Full Press Release Details
Third Quarter 2021 Financial Results
October 27, 2021 - Innoviva, Inc.
(NASDAQ: INVA) ("Innoviva" and "the Company") today reported financial results for the third quarter ended September 30,
Pavel Raifeld, Chief Executive Officer
of Innoviva, Inc., stated, "Our royalty revenues grew 10% year over year, displaying strong positive momentum in a volatile
ELLIPTA global net sales decreased 15% compared to the third quarter of 2020 mainly because the significant favorable
prior period adjustment in the U.S. in 2020 was not repeated. Non-U.S. sales increased 4% with strong growth in Japan and the EU despite
generic competition and class-wide pressures. ANORO ELLIPTA global net sales decreased by 2% in the third
quarter of 2021 due to pandemic-driven LABA/LAMA class weakness. U.S. net sales decreased with slower new patient growth. Non-U.S.
ANORO ELLIPTA net sales increased 8% because of meaningful growth in select markets despite class challenges.
TRELEGY ELLIPTA global net sales increased 77% in the third quarter of 2021, driven by excellent
U.S. growth for the triple therapy class and favorable prior period adjustment. Non-US TRELEGY ELLIPTA sales
also grew as Trelegy continues to launch in new markets."
Mr. Raifeld concluded, "We are
pleased with the growth and resilience in our core royalty business. In addition, we are excited by strong progress across our asset
portfolio, including recent pivotal clinical data read out at Entasis Therapeutics. Our financial performance remains robust, with basic
net income per share exceeding $1 for the quarter, a nearly four-fold increase over the third quarter of 2020, supported by the recently
completed equity repurchase, as we continue to focus on shareholder value creation through thoughtful capital deployment and operational
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 and ANORO ELLIPTA .
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
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| Royalty revenue from a related party, net (1) | $ | 97,862 | $ | 88,694 | $ | 284,186 | $ | 236,318 | ||||||||
| Revenue from collaborative arrangements with a related party | - | - | - | 10,000 | ||||||||||||
| Total net revenue | 97,862 | 88,694 | 284,186 | 246,318 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 449 | 1,010 | 536 | 1,569 | ||||||||||||
| General and administrative | 2,860 | 3,254 | 13,074 | 8,413 | ||||||||||||
| Total operating expenses | 3,309 | 4,264 | 13,610 | 9,982 | ||||||||||||
| Income from operations | 94,553 | 84,430 | 270,576 | 236,336 | ||||||||||||
| Other income (expense), net | (652 | ) | (13 | ) | (2,036 | ) | 85 | |||||||||
| Interest income | 453 | 41 | 503 | 1,501 | ||||||||||||
| Interest expense | (4,790 | ) | (4,603 | ) | (14,229 | ) | (13,680 | ) | ||||||||
| Changes in fair values of equity and long-term investments, net | 33,613 | (29,368 | ) | 133,973 | 39,245 | |||||||||||
| Income before income taxes | 123,177 | 50,487 | 388,787 | 263,487 | ||||||||||||
| Income tax expense, net | 20,531 | 8,866 | 65,600 | 44,689 | ||||||||||||
| Net income | 102,646 | 41,621 | 323,187 | 218,798 | ||||||||||||
| Net income attributable to noncontrolling interest | 30,208 | 13,403 | 67,678 | 48,299 | ||||||||||||
| Net income attributable to Innoviva stockholders | $ | 72,438 | $ | 28,218 | $ | 255,509 | $ | 170,499 | ||||||||
| Basic net income per share attributable to Innoviva stockholders | $ | 1.04 | $ | 0.28 | $ | 2.96 | $ | 1.68 | ||||||||
| Diluted net income per share attributable to Innoviva stockholders | $ | 0.90 | $ | 0.26 | $ | 2.63 | $ | 1.53 | ||||||||
| Shares used to compute basic net income per share | 69,458 | 101,358 | 86,298 | 101,306 | ||||||||||||
| Shares used to compute diluted net income per share | 81,699 | 113,572 | 98,536 | 113,543 |
(1) Total net revenue from a related party
is comprised of the following (in thousands):
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Royalties from a related party | $ | 101,318 | $ | 92,150 | $ | 294,554 | $ | 246,686 | ||||||||
| Amortization of capitalized fees paid to a related party | (3,456 | ) | (3,456 | ) | (10,368 | ) | (10,368 | ) | ||||||||
| Royalty revenue from a related party, net | $ | 97,862 | $ | 88,694 | $ | 284,186 | $ | 236,318 |
Condensed Consolidated
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (unaudited) | (1) | |||||||
| Assets | ||||||||
| Cash, cash equivalents and marketable securities | $ | 135,115 | $ | 246,487 | ||||
| Other current assets | 101,813 | 95,571 | ||||||
| Property and equipment, net | 15 | 28 | ||||||
| Equity and long-term investments | 507,116 | 438,258 | ||||||
| Capitalized fees paid to a related party, net | 114,885 | 125,253 | ||||||
| Deferred tax assets, net | 28,159 | 93,759 | ||||||
| Other assets | 136 | 214 | ||||||
| Total assets | $ | 887,239 | $ | 999,570 | ||||
| Liabilities and stockholders' equity | ||||||||
| Other current liabilities | $ | 1,457 | $ | 1,958 | ||||
| Accrued interest payable | 1,668 | 4,152 | ||||||
| Convertible subordinated notes, net | 240,215 | 239,783 | ||||||
| Convertible senior notes, net | 152,080 | 145,734 | ||||||
| Other long-term liabilities | 14 | 106 | ||||||
| Innoviva stockholders' equity | 402,811 | 539,912 | ||||||
| Noncontrolling interest | 88,994 | 67,925 | ||||||
| Total liabilities and stockholders' equity | $ | 887,239 | $ | 999,570 |
(1) The selected consolidated balance sheet
amounts at December 31, 2020 are derived from audited financial statements.
| Nine Months Ended September 30, | ||||||||
| 2021 | 2020 | |||||||
| (unaudited) | ||||||||
| Net cash provided by operating activities | $ | 265,432 | $ | 227,833 | ||||
| Net cash provided by investing activities | 63,627 | 544 | ||||||
| Net cash used in financing activities | (440,431 | ) | (27,280 | ) |
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