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Innoviva Reports Fourth Quarter and Full Year 2023 Financial Results; Highlights Recent Company Progress Core royalty platform on track; received GSK royalties of $69.6 million for fourth quarter Achieved net product rev

Key Takeaway: Innoviva, Inc. reported its financial results for Q4 and full year 2023, showcasing significant achievements including a 35% year-on-year growth in product revenues. The company successfully launched XACDURO for Acinetobacter infections and reported positive Phase 3 data for the oral drug zoliflodacin. Innoviva ended the year with over $275 million in cash and receivables, reinforcing its strong financial position. The company's leadership emphasizes a focus on driving long-term shareholder value through disciplined financial strategies and innovative therapeutics.

Market Sentiment Analysis

POSITIVE FACTORS

  • Achieved 35% year-on-year growth in product revenues for Q4 2023.
  • Successfully launched XACDURO, the first pathogen-targeted antibacterial for Acinetobacter infections.
  • Reported positive Phase 3 data for zoliflodacin, a treatment for uncomplicated gonorrhea.
  • Maintained strong cash flow with over $275 million in cash and receivables.

CONCERNS & RISKS

  • Potential fluctuations in future royalty revenue from respiratory products partnered with GSK.
  • Risks associated with clinical development timelines and commercialization strategies.
  • Ongoing competition in the critical care and infectious disease market.
  • General market volatility impacting growth strategy execution.

Full Press Release Details

Fourth Quarter and Full Year 2023 Financial Results; Highlights Recent Company Progress
platform on track; received GSK royalties of $69.6 million for fourth quarter
product revenues of $19.7 million for the fourth quarter of 2023 representing 35% year on year growth
progress in 2023: Approval and launch of first pathogen targeted antibacterial XACDURO for treatment of HABP/VABP caused
by Acinetobacter infections; positive topline Phase 3 data for oral drug zoliflodacin for treatment of uncomplicated gonorrhea
million our common stock for $15.4 million in the fourth quarter of 2023
Calif. - February 29, 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 fourth quarter and full year ended December 31, 2023 and highlighted
select corporate achievements.
Pavel Raifeld, Chief Executive Officer
of Innoviva, said: "2023 was a successful and transformational year for Innoviva. We have seen continued strong cash flow from
our core royalty portfolio, which we have been investing prudently with a laser focus on driving long-term shareholder value. Last year
showcased the success of our approach with the formation and significant pipeline and commercial progress of
our therapeutics platform, which is focused on becoming the industry leader in critical care and infectious disease."
Matthew Ronsheim, Ph.D., President of
IST, noted, "Our therapeutics platform achieved tremendous success in its first year: we saw the approval and launch of XACDURO ,
the first pathogen targeted antibacterial approved by the FDA for life threatening Acinetobacter infections caused by susceptible
isolates; we reported positive Phase III data for zoliflodacin, the potential first novel oral treatment for gonorrhea; and our targeted
and lean commercial platform delivered meaningful growth in our core marketed products GIAPREZA and XERAVA .
With our best-in-class capabilities and leverageable commercial infrastructure, we are excited about our ability to deliver life-saving
drugs to patients in areas of high unmet medical need and about our significant growth prospects in the coming years."
Mr. Raifeld concluded, "Innoviva's
strong financials reflect a new royalty base (following value-accretive 2022 TRELEGY ELLIPTA royalties
monetization), a full year of integrated operations for our therapeutics platform, and significant value creation in our strategic healthcare
assets. Innoviva continued to exercise financial discipline and ended the year with over $275 million in cash and account receivables,
while returning capital with share repurchases of over $75 million and paying down outstanding debt of nearly $100 million. We believe
our diversified growth strategy, a strong leadership team, and our focus on cost discipline position us well to deliver shareholder value."
Financial Highlights
Key 2023 R&D Highlights
Update on Strategic Healthcare Assets
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.
BREO and TRELEGY 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, 2022 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.
Corporate Communications
Investors and Media:
Condensed Consolidated Statements of Income
(in thousands, except per share data)
Three Months Ended Year Ended
December 31, December 31,
2023 2022 2023 2022
Revenue:
Royalty revenue, net (1) $ 66,165 $ 51,216 $ 238,846 $ 311,645
Net product sales 19,675 14,587 60,617 19,694
License Revenue - - 11,000 -
Total revenue 85,840 65,803 310,463 331,339
Expenses:
Cost of products sold (inclusive of amortization of inventory fair value adjustments) 13,130 10,113 41,040 13,793
Cost of license revenue - - 1,600 -
Selling, general and administrative 26,319 17,454 98,232 63,538
Research and development 2,356 9,985 33,922 41,432
Amortization of acquired intangible assets 6,510 4,070 21,784 5,581
Gain on TRC sale - - - (266,696 )
Loss on debt extinguishment - - - 20,662
Changes in fair values of equity method investments, net (9,506 ) 117,274 (77,392 ) 161,749
Changes in fair values of equity and long-term investments, net (16,016 ) (31,868 ) (11,129 ) (8,462 )
Interest and dividend income (4,786 ) (3,188 ) (15,818 ) (6,369 )
Interest expense 5,952 4,028 19,157 15,789
Other expense (income), net 680 2,623 4,969 3,373
Total expenses 24,639 130,491 116,365 44,390
Income before income taxes 61,201 (64,688 ) 194,098 286,949
Income tax expense (330 ) 3,626 14,376 66,687
Net income 61,531 (68,314 ) 179,722 220,262
Net income attributable to noncontrolling interest - - - 6,341
Net income attributable to Innoviva stockholders $ 61,531 $ (68,314 ) $ 179,722 $ 213,921
Basic net income per share attributable to Innoviva stockholders $ 0.97 $ (0.98 ) $ 2.75 $ 3.07
Diluted net income per share attributable to Innoviva stockholders $ 0.76 $ (0.98 ) $ 2.20 $ 2.37
Shares used to compute basic net income per share 63,710 69,656 65,435 69,644
Shares used to compute diluted net income per share 84,995 69,656 86,876 95,248
(1) Total net revenue is comprised of the following (in thousands):
Three Months Ended Year Ended
December 31, December 31,
2023 2022 2023 2022
(unaudited) (unaudited)
Royalties $ 69,620 $ 54,671 $ 252,669 $ 325,468
Amortization of capitalized fees (3,455 ) (3,455 ) (13,823 ) (13,823 )
Royalty revenue, net $ 66,165 $ 51,216 $ 238,846 $ 311,645
Condensed Consolidated Balance Sheets
December 31, December 31,
2023 2022
Assets
Cash and cash equivalents $ 193,513 $ 291,049
Royalty and product sale receivables 84,075 64,073
Inventory, net 40,737 55,897
Prepaid expense and other current assets 25,894 32,492
Property and equipment, net 483 170
Equity and long-term investments 560,978 403,013
Capitalized fees 83,784 97,607
Right-of-use assets 2,536 3,265
Goodwill 17,905 26,713
Intangible assets 230,335 252,919
Other assets 3,267 4,299
Total assets $ 1,243,507 $ 1,231,497
Liabilities and stockholders' equity
Other current liabilities $ 33,435 $ 32,322
Accrued interest payable 3,422 4,359
Deferred revenues 1,277 2,094
Convertible subordinated notes, due 2023, net - 96,193
Convertible senior notes, due 2025, net 191,295 190,583
Convertible senior notes, due 2028, net 254,939 253,597
Other long term liabilities 71,870 70,918
Deferred tax liabilities 563 5,771
Income tax payable - long term 11,751 9,872
Innoviva stockholders' equity 674,955 565,788
Total liabilities and stockholders' equity $ 1,243,507 $ 1,231,497
Year Ended December 31,
2023 2022
Net cash provided by operating activities $ 141,064 $ 201,726
Net cash used in investing activities (66,761 ) (56,634 )
Net cash used in financing activities (171,839 ) (55,568 )
Net change $ (97,536 ) $ 89,524
Cash and cash equivalents at beginning of period 291,049 201,525
Cash and cash equivalents at end of period $ 193,513 $ 291,049

Frequently Asked Questions

What were Innoviva's product revenues for Q4 2023?

Product revenues for Q4 2023 were $19.7 million, showing a 35% year-over-year growth.

What major product was launched by Innoviva in 2023?

In 2023, Innoviva launched XACDURO, the first pathogen-targeted antibacterial for Acinetobacter infections.

How much did Innoviva repurchase in common stock in Q4 2023?

Innoviva repurchased over $75 million in common stock during the fourth quarter of 2023.

What is zoliflodacin developed for?

Zoliflodacin is being developed as a novel oral treatment for uncomplicated gonorrhea.

What is Innoviva's current cash position?

As of year-end 2023, Innoviva had over $275 million in cash and account receivables.

Last updated: Feb 29, 2024