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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): February 26, 2025

 

INNOVIVA, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware 000-30319 94-3265960
(State or Other Jurisdiction of
Incorporation)
(Commission File Number) (I.R.S. Employer Identification Number)

 

1350 Old Bayshore Highway,
Suite 400

Burlingame, California
94010

(650) 238-9600

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

  ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
  ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
  ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
  ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.01 per share   INVA   The NASDAQ Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 


 

Item 2.02. Results of Operations and Financial Condition

 

On February 26, 2025, Innoviva, Inc. (the “Company”) issued a press release regarding its results of operations and financial condition for the quarter ended December 31, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report.

 

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits

 

(d) Exhibits

 

99.1   Press Release dated February 26, 2025
104   Cover Page Interactive File (the cover page tags are embedded within the Inline XBRL document)

 

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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  INNOVIVA, INC.
   
Date: February 26, 2025 By: /s/ Pavel Raifeld
    Pavel Raifeld
    Chief Executive Officer

 

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EX-99.1 2 tm257428d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

Innoviva Reports Fourth Quarter and Full Year 2024 Financial Results; Highlights Recent Company Progress

 

Core royalty platform continues to deliver with GSK royalties of $66.0 million for the fourth quarter and $255.6 million for the full year

 

Innoviva Specialty Therapeutics achieved U.S. net product sales of $24.9 million for the fourth quarter and $80.9 million for the full year, reflecting 47% year-over-year growth

 

Therapeutics platform strengthened with acquisition of exclusive U.S. commercialization and distribution rights to ZEVTERA® (ceftobiprole), launching mid-2025

 

BURLINGAME, Calif. – February 26, 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 fourth quarter and full year ended December 31, 2024, and highlighted select corporate progress and achievements.

 

Pavel Raifeld, Chief Executive Officer of Innoviva, said: “2024 was an exceptional year for Innoviva. Our core royalty portfolio and therapeutics business both delivered strong year-over-year revenue growth. The excellent performance of IST in 2024 – including revenue growth, new product acquisition through partnership, and significant pipeline progress – is a clear validation of our strategy to build a leading commercial business in critical care and infectious disease.”

 

Mr. Raifeld continued, “In 2024, IST’s revenue growth was driven by the successful launch of XACDURO® and a renewed commercial strategy unlocking new opportunities for GIAPREZA®. Additionally, both XACDURO® and XERAVA® received favorable guidelines placement, which has helped increase access to patients. We also added a fourth approved product to our leverageable commercial infrastructure by licensing ZEVTERA® in the U.S., showcasing both our potential to be a preferred commercial partner and the value creation opportunities enabled by the strength of our operating platform.”

 

“Looking ahead, we anticipate another strong year in 2025 highlighted by an NDA submission for zoliflodacin, the launch of ZEVTERA® in mid-2025, and continued growth of our marketed products, with U.S. net product sales forecasted to exceed $100 million. Backed by nearly $400 million cash and receivables, Innoviva is a well-capitalized company focused on continued value creation through disciplined capital deployment and operational excellence,” concluded Mr. Raifeld.

 

Financial Highlights

 

· Royalty revenue: Fourth quarter 2024 gross royalty revenue from Glaxo Group Limited (“GSK”) was $66.0 million and full year was $255.6 million, compared to $69.6 million for the fourth quarter of 2023 and $252.7 million for the full year 2023.

 

· Net Product Sales: Fourth quarter 2024 net product sales were $28.9 million, which included U.S. net product sales of $24.9 million, compared to $19.7 million for the fourth quarter of 2023, and ex-U.S. net product sales of $4.0 million. U.S. net product sales consisted of $15.9 million from GIAPREZA®, $3.1 million from XERAVA®, and $5.9 million from XACDURO®. Full year 2024 net product sales were $97.5 million, which included U.S. net product sales of $80.9 million, compared to $55.1 million for full year 2023, and ex-U.S. net product sales of $16.6 million. U.S. net product sales consisted of $53.4 million from GIAPREZA®, $12.8 million from XERAVA®, and $14.7 million from XACDURO®.

 

 

 

 

· License revenue: Fourth quarter 2024 license revenue of $0.4 million included product development cost-sharing reimbursements from our partner. Full year 2024 license revenue of $19.5 million consisted of an $8.0 million milestone payment and $11.5 million cost-sharing reimbursements, compared to $11.0 million milestone payments in full year 2023.

 

· Equity and long-term investments: Fourth quarter and full year 2024 changes in fair values of equity and long-term investments of $19.6 million and $123.4 million, respectively, were primarily attributable to share price depreciation of Armata Pharmaceuticals and other equity investments.

 

· Net income: Fourth quarter 2024 net income of $20.3 million ($0.32 basic earnings per share) and full year 2024 net income of $23.4 million ($0.37 basic earnings per share) were driven primarily by higher revenue, offset by the negative impact of changes in the fair values of equity investments.

 

· Cash and cash equivalents: Totaled $305.0 million. Royalty and net product sales receivables totaled $86.4 million as of December 31, 2024.

 

Key Business and R&D Highlights

 

· ZEVTERA® (ceftobiprole): 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).

 

o In the fourth quarter of 2024, Innoviva licensed U.S. commercialization and distribution rights to ZEVTERA® from Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN).

 

o The Company anticipates launching ZEVTERA® in the U.S. in mid-2025.

 

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

 

o In 2024, the Company reported positive Phase 3 data for zoliflodacin, in which a single dose of oral zoliflodacin achieved a statistically non-inferior microbiological cure rate compared to the current global standard of care. Oral zoliflodacin was generally well tolerated and emergent adverse events were comparable between treatment arms. No deaths or other serious adverse events were reported.

 

o The Company remains on track to submit the zoliflodacin NDA to the U.S. FDA in early 2025.

 

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· 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.

  

o XACDURO® was approved in China by the National Medical Products Administration for use in Chinese patients 18 years of age and older in May 2024.

 

o In July, XACDURO® was named as the preferred agent for the treatment of Carbapenem-resistant Acinetobacter baumannii infections, in combination with a carbapenem, in the updated 2024 IDSA treatment guidance.

 

o In August, XACDURO® was nominated for the prestigious Prix Galien USA award for Best Biotechnology Product.

 

Update on Strategic Healthcare Assets

 

· Our portfolio of strategic assets under the Company’s various subsidiaries was valued at $501.5 million as of December 31, 2024. In the fourth quarter 2024, we continued to support product developments and invested $10.9 million in Gate Neurosciences, Inc., a leader in developing precision medicines targeting synaptic health.

 

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 innovative healthcare assets include infectious disease and critical care 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 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. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S.

 

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

 

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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 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, 2023 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.

 

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INNOVIVA, INC.

Condensed Consolidated Statements of Income

(in thousands, except per share data)

(Unaudited) 

 

    Three Months Ended     Year Ended  
    December 31,     December 31,  
    2024     2023     2024     2023  
Revenue:                                
Royalty revenue, net (1)   $ 62,520     $ 66,165     $ 241,733     $ 238,846  
Net product sales     28,935       19,675       97,492       60,617  
License Revenue     351       -       19,486       11,000  
Total revenue     91,806       85,840       358,711       310,463  
Expenses:                                
Cost of products sold (inclusive of amortization of inventory fair value adjustments)     7,165       13,130       36,598       41,040  
Cost of license revenue     -       -       -       1,600  
Selling, general and administrative     31,326       26,319       115,690       98,232  
Research and development     3,665       2,356       13,654       33,922  
Amortization of acquired intangible assets     6,511       6,510       25,902       21,784  
Changes in fair values of equity method investments, net     21,256       (9,506 )     64,253       (77,392 )
Changes in fair values of equity and long-term investments, net     (1,666 )     (16,016 )     59,161       (11,129 )
Interest and dividend income     (5,768 )     (4,786 )     (19,141 )     (15,818 )
Interest expense     4,749       5,952       22,209       19,157  
Other expense (income), net     (126 )     680       2,997       4,969  
Total expenses     67,112       24,639       321,323       116,365  
Income before income taxes     24,694       61,201       37,388       194,098  
Income tax expense     4,362       (330 )     13,996       14,376  
Net income     20,332       61,531       23,392       179,722  
                                 
Net income per share                                
Basic net income per share attributable to Innoviva stockholders   $ 0.32     $ 0.97     $ 0.37     $ 2.75  
Diluted net income per share attributable to Innoviva stockholders   $ 0.26     $ 0.76     $ 0.36     $ 2.20  
                                 
Shares used to compute basic net income per share     62,626       63,710       62,726       65,435  
Shares used to compute diluted net income per share     84,200       84,995       74,187       86,876  

 

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

  

    Three Months Ended     Year Ended  
    December 31,     December 31,  
    2024     2023     2024     2023  
    (unaudited)     (unaudited)  
Royalties   $ 65,975     $ 69,620     $ 255,556     $ 252,669  
Amortization of capitalized fees     (3,455 )     (3,455 )     (13,823 )     (13,823 )
Royalty revenue, net   $ 62,520     $ 66,165     $ 241,733     $ 238,846  

 

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INNOVIVA, INC.

Condensed Consolidated Balance Sheets 

(in thousands)

(unaudited)

 

    December 31,     December 31,  
    2024     2023  
Assets                
Cash and cash equivalents   $ 304,964     $ 193,513  
Royalty and product sale receivables     86,366       84,075  
Inventory, net     33,725       40,737  
Prepaid expense and other current assets     21,719       25,894  
Current portion of ISP Fund investments     107,532       -  
Property and equipment, net     514       483  
Equity and long-term investments     393,957       560,978  
Capitalized fees     69,961       83,784  
Right-of-use assets     2,453       2,536  
Goodwill     17,905       17,905  
Intangible assets     208,433       230,335  
Deferred tax assets     12,054       -  
Other assets     41,477       3,267  
Total assets   $ 1,301,060     $ 1,243,507  
                 
Liabilities and stockholders’ equity                
Other current liabilities   $ 39,507     $ 33,435  
Accrued interest payable     3,422       3,422  
Deferred revenues     1,126       1,277  
Convertible senior notes, due 2025, net     192,028       191,295  
Convertible senior notes, due 2028, net     256,316       254,939  
Other long term liabilities     64,275       71,870  
Deferred tax liabilities     -       563  
Income tax payable - long term     53,227       11,751  
Innoviva stockholders’ equity     691,159       674,955  
Total liabilities and stockholders’ equity   $ 1,301,060     $ 1,243,507  

  

INNOVIVA, INC.

Cash Flows Summary

(in thousands)

(unaudited) 

 

    Year Ended December 31,  
    2024     2023  
Net cash provided by operating activities   $ 188,690     $ 141,064  
Net cash used in investing activities     (63,786 )     (66,761 )
Net cash used in financing activities     (13,453 )     (171,839 )
Net change   $ 111,451     $ (97,536 )
Cash and cash equivalents at beginning of period     193,513       291,049  
Cash and cash equivalents at end of period   $ 304,964     $ 193,513  

 

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Contacts

 

Innoviva, Inc.

David Patti

Corporate Communications

(908) 421-5971

david.patti@inva.com

 

Investors and Media:

Argot Partners
(212) 600-1902
innoviva@argotpartners.com

 

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