Vilanterol Trifenatate

Pictured: Entrance to the FTC's office in Washington, DC/iStock, hapabapa The U.S. Federal Trade Commission on Tuesday sent warning letters to 10 pharmaceutical companies, challenging patents for several drugs including Novo Nordisk’s blockbuster diabetes treatment Ozempic (semaglutide) and GSK’s asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol). The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate. “By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina Khan said in a statement. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need,” Khan added. In addition to Ozempic and Trelegy Ellipta, the FTC’s latest round of patent challenges also targets Novo’s Saxenda (liraglutide) and Victoza (liraglutide)—both indicated for type 2 diabetes—and Novartis’ inhaler products Seebri Breezhaler (glycopyrronium bromide) and Utibron Neohaler (indacaterol and glycopyrrolate), approved for chronic obstructive pulmonary disease. The pharma companies now have 30 days to either withdraw or amend their disputed listings, or confirm “under penalty or perjury” that these patents indeed comply with the statutory and regulatory requirements. A GSK spokesperson in a statement to Endpoints News said that the company is reviewing the FTC’s letter. GSK takes “the FTC’s views seriously; however, we will also do our own analysis as the law requires. Once complete, we will respond to the FDA and FTC.” Meanwhile, a Boehringer Ingelheim spokesperson said that the pharma “has never wrongfully submitted patents for listing in the Orange Book.” Tuesday’s warnings follow an initial salvo in November 2023, when the FTC challenged more than 100 patents by 10 pharma companies including AbbVie, AstraZeneca and subsidiaries of GSK and Teva Pharmaceuticals. At the time, the antitrust watchdog targeted a wide range of pharmaceutical products, including inhaler devices, multidose bottles and epinephrine autoinjectors. Aside from the FTC, members of Congress have also started targeting the high cost of medication in the U.S., paying particular attention to Ozempic. Last week, Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, launched a probe into the ‘outrageously high prices’ of Ozempic, as well as its sister weight-loss therapy Wegovy (semaglutide). Sanders in a letter to Novo CEO Lars Fruergaard Jørgensen asked for additional information regarding Ozempic and Wegovy, including revenue, prices paid by public and private payers, R&D spending and the pharma’s tactics to extend their exclusivity. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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 BURLINGAME, Calif.--(BUSINESS WIRE)-- 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 pro 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 the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at . 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 value adjustments, 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