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): November 6, 2024

 

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 Stock Market LLC

 

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 November 6, 2024, Innoviva, Inc. (the “Company”) issued a press release regarding its results of operations and financial condition for the quarter ended September 30, 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 November 6, 2024
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: November 6, 2024	By:	/s/ Pavel Raifeld
		Pavel Raifeld
		Chief Executive Officer

 

 

Exhibit 99.1

 

 

 

Innoviva Reports Third Quarter 2024 Financial Results; Highlights Recent Company Progress

 

Core royalty platform continued strong performance, receiving GSK royalties of $60.5 million with 6% year-over-year growth

 

Innoviva Specialty Therapeutics’ (IST) marketed portfolio achieved U.S. net product sales of $19.7 million, reflecting 68% year-over-year growth

 

BURLINGAME, Calif. – November 6, 2024 – 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 third quarter ended September 30, 2024, and highlighted select corporate achievements.

 

“For the third quarter of 2024, we continue to deliver strong revenue growth, with solid performance from our core GSK royalty assets, and accelerating sales from our IST commercial products, GIAPREZA^®, XACDURO^® and XERAVA^®. Since the formation of IST, now in its second year of operation, we have shown consistent sales expansion in our commercial products, primarily driven by increasing product demand, validating our investment in hospital-based therapeutics,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “Of special note, XACDURO^® was nominated for the Best Biotechnology Product by The Galien Foundation USA in recognition of its pioneering science and positive impact on patients. We are proud of this recognition which highlights the commitment and innovation we are bringing to this space, where there is significant unmet medical need and an immense demand for new drugs. We also continue to further advance our pipeline and are on track to submit a New Drug Application (“NDA”) for zoliflodacin, potentially first in class, single dose oral drug for the treatment of uncomplicated gonorrhea, to the U.S. FDA in early 2025.”

 

Mr. Raifeld continued, “Over the past quarter, we also saw meaningful operational progress across our strategic healthcare assets. We remain focused on prudent capital allocation in our quest to maximize shareholder value and see multiple opportunities for continued value creation.”

 

Financial Highlights

 

·

Royalty revenue: Third quarter 2024 gross royalty revenue from Glaxo Group Limited (“GSK”) was $60.5 million, compared to $57.0 million for the third quarter 2023.

 

·

Net Product Sales: Third quarter 2024 net product sales were $27.8 million, which included U.S. net product sales of $19.7 million and ex-U.S. product sales of $8.1 million. U.S. net product sales consisted of $13.1 million from GIAPREZA®, $2.3 million from XERAVA®, and $4.3 million from XACDURO®, a 68% increase compared to $11.8 million for the third quarter 2023.

 

·

License Revenue: Third quarter 2024 license revenue of $4.6 million included product development cost-sharing reimbursements from our partner.

 

 

 

 

·

Equity and long-term investments: Third quarter 2024 unfavorable net change in fair value of equity and long-term investments of $35.2 million was primarily due to lower share price of Armata Pharmaceuticals (“Armata”).

 

·

Net income: Net income of $1.2 million, or $0.02 basic per share, for the third quarter of 2024, compared to a net income of $82.0 million, or $1.26 basic per share, for the third quarter of 2023.

 

·

Cash and cash equivalents: Totaled $260.6 million. Royalty and product sales receivables totaled $91.1 million as of September 30, 2024.

 

Key Business and R&D Highlights

 

·

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 recently nominated for the 2024 Prix Galien USA Award for Best Biotechnology Product, which recognizes excellence in scientific innovation that improves the state of human health.

 

·

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 September 2024, we presented additional findings on our investigational agent zoliflodacin at the 2024 Sexually Transmitted Infections Prevention Conference in Atlanta. The first oral presentation demonstrated that zoliflodacin had potent in vitro activity against 200 clinical isolates, consistent with previous U.S. surveillance data. The second presentation demonstrated that microbiological cure rates for specific subgroups were comparable to the primary endpoint analysis. Safety in these subgroups was also comparable.

 

o

In October 2024, we had five presentations at IDWeek 2024, which took place in Los Angeles. One oral presentation on zoliflodacin included a review of the unique public-private partnership that led the clinical development of zoliflodacin. The second presentation highlighted the activity of sulbactam-durlobactam and standard-of-care antibiotics against Acinetobacter baumannii-calcoaceticus complex for hospitalized patients in the U.S. Three posters were presented including two on zoliflodacin: In vitro activity against baseline isolates in U.S. participants from the phase 3 trial and a pharmacometrics analysis supporting dose selection. Surveillance data of eravacycline against clinical pathogens, collected worldwide from multiple infections sites during 2018-2022 was also presented.

 

o

We continue to advance zoliflodacin following its successful Phase 3 clinical trial results and expect to submit an NDA to the U.S. FDA in early 2025.

 

 

 

 

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.

 

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, 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.

 

 

 

 

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

 

 

 

INNOVIVA, INC.

Condensed Consolidated Statements of Income and Comprehensive Income

(in thousands, except per share data)

(unaudited)

 

		Three Months Ended								Nine Months Ended
		September 30,								September 30,
		2024				2023				2024				2023
Revenue:
Royalty revenue, net (1)		$	57,056			$	53,558			$	179,213			$	172,681
Net product sales			27,822				13,701				68,557				40,942
License revenue			4,630				-				19,135				11,000
Total revenue			89,508				67,259				266,905				224,623
Expenses:
Cost of products sold (inclusive of amortization of inventory fair value adjustments)			9,990				10,182				29,433				27,910
Cost of license revenue			-				-				-				1,600
Selling, general and administrative			26,219				28,636				84,364				71,913
Research and development			3,551				3,989				9,989				31,566
Amortization of acquired intangible assets			6,511				6,511				19,391				15,274
Changes in fair values of equity method investments, net			18,231				(71,980	)			42,997				(67,886	)
Changes in fair values of equity and long-term investments, net			16,936				2,640				60,827				4,887
Interest and dividend income			(5,500	)			(4,114	)			(13,373	)			(11,032	)
Interest expense			5,807				4,396				17,460				13,205
Other expense, net			914				1,047				3,123				4,289
Total expenses, net			82,659				(18,693	)			254,211				91 ,726
Income before income taxes			6,849				85,952				12,694				132,897
Income tax expense, net			5,636				3,906				9634				14,706
Net income and comprehensive income		$	1,213			$	82,046			$	3,060			$	118,191
Net income per share
Basic		$	0.02			$	1.26			$	0.05			$	1.79
Diluted		$	0.02			$	0.98			$	0.05			$	1.45
Shares used to compute net income per share
Basic			62,569				64,953				62,759				66,016
Diluted			62,951				86,164				63,020				87,504

 

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

 

		Three Months Ended								Nine Months Ended
		September 30,								September 30,
		2024				2023				2024				2023
		(unaudited)								(unaudited)
Royalties		$	60,512			$	57,014			$	189,581			$	183,049
Amortization of capitalized fees			(3,456	)			(3,456	)			(10,368	)			(10,368	)
Royalty revenue, net		$	57,056			$	53,558			$	179,213			$	172,681

 

 

 

INNOVIVA, INC.

Condensed Consolidated Balance Sheets

(in thousands)

(unaudited)

 

		September 30,				December 31,
		2024				2023
Assets
Cash and cash equivalents		$	260,630			$	193,513
Royalty and product sale receivables			91,058				84,075
Inventory			34,236				40,737
Prepaid expense and other current assets			14,697				25,894
Property and equipment, net			544				483
Equity and long-term investments			507,718				560,978
Capitalized fees paid, net			73,416				83,784
Right-of-use assets			2,789				2,536
Goodwill			17,905				17,905
Intangible assets			210,944				230,335
Deferred tax asset, net			14,875				-
Other assets			2,800				3,267
Total assets		$	1,231,612			$	1,243,507
Liabilities and stockholders’ equity
Other current liabilities		$	30,357			$	33,435
Accrued interest payable			833				3,422
Deferred revenue			717				1,277
Convertible senior notes, due 2025, net			191,843				191,295
Convertible senior notes, due 2028, net			255,972				254,939
Other long-term liabilities			71,449				71,870
Deferred tax liabilities, net			-				563
Income tax payable, long-term			11,899				11,751
Innoviva stockholders’ equity			668,542				674,955
Total liabilities and stockholders’ equity		$	1,231,612			$	1,243,507

 

 

 

 

INNOVIVA, INC.

Cash Flows Summary

(in thousands)

(unaudited)

 

		Nine Months Ended
		September 30,
		2024				2023
Net cash provided by operating activities		$	129,451			$	107,808
Net cash used in investing activities			(48,308	)			(61,610	)
Net cash used in financing activities			(14,026	)			(157,250	)
Net change			67,117				(111 ,052	)
Cash and cash equivalents at beginning of period			193,513				291,049
Cash and cash equivalents at end of period		$	260,630			$	179,997

 

 

v3.24.3

Cover	Nov. 06, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 06, 2024
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
Entity Address, Postal Zip Code	94010
City Area Code	650
Local Phone Number	238-9600
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
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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