Business Wire | Oct 27, 2021 04:05PM EDT

Innoviva Reports Third Quarter 2021 Financial Results

Oct. 27, 2021

BURLINGAME, Calif--(BUSINESS WIRE)--Oct. 27, 2021--Innoviva, Inc. (NASDAQ: INVA) ("Innoviva" and "the Company") today reported financial results for the third quarter ended September 30, 2021.

* Gross royalty revenues of $101.3 million from Glaxo Group Limited ("GSK") for the third quarter of 2021 included royalties of $54.1 million from global net sales of RELVAR(r)/BREO(r) ELLIPTA(r), royalties of $11.6 million from global net sales of ANORO(r) ELLIPTA(r) and royalties of $35.6 million from global net sales of TRELEGY(r) ELLIPTA(r).[1] * Increase in fair values of strategic equity and long term investments of $33.6 million in the third quarter of 2021 was mainly due to higher net valuation as of September 30, 2021. * Income from operations increased by 12% to $94.6 million, compared to the same quarter in 2020. * Basic and diluted net income per share attributable to Innoviva stockholders increased 3.7 and 3.5 times to $1.04 and $0.90 from $0.28 and $0.26, respectively, compared to the same quarter in 2020, * Net cash and cash equivalents totaled $135.1 million, and receivables from GSK totaled $101.3 million as of September 30, 2021.

Pavel Raifeld, Chief Executive Officer of Innoviva, Inc., stated, "Our royalty revenues grew 10% year over year, displaying strong positive momentum in a volatile environment."

"RELVAR(r)/BREO(r) ELLIPTA(r) 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(r) ELLIPTA(r) 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(r) ELLIPTA(r) net sales increased 8% because of meaningful growth in select markets despite class challenges. TRELEGY(r) ELLIPTA(r) 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(r) ELLIPTA(r) 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 excellence."

Recent Highlights

* GSK Net Sales: Third quarter 2021 net sales of RELVAR(r)/BREO(r) ELLIPTA(r) by GSK were $360.6 million, down 15% from $426.0 million in the same quarter of 2020, with $146.0 million in net sales from the U.S. market and $214.6 million from non-U.S. markets. Third quarter 2021 net sales of ANORO(r) ELLIPTA(r) by GSK were $179.1 million, down 2% from $182.8 million in the same quarter of 2020, with $102.0 million net sales from the U.S. market and $77.1 million from non-U.S. markets. Third quarter 2021 net sales of TRELEGY(r) ELLIPTA(r) by GSK were $445.6 million, up 77% from $251.9 million in the same quarter of 2020, with $314.8 million in net sales from the U.S. market and $130.8 million in net sales from non-U.S. markets.

1 For TRELEGY (r) ELLIPTA(r), 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.

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(r)/BREO(r) ELLIPTA(r) (fluticasone furoate/ vilanterol, "FF/VI"), ANORO(r) ELLIPTA(r) (umeclidinium bromide/ vilanterol, "UMEC/VI") and TRELEGY(r) ELLIPTA(r) (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(r)/BREO(r) ELLIPTA(r) and ANORO(r) ELLIPTA(r). 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(r) ELLIPTA(r) 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(r)/BREO(r) ELLIPTA(r) and ANORO(r) ELLIPTA(r).

ANORO(r), RELVAR(r), BREO(r), TRELEGY(r) and ELLIPTA(r) 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(r)/BREO(r) ELLIPTA(r), ANORO(r) ELLIPTA(r) and TRELEGY(r) ELLIPTA(r) 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.

INNOVIVA, INC.Condensed Consolidated Statements of Income(in thousands, except per share data)(Unaudited) Three Months Ended Nine Months Ended September 30, September 30,

2021 2020 2021 2020

Revenue: Royaltyrevenue from a $ 97,862 $ 88,694 $ 284,186 $ 236,318 related party,net^ (1) Revenuefrom collaborative - - - 10,000 arrangementswith a relatedpartyTotal net 97,862 88,694 284,186 246,318 revenue^ Operating expenses: Research 449 1,010 536 and 1,569development General and 2,860 3,254 13,074 administrative 8,413

Total 3,309 4,264 13,610 operating 9,982expenses Income from 94,553 84,430 270,576 236,336 operations Other income (652 ) (13 ) (2,036 ) (expense), net 85

Interest 453 41 503 income 1,501

Interest (4,790 ) (4,603 ) (14,229 ) (13,680 )expenseChanges infair values ofequity and 33,613 (29,368 ) 133,973 39,245 long-terminvestments,netIncome before 123,177 50,487 388,787 263,487 income taxesIncome tax 20,531 8,866 65,600 44,689 expense, net Net 102,646 41,621 323,187 218,798 income Netincomeattributable 30,208 13,403 67,678 48,299 tononcontrollinginterest Netincome $ 72,438 $ 28,218 $ 255,509 $ 170,499 attributable to Innovivastockholders Basic netincome pershare $ 1.04 $ 0.28 $ 2.96 $ 1.68 attributableto InnovivastockholdersDiluted netincome pershare $ 0.90 $ 0.26 $ 2.63 $ 1.53 attributableto Innovivastockholders Shares used tocompute basic 69,458 101,358 86,298 101,306 net income pershareShares used tocompute 81,699 113,572 98,536 113,543 diluted net income pershare(1) Total net revenue from a related party is comprised of the following (in thousands):(1) Total net revenue from a related party is comprised of the following (inthousands):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

Three Months Ended Nine Months Ended September 30, September 30,

2021 2020 2021 2020

(unaudited) (unaudited)

Royalties from a $ 101,318 $ 92,150 $ 294,554 $ 246,686 relatedpartyAmortizationof capitalized (3,456 ) (3,456 ) (10,368 ) (10,368 ) fees paid toa relatedparty Royalty revenue from $ 97,862 $ 88,694 $ 284,186 $ 236,318 a relatedparty, netINNOVIVA, INC.Condensed Consolidated Balance Sheets(in thousands)September 30,

December 31,

2021

2020

(unaudited)

(1)

AssetsCash, cash equivalents and marketable securities$

135,115

$

246,487

Other current assets101,813

95,571

Property and equipment, net 15

28

Equity and long-term investments507,116

438,258

Capitalized fees paid to a related party, net114,885

125,253

Deferred tax assets, net28,159

93,759

Other assets136

214

Total assets$

887,239

$

999,570

Liabilities and stockholders' equityOther current liabilities $

1,457

$

1,958

Accrued interest payable1,668

4,152

Convertible subordinated notes, net240,215

239,783

Convertible senior notes, net152,080

145,734

Other long-term liabilities 14

106

Innoviva stockholders' equity 402,811

539,912

Noncontrolling interest88,994

67,925

Total liabilities and stockholders' equity $

887,239

$

999,570

INNOVIVA, INC.Condensed Consolidated Balance Sheets(in thousands) September 30, December 31,

2021 2020

(unaudited) (1)

Assets Cash, cashequivalents $ 135,115 $ 246,487 and marketablesecuritiesOther current 101,813 95,571 assetsProperty and equipment, 15 28net Equity and 507,116 438,258 long-term investmentsCapitalizedfees paid to a 114,885 125,253 related party,netDeferred tax 28,159 93,759 assets, net Other assets 136 214

$ 887,239 $ 999,570 Total assets Liabilitiesand stockholders'equityOther current $ 1,457 $ 1,958 liabilities Accrued interest 1,668 4,152payableConvertible 240,215 239,783 subordinated notes, netConvertible 152,080 145,734 senior notes, netOther long-term 14 106liabilities Innoviva 402,811 539,912 stockholders' equity Noncontrolling 88,994 67,925 interest Totalliabilities $ 887,239 $ 999,570 andstockholders'equity (1) The selected consolidated balance sheet amounts at December 31, 2020 are derived from audited financial(1) The selected consolidated balance sheet amounts at December 31, 2020 arederived from audited financialINNOVIVA, INC.Cash Flows Summary(in thousands)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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