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 |