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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Innoviva Inc | NASDAQ:INVA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.14 | 0.92% | 15.37 | 15.04 | 15.63 | 15.37 | 15.09 | 15.24 | 403,984 | 22:30:00 |
Innoviva, Inc. (NASDAQ:INVA) ("Innoviva," or "the Company") today reported financial results for the first quarter ended March 31, 2020.
“Global net sales of RELVAR®/BREO® ELLIPTA® increased 31% versus the first quarter of 2019. U.S. net sales increased by 47% as increased pricing discounts in the ICS/LABA sector were offset by a one-time significant positive prior period rebate adjustment and continued volume growth. Non-U.S. sales increased 23% versus the first quarter of 2019, driven by sales growth in certain European markets and in Japan. ANORO® ELLIPTA® global net sales increased 15% in the first quarter of 2020. U.S. net sales increased 8% as volume growth offset price pressure from increased amounts of sales through market segments with higher rebates. Non-U.S. ANORO® ELLIPTA® net sales grew 24% year over year in the quarter supported by growth in certain European markets. In addition, TRELEGY® ELLIPTA® global net sales were $248.2 million,” stated Geoffrey Hulme, Interim Principal Executive Officer.
Hulme continued, “At this point, the impact of the COVID-19 pandemic on the global sales of our three collaboration products is uncertain. Based on our end-market observations, first quarter sales levels may have benefited from unspecified levels of increased patient inventory stocking. Also, the significant RELVAR ®/BREO ®ELLIPTA® positive prior period rebate adjustment that occurred during the first quarter is not likely to recur in future quarters.”
Hulme concluded, “After the end of the quarter, we were pleased to announce the first closing of a new investment in Entasis Therapeutics, a company focused on the development of novel antibiotics to address multi-drug resistant gram-negative bacteria. Antibiotic-resistant bacterial infections pose an increasing global health risk and are creating a growing need for new treatment options. Innoviva’s investment will help Entasis continue to develop two antibiotics currently in phase three trials. The Armata and Entasis transactions are part of our ongoing efforts to pursue capital allocation options that maximize future shareholder value.”
Recent Highlights
1 For TRELEGY ® ELLIPTA®, Innoviva is entitled to 15% of royalty payments made by GSK that are assigned to TRC, LLC.
About Innoviva
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®.
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 impact of the COVID-19 pandemic; 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. 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, which is 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
March 31,
2020
2019
Revenue: Royalty revenue from a related party, net (1)$
78,678
$
55,183
Operating expenses: General and administrative
2,563
3,015
Total operating expenses
2,563
3,015
Income from operations
76,115
52,168
Other income, net
68
1
Interest income
1,302
975
Interest expense
(4,516
)
(4,617
)
Changes in fair values of equity investments
21,915
-
Income before income taxes
94,884
48,527
Income tax expense, net
15,932
8,508
Net income
78,952
40,019
Net income attributable to noncontrolling interest
13,515
6,229
Net income attributable to Innoviva stockholders
$
65,437
$
33,790
Basic net income per share attributable to Innoviva stockholders
$
0.65
$
0.33
Diluted net income per share attributable to Innoviva stockholders
$
0.59
$
0.31
Shares used to compute basic net income per share
101,235
101,059
Shares used to compute diluted net income per share
113,509
113,376
(1) Total net revenue from a related party is comprised of the following (in thousands):
Three Months Ended
March 31,
2020
2019
(unaudited)
Royalties from a related party$
82,134
$
58,639
Amortization of capitalized fees paid to a related party
(3,456
)
(3,456
)
Royalty revenue from a related party, net$
78,678
$
55,183
INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands)
March 31,
December 31,
2020
2019
(unaudited)
(1)
Assets Cash, cash equivalents and marketable securities$
383,951
$
350,845
Other current assets
82,956
80,389
Property and equipment, net
42
33
Equity investments
46,915
-
Capitalized fees paid to a related party, net
135,620
139,076
Deferred tax assets, net
138,239
154,171
Other assets
288
312
Total assets
$
788,011
$
724,826
Liabilities and stockholders’ equity Other current liabilities
$
1,130
$
1,219
Accrued interest payable
1,668
4,152
Convertible subordinated notes, net
239,355
239,217
Convertible senior notes, net
139,797
137,903
Other long-term liabilities
192
219
Innoviva stockholders’ equity
379,543
313,495
Noncontrolling interest
26,326
28,621
Total liabilities and stockholders’ equity
$
788,011
$
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)
Three Months Ended March 31,
2020
2019
(unaudited)
Net cash provided by operating activities$
73,481
$
76,655
Net cash provided by (used in) investing activities
16,044
(74,167
)
Net cash provided by (used in) financing activities
(15,640
)
246
View source version on businesswire.com: https://www.businesswire.com/news/home/20200429005748/en/
Investors & Media: Dan Zacchei / Alex Kovtun Sloane & Company 212-446-9500 dzacchei@sloanepr.com / akovtun@sloanepr.com
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