Received GSK royalties of $65.7 million, net
product revenues of $15.7 million and license revenue of $3.0
million in the second quarter of 2023
Received FDA approval for XACDURO® for
treatment of hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia caused by susceptible
strains of Acinetobacter
Repurchased $9.2 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 second
quarter ended June 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
second quarter 2023 was $65.7 million, which included royalties of
$54.4 million from global net sales of RELVAR®/BREO® ELLIPTA® and
royalties of $11.3 million from global net sales of ANORO® ELLIPTA®
compared to $111.7 million for the second quarter of 2022, which
included royalties of $59.3 million from global net sales of
RELVAR®/BREO® ELLIPTA® and $9.6 million from global net sales of
ANORO® ELLIPTA®, respectively. The decrease was primarily due to
the sale of our subsidiary, Theravance Respiratory Company, and its
TRELEGY® ELLIPTA® royalty stream in July 2022.
- Net product sales and license revenue for the second quarter of
2023 was $18.7 million, which included $11.2 million from GIAPREZA®
net sales, $4.5 million from XERAVA® net sales and an $3.0 million
milestone payment from our partner for FDA approval of
XACDURO®.
- Net income was $1.3 million, or $0.02 basic per share, for the
second quarter of 2023, compared to net income of $0.9 million, or
$0.01 basic per share, for the second quarter of 2022.
- Cash and cash equivalents totaled $173.0 million. Royalty,
product sales and milestone receivables totaled $81.0 million as of
June 30, 2023.
"The second quarter of 2023 was marked by strong revenues
stemming from our robust royalty portfolio and historically highest
sales from our internal product portfolio,” said Pavel Raifeld,
Chief Executive Officer of Innoviva. “We ended the quarter on a
strong note with the approval of XACDURO® (sulbactam for injection;
durlobactam for injection) for treatment of hospital-acquired
bacterial pneumonia and ventilator-associated bacterial pneumonia.
This is the first pathogen-targeted therapy to be approved for
these life-threatening infections caused by Acinetobacter
Baumannii-calcoaceticus complex, and we plan to bring this product
to patients later this year. We remained disciplined on costs and
saw meaningful operational progress among our investees, market
volatility notwithstanding. We are excited about the prospects of
our business and continue to pursue shareholder value accretive
activities, such as share repurchases.”
Second Quarter 2023 and Recent Highlights
GSK Net Sales
- Second quarter 2023 net sales of RELVAR®/BREO® ELLIPTA® by GSK
were $363.0 million with $149.8 million in net sales from the U.S.
market and $213.2 million from non-U.S. markets.
- Second quarter 2023 net sales of ANORO® ELLIPTA® by GSK were
$173.3 million with $85.5 million net sales from the U.S. market
and $87.8 million from non-U.S. markets.
Corporate Updates
- During the second quarter of 2023, Innoviva repurchased 775,504
shares of its outstanding common stock for $9.2 million.
- On July 11, 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 build-out of its
state-of-the art cGMP manufacturing facility.
- On July 11, 2023, Innoviva director, Deborah Birx, resigned
from Innoviva Board and joined Armata as Chief Executive
Officer.
Clinical Updates
- On May 23, 2023, Innoviva’s wholly owned subsidiary, Innoviva
Specialty Therapeutics, received FDA’s approval of 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). The company is preparing to launch
XACDURO® later this year.
- Recruitment is now complete in the registrational Phase 3
Zoliflodacin study. Oral Zoliflodacin is a novel oral antibiotic in
development for the treatment of uncomplicated gonorrhea infection.
Top-line results for this ongoing Phase 3 trial are expected in
late 2023.
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 Six Months Ended June 30, June 30,
2023
2022
2023
2022
Revenue: Royalty revenue, net (1)
$
62,265
$
108,220
$
119,123
$
198,279
Net product sales
15,727
-
27,241
-
License revenue
3,000
-
11,000
-
Total revenue
80,992
108,220
157,364
198,279
Expenses: Cost of products sold (inclusive of amortization of
inventory fair valueadjustments, excluding depreciation and
amortization of intangible assets)
8,979
-
17,728
-
Cost of license revenue
-
-
1,600
-
Selling, general and administrative
23,542
11,782
43,277
18,274
Research and development
14,989
13,884
27,577
19,722
Amortization of acquired intangible assets
4,958
-
8,763
-
Loss on debt extinguishment
-
-
-
20,662
Changes in fair values of equity method investments, net
19,911
42,823
4,094
54,773
Changes in fair values of equity and long-term investments, net
83
15,777
2,247
13,238
Interest and dividend income
(3,553
)
(724
)
(6,918
)
(1,046
)
Interest expense
4,382
3,655
8,809
6,665
Other expense, net
1,896
528
3,242
778
Total expenses
75,187
87,725
110,419
133,066
Income before income taxes
5,805
20,495
46,945
65,213
Income tax expense
4,525
(876
)
10,800
5,984
Net income
1,280
21,371
36,145
59,229
Net income attributable to noncontrolling interest
-
20,432
-
42,517
Net income attributable to Innoviva stockholders
$
1,280
$
939
$
36,145
$
16,712
Basic net income per share attributable to Innoviva
stockholders
$
0.02
$
0.01
$
0.54
$
0.24
Diluted net income per share attributable to Innoviva stockholders
$
0.02
$
0.05
$
0.46
$
0.24
Shares used to compute basic net income per share
65,341
69,643
66,557
69,594
Shares used to compute diluted net income per share
65,489
95,653
88,175
94,692
(1) Total net revenue is comprised of the following (in thousands):
Three Months Ended Six Months Ended June 30, June 30,
2023
2022
2023
2022
(unaudited) (unaudited) Royalties
$
65,721
$
111,676
$
126,035
$
205,191
Amortization of capitalized fees
(3,456
)
(3,456
)
(6,912
)
(6,912
)
Royalty revenue, net
$
62,265
$
108,220
$
119,123
$
198,279
INNOVIVA, INC. Condensed Consolidated Balance Sheets (in
thousands) (unaudited) June 30, December 31,
2023
2022
Assets Cash and cash equivalents
$
173,025
$
291,049
Royalty and product sale receivables
80,996
64,073
Inventory, net
46,846
55,897
Prepaid expense and other current assets
22,671
32,492
Property and equipment, net
161
170
Equity and long-term investments
433,001
403,013
Capitalized fees
90,695
97,607
Right-of-use assets
2,719
3,265
Goodwill
14,882
26,713
Intangible assets
243,356
252,919
Deferred tax assets
6,327
-
Other assets
3,562
4,299
Total assets
$
1,118,241
$
1,231,497
Liabilities and stockholders’ equity Other current
liabilities
$
32,722
$
32,322
Accrued interest payable
3,422
4,359
Deferred revenue
3,254
2,094
Convertible subordinated notes, due 2023, net
-
96,193
Convertible senior notes, due 2025, net
190,937
190,583
Convertible senior notes, due 2028, net
254,264
253,597
Other long term liabilities
68,584
70,918
Deferred tax liabilities
-
5,771
Income tax payable - long term
9,971
9,872
Innoviva stockholders’ equity
555,087
565,788
Total liabilities and stockholders’ equity
$
1,118,241
$
1,231,497
INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited)
Six Months Ended June 30,
2023
2022
Net cash provided by operating activities
$
63,866
$
177,137
Net cash used in investing activities
(35,722
)
(145,678
)
Net cash (used in) provided by financing activities
(146,168
)
50,596
Net change
$
(118,024
)
$
82,055
Cash and cash equivalents at beginning of period
291,049
201,525
Cash, cash equivalents and restricted cash at end of period
$
173,025
$
283,580
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230802433840/en/
Investors and Media Contact: Argot Partners (212)
600-1902 innoviva@argotpartners.com
Grafico Azioni Innoviva (NASDAQ:INVA)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Innoviva (NASDAQ:INVA)
Storico
Da Set 2023 a Set 2024