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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Innoviva Inc | NASDAQ:INVA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.035 | 0.20% | 17.225 | 17.21 | 17.24 | 17.35 | 17.22 | 17.29 | 10,724 | 15:01:35 |
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.
"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
Corporate Updates
Clinical Updates
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20231101529542/en/
Investors and Media Contact: Argot Partners (212) 600-1902 innoviva@argotpartners.com
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