Innoviva Reports Third Quarter 2022 Financial Results and Highlights Recent Company Progress

09 Nov 2022
www.biospace.com
Financial StatementAcquisitionCollaborate
Royalties at $65.6 million in the third quarter of 2022, compared to $65.7 million in the same quarter of 2021, for RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA® Announced new $100.0 million share repurchase program Completed the sale of 15% ownership interest in Theravance Respiratory Company (“TRC”) to Royalty Pharma Completed acquisition of the remaining approximately 40% equity of Entasis Therapeutics Holdings Inc. (“Entasis”) Completed acquisition of La Jolla Pharmaceutical Company (“La Jolla”) BURLINGAME, Calif.--(BUSINESS WIRE)-- 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. Gross royalty revenues of $65.6 million from Glaxo Group Limited (“GSK”) for the third quarter of 2022 included royalties of $55.7 million from global net sales of RELVAR®/BREO® ELLIPTA® and royalties of $9.9 million from global net sales of ANORO® ELLIPTA®. Income before income taxes increased to $286.4 million, compared to $123.2 million the same quarter in 2021, primarily due to the gain from the sale of 15% ownership interest in TRC. Increase in fair values of equity and long-term investments of $0.1 million in the third quarter of 2022 was mainly due to the volatility in the capital markets. Net cash provided by operating activities was $192.8 million in the first nine months of 2022, compared to $265.4 million in the same period of 2021. Net cash and cash equivalents totaled $300.8 million, and royalty and product sale receivables totaled $72.3 million as of 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 GSK Net Sales: Third quarter 2022 net sales of RELVAR®/BREO® ELLIPTA® by GSK were $371.1 million, up 3% from $360.6 million in the same quarter of 2021, with $184.5 million in net sales from the U.S. market and $186.6 million from non-U.S. markets. Third quarter 2022 net sales of ANORO® ELLIPTA® by GSK were $153.0 million, down 15% from $179.1 million in the same quarter of 2021, with $77.6 million net sales from the U.S. market and $75.4 million from non-U.S. markets. Corporate Updates: Innoviva’s Board of Directors has authorized a new share repurchase program under which the Company may repurchase up to $100.0 million of its outstanding shares of common stock. The timing and amount of any share repurchases under the share repurchase program will be determined by Innoviva’s management in its discretion based on ongoing assessments of the capital needs of the business, the market price of Innoviva’s common stock, prevailing stock prices, general market conditions and other considerations. Share repurchases under the program may be made through a variety of methods, which may include open market purchases, privately negotiated transactions, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination thereof or by other means in accordance with federal securities laws. This program has no termination date, may be suspended or discontinued at any time at the Company’s discretion and does not obligate the Company to acquire any amount of common stock. On July 20, 2022, we completed the sale of our 15% ownership interest in TRC to Royalty Pharma for $282 million, including payment for our portion of TRC’s cash balance of $4.4 million and a potential $50.0 million sales-based milestone payment and received full ownership of equity and other investments that TRC owned prior to the transaction. On July 11, 2022, we completed the purchase of all the issued and outstanding equity securities of Entasis not already owned by Innoviva for $42.4 million. Entasis brings to Innoviva an infectious disease focused R&D platform anchored by its lead asset sulbactam-durlobactam (SUL-DUR). On August 22, 2022, we completed the acquisition of La Jolla for a net cash price of $150.5 million. La Jolla brings to Innoviva an established product portfolio, 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. Clinical Updates: At the annual meeting of the Infectious Disease Society of America which took place from October 19 to October 23, 2022 in Washington, D.C., our wholly owned subsidiary, Entasis, had six presentations on SUL-DUR data reinforcing the positive safety and efficacy findings from the Company’s pivotal Phase 3 ATTACK trial, while another wholly owned subsidiary, La Jolla, had five abstracts on XERAVA® which focused primarily on its use in combination therapies. 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 the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at . 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
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-
Drugs
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.