EX-99.1 2 tm2514212d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

 

Innoviva Reports First Quarter 2025 Financial Results; Highlights Recent Company Progress

 

Core royalty platform maintained strong performance, generating $61.3 million in revenue

 

Innoviva Specialty Therapeutics achieved U.S. net product sales of $26.4 million for the first quarter, reflecting 52% year-over-year growth

 

Continued momentum across therapeutics platform with regulatory submissions for zoliflodacin and commercial launch of ZEVTERA® (ceftobiprole) progressing as planned

 

BURLINGAME, Calif. – May 7, 2025 – Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the first quarter ended March 31, 2025, and highlighted select corporate progress and achievements.

 

“We are pleased with our strong first quarter financial results, highlighted by robust cash flows from our GSK royalties portfolio and continued excellent growth from the IST-marketed products,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “Our therapeutics business remains a key driver, with an NDA filing for zoliflodacin on track and the U.S. commercial launch of ZEVTERA® (ceftobiprole) anticipated by mid-2025, underscoring our commitment to delivering innovative treatments to patients and our ability to leverage the operating platform.”

 

“Additionally, we remain dedicated to creating value for our shareholders by strategically enhancing our healthcare assets. We are cognizant of the increasing market volatility and believe that the strength of our balance sheet, combined with a disciplined approach to capital allocation, positions us well to advance our diversified portfolio and capitalize on new opportunities, thereby supporting sustained growth across market environments,” concluded Mr. Raifeld.

 

Financial Highlights

 

·Royalty revenue: First quarter 2025 gross royalty revenue from Glaxo Group Limited (“GSK”) was $61.3 million, compared to $61.9 million for the first quarter of 2024.

 

·Net product sales: First quarter 2025 net product sales totaled $30.3 million, consisting of $26.4 million in U.S. net product sales and $3.9 million in ex-U.S. net product sales, compared to $19.1 million in net product sales for the first quarter of 2024. U.S. net product sales included $17.4 million from GIAPREZA®, $5.8 million from XACDURO®, and $3.2 million from XERAVA®, representing a 52% increase compared to total U.S. net product sales of $17.4 million in the first quarter of 2024.

 

·Income from operations: First quarter 2025 income from operation was $41.4 million, an increase of 61% from $25.8 million in the first quarter of 2024.

 

·Equity and long-term investments: First quarter 2025 unfavorable changes in fair values of equity and long-term investments totaled $78.8 million, compared to favorable changes of $22.0 million in the first quarter of 2024, primarily due to the share price depreciation of Armata Pharmaceuticals and certain equity investments managed by ISP Fund LP.

 

 

 

 

 

·Net income: First quarter 2025 net loss was $46.6 million, or ($0.74) basic per share, compared to net income of $36.5 million, or $0.58 basic per share, for the first quarter of 2024.

 

·Cash and cash equivalents: Totaled $319.1 million. Royalty and net product sales receivables totaled $77.9 million as of March 31, 2025.

 

Key Business and R&D Highlights

 

·Zoliflodacin: a potential first-in-class, single dose, oral antibiotic is currently being developed together with The Global Antibiotic Research & Development Partnership ("GARDP") for the treatment of patients with uncomplicated gonorrhea.

 

oZoliflodacin NDA on track for filing with the U.S. FDA in the first half of 2025.

 

·ZEVTERA® (ceftibiprole): an advanced-generation cephalosporin antibiotic that is approved in the U.S. for three specific treatment indications. ZEVTERA® is the only FDA-approved methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin antibiotic for treating adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB) and endocarditis. ZEVTERA® is indicated for the treatment of adult patients with SAB, including right-sided infective endocarditis, adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).

 

oFollowing the exclusive distribution and license agreement with Basilea Pharmaceutica Ltd in December 2024, Innoviva anticipates launching ZEVTERA® in the U.S. in mid-2025.

 

·XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: a targeted antibacterial treatment for patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

 

oIn April, the Company presented data on the activity of durlobactam against Enterobacterales at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global).

 

·Update on Strategic Healthcare Assets

 

oInnoviva’s portfolio of strategic assets held through the Company’s various subsidiaries was valued at $457.6 million as of March 31, 2025. In the first quarter of 2025, we invested a total of $34.7 million in various strategic healthcare assets, including $15.0 million in a convertible note of Gate Neurosciences and $10.0 million in a term loan to Armata Pharmaceuticals.

 

About Innoviva

 

Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other commercial and marketed products include infectious disease and critical care assets: GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock; XERAVA® (eravacycline), approved for the treatment of complicated intra-abdominal infections in adults; and XACDURO® (sulbactam for injection; durlobactam for injection), approved for the treatment of hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter in adults. In addition, ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, will be exclusively commercialized by us in the U.S. under a distribution and license agreement with Basilea Pharmaceutica Ltd., (“Basilea”), entered into in December 2024. We continue to advance our pipeline with zoliflodacin, a potentially first in class, single-dose oral treatment for uncomplicated gonorrhea.

 

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ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil.

 

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®, XACDURO® and ZEVTERA® 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 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, 2024 and subsequently 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.

 

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INNOVIVA, INC.
Condensed Consolidated Statements of Income
(in thousands, except per share data)
(Unaudited)
 
   Three Months Ended 
   March 31, 
   2025   2024 
Revenue:          
Royalty revenue, net (1)  $57,807   $58,415 
Net product sales   30,279    19,084 
License and other revenue   546    — 
Total revenue   88,632    77,499 
Cost of products sold (inclusive of amortization of inventory fair value adjustments)   8,842    10,971 
Amortization of acquired intangible assets   6,475    6,440 
Gross profit   73,315    60,088 
Operating expenses:          
Selling, general and administrative   27,491    30,405 
Research and development   4,396    3,878 
Total operating expenses   31,887    34,283 
Income from operations   41,428    25,805 
Changes in fair values of equity method investments, net   (13,549)   35,342 
Changes in fair values of equity and long-term investments, net   (65,299)   (13,335)
Interest and dividend income   4,538    4,399 
Interest expense   (4,711)   (5,851)
Other expense, net   (996)   (1,236)
Income (loss) before income taxes   (38,589)   45,124 
Income tax expense   (7,995)   (8,592)
Net income (loss)  $(46,584)  $36,532 
           
Net income (loss) per share:          
Basic  $(0.74)  $0.58 
Diluted  $(0.74)  $0.46 
           
Shares used to compute net income (loss) per share:          
Basic   62,709    63,185 
Diluted   62,709    84,531 

 

(1) Total net revenue is comprised of the following (in thousands):          

 

   Three Months Ended 
   March 31, 
   2025   2024 
         
   (unaudited) 
Royalties  $61,263   $61,871 
Amortization of capitalized fees   (3,456)   (3,456)
Royalty revenue, net  $57,807   $58,415 

 

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INNOVIVA, INC.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
         
   March 31,   December 31, 
   2025   2024 
Assets          
Cash and cash equivalents  $319,090   $304,964 
Royalty and product sale receivables   77,936    86,366 
Inventory, net   41,479    33,725 
Prepaid expense and other current assets   15,727    21,719 
Current portion of ISP Fund investments   127,790    107,532 
Property and equipment, net   483    514 
Equity method and equity and long-term investments   329,844    393,957 
Capitalized fees   66,505    69,961 
Right-of-use assets   2,110    2,453 
Goodwill   17,905    17,905 
Intangible assets   201,958    208,433 
Deferred tax assets   12,294    12,054 
Other assets   41,269    41,477 
Total assets  $1,254,390   $1,301,060 
           
           
Liabilities and stockholders’ equity          
Other current liabilities  $40,695   $39,507 
Accrued interest payable   833    3,422 
Deferred revenues   1,002    1,126 
Convertible senior notes, due 2025, net   192,215    192,028 
Convertible senior notes, due 2028, net   256,670    256,316 
Other long term liabilities   62,009    64,275 
Income tax payable - long term   54,061    53,227 
Innoviva stockholders’ equity   646,905    691,159 
Total liabilities and stockholders’ equity  $1,254,390   $1,301,060 

 

INNOVIVA, INC.
Cash Flows Summary
(in thousands)
(unaudited)
     
   Three Months Ended March 31, 
   2025   2024 
Net cash provided by operating activities  $48,617   $37,047 
Net cash used in investing activities   (34,674)   (43,038)
Net cash provided by (used in) financing activities   183    (9,165)
Net change  $14,126   $(15,156)
Cash and cash equivalents at beginning of period   304,964    193,513 
Cash and cash equivalents at end of period  $319,090   $178,357 

 

Contacts

 

Innoviva, Inc. 

David Patti 

Corporate Communications 

(908) 421-5971 

[email protected]

 

Investors and Media: 

Argot Partners
(212) 600-1902
[email protected]

 

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