Core royalty platform continued strong
performance, receiving GSK royalties of $60.5 million with 6%
year-over-year growth
Innoviva Specialty Therapeutics’ (IST) marketed
portfolio achieved U.S. net product sales of $19.7 million,
reflecting 68% year-over-year growth
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 third quarter ended September 30, 2024,
and highlighted select corporate achievements.
“For the third quarter of 2024, we continue to deliver strong
revenue growth, with solid performance from our core GSK royalty
assets, and accelerating sales from our IST commercial products,
GIAPREZA®, XACDURO® and XERAVA®. Since the formation of IST, now in
its second year of operation, we have shown consistent sales
expansion in our commercial products, primarily driven by
increasing product demand, validating our investment in
hospital-based therapeutics,” said Pavel Raifeld, Chief Executive
Officer of Innoviva. “Of special note, XACDURO® was nominated for
the Best Biotechnology Product by The Galien Foundation USA in
recognition of its pioneering science and positive impact on
patients. We are proud of this recognition which highlights the
commitment and innovation we are bringing to this space, where
there is significant unmet medical need and an immense demand for
new drugs. We also continue to further advance our pipeline and are
on track to submit a New Drug Application (“NDA”) for zoliflodacin,
potentially first in class, single dose oral drug for the treatment
of uncomplicated gonorrhea, to the U.S. FDA in early 2025.”
Mr. Raifeld continued, “Over the past quarter, we also saw
meaningful operational progress across our strategic healthcare
assets. We remain focused on prudent capital allocation in our
quest to maximize shareholder value and see multiple opportunities
for continued value creation.”
Financial Highlights
- Royalty revenue: Third quarter 2024 gross royalty
revenue from Glaxo Group Limited (“GSK”) was $60.5 million,
compared to $57.0 million for the third quarter 2023.
- Net Product Sales: Third quarter 2024 net product sales
were $27.8 million, which included U.S. net product sales of $19.7
million and ex-U.S. product sales of $8.1 million. U.S. net product
sales consisted of $13.1 million from GIAPREZA®, $2.3 million from
XERAVA®, and $4.3 million from XACDURO®, a 68% increase compared to
$11.8 million for the third quarter 2023.
- License Revenue: Third quarter 2024 license revenue of
$4.6 million included product development cost-sharing
reimbursements from our partner.
- Equity and long-term investments: Third quarter 2024
unfavorable net change in fair value of equity and long-term
investments of $35.2 million was primarily due to lower share price
of Armata Pharmaceuticals (“Armata”).
- Net income: Net income of $1.2 million, or $0.02 basic
per share, for the third quarter of 2024, compared to a net income
of $82.0 million, or $1.26 basic per share, for the third quarter
of 2023.
- Cash and cash equivalents: Totaled $260.6 million.
Royalty and product sales receivables totaled $91.1 million as of
September 30, 2024.
Key Business and R&D Highlights
- XACDURO® (sulbactam for injection; durlobactam for
injection), co-packaged for intravenous use, a targeted
antibacterial treatment for patients with hospital-acquired
bacterial pneumonia and ventilator-associated bacterial pneumonia
(HABP/VABP) caused by susceptible isolates of Acinetobacter
baumannii-calcoaceticus complex.
- XACDURO® was recently nominated for the 2024 Prix Galien
USA Award for Best Biotechnology Product, which recognizes
excellence in scientific innovation that improves the state of
human health.
- Zoliflodacin: a potential first-in-class, single dose,
oral antibiotic is currently being developed in partnership with
The Global Antibiotic Research & Development Partnership
("GARDP") for the treatment of patients with uncomplicated
gonorrhea.
- In September 2024, we presented additional findings on our
investigational agent zoliflodacin at the 2024 Sexually Transmitted
Infections Prevention Conference in Atlanta. The first oral
presentation demonstrated that zoliflodacin had potent in vitro
activity against 200 clinical isolates, consistent with previous
U.S. surveillance data. The second presentation demonstrated that
microbiological cure rates for specific subgroups were comparable
to the primary endpoint analysis. Safety in these subgroups was
also comparable.
- In October 2024, we had five presentations at IDWeek 2024,
which took place in Los Angeles. One oral presentation on
zoliflodacin included a review of the unique public-private
partnership that led the clinical development of zoliflodacin. The
second presentation highlighted the activity of
sulbactam-durlobactam and standard-of-care antibiotics against
Acinetobacter baumannii-calcoaceticus complex for hospitalized
patients in the U.S. Three posters were presented including two on
zoliflodacin: In vitro activity against baseline isolates in U.S.
participants from the phase 3 trial and a pharmacometrics analysis
supporting dose selection. Surveillance data of eravacycline
against clinical pathogens, collected worldwide from multiple
infections sites during 2018-2022 was also presented.
- We continue to advance zoliflodacin following its successful
Phase 3 clinical trial results and expect to submit an NDA to the
U.S. FDA in early 2025.
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® and BREO® 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, 2023 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 and
Comprehensive Income (in thousands, except per share data)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2024
2023
2024
2023
Revenue:
Royalty revenue, net (1)
$
57,056
$
53,558
$
179,213
$
172,681
Net product sales
27,822
13,701
68,557
40,942
License revenue
4,630
-
19,135
11,000
Total revenue
89,508
67,259
266,905
224,623
Expenses:
Cost of products sold (inclusive of amortization
of inventory fair value adjustments)
9,990
10,182
29,433
27,910
Cost of license revenue
-
-
-
1,600
Selling, general and administrative
26,219
28,636
84,364
71,913
Research and development
3,551
3,989
9,989
31,566
Amortization of acquired intangible assets
6,511
6,511
19,391
15,274
Changes in fair values of equity method
investments, net
18,231
(71,980
)
42,997
(67,886
)
Changes in fair values of equity and long-term
investments, net
16,936
2,640
60,827
4,887
Interest and dividend income
(5,500
)
(4,114
)
(13,373
)
(11,032
)
Interest expense
5,807
4,396
17,460
13,205
Other expense, net
914
1,047
3,123
4,289
Total expenses, net
82,659
(18,693
)
254,211
91,726
Income before income taxes
6,849
85,952
12,694
132,897
Income tax expense, net
5,636
3,906
9,634
14,706
Net income
and comprehensive income
$
1,213
$
82,046
$
3,060
$
118,191
Net
income per share
Basic
$
0.02
$
1.26
$
0.05
$
1.79
Diluted
$
0.02
$
0.98
$
0.05
$
1.45
Shares used to compute net income per share
Basic
62,569
64,953
62,759
66,016
Diluted
62,951
86,164
63,020
87,504
(1) Total net revenue is comprised of the following (in thousands):
Three
Months Ended Nine Months Ended September 30,
September 30,
2024
2023
2024
2023
(unaudited) (unaudited)
Royalties
$
60,512
$
57,014
$
189,581
$
183,049
Amortization of capitalized fees
(3,456
)
(3,456
)
(10,368
)
(10,368
)
Royalty revenue, net
$
57,056
$
53,558
$
179,213
$
172,681
INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands)
(unaudited) September 30,
December 31,
2024
2023
Assets Cash and cash equivalents
$
260,630
$
193,513
Royalty and product sale receivables
91,058
84,075
Inventory
34,236
40,737
Prepaid expense and other current assets
14,697
25,894
Property and equipment, net
544
483
Equity and long-term investments
507,718
560,978
Capitalized fees paid, net
73,416
83,784
Right-of-use assets
2,789
2,536
Goodwill
17,905
17,905
Intangible assets
210,944
230,335
Deferred tax asset, net
14,875
-
Other assets
2,800
3,267
Total assets
$
1,231,612
$
1,243,507
Liabilities
and stockholders’ equity Other current
liabilities
$
30,357
$
33,435
Accrued interest payable
833
3,422
Deferred revenue
717
1,277
Convertible senior notes, due 2025, net
191,843
191,295
Convertible senior notes, due 2028, net
255,972
254,939
Other long-term liabilities
71,449
71,870
Deferred tax liabilities, net
-
563
Income tax payable, long-term
11,899
11,751
Innoviva stockholders’ equity
668,542
674,955
Total
liabilities and stockholders’ equity
$
1,231,612
$
1,243,507
INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited)
Nine Months Ended September 30,
2024
2023
Net cash provided by operating activities
$
129,451
$
107,808
Net cash used in investing activities
(48,308
)
(61,610
)
Net cash used in financing activities
(14,026
)
(157,250
)
Net change
67,117
(111,052
)
Cash and cash equivalents at beginning of period
193,513
291,049
Cash and cash equivalents at end of period
$
260,630
$
179,997
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241106330461/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
Innoviva (NASDAQ:INVA)
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