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BURLINGAME, Calif.--(BUSINESS WIRE)--Nov 9, 2022--
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” and “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, 2022.
Pavel Raifeld, Chief Executive Officer of Innoviva, Inc., stated: “Our diversified core royalty business continues to perform well and deliver strong revenues despite challenging market conditions. RELVAR ® /BREO ® ELLIPTA ® global net sales grew slightly compared to third quarter 2021 with U.S. net sales growth compensating for foreign currency changes and a slowdown in non-U.S. markets. ANORO ® ELLIPTA ® global net sales decreased by 15% compared to third quarter of 2021 mainly due to pricing pressures and foreign currency changes."
Mr. Raifeld continued: “Over the past quarter, we significantly advanced our strategy with the acquisitions of Entasis and La Jolla, giving us a strong footprint in the hospital and infectious disease space with an attractive growth outlook rooted in a robust portfolio of marketed and pipeline products. Our financials have started to reflect the growing complexity of our business given the newly acquired operating platform which we believe has excellent value creation potential.”
“We remain committed to a disciplined, thoughtful, and thorough approach to capital allocation. The new share repurchase program underscores our confidence in Innoviva’s prospects and value embedded within our business, supported by the strength of our balance sheet and cashflows, as we seek to take advantage of market dislocations. We explore all avenues in our efforts to create shareholder value,” concluded Mr. Raifeld.
Recent Highlights
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 healthcare assets include infectious disease and hospital assets stemming from acquisitions of Entasis Therapeutics, including its lead asset sulbactam-durlobactam, and La Jolla Pharmaceutical, 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 ® and XERAVA ® 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, 2021 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. Additional risk factors are presented on Form 8-K filed on August 23, 2022. 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, | ||||||||||||||||
|
|
|
| 2022 |
|
|
| 2021 |
|
|
| 2022 |
|
|
| 2021 |
|
| Revenue: | |||||||||||||||||
| Royalty revenue, net (1) | $ | 62,150 |
| $ | 97,862 |
| $ | 260,429 |
| $ | 284,186 |
| |||||
| Net product sales |
| 5,107 |
|
| - |
|
| 5,107 |
|
| - |
| |||||
| Total revenue |
| 67,257 |
|
| 97,862 |
|
| 265,536 |
|
| 284,186 |
| |||||
| Expenses: | |||||||||||||||||
| Cost of products sold (inclusive of amortization of inventory fair value adjustments) |
| 3,680 |
|
| - |
|
| 3,680 |
|
| - |
| |||||
| Selling, general and administrative |
| 27,810 |
|
| 2,860 |
|
| 46,084 |
|
| 13,074 |
| |||||
| Research and development |
| 11,725 |
|
| 449 |
|
| 31,447 |
|
| 536 |
| |||||
| Amortization of acquired intangible assets |
| 1,511 |
|
| - |
|
| 1,511 |
|
| - |
| |||||
| Gain on TRC sale |
| (266,696 | ) |
| - |
|
| (266,696 | ) |
| - |
| |||||
| Loss on debt extinguishment |
| - |
|
| - |
|
| 20,662 |
|
| - |
| |||||
| Changes in fair values of equity and long-term investments, net |
| (130 | ) |
| (33,613 | ) |
| 67,881 |
|
| (133,973 | ) | |||||
| Interest and dividend income |
| (2,135 | ) |
| (453 | ) |
| (3,181 | ) |
| (503 | ) | |||||
| Interest expense |
| 5,096 |
|
| 4,790 |
|
| 11,761 |
|
| 14,229 |
| |||||
| Other expense (income), net |
| (28 | ) |
| 652 |
|
| 750 |
|
| 2,036 |
| |||||
| Total expenses |
| (219,167 | ) |
| (25,315 | ) |
| (86,101 | ) |
| (104,601 | ) | |||||
| Income before income taxes |
| 286,424 |
|
| 123,177 |
|
| 351,637 |
|
| 388,787 |
| |||||
| Income tax expense (benefit), net |
| 57,077 |
|
| 20,531 |
|
| 63,061 |
|
| 65,600 |
| |||||
| Net income |
| 229,347 |
|
| 102,646 |
|
| 288,576 |
|
| 323,187 |
| |||||
| Net income attributable to noncontrolling interest |
| (36,176 | ) |
| 30,208 |
|
| 6,341 |
|
| 67,678 |
| |||||
| Net income attributable to Innoviva stockholders | $ | 265,523 |
| $ | 72,438 |
| $ | 282,235 |
| $ | 255,509 |
| |||||
| Basic net income per share attributable to Innoviva stockholders | $ | 3.81 |
| $ | 1.04 |
| $ | 4.05 |
| $ | 2.96 |
| |||||
| Diluted net income per share attributable to Innoviva stockholders | $ | 2.80 |
| $ | 0.90 |
| $ | 3.07 |
| $ | 2.63 |
| |||||
| Shares used to compute basic net income per share |
| 69,731 |
|
| 69,458 |
|
| 69,640 |
|
| 86,298 |
| |||||
| Shares used to compute diluted net income per share |
| 95,830 |
|
| 81,699 |
|
| 95,072 |
|
| 98,536 |
|
| (1) Total net revenue from a related party is comprised of the following (in thousands): | |||||||||
| Three Months Ended | Nine Months Ended | ||||||||
| September 30, | September 30, | ||||||||
2022 | 2021 | 2022 | 2021 | ||||||
| (unaudited) | (unaudited) | ||||||||
| Royalties from a related party | $ 65,606 | $ 101,318 | $ 270,797 | $ 294,554 | |||||
| Amortization of capitalized fees paid to a related party | (3,456) | (3,456) | (10,368) | (10,368) | |||||
| Royalty revenue from a related party, net | $ 62,150 | $ 97,862 | $ 260,429 | $ 284,186 |
| INNOVIVA, INC. | |||||
| Condensed Consolidated Balance Sheets | |||||
| (in thousands) | |||||
| (unaudited) | |||||
| September 30, | December 31, | ||||
| 2022 |
| 2021 | ||
| Assets | |||||
| Cash and cash equivalents | $ | 300,789 | $ | 201,525 | |
| Short-term marketable securities |
| 282 |
| - | |
| Royalty and product sale receivables |
| 72,349 |
| 110,711 | |
| Inventory, net |
| 70,807 |
| - | |
| Prepaid expense and other current assets |
| 10,364 |
| 1,437 | |
| Property and equipment, net |
| 165 |
| 12 | |
| Equity and long-term investments |
| 489,111 |
| 483,845 | |
| Capitalized fees |
| 101,062 |
| 111,430 | |
| Right-of-use assets |
| 3,679 |
| 97 | |
| Goodwill |
| 15,995 |
| - | |
| Intangible assets |
| 258,489 |
| - | |
| Deferred tax assets, net |
| - |
| 17,327 | |
| Other assets |
| 4,620 |
| 11 | |
| Total assets | $ | 1,327,712 | $ | 926,395 | |
| Liabilities and stockholders’ equity | |||||
| Other current liabilities | $ | 25,398 | $ | 1,655 | |
| Accrued interest payable |
| 5,702 |
| 4,152 | |
| Deferred revenues |
| 2,849 |
| - | |
| Income tax payable |
| 33,804 |
| - | |
| Convertible subordinated notes, due 2023, net |
| 96,131 |
| 240,364 | |
| Convertible senior notes, due 2025, net |
| 190,408 |
| 154,289 | |
| Convertible senior notes, due 2028, net |
| 253,271 |
| - | |
| Other long term liabilities |
| 78,781 |
| - | |
| Innoviva stockholders’ equity |
| 641,368 |
| 414,743 | |
| Noncontrolling interest |
| - |
| 111,192 | |
| Total liabilities and stockholders’ equity | $ | 1,327,712 | $ | 926,395 |
| INNOVIVA, INC. | |||||||||
| Cash Flows Summary | |||||||||
| (in thousands) | |||||||||
| (unaudited) | |||||||||
Nine Months Ended September 30, | |||||||||
2022 |
| 2021 | |||||||
| Net cash provided by operating activities | $ | 192,827 |
| $ | 265,432 |
| |||
| Net cash provided by (used in) investing activities |
| (47,956 | ) |
| 63,627 |
| |||
| Net cash used in financing activities |
| (45,567 | ) |
| (440,431 | ) | |||
| Net change | $ | 99,304 |
| $ | (111,372 | ) | |||
| Cash and cash equivalents at beginning of period |
| 201,525 |
|
| 246,487 |
| |||
| Cash, cash equivalents and restricted cash at end of period | $ | 300,829 |
| $ | 135,115 |
View source version on businesswire.com:https://www.businesswire.com/news/home/20221109005827/en/
CONTACT: Innoviva Contacts:
Argot Partners
(212) 600-1902
innoviva@argotpartners.com
KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: RESEARCH CLINICAL TRIALS BIOTECHNOLOGY OTHER HEALTH HEALTH PHARMACEUTICAL GENERAL HEALTH OTHER SCIENCE SCIENCE
SOURCE: Innoviva, Inc.
Copyright Business Wire 2022.
PUB: 11/09/2022 04:05 PM/DISC: 11/09/2022 04:07 PM
http://www.businesswire.com/news/home/20221109005827/en