compensation for employees, that had not yet been exercised. The weighted average exercise price of these options at December 31, 2022, was USD 66.07, and they had contractual lives of 10 years, with remaining lives less than one year. In the first quarter of 2023, the market maker exercised 3 million written call options and as a result there are no written call option outstanding at September 30, 2023.
4.3. In December 2021, Novartis entered into an irrevocable, non-discretionary arrangement with a bank to repurchase Novartis shares on the second trading line under its up-to USD 15.0 billion share buyback. The arrangement was updated in July 2022, December 2022, and May 2023, and concluded in June 2023.
In June 2023, Novartis entered into an irrevocable, non-discretionary arrangement with a bank to repurchase 11.7 million Novartis shares on the second trading line, which concluded in July 2023.
In July 2023, Novartis entered into a new irrevocable, non-discretionary arrangement with a bank to repurchase Novartis shares on the second trading line under its new up-to USD 15.0 billion share buyback. Novartis is able to cancel this arrangement but may be subject to a 90-day waiting period under certain conditions. As of September 30, 2023, these waiting period conditions were not applicable and as a result, there was no requirement to record a liability under this arrangement as of September 30, 2023.
4.4. Transaction costs in first nine months 2023 of USD 91 million, net of tax of USD 17 million, that are directly attributable to the Distribution (spin-off) of Sandoz business to Novartis AG shareholders and that would otherwise have been avoided, are recorded as a deduction from equity (retained earning). See Note 2.
4.5. Other movements include, for subsidiaries in hyperinflationary economies, the impact of the restatement of the equity balances of the current period as well as restatement of the non-monetary assets and liabilities with the general price index at the beginning of the period.
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5. Financial instruments
Fair value by hierarchy
The following table illustrates the three hierarchical levels for valuing financial instruments at fair value as of September 30, 2023, and December 31, 2022. For additional information on the hierarchies and other matters, please refer to the Consolidated Financial Statements in the 2022 Annual Report, published on February 1, 2023.
 
Level 1
Level 2
Level 3
Total

(USD millions)
Sep 30,
2023
Dec 31,
2022
Sep 30,
2023
Dec 31,
2022
Sep 30,
2023
Dec 31,
2022
Sep 30,
2023
Dec 31,
2022
Financial assets
Cash and cash equivalents
Debt securities
60
60
Total cash and cash equivalents at fair value
60
60
Marketable securities
Debt securities
8
9
8
9
Derivative financial instruments
117
204
117
204
Total marketable securities and derivative financial instruments at fair value
125
213
125
213
Current contingent consideration receivables
60
43
60
43
Current financial investments - equity securities
182
56
238
Long-term financial investments
Debt and equity securities
220
473
10
10
551
699
781
1 182
Fund investments
7
20
198
261
205
281
Non-current contingent consideration receivables
592
607
592
607
Total long-term financial investments at fair value
227
493
10
10
1 341
1 567
1 578
2 070
Associated companies at fair value through profit or loss
111
129
111
129
Financial liabilities
Current contingent consideration liabilities
-32
-131
-32
-131
Current other financial liabilities
-142
-142
Derivative financial instruments
-66
-55
-66
-55
Dividend in kind distribution liability 1
-13 962
-13 962
Total current financial liabilities at fair value
-66
-55
-14 136
-131
-14 202
-186
Non-current contingent consideration liabilities
-432
-704
-432
-704
Non-current other financial liabilities
-23
-232
-23
-232
Total non-current financial liabilities at fair value
-455
-936
-455
-936
 1  See Note 3 for further disclosures
In the first nine months of 2023, there were three transfers of equity securities from Level 3 to Level 1 for USD 63 million mainly due to Initial Public Offering.
The fair value of straight bonds amounted to USD 17.9 billion at September 30, 2023 (USD 20.3 billion at December 31, 2022) compared with the carrying amount of USD 20.2 billion at September 30, 2023 (USD 22.3 billion at December 31, 2022). For all other financial assets and liabilities, the carrying amount is a reasonable approximation of the fair value.
The carrying amount of financial assets included in the line total long-term financial investments of USD 1.6 billion at September 30, 2023 (USD 2.1 billion at December 31, 2022) is included in the line “Financial assets” of the consolidated balance sheets. The carrying amount of financial assets included in the line current financial investments - equity securities of USD 238 million at September 30, 2023 (nil at December 31, 2022) is included in the line “Other current assets” of the consolidated balance sheets. The carrying amount of non-current contingent consideration liabilities and non-current other financial liabilities included in the line total non-current financial liabilities at fair value of USD 0.5 billion at September 30, 2023 (USD 0.9 billion at December 31, 2022) is included in the line “Provisions and other non-current liabilities” of the consolidated balance sheet.
The Company’s exposure to financial risks has not changed significantly during the period and there have been no major changes to the risk management department or in any risk management policies.
32

6. Details to the consolidated statements of cash flows
6.1. Non-cash items and other adjustments from continuing operations
The following table shows the reversal of non-cash items and other adjustments in the consolidated statements of cash flows.
(USD millions)
Q3 2023
Q3 2022
Depreciation, amortization and impairments on:
   Property, plant and equipment
295
307
   Right-of-use assets
64
64
   Intangible assets
2 752
1 544
   Financial assets 1
-6
90
Change in provisions and other non-current liabilities
-130
228
Gains on disposal and other adjustments on property, plant and equipment; intangible assets;
financial assets; and other non-current assets, net

-65

-15
Equity-settled compensation expense
205
208
Loss from associated companies
3
5
Income taxes
39
257
Net financial expense
207
234
Other
-35
-2
Total
3 329
2 920
 1  Includes fair value changes
(USD millions)
9M 2023
9M 2022
Depreciation, amortization and impairments on:
   Property, plant and equipment
760
1 025
   Right-of-use assets
197
200
   Intangible assets
5 732
3 658
   Financial assets 1
69
288
Change in provisions and other non-current liabilities
232
835
Gains on disposal and other adjustments on property, plant and equipment; intangible assets;
financial assets; and other non-current assets, net

-281

-181
Equity-settled compensation expense
617
602
Loss from associated companies
7
8
Income taxes
812
874
Net financial expense
434
575
Other
-1
-9
Total
8 578
7 875
 1  Includes fair value changes
In the third quarter of 2023, other than through business combinations, there were no additions to intangible assets (Q3 2022: USD 325 million) with deferred payments.
In the third quarter of 2023, there were USD 46 million (Q3 2022: USD 59 million) additions to right-of-use assets recognized.
In the nine-month period of 2023, other than through business combinations, there were no additions to intangible assets with deferred payments.
In the nine-month period of 2022, other than through business combinations, there were USD 644 million additions to intangible assets with deferred payments.
In the nine-month period of 2023, there were USD 238 million (9M 2022: USD 166 million) additions to right-of-use assets recognized.
6.2. Total amount of income taxes paid
In the first nine month period of 2023, the amount of income taxes paid by continuing operations was USD 1 694 million (Q3 2023: USD 426 million) and by discontinued operations was USD 162 million (Q3 2023: USD 52 million), which was included within “Net cash flows from operating activities from discontinued operations.” In the first nine month period of 2023, the total amount of income taxes paid by the Company was USD 1 856 million (Q3 2023: USD 478 million).
In the first nine month period of 2022, the total amount of income taxes paid by continuing operations was USD 1 368 million (Q3 2022: USD 260 million) and by discontinued operations was USD 191 million (Q3 2022: USD 60 million), which was included within “Net cash flows
33

from operating activities from discontinued operations.” In the first nine month period of 2022, the total amount of income taxes paid by the Company was USD 1 559 million (Q3 2022: USD 320 million).
6.3. Cash flows from changes in working capital and other operating items included in the net cash flows from operating activities from continuing operations
(USD millions)
Q3 2023
Q3 2022
9M 2023
9M 2022
Increase in inventories
-33
-129
-579
-514
Increase in trade receivables
-117
-136
-1 264
-825
Decrease in trade payables
-184
-121
-85
-325
Change in other current and non-current assets
16
127
-84
-86
Change in other current liabilities
1 496
706
2 027
498
Total
1 178
447
15
-1 252
6.4. Cash flows arising from acquisitions and divestments of businesses, net
The following table is a summary of the cash flow impact of acquisitions and divestments of businesses. The most significant transactions are described in Note 3.
(USD millions)
Q3 2023
Q3 2022
9M 2023
9M 2022
Net assets recognized as a result of acquisitions of businesses
-3 696
9
-3 696
-1 077
Fair value of previously held equity interests
27
-2
27
22
Contingent consideration payable, net
163
-7
153
224
Payments (incl. prepayments), deferred consideration and other adjustments, net
61
-39
1
Cash flows used for acquisitions of businesses
-3 445
0
-3 555
-830
Cash flows from/(used for) divestments of businesses, net 1
2
8
5
-3
Cash flows (used in)/from acquisitions and divestments of businesses, net
-3 443
8
-3 550
-833
 1  In the first nine months of 2023, USD 5 million (Q3 2023: USD 2 million) represented the net cash inflows from divestments in prior years.
     In the first nine months of 2022, USD 3 million (Q3 2022: USD 8 million net cash inflows) net cash outflows from divestments of businesses included USD 20 million (Q3 2022: nil) reduction to cash and cash equivalents due to the derecognized cash and cash equivalents following a loss of control of a company upon expiry of an option to purchase the company, partly offset by net cash inflows of USD 17 million (Q3 2022: USD 8 million) from business divestments in the 2022 periods and in prior years.
     In the first nine months of 2022, the net identifiable assets of divested businesses amounted to USD 106 million (Q3 2022: nil), comprised of non-current assets of USD 113 million (Q3 2022: nil), current assets of USD 22 million (Q3 2022: nil), including USD 20 million (Q3 2022: nil) cash and cash equivalents and of non-current and current liabilities of USD 29 million (Q3 2022: nil).
Notes 3 and 7 provide further information regarding acquisitions and divestments of businesses. All acquisitions were for cash.
34

7. Acquisitions of businesses
Fair value of assets and liabilities arising from acquisitions of businesses:
(USD millions)
9M 2023
9M 2022
Property, plant and equipment
18
13
Right-of-use assets
16
12
Acquired research and development
2 408
1 213
Other intangible assets
15
Deferred tax assets
182
53
Non-current financial and other assets
148
Trade receivable and financial and other current assets
181
5
Cash and cash equivalents
226
88
Deferred tax liabilities
-592
-301
Current and non-current lease liabilities
-50
-12
Trade payables and other liabilities
-152
-68
Net identifiable assets acquired
2 400
1 003
Acquired cash and cash equivalents
-226
-88
Goodwill
1 522
162
Net assets recognized as a result of acquisitions of businesses 1
3 696
1 077
 1  All net assets recognized relate to business combinations of continuing operations.
Note 3 details significant acquisitions of businesses, specifically the acquisition of DTx Pharma and Chinook Therapeutics in the third quarter of 2023. In the first nine months of 2022, there was the acquisition of Gyroscope. The goodwill arising out of the acquisitions was mainly attributable to synergies, the accounting for deferred tax liabilities on acquired assets and the assembled workforce. None of the goodwill was tax deductible.
8. Legal proceedings update
A number of Novartis companies are, and will likely continue to be, subject to various legal proceedings, including litigations, arbitrations and governmental investigations, that arise from time to time. Legal proceedings are inherently unpredictable. As a result, the Company may become subject to substantial liabilities that may not be covered by insurance and may in the future incur judgments or enter into settlements of claims that could have a material adverse effect on its results of operations or cash flow. Note 20 to the Consolidated Financial Statements in our 2022 Annual Report and 2022 Form 20-F contains a summary as of the date of these reports of significant legal proceedings to which Novartis or its subsidiaries were a party. The following is a summary as of October 23, 2023, of significant developments in those proceedings, as well as any new significant proceedings commenced since the date of the 2022 Annual Report and 2022 Form 20-F.
Investigations and related litigations
Lucentis/Avastin® matters
In connection with an investigation into whether Novartis entities, F. Hoffmann-La Roche AG, Genentech Inc. and Roche S.p.A. colluded to artificially preserve the market positions of Avastin® and Lucentis, in 2014 the Italian Competition Authority (ICA) imposed a fine equivalent to USD 125 million on the Novartis entities. Novartis paid the fine, subject to the right to later claim recoupment, and appealed before the Consiglio di Stato (CdS). In 2014 and 2015, the Italian Ministry of Health and the Lombardia region sent letters with payment requests for a total equivalent of approximately USD 1.3 billion in damages from Novartis and Roche entities based on these allegations. In 2019, the CdS upheld the ICA decision and fine. Following that CdS decision, several additional Italian regions and hospitals sent letters claiming damages for an aggregate amount of approximately USD 330 million. Novartis filed a revocation action before the CdS in 2019 and a further appeal before the Supreme Court in 2020. Respectively in October 2021 and May 2023, the Supreme Court and the CdS rejected Novartis’s actions.
The ICA decision is now final.
In 2019, the French Competition Authority (FCA) issued a Statement of Objections against Novartis entities, alleging anti-competitive practices on the French market for anti-vascular endothelial growth factor treatments for wet age-related macular degeneration from 2008 to 2013. In 2020, the FCA issued a decision finding that the Novartis entities had infringed competition law by abusing a dominant position and imposing a fine
35

equivalent to approximately USD 452 million. Novartis paid the fine, again subject to recoupment, and appealed the FCA’s decision. In February 2023, the Paris Court of Appeal (Court) overturned the FCA’s decision which triggered the reimbursement of the originally paid fine (recorded as “Other income” in the Company’s consolidated income statement), and in March 2023, the FCA filed an appeal of the Court’s decision. Novartis entities are the subject of similar investigations and proceedings involving competition authorities, which are disclosed in the 2022 Annual Report and 2022 Form 20-F.
Inflation Reduction Act (IRA) litigation
In 2023, following the U.S. government’s selection of Entresto for the first round of the IRA’s “Medicare Drug Price Negotiation Program,” NPC filed a complaint in the U.S. District Court (USDC) for the District of New Jersey on the grounds that those drug price-setting provisions are unconstitutional under the First, Fifth and Eighth Amendments to the U.S. Constitution.
Antitrust class actions
Exforge
Since 2018, Novartis Group companies as well as other pharmaceutical companies have been sued by various direct and indirect purchasers of Exforge in multiple US individual and putative class action complaints. They claim that Novartis made a reverse payment in the form of an agreement not to launch an authorized generic, alleging violations of federal antitrust law and state antitrust, consumer protection and common laws, and seeking damages as well as injunctive relief. The cases were consolidated in the S.D.N.Y. In 2022, Novartis agreed to a settlement in principle to pay USD 245 million to resolve these cases. In Q1 2023 Novartis paid USD 245 million to fund the required trust accounts. Certain of these settlements were subject to court approval, a process that was completed in October 2023, which means the matters are finally disposed of and completed.
Discontinued operations
On October 4, 2023, the separation and spin-off of the Sandoz business was completed (see Note [3]). Pursuant to the Separation and Distribution Agreement between Novartis and Sandoz entered into in connection with that separation and spin-off, Sandoz and Novartis agreed, subject to certain limitations, exclusions and conditions, that Sandoz would retain or assume (as applicable) liabilities, including pending and future claims, which relate to the spun-off Sandoz business (whether arising prior to, at or after the date of execution of the Separation and Distribution Agreement), including the matters described below (the description of which was accurate as at the time of the spin-off). Additionally, pursuant to the Separation and Distribution Agreement, Sandoz has agreed to indemnify Novartis and each of its directors, officers, managers, members, agents and employees against liabilities incurred in connection with the spun-off Sandoz business, including the matters described below.
Government generic pricing antitrust investigations, antitrust class actions in the United States
Since 2016, Sandoz Inc. has been part of an investigation into alleged price fixing and market allocation of generic drugs in the United States. In 2020, Sandoz Inc. reached a resolution with the DOJ Antitrust Division, pursuant to which Sandoz Inc. paid USD 195 million and entered into a deferred prosecution agreement (DPA). The Sandoz Inc. resolution related to instances of misconduct at the Company between 2013 and 2015 with regard to certain generic drugs sold in the United States. The term of the DPA concluded in March 2023 and the underlying matter has been dismissed. Sandoz Inc. also finalized a resolution with the DOJ Civil Division and in 2021 paid USD 185 million to settle related claims arising under the False Claims Act, and entered into a corporate integrity agreement with the Office of Inspector General (OIG) of the US Department of Health and Human Services (HHS). This resolved all federal government matters related to price fixing allegations.
Since the third quarter of 2016, Sandoz Inc. and Fougera Pharmaceuticals Inc. have been sued alongside other generic pharmaceutical companies in numerous related individual and putative class action complaints by direct and indirect private purchasers and by over 50 US states and territories, represented by their respective Attorneys General. Plaintiffs claim that defendants, including Sandoz Inc., engaged in price fixing and market allocation of generic drugs in the United States, and seek damages and injunctive relief. The litigation includes complaints alleging product-specific conspiracies, as well as complaints alleging the existence of an overarching industry conspiracy, and assert claims for damages and penalties under federal and state antitrust and consumer protection acts. The cases have been consolidated for pretrial purposes in the USDC for the Eastern District of Pennsylvania, and as at the date of the spin-off the claims are being vigorously contested by Sandoz.
Government opioid litigation in the United States and Canada relating to Sandoz products
Sandoz and Novartis entities are named as defendants in opioids litigation in the US and Canada. In the US, Sandoz is named in more than 600 complaints filed in multidistrict litigation (MDL) in US federal court in the Northern District of Ohio and 149 of those cases also name Novartis AG and/or NPC. In addition to the MDL, fewer than 10 lawsuits have been filed against Sandoz and, in certain cases, certain Novartis entities in US state and federal courts. The plaintiffs are various US political subdivisions (including certain cities, counties, states, other governmental agencies and tribes), school districts, hospitals and third-party payors, and they seek civil damages under various state law grounds, including consumer protection and nuisance, allegedly arising from the manufacture, promotion, sale and distribution of opioids. On August 31, 2023, Sandoz entered into a settlement for the opioids litigation in the US. Under the settlement, Sandoz will pay USD 100 million into a qualified settlement fund administered by a third party within 30 days of the time when 85% of plaintiffs who filed cases against Sandoz agree to participate in the settlement. The deadline for plaintiffs to elect to participate in the settlement is January 31, 2024, although that date can be extended.
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In Canada, Sandoz has been named in 6 class actions initiated in the provinces of British Columbia, Ontario, Alberta, Saskatchewan, and Québec. The claims are being vigorously contested.
In addition to the matters described above, there have been other non-material developments in the other legal matters described in Note 20 to the Consolidated Financial Statements contained in our 2022 Annual Report and 2022 Form 20-F.
Novartis believes that its total provisions for investigations, product liability, arbitration and other legal matters are adequate based upon currently available information. However, given the inherent difficulties in estimating liabilities, there can be no assurance that additional liabilities and costs will not be incurred beyond the amounts provided.
9. Operating segment
Prior to the September 15, 2023, shareholders’ approval of the spin-off of the Sandoz business (refer to Note 2 and Note 3 for additional information), the businesses of Novartis were divided operationally on a worldwide basis into two identified reporting segments: Innovative Medicines Division and the Sandoz Division. In addition, we separately reported Corporate activities.
Following the September 15, 2023, shareholders’ approval of the spin-off of the Sandoz business (see Note 2 and Note 3), the Company reported its consolidated financial statements for the current and prior years as “continuing operations” and “discontinued operations” (see Note 1).
Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities.
Discontinued operations include the Sandoz Division and selected portions of corporate activities attributable to Sandoz’s business, as well as certain expenses related to the spin-off. For further details and disclosures on discontinued operations, refer to Note 3 and Note 12.
Effective January 1, 2023, the Sandoz business bio-technology manufacturing services to other companies’ activities and the Coartem brand were transferred to the Novartis continuing operations. The financial information of the Novartis continuing operations and discontinued operations were accordingly adapted in 2023 and prior years, in compliance with IFRS. This restatement had no impact on the reported financial results and consolidated balance sheet of the total Company.
With the spin-off of the Sandoz business, Novartis operates as a single global operating segment, as a focused innovative medicines company that is engaged in the research, development, manufacturing and commercialization and sale of innovative medicines.
The Company’s research, development manufacturing and supply of products and functional activities are managed globally on a vertically integrated basis. Commercial efforts that coordinate marketing, sales and distribution of these products are organized by geographic region or therapeutic area.
The Executive Committee of Novartis (ECN), chaired by the CEO, is the governance body that is responsible for allocating resources and assessing the business performance of the operating segment of the Company on a global basis and is the chief operating decision-maker (CODM) for the Company.
The determination of a single operating segment is consistent with the consolidated financial information regularly reviewed by the CODM for purposes of assessing performance and allocating resources.
See Note 10 for revenue and geographic information disclosures.
37

10. Revenues and geographic information
Net sales
Net sales information
Net sales from continuing operations comprise the following:
(USD millions)
Q3 2023
Q3 2022
9M 2023
9M 2022
Net sales to third parties from continuing operations
11 436
10 299
33 212
31 006
Sales to discontinued operations
346
193
805
624
Net sales from continuing operations
11 782
10 492
34 017
31 630
Net sales from continuing operations by region1
Third quarter
Q3 2023
USD m
Q3 2022
USD m
% change
USD
% change
cc 2
Q3 2023
% of total
Q3 2022
% of total
   Europe
3 930
3 360
17
11
33
32
   US
4 648
4 117
13
13
39
39
   Asia/Africa/Australasia
2 349
2 272
3
8
20
22
   Canada and Latin America
855
743
15
21
8
7
Total
11 782
10 492
12
12
100
100
   Of which in Established Markets
8 719
7 729
13
10
74
74
   Of which in Emerging Growth Markets
3 063
2 763
11
17
26
26
 1  Net sales from continuing operations by location of customer. Emerging Growth Markets comprise all markets other than the Established Markets of the US, Canada, Western Europe, Japan, Australia and New Zealand.
 2  Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 48.
Net sales from continuing operations by region1
Nine months to September 30
9M 2023
USD m
9M 2022
USD m
% change
USD
% change
cc 2
9M 2023
% of total
9M 2022
% of total
   Europe
11 281
10 776
5
5
33
34
   US
13 196
11 717
13
13
39
37
   Asia/Africa/Australasia
7 077
6 944
2
9
21
22
   Canada and Latin America
2 463
2 193
12
20
7
7
Total
34 017
31 630
8
10
100
100
   Of which in Established Markets
25 070
23 401
7
7
74
74
   Of which in Emerging Growth Markets
8 947
8 229
9
17
26
26
 1  Net sales from continuing operations by location of customer. Emerging Growth Markets comprise all markets other than the Established Markets of the US, Canada, Western Europe, Japan, Australia and New Zealand.
 2  Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 48.
38

Net sales from continuing operations by core therapeutic area; other promoted brands; and established brands
Third quarter
Q3 2023
Q3 2022
% change
% change
USD m
USD m 1
USD
cc 2
Cardiovascular, Renal and Metabolic
Entresto
1 485
1 135
31
31
Leqvio
90
34
165
165
Total Cardiovascular, Renal and Metabolic
1 575
1 169
35
34
Immunology
Cosentyx
1 329
1 274
4
4
Xolair 3
369
322
15
13
Ilaris
335
272
23
24
Total Immunology
2 033
1 868
9
9
Neuroscience
Kesimpta
657
289
127
124
Zolgensma
308
319
-3
-2
Mayzent
103
94
10
9
Aimovig
69
50
38
32
Total Neuroscience
1 137
752
51
50
Oncology
Promacta/Revolade
576
523
10
10
Kisqali
562
327
72
76
Tafinlar + Mekinist
482
450
7
8
Tasigna
464
489
-5
-5
Jakavi
427
386
11
9
Pluvicto
256
80
220
217
Lutathera
159
132
20
19
Kymriah
124
134
-7
-9
Piqray/Vijoice
128
103
24
24
Votrient
102
118
-14
-14
Scemblix
106
41
159
157
Adakveo
45
50
-10
-11
Tabrecta
36
36
0
1
Total Oncology
3 467
2 869
21
21
Other Promoted Brands
Ultibro Group
104
108
-4
-7
Xiidra
64
109
-41
-41
Beovu
47
52
-10
-9
Other respiratory
21
19
11
21
Total Other Promoted Brands
236
288
-18
-19
Total Promoted Brands
8 448
6 946
22
21
Established Brands
Lucentis
363
455
-20
-22
Sandostatin
338
295
15
15
Gilenya
270
507
-47
-48
Exforge Group
187
185
1
3
Galvus Group
181
212
-15
-4
Diovan Group
153
160
-4
-1
Gleevec/Glivec
144
178
-19
-17
Afinitor/Votubia
85
125
-32
-30
Contract manufacturing 4
471
271
74
60
Other 5
1 142
1 158
-1
-2
Total Established Brands 4, 5
3 334
3 546
-6
-7
Total net sales from continuing operations
11 782
10 492
12
12
 1  In Q1 2023 Lucentis was reclassified from Other Promoted Brands to Established Brands and Gilenya was reclassified from Neuroscience to Established Brands. These reclassifications have been reflected in Q3 2022.
 2  Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 48.
 3  Net sales to from continuing operations reflect Xolair sales for all indications.
 4  2022 restated to reflect the transfer of the Sandoz Division’s biotechnology manufacturing services to other companies’ activities to the Innovative Medicines Division that was effective as of January 1, 2023.
 5  2022 restated to reflect the transfer of the Coartem brand from the Sandoz Division to the Innovative Medicines Division that was effective as of January 1, 2023.
39

Net sales from continuing operations by core therapeutic area; other promoted brands; and established brands
Nine months to September 30
9M 2023
9M 2022
% change
% change
USD m
USD m 1
USD
cc 2
Cardiovascular, Renal and Metabolic
Entresto
4 400
3 353
31
33
Leqvio
232
70
231
231
Total Cardiovascular, Renal and Metabolic
4 632
3 423
35
37
Immunology
Cosentyx
3 677
3 708
-1
1
Xolair 3
1 085
1 042
4
6
Ilaris
979
832
18
20
Other
1
nm
nm
Total Immunology
5 741
5 583
3
4
Neuroscience
Kesimpta
1 530
723
112
112
Zolgensma
928
1 061
-13
-11
Mayzent
286
258
11
12
Aimovig
197
159
24
24
Other
1
nm
nm
Total Neuroscience
2 941
2 202
34
35
Oncology
Promacta/Revolade
1 706
1 548
10
12
Kisqali
1 470
874
68
74
Tafinlar + Mekinist
1 436
1 305
10
13
Tasigna
1 402
1 448
-3
-1
Jakavi
1 276
1 173
9
11
Pluvicto
707
92
nm
nm
Lutathera
458
343
34
34
Kymriah
388
397
-2
-1
Piqray/Vijoice
374
261
43
44
Votrient
313
371
-16
-14
Scemblix
288
97
197
198
Adakveo
150
143
5
5
Tabrecta
113
97
16
17
Other
1
2
nm
nm
Total Oncology
10 082
8 151
24
26
Other Promoted Brands
Ultibro Group
332
366
-9
-8
Xiidra
249
342
-27
-27
Beovu
151
154
-2
1
Other respiratory
69
58
19
27
Total Other Promoted Brands
801
920
-13
-11
Total Promoted Brands
24 197
20 279
19
21
Established Brands
Lucentis
1 174
1 476
-20
-19
Sandostatin
998
933
7
8
Gilenya
771
1 667
-54
-53
Exforge Group
557
584
-5
-1
Galvus Group
539
650
-17
-10
Diovan Group
466
510
-9
-4
Gleevec/Glivec
433
570
-24
-21
Afinitor/Votubia
311
406
-23
-21
Contract manufacturing 4
1 174
879
34
30
Other 5
3 397
3 676
-8
-3
Total Established Brands 4, 5
9 820
11 351
-13
-11
Total net sales from continuing operations
34 017
31 630
8
10
 1  In Q1 2023 Lucentis was reclassified from Other Promoted Brands to Established Brands and Gilenya was reclassified from Neuroscience to Established Brands.These reclassifications have been reflected in 9M 2022.
 2  Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 48.
 3  Net sales from continuing operations reflect Xolair sales for all indications.
 4  2022 restated to reflect the transfer of the Sandoz Division’s biotechnology manufacturing services to other companies’ activities to the Innovative Medicines Division that was effective as of January 1, 2023.
 5  2022 restated to reflect the transfer of the Coartem brand from the Sandoz Division to the Innovative Medicines Division that was effective as of January 1, 2023.
    
nm = not meaningful
40

Net sales from continuing operations of the top 20 brands in 2023
Third quarter
US
Rest of world
Total
Brands
Brand classification by therapeutic area, other promoted brands or established brands
Key indications
USD m
% change USD/cc 1
USD m
% change USD
% change cc 1
USD m
% change USD
% change cc 1
Entresto
Cardiovascular, Renal and Metabolic
Chronic heart failure, hypertension
728
28
757
34
34
1 485
31
31
Cosentyx
Immunology
Psoriasis (PsO), ankylosing spondylitis (AS), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSPA), hidradenitis suppurativa (HS)
717
-3
612
15
15
1 329
4
4
Promacta/Revolade
Oncology
Immune thrombocytopenia (ITP), severe aplastic anemia (SAA)
314
11
262
10
8
576
10
10
Kesimpta
Neuroscience
Relapsing-remitting multiple sclerosis (RRMS)
407
70
250
nm
nm
657
127
124
Kisqali
Oncology
HR+/HER2- metastatic breast cancer
294
119
268
39
45
562
72
76
Tafinlar + Mekinist
Oncology
BRAF V600+ metastatic adjuvant melanoma, advanced non-small cell lung cancer (NSCLC), tumor agnostic with BRAF mutation indication
201
15
281
2
3
482
7
8
Tasigna
Oncology
Chronic myeloid leukemia (CML)
221
-6
243
-5
-5
464
-5
-5
Jakavi
Oncology
Myelofibrosis (MF), polycytomia vera (PV), graft-versus-host disease (GvHD)
427
11
9
427
11
9
Lucentis 2
Established Brands
Age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO)
363
-20
-22
363
-20
-22
Xolair 3
Immunology
Severe allergic asthma (SAA), chronic spontaneous urticaria (CSU), nasal polyps
369
15
13
369
15
13
Sandostatin
Established Brands
Carcinoid tumors, acromegaly
218
15
120
14
16
338
15
15
Ilaris
Immunology
Auto-inflammatory (CAPS, TRAPS, HIDS/MKD, FMF, SJIA, AOSD, gout)
182
27
153
19
20
335
23
24
Zolgensma
Neuroscience
Spinal muscular atrophy (SMA)
89
-10
219
0
2
308
-3
-2
Gilenya 2
Established Brands
Relapsing multiple sclerosis (RMS)
120
-63
150
-17
-19
270
-47
-48
Pluvicto
Oncology
PSMA-positive mCRPC patients post-ARPI, post-Taxane
238
222
18
200
165
256
220
217
Exforge Group
Established Brands
Hypertension
3
-40
184
2
4
187
1
3
Galvus Group
Established Brands
Type 2 diabetes
181
-15
-4
181
-15
-4
Diovan Group
Established Brands
Hypertension
11
0
142
-5
-1
153
-4
-1
Lutathera
Oncology
GEP-NETs gastroenteropancreatic neuroendocrine tumors
114
18
45
29
23
159
20
19
Gleevec/Glivec
Established Brands
Chronic myeloid leukemia (CML), gastrointestinal stromal tumors (GIST)
41
-16
103
-20
-18
144
-19
-17
Top 20 brands total
3 898
16
5 147
11
12
9 045
13
13
Rest of portfolio 4
750
1
1 987
13
10
2 737
9
7
Total net sales from continuing operations  4
4 648
13
7 134
12
11
11 782
12
12
 1  Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 48.
 2  In Q1 2023 Lucentis was reclassified from Other Promoted Brands to Established Brands and Gilenya was reclassified from Neuroscience to Established Brands.
 3  Net sales from continuing operations reflect Xolair sales for all indications.
 4  % change has been restated to reflect the transfers of the Sandoz Division’s biotechnology manufacturing services and the Coartem brand to the Innovative Medicines Division that were effective as of January 1, 2023.
nm = not meaningful
41

Net sales from continuing operations of the top 20 brands in 2023
Nine months to September 30
US
Rest of world
Total
Brands
Brand classification by therapeutic area, other promoted brands or established brands
Key indications
USD m
% change USD/cc 1
USD m
% change USD
% change cc 1
USD m
% change USD
% change cc 1
Entresto
Cardiovascular, Renal and Metabolic
Chronic heart failure, hypertension
2 187
32
2 213
31
35
4 400
31
33
Cosentyx
Immunology
Psoriasis (PsO), ankylosing spondylitis (AS), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSPA), hidradenitis suppurativa (HS)
1 895
-11
1 782
13
17
3 677
-1
1
Promacta/Revolade
Oncology
Immune thrombocytopenia (ITP), severe aplastic anemia (SAA)
904
13
802
7
10
1 706
10
12
Kesimpta
Neuroscience
Relapsing-remitting multiple sclerosis (RRMS)
1 075
75
455
nm
nm
1 530
112
112
Kisqali
Oncology
HR+/HER2- metastatic breast cancer
700
117
770
40
49
1 470
68
74
Tafinlar + Mekinist
Oncology
BRAF V600+ metastatic adjuvant melanoma, advanced non-small cell lung cancer (NSCLC), tumor agnostic with BRAF mutation indication
591
17
845
5
10
1 436
10
13
Tasigna
Oncology
Chronic myeloid leukemia (CML)
664
2
738
-7
-4
1 402
-3
-1
Jakavi
Oncology
Myelofibrosis (MF), polycytomia vera (PV), graft-versus-host disease (GvHD)
1 276
9
11
1 276
9
11
Lucentis 2
Established Brands
Age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO)
1 174
-20
-19
1 174
-20
-19
Xolair 3
Immunology
Severe allergic asthma (SAA), chronic spontaneous urticaria (CSU), nasal polyps
1 085
4
6
1 085
4
6
Sandostatin
Established Brands
Carcinoid tumors, acromegaly
630
6
368
10
14
998
7
8
Ilaris
Immunology
Auto-inflammatory (CAPS, TRAPS, HIDS/MKD, FMF, SJIA, AOSD, gout)
486
20
493
15
19
979
18
20
Zolgensma
Neuroscience
Spinal muscular atrophy (SMA)
282
-16
646
-11
-8
928
-13
-11
Gilenya 2
Established Brands
Relapsing multiple sclerosis (RMS)
304
-68
467
-34
-32
771
-54
-53
Pluvicto
Oncology
PSMA-positive mCRPC patients post-ARPI, post-Taxane
670
nm
37
270
242
707
nm
nm
Exforge Group
Established Brands
Hypertension
11
-8
546
-5
-1
557
-5
-1
Galvus Group
Established Brands
Type 2 diabetes
539
-17
-10
539
-17
-10
Diovan Group
Established Brands
Hypertension
38
0
428
-9
-4
466
-9
-4
Lutathera
Oncology
GEP-NETs gastroenteropancreatic neuroendocrine tumors
324
36
134
29
30
458
34
34
Gleevec/Glivec
Established Brands
Chronic myeloid leukemia (CML), gastrointestinal stromal tumors (GIST)
118
-24
315
-24
-20
433
-24
-21
Top 20 brands total
10 879
14
15 113
5
9
25 992
9
11
Rest of portfolio 4
2 317
6
5 708
3
6
8 025
4
6
Total net sales from continuing operations  4
13 196
13
20 821
5
8
34 017
8
10
 1  Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 48.
 2  In Q1 2023 Lucentis was reclassified from Other Promoted Brands to Established Brands and Gilenya was reclassified from Neuroscience to Established Brands.
 3  Net sales from continuing operations reflect Xolair sales for all indications.
 4  % change has been restated to reflect the transfers of the Sandoz Division’s biotechnology manufacturing services and the Coartem brand to the Innovative Medicines Division that were effective as of January 1, 2023.
nm = not meaningful
42

Other revenues
(USD millions)
Q3 2023
Q3 2022
9M 2023
9M 2022
Profit sharing income
251
246
696
674
Royalty income
22
10
63
21
Milestone income
7
8
35
47
Other 1
30
27
73
123
Total other revenues
310
291
867
865
 1  Other includes revenue from activities such as manufacturing or other services rendered, to the extent such revenue is not recorded under net sales.
11. Other interim disclosures
Restructuring provisions movements
(USD millions)
Q3 2023
Q3 2022
9M 2023
9M 2022
Balance at beginning of period
1 045
731
1 131
345
Provisions related to
discontinued operations 1

-41


-51

Additions to provisions 2
58
289
523
851
Cash payments
-179
-87
-645
-231
Releases of provisions 3
-23
-20
-115
-35
Transfers
-42
-1
-43
-1
Currency translation effects
-9
-9
9
-26
Balance at closing of period
809
903
809
903
 1  Notes 2, 3 and 12 provide information related to discontinued operations.
 2  Provisions charged to the consolidated income statement from continuing operations were USD 283 million in Q3 2022 and USD 816 million in 9M 2022.
 3  Releases of provisions credited to the consolidated income statement from continuing operations were USD 15 million in Q3 2022 and USD 25 million in 9M 2022.
In the first nine months of 2023, additions to provisions of USD 523 million (Q3: USD 58 million) mainly related to the continuation of the initiative announced in April 2022, to implement a new streamlined organizational model designed to support innovation, growth and productivity.
In the first nine months of 2022, additions to provisions of USD 851 million (Q3: USD 289 million) mainly related to the initiative announced in April 2022, to implement a new streamlined organizational model designed to support innovation, growth and productivity, as well as, to the continuation of the Innovative Medicines Division and the Operations unit 2021 restructuring initiatives.
Property, plant and equipment and intangible assets
The following table shows the property, plant and equipment, the right-of-use assets and the intangible assets impairment charges and reversals recognized:
(USD millions)
Q3 2023
Q3 2022
9M 2023
9M 2022
Property, plant and equipment impairment charges
-27
-61
-85
-320
Property, plant and equipment impairment reversal
-37
0
11
2
Right-of-use assets impairment charges
-2
-2
Intangible assets impairment charges 1
-1 739
-595
-2 665
-858
 1  First nine months 2023 intangible assets impairment charges include the write-down of IPR&D on the cessation of clinical development programs, including the clinical development programs PPY988 (USD 1.0 billion) and VDT482 (USD 0.4 billion), and the clinical research program NIZ985 (USD 0.3 billion); as well as the write-down of a currently marketed product by USD 0.3 billion to reflect reduction in its recoverable amount.
     First nine months 2022 intangible assets impairment charges include the write-down of IPR&D on the cessation of clinical development programs, including UNR844 (USD 0.6 billion).
In the first nine months of 2023, there were no reversals of prior-year impairment charges on intangible assets (9M 2022: nil) and right-of-use assets (9M 2022: nil).
In the first nine months 2023 additions to property, plant and equipment and depreciation amounted to USD
43

648 million, and USD 686 million respectively, (Q3 2023: USD 261 million and USD 231 million respectively).
In the first nine months 2022 additions to property, plant and equipment and depreciation amounted to USD 625 million, and USD 708 million respectively, (Q3 2022: USD 248 million and USD 246 million respectively).
In the first nine months of 2023 additions to intangible assets and amortization amounted to USD 1 033 million, and USD 3 067 million respectively, (Q3 2023: USD 318 million and USD 1 014 million respectively).
In the first nine months of 2022 additions to intangible assets and amortization amounted to USD 1 646 million, and USD 2 800 million respectively, (Q3 2022: USD 559 million and USD 948 million respectively).
Completion of the Divestment of intangible assets
On June 30, 2023, Novartis entered into an agreement with Bausch + Lomb Corporation to divest the currently marketed product Xiidra and certain IPR&D assets related to ‘front of eye’ ophthalmology. The transaction was accounted for as a divestment of assets. The transaction closed on September 29, 2023.
The purchase price consists of a total cash payment of USD 1.75 billion and potential milestone payments related to the currently marketed product and IPR&D assets of up to USD 750 million.
Financial debt
In the third quarter of 2023, Novartis repaid the 0.5% coupon bond with a notional amount of EUR 750 million issued in 2018 by Novartis Finance SA, Luxembourg, in accordance with its terms.
In the third quarter of 2023, Novartis repaid the 0.125% coupon bond with a notional amount of EUR 1.25 billion issued in 2016 by Novartis Finance SA, Luxembourg, in accordance with its terms.
12. Discontinued operations
Discontinued operations include the operational results from the Sandoz business together with certain corporate activities attributable to the Sandoz business, as well as certain other expenses related to the spin-off (refer to Notes 2 and 3 for further details).
The Sandoz business operates in the off-patent medicines segment and specializes in the development, manufacturing, and marketing of generic pharmaceuticals and biosimilars. The Sandoz business is organized globally into two franchises: Generics and Biosimilars.
Consolidated income statement – Discontinued operations
(USD millions)
Q3 2023
Q3 2022
9M 2023
9M 2022
Net sales to third parties from discontinued operations
2 329
2 244
7 128
6 849
Sales to continuing operations
147
42
300
149
Net sales from discontinued operations
2 476
2 286
7 428
6 998
Other revenues
7
8
19
21
Cost from goods sold
-1 493
-1 167
-4 044
-3 645
Gross profit from discontinued operations
990
1 127
3 403
3 374
Selling, general and administration
-581
-477
-1 728
-1 496
Research and development
-230
-194
-671
-598
Other income
28
17
56
96
Other expense
-293
-131
-795
-319
Operating (loss)/income from discontinued operations
-86
342
265
1 057
as % from net sales
-3.5%
15.0%
3.6%
15.1%
Income from associated companies
1
1
2
2
Interest expense
-14
-9
-33
-25
Other financial income and expense
-2
-2
-20
-12
(Loss)/Income before taxes from discontinued operations
-101
332
214
1 022
Taxes 1
351
-87
226
-267
Net income from discontinued operations
250
245
440
755
 1  The tax rate in the third quarter 2023 and in the first nine months 2023 was impacted by non-recurring items such as tax benefits arising from intercompany transactions to effect the spin-off of the Sandoz business, net decreases in uncertain tax positions of the Sandoz business and the favorable settlement of a tax matter related to the Alcon business, which was spun-off in 2019. Excluding these impacts, the tax rate would have been 28% in third quarter 2023 and 31.2% in the first nine months 2023, compared to 26.2% and 26.1% in third quarter 2022 and the first nine months 2022, respectively. The tax rate in the third quarter 2023 is higher than the prior year period primarily due to a change in profit mix. The tax rate in the first nine months 2023 is higher than the prior year period primarily due to a change in profit mix and the increased relative impact of recurring permanent items as a result of lower income before taxes for the first nine months 2023 compared to 2022.
44

Discontinued operations net assets
The following table presents the Sandoz business assets and liabilities classified as assets related to discontinued operations and liabilities related to discontinued operations in the September 30, 2023, consolidated balance sheet:

(USD millions)
Sep 30,
2023
(unaudited)
Assets related to discontinued operations
Property, plant and equipment
1 447
Right-of-use assets
133
Goodwill
7 424
Intangible assets other than goodwill
1 481
Deferred tax assets
661
Financial assets, investments in associated companies and other non-current assets
142
Inventories
2 565
Trade receivables
2 277
Cash and cash equivalents 1
648
Other current assets and income tax receivables
696
Assets related to discontinued operations
17 474
Liabilities related to discontinued operations
Non-current and current financial debts
3 691
Non-current and current lease liabilities
139
Deferred tax liabilities
270
Non-current and current provisions and other liabilities
3 335
Trade payables
1 152
Current income tax liabilities
203
Liabilities related to discontinued operations
8 790
Net assets related to discontinued operations
8 684
 1  On October 2, 2023 through a series of intercompany transactions in connection with the Distribution (spin-off) of the Sandoz business to Novartis AG shareholders (refer to Note 3 for further details) USD 38 million was paid in cash from a Novartis affiliate to the Sandoz business. Including this transaction, cash and cash equivalents on Distribution date October 3, 2023, amounted to USD 686 million.
45

Supplemental disclosures related to Discontinued operations
Net income
Included in net income from discontinued operations are:
(USD millions)
Q3 2023
Q3 2022
9M 2023
9M 2022
Interest income
1
1
2
2
Depreciation of property, plant and equipment
-45
-44
-144
-147
Depreciation of right-of-use assets
-14
-8
-32
-25
Amortization of intangible assets
-60
-55
-171
-168
Impairment charges on property, plant and equipment
-3
-5
-1
Impairment charges on intangible assets
-30
-7
-44
-11
Additions to restructuring provisions
-11
-5
-27
-35
Equity-based compensation of Novartis equity plans
-24
-17
-60
-46
Balance sheet
The following shows the additions to property, plant and equipment, right-of-use assets and to goodwill and intangible assets for discontinued operations for the period from January 1, 2023, to the date of reclassification:

(USD millions)
Sep 30,
2023
(unaudited)
Additions to property, plant and equipment
245
Additions to right-of-use assets
66
Additions to goodwill and intangible assets
221
Financial debt
Sandoz business entered into financing agreements with a group of banks under which it borrowed on September 28, 2023 a total amount of USD 3.3 billion. See Note 3 for further disclosures.
Net cash flows from financing activities from discontinued operations
In the first nine months of 2023, the net cash inflows from financing activities from discontinued operations of USD 3.4 billion (9M 2022: USD 14 million; Q3 2023: USD 3.5 billion; Q3 2022: USD 11 million) were mainly driven by USD 3.6 billion (Q3 2023: USD 3.5 billion) cash inflows from bank borrowings (including the USD 3.3 billion Sandoz business borrowings on September 28, 2023, from a group of banks) in connection with the Distribution (spin-off) of the Sandoz business to Novartis AG shareholders (see Note 3).
For additional information related to the Distribution (spin-off) of the Sandoz business to Novartis AG shareholders, refer to Notes 2 and 3.
46

13. Events subsequent to the September 30, 2023, consolidated balance sheet
Spin-off of the Sandoz business through a dividend in kind distribution to Novartis AG shareholders
The Novartis AG shareholders approved the spin-off of the Sandoz business at the 2023 EGM held on September 15, 2023, subject to completion of certain conditions precedent to the distribution. The conditions precedent to the spin-off were met and on October 3, 2023, the spin-off of the Sandoz business was effected by way of a distribution of a dividend in kind of Sandoz Group AG shares to Novartis AG shareholders and ADR (American Depositary Receipt) holders (the Distribution). Through the Distribution, each Novartis AG shareholder received 1 Sandoz Group AG share for every 5 Novartis AG shares/ ADRs they held on October 3, 2023, close of business. As of October 4, 2023, the shares of Sandoz Group AG are listed on the SIX Swiss Exchange (SIX) under the symbol “SDZ.” In the fourth quarter 2023, the Company will recognize a non-taxable, noncash gain as at the Distribution date of the spin-off of the Sandoz business amounting to approximately USD 5.9 billion, representing primarily the excess amount of the distribution liability, which is the estimated fair value of the Sandoz business distributed to Novartis AG shareholders, over the then carrying value of Sandoz business net assets.
For additional information see Note 3 and Note 12.
47

Supplementary information (unaudited)

Non-IFRS disclosures
Novartis uses certain non-IFRS metrics when measuring performance, especially when measuring current-year results against prior periods, including core results, constant currencies and free cash flow.
Despite the use of these measures by management in setting goals and measuring the Company’s performance, these are non-IFRS measures that have no standardized meaning prescribed by IFRS. As a result, such measures have limits in their usefulness to investors.
Because of their non-standardized definitions, the non-IFRS measures (unlike IFRS measures) may not be comparable to the calculation of similar measures of other companies. These non-IFRS measures are presented solely to permit investors to more fully understand how the Company’s management assesses underlying performance. These non-IFRS measures are not, and should not be viewed as, a substitute for IFRS measures.
As an internal measure of Company performance, these non-IFRS measures have limitations, and the Company’s performance management process is not solely restricted to these metrics.
Core results
The Company’s core results – including core operating income, core net income and core earnings per share – exclude fully the amortization and impairment charges of intangible assets, excluding software, net gains and losses on fund investments and equity securities valued at fair value through profit and loss, and certain acquisition- and divestment-related items. The following items that exceed a threshold of USD 25 million are also excluded: integration- and divestment-related income and expenses; divestment gains and losses; restructuring charges/releases and related items; legal-related items; impairments of property, plant and equipment, software, and financial assets, and income and expense items that management deems exceptional and that are or are expected to accumulate within the year to be over a USD 25 million threshold.
Novartis believes that investor understanding of the Company’s performance is enhanced by disclosing core measures of performance since, core measures exclude items that can vary significantly from year to year, they enable better comparison of business performance across years. For this same reason, Novartis uses these core measures in addition to IFRS and other measures as important factors in assessing the Company’s performance.
The following are examples of how these core measures are utilized:
• In addition to monthly reports containing financial information prepared under International Financial Reporting Standards (IFRS), senior management receives a monthly analysis incorporating these core measures.
• Annual budgets are prepared for both IFRS and core measures.
As an internal measure of Company performance, the core results measures have limitations, and the Company’s performance management process is not solely restricted to these metrics. A limitation of the core results measures is that they provide a view of the Company’s operations without including all events during a period, such as the effects of an acquisition, divestment, or amortization/impairments of purchased intangible assets, impairments to property, plant and equipment and restructurings and related items.
Constant currencies
Changes in the relative values of non-US currencies to the US dollar can affect the Company’s financial results and financial position. To provide additional information that may be useful to investors, including changes in sales volume, we present information about our net sales and various values relating to operating and net income that are adjusted for such foreign currency effects.
Constant currency calculations have the goal of eliminating two exchange rate effects so that an estimate can be made of underlying changes in the consolidated income statement excluding the impact of fluctuations in exchanges rates:
• The impact of translating the income statements of consolidated entities from their non-USD functional currencies to USD
• The impact of exchange rate movements on the major transactions of consolidated entities performed in currencies other than their functional currency.
We calculate constant currency measures by translating the current year’s foreign currency values for sales and other income statement items into USD (excluding the IAS 29 “Financial Reporting in Hyperinflationary Economies” adjustments to the local currency income statements of subsidiaries operating in hyperinflationary economies), using the average exchange rates from the prior year and comparing them to the prior year values in USD.
We use these constant currency measures in evaluating the Company’s performance, since they may assist us in evaluating our ongoing performance from year to year. However, in performing our evaluation, we also consider equivalent measures of performance that are not affected by changes in the relative value of currencies.
Growth rate calculation
For ease of understanding, Novartis uses a sign convention for its growth rates such that a reduction in operating expenses or losses compared with the prior year is shown as a positive growth.
Free cash flow
Effective January 1, 2023, Novartis revised its definition of free cash flow, to define free cash flow as net cash flows from operating activities less purchases of property, plant and equipment. This new definition provides a simpler performance measure focusing on core operating activities, and also excludes items that can vary
48

significantly from year to year which enables better comparison of business performance across years. The prior year free cash flow amounts have been revised to conform with the new free cash flow definition to aid in comparability.
Free cash flow is a non-IFRS measure and is not intended to be a substitute measure for net cash flows from operating activities as determined under IFRS. Free cash flow is presented as additional information because management believes it is a useful supplemental indicator of the Company’s ability to operate without reliance on additional borrowing or use of existing cash. Free cash flow is a measure of the net cash generated that is available for investment in strategic opportunities, returning to shareholders and for debt repayment. Free cash flow is a non-IFRS measure, which means it should not be interpreted as a measure determined under IFRS.
Additional information
Net debt
Novartis calculates net debt as current financial debts and derivative financial instruments plus non-current financial debts less cash and cash equivalents and marketable securities, commodities, time deposits and derivative financial instruments.
Net debt is presented as additional information because it sets forth how management monitors net debt or liquidity and management believes it is a useful supplemental indicator of the Company’s ability to pay dividends, to meet financial commitments, and to invest in new strategic opportunities, including strengthening its balance sheet.
See page 57 for additional disclosures related to net debt.
49

CORE RESULTS – Reconciliation from IFRS results to core results – Total Company
(USD millions unless indicated otherwise)
Q3 2023
Q3 2022
9M 2023
9M 2022
IFRS operating income from continuing operations
1 762
1 826
7 187
6 191
Amortization of intangible assets
955
903
2 896
2 675
Impairments
   Intangible assets
1 738
592
2 664
855
   Property, plant and equipment related to the company-wide
   rationalization of manufacturing sites

46

58

3

309
   Other property, plant and equipment
11
1
33
1
Total impairment charges
1 795
651
2 700
1 165
Acquisition or divestment of businesses and related items
   - Income
-1
-64
-3
   - Expense
20
23
7
Total acquisition or divestment of businesses and related items, net
19
-41
4
Other items
   Divestment gains
-90
9
-222
-139
   Financial assets - fair value adjustments
-6
90
69
288
   Restructuring and related items
   - Income
-59
-18
-154
-29
   - Expense
156
468
951
1 188
   Legal-related items
   - Income
-484
-51
   - Expense
18
31
120
   Additional income
-169
-178
-439
-297
   Additional expense
42
3
57
34
Total other items
-126
392
-191
1 114
Total adjustments
2 643
1 946
5 364
4 958
Core operating income from continuing operations
4 405
3 772
12 551
11 149
as % of net sales
37.4%
36.0%
36.9%
35.2%
(Loss)/income from associated companies
-3
-5
-7
-8
Interest expense
-222
-206
-638
-593
Other financial income and expense
15
-28
204
18
Core adjustments to other financial income and expense
31
22
89
72
Income taxes, adjusted for above items (core income taxes)
-641
-520
-1 879
-1 655
Core net income from continuing operations
3 585
3 035
10 320
8 983
Core net income from discontinued operations 1
199
384
889
1 118
Core net income
3 784
3 419
11 209
10 101
Core net income attributable to shareholders of Novartis AG
3 782
3 417
11 205
10 101
Core basic EPS from continuing operations (USD) 2
1.74
1.40
4.95
4.09
Core basic EPS from discontinued operations (USD) 1, 2
0.09
0.18
0.42
0.51
Core basic EPS (USD) 2
1.83
1.58
5.37
4.60
 1  For details on discontinued operations reconciliation from IFRS to core net income, please refer to page 53.
 2  Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
50

CORE RESULTS – Reconciliation from IFRS results to core results – Total Company
Third quarter

(USD millions unless indicated otherwise)


Q3 2023
IFRS results

Amortization
of intangible
assets 1



Impairments 2
Acquisition or
divestment of
businesses and
related items 3


Other
items 4


Q3 2023
Core results


Q3 2022
Core results
Gross profit from continuing operations
8 975
786
28
9 789
8 890
Operating income from continuing operations
1 762
955
1 795
19
-126
4 405
3 772
Income before taxes from continuing operations
1 552
955
1 795
19
-95
4 226
3 555
Income taxes 5
-39
-641
-520
Net income from continuing operations
1 513
3 585
3 035
Net income from discontinued operations 6
250
199
384
Net income
1 763
3 784
3 419
Basic EPS from continuing operations (USD) 7
0.73
1.74
1.40
Basic EPS from discontinued operations (USD) 6, 7
0.12
0.09
0.18
Basic EPS (USD) 7
0.85
1.83
1.58
The following are adjustments to arrive at core gross profit from continuing operations
Cost of goods sold
-3 117
786
28
-2 303
-1 893
The following are adjustments to arrive at core operating income from continuing operations
Selling, general and administration
-3 091
-2
-3 093
-2 929
Research and development
-3 925
169
1 738
18
-187
-2 187
-2 070
Other income
224
36
-1
-80
179
19
Other expense
-421
21
2
115
-283
-138
The following are adjustments to arrive at core income before taxes from continuing operations
Other financial income and expense
15
31
46
-6
 1  Amortization of intangible assets: cost of goods sold includes the amortization of acquired rights to currently marketed products and other production-related intangible assets; research and development includes the amortization of acquired rights to technologies
 2  Impairments: research and development include net impairment charges related to intangible assets; other income and other expense includes net impairment charges related to property, plant and equipment
 3  Acquisition or divestment of businesses and related items, including restructuring and integration charges: research & development and other expense include restructuring and integration cost charges
 4  Other items: cost of goods sold, selling, general and administration, research and development, other income and other expense include restructuring income and charges related to the initiative to implement a new streamlined organizational model, the company-wide rationalization of manufacturing sites and other net restructuring charges and related items; cost of goods sold and research and development also include contingent consideration adjustments; selling, general and administration includes adjustments to provisions; other income and other expense include fair value adjustments and divestment gains and losses on financial assets and fair value adjustment on a contingent receivable; other expense includes also legal related items; other financial income and expense includes the monetary loss on the restatement of non-monetary items for subsidiaries in hyperinflationary economies
 5  Taxes on the adjustments between IFRS and core results, for each item included in the adjustment, take into account the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on other items, although this is not always the case for items arising from legal settlements in certain jurisdictions. Adjustments related to income from associated companies are recorded net of any related tax effect. Due to these factors and the differing effective tax rates in the various jurisdictions, the tax on the total adjustments of USD 2.7 billion to arrive at the core results before tax amounts to USD 602 million. The average tax rate on the adjustments is 22.5% since the quarterly core tax charge of 15.2% has been applied to the pre-tax income of the period.
 6  For details on discontinued operations reconciliation from IFRS to core net income please refer to page 53.
 7  Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
51

CORE RESULTS – Reconciliation from IFRS results to core results – Total Company
Nine months to September 30

(USD millions unless indicated otherwise)


9M 2023
IFRS results

Amortization
of intangible
assets 1



Impairments 2
Acquisition or
divestment of
businesses and
related items 3


Other
items 4


9M 2023
Core results


9M 2022
Core results
Gross profit from continuing operations
25 434
2 529
310
107
28 380
26 683
Operating income from continuing operations
7 187
2 896
2 700
-41
-191
12 551
11 149
Income before taxes from continuing operations
6 746
2 896
2 700
-41
-102
12 199
10 638
Income taxes 5
-812
-1 879
-1 655
Net income from continuing operations
5 934
10 320
8 983
Net income from discontinued operations 6
440
889
1 118
Net income
6 374
11 209
10 101
Basic EPS from continuing operations (USD) 7
2.84
4.95
4.09
Basic EPS from discontinued operations (USD) 6, 7
0.21
0.42
0.51
Basic EPS (USD) 7
3.05
5.37
4.60
The following are adjustments to arrive at core gross profit from continuing operations
Cost of goods sold
-9 450
2 529
310
107
-6 504
-5 812
The following are adjustments to arrive at core operating income from continuing operations
Selling, general and administration
-9 073
28
-9 045
-9 003
Research and development
-8 804
367
2 356
18
-306
-6 369
-6 173
Other income
1 322
-10
-64
-929
319
209
Other expense
-1 692
44
5
909
-734
-567
The following are adjustments to arrive at core income before taxes from continuing operations
Other financial income and expense
204
89
293
90
 1  Amortization of intangible assets: cost of goods sold includes the amortization of acquired rights to currently marketed products and other production-related intangible assets; research and development includes the amortization of acquired rights to technologies
 2  Impairments: cost of goods sold, research and development, other income and other expense include net impairment charges related to intangible assets; other income and other expense includes also net impairment charges related to property, plant and equipment
 3  Acquisition or divestment of businesses and related items, including restructuring and integration charges: other income includes a favorable stamp duties tax settlement related to a prior periods acquisition; other income and other expense include also restructuring and integration costs charges and reversals
 4  Other items: cost of goods sold, selling, general and administration, research and development, other income and other expense include restructuring income and charges related to the initiative to implement a new streamlined organizational model, the company-wide rationalization of manufacturing sites and other net restructuring charges and related items; cost of goods sold and research and development also include contingent consideration adjustments; cost of goods sold and selling, general and administration includes also adjustments to provisions; research and development also include a write-off prepaid expenses for a terminated clinical development program; other income and other expense include fair value adjustments, divestment gains, losses and gains on financial assets, legal related items and fair value adjustment on a contingent receivable, other income includes also gains from the divestment of products and curtailment gains; other financial income and expense includes the monetary loss on the restatement of non-monetary items for subsidiaries in hyperinflationary economies
 5  Taxes on the adjustments between IFRS and core results, for each item included in the adjustment, take into account the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on other items, although this is not always the case for items arising from legal settlements in certain jurisdictions. Adjustments related to income from associated companies are recorded net of any related tax effect. Due to these factors and the differing effective tax rates in the various jurisdictions, the tax on the total adjustments of USD 5.5 billion to arrive at the core results before tax amounts to USD 1.1 billion. The average tax rate on the adjustments is 19.6% since the full year core tax charge of 15.4% has been applied to the pre-tax income of the period.
 6  For details on discontinued operations reconciliation from IFRS to core net income please refer to page 53.
 7  Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
52

CORE RESULTS – Reconciliation from IFRS results to core results – Discontinued operations
Third quarter

(USD millions)


Q3 2023
IFRS results

Amortization
of intangible
assets 1



Impairments 2
Acquisition or
divestment of
businesses and
related items


Other
items 3


Q3 2023
Core results


Q3 2022
Core results
Gross profit from discontinued operations
990
54
22
21
1 087
1 209
Operating (loss)/income from discontinued operations
-86
54
30
252
250
510
Income before taxes from discontinued operations
-101
54
30
257
240
502
Income taxes
351
-41
-118
Net income from discontinued operations
250
199
384
Basic EPS from discontinued operations (USD)
0.12
0.09
0.18
The following are adjustments to arrive at core gross profit from discontinued operations
Cost of goods sold
-1 493
54
22
21
-1 396
-1 089
The following are adjustments to arrive at core operating income from discontinued operations
Research and development
-230
8
-222
-193
Other income
28
-2
26
11
Other expense
-293
233
-60
42
The following are adjustments to arrive at core income before taxes from discontinued operations
Other financial income and expense
-2
5
3
 1  Amortization of intangible assets: cost of goods sold includes the amortization of acquired rights to currently marketed products and other production-related intangible assets
 2  Impairments: cost of goods sold and research and development include impairment charges related to intangible assets
 3  Other items: cost of goods sold, selling, other income and other expense include charges related to the Sandoz spin-off (see Note 3 and Note 12), the company-wide rationalization of manufacturing sites and other net restructuring charges and related items; other expense includes also legal-related items; other financial income and expense includes the monetary loss on the restatement of non-monetary items for subsidiaries in hyperinflationary economies
Nine months to September 30

(USD millions)


9M 2023
IFRS results

Amortization
of intangible
assets 1



Impairments 2
Acquisition or
divestment of
businesses and
related items


Other
items 3


9M 2023
Core results


9M 2022
Core results
Gross profit from discontinued operations
3 403
165
34
57
3 659
3 623
Operating income from discontinued operations
265
165
43
712
1 185
1 486
Income before taxes from discontinued operations
214
165
43
718
1 140
1 460
Income taxes
226
-251
-342
Net income from discontinued operations
440
889
1 118
Basic EPS from discontinued operations (USD)
0.21
0.42
0.51
The following are adjustments to arrive at core gross profit from discontinued operations
Cost of goods sold
-4 044
165
34
57
-3 788
-3 396
The following are adjustments to arrive at core operating income from discontinued operations
Selling, general and administration
-1 728
25
-1 703
-1 488
Research and development
-671
10
-661
-597
Other income
56
-1
-24
31
75
Other expense
-795
654
-141
-127
The following are adjustments to arrive at core income before taxes from discontinued operations
Other financial income and expense
-20
6
-14
-3
 1  Amortization of intangible assets: cost of goods sold includes the amortization of acquired rights to currently marketed products and other production-related intangible assets
 2  Impairments: cost of goods sold and research and development include impairment charges related to intangible assets; other income includes a reversal of impairment charges related to property, plant and equipment
 3  Other items: cost of goods sold, selling, general and administration, other income and other expense include charges related to the Sandoz spin-off (see Note 3 and Note 12), the company-wide rationalization of manufacturing sites and other net restructuring charges and related items; cost of goods sold and selling, general and administration also include adjustments to provisions; other expense includes legal-related items; other financial income and expense includes the monetary loss on the restatement of non-monetary items for subsidiaries in hyperinflationary economies
53

Free cash flow
The following table is a reconciliation of the three major categories of the IFRS consolidated statements of cash flows to free cash flow:
Third quarter
Q3 2023
Q3 2022

(USD millions)

IFRS
cash flow


Adjustments

Free
cash flow

IFRS
cash flow


Adjustments 1
Revised
Free
cash flow 1
Net cash flows from operating activities from continuing operations
5 304
5 304
4 275
4 275
Net cash flows from operating activities from discontinued operations
74
74
446
446
Total net cash flows from operating activities
5 378
5 378
4 721
4 721
Net cash flows (used in)/from investing activities from continuing operations
-2 004
1 743
-261
5 309
-5 530
-221
Net cash flows used in investing activities from discontinued operations
-208
134
-74
-111
46
-65
Total net cash flows (used in)/from investing activities 2
-2 212
1 877
-335
5 198
-5 484
-286
Net cash flows used in financing activities from continuing operations
-4 306
4 306
0
-4 749
4 749
0
Net cash flows from financing activities from discontinued operations
3 474
-3 474
0
11
-11
0
Total net cash flows used in financing activities 3
-832
832
0
-4 738
4 738
0
Free cash flow from continuing operations 1
5 043
4 054
Free cash flow from discontinued operations 1
0
381
Free cash flow 1
5 043
4 435
 1  To aid in comparability, the prior year adjustments and free cash flow amounts have been revised to conform with the new free cash flow definition that was effective as of January 1, 2023.
 2  With the exception of purchases of property, plant and equipment, all net cash flows from investing activities from continuing operations and from discontinued operations are excluded from the free cash flow.
 3  Net cash flows (used in)/from financing activities from continuing operations and from discontinued operations are excluded from the free cash flow.
54

Free cash flow
Nine months to September 30
9M 2023
9M 2022

(USD millions)

IFRS
cash flow


Adjustments

Free
cash flow

IFRS
cash flow


Adjustments 1
Revised
Free
cash flow 1
Net cash flows from operating activities from continuing operations
11 673
11 673
9 271
9 271
Net cash flows from operating activities from discontinued operations
238
238
854
854
Total net cash flows from operating activities
11 911
11 911
10 125
10 125
Net cash flows from/(used in) investing activities from continuing operations
7 741
-8 395
-654
3 223
-3 833
-610
Net cash flows used in investing activities from discontinued operations
-385
166
-219
-288
98
-190
Total net cash flows from/(used in) investing activities 2
7 356
-8 229
-873
2 935
-3 735
-800
Net cash flows used in financing activities from continuing operations
-17 068
17 068
0
-16 582
16 582
0
Net cash flows from financing activities from discontinued operations
3 397
-3 397
0
14
-14
0
Total net cash flows used in financing activities 3
-13 671
13 671
0
-16 568
16 568
0
Free cash flow from continuing operations 1
11 019
8 661
Free cash flow from discontinued operations 1
19
664
Free cash flow 1
11 038
9 325
 1  To aid in comparability, the prior year adjustments and free cash flow amounts have been revised to conform with the new free cash flow definition that was effective as of January 1, 2023.
 2  With the exception of purchases of property, plant and equipment, all net cash flows from investing activities from continuing operations and from discontinued operations are excluded from the free cash flow.
 3  Net cash flows (used in)/from financing activities from continuing operations and from discontinued operations are excluded from the free cash flow.
    
55

The following table is a summary of the free cash flow:
Third quarter
(USD millions)
Q3 2023
Q3 2022
Operating income from continuing operations
1 762
1 826
Adjustments for non-cash items
   Depreciation, amortization and impairments
3 105
2 005
   Change in provisions and other non-current liabilities
-130
228
   Other
105
191
Operating income adjusted for non-cash items from continuing operations
4 842
4 250
Dividends received from associated companies and others
1
Interest received and change in other financial receipts
146
171
Interest paid and change in other financial payments
-182
-140
Income taxes paid
-426
-260
Payments out of provisions and other net cash movements in non-current liabilities
-255
-193
Change in inventories and trade receivables less trade payables
-334
-386
Change in other net current assets and other operating cash flow items
1 512
833
Net cash flows from operating activities from continuing operations
5 304
4 275
Purchases of property, plant and equipment
-261
-221
Free cash flow from continuing operations 1
5 043
4 054
Free cash flow from discontinued operations 1, 2
0
381
Total free cash flow 1
5 043
4 435
 1  To aid in comparability, the prior year free cash flow amounts have been revised to conform with the new free cash flow definition that was effective as of January 1, 2023
 2  In the third quarter of 2023, the free cash flow from discontinued operations was zero (Q3 2022: USD 381 million cash inflow) consisting of USD 74 million (Q3 2022: USD 446 million) net cash inflows from operating activities from discontinued operations, less purchases of property, plant and equipment by discontinued operations of USD 74 million (Q3 2022: USD 65 million).
Nine months to September 30
(USD millions)
9M 2023
9M 2022
Operating income from continuing operations
7 187
6 191
Adjustments for non-cash items
   Depreciation, amortization and impairments
6 758
5 171
   Change in provisions and other non-current liabilities
232
835
   Other
335
412
Operating income adjusted for non-cash items from continuing operations
14 512
12 609
Dividends received from associated companies and others
2
1
Interest received and other financial receipts
546
208
Interest paid and other financial payments
-527
-476
Income taxes paid
-1 694
-1 368
Payments out of provisions and other net cash movements in non-current liabilities
-1 181
-451
Change in inventories and trade receivables less trade payables
-1 928
-1 664
Change in other net current assets and other operating cash flow items
1 943
412
Net cash flows from operating activities from continuing operations
11 673
9 271
Purchases of property, plant and equipment
-654
-610
Free cash flow from continuing operations 1
11 019
8 661
Free cash flow from discontinued operations 1, 2
19
664
Total free cash flow 1
11 038
9 325
 1  To aid in comparability, the prior year free cash flow amounts have been revised to conform with the new free cash flow definition that was effective as of January 1, 2023
 2  In the first nine months of 2023, the free cash flow from discontinued operations was a cash inflow of USD 19 million (9M 2022: USD 664 million) consisting of USD 238 million (9M 2022: USD 854 million) net cash inflows from operating activities from discontinued operations, less purchases of property, plant and equipment by discontinued operations of USD 219 million (9M 2022: USD 190 million).
    
56

Additional information
Net debt
Condensed consolidated changes in net debt
Third quarter
(USD millions)
Q3 2023 1
Q3 2022
Net change in cash and cash equivalents
1 520
5 101
Change in marketable securities, commodities, time deposits, financial debts and derivatives financial instruments
3 023
-3 266
Change in net debt
4 543
1 835
Net debt at July 1
-15 374
-9 519
Net debt at September 30
-10 831
-7 684
 1  Excluding net debt related to discontinued operations
Nine months to September 30
(USD millions)
9M 2023 1
9M 2022
Net change in cash and cash equivalents
4 888
-3 681
Change in marketable securities, commodities, time deposits, financial debts and derivatives financial instruments
-8 474
-3 135
Change in net debt
-3 586
-6 816
Net debt at January 1
-7 245
-868
Net debt at September 30
-10 831
-7 684
 1  Excluding net debt related to discontinued operations
Components of net debt

(USD millions)
Sep 30,
2023 1
Dec 31,
2022
Sep 30,
2022
Non-current financial debts
-18 068
-20 244
-19 732
Current financial debts and derivative financial instruments
-5 458
-5 931
-7 055
Total financial debts
-23 526
-26 175
-26 787
Less liquidity
   Cash and cash equivalents
12 405
7 517
8 726
   Marketable securities, commodities, time deposits and derivative financial instruments
290
11 413
10 377
Total liquidity
12 695
18 930
19 103
Net debt at end of period
-10 831
-7 245
-7 684
 1  Excluding net debt related to discontinued operations
Share information
Sep 30,
2023
Sep 30,
2022
Number of shares outstanding
2 055 460 483
2 150 980 441
Registered share price (CHF)
93.87
75.53
ADR price (USD)
101.86
76.01
Market capitalization (USD billions) 1
211.7
166.2
Market capitalization (CHF billions) 1
192.9
162.5
 1  Market capitalization is calculated based on the number of shares outstanding (excluding treasury shares). Market capitalization in USD is based on the market capitalization in CHF converted at the quarter end CHF/USD exchange rate.
57

Effects of currency fluctuations
Principal currency translation rates

(USD per unit)

Average
rates
Q3 2023

Average
rates
Q3 2022

Average
rates
9M 2023

Average
rates
9M 2022
Period-end
rates
Sep 30,
2023
Period-end
rates
Sep 30,
2022
1 CHF
1.132
1.034
1.109
1.051
1.097
1.023
1 CNY
0.138
0.146
0.142
0.152
0.137
0.141
1 EUR
1.088
1.007
1.084
1.065
1.059
0.980
1 GBP
1.266
1.177
1.244
1.258
1.224
1.114
100 JPY
0.692
0.724
0.726
0.785
0.672
0.692
100 RUB
1.063
1.663
1.221
1.445
1.031
1.721
Currency impact on key figures
The following table provides a summary of the currency impact on key Company figures due to their conversion into US dollars, the Company’s reporting currency, of the financial data from entities reporting in non-US dollars. Constant currency (cc) calculations apply the exchange rates of the prior year period to the current period financial data for entities reporting in non-US dollars.
Third quarter

Change in
USD %
Q3 2023
Change in
constant
currencies %
Q3 2023
Percentage
point currency
impact
Q3 2023
Net sales from continuing operations
12
12
0
Operating income from continuing operations
-4
13
-17
Net income from continuing operations
14
37
-23
Basic earnings per share (USD) from continuing operations
20
45
-25
Core operating income from continuing operations
17
21
-4
Core net income from continuing operations
18
23
-5
Core basic earnings per share (USD) from continuing operations
24
29
-5
    
Nine months to September 30

Change in
USD %
9M 2023
Change in
constant
currencies %
9M 2023
Percentage
point currency
impact
9M 2023
Net sales from continuing operations
8
10
-2
Operating income from continuing operations
16
31
-15
Net income from continuing operations
25
41
-16
Basic earnings per share (USD) from continuing operations
31
49
-18
Core operating income from continuing operations
13
19
-6
Core net income from continuing operations
15
22
-7
Core basic earnings per share (USD) from continuing operations
21
28
-7
    
58

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “guidance,” “expected,” “momentum,” “continue,” “drivers,” “confident,” “outlook,” “remain,” “committed,” “prioritized,” “prioritizing,” “continued,” “growing,” “growth,” “plans,” “on-track,” “continuing,” “anticipated,” “to follow,” “will,” “outlook,” “may,” “upcoming,” “ongoing,” “focus,” “pipeline,” “potential,” “estimated,” “launch,” “to deliver,” “transformation,” “transformative,” “address,” “planned,” “focusing,” “accelerated,” “long-term,” “innovation,” “priority,” “can,” “awaiting,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding potential future, pending or announced transactions; or regarding potential future sales or earnings of Novartis; or regarding discussions of strategy, priorities, plans, expectations or intentions, including our transformation into a “pure-play” innovative medicines business; or regarding our liquidity or cash flow positions and our ability to meet our ongoing financial obligations and operational needs; or regarding our USD 15 billion share buyback; or regarding our appeal of the negative decision of the US District Court for the District of Delaware on the validity of our patent covering Entresto and combinations of sacubitril and valsartan. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee expected benefits or synergies from the transactions described in this press release will be achieved in the expected timeframe, or at all. In particular, our expectations could be affected by, among other things: liquidity or cash flow disruptions affecting our ability to meet our ongoing financial obligations and to support our ongoing business activities; the impact of a partial or complete failure of the return to normal global healthcare systems including prescription dynamics; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding potential significant breaches of data security or data privacy, or disruptions of our information technology systems; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the development of the products described in this press release; the potential that the benefits and opportunities expected from our planned spin-off of Sandoz may not be realized or may be more difficult or take longer to realize than expected; the uncertainties in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; safety, quality, data integrity, or manufacturing issues; uncertainties involved in the development or adoption of potentially transformational technologies and business models; uncertainties regarding actual or potential legal proceedings, investigations or disputes; our performance on environmental, social and governance measures; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
All product names appearing in italics are trademarks owned by or licensed to Novartis AG and its subsidiaries. BAUSCH + LOMB is a registered trademark of Bausch & Lomb Incorporated.
59

About Novartis
Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.
Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 8:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting https://www.novartis.com/investors/event-calendar.
Detailed financial results accompanying this press release are included in the condensed interim financial report at the link below. Additional information is provided on Novartis divisions and pipeline of selected compounds in late stage development and a copy of today's earnings call presentation can be found at https://www.novartis.com/investors/event-calendar.
Important dates
November 13, 2023
Impact and Health Equity Annual Event
November 28, 2023
R&D Day
60


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