Received GSK royalties of $57.0 million and net
product revenues of $13.7 million in the third quarter of 2023
Launched first-in-class therapy XACDURO® for
treatment of hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia caused by susceptible
strains of Acinetobacter
Announced positive topline Phase 3 zoliflodacin
data for treatment of gonorrhea in November 2023
Repurchased $11.0 million of common stock
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a
diversified holding company with a portfolio of royalties and other
healthcare assets, today reported financial results for the third
quarter ended September 30, 2023, highlighted select corporate
achievements and provided an overview of its key business
initiatives.
- Gross royalty revenue from Glaxo Group Limited (“GSK”) for the
third quarter 2023 was $57.0 million, which included royalties of
$45.6 million from global net sales of RELVAR®/BREO® ELLIPTA® and
royalties of $11.4 million from global net sales of ANORO® ELLIPTA®
compared to $65.6 million for the third quarter of 2022, which
included royalties of $55.7 million from global net sales of
RELVAR®/BREO® ELLIPTA® and $9.9 million from global net sales of
ANORO® ELLIPTA®, respectively.
- Net product sales and license revenue for the third quarter of
2023 was $13.7 million, which included $8.0 million from GIAPREZA®
net sales, $5.1 million from XERAVA® net sales and $0.6 million
from XACDURO® net sales.
- Net income was $82.0 million, or $1.26 basic per share, for the
third quarter of 2023, compared to net income of $265.5 million, or
$3.81 basic per share, for the third quarter of 2022; the decrease
was primarily driven by non-repeated gain on sales of our
subsidiary, Theravance Respiratory Company, and its TRELEGY®
ELLIPTA® royalty stream in July 2022.
- Cash and cash equivalents totaled $180.0 million. Royalty,
product sales and milestone receivables totaled $67.8 million as of
September 30, 2023.
"The third quarter of 2023 was marked by significant revenues
stemming from our royalty portfolio and solid performance by our
internal product portfolio,” said Pavel Raifeld, Chief Executive
Officer of Innoviva. “A few weeks ago, we launched XACDURO® in the
United States and are encouraged by the market receptivity.
Moreover, we announced positive topline data from the Phase 3 trial
of our lead pipeline asset, zoliflodacin, and are excited about its
potential to affect the treatment paradigm for gonorrhea patients,
especially in the presence of antimicrobial resistance concerns.
These milestones reinforce the strength and promise of our
infectious disease and critical care business.”
Mr. Raifeld concluded, “We continued to exercise cost discipline
and saw meaningful operational progress among our investees. In
addition, we benefited from significant increases in the equity
fair values of our investments. We are confident in the prospects
of our business and plan to continue to pursue shareholder-friendly
policies, such as share repurchases.”
Third Quarter 2023 and Recent Highlights
GSK Net Sales
- Third quarter 2023 net sales of RELVAR®/BREO® ELLIPTA® by GSK
were $303.9 million with $109.5 million in net sales from the U.S.
market and $194.4 million from non-U.S. markets.
- Third quarter 2023 net sales of ANORO® ELLIPTA® by GSK were
$175.8 million with $89.2 million net sales from the U.S. market
and $86.6 million from non-U.S. markets.
Corporate Updates
- During the third quarter of 2023, Innoviva repurchased 856,750
shares of its outstanding common stock for $11.0 million.
- On July 10, 2023, Innoviva’s wholly owned subsidiary, Innoviva
Strategic Opportunities, entered into a credit and security
agreement with Armata Pharmaceuticals, Inc. (NYSE: ARMP) (“Armata”)
and invested $25.0 million to advance Armata’s pipeline of
therapeutic phage candidates and support the buildout of its
state-of-the art cGMP manufacturing facility.
- On August 21, 2023, Innoviva appointed Stephen Basso as Chief
Financial Officer.
Clinical Updates
- In September 2023, Innoviva’s wholly owned subsidiary, Innoviva
Specialty Therapeutics, launched XACDURO® (sulbactam for injection;
durlobactam for injection), co-packaged for intravenous 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 (Acinetobacter).
XACDURO® is the first and only pathogen-targeted antibiotic and a
significant advancement in the way healthcare professionals treat
Acinetobacter.
- In November 2023, in collaboration with The Global Antibiotic
Research & Development Partnership (GARDP), we 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, a prevalent disease affecting over 80
million patients a year globally with rapidly rising antimicrobial
resistance concerns. Study investigators found that oral
zoliflodacin demonstrated statistical non-inferiority of
microbiological cure at the urogenital site when compared to
treatment with intramuscular injection of ceftriaxone and oral
azithromycin, a current global standard of care regimen. In the
study, zoliflodacin demonstrated a favorable safety profile and was
generally well tolerated, with the majority of adverse events being
mild-to-moderate. There were no discontinuations reported due to
adverse events, serious adverse events, or deaths.
About Innoviva
Innoviva is a diversified holding company with a portfolio of
royalties and other healthcare assets. Innoviva’s royalty portfolio
includes respiratory assets partnered with Glaxo Group Limited
(“GSK”), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/
vilanterol, “FF/VI”) and ANORO® ELLIPTA® (umeclidinium bromide/
vilanterol, “UMEC/VI”). Under the Long-Acting Beta2 Agonist
(“LABA”) Collaboration Agreement, 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 hospital 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 (Acinetobacter) 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, 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
Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
Revenue: Royalty revenue, net (1)
$
53,558
$
62,150
$
172,681
$
260,429
Net product sales
13,701
5,107
40,942
5,107
License revenue
-
-
11,000
-
Total revenue
67,259
67,257
224,623
265,536
Expenses: Cost of products sold (inclusive of amortization of
inventory fair valueadjustments, excluding depreciation and
amortization of intangible assets)
10,182
3,680
27,910
3,680
Cost of license revenue
-
-
1,600
-
Selling, general and administrative
28,636
27,810
71,913
46,084
Research and development
3,989
11,725
31,566
31,447
Amortization of acquired intangible assets
6,511
1,511
15,274
1,511
Gain on sale of Theravance Respiratory Company, LLC (“TRC”)
-
(266,696
)
-
(266,696
)
Loss on debt extinguishment
-
-
-
20,662
Changes in fair values of equity method investments, net
(71,980
)
(10,298
)
(67,886
)
44,475
Changes in fair values of equity and long-term investments, net
2,640
10,168
4,887
23,406
Interest and dividend income
(4,114
)
(2,135
)
(11,032
)
(3,181
)
Interest expense
4,396
5,096
13,205
11,761
Other expense, net
1,047
(28
)
4,289
750
Total expenses
(18,693
)
(219,167
)
91,726
(86,101
)
Income before income taxes
85,952
286,424
132,897
351,637
Income tax expense
3,906
57,077
14,706
63,061
Net income
82,046
229,347
118,191
288,576
Net income attributable to noncontrolling interest
-
(36,176
)
-
6,341
Net income attributable to Innoviva stockholders
$
82,046
$
265,523
$
118,191
$
282,235
Basic net income per share attributable to Innoviva
stockholders
$
1.26
$
3.81
$
1.79
$
4.05
Diluted net income per share attributable to Innoviva stockholders
$
0.98
$
2.80
$
1.45
$
3.07
Shares used to compute basic net income per share
64,953
69,731
66,016
69,640
Shares used to compute diluted net income per share
86,164
95,830
87,504
95,072
(1) Total net revenue is comprised of the following (in thousands):
Three Months Ended
Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
(unaudited) (unaudited) Royalties
$
57,014
$
65,606
$
183,049
$
270,797
Amortization of capitalized fees
(3,456
)
(3,456
)
(10,368
)
(10,368
)
Royalty revenue, net
$
53,558
$
62,150
$
172,681
$
260,429
INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands)
(unaudited)
September 30,
December 31,
2023
2022
Assets Cash and cash equivalents
$
179,997
$
291,049
Royalty and product sale receivables
67,765
64,073
Inventory, net
40,515
55,897
Prepaid expense and other current assets
16,722
32,492
Property and equipment, net
361
170
Equity and long-term investments
529,531
403,013
Capitalized fees
87,239
97,607
Right-of-use assets
2,828
3,265
Goodwill
17,905
26,713
Intangible assets
236,845
252,919
Deferred tax assets
4,952
-
Other assets
3,444
4,299
Total assets
$
1,188,104
$
1,231,497
Liabilities and stockholders’ equity Other current
liabilities
$
33,802
$
32,322
Accrued interest payable
833
4,359
Deferred revenue
1,548
2,094
Convertible subordinated notes, due 2023, net
-
96,193
Convertible senior notes, due 2025, net
191,115
190,583
Convertible senior notes, due 2028, net
254,603
253,597
Other long term liabilities
68,690
70,918
Deferred tax liabilities
-
5,771
Income tax payable - long term
10,020
9,872
Innoviva stockholders’ equity
627,493
565,788
Total liabilities and stockholders’ equity
$
1,188,104
$
1,231,497
INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited)
Nine Months Ended September
30,
2023
2022
Net cash provided by operating activities
$
107,808
$
192,827
Net cash used in investing activities
(61,610
)
(47,956
)
Net cash used in financing activities
(157,250
)
(45,567
)
Net change
$
(111,052
)
$
99,304
Cash and cash equivalents at beginning of period
291,049
201,525
Cash, cash equivalents and restricted cash at end of period
$
179,997
$
300,829
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version on businesswire.com: https://www.businesswire.com/news/home/20231101529542/en/
Investors and Media Contact: Argot Partners (212)
600-1902 innoviva@argotpartners.com
Innoviva (NASDAQ:INVA)
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