Full Press Release Details
First Quarter 2021 Financial Results
Calif., April 28, 2021 - Innoviva, Inc. (NASDAQ: INVA) ("Innoviva"
and "the Company") today reported financial results for the first quarter ended March 31, 2021.
Pavel Raifeld, Chief Executive Officer of Innoviva, Inc., stated:
"Our royalty revenues grew 8% year over year, meaningfully positively impacted by non-recurring items in the quarter, including
prior-period adjustments and favorable foreign exchange rates."
ELLIPTA global net sales increased modestly compared to the first quarter of 2020. U.S. net sales increased by
5% as a decline in volume was more than offset by a favorable prior-period adjustment. Non-U.S. sales decreased by 2% as the ICS/LABA
class growth declined and the positive prior-year stockpiling impact was not repeated. ANORO ELLIPTA
global net sales increased by 7% in the first quarter of 2021. U.S. net
sales increased by 8% due to a favorable prior-period adjustment and beneficial pricing trends, offsetting negative volume dynamics. Non-U.S.
sales increased by 5%, supported by a positive currency impact. TRELEGY ELLIPTA
global net sales increased by 37% in the first quarter of 2021,
driven by strong volume growth and a favorable prior-period adjustment in the U.S. as well as ongoing launches in non-U.S. markets."
Mr. Raifeld continued, "We are pleased with our portfolio's
performance this quarter in the face of intensifying competition from generic and novel therapies, especially in the ICS/LABA class,
and uncertainty related to the ongoing pandemic."
Mr. Raifeld concluded, "Over the past quarter we continued to
strategically deploy capital in promising healthcare companies, successfully resolved our arbitration with Theravance BioPharma and strengthened
our Board, positioning Innoviva for further 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 and ANORO
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.
Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (unaudited) | (1) | |||||||
| Assets | ||||||||
| Cash, cash equivalents and marketable securities | $ | 282,890 | $ | 246,487 | ||||
| Other current assets | 90,043 | 95,571 | ||||||
| Property and equipment, net | 24 | 28 | ||||||
| Equity and long-term investments | 519,325 | 438,258 | ||||||
| Capitalized fees paid to a related party, net | 121,797 | 125,253 | ||||||
| Deferred tax assets, net | 74,023 | 93,759 | ||||||
| Other assets | 188 | 214 | ||||||
| Total assets | $ | 1,088,290 | $ | 999,570 | ||||
| Liabilities and stockholders' equity | ||||||||
| Other current liabilities | $ | 2,136 | $ | 1,958 | ||||
| Accrued interest payable | 1,668 | 4,152 | ||||||
| Convertible subordinated notes, net | 239,925 | 239,783 | ||||||
| Convertible senior notes, net | 147,803 | 145,734 | ||||||
| Other long-term liabilities | 77 | 106 | ||||||
| Innoviva stockholders' equity | 634,461 | 539,912 | ||||||
| Noncontrolling interest | 62,220 | 67,925 | ||||||
| Total liabilities and stockholders' equity | $ | 1,088,290 | $ | 999,570 |
(1) The selected consolidated balance sheet amounts at December 31,
2020 are derived from audited financial statements.
Consolidated Statements of Income
thousands, except per share data)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2021 | 2020 | |||||||
| Revenue: | ||||||||
| Royalty revenue from a related party, net (1) | $ | 85,518 | $ | 78,678 | ||||
| Operating expenses: | ||||||||
| Research and development | 49 | - | ||||||
| General and administrative | 5,986 | 2,563 | ||||||
| Total operating expenses | 6,035 | 2,563 | ||||||
| Income from operations | 79,483 | 76,115 | ||||||
| Other income (expense), net | (433 | ) | 68 | |||||
| Interest income | 30 | 1,302 | ||||||
| Interest expense | (4,694 | ) | (4,516 | ) | ||||
| Changes in fair values of equity and long-term investments, net | 55,045 | 21,915 | ||||||
| Income before income taxes | 129,431 | 94,884 | ||||||
| Income tax expense, net | 19,736 | 15,932 | ||||||
| Net income | 109,695 | 78,952 | ||||||
| Net income attributable to noncontrolling interest | 15,572 | 13,515 | ||||||
| Net income attributable to Innoviva stockholders | $ | 94,123 | $ | 65,437 | ||||
| Basic net income per share attributable to Innoviva stockholders | $ | 0.93 | $ | 0.65 | ||||
| Diluted net income per share attributable to Innoviva stockholders | $ | 0.84 | $ | 0.59 | ||||
| Shares used to compute basic net income per share | 101,365 | 101,235 | ||||||
| Shares used to compute diluted net income per share | 113,624 | 113,509 |
Total net revenue from a related party is comprised of the following (in thousands):
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2021 | 2020 | |||||||
| (unaudited) | ||||||||
| Royalties from a related party | $ | 88,974 | $ | 82,134 | ||||
| Amortization of capitalized fees paid to a related party | (3,456 | ) | (3,456 | ) | ||||
| Royalty revenue from a related party, net | $ | 85,518 | $ | 78,678 |
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| (unaudited) | ||||||||
| Net cash provided by operating activities | $ | 84,107 | $ | 73,481 | ||||
| Net cash provided by (used in) investing activities | (26,394 | ) | 16,044 | |||||
| Net cash used in financing activities | (21,310 | ) | (15,640 | ) |
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