Full Press Release Details
Reports Fourth Quarter 2020 Financial Results
BURLINGAME, Calif., February 3, 2021 -
Innoviva, Inc. (NASDAQ: INVA) (the Company) today reported financial results for the fourth quarter ended December 31,
Pavel Raifeld, Chief Executive Officer of Innoviva, Inc., stated:
"RELVAR /BREO ELLIPTA global net sales increased by 5%, ANORO
ELLIPTA global net sales increased by 10%, and TRELEGY ELLIPTA global net sales
increased by 42% in the fourth quarter of 2020, compared to the same quarter of 2019. We are pleased with the excellent growth
demonstrated by all our products despite continued volatility in our core markets."
Mr. Raifeld concluded, "2020 was a strong year for us.
Our revenues have demonstrated impressive sustainability in a challenging environment, while our operations have remained efficient
and robust. We successfully deployed nearly $400 million of capital across a number of promising assets and strategically positioned
Innoviva for significant shareholder value creation".
ELLIPTA , Innoviva is entitled to 15% of royalty payments made by GSK that are assigned to TRC, LLC.
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
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, 2019 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.
| INNOVIVA, INC. | ||||||||||||||||
| Condensed Consolidated Statements of Income | ||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Royalty revenue from a related party, net (1) | $ | 90,476 | $ | 75,971 | $ | 326,794 | $ | 261,016 | ||||||||
| Revenue from collaborative arrangements with a related party | - | - | 10,000 | - | ||||||||||||
| Total net revenue | 90,476 | 75,971 | 336,794 | 261,016 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 219 | - | 1,788 | - | ||||||||||||
| General and administrative | 5,470 | 2,332 | 13,883 | 14,656 | ||||||||||||
| Total operating expenses | 5,689 | 2,332 | 15,671 | 14,656 | ||||||||||||
| Income from operations | 84,787 | 73,639 | 321,123 | 246,360 | ||||||||||||
| Other expense, net | (433 | ) | (223 | ) | (348 | ) | (345 | ) | ||||||||
| Interest income | 23 | 1,538 | 1,524 | 5,540 | ||||||||||||
| Interest expense | (4,651 | ) | (4,689 | ) | (18,331 | ) | (18,660 | ) | ||||||||
| Changes in fair values of equity investments | 11,032 | - | 50,277 | - | ||||||||||||
| Income before income taxes | 90,758 | 70,265 | 354,245 | 232,895 | ||||||||||||
| Income tax expense, net | 15,742 | 12,403 | 60,431 | 41,902 | ||||||||||||
| Net income | 75,016 | 57,862 | 293,814 | 190,993 | ||||||||||||
| Net income attributable to noncontrolling interest | 21,113 | 11,913 | 69,412 | 33,705 | ||||||||||||
| Net income attributable to Innoviva stockholders | $ | 53,903 | $ | 45,949 | $ | 224,402 | $ | 157,288 | ||||||||
| Basic net income per share attributable to Innoviva stockholders | $ | 0.53 | $ | 0.45 | $ | 2.21 | $ | 1.55 | ||||||||
| Diluted net income per share attributable to Innoviva stockholders | $ | 0.48 | $ | 0.42 | $ | 2.02 | $ | 1.43 | ||||||||
| Shares used to compute basic net income per share | 101,361 | 101,199 | 101,320 | 101,150 | ||||||||||||
| Shares used to compute diluted net income per share | 113,590 | 113,453 | 113,554 | 113,409 |
(1) Total net revenue from a related party is comprised of the following (in thousands):
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Royalties from a related party | $ | 93,931 | $ | 79,426 | $ | 340,617 | $ | 274,839 | ||||||||
| Amortization of capitalized fees paid to a related party | (3,455 | ) | (3,455 | ) | (13,823 | ) | (13,823 | ) | ||||||||
| Royalty revenue from a related party, net | $ | 90,476 | $ | 75,971 | $ | 326,794 | $ | 261,016 |
| INNOVIVA, INC. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands) | ||||||||
| December 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| (1) | ||||||||
| Assets | ||||||||
| Cash, cash equivalents and marketable securities | $ | 246,487 | $ | 350,845 | ||||
| Other current assets | 95,571 | 80,389 | ||||||
| Property and equipment, net | 28 | 33 | ||||||
| Equity and other long term investments | 438,258 | - | ||||||
| Capitalized fees paid to a related party, net | 125,253 | 139,076 | ||||||
| Deferred tax assets, net | 93,759 | 154,171 | ||||||
| Other assets | 214 | 312 | ||||||
| Total assets | $ | 999,570 | $ | 724,826 | ||||
| Liabilities and stockholders' equity | ||||||||
| Other current liabilities | $ | 1,958 | $ | 1,219 | ||||
| Accrued interest payable | 4,152 | 4,152 | ||||||
| Convertible subordinated notes, net | 239,783 | 239,217 | ||||||
| Convertible senior notes, net | 145,734 | 137,903 | ||||||
| Other long-term liabilities | 106 | 219 | ||||||
| Innoviva stockholders' equity | 539,912 | 313,495 | ||||||
| Noncontrolling interest | 67,925 | 28,621 | ||||||
| Total liabilities and stockholders' equity | $ | 999,570 | $ | 724,826 |
(1) The selected consolidated balance
sheet amounts at December 31, 2019 are derived from audited financial statements.
| INNOVIVA, INC. | ||||||||
| Cash Flows Summary | ||||||||
| (in thousands) | ||||||||
| Year Ended December 31, | ||||||||
| 2020 | 2019 | |||||||
| (unaudited) | ||||||||
| Net cash provided by operating activities | $ | 313,113 | $ | 257,458 | ||||
| Net cash used in investing activities | (314,937 | ) | (18,003 | ) | ||||
| Net cash used in financing activities | (29,785 | ) | (23,776 | ) |
Investor & Media Contacts:
Alex Kovtun / James Goldfarb