INVA Innoviva Inc

 

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)

 

 

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

 

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.

 

 

 

 

·

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.

 

 

 

 

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.

 

 

 

 

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

 

 

 

  

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

 

 

 

 

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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Document Period End Date	Feb. 26, 2025
Entity File Number	000-30319
Entity Registrant Name	INNOVIVA, INC.
Entity Central Index Key	0001080014
Entity Tax Identification Number	94-3265960
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1350 Old Bayshore Highway
Entity Address, Address Line Two	Suite 400
Entity Address, City or Town	Burlingame
Entity Address, State or Province	CA
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Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	INVA
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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