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

Rhea-AI Summary

Innoviva (NASDAQ: INVA) reported strong financial results for Q4 and full year 2024. GSK royalties reached $66.0M in Q4 and $255.6M for the full year. The company's Specialty Therapeutics division achieved significant growth with U.S. net product sales of $24.9M in Q4 and $80.9M for 2024, representing 47% year-over-year growth.

Q4 net income was $20.3M ($0.32 per share), while full-year net income reached $23.4M ($0.37 per share). The company ended 2024 with $305.0M in cash and $86.4M in receivables.

Key developments include acquiring U.S. rights to ZEVTERA®, planning for mid-2025 launch, and positive Phase 3 data for zoliflodacin. Product performance showed strong results: GIAPREZA® ($53.4M), XERAVA® ($12.8M), and XACDURO® ($14.7M) in annual U.S. sales. The company forecasts U.S. net product sales to exceed $100M in 2025.

Positive

• 47% YoY growth in U.S. net product sales to $80.9M
• Strong cash position of $305M plus $86.4M in receivables
• Acquired U.S. rights to ZEVTERA, expanding product portfolio
• Positive Phase 3 data for zoliflodacin
• XACDURO received favorable guidelines placement

Negative

• Q4 GSK royalties declined to $66.0M from $69.6M YoY
• Significant fair value losses ($123.4M) on equity investments
• Lower net income of $23.4M in 2024 compared to previous year

Insights

Financial Analyst

Innoviva delivered strong financial results for Q4 and full-year 2024, demonstrating the effectiveness of its diversified business model with two complementary revenue streams. While royalty revenue from GSK showed modest year-over-year growth ($255.6 million vs $252.7 million in 2023), the real growth engine was Innoviva Specialty Therapeutics (IST), which achieved 47% year-over-year growth in U.S. net product sales to $80.9 million.

Breaking down the product performance reveals GIAPREZA as the standout performer, contributing $15.9 million in Q4 (approximately 64% of U.S. product sales) and $53.4 million for the full year. The Q4 figure suggests accelerating momentum, as it represents nearly 30% of annual sales. Meanwhile, XACDURO is gaining traction following its recent launch, generating $5.9 million in Q4 sales.

The company's reported net income ($23.4 million for 2024) was significantly impacted by $123.4 million in negative fair value adjustments on equity investments. This substantial difference between operational performance and bottom-line results raises questions about the company's investment strategy and portfolio management, particularly regarding its position in Armata Pharmaceuticals.

Looking ahead, Innoviva's forecast of exceeding $100 million in U.S. product sales for 2025 represents at least 23% growth from 2024 levels. This appears achievable considering the mid-2025 launch of ZEVTERA and continued growth of existing products, especially with XACDURO's recent favorable guideline placement. The company's strong balance sheet ($305 million cash plus $86.4 million in receivables) provides ample flexibility for additional strategic investments beyond the recent $10.9 million stake in Gate Neurosciences.

The upcoming NDA submission for zoliflodacin represents another potential growth catalyst, addressing the significant unmet need in uncomplicated gonorrhea treatment with a novel single-dose oral option. If approved, this would further diversify Innoviva's infectious disease portfolio and strengthen its competitive positioning in the specialty pharmaceutical market.

Pharmaceutical Industry Expert

Innoviva has successfully executed its transformation from a royalty-holding company to an emerging leader in critical care and infectious disease therapeutics. While the GSK royalty stream ($255.6 million in 2024) provides stable cash flow, the company's specialty therapeutics business is now driving growth with 47% year-over-year revenue increase to $80.9 million.

The acquisition of U.S. rights to ZEVTERA represents a strategically important addition to Innoviva's antimicrobial portfolio. As the only FDA-approved cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA) in bloodstream infections, ZEVTERA addresses a significant medical need with treatment options. This positions it well in a market where approximately 119,000 bloodstream infections with S. aureus occur annually in the U.S., with MRSA accounting for roughly 40-50% of these cases.

The company's clinical development program is advancing with zoliflodacin, which addresses the growing problem of antibiotic-resistant gonorrhea. The CDC estimates over 700,000 gonorrhea infections annually in the U.S., with resistance to multiple antibiotics increasingly limiting treatment options. Zoliflodacin's novel mechanism of action (targeting DNA gyrase) and single-dose oral administration represent significant advantages over current injectable treatments, potentially improving compliance and treatment accessibility.

Innoviva's strategic approach to the challenging antimicrobial market deserves recognition. Rather than developing individual antibiotics in isolation, they've built a synergistic portfolio targeting hospital-based infectious disease specialists and critical care physicians. This shared call point strategy allows for more efficient commercialization. The favorable guideline placements for both XACDURO (preferred agent for carbapenem-resistant Acinetobacter baumannii in IDSA guidelines) and XERAVA will drive institutional formulary adoption and usage.

The nomination of XACDURO for the prestigious Prix Galien award underscores its innovation as the first FDA-approved treatment specifically for Acinetobacter baumannii infections in over 15 years. With $391.4 million in combined cash and receivables plus a $501.5 million strategic healthcare asset portfolio, Innoviva maintains significant financial flexibility to continue expanding its infectious disease and critical care franchise through additional acquisitions while supporting internal pipeline development.

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.--(BUSINESS WIRE)-- 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 for 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^®, $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^® (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).
  • In the fourth quarter of 2024, Innoviva licensed U.S. commercialization and distribution rights to ZEVTERA^® from Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN).
  • 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.
  • 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.
  • 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.
  • 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.
  • In July, XACDURO^® was named as the preferred agent for the treatment of Carbapenem-resistant Acinetobacter baumannaii infections, in combination with a carbapenem, in the updated 2024 IDSA treatment guidance.
  • 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

 

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Innoviva, Inc.

David Patti

Corporate Communications

(908) 421-5971

david.patti@inva.com

Investors and Media:

Argot Partners

(212) 600-1902

innoviva@argotpartners.com

Source: Innoviva, Inc.

FAQ

What were Innoviva's (INVA) Q4 2024 royalty revenues from GSK?

Innoviva's Q4 2024 royalty revenue from GSK was $66.0 million.

How much did Innoviva's (INVA) U.S. net product sales grow in 2024?

U.S. net product sales grew 47% year-over-year, reaching $80.9 million in 2024 compared to $55.1 million in 2023.

When will Innoviva (INVA) launch ZEVTERA in the United States?

Innoviva plans to launch ZEVTERA in the U.S. market in mid-2025.

What is Innoviva's (INVA) sales forecast for 2025?

Innoviva forecasts U.S. net product sales to exceed $100 million in 2025.

What was Innoviva's (INVA) cash position at the end of 2024?

Innoviva had $305.0 million in cash and $86.4 million in receivables as of December 31, 2024.