Royalty Revenue Increased 15% YOY to Record
$114.4 million
Announces Acceleration into 2023 of Remaining
$250M Share Repurchase through
ASR
GAAP Diluted EPS of $0.61 and Non-GAAP Diluted EPS of $0.751
Maintained Revenue Guidance and Raised 2023
EBITDA Guidance to $430-$445 million and Non-GAAP EPS Guidance to
$2.70-$2.80
SAN
DIEGO, Nov. 6, 2023 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company")
today reported its financial and operating results for the third
quarter ended September 30, 2023 and provided an update on its
recent corporate activities and outlook.
"I am delighted that our strong operating performance and
expense management throughout the year have resulted in an increase
to EBITDA and non-GAAP EPS guidance. Today, we also announced an
acceleration into this year of the remaining $250 million under the current approved
$750 million share repurchase plan,
authorized in 2021. This action is part of our disciplined and
balanced approach to capital allocation and reflects our assessment
that share repurchases today are a strong return on investment
opportunity," said Helen Torley,
president and CEO of Halozyme. "Supporting our conviction in
long-term revenue growth and durability, the third quarter was
remarkable, with multiple, meaningful, de-risking events and
progress for our upcoming series of Wave 3 potential product
launches, projected for 2023-2025. I am also pleased with the
progress in the quarter in advancing discussions on development of
our HVAI."
Recent Corporate Highlights:
- Announced an acceleration, into this year, of the remaining
$250 million under the current
approved $750 million share
repurchase plan authorized in 2021. The Company intends to execute
the $250 million share repurchase by
entering into an accelerated share repurchase ("ASR") transaction
with a financial Institution, immediately, subject to market
conditions.
- In August 2023, the Company
announced positive results of a clinical study with its high-volume
auto-injector demonstrating SC administration of 10 mL of a
representative biologic product co-formulated with our
ENHANZE® drug delivery technology in approximately 30
seconds. The results were presented at the 13th annual
Partnership Opportunities in Drug Delivery ("PODD") conference in
October 2023.
Recent Partner Highlights:
- In November 2023, Halozyme and
Acumen entered into a global collaboration and non-exclusive
license agreement that provides Acumen access to
ENHANZE® technology for a single target. Acumen intends
to explore the potential use of ENHANZE for ACU193, Acumen's
clinical stage monoclonal antibody candidate to target Amyloid-β
Oligomers for the treatment of early Alzheimer's disease.
- In October 2023, Bristol Myers
Squibb reported positive topline results from the Phase 3
CheckMate-67T trial evaluating a SC formulation of Opdivo
(nivolumab) with ENHANZE® in patients with advanced or
metastatic clear cell renal cell carcinoma ("ccRCC") who have
received prior systemic therapy. The study met its co-primary
pharmacokinetics ("PK") endpoints and a key secondary
endpoint.
- In September 2023, Chugai
Pharmaceuticals, a member of the Roche Group, announced that it had
obtained regulatory approval for Phesgo® from the
Ministry of Health, Labour and Welfare ("MHLW") in Japan. Halozyme is entitled to receive
royalties for Phesgo® sales in Japan under its agreement with Roche.
- In September 2023, argenx
announced the Committee for Medicinal Products for Human Use
("CHMP") of the European Medicines Agency ("EMA") has recommended
European Commission ("EC") approval of the SC injectable
formulation of efgartigimod as an add on to standard therapy for
the treatment of adult patients with generalized myasthenia gravis
("gMG") who are anti-acetylcholine receptor ("AChR") antibody
positive. The EC is expected to make a decision on the argenx
marketing authorization application within approximately 67 days
following the CHMP recommendation.
- In September 2023, Zai Lab limited (argenx commercial partner for
China) announced the Center for
Drug Evaluation ("CDE") of the National Medical Products
Administration ("NMPA") granted Breakthrough Therapy Designation
for efgartigimod alfa injection (SC injection) (efgartigimod SC)
for the treatment of patients with chronic inflammatory
demyelinating polyneuropathy ("CIDP"). The Breakthrough Therapy
Designation for efgartigimod SC was supported by data from both
global and Chinese patients enrolled in the ADHERE study.
- In September 2023, Roche informed
the Company that there will be a delay in the projected launch
timing for Tecentriq® SC in the U.S. as a result of
Roche's need to update chemistry, manufacturing, and controls
("CMC") processes for Tecentriq® SC. Roche expects these
updates to be completed in 2023 to support a potential launch of
Tecentriq® SC in the U.S. in 2024. There is no expected impact on
ex-U.S. filings for Tecentriq® SC.
- In August 2023, Roche announced
the approval of Tecentriq® SC with ENHANZE®
by the Medicines and Healthcare products Regulatory Agency ("MHRA")
in Great Britain, triggering an
$8.0 million milestone payment to
Halozyme and the right to receive royalties on net product
sales.
- In August 2023, ViiV initiated a
Phase 2b study to evaluate the
efficacy, safety, PK and tolerability of VH3810109 (N6LS)
administered subcutaneously with ENHANZE® in combination
with cabotegravir.
- In August 2023, ViiV achieved a
development milestone, which triggered a $5
million milestone payment to Halozyme.
- In July 2023, argenx reported
positive data from the ADHERE study evaluating VYVGART®
Hytrulo with ENHANZE® in adults with CIDP. The study met
its primary endpoint resulting in a 61% reduction in risk of
relapse compared to placebo.
- In July 2023, Roche announced
that the Phase III OCARINA II trial evaluating OCREVUS®
(ocrelizumab) with ENHANZE® as a twice a year 10-minute
SC injection met its primary and secondary endpoints in patients
with relapsing forms of multiple sclerosis ("MS") or primary
progressive MS ("RMS" or "PPMS").
Third Quarter 2023 Financial Highlights:
- Revenue was $216.0 million
compared to $209.0 million in the
third quarter of 2022. The 3% year-over-year increase was driven by
growth in ENHANZE® revenue streams with an increase in
royalty revenue and an increase in product sales as a result of an
increase in bulk rHuPH20 sales driven by partner demand and
continued growth in XYOSTED®, partially offset by in the
timing of milestone revenue. Revenue for the quarter included
$114.4 million in royalties, an
increase of 15% compared to $99.6
million in the prior year period, primarily attributable to
increases in revenue of subcutaneous DARZALEX®
(daratumumab) and Phesgo®.
- Cost of sales was $54.8 million,
compared to $47.3 million in the
third quarter of 2022. The increase was driven by growth in
proprietary product sales and bulk rHuPH20 demand.
- Amortization of intangibles expense was $20.3 million, compared to $27.2 million in the third quarter of 2022. The
decrease was due to a remeasurement period adjustment of our
acquired intangible assets recorded in the fourth quarter of 2022,
partially offset by an impairment charge of $2.5 million to fully impair the
TLANDO® product rights intangible asset as a result of
the license agreement termination notice provided to Lipocine in
September 2023.
- Research and development expense was $17.3 million, compared to $16.7 million in the third quarter of 2022.
Selling, general and administrative expense was $35.3 million, compared to $34.5 million in the third quarter of 2022. The
increases were primarily due to an increase in compensation
expense.
- Operating income was $88.3
million, compared to operating income of $83.3 million in the third quarter of 2022.
- Net Income was $81.8 million,
compared with net income of $61.6
million in the third quarter of 2022.
- EBITDA was $124.6 million,
compared with EBITDA of $109.8
million in the third quarter of 2022. Adjusted EBITDA was
$114.9 million, compared with
Adjusted EBITDA of $110.2 million in
the third quarter of 2022.1
- Earnings per Share: GAAP diluted earnings per share was
$0.61, compared with $0.44 in the third quarter of 2022. Non-GAAP
diluted earnings per share was $0.75,
compared with $0.74 in the third
quarter of 2022.1
- Cash, cash equivalents and marketable securities were
$483.3 million on September 30, 2023, compared to $362.8 million on December
31, 2022. The increase was primarily due to the cash
provided by operating activities, partially offset by repurchase of
common stock for $150.0 million in
the first quarter of 2023.
Financial Outlook for 2023
The Company is raising its EBITDA and non-GAAP EPS guidance
ranges to reflect strong expense management. For the full year
2023, the Company now expects:
- Total revenue of $825 million to
$845 million, representing growth of
25% to 28% over 2022 total revenue primarily driven by continued
strength in Wave 2 products, including DARZALEX® SC and
Phesgo® utilizing ENHANZE®, as well as full
year auto-injector royalty and product contribution. The Company
expects revenue from royalties of $445
million to $455 million,
representing growth of 23% to 26%.
- EBITDA of $430 million to
$445 million, representing growth of
>30% over 2022. EBITDA excludes the impact of amortization costs
related to the Antares Pharma acquisition.1
- Non-GAAP diluted earnings per share of $2.70 to $2.80,
representing growth of 22% over 20221. The Company's
earnings per share guidance does not consider the impact of
potential future share repurchases.
Table 1. 2023 Financial Guidance
|
|
Guidance
Range
|
|
Previous Guidance
Range
|
Total
Revenue
|
|
$825 to $845
million
|
|
$825 to $845
million
|
Royalty
Revenue
|
|
$445 to $455
million
|
|
$445 to $455
million
|
EBITDA
|
|
$430 to $445
million
|
|
$420 to $440
million
|
Non-GAAP Diluted
EPS
|
|
$2.70 to
$2.80
|
|
$2.65 to
$2.75
|
Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the
third quarter ended September 30, 2023 today, Monday,
November 6, 2023 at 1:30 p.m.
PT/4:30 p.m. ET. The
conference call may be accessed live with pre-registration via
link: https://conferencingportals.com/event/xUgmoVIG. The call
will also be webcast live through the "Investors" section of
Halozyme's corporate website and a recording will be made available
following the close of the call. To access the webcast and
additional documents related to the call, please visit
Halozyme.com.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. As the innovators of the
ENHANZE® technology with the proprietary enzyme rHuPH20,
Halozyme's commercially-validated solution is used to facilitate
the delivery of injected drugs and fluids in order to reduce the
treatment burden to patients. Having touched more than 700,000
patient lives in post-marketing use in seven commercialized
products across more than 100 global markets, Halozyme has licensed
its ENHANZE® technology to leading pharmaceutical and
biotechnology companies including Roche, Takeda, Pfizer, AbbVie,
Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon
Therapeutics, ViiV Healthcare, Chugai Pharmaceutical and Acumen
Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for
itself or with partners, drug-device combination products using its
advanced auto-injector technology that are designed to provide
commercial or functional advantages such as improved convenience
and tolerability, and enhanced patient comfort and adherence. The
Company has a commercial portfolio of proprietary products
including XYOSTED® and TLANDO® and
partnered commercial products and ongoing product development
programs with several pharmaceutical companies including Teva
Pharmaceuticals and Idorsia Pharmaceuticals.
Halozyme is headquartered in San
Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations
facility.
For more information visit www.halozyme.com and connect with us
on LinkedIn and Twitter.
Note Regarding Use of Non-GAAP Financial Measures
In addition to disclosing financial measures prepared in
accordance with U.S. generally accepted accounting principles
("GAAP"), this press release and the accompanying tables contain
certain non-GAAP financial measures. The Company reports earnings
before interest, taxes, depreciation, and amortization ("EBITDA"),
adjusted EBITDA and Non-GAAP diluted earnings per share, and
guidance with respect to those measures, in addition to, and not as
a substitute for, or superior to, financial measures calculated in
accordance with GAAP. The Company calculates non-GAAP diluted
earnings per share excluding share-based compensation expense,
amortization of debt discount, intangible asset amortization,
transaction costs for business combinations, realized gains or
losses on marketable security sales and certain adjustments to
income tax expense. The Company calculates EBITDA excluding
interest, taxes, depreciation and amortization. The Company
calculates adjusted EBITDA excluding transaction costs for business
combinations. Reconciliations between GAAP and Non-GAAP financial
measures are included at the end of this press release. The Company
does not provide reconciliations of forward-looking adjusted
measures to GAAP due to the inherent difficulty in forecasting and
quantifying certain amounts that are necessary for such
reconciliation, including adjustments that could be made for
changes in contingent liabilities, share-based compensation expense
and the effects of any discrete income tax items. The Company
evaluates other items of income and expense on an individual basis
for potential inclusion in the calculation of Non-GAAP financial
measures and considers both the quantitative and qualitative
aspects of the item, including (i) its size and nature, (ii)
whether or not it relates to the Company's ongoing business
operations and (iii) whether or not the Company expects it to occur
as part of the Company's normal business on a regular basis.
Non-GAAP financial measures do not have any standardized meaning
and are therefore unlikely to be comparable to similarly titled
measures presented by other companies. These non-GAAP financial
measures are not meant to be considered in isolation and should be
read in conjunction with the Company's consolidated financial
statements prepared in accordance with GAAP; and are not prepared
under any comprehensive set of accounting rules or principles. In
addition, from time to time in the future there may be other items
that the Company may exclude for purposes of its non-GAAP financial
measures; and the Company may in the future cease to exclude items
that it has historically excluded for purposes of its non-GAAP
financial measures. The Company considers these non-GAAP financial
measures to be important because they provide useful measures of
the operating performance of the Company, exclusive of factors that
do not directly affect what the Company considers to be its core
operating performance, as well as unusual events. The non-GAAP
measures also allow investors and analysts to make additional
comparisons of the operating activities of the Company's core
business over time and with respect to other companies, as well as
assessing trends and future expectations. The Company uses non-GAAP
financial information in assessing what it believes is a meaningful
and comparable set of financial performance measures to evaluate
operating trends, as well as in establishing portions of our
performance-based incentive compensation programs.
Safe Harbor Statement
In addition to historical information, the statements set forth
in this press release include forward-looking statements including,
without limitation, statements concerning the Company's financial
performance (including the Company's financial outlook for 2023)
and expectations for future growth, achieving operational goals,
profitability, return on investment, revenues (including royalty,
milestone and product sales revenue), EBITDA, non-GAAP diluted
earnings-per-share and potential share repurchase under its share
repurchase program. Forward-looking statements regarding the
Company's ENHANZE® drug delivery technology may include the
possible benefits and attributes of ENHANZE®, its potential
application to aid in the dispersion and absorption of other
injected therapeutic drugs and facilitating more rapid delivery and
administration of higher volumes of injectable medications through
subcutaneous delivery. Forward-looking statements regarding the
Company's business may include potential growth and receipt of
royalty and milestone payments driven by our partners' development
and commercialization efforts, potential new clinical trial study
starts and clinical data, regulatory submissions and product
launches, the size and growth prospects of our partners' drug
franchises, potential new or expanded collaborations and
collaborative targets and regulatory review and potential approvals
of new partnered or proprietary products and the Company's
development and partnership potential of a high volume
auto-injector. These forward-looking statements are typically, but
not always, identified through use of the words "believe,"
"enable," "may," "will," "could," "intends," "estimate,"
"anticipate," "plan," "predict," "probable," "potential,"
"possible," "should," "continue," and other words of similar
meaning and involve risk and uncertainties that could cause actual
results to differ materially from those in the forward-looking
statements. Actual results could differ materially from the
expectations contained in these forward-looking statements as a
result of several factors, including unexpected levels of revenues,
expenditures and costs, unexpected delays in the execution of the
Company's share repurchase program, unexpected results or delays in
the growth of the Company's business, or in the development,
regulatory review or commercialization of the Company's partnered
or proprietary products (including its high volume auto-injector),
regulatory approval requirements, unexpected adverse events or
patient outcomes and competitive conditions. These and other
factors that may result in differences are discussed in greater
detail in the Company's most recent Annual Report on Form 10-K and
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission. Except as required by law, the Company
undertakes no duty to update forward-looking statements to reflect
events after the date of this release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Dawn Schottlandt
Argot Partners
212-600-1902
Halozyme@argotpartners.com
Footnotes:
1. Reconciliations between GAAP reported
and non-GAAP financial information and adjusted guidance measures
are provided at the end.
Halozyme
Therapeutics, Inc
Consolidated
Statements of Operations
(Unaudited)
(In thousands,
except per share amounts)
|
|
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$ 114,433
|
|
$
99,551
|
|
$ 325,813
|
|
$ 254,496
|
Product sales,
net
|
|
86,569
|
|
61,427
|
|
221,252
|
|
129,867
|
Revenues under
collaborative agreements
|
|
15,031
|
|
47,998
|
|
52,149
|
|
94,257
|
Total
revenues
|
|
216,033
|
|
208,976
|
|
599,214
|
|
478,620
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
54,823
|
|
47,319
|
|
140,063
|
|
97,184
|
Amortization of
intangibles
|
|
20,341
|
|
27,193
|
|
56,011
|
|
38,596
|
Research and
development
|
|
17,321
|
|
16,705
|
|
55,027
|
|
44,041
|
Selling, general and
administrative
|
|
35,269
|
|
34,467
|
|
111,574
|
|
105,777
|
Total operating
expenses
|
|
127,754
|
|
125,684
|
|
362,675
|
|
285,598
|
Operating
income
|
|
88,279
|
|
83,292
|
|
236,539
|
|
193,022
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Investment and other
(expense) income, net
|
|
4,786
|
|
641
|
|
10,957
|
|
194
|
Inducement expense
related to convertible note
|
|
—
|
|
(2,712)
|
|
—
|
|
(2,712)
|
Contingent liability
fair value measurement gain
|
|
13,200
|
|
—
|
|
13,200
|
|
—
|
Interest
expense
|
|
(4,505)
|
|
(7,514)
|
|
(13,542)
|
|
(12,377)
|
Net income before
income taxes
|
|
101,760
|
|
73,707
|
|
247,154
|
|
178,127
|
Income tax
expense
|
|
19,923
|
|
12,073
|
|
50,948
|
|
33,700
|
Net income
|
|
$
81,837
|
|
$
61,634
|
|
$ 196,206
|
|
$ 144,427
|
|
|
|
|
|
|
|
|
|
Net income per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
0.62
|
|
$
0.45
|
|
$
1.48
|
|
$
1.05
|
Diluted
|
|
$
0.61
|
|
$
0.44
|
|
$
1.45
|
|
$
1.02
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net income per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
131,965
|
|
136,527
|
|
132,896
|
|
137,370
|
Diluted
|
|
134,083
|
|
139,387
|
|
135,233
|
|
141,019
|
Halozyme
Therapeutics, Inc
Consolidated Balance
Sheets
(Unaudited)
(In
thousands)
|
|
|
|
September
30,
2023
|
|
December 31,
2022
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
274,227
|
|
$
234,195
|
Marketable securities,
available-for-sale
|
|
209,055
|
|
128,599
|
Accounts receivable,
net and contract assets
|
|
217,325
|
|
231,072
|
Inventories,
net
|
|
128,921
|
|
100,123
|
Prepaid expenses and
other current assets
|
|
49,478
|
|
45,024
|
Total current
assets
|
|
879,006
|
|
739,013
|
Property and equipment,
net
|
|
74,669
|
|
75,570
|
Prepaid expenses and
other assets
|
|
18,115
|
|
26,301
|
Goodwill
|
|
416,821
|
|
409,049
|
Intangible assets,
net
|
|
490,641
|
|
546,652
|
Deferred tax assets,
net
|
|
13,410
|
|
44,426
|
Restricted
cash
|
|
—
|
|
500
|
Total
assets
|
|
$ 1,892,662
|
|
$
1,841,511
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
19,318
|
|
$
17,693
|
Accrued
expenses
|
|
95,200
|
|
96,516
|
Deferred revenue,
current portion
|
|
667
|
|
3,246
|
Current portion of
long-term debt, net
|
|
—
|
|
13,334
|
Total current
liabilities
|
|
115,185
|
|
130,789
|
Deferred revenue, net
of current portion
|
|
2,253
|
|
2,253
|
Long-term debt,
net
|
|
1,497,621
|
|
1,492,766
|
Other long-term
liabilities
|
|
28,422
|
|
30,433
|
Contingent
liability
|
|
—
|
|
15,472
|
Total
liabilities
|
|
1,643,481
|
|
1,671,713
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
|
132
|
|
135
|
Additional paid-in
capital
|
|
25,537
|
|
27,368
|
Accumulated other
comprehensive loss
|
|
1,227
|
|
(922)
|
Retained earnings
(accumulated deficit)
|
|
222,285
|
|
143,217
|
Total stockholders'
equity
|
|
249,181
|
|
169,798
|
Total liabilities and
stockholders' equity
|
|
$ 1,892,662
|
|
$
1,841,511
|
Halozyme
Therapeutics, Inc
GAAP to Non-GAAP
Reconciliations
Net Income and
Diluted EPS
(Unaudited)
(In thousands,
except per share amounts)
|
|
|
|
Three Months
Ended
September
30,
|
|
|
2023
|
|
2022
|
GAAP Net
Income
|
|
$
81,837
|
|
$
61,634
|
Adjustments:
|
|
|
|
|
Inducement expense
related to convertible notes
|
|
—
|
|
2,712
|
Share-based
compensation
|
|
9,367
|
|
6,797
|
Amortization of debt
discount
|
|
1,824
|
|
3,932
|
Amortization of
intangible assets
|
|
17,834
|
|
27,193
|
Transaction costs for
business combinations(1)
|
|
—
|
|
439
|
Amortization of
inventory step-up at fair value(2)
|
|
493
|
|
5,830
|
TLANDO Related
Adjustments:
|
|
|
|
|
Gain on changes in
fair value of contingent liability(3)
|
|
(13,200)
|
|
—
|
Inventory
write-off(3)
|
|
3,509
|
|
825
|
Impairment charge of
TLANDO product rights intangible assets(3)
|
|
2,507
|
|
|
Income tax effect of
above adjustments(4)
|
|
(3,649)
|
|
(6,034)
|
Non-GAAP Net
Income
|
|
$
100,522
|
|
$
103,328
|
|
|
|
|
|
GAAP Diluted
EPS
|
|
$
0.61
|
|
$
0.44
|
Adjustments:
|
|
|
|
|
Inducement expense
related to convertible notes
|
|
—
|
|
0.02
|
Share-based
compensation
|
|
0.07
|
|
0.05
|
Amortization of debt
discount
|
|
0.01
|
|
0.03
|
Amortization of
intangible assets
|
|
0.13
|
|
0.20
|
Transaction costs for
business combinations(1)
|
|
—
|
|
—
|
Amortization of
inventory step-up at fair value(2)
|
|
—
|
|
0.04
|
TLANDO Related
Adjustments:
|
|
|
|
|
Gain on changes in
fair value of contingent liability(3)
|
|
(0.10)
|
|
—
|
Inventory
write-off(3)
|
|
0.03
|
|
0.01
|
Impairment charge of
TLANDO product rights intangible assets(3)
|
|
0.02
|
|
—
|
Income tax effect of
above adjustments(4)
|
|
(0.03)
|
|
(0.04)
|
Non-GAAP Diluted
EPS
|
|
$
0.75
|
|
$
0.74
|
|
|
|
|
|
GAAP & Non-GAAP
Diluted Shares
|
|
134,083
|
|
139,387
|
|
Dollar amounts, as
presented, are rounded. Consequently, totals may not add
up.
|
(1)
|
Amount represents
incremental costs including legal fees, accounting fees and
advisory fees incurred for the Antares acquisition.
|
(2)
|
Amounts relate to
amortization of the inventory step-up associated with purchase
accounting for the Antares acquisition.
|
(3)
|
Amounts relate to fair
value gain on contingent liability, inventory write-off and
impairment of TLANDO product rights intangible assets due to the
termination of the TLANDO license agreement in September
2023.
|
(4)
|
Adjustments relate to
taxes for the reconciling items, as well as excess benefits or tax
deficiencies from stock-based compensation, and the quarterly
impact of other discrete items.
|
Halozyme
Therapeutics, Inc
GAAP to Non-GAAP
Reconciliations
Diluted
EPS
|
|
|
|
Twelve Months
Ended
December 31,
2022
|
|
2023
Guidance
|
|
Percentage
Change
|
|
|
|
|
|
|
|
GAAP Diluted
EPS
|
|
$
1.44
|
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
Inducement expense
related to convertible notes
|
|
0.02
|
|
|
|
|
Share-based
compensation
|
|
0.17
|
|
|
|
|
Amortization of debt
discount
|
|
0.06
|
|
|
|
|
Amortization of
intangible assets
|
|
0.31
|
|
|
|
|
Transaction costs for
business combinations(1)
|
|
0.16
|
|
|
|
|
Severance and
share-based compensation acceleration
expense(2)
|
|
0.16
|
|
|
|
|
Amortization of
inventory step-up at fair value(3)
|
|
0.06
|
|
|
|
|
Realized loss from
marketable securities(4)
|
|
0.01
|
|
|
|
|
Income tax effect of
above adjustments(5)
|
|
(0.17)
|
|
|
|
|
Non-GAAP Diluted
EPS
|
|
$
2.21
|
|
$2.70 -
$2.80
|
|
22% -
27%
|
|
Dollar amounts, as
presented, are rounded. Consequently, totals may not add
up.
|
(1)
|
Amount represents
incremental costs including legal fees, accounting fees and
advisory fees incurred for the Antares acquisition.
|
(2)
|
Amount represents
severance cost and acceleration of unvested equity awards as part
of the Antares merger agreement.
|
(3)
|
Amount related to
amortization of the inventory step-up associated with purchase
accounting for the Antares acquisition.
|
(4)
|
Amount represents
realized loss from the sale of our marketable securities to finance
the acquisition of Antares.
|
(5)
|
Adjustments relate to
taxes for the reconciling items, as well as excess benefits or tax
deficiencies from stock-based compensation, and the quarterly
impact of other discrete items.
|
Halozyme
Therapeutics, Inc
GAAP to Non-GAAP
Reconciliations
EBITDA
(Unaudited)
(In
thousands)
|
|
|
|
Three Months
Ended
September
30,
|
|
|
2023
|
|
2022
|
GAAP Net
Income
|
|
$
81,837
|
|
$
61,634
|
Adjustments:
|
|
|
|
|
Investment and other
income
|
|
(4,786)
|
|
(641)
|
Interest
expense
|
|
4,505
|
|
7,514
|
Income tax
expense
|
|
19,923
|
|
12,073
|
Depreciation and
amortization
|
|
23,078
|
|
29,203
|
EBITDA
|
|
124,557
|
|
109,783
|
Adjustments:
|
|
|
|
|
Gain on changes in
fair value of contingent liability
|
|
(13,200)
|
|
—
|
Inventory
write-off
|
|
3,509
|
|
—
|
Transaction costs for
business combinations
|
|
—
|
|
439
|
Adjusted
EBITDA
|
|
$
114,866
|
|
$
110,222
|
Halozyme
Therapeutics, Inc
GAAP to Non-GAAP
Reconciliations
EBITDA
(Unaudited)
(In
millions)
|
|
|
|
Twelve Months
Ended
December 31,
2022
|
|
2023 Guidance
Range
|
|
Percentage
Change
|
GAAP Net
Income
|
|
$
202
|
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
Investment and other
income
|
|
(1)
|
|
|
|
|
Interest
expense
|
|
17
|
|
|
|
|
Income tax
expense
|
|
47
|
|
|
|
|
Depreciation and
amortization
|
|
50
|
|
|
|
|
EBITDA
|
|
315
|
|
$430 -
$445
|
|
37% -
41%
|
Adjustments:
|
|
|
|
|
|
|
Severance and
share-based compensation acceleration expense
|
|
23
|
|
|
|
|
Transaction costs for
business combinations
|
|
22
|
|
|
|
|
Gain on changes in
fair value of contingent liability
|
|
|
|
(13)
|
|
|
Inventory
write-off
|
|
|
|
3
|
|
|
Adjusted
EBITDA
|
|
$
360
|
|
$425 -
$440
|
|
18% -
22%
|
|
Dollar amounts, as
presented, are rounded. Consequently, totals may not add
up.
|
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SOURCE Halozyme Therapeutics, Inc.