Core royalty platform on track; received GSK
royalties of $69.6 million for fourth quarter
Achieved net product revenues of $19.7 million
for the fourth quarter of 2023 representing 35% year on year
growth
Strong pipeline progress in 2023: Approval and
launch of first pathogen targeted antibacterial XACDURO® for
treatment of HABP/VABP caused by Acinetobacter infections; positive
topline Phase 3 data for oral drug zoliflodacin for treatment of
uncomplicated gonorrhea
Repurchased 1.1 million our common stock for
$15.4 million in the fourth quarter of 2023
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a
diversified holding company with a core royalties portfolio, a
leading critical care and infectious disease platform known as
Innoviva Specialty Therapeutics (“IST”), and a portfolio of
strategic investments in healthcare assets, today reported
financial results for the fourth quarter and full year ended
December 31, 2023 and highlighted select corporate
achievements.
Pavel Raifeld, Chief Executive Officer of Innoviva, said: “2023
was a successful and transformational year for Innoviva. We have
seen continued strong cash flow from our core royalty portfolio,
which we have been investing prudently with a laser focus on
driving long-term shareholder value. Last year showcased the
success of our approach with the formation and significant pipeline
and commercial progress of our therapeutics platform, which is
focused on becoming the industry leader in critical care and
infectious disease.”
Matthew Ronsheim, Ph.D., President of IST, noted, “Our
therapeutics platform achieved tremendous success in its first
year: we saw the approval and launch of XACDURO®, the first
pathogen targeted antibacterial approved by the FDA for life
threatening Acinetobacter infections caused by susceptible
isolates; we reported positive Phase III data for zoliflodacin, the
potential first novel oral treatment for gonorrhea; and our
targeted and lean commercial platform delivered meaningful growth
in our core marketed products GIAPREZA® and XERAVA®. With our
best-in-class capabilities and leverageable commercial
infrastructure, we are excited about our ability to deliver
life-saving drugs to patients in areas of high unmet medical need
and about our significant growth prospects in the coming
years.”
Mr. Raifeld concluded, “Innoviva’s strong financials reflect a
new royalty base (following value-accretive 2022 TRELEGY® ELLIPTA®
royalties monetization), a full year of integrated operations for
our therapeutics platform, and significant value creation in our
strategic healthcare assets. Innoviva continued to exercise
financial discipline and ended the year with over $275 million in
cash and account receivables, while returning capital with share
repurchases of over $75 million and paying down outstanding debt of
nearly $100 million. We believe our diversified growth strategy, a
strong leadership team, and our focus on cost discipline position
us well to deliver shareholder value.”
Financial Highlights
- Royalty revenue: Fourth quarter 2023 gross royalty
revenue from Glaxo Group Limited (“GSK”) was $69.6 million and full
year was $252.7 million, compared to $54.7 million for the fourth
quarter of 2022 and $253.4 million for the full year 2022.
- Net Product Sales: Fourth quarter 2023 net product sales
and license revenue were $19.7 million, which included $13.1
million from GIAPREZA®, $5.2 million from XERAVA®, and $1.4 million
from XACDURO®, compared to $14.6 million for the fourth quarter of
2022. Full year 2023 net product sales and license revenue was
$71.6 million, which included $41.3 million from GIAPREZA®, $17.3
million from XERAVA®, $2.0 million from XACDURO®, and $11.0 million
in milestone payments from our partners.
- Equity and long-term investments: Fourth quarter and
full year 2023 change in fair values of equity and long-term
investments of $25.5 million and $88.5 million, respectively, was
primarily attributable to Armata Pharmaceuticals (“Armata”) share
price appreciation.
- Net income: Fourth quarter 2023 net income was $61.5
million, or $0.97 basic per share, compared to a net loss of $68.3
million, or $(0.98) basic per share, for the fourth quarter 2022,
driven primarily by higher revenue and positive impact of change in
fair values of equity. Full year 2023 net income was $179.7
million, or $2.75 basic per share, compared to net income of $213.9
million, or $3.07 basic per share, for the full year 2022.
- Share repurchase: During the fourth quarter 2023,
Innoviva repurchased 1,121,835 shares of its outstanding common
stock for $15.4 million. During the year 2023, Innoviva repurchased
6,173,565 shares of its outstanding common stock for $76.5 million.
Approximately $15 million of the authorized program remains
outstanding as of year-end.
- Cash and cash equivalents: Totaled $193.5 million.
Royalty and net product sales receivables totaled $84.1 million as
of December 31, 2023.
Key 2023 R&D Highlights
- Zoliflodacin: potential first-in-class oral antibiotic
to treat uncomplicated gonorrhea
- In November 2023, in collaboration with The Global Antibiotic
Research & Development Partnership (GARDP), Innoviva announced
that zoliflodacin, a first-in-class antibiotic, met its primary
endpoint in a global pivotal phase 3 clinical trial for the
treatment of uncomplicated gonorrhea. The Company expects a New
Drug Application to be submitted to the U.S. FDA in the next twelve
months.
- XACDURO® (sulbactam for injection; durlobactam for
injection), co-packaged for intravenous use: targeted antibacterial
for HABP/VABP caused by Acinetobacter
- In May 2023, the U.S. Food and Drug Administration (FDA)
approved XACDURO® for use in patients 18 years of age and older for
the treatment of hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia (HABP/VABP) caused by
susceptible isolates of Acinetobacter baumannii-calcoaceticus
complex.
- Earlier in May, The Lancet Infectious Diseases published
detailed results from the pivotal Phase 3 ATTACK trial of
sulbactam-durlobactam.
Update on Strategic Healthcare Assets
- Our portfolio of strategic assets under the Company’s various
subsidiaries was valued at $561.0 million as of December 31, 2023.
In fourth quarter 2023, Innoviva invested an additional $5.0
million in one of our assets, Gate Neurosciences, to support its
strategy of developing next generation targeted CNS therapies.
About Innoviva
Innoviva is a diversified holding company with a core royalties
portfolio, a leading critical care and infectious disease platform
known as Innoviva Specialty Therapeutics (“IST”), and a portfolio
of strategic investments in healthcare assets. Innoviva’s royalty
portfolio includes respiratory assets partnered with Glaxo Group
Limited (“GSK”) Innoviva is entitled to receive royalties from GSK
on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s
other innovative healthcare assets include infectious disease and
critical care assets stemming from acquisitions of Entasis
Therapeutics, including XACDURO® (sulbactam for injection;
durlobactam for injection), co-packaged for intravenous use
approved for the treatment of adults with hospital-acquired
bacterial pneumonia and ventilator-associated bacterial pneumonia
caused by susceptible strains of Acinetobacter
baumannii-calcoaceticus complex and the investigational
zoliflodacin currently being developed for the treatment of
uncomplicated gonorrhea, and La Jolla Pharmaceutical Company,
including GIAPREZA® (angiotensin II), approved to increase blood
pressure in adults with septic or other distributive shock and
XERAVA® (eravacycline) for the treatment of complicated
intra-abdominal infections in adults.
ANORO®, RELVAR®, BREO® and TRELEGY® are trademarks of the GSK
group of companies.
Forward Looking Statements
This press release contains certain “forward-looking” statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995 regarding, among other things, statements relating to
goals, plans, objectives, and future events. Innoviva intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. The words “anticipate”, “expect”,
“goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”,
“target” and similar expressions are intended to identify such
forward-looking statements. Such forward-looking statements involve
substantial risks, uncertainties, and assumptions. These statements
are based on the current estimates and assumptions of the
management of Innoviva as of the date of this press release and are
subject to known and unknown risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause the
actual results of Innoviva to be materially different from those
reflected in the forward-looking statements. Important factors that
could cause actual results to differ materially from those
indicated by such forward-looking statements include, among others,
risks related to: expected cost savings; lower than expected future
royalty revenue from respiratory products partnered with GSK; the
commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®,
GIAPREZA®, XERAVA® and XACDURO® in the jurisdictions in which these
products have been approved; the strategies, plans and objectives
of Innoviva (including Innoviva’s growth strategy and corporate
development initiatives); the timing, manner, and amount of
potential capital returns to shareholders; the status and timing of
clinical studies, data analysis and communication of results; the
potential benefits and mechanisms of action of product candidates;
expectations for product candidates through development and
commercialization; the timing of regulatory approval of product
candidates; and projections of revenue, expenses and other
financial items; the impact of the novel coronavirus (“COVID-19”);
the timing, manner and amount of capital deployment, including
potential capital returns to stockholders; and risks related to the
Company’s growth strategy. Other risks affecting Innoviva are
described under the headings “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” contained in Innoviva’s Annual Report on Form 10-K for
the year ended December 31, 2022 and Quarterly Reports on Form
10-Q, which are on file with the Securities and Exchange Commission
(“SEC”) and available on the SEC’s website at www.sec.gov. Past
performance is not necessarily indicative of future results. No
forward-looking statements can be guaranteed, and actual results
may differ materially from such statements. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. The information in this press release
is provided only as of the date hereof, and Innoviva assumes no
obligation to update its forward-looking statements on account of
new information, future events or otherwise, except as required by
law.
INNOVIVA, INC. Condensed Consolidated Statements of Income (in
thousands, except per share data) (Unaudited)
Three
Months Ended Year Ended December 31, December
31,
2023
2022
2023
2022
Revenue:
Royalty revenue, net (1)
$
66,165
$
51,216
$
238,846
$
311,645
Net product sales
19,675
14,587
60,617
19,694
License Revenue
-
-
11,000
-
Total revenue
85,840
65,803
310,463
331,339
Expenses:
Cost of products sold (inclusive of amortization of
inventory fair value adjustments)
13,130
10,113
41,040
13,793
Cost of license revenue
-
-
1,600
-
Selling, general and administrative
26,319
17,454
98,232
63,538
Research and development
2,356
9,985
33,922
41,432
Amortization of acquired intangible assets
6,510
4,070
21,784
5,581
Gain on TRC sale
-
-
-
(266,696
)
Loss on debt extinguishment
-
-
-
20,662
Changes in fair values of equity method
investments, net
(9,506
)
117,274
(77,392
)
161,749
Changes in fair values of equity and long-term
investments, net
(16,016
)
(31,868
)
(11,129
)
(8,462
)
Interest and dividend income
(4,786
)
(3,188
)
(15,818
)
(6,369
)
Interest expense
5,952
4,028
19,157
15,789
Other expense (income), net
680
2,623
4,969
3,373
Total expenses
24,639
130,491
116,365
44,390
Income before income taxes
61,201
(64,688
)
194,098
286,949
Income tax expense
(330
)
3,626
14,376
66,687
Net income
61,531
(68,314
)
179,722
220,262
Net income
attributable to noncontrolling interest
-
-
-
6,341
Net income
attributable to Innoviva stockholders
$
61,531
$
(68,314
)
$
179,722
$
213,921
Basic net income per share attributable to Innoviva stockholders
$
0.97
$
(0.98
)
$
2.75
$
3.07
Diluted net income per share attributable to Innoviva stockholders
$
0.76
$
(0.98
)
$
2.20
$
2.37
Shares used to compute basic net income per share
63,710
69,656
65,435
69,644
Shares used to compute diluted net income per share
84,995
69,656
86,876
95,248
(1) Total net revenue is comprised of the
following (in thousands):
Three Months Ended Year
Ended December 31, December 31,
2023
2022
2023
2022
(unaudited) (unaudited)
Royalties
$
69,620
$
54,671
$
252,669
$
325,468
Amortization of capitalized fees
(3,455
)
(3,455
)
(13,823
)
(13,823
)
Royalty revenue, net
$
66,165
$
51,216
$
238,846
$
311,645
INNOVIVA,
INC. Condensed Consolidated Balance Sheets (in
thousands) (unaudited)
December 31, December 31,
2023
2022
Assets Cash and cash
equivalents
$
193,513
$
291,049
Royalty and product sale receivables
84,075
64,073
Inventory, net
40,737
55,897
Prepaid expense and other current assets
25,894
32,492
Property and equipment, net
483
170
Equity and long-term investments
560,978
403,013
Capitalized fees
83,784
97,607
Right-of-use assets
2,536
3,265
Goodwill
17,905
26,713
Intangible assets
230,335
252,919
Other assets
3,267
4,299
Total
assets
$
1,243,507
$
1,231,497
Liabilities and stockholders’ equity
Other current liabilities
$
33,435
$
32,322
Accrued interest payable
3,422
4,359
Deferred revenues
1,277
2,094
Convertible subordinated notes, due 2023, net
-
96,193
Convertible senior notes, due 2025, net
191,295
190,583
Convertible senior notes, due 2028, net
254,939
253,597
Other long term liabilities
71,870
70,918
Deferred tax liabilities
563
5,771
Income tax payable - long term
11,751
9,872
Innoviva stockholders’ equity
674,955
565,788
Total
liabilities and stockholders’ equity
$
1,243,507
$
1,231,497
INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited)
Year Ended December 31,
2023
2022
Net cash provided by operating activities
$
141,064
$
201,726
Net cash used in investing activities
(66,761
)
(56,634
)
Net cash used in financing activities
(171,839
)
(55,568
)
Net change
$
(97,536
)
$
89,524
Cash and cash equivalents at beginning of period
291,049
201,525
Cash and cash equivalents at end of period
$
193,513
$
291,049
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240229441244/en/
Innoviva, Inc. David Patti Corporate Communications (908)
421-5971 david.patti@inva.com Investors and Media: Argot Partners
(212) 600-1902 innoviva@argotpartners.com
Grafico Azioni Innoviva (NASDAQ:INVA)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Innoviva (NASDAQ:INVA)
Storico
Da Gen 2024 a Gen 2025
