EX-99.1 2 tm2025990d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

Innoviva Reports Second Quarter 2020 Financial Results

 

·Royalties increased by 7% to $72.4 million in the second quarter of 2020, compared to the same quarter in 2019.

 

·Pavel Raifeld named as Chief Executive Officer.

 

·Invested $35 million into common stock and warrants of Entasis Therapeutics Holding Inc. (NASDAQ: ETTX), a leader in anti-infectives development.

 

BURLINGAME, Calif., July 29, 2020 Innoviva, Inc. (NASDAQ: INVA) (the Company) today reported financial results for the second quarter ended June 30, 2020.

 

·Gross royalty revenues of $72.4 million from Glaxo Group Limited (“GSK”) for the second quarter of 2020 included royalties of $45.6 million from global net sales of RELVAR®/BREO® ELLIPTA®, royalties of $11.2 million from global net sales of ANORO® ELLIPTA® and royalties of $15.6 million from global net sales of TRELEGY® ELLIPTA®.[1]

 

·Changes in fair values of equity investments of $46.7 million reflected the unrealized gains of $13.4 million related to our investment in Armata Pharmaceuticals Inc. and $33.3 million related to our investment in Entasis Therapeutics Holdings, Inc.  

 

·Income before income taxes increased by 109% to $118.1 million, compared to the same quarter in 2019.

 

·Net cash and cash equivalents, short-term investments and marketable securities, excluding $4.9 million cash balance attributable to a variable interest entity, totaled $412.2 million, and receivables from GSK totaled $82.4 million, as of June 30, 2020.

 

Pavel Raifeld, Chief Executive Officer, stated: “RELVAR®/BREO® ELLIPTA® global net sales decreased by 3% compared to the second quarter of 2019. U.S. net sales decreased by 11% as continued volume growth was more than offset by greater price discounting in the ICS/LABA sector. Non-U.S. sales increased by 2%, driven by sales growth in certain European markets, Japan and Canada.

 

ANORO® ELLIPTA® global net sales increased by 5% in the second quarter of 2020 compared to the second quarter of the prior year. U.S. net sales increased by 7% due to significant volume growth, despite pricing pressure stemming from channel mix shift. Non-U.S. ANORO® ELLIPTA® net sales increased 2%, supported by growth in certain European markets. In addition, TRELEGY® ELLIPTA® global net sales were $240.5 million, compared to $151.4 million during comparable period a year ago.

 

 

 

 

 

 

 

While the ultimate COVID-19 impact remains uncertain, we have seen signs of normalization over the past quarter. We were pleased with the meaningful volume growth across the portfolio, despite the challenging environment and certain pandemic-related stockpiling earlier in the year,” continued Mr. Raifeld.

 

Mr. Raifeld concluded, “After spending several weeks at Innoviva, I am even more excited about the potential for significant shareholder value creation. Capital allocation and cost discipline remain our key priorities, and we expect to continue to opportunistically invest in promising, differentiated assets, such as those developed by Armata and Entasis, that address significant unmet medical needs and offer attractive return profiles.”

 

Recent Highlights

 

·GSK Net Sales:

 

oSecond quarter 2020 net sales of RELVAR®/BREO® ELLIPTA® by GSK were $303.8 million, down 3% from $313.9 million in the second quarter of 2019, with $103.3 million in net sales from the U.S. market and $200.5 million from non-U.S. markets.

 

oSecond quarter 2020 net sales of ANORO® ELLIPTA® by GSK were $172.3 million, up 5% from $163.6 million in the second quarter of 2019, with $109.8 million net sales from the U.S. market and $62.5 million from non-U.S. markets.

 

oSecond quarter 2020 net sales of TRELEGY® ELLIPTA® by GSK were $240.5 million, up significantly from $151.4 million in the second quarter of 2019, with $174.8 million in net sales from the U.S. market and $65.7 million in net sales from non-U.S. markets.

 

·Capital Allocation:

 

oDuring the second quarter of 2020, the Company invested $35.0 million in 14.0 million shares of common stock of Entasis Therapetutics, Inc., a company focused on development of novel anti-bacterial therapies for multi-drug resistant Gram-negative bacteria, which pose well acknowledged public health risk and a rapidly growing medical need, and warrants to purchase up to an additional 14.0 million shares of the common stock at $2.50 per share. With this initial investment, Innoviva owned approximately 51% of Entasis’s common stock as of June 30, 2020. Innoviva has a right to designate two members to Entasis’s board.

 

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 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
June 30,
   Six Months Ended
June 30,
 
   2020   2019   2020   2019 
Revenue:                    
Royalty revenue from a related party, net (1)  $68,946   $64,107   $147,624   $119,290 
Revenue from collaborative arrangements with a related party   10,000    -    10,000    - 
Total net revenue   78,946    64,107    157,624    119,290 
                     
Operating expenses:                    
Research and development   559    -    559    - 
General and administrative   2,596    4,347    5,159    7,362 
Total operating expenses   3,155    4,347    5,718    7,362 
                     
Income from operations   75,791    59,760    151,906    111,928 
                     
Other income (expense), net   30    (8)   98    (7)
Interest income   158    1,403    1,460    2,378 
Interest expense   (4,561)   (4,661)   (9,077)   (9,278)
Changes in fair values of equity investments   46,698    -    68,613    - 
Income before income taxes   118,116    56,494    213,000    105,021 
Income tax expense, net   19,891    10,433    35,823    18,941 
Net income   98,225    46,061    177,177    86,080 
Net income attributable to noncontrolling interest   21,381    8,321    34,896    14,550 
Net income attributable to Innoviva stockholders  $76,844   $37,740   $142,281   $71,530 
                     
Basic net income per share attributable to Innoviva stockholders  $0.76   $0.37   $1.40   $0.71 
Diluted net income per share attributable to Innoviva stockholders  $0.69   $0.34   $1.27   $0.65 
                     
Shares used to compute basic net income per share   101,324    101,151    101,280    101,105 
Shares used to compute diluted net income per share   113,545    113,391    113,527    113,384 

 

(1) Total net revenue from a related party is comprised of the following (in thousands):

 

   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
   2020   2019   2020   2019 
   (unaudited)   (unaudited) 
Royalties from a related party  $72,402   $67,563   $154,536   $126,202 
Amortization of capitalized fees paid to a related party   (3,456)   (3,456)   (6,912)   (6,912)
Royalty revenue from a related party, net  $68,946   $64,107   $147,624   $119,290 

 

 

 

 

INNOVIVA, INC.

Condensed Consolidated Balance Sheets

(in thousands)

 

   June 30,   December 31, 
   2020   2019 
   (unaudited)   (1) 
Assets          
Cash, cash equivalents and marketable securities  $417,146   $350,845 
Other current assets   83,047    80,389 
Property and equipment, net   37    33 
Equity investments   128,613    - 
Capitalized fees paid to a related party, net   132,164    139,076 
Deferred tax assets, net   118,348    154,171 
Other assets   264    312 
Total assets  $879,619   $724,826 
           
Liabilities and stockholders’ equity          
Other current liabilities  $1,262   $1,219 
Accrued interest payable   4,152    4,152 
Convertible subordinated notes, net   239,499    239,217 
Convertible senior notes, net   141,731    137,903 
Other long-term liabilities   163    219 
           
Innoviva stockholders’ equity   456,907    313,495 
Noncontrolling interest   35,905    28,621 
           
Total liabilities and stockholders’ equity  $879,619   $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)

 

   Six Months Ended June 30, 
   2020   2019 
   (unaudited) 
Net cash provided by operating activities  $153,275   $133,151 
Net cash provided by (used in) investing activities   9,044    (54,060)
Net cash provided by (used in) financing activities   (27,268)   444 

 

Investor & Media Contacts:

 

Dan Zacchei / Alex Kovtun

Sloane & Company

212-486-9500

dzacchei@sloanepr.com / akovtun@sloanepr.com