Full Press Release Details
Innoviva Reports Fourth Quarter 2021 Financial
BURLINGAME, Calif., February 9, 2022 -
Innoviva, Inc. (NASDAQ: INVA) ("Innoviva" and "the Company") today reported financial results
for the fourth quarter and the year ended December 31, 2021.
Pavel Raifeld, Chief Executive Officer of Innoviva, Inc., stated
"Our royalty revenues in the fourth quarter grew 18% year over year, displaying strong positive momentum in a volatile environment."
"RELVAR /BREO ELLIPTA
global net sales increased 3% compared to the fourth quarter of 2020 supported by increased patient adherence and favorable prior period
adjustments in the U.S. market. Non-U.S. sales decreased slightly due to class-wide pandemic pressures affecting new patient growth. ANORO
ELLIPTA global net sales decreased by 17% compared to fourth quarter of 2020 mainly due to by pandemic-driven LABA/LAMA
class weakness in the U.S. Non-U.S. ANORO ELLIPTA net sales also decreased slightly due to lower than
expected class growth driven predominantly by the ongoing pandemic. TRELEGY ELLIPTA global net sales increased
53% compared to fourth quarter of 2020, driven by strong U.S. growth for the triple therapy class and favorable prior period adjustments.
Non-US TRELEGY ELLIPTA sales also grew meaningfully supported by class growth and continued launches in
Mr. Raifeld concluded, "Our core royalty business has performed
very well last year under challenging conditions, attesting to its multiple growth drivers and significant diversification. We are equally
pleased with the progress across our strategic investments and the repurchase of GSK's equity stake, collectively accounting for
over $450 million deployed in 2021 and contributing to our diluted net income per share growth of over 40% to $2.87. Our excellent operating
cash flow generation, exceeding $350 million in 2021, and strong cash position enable thoughtful, flexible business development, and we
are excited about many opportunities we see in the current environment to advance our strategy. We are well positioned for and remain
laser focused on continued strong execution to ensure sustained shareholder value creation."
1 For TRELEGY ELLIPTA ,
the amount represents 100% of royalty payments made by GSK to Theravance Respiratory Company, LLC ("TRC"). Innoviva owns 15%
of the economic interest in TRC.
Innoviva, Inc. (referred to as "Innoviva", the "Company",
or "we" and other similar pronouns), is a company with a portfolio of royalties that include respiratory assets partnered
with Glaxo Group Limited ("GSK"), including RELVAR /BREO ELLIPTA (fluticasone
furoate/ vilanterol, "FF/VI"), ANORO ELLIPTA (umeclidinium bromide/ vilanterol, "UMEC/VI")
and TRELEGY ELLIPTA (the combination FF/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 is also entitled to 15% of royalty payments made by
GSK under its agreements originally entered into with us, and since assigned to Theravance Respiratory Company, LLC ("TRC"),
relating to TRELEGY ELLIPTA and any other product or combination of products that may be discovered and
developed in the future under the LABA Collaboration Agreement and the Strategic Alliance Agreement with GSK (referred to herein as the
"GSK Agreements"), which have been assigned to TRC other than RELVAR /BREO ELLIPTA
ANORO , RELVAR , BREO ,
TRELEGY and ELLIPTA are trademarks of the GlaxoSmithKline 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 and TRELEGY ELLIPTA 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 beyond the existing respiratory portfolio); 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"). 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, 2020 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.
Condensed Consolidated Statements of Income
(in thousands, except per share data)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| Royalty revenue from a related party, net (1) | $ | 107,680 | $ | 90,476 | $ | 391,866 | $ | 326,794 | ||||||||
| Revenue from collaborative arrangements with a related party | - | - | - | 10,000 | ||||||||||||
| Total net revenue | 107,680 | 90,476 | 391,866 | 336,794 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 40 | 219 | 576 | 1,788 | ||||||||||||
| General and administrative | 3,113 | 5,470 | 16,187 | 13,883 | ||||||||||||
| Total operating expenses | 3,153 | 5,689 | 16,763 | 15,671 | ||||||||||||
| Income from operations | 104,527 | 84,787 | 375,103 | 321,123 | ||||||||||||
| Interest and dividend income | 454 | 23 | 1,839 | 1,524 | ||||||||||||
| Other income (expense), net | (708 | ) | (433 | ) | (3,626 | ) | (348 | ) | ||||||||
| Interest expense | (4,841 | ) | (4,651 | ) | (19,070 | ) | (18,331 | ) | ||||||||
| Changes in fair values of equity and long-term investments, net | (42,943 | ) | 11,032 | 91,030 | 50,277 | |||||||||||
| Income before income taxes | 56,489 | 90,758 | 445,276 | 354,245 | ||||||||||||
| Income tax expense, net | 10,839 | 15,742 | 76,439 | 60,431 | ||||||||||||
| Net income | 45,650 | 75,016 | 368,837 | 293,814 | ||||||||||||
| Net income attributable to noncontrolling interest | 35,305 | 21,113 | 102,983 | 69,412 | ||||||||||||
| Net income attributable to Innoviva stockholders | $ | 10,345 | $ | 53,903 | $ | 265,854 | $ | 224,402 | ||||||||
| Basic net income per share attributable to Innoviva stockholders | $ | 0.15 | $ | 0.53 | $ | 3.24 | $ | 2.21 | ||||||||
| Diluted net income per share attributable to Innoviva stockholders | $ | 0.14 | $ | 0.48 | $ | 2.87 | $ | 2.02 | ||||||||
| Shares used to compute basic net income per share | 69,492 | 101,361 | 82,062 | 101,320 | ||||||||||||
| Shares used to compute diluted net income per share | 81,770 | 113,590 | 94,311 | 113,554 |
net revenue from a related party is comprised of the following (in thousands):
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| (unaudited) | ||||||||||||||||
| Royalties from a related party | $ | 111,135 | $ | 93,931 | $ | 405,689 | $ | 340,617 | ||||||||
| Amortization of capitalized fees paid to a related party | (3,455 | ) | (3,455 | ) | (13,823 | ) | (13,823 | ) | ||||||||
| Royalty revenue from a related party, net | $ | 107,680 | $ | 90,476 | $ | 391,866 | $ | 326,794 |
Condensed Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (1) | ||||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 201,525 | $ | 246,487 | ||||
| Other current assets | 112,148 | 95,571 | ||||||
| Property and equipment, net | 12 | 28 | ||||||
| Equity and long-term investments | 483,845 | 438,258 | ||||||
| Capitalized fees paid to a related party, net | 111,430 | 125,253 | ||||||
| Deferred tax assets, net | 17,327 | 93,759 | ||||||
| Other assets | 108 | 214 | ||||||
| Total assets | $ | 926,395 | $ | 999,570 | ||||
| Liabilities and stockholders' equity | ||||||||
| Other current liabilities | $ | 1,655 | $ | 1,958 | ||||
| Accrued interest payable | 4,152 | 4,152 | ||||||
| Convertible subordinated notes, net | 240,364 | 239,783 | ||||||
| Convertible senior notes, net | 154,289 | 145,734 | ||||||
| Other long-term liabilities | - | 106 | ||||||
| Innoviva stockholders' equity | 414,743 | 539,912 | ||||||
| Noncontrolling interest | 111,192 | 67,925 | ||||||
| Total liabilities and stockholders' equity | $ | 926,395 | $ | 999,570 |
consolidated balance sheet amounts at December 31, 2020 are derived from audited financial statements.
| Year Ended December 31, | ||||||||
| 2021 | 2020 | |||||||
| (unaudited) | ||||||||
| Net cash provided by operating activities | $ | 363,813 | $ | 313,113 | ||||
| Net cash provided by (used in) investing activities | 43,722 | (314,937 | ) | |||||
| Net cash used in financing activities | (452,497 | ) | (29,785 | ) |
Investor & Media Contacts: