Full Press Release Details
Innoviva Reports Fourth Quarter 2022 Financial
Results and Highlights Recent Company Progress
Calif.-(BUSINESS WIRE)- February 28, 2023-Innoviva, Inc. (NASDAQ: INVA) ("Innoviva" or "the
Company"), a diversified holding company with a portfolio of royalties and other healthcare
assets, today reported financial results for the fourth quarter ended December 31, 2022.
Pavel Raifeld, Chief Executive Officer of Innoviva,
stated: "Our diversified core royalty business remains solid. RELVAR /BREO ELLIPTA
global net sales decreased in the fourth quarter of 2022 primarily due to unfavorable prior period adjustments in the U.S., despite stable
volume trends. ANORO ELLIPTA global net sales decreased slightly compared to the fourth quarter of 2021
mainly due to foreign exchange rate changes."
Mr. Raifeld continued:
"We continue to advance our strategy of building a best-in-class hospital and infectious disease business formed through acquisitions
of Entasis Therapeutics and La Jolla Pharmaceutical. Notably, GIAPREZA and XERAVA had their strongest quarter ever, the FDA accepted our
SUL-DUR NDA with Priority Review, and enrollment in our Phase 3 registrational trial of zoliflodacin remains on track, with study completion
anticipated in 2023. We believe this platform will afford us multiple opportunities to create and crystalize shareholder value."
markets volatility has significantly impacted income over the past quarter, primarily manifesting through decline in Armata's
share price, most losses have been recouped following recent stock rallies. We remain excited about our prospects and continue to be
disciplined with our capital, executing on the $100 million share buyback program and optimizing our operating footprint following
recent acquisitions," said Mr. Raifeld.
Innoviva is a diversified
holding company with a portfolio of royalties and other healthcare assets. Innoviva's royalty portfolio includes respiratory assets
partnered with Glaxo Group Limited ("GSK"), including RELVAR /BREO ELLIPTA
(fluticasone furoate/ vilanterol, "FF/VI") and ANORO ELLIPTA (umeclidinium bromide/ vilanterol,
"UMEC/VI"). Under the Long-Acting Beta2 Agonist ("LABA") Collaboration Agreement, Innoviva is entitled to
receive royalties from GSK on sales of RELVAR /BREO ELLIPTA and ANORO
ELLIPTA . Innoviva's other healthcare assets include infectious disease and hospital assets stemming from acquisitions
of Entasis Therapeutics, including its lead asset sulbactam-durlobactam, and La Jolla Pharmaceutical, 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.
and BREO are trademarks of the GSK group of companies.
Forward Looking Statements
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 and XERAVA 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, 2021 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. Additional
risk factors are presented on Form 8-K filed on August 23, 2022. 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.
Condensed Consolidated Statements of Income
(in thousands, except per share data)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Royalty revenue, net (1) | $ | 51,216 | $ | 107,680 | $ | 311,645 | $ | 391,866 | ||||||||
| Net product sales | 14,587 | - | 19,694 | - | ||||||||||||
| Total revenue | 65,803 | 107,680 | 331,339 | 391,866 | ||||||||||||
| Expenses: | ||||||||||||||||
| Cost of products sold (inclusive of amortization of inventory fair value adjustments) | 10,113 | - | 13,793 | - | ||||||||||||
| Selling, general and administrative | 17,390 | 3,113 | 63,538 | 16,187 | ||||||||||||
| Research and development | 10,049 | 40 | 41,432 | 576 | ||||||||||||
| Amortization of acquired intangible assets | 4,070 | - | 5,581 | - | ||||||||||||
| Gain on TRC sale | - | - | (266,696 | ) | ||||||||||||
| Loss on debt extinguishment | - | - | 20,662 | |||||||||||||
| Changes in fair values of equity method investments, net | 117,275 | 9,025 | 161,749 | (84,392 | ) | |||||||||||
| Changes in fair values of equity and long-term investments, net | (31,868 | ) | 33,917 | (8,462 | ) | (6,638 | ) | |||||||||
| Interest and dividend income | (3,188 | ) | (454 | ) | (6,369 | ) | (1,839 | ) | ||||||||
| Interest expense | 4,028 | 4,841 | 15,789 | 19,070 | ||||||||||||
| Other expense (income), net | 2,622 | 708 | 3,373 | 3,626 | ||||||||||||
| Total expenses | 130,491 | 51,190 | 44,390 | (53,410 | ) | |||||||||||
| Income before income taxes | (64,688 | ) | 56,490 | 286,949 | 445,276 | |||||||||||
| Income tax expense | 3,626 | 10,839 | 66,687 | 76,439 | ||||||||||||
| Net income | (68,314 | ) | 45,651 | 220,262 | 368,837 | |||||||||||
| Net income attributable to noncontrolling interest | - | 35,305 | 6,341 | 102,983 | ||||||||||||
| Net income attributable to Innoviva stockholders | $ | (68,314 | ) | $ | 10,346 | $ | 213,921 | $ | 265,854 | |||||||
| Basic net income per share attributable to Innoviva stockholders | $ | (0.98 | ) | $ | 0.15 | $ | 3.07 | $ | 3.24 | |||||||
| Diluted net income per share attributable to Innoviva stockholders | $ | (0.98 | ) | $ | 0.14 | $ | 2.37 | $ | 2.87 | |||||||
| Shares used to compute basic net income per share | 69,656 | 69,492 | 69,644 | 82,062 | ||||||||||||
| Shares used to compute diluted net income per share | 69,656 | 81,770 | 95,249 | 94,310 |
(1) Total net revenue is comprised of the following (in thousands):
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Royalties | $ | 54,671 | $ | 111,135 | $ | 325,468 | $ | 405,689 | ||||||||
| Amortization of capitalized fees | (3,455 | ) | (3,455 | ) | (13,823 | ) | (13,823 | ) | ||||||||
| Royalty revenue, net | $ | 51,216 | $ | 107,680 | $ | 311,645 | $ | 391,866 |
Condensed Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 291,049 | $ | 201,525 | ||||
| Royalty and product sale receivables | 64,073 | 110,711 | ||||||
| Inventory, net | 55,897 | - | ||||||
| Prepaid expense and other current assets | 32,492 | 1,437 | ||||||
| Property and equipment, net | 170 | 12 | ||||||
| Equity and long-term investments | 403,013 | 483,845 | ||||||
| Capitalized fees | 97,607 | 111,430 | ||||||
| Right-of-use assets | 3,265 | 97 | ||||||
| Goodwill | 26,713 | - | ||||||
| Intangible assets | 252,919 | - | ||||||
| Deferred tax assets, net | - | 17,327 | ||||||
| Other assets | 4,299 | 11 | ||||||
| Total assets | $ | 1,231,497 | $ | 926,395 | ||||
| Liabilities and stockholders' equity | ||||||||
| Other current liabilities | $ | 32,322 | $ | 1,655 | ||||
| Accrued interest payable | 4,359 | 4,152 | ||||||
| Deferred revenues | 2,094 | - | ||||||
| Convertible subordinated notes, due 2023, net | 96,193 | 240,364 | ||||||
| Convertible senior notes, due 2025, net | 190,583 | 154,289 | ||||||
| Convertible senior notes, due 2028, net | 253,597 | - | ||||||
| Other long term liabilities | 70,918 | - | ||||||
| Deferred tax liabilities | 5,771 | |||||||
| Income tax payable - long term | 9,872 | - | ||||||
| Innoviva stockholders' equity | 565,788 | 414,743 | ||||||
| Noncontrolling interest | - | 111,192 | ||||||
| Total liabilities and stockholders' equity | $ | 1,231,497 | $ | 926,395 |
| Year Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Net cash provided by operating activities | $ | 201,726 | $ | 363,813 | ||||
| Net cash provided by (used in) investing activities | (56,634 | ) | 43,722 | |||||
| Net cash used in financing activities | (55,568 | ) | (452,497 | ) | ||||
| Net change | $ | 89,524 | $ | (44,962 | ) | |||
| Cash and cash equivalents at beginning of period | 201,525 | 246,487 | ||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 291,049 | $ | 201,525 |