Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 20192020

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                    to                   

Commission File Number: 000-30319

INNOVIVA, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

94-3265960

(State or Other Jurisdiction of
Incorporation or Organization)

(I.R.S. Employer
Identification No.)

2000 Sierra Point Parkway,1350 Old Bayshore Highway Suite 500400

BrisbaneBurlingame, CA 9400594010

(Address of Principal Executive Offices)

(650238-9600

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.01 per share

INVA

INVA

The NASDAQ Global Select Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes    No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes    No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Act.

Large accelerated filer 

Accelerated filer 

Non-accelerated filer 

Smaller reporting company 

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes    No  

The number of shares of registrant’s common stock outstanding on July 17, 201920, 2020 was 101,279,669.101,392,431.

Table of Contents

TABLE OF CONTENTS

PART I —I. FINANCIAL INFORMATION

Item 1. Financial Statements

Condensed Consolidated Balance Sheets as of June 30, 20192020 (Unaudited) and December 31, 20182019

3

Unaudited Condensed Consolidated Statements of OperationsIncome for the Three and Six Months Ended June 30, 20192020 and 20182019

4

Unaudited Condensed Consolidated Statements of Comprehensive Income for the Three and Six Months Ended June 30, 20192020 and 20182019

5

Unaudited Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the Three and Six Months Ended June 30, 20192020 and 20182019

6

Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 20192020 and 20182019

87

Notes to Unaudited Condensed Consolidated Financial Statements

98

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

1816

Item 3. Quantitative and Qualitative Disclosures About Market Risk

2422

Item 4. Controls and Procedures

2422

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

2522

Item 1A. Risk Factors

2523

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

2523

Item 3. Defaults Upon Senior Securities

2523

Item 4. Mine Safety Disclosure

2523

Item 5. Other Information

2523

Item 6. Exhibits

2624

Signatures

2725

Exhibits

2

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PART I —I. FINANCIAL INFORMATION

Item 1. Financial Statements

INNOVIVA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except per share data)

    

June 30, 

    

December 31, 

    

June 30, 

    

December 31, 

2019

2018

2020

2019

(unaudited)

*

(unaudited)

*

Assets

Current assets:

Cash and cash equivalents

$

141,952

$

62,417

$

413,147

$

278,096

Short-term marketable securities

 

107,711

 

52,491

 

3,999

 

72,749

Related party receivables from collaborative arrangements

 

67,563

 

83,286

 

82,402

 

79,427

Prepaid expenses and other current assets

 

459

 

849

 

645

 

962

Total current assets

 

317,685

 

199,043

 

500,193

 

431,234

Property and equipment, net

 

136

 

160

 

37

 

33

Operating lease right-of-use asset

1,348

Equity investments

128,613

Capitalized fees paid to a related party, net

 

145,987

 

152,899

 

132,164

 

139,076

Deferred tax assets

177,114

196,054

Deferred tax assets, net

118,348

154,171

Other assets

 

37

 

37

 

264

 

312

Total assets

$

642,307

$

548,193

$

879,619

$

724,826

Liabilities and Stockholders’ Equity

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

1,139

$

11

$

195

$

10

Accrued personnel-related expenses

 

371

 

470

 

291

 

647

Accrued interest payable

 

4,262

 

4,264

 

4,152

 

4,152

Other accrued liabilities

 

1,386

 

955

 

776

 

562

Operating lease liability, current portion

317

Total current liabilities

 

7,475

 

5,700

 

5,414

 

5,371

Long-term debt, net of discount and issuance costs

 

386,675

 

382,855

 

381,230

 

377,120

Operating lease liability, net of current portion

1,157

Other long-term liabilities

 

298

 

586

 

163

 

219

Commitments and contingencies

Commitments and contingencies (Note 8)

Stockholders’ equity:

Preferred stock: $0.01 par value, 230 shares authorized, no shares issued and outstanding

Common stock: $0.01 par value, 200,000 shares authorized, 101,272 and 101,098 issued and outstanding as of June 30, 2019 and December 31, 2018, respectively

 

1,013

 

1,011

Preferred stock: $0.01 par value, 230 shares authorized, 0 shares issued and outstanding

Common stock: $0.01 par value, 200,000 shares authorized, 101,392 and 101,288 issued and outstanding as of June 30, 2020 and December 31, 2019, respectively

 

1,015

 

1,013

Additional paid-in capital

 

1,257,799

 

1,256,267

 

1,260,017

 

1,258,859

Accumulated other comprehensive income (loss)

 

33

 

(3)

 

(2)

 

27

Accumulated deficit

 

(1,032,162)

 

(1,103,692)

 

(804,123)

 

(946,404)

Total Innoviva stockholders’ equity

226,683

153,583

456,907

313,495

Noncontrolling interest

20,019

5,469

35,905

28,621

Total stockholders’ equity

 

246,702

 

159,052

 

492,812

 

342,116

Total liabilities and stockholders’ equity

$

642,307

$

548,193

$

879,619

$

724,826

*Condensed consolidatedConsolidated balance sheet as of December 31, 20182019 has been derived from audited consolidated financial statements.

See accompanying notes to condensed consolidated financial statements.

3

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INNOVIVA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSINCOME

(In thousands, except per share data)

(Unaudited)

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2019

    

2018

    

2019

    

2018

Royalty revenue from a related party, net of amortization of capitalized fees paid to a related party of $3,456 in the three months ended June 30, 2019 and 2018, and $6,912 in the six months ended June 30, 2019 and 2018

$

64,107

$

67,086

$

119,290

$

119,466

Operating expenses:

General and administrative

 

4,347

 

4,411

 

7,362

 

13,396

General and administrative - related party

2,700

Total operating expenses

 

4,347

 

4,411

 

7,362

 

16,096

Income from operations

 

59,760

 

62,675

 

111,928

 

103,370

Other income (expense), net

 

(8)

 

39

 

(7)

 

(3,060)

Interest income

 

1,403

 

380

 

2,378

 

771

Interest expense

 

(4,661)

 

(6,478)

 

(9,278)

 

(14,135)

Income before income taxes

56,494

56,616

105,021

86,946

Income tax expense, net

10,433

18,941

Net income

46,061

56,616

86,080

86,946

Net income attributable to noncontrolling interest

8,321

1,990

14,550

2,739

Net income attributable to Innoviva stockholders

$

37,740

$

54,626

$

71,530

$

84,207

Basic net income per share attributable to Innoviva stockholders

$

0.37

$

0.54

$

0.71

$

0.84

Diluted net income per share attributable to Innoviva stockholders

$

0.34

$

0.49

$

0.65

$

0.77

Shares used to compute Innoviva basic and diluted net income per share:

Shares used to compute basic net income per share

101,151

100,873

101,105

100,739

Shares used to compute diluted net income per share

113,391

113,399

113,384

113,483

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2020

    

2019

    

2020

    

2019

Royalty revenue from a related party, net of amortization of capitalized fees paid to a related party of $3,456 in the three months ended June 30, 2020 and 2019, and $6,912 in the six months ended June 30, 2020 and 2019

$

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 Innoviva basic and diluted net income per share:

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

See accompanying notes to condensed consolidated financial statements.

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INNOVIVA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(In thousands)

(Unaudited)

Three Months Ended June 30, 

Six Months Ended June 30, 

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2019

    

2018

    

2019

    

2018

    

2020

    

2019

    

2020

    

2019

Net income

$

46,061

$

56,616

$

86,080

$

86,946

$

98,225

$

46,061

$

177,177

$

86,080

Unrealized gain on marketable securities, net

 

23

 

12

 

36

 

8

 

(35)

 

23

 

(29)

 

36

Comprehensive income

46,084

56,628

86,116

86,954

98,190

46,084

177,148

86,116

Comprehensive income attributable to noncontrolling interest

8,321

1,990

14,550

2,739

21,381

8,321

34,896

14,550

Comprehensive income attributable to Innoviva stockholders

$

37,763

$

54,638

$

71,566

$

84,215

$

76,809

$

37,763

$

142,252

$

71,566

See accompanying notes to condensed consolidated financial statements.

5

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INNOVIVA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

(In thousands)

(Unaudited)

Six Months Ended June 30, 2019

Accumulated Other

Total

Common Stock

Additional Paid-In

Comprehensive

Accumulated

Noncontrolling

Stockholders’

    

Shares

    

Amount

    

Capital

    

Income (Loss)

    

Deficit

    

Interest

    

Equity

Balance as of December 31, 2018

 

101,098

$

1,011

$

1,256,267

$

(3)

$

(1,103,692)

$

5,469

$

159,052

Exercise of stock options, and issuance of common stock units and stock awards, net of repurchase of shares to satisfy tax withholding

 

85

 

1

 

253

 

 

 

 

254

Stock-based compensation

 

 

 

605

 

 

 

 

605

Net income

 

 

 

 

 

33,790

 

6,229

 

40,019

Other comprehensive income

 

 

 

 

13

 

 

 

13

Balance as of March 31, 2019

 

101,183

1,012

1,257,125

10

(1,069,902)

11,698

199,943

Exercise of stock options, and issuance of common stock units and stock awards, net of repurchase of shares to satisfy tax withholding

89

1

200

201

Stock-based compensation

474

474

Net income

37,740

8,321

46,061

Other comprehensive income

23

23

Balance as of June 30, 2019

101,272

$

1,013

$

1,257,799

$

33

$

(1,032,162)

$

20,019

$

246,702

Six months ended June 30, 2020

Additional

Accumulated Other

Total

Common Stock

Paid-In

Comprehensive

Accumulated

Noncontrolling

Stockholders’

    

Shares

    

Amount

    

Capital

    

Income (Loss)

    

Deficit

    

Interest

    

Equity

Balance as of December 31, 2019

 

101,288

1,013

1,258,859

27

$

(946,404)

$

28,621

$

342,116

Distributions to noncontrolling interest

 

 

 

 

 

 

(15,810)

 

(15,810)

Exercise of stock options, and issuance of common stock units and stock awards, net of repurchase of shares to satisfy tax withholding

 

32

 

 

170

 

 

 

 

170

Stock-based compensation

 

 

 

435

 

 

 

 

435

Net income

 

 

 

 

 

65,437

 

13,515

 

78,952

Other comprehensive income

 

 

 

 

6

 

 

 

6

Balance as of March 31, 2020

 

101,320

$

1,013

$

1,259,464

$

33

$

(880,967)

$

26,326

$

405,869

Equity activity of noncontrolling interest from a consolidated variable interest entity

350

350

Distributions to noncontrolling interest

 

 

 

 

 

 

(12,152)

 

(12,152)

Exercise of stock options, and issuance of common stock units and stock awards, net of repurchase of shares to satisfy tax withholding

 

72

 

2

 

178

 

 

 

 

180

Stock-based compensation

 

 

 

375

 

 

 

 

375

Net income

 

 

 

 

 

76,844

 

21,381

 

98,225

Other comprehensive income

 

 

 

 

(35)

 

 

 

(35)

Balance as of June 30, 2020

 

101,392

$

1,015

$

1,260,017

$

(2)

$

(804,123)

$

35,905

$

492,812

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Six Months Ended June 30, 2018

Six months ended June 30, 2019

Accumulated Other

Total

Additional

Accumulated Other

Total

Common Stock

Additional Paid-In

Comprehensive

Accumulated

Treasury Stock

Noncontrolling

Stockholders’

Common Stock

Paid-In

Comprehensive

Accumulated

Noncontrolling

Stockholders’

    

Shares

Amount

    

Capital

    

Loss

    

Deficit

    

Shares

    

Amount

    

Interest

    

Deficit

    

Shares

Amount

    

Capital

    

Income (Loss)

    

Deficit

    

Interest

    

Equity

Balance as of December 31, 2017

102,046

$

1,019

$

1,258,151

$

(18)

$

(1,498,748)

(150)

$

(3,263)

$

152

$

(242,707)

Distributions to noncontrolling interest

(90)

(90)

Exercise of stock options, and issuance of common stock units and stock awards, net of cancellation of stock awards and repurchase of shares to satisfy tax withholding

(571)

(5)

(2,492)

(2,497)

Balance as of December 31, 2018

101,098

$

1,011

$

1,256,267

$

(3)

$

(1,103,692)

$

5,469

$

159,052

Exercise of stock options, and issuance of common stock units and stock awards, net of repurchase of shares to satisfy tax withholding

85

1

253

254

Stock-based compensation

2,169

2,169

605

605

Cash dividend forfeited

52

52

Net income

29,581

749

30,330

Other comprehensive loss

(4)

(4)

Balance as of March 31, 2018

101,475

1,014

1,257,880

(22)

(1,469,167)

(150)

(3,263)

811

(212,747)

Distributions to noncontrolling interest

(809)

(809)

Exercise of stock options, and issuance of common stock units and stock awards, net of cancellation of stock awards and repurchase of shares to satisfy tax withholding

182

1

110

111

Stock-based compensation

1,452

1,452

Cash dividend forfeited

1

1

Net income

54,626

1,990

56,616

33,790

6,229

40,019

Other comprehensive income

12

12

13

13

Balance as of June 30, 2018

101,657

$

1,015

$

1,259,443

$

(10)

$

(1,414,541)

(150)

$

(3,263)

$

1,992

$

(155,364)

Balance as of March 31, 2019

101,183

$

1,012

$

1,257,125

$

10

$

(1,069,902)

$

11,698

$

199,943

Exercise of stock options, and issuance of common stock units and stock awards, net of repurchase of shares to satisfy tax withholding

89

1

200

201

Stock-based compensation

474

474

Net income

37,740

8,321

46,061

Other comprehensive income

23

23

Balance as of June 30, 2019

101,272

$

1,013

$

1,257,799

$

33

$

(1,032,162)

$

20,019

$

246,702

See accompanying notes to condensed consolidated financial statements.

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INNOVIVA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

Six Months Ended June 30, 

    

2019

    

2018

Cash flows from operating activities

Net income

$

86,080

$

86,946

Adjustments to reconcile net income to net cash provided by operating activities:

Deferred income taxes

18,940

Depreciation and amortization

 

7,080

 

6,936

Stock-based compensation

 

1,079

 

3,621

Amortization of debt discount and issuance costs

3,820

4,028

Amortization of discount on short-term investments

(1,124)

(160)

Amortization of lease guarantee

 

(162)

 

(162)

Loss on extinguishment of debt

3,137

Changes in operating assets and liabilities:

Receivables from collaborative arrangements

 

15,723

 

(2)

Prepaid expenses and other current assets

 

390

 

178

Accounts payable

 

1,128

 

(543)

Accrued personnel-related expenses and other accrued liabilities

 

343

 

(1,539)

Accrued interest payable

 

(2)

 

(805)

Operating lease liability

(144)

Other long-term liabilities

 

 

4

Net cash provided by operating activities

 

133,151

 

101,639

Cash flows from investing activities

Maturities of marketable securities

 

57,875

 

54,875

Purchases of marketable securities

 

(111,935)

 

(19,284)

Net cash provided by (used in) investing activities

(54,060)

 

35,591

Cash flows from financing activities

Repurchase of shares to satisfy tax withholding

(74)

(2,840)

Payments of principal on senior secured term loans

(120,000)

Payments of cash dividends to stockholders

(11)

(55)

Proceeds from issuances of common stock, net

529

454

Distributions to noncontrolling interest

(899)

Net cash provided by (used in) financing activities

 

444

 

(123,340)

Net increase in cash and cash equivalents

 

79,535

 

13,890

Cash and cash equivalents at beginning of period

 

62,417

 

73,336

Cash and cash equivalents at end of period

$

141,952

$

87,226

Supplemental disclosure of cash flow information

Cash paid for interest

$

5,461

$

10,913

Six Months Ended June 30, 

    

2020

    

2019

Cash flows from operating activities

Net income

$

177,177

$

86,080

Adjustments to reconcile net income to net cash provided by operating activities:

Deferred income taxes

35,823

18,940

Depreciation and amortization

 

6,921

 

7,080

Stock-based compensation

 

810

 

1,079

Amortization of debt discount and issuance costs

4,110

3,820

Amortization of discount on short-term investments

(336)

(1,124)

Amortization of lease guarantee

(135)

(162)

Changes in fair values of equity investments

(68,613)

Other non-cash items

6

Changes in operating assets and liabilities:

Receivables from collaborative arrangements

 

(2,975)

 

15,723

Prepaid expenses and other current assets

 

317

 

390

Accounts payable

 

185

 

1,128

Accrued personnel-related expenses and other accrued liabilities

 

(15)

 

343

Accrued interest payable

 

 

(2)

Operating lease liability

(144)

Net cash provided by operating activities

 

153,275

 

133,151

Cash flows from investing activities

Maturities of marketable securities

 

82,000

 

57,875

Purchases of marketable securities

 

(12,943)

 

(111,935)

Purchases of equity investments

(60,000)

Purchases of property and equipment

(13)

Net cash provided by (used in) investing activities

9,044

 

(54,060)

Cash flows from financing activities

Repurchase of shares to satisfy tax withholding

(72)

(74)

Payments of cash dividends to stockholders

(11)

Proceeds from issuances of common stock, net

422

529

Net proceeds from the issuance of variable interest entity's equity

344

Distributions to noncontrolling interest

(27,962)

Net cash provided by (used in) financing activities

 

(27,268)

 

444

Net increase in cash and cash equivalents

 

135,051

 

79,535

Cash and cash equivalents at beginning of period

 

278,096

 

62,417

Cash and cash equivalents at end of period

$

413,147

$

141,952

Supplemental disclosure of cash flow information

Cash paid for interest

$

4,967

$

5,461

See accompanying notes to condensed consolidated financial statements.

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INNOVIVA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Description of Operations and Summary of Significant Accounting Policies

Description of Operations

Innoviva Inc. (referred to as “Innoviva”"Innoviva", the “Company”"Company", or “we”"we" and other similar pronouns) is focused on royalty management. Innoviva’sa company with a portfolio includes theof royalties that include respiratory assets partnered with Glaxo Group Limited (“GSK”), including RELVAR®/BREO®ELLIPTA® (fluticasone furoate/ vilanterol, “FF/VI”), ANORO® ELLIPTA®(umeclidinium (umeclidinium bromide/ vilanterol, “UMEC/VI”) and TRELEGY® ELLIPTA® (the combination FF/UMEC/VI). Under the Long-Acting Beta2Beta2 Agonist (“LABA”) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® as follows: 15% on the first $3.0 billion of annual global net sales and 5% for all annual global net sales above $3.0 billion; and royalties from the sales of and ANORO® ELLIPTA® which tier upward at a range from 6.5% to 10%. 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”), including TRELEGY® ELLIPTA® and any other product or combination of products that may be discovered or 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®.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by US GAAP for complete financial statements. In our opinion, the unaudited condensed consolidated financial statements have been prepared on the same basis as audited consolidated financial statements and include all adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation of our financial position, results of operations, comprehensive income and cash flows. The interim results are not necessarily indicative of the results of operations to be expected for the year ending December 31, 20192020 or any other period.

The accompanying unaudited condensedconsolidated financial statements include the accounts of Innoviva and certain variable interest entities for which we are the primary beneficiary. All intercompany transactions have been eliminated. For consolidated entities where we own or are exposed to less than 100% of the economics, we record net income (loss) attributable to noncontrolling interest in our unaudited consolidated statements of income equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties. The accompanying unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 20182019 filed with the Securities and Exchange Commission (“SEC”) on February 19, 2020, and as amended on February 21, 2020 (“2019 (“2018 Form 10-K”).

Variable Interest EntityEntities

We evaluate our ownership, contractual and other interest in the entities that we invest in to determine if they are variable interest entities (“VIE”VIEs”), whether we have a variable interest in those entities and the nature and extent of those interests. Based on our evaluation, if we determine we are the primary beneficiary of a VIE, we consolidate the entityentity’s financial results into our financial statements.

We consolidate the financial results of TRC and Pulmoquine Therapeutics, Inc. (“Pulmoquine”), which we have determined to be a VIE,VIEs, because we have the power to direct the economically significant activities of TRCthese entities and the obligation to absorb losses of, or the right to receive benefits from TRC. As of June 30, 2019them, and December 31, 2018, $9.8 million and $6.4 million, respectively,we are the primary beneficiary of the related party receivables from collaborative arrangements were attributable to TRC. The cash balance attributable to TRC as of June 30, 2019 was $13.8 million. Total revenue for TRC related to TRELEGY® ELLIPTA® was $9.8 million and $2.4 million for the three months ended June 30, 2019 and 2018, respectively, and $17.2 million and $3.3 million for the six months ended June 30, 2019 and 2018, respectively.entities.

Accounting Pronouncement Adopted by the Company

In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2016 02, Leases (Topic 842), which requires an entity to recognize right of use assets representing its

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rightEquity Investments

We invest from time to use the underlying asset for the lease term and lease liabilities representing the present valuetime in equity securities of the future lease payments for both financing and operating leases on its consolidated balance sheets. For a lease with a term of 12 monthsprivate or less, the standard allows an entity to elect not to recognize a right-of-use asset and a lease liability and recognize the lease expense on a straight-line basis. We adopted the standard on the effective date of January 1, 2019 using the alternative transition approach. This approach is similar to a prospective transition, which requires the application of ASC 842 at the effective date with a cumulative-effect adjustment recognized through retained earnings. Under this approach,public companies. If we determine that we do not presenthave control over these companies under either voting or VIE models, we then determine if we have an ability to exercise significant influence via voting interests, board representation or other business relationships. We may account for the adjusted comparative periods. Our pro-rata shareequity investments where we exercise significant influence using either an equity method of common area expenses are recorded as lease expense when incurred since they are variable and considered nonlease componentsaccounting or at fair value by electing the fair value option under Accounting Standards Codification ("ASC") Topic 825, Financial Instruments. If the fair value option is applied to an investment that would otherwise be accounted for under the standard. The mostequity method, we apply it to all our financial interests in the same entity (equity and debt, including guarantees) that are eligible items. All gains and losses from fair value changes, unrealized and realized, are presented as changes in fair values of equity investments, net on the consolidated statements of income.

If we conclude that we do not have an ability to exercise significant impactinfluence over an investee, we may elect to account for an equity security without a readily determinable fair value at its cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.

As of June 30, 2020, we accounted for our equity investments in common stock and warrants of Armata Pharmaceuticals, Inc. (NYSE American: ARMP) (“Armata ") and Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX) ("Entasis”) at fair value by electing the fair value option and presented the investments as equity investments on the consolidated balance sheets.

Accounting Pronouncement Adopted by the Company

In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13 Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments, as clarified in subsequent amendments to the initial guidance (collectively, Topic 326). Topic 326 requires measurement and recognition of expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecast. ASC 326 must be adopted using a modified retrospective approach with a cumulative effect adjustment as of the beginning of the reporting period in which the guidance is adopted. Topic 326 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption to us is that we recognized a right of use asset in the amount of $1.5 million and lease liabilities in the total amount of $1.6 million atpermitted. We adopted Topic 326 effective January 1, 2019 for the operating lease on our corporate headquarters.2020. The adoption did not have a material impact on our retained earnings and consolidated statements of operations and cash flows.financial statements.

Recently Issued Accounting Standards or Updates Not Yet Adopted

In August 2018,December 2019, the U.S. Securities and Exchange Commission (the “SEC”) adoptedFASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the final rule under SEC Release No. 33-10532, Disclosure Update and SimplificationAccounting for Income Taxes”, amendingwhich is intended to simplify various aspects related to accounting for income taxes by removing certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements relatingexceptions to the analysis of stockholders’ equitygeneral principles in Topic 740. The pronouncement is effective for fiscal years, and for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders’ equity presentedperiods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. We are currently in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliationprocess of evaluating the effects of the beginning balance to the ending balanceprovisions of each period for which a statement of income is required to be filed. This final rule is effectiveASU 2019-12 on November 5, 2018. Effective January 1, 2019, the Company adopted SEC Release No. 33-10532. In accordance with the new guidance, the Company has added a Condensed Consolidated Statement of Changes in Stockholders’ Equity (Deficit) in its Form 10-Q and elected to present a reconciliation in a single statement that shows the changes in stockholders equity for each interim period, as well as each comparable period.our financial statements.

2. Net Income Per Share

Basic net income per share attributable to Innoviva stockholders is computed by dividing net income attributable to Innoviva stockholders by the weighted-average number of shares of common stock outstanding. Diluted net income per share attributable to Innoviva stockholders is computed by dividing net income attributable to Innoviva stockholders by the weighted-average number of shares of common stock and dilutive potential common stock equivalents then outstanding. Dilutive potential common stock equivalents include the assumed exercise, vesting and issuance of employee stock awards using the treasury stock method, as well as common stock issuable upon assumed conversion of our convertible subordinated notes due 2023 (the “2023 Notes”) using the if-convertedif converted method.

Our convertible senior notes due 2025 (the “2025 Notes”) are convertible, based on the applicable conversion rate, into cash, shares of our common stock or a combination thereof, at our election. Our current intent is to settle the principal amount of the 2025 Notes in cash upon conversion. The impact of the assumed conversion premium to diluted net income per share is computed using the treasury stock method. As the average market price per share of our common stock as reported on The Nasdaq Global Select Market during the relevant periods was lower than the initial conversion price of $17.26 per share, there was no0 dilutive effect of the assumed conversion premium for the three and six months ended June 30, 20192020 and 2018,2019, respectively.

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The following table shows the computation of basic and diluted net income per share for the three and six months ended June 30, 20192020 and 2018:2019:

Three Months Ended June 30, 

Six Months Ended June 30, 

Three Months Ended June 30, 

Six Months Ended June 30, 

(In thousands except per share data)

    

2019

    

2018

    

2019

    

2018

    

2020

    

2019

    

2020

    

2019

Numerator:

Net income attributable to Innoviva stockholders, basic

$

37,740

$

54,626

$

71,530

$

84,207

$

76,844

$

37,740

$

142,281

$

71,530

Add: interest expense on 2023 Notes

1,158

1,417

2,325

2,829

1,184

1,158

2,364

2,325

Net income attributable to Innoviva stockholders, diluted

$

38,898

$

56,043

$

73,855

$

87,036

$

78,028

$

38,898

$

144,645

$

73,855

Denominator:

Weighted-average shares used to compute basic net income per share attributable to Innoviva stockholders

 

101,151

 

100,873

 

101,105

 

100,739

 

101,324

 

101,151

 

101,280

 

101,105

Dilutive effect of 2023 Notes

12,189

12,189

12,189

12,189

12,189

12,189

12,189

12,189

Dilutive effect of options and awards granted under equity incentive plan and employee stock purchase plan

51

337

90

555

32

51

58

90

Weighted-average shares used to compute diluted net income per share attributable to Innoviva stockholders

 

113,391

 

113,399

 

113,384

 

113,483

 

113,545

 

113,391

 

113,527

 

113,384

Net income per share attributable to Innoviva stockholders

Basic

$

0.37

$

0.54

$

0.71

$

0.84

$

0.76

$

0.37

$

1.40

$

0.71

Diluted

$

0.34

$

0.49

$

0.65

$

0.77

$

0.69

$

0.34

$

1.27

$

0.65

Anti-Dilutive Securities

The following common stock equivalents were not included in the computation of diluted net income per share because their effect was anti-dilutive:

Three Months Ended June 30, 

Six Months Ended June 30, 

Three Months Ended June 30, 

Six Months Ended June 30, 

(In thousands)

    

2019

    

2018

    

2019

    

2018

    

2020

    

2019

    

2020

    

2019

Outstanding options and awards granted under equity incentive plan and employee stock purchase plan

 

1,188

1,633

 

1,120

1,562

 

1,154

1,188

1,124

1,120

3. Revenue Recognition and Collaborative Arrangements

Revenue is recognized when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. Revenue is recognized through a five-step process: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price for the contract; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) a performance obligation is satisfied. We recognize the royalty revenue on licensee net sales of products with respect to which we have contractual royalty rights in the period in which the royalties are earned and reported to us. Royalties are recognized net of amortization of capitalized fees associated with any approval and launch milestone payments made to GSK.

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3. Revenue Recognition and Collaborative Arrangements

Net Revenue from Collaborative Arrangements

Net revenue recognized under our GSK Agreements was as follows:

Three Months Ended June 30, 

Six Months Ended June 30, 

Three Months Ended June 30, 

Six Months Ended June 30, 

(In thousands)

    

2019

    

2018

    

2019

    

2018

    

2020

    

2019

    

2020

    

2019

Royalties from a related party - RELVAR/BREO

$

47,086

$

57,515

$

89,826

$

103,675

$

45,570

$

47,086

$

101,719

$

89,826

Royalties from a related party - ANORO

10,635

10,656

19,205

19,380

11,199

10,635

21,049

19,205

Royalties from a related party - TRELEGY

9,842

2,371

17,171

3,323

15,633

9,842

31,768

17,171

Total royalties from a related party

67,563

70,542

126,202

126,378

72,402

67,563

154,536

126,202

Less: amortization of capitalized fees paid to a related party

 

(3,456)

 

(3,456)

 

(6,912)

 

(6,912)

 

(3,456)

 

(3,456)

 

(6,912)

 

(6,912)

Royalty revenue from GSK

$

64,107

$

67,086

$

119,290

$

119,466

Royalty revenue

68,946

64,107

147,624

119,290

Strategic alliance - MABA program

10,000

10,000

Total net revenue from GSK

$

78,946

$

64,107

$

157,624

$

119,290

During the three months ended June 30, 2020, we recognized $10.0 million in revenue in connection with the termination of the Bifunctional Muscarinic Antagonist-Beta2 Agonist (“MABA”) program under the Strategic Alliance Agreement with GSK.

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4. Consolidated Entities

Theravance Respiratory Company, LLC

As of June 30, 2020, and December 31, 2019, $25.6 million and $14.4 million, respectively, of the related party receivables from collaborative arrangements were attributable to TRC. The cash balance attributable to TRC as of June 30, 2020 was $16.5 million. Total revenue for TRC related to TRELEGY® ELLIPTA® was $15.6 million and $9.8 million for the three months ended June 30, 2020 and 2019, respectively, and $31.8 million and $17.2 million for the six months ended June 30, 2020 and 2019, respectively. Total revenue for TRC also included a $10.0 million fee for the termination of the MABA program for the three and six months ended June 30, 2020. Total operating expenses were $0.5 million and $0.8 million for the three and six months ended June 30, 2020, respectively, compared to minimal amounts for the same periods in 2019.

Pulmoquine Therapeutics, Inc.

On April 20, 2020, we entered into a securities purchase agreement with Pulmoquine to purchase 5,808,550 shares of Series A preferred stock for $5.0 million in cash. Upon consummation of the transaction, we owned approximately 90.9% of Pulmoquine's outstanding shares and hold a majority voting interest. Pulmoquine is a biotechnology company focused on the research and development of an aerosolized formulation of hydroxychloroquine to treat respiratory infections, such as the novel coronavirus (“COVID-19”). As of June 30, 2020, total assets including cash balance attributable to Pulmoquine was $4.9 million. Pulmoquine does not currently generate revenue. Total operating expense was $0.6 million for the three and six months ended June 30, 2020.

5. Financial Instruments and Fair Value Measurements

Equity Investment in Armata

On January 27, 2020, we entered into a securities purchase agreement to acquire 8,710,800 shares of Armata’s common stock and warrants to purchase up to 8,710,800 additional shares of its common stock for $25.0 million in cash. Armata is a clinical stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections. The investment is to support Armata’s ongoing advancement of its bacteriophage development programs including the expected first in human studies related to Armata's lead phage candidate, AP-PA02, targeting Pseudomonas aeruginosa, as well as AP-SA02, its phage candidate targeting Staphylococcus Aureus.

The investment was closed in 2 tranches on February 12, 2020 and March 27, 2020. NaN of our board members joined Armata’s board. After the second closing, we owned approximately 46.7% of Armata’s common stock.

The investment provides Innoviva the ability to have significant influence, but not control over Armata’s operations. Based on our evaluation, we determined that Armata is a VIE, but Innoviva is not the primary beneficiary of the VIE. We elected the fair value option to account for both Armata’s common stock and warrants at fair value. The fair value of Armata’s common stock is measured based on its closing market price. The warrants have an exercise price of $2.87 per share, are exercisable immediately within five years from the issuance date of the warrants, and include a cashless exercise option. We use the Black-Scholes-Merton pricing model to estimate the fair value of these warrants with the following input assumptions: Armata’s closing market price on the valuation date, the risk-free interest rate computed based on the U.S. Treasury yield, the remaining contractual term as the expected term, and the expected stock price volatility calculated based on the historical volatility of the common stock of Armata’s peer companies.

As of June 30, 2020, the fair values of Armata’s common stock and warrants were estimated at $34.1 million and $26.2 million, respectively. The total fair value of both financial instruments in the amount of $60.3 million was recorded as equity investments on the consolidated balance sheets as of June 30, 2020. We recorded $13.4 million and $35.3 million of unrealized gains and fair value changes in Armata’s investments as changes in fair values of equity investments, net on the consolidated statements of income for the three and six months ended June 30, 2020, respectively.

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4. Available-for-Sale SecuritiesEquity Investment in Entasis

On April 12, 2020, we entered into a securities purchase agreement with Entasis to purchase 14,000,000 shares of Entasis common stock as well as warrants to purchase 14,000,000 additional shares of its common stock for approximately $35.0 million in cash. Entasis is a clinical-stage biotechnology company focused on the discovery and Fair Value Measurementsdevelopment of novel antibacterial products. The investment is to support Entasis's ongoing advancement of its pathogen-targeted antibacterial product candidates, which include their global Phase 3 registration trial evaluating a fixed-dose combination of sulbactam and durlobactam (SUL-DUR) against Acinetobacter baumanii infections.

The investment was closed in 2 tranches on April 22, 2020 and June 11, 2020. Innoviva has a right to designate 2 members to Entasis's board. After the second closing, we owned approximately 51.3% of Entasis's common stock.

The investment provides Innoviva the ability to have significant influence, but not control, over Entasis's operations. Based on our evaluation, we determined that Entasis is a VIE, but Innoviva is not the primary beneficiary of the VIE. We elected the fair value option to account for both Entasis's common stock and warrants at fair value. The fair value of Entasis's common stock is measured based on its closing market price at each balance sheet date. The warrants have an exercise price of $2.50 per share, are exercisable immediately within five years from the issuance date of the warrants and include a cashless exercise option. We use the Black-Scholes-Merton pricing model to estimate the fair value of these warrants with the following input assumptions: Entasis's closing market price on the valuation date, the risk-free interest rate computed based on the U.S. Treasury yield, the remaining contractual term as the expected term, and the expected stock price volatility calculated based on the historical volatility of the common stock of Entasis's peer companies.

As of June 30, 2020, the fair values of Entasis's common stock and warrants were estimated at $41.4 million and $26.9 million, respectively. The total fair value of both financial instruments in the amount of $68.3 million was recorded as equity investments on the consolidated balance sheets. We recorded $33.3 million of unrealized gains and fair value changes in Entasis's investments as changes in fair values of equity investments, net on the consolidated statements of income for the three and six months ended June 30, 2020.

Available-for-Sale Securities

The estimated fair value of available-for-sale securities is based on quoted market prices for these or similar investments that were based on prices obtained from a commercial pricing service. Available-for-sale securities are summarized below:

June 30, 2019

June 30, 2020

    

    

Gross

    

Gross

    

    

    

Gross

    

Gross

    

Unrealized

Unrealized

Estimated

Unrealized

Unrealized

Estimated

(In thousands)

Amortized Cost

Gains

Losses

Fair Value

Amortized Cost

Gains

Losses

Fair Value

U.S. government securities

$

49,012

$

25

$

$

49,037

$

3,993

$

6

$

$

3,999

U.S. government agencies

19,919

8

19,927

U.S. commercial paper

 

38,747

 

 

 

38,747

Money market funds

 

120,581

 

 

 

120,581

 

378,472

 

 

 

378,472

Total

$

228,259

$

33

$

$

228,292

$

382,465

$

6

$

$

382,471

December 31, 2018

December 31, 2019

    

    

Gross

    

Gross

    

    

    

Gross

    

Gross

    

Unrealized

Unrealized

Estimated

Unrealized

Unrealized

Estimated

(In thousands)

Amortized Cost

Gains

Losses

Fair Value

Amortized Cost

Gains

Losses

Fair Value

U.S. government securities

$

29,736

$

$

(3)

$

29,733

$

53,799

$

35

$

$

53,834

U.S. government agencies

4,971

4,971

U.S. corporate notes

2,875

2,875

U.S. commercial paper

 

22,037

 

 

 

22,037

 

18,915

 

 

 

18,915

Money market funds

 

49,358

 

 

 

49,358

 

233,992

 

 

 

233,992

Total

$

108,977

$

$

(3)

$

108,974

$

306,706

$

35

$

$

306,741

As of June 30, 2019,2020, all of the available-for-sale debt securities had contractual maturities within one year, and the weighted average maturityduration of marketabledebt securities was approximately two months.one month. There was 0 credit loss of these securities as of June 30, 2020.

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Fair Value Measurements

Our available-for-sale securities and equity investments are measured at fair value on a recurring basis and our debt is carried at amortized cost basis. The estimated fair values were as follows:

Estimated Fair Value Measurements as of June 30, 2019 Using:

Estimated Fair Value Measurements as of June 30, 2020 Using:

Quoted Price in

Quoted Price in

Active Markets

Significant Other

Significant

Active Markets

Significant Other

Significant

for Identical

Observable

Unobservable

for Identical

Observable

Unobservable

Types of Instruments

Assets

Inputs

Inputs

Assets

Inputs

Inputs

(In thousands)

    

Level 1

    

Level 2

    

Level 3

    

Total

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets

U.S. government securities

$

$

49,037

$

$

49,037

$

$

3,999

$

$

3,999

U.S. government agencies

19,927

19,927

U.S. commercial paper

 

 

38,747

 

 

38,747

Money market funds

 

120,581

 

 

 

120,581

 

378,472

 

 

 

378,472

Equity investment - Armata Common Stock

34,146

34,146

Equity investment - Armata Warrants

26,181

26,181

Equity investment - Entasis Common Stock

41,440

41,440

Equity investment - Entasis Warrants

26,846

26,846

Total assets measured at estimated fair value

$

120,581

$

107,711

$

$

228,292

$

454,058

$

57,026

$

$

511,084

Debt

Term B Loan

$

$

13,750

$

$

13,750

2023 Notes

252,754

252,754

$

$

246,303

$

$

246,303

2025 Notes

 

 

208,181

 

 

208,181

 

 

198,997

 

 

198,997

Total fair value of debt

$

$

474,685

$

$

474,685

$

$

445,300

$

$

445,300

Estimated Fair Value Measurements as of December 31, 2019 Using:

Quoted Price in

Active Markets

Significant Other

Significant

Estimated Fair Value Measurements as of December 31, 2018 Using:

for Identical

Observable

Unobservable

Types of Instruments

Quoted Price in Active Markets for Identical Assets

Significant Other Observable Inputs

Significant Unobservable Inputs

Assets

Inputs

Inputs

(In thousands)

    

Level 1

    

Level 2

    

Level 3

    

Total

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets

U.S. government securities

$

$

29,733

$

$

29,733

$

$

53,834

$

$

53,834

U.S. government agencies

4,971

4,971

U.S. corporate notes

2,875

2,875

U.S. commercial paper

 

 

22,037

 

 

22,037

 

 

18,915

 

 

18,915

Money market funds

 

49,358

 

 

 

49,358

 

233,992

 

 

 

233,992

Total assets measured at estimated fair value

$

49,358

$

59,616

$

$

108,974

$

233,992

$

72,749

$

$

306,741

Debt

Term B Loan

$

$

13,750

$

$

13,750

2023 Notes

258,918

258,918

$

$

243,394

$

$

243,394

2025 Notes

230,692

230,692

208,976

208,976

Total fair value of debt

$

$

503,360

$

$

503,360

$

$

452,370

$

$

452,370

The fair value of our marketable securities classified within Level 2 is based upon observable inputs that may include benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data, including market research publications.

The fair values of our equity investments in Armata and Entasis's common stock are based on their respective closing market prices per share at the reporting date and are classified as Level 1 financial instruments. The fair values of our equity investments in Armata and Entasis's warrants are included within Level 2 as the assumptions used in the valuation model are based on the observable inputs that include their respective closing market prices per share, their respective comparable companies’ market data and the U.S. Treasury yield.

The fair value of our 2023 Notes and of our 2025 Notes is based on recent trading prices of the instruments. The carrying amount of our initial senior secured term loan (the “Term B Loan”) before deducting debt issuance costs approximates fair value as the loan carries a variable interest rate that is tied to the LIBOR rate plus an applicable spread.

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5.6. Stock-Based Compensation

Stock-based compensation expense is included in the consolidated statements of income as follows:

Market-Based RSAs and RSUs

Three Months Ended June 30, 

Six Months Ended June 30, 

(In thousands)

    

2020

    

2019

    

2020

    

2019

General and administrative

$

375

$

474

$

810

$

1,079

2016 Market-Based RSAs and RSUs

On January 14, 2016, the Compensation Committee approved and granted 282,394 RSAs and 46,294 RSUs to senior management. These awards include a market condition based on Total Shareholder Return (“TSR”) and a service condition that requires continued employment.

In February 2018, the Compensation Committee certified the maximum achievement of the TSR as of the first measurement date, January 12, 2018. RSAs totaling 69,440 and RSUs totaling 30,862 representing two-thirds of the amounts were released on February 20, 2018. In connection with the separation of certain members of senior management from the Company in early February 2018, the Board of Directors agreed to accelerate the vesting and distribution of an aggregate of 118,821 RSAs to these members of senior management. The remaining 59,411 RSAs for these members of senior management were forfeited. As a net result of the vesting acceleration of the RSAs and the forfeiture of those unvested RSAs, an additional $0.7 million compensation expense was recognized during the three months ended March 31, 2018.

In August and September 2018, the remaining 34,722 RSAs and 15,432 RSUs were forfeited due to the additional separation of senior management members, and $0.2 million of previously recognized compensation expense was reversed.

2017 Market-Based RSAs and RSUs

On January 17, 2017, the Compensation Committee approved and granted 353,508 RSAs and 53,360 RSUs to senior management. These awards include a market condition based on the TSR of Innoviva’s common stock as compared to the TSR of NASDAQ Biotechnology Index (“Index”) and a service condition that requires continued employment.

In connection with the separation of certain members of senior management from the Company in February 2018, an aggregate of 233,448 RSAs were forfeited, and $0.8 million of previously recognized compensation expense was reversed during the three months ended June 30, 2018.

In August and September 2018, the remaining 120,060 RSAs and 53,360 RSUs were forfeited due to the additional separation of senior management members, and $0.9 million of previously recognized compensation expense was reversed.

2018 Market-Based RSAs and RSUs

On March 2, 2018, the Compensation Committee approved and granted 111,668 RSAs and 49,630 RSUs to senior management. These awards include a market condition based on the TSR of Innoviva’s common stock over a three-year performance period from the date of grant for the RSAs and from the date of grant until September 30, 2020 for RSUs, and a service condition that requires continued employment. The grant date fair value of these awards was determined using a Monte Carlo valuation model. The aggregate value of $1.7 million was to be recognized as compensation expense over the implied service period and would not be reversed if the market condition was not met, but with the exception of such person’s continued employment with the Company.

In August and September 2018, all of 111,668 RSAs and 49,630 RSUs were forfeited, and $0.2 million of previously recognized compensation expense was reversed due to the separation of these senior management members.

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Stock-Based Compensation Expense

Stock-based compensation expense is included in the condensed consolidated statements of operations as follows:

Three Months Ended June 30, 

Six Months Ended June 30, 

(In thousands)

    

2019

    

2018

    

2019

    

2018

General and administrative

$

474

$

1,452

$

1,079

$

3,621

As of June 30, 2019, unrecognized stock-based compensation cost was as follows:

Unrecognized

Compensation

(In thousands)

    

Cost

RSUs

$

1,095

RSAs

1,192

Total unrecognized compensation cost

$

2,287

6.7. Debt

Our debt consists of:

June 30, 

December 31, 

June 30, 

December 31, 

(In thousands)

    

2019

    

2018

    

2020

    

2019

Term B Loan

$

13,750

$

13,750

2023 Notes

 

240,984

 

240,984

 

$

240,984

 

$

240,984

2025 Notes

192,500

192,500

192,500

192,500

Total debt

447,234

447,234

433,484

433,484

Unamortized debt discount and issuance costs

(60,559)

(64,379)

(52,254)

(56,364)

Net long-term debt

 

$

386,675

 

$

382,855

 

$

381,230

 

$

377,120

Prepayments of Senior Secured Term Loans

On February 28 and August 1, 2018, we prepaid the principal balance of the Term B Loan by $120.0 million and $110.0 million, respectively. With the prepayments, we incurred a loss on the extinguishment of debt of $3.1 million and $2.6 million, respectively, representing unamortized debt issuance costs. The loss on the extinguishment of debt is presented as part of other expense, net in our consolidated statements of operations. As of June 30, 2019, the outstanding principal balance of the Term B Loan was $13.8 million.

Convertible Senior Notes Due 2025

In accordance with accounting guidance for debt with conversion and other options, we separately account for the liability and equity components of the 2025 Notes by allocating the proceeds between the liability component and the embedded conversion option (“equity component”) due to our ability to settle the conversion obligation of the 2025 Notes in cash, common stock or a combination of cash and common stock, at our option. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature using the income approach. The allocation was performed in a manner that reflected our non-convertible debt borrowing rate for similar debt. The equity component of the 2025 Notes was recognized as a debt discount and represents the difference between the proceeds from the issuance of the 2025 Notes and the fair value of the liability of the 2025 Notes on the date of issuance. The excess of the principal amount of the liability component over its carrying amount (“debt discount”) is amortized to interest expense using the effective interest method over the term of the 2025 Notes. The equity component is not remeasured as long as it continues to meet the conditions for equity classification.

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Our outstanding 2025 Notes balances consisted of the following:

June 30,

December 31,

June 30, 

December 31, 

(In thousands)

    

2019

    

2018

    

2020

    

2019

Liability component

 

 

 

 

Principal

$

192,500

$

192,500

$

192,500

$

192,500

Debt discount and issuance costs, net

 

(58,261)

 

(61,766)

 

(50,768)

 

(54,597)

Net carrying amount

 

$

134,239

 

$

130,734

 

$

141,732

 

$

137,903

Equity component, net

$

65,361

$

65,361

$

65,361

$

65,361

The following table sets forth total interest expense recognized related to the 2025 Notes for the three and six months ended June 30, 20192020 and 2018:2019:

Three Months Ended June 30, 

Six Months Ended June 30, 

Three Months Ended June 30, 

Six Months Ended June 30, 

(In thousands)

    

2019

2018

2019

2018

    

2020

2019

2020

2019

Contractual interest expense

$

1,203

$

1,203

    

$

2,406

    

$

2,393

$

1,203

$

1,203

    

$

2,406

    

$

2,406

Amortization of debt issuance costs

136

125

269

248

149

136

294

269

Amortization of debt discount

 

1,635

1,496

3,236

2,975

 

1,786

1,635

3,535

3,236

Total interest and amortization expense

 

$

2,974

$

2,824

$

5,911

$

5,616

 

$

3,138

$

2,974

$

6,235

$

5,911

Debt Maturities

The aggregate scheduled maturities of our long-term debt as of June 30, 2019, are as follows:

(In thousands)

    

 

Years ending December 31:

 

2019 to 2021

$

2022

13,750

2023

240,984

Thereafter

192,500

Total

 

$

447,234

7. Related Party Transaction

On February 12, 2018, the Company entered into an agreement with Sarissa Capital Management LP, and certain of its affiliates (collectively, the “Sarissa Group”) related to the Company’s 2018 Annual Meeting of Stockholders (the “2018 Annual Meeting”). The agreement provided for, among other things, the concurrent appointment of three designees of the Sarissa Group as members of the Company’s Board of Directors and an agreement to recommend and nominate a five-person slate of directors for election at the 2018 Annual Meeting composed of the three new directors and two current directors of the Company and partially reimburse the Sarissa Group $2.7 million for expenses, which reimbursement obligation relating to the 2018 Annual Meeting arose upon execution of the agreement. The Sarissa Group is considered to be a related party due to its representation on the Board of Directors.

8. Income Taxes

Provisional income tax expense for the three and six months ended June 30, 2019 was $10.4 million and $18.9 million, respectively, compared to minimal amounts for the same periods in 2018 as a full valuation allowance was maintained on the Company's gross deferred taxes. The difference between the Company’s effective income tax rate of 18% for the six months ended June 30, 2019 and the U.S. federal statutory rate of 21% is primarily attributable to state income tax, non-deductible expenses and noncontrolling interest.

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Debt Maturities

The aggregate scheduled maturities of our long-term debt as of June 30, 2020, are as follows:

(In thousands)

    

 

Years ending December 31:

 

2020 to 2022

$

2023

240,984

2024

Thereafter

192,500

Total

 

$

433,484

9. Lease8. Commitments and Contingencies

We have an operating lease for our corporate headquarters with a remaining lease term of approximately four years. The lease includes a five-year renewal option at our sole discretion. The total operating lease expense for this lease was $0.1 million for the three months ended June 30, 2019 and 2018, respectively; and $0.2 million for the six months ended June 30, 2019 and 2018, respectively.

Cash paid for amount included in the measurement of operating lease liabilities was $0.1 million and $0.2 million for the three and six months ended June 30, 2019, respectively. The lease liabilities were measured using a discount rate of 7.15% based on the most recent borrowing rate for our senior secured Term B Loan at the time of adoption of ASC 842 as discussed in Note 1.Lease

Future minimum operating lease payments on our corporate headquarters as of June 30, 20192020 are as follows:

(In thousands)

    

    

Years ending December 31:

Remainder of 2019

$

204

2020

 

416

Remainder of 2020

$

60

2021

 

428

 

123

2022

 

441

 

109

2023

 

201

Total future minimum lease payments

 

1,690

Imputed interest

 

(216)

Thereafter

 

Total

$

1,474

$

292

Reported as of June 30, 2019

Operating lease liability, current portion

$

317

Operating lease liability, net of current portion

 

1,157

Total

$

1,474

10. Subsequent Events9. Income Taxes

In May 2019, Theravance Biopharma, who is the owner of 85% of the economic interests in TRC, initiated arbitration against the Company and TRC, relating to a dispute as to the determination by Innoviva (as manager of TRC) to cause TRC to explore potential reinvestment opportunitiesProvisional income tax expense for the royalty proceeds received by GSK into initiatives that Innoviva believes will increasethree and six months ended June 30, 2020 was $19.9 million and $35.8 million, respectively, compared to $10.4 million and $18.9 million for the valuesame periods in 2019 respectively. The Company’s effective income tax rate for the six months ended June 30, 2020 was 17%, compared to 18% for the same period in 2019. The difference between the Company’s effective income tax rate and the U.S. federal statutory income tax rate of TRC21% is primarily attributable to state income tax, non-deductible expenses and TRELEGY® ELLIPTA®. Theravance Biopharma alleges that in causing TRC to not distribute substantially all royalty proceeds received from GSK, Innoviva breached the limited liability company operating agreement governing TRC (the “Operating Agreement”), as well as the fiduciary duties applicable to Innoviva as manager of TRC. The hearing in respect of the arbitration commenced on July 23, 2019 and is expected to last several days. While Innoviva believes that it has complied with all applicable duties and is not in breach of the Operating Agreement, Theravance Biopharma is alleging such breach and is seeking material damages and there is no certainty that the arbitrator will rule in favor of Innoviva.

noncontrolling interest.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Forward-Looking Statements

The information in this Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements involve substantial risks, uncertainties and assumptions. All statements contained herein that are not of historical fact, including, without limitation, statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, intentions, expectations, goals and objectives, may be forward-looking statements. The words “anticipates,” “believes,” “could,” “designed,” “estimates,” “expects,” “goal,” “intends,” “may,” “objective,” “plans,” “projects,” “pursue,” “will,” “would” and similar expressions (including the negatives thereof) are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, expectations or objectives disclosed in our forward-looking statements and the assumptions underlying our forward-looking statements may prove incorrect. Therefore, you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and objectives disclosed in the forward-looking statements that we make. All written and verbal forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Important factors that we believe could cause actual results or events to differ materially from our forward-looking statements include, but are not limited to, risks related to: 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 the Company (including the Company’s growth strategy and corporate development initiatives beyond the existing respiratory portfolio); the timing, manner and amount of potential capital returns to stockholders; 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; projections of revenue, expenses and other financial items; the impact of the COVID-19 pandemic; and risks discussed in “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 20182019 filed with the Securities and Exchange Commission (“SEC”) on February 19, 2020 (“2019 (“2018 Form 10-K”) and Item 1A of Part II of our Quarterly Reports on Form 10-Q and below in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Item 2 of Part I. All forward-looking statements in this Quarterly Report on Form 10-Q are based on current expectations as of the date hereof and we do not assume any obligation to update any forward-looking statements on account of new information, future events or otherwise, except as required by law.

We encourage you to read our consolidated financial statements contained in this Quarterly Report on Form 10-Q. We also encourage you to read Item 1A of Part I of our 20182019 Form 10-K and Item 1A of Part II of our Quarterly Reports on Form 10-Q entitled “Risk Factors,” which contain a more complete discussion of the risks and uncertainties associated with our business. In addition to the risks described above and in Item 1A of Part I of our 20182019 Form 10-K and Item 1A of Part II of this report, other unknown or unpredictable factors also could affect our results. Therefore, the information in this report should be read together with other reports and documents that we file with the SEC from time to time, including on Form 10-K, Form 10-Q and Form 8-K, which may supplement, modify, supersede or update those risk factors. As a result of these factors, we cannot assure you that the forward-looking statements in this report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.

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OVERVIEW

Executive Summary

Innoviva, Inc. (“Innoviva”, the “Company”, the “Registrant” or “we”) and other similar pronouns) is focused on royalty management. Innoviva’sa company with a portfolio includes theof royalties that include respiratory assets partnered with Glaxo Group Limited (“GSK”), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/ vilanterol, “FF/VI”), ANORO® ELLIPTA® (umeclidinium

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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® as follows: 15% on the first $3.0 billion of annual global net sales and 5% for all annual global net sales above $3.0 billion; and royalties from the sales of ANORO® ELLIPTA®, which tier upward at a range from 6.5% to 10%. 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”),TRC, including TRELEGY® ELLIPTA® and any other product or combination of products that may be discovered or 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®.

Our company structure and organization are tailored to our focused activities of managing our respiratory assets with GSK, the commercial and developmental obligations associated with the GSK Agreements, intellectual property, licensing operations, business development activities and providing for certain essential reporting and management functions of a public company. As of June 30, 2019,2020, we had sixfive employees. Our revenues consist of royalties and potential milestone payments, if any, from our respiratory partnership agreements with GSK.

Recent Highlights

GSK Net Sales:

GSK Net Sales:
oSecond quarter 20192020 net sales of RELVAR®/BREO® ELLIPTA® by GSK were $313.9$303.8 million, down 18%3% from $383.4$313.9 million in the second quarter of 2018,2019, with $116.4$103.3 million in net sales from the U.S. market and $197.5$200.5 million from non-U.S. markets.
oSecond quarter 20192020 net sales of ANORO® ELLIPTA® by GSK were $163.6$172.3 million, down slightlyup 5% from $163.9$163.6 million in the second quarter of 2018,2019, with $102.2$109.8 million net sales from the U.S. market and $61.4$62.5 million from non-U.S. markets.
oSecond quarter 20192020 net sales of TRELEGY® ELLIPTA® by GSK were $151.4$240.5 million, up significantly from $36.5$151.4 million in the second quarter of 2018,2019, with $109.5$174.8 million in net sales from the U.S. market and $41.9$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 Entasis’s common stock 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.
Other:
oIn May 2020, Pavel Raifeld was named as Chief Executive Officer.

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Collaborative Arrangements with GSK

LABA Collaboration

In November 2002, we entered into our LABA Collaboration Agreement with GSK to develop and commercialize once-daily LABA products for the treatment of chronic obstructive pulmonary disease (“COPD”) and asthma. The collaboration has developed three combination products: (1) RELVAR®/BREO® ELLIPTA® (FF/VI) (BREO® ELLIPTA®is the proprietary name in the U.S. and Canada and RELVAR® ELLIPTA® is the proprietary name outside the U.S. and Canada), a once-daily combination medicine consisting of a LABA, vilanterol (VI), and an inhaled corticosteroid (ICS), fluticasone furoate (FF), (2) ANORO® ELLIPTA® (UMEC/VI), a once-daily medicine combining a long-acting muscarinic antagonist (“LAMA”), umeclidinium bromide (UMEC), with a LABA, VI and (3) TRELEGY® ELLIPTA®, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), a once-daily combination medicine consisting of an ICS, LAMA and LABA.

As a result of the launch and approval of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA® in the U.S., Japan and Europe, in accordance with the LABA Collaboration Agreement, we paid milestone fees to GSK totaling $220.0 million during the year ended December 31, 2014. The milestone fees paid to GSK were recognized as capitalized fees paid to a related party, which are being amortized over their estimated useful lives commencing upon the commercial launch of the products.

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2004 Strategic Alliance

In March 2004, we entered into the Strategic Alliance Agreement with GSK where GSK received an option to license exclusive development and commercialization rights to product candidates from certain of our discovery programs on pre-determined terms and on an exclusive, worldwide basis. In 2005, GSK licensed our MABA program for the treatment of COPD, and in October 2011, we and GSK expanded the MABA program by adding six additional Innoviva-discovered preclinical MABA compounds (the “Additional MABAs”). The development program has beenwas funded in full by GSK. In June of 2020, GSK is interminated the processprogram and agreed to pay a $10.0 million termination fee to TRC. This fee was recognized as revenue from collaborative arrangements with a related party on our consolidated statements of determining next stepsincome for the program. For a detailed discussion of our alliance with GSK, see Management’s Discussionthree and Analysis of Financial Condition and Results of Operations contained in Part II, Item 7 of our 2018 Form 10-K.six months ended June 30, 2020, respectively.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2016 02, Leases (Topic 842), which requires an entityAs part of our capital allocation strategies, we invest from time to recognize righttime in equity securities of use assets representing its right to use the underlying asset for the lease term and lease liabilities representing the present value of the future lease payments for both financing and operating leases on its consolidated balance sheets. For a lease with a term of 12 monthsprivate or less, the standard allows an entity to elect not to recognize a right-of-use asset and a lease liability and recognize the lease expense on a straight-line basis. We adopted the standard on the effective date of January 1, 2019 using the alternative transition approach. This approach is similar to a prospective transition, which requires the application of ASC 842 at the effective date with a cumulative-effect adjustment recognized through retained earnings. Under this approach,public companies. If we determine that we do not presenthave control over these companies under either voting or VIE models, we then determine if we have an ability to exercise significant influence via voting interests, board representation or other business relationships. We may account for the adjusted comparative periods. Our pro-rata shareequity investments where we exercise significant influence using either an equity method of common area expenses are recorded as lease expense when incurred since they are variable and considered nonlease componentsaccounting or at fair value by electing the fair value option. If the fair value option is applied to an investment that would otherwise be accounted for under the standard. The most significant impact of the adoptionequity method, we apply it to us is that we recognized a right of use assetall our financial interests in the amountsame entity (equity and debt, including guarantees) that are eligible items. All gains and losses from fair value changes, unrealized and realized, are presented as changes in fair values of $1.5 million and lease liabilities inequity investments, net on the total amount of $1.6 million at January 1, 2019 for the operating lease on our corporate headquarters. The adoption did not have a material impact on our retained earnings and consolidated statements of operations and cash flows.income.

If we conclude that we do not have an ability to exercise significant influence over an investee, we may elect to account for an equity security without a readily determinable fair value at its cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.

There were no other significant changes to our critical accounting policies and estimates. Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 20182019 filed with the SEC on February 19, 20192020 provides a more complete discussion of our critical accounting policies and estimates.

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Results of Operations

Net Revenue

Total net revenue, as compared to the prior year period,periods, was as follows:

Three Months Ended June 30, 

Change

 

Six Months Ended June 30, 

Change

 

Three Months Ended June 30, 

Change

 

Six Months Ended June 30, 

Change

 

(In thousands)

    

2019

    

2018

    

$

    

%

 

    

2019

    

2018

    

$

    

%

 

    

2020

    

2019

    

$

    

%

 

2020

    

2019

    

$

    

%

 

Royalties from a related party - RELVAR/BREO

$

47,086

$

57,515

$

(10,429)

(18)

%

$

89,826

$

103,675

$

(13,849)

(13)

%

$

45,570

$

47,086

$

(1,516)

(3)

%

$

101,719

$

89,826

$

11,893

13

%

Royalties from a related party - ANORO

 

10,635

 

10,656

 

(21)

0

%

 

19,205

 

19,380

 

(175)

(1)

%

 

11,199

 

10,635

 

564

5

%

 

21,049

 

19,205

 

1,844

10

%

Royalties from a related party - TRELEGY

 

9,842

 

2,371

 

7,471

*

 

17,171

 

3,323

 

13,848

*

 

15,633

 

9,842

 

5,791

59

%

 

31,768

 

17,171

 

14,597

85

%

Total royalties from a related party

 

67,563

 

70,542

 

(2,979)

(4)

%

 

126,202

 

126,378

 

(176)

0

%

 

72,402

 

67,563

 

4,839

7

%

 

154,536

 

126,202

 

28,334

22

%

Less: amortization of capitalized fees paid to a related party

 

(3,456)

 

(3,456)

 

 

(6,912)

 

(6,912)

 

 

(3,456)

 

(3,456)

 

0

%

 

(6,912)

 

(6,912)

 

0

%

Royalty revenue from GSK

$

64,107

$

67,086

$

(2,979)

(4)

%

$

119,290

$

119,466

$

(176)

0

%

Royalty revenue

68,946

64,107

4,839

8

%

147,624

119,290

28,334

24

%

Strategic alliance -MABA program

10,000

10,000

*

10,000

10,000

*

Total net revenue from GSK

$

78,946

$

64,107

$

14,839

23

%

$

157,624

$

119,290

$

38,334

32

%

*Not meaningful

* Not Meaningful

Total net revenue decreasedincreased to $64.1$78.9 million and $119.3$157.6 million for the three and six months ended June 30, 2019,2020, compared to $67.1$64.1 million and $119.5$119.3 million, respectively, for the same periodsperiod a year ago. Royalties for RELVAR®/BREO® ELLIPTA® were lower primarily due to the increasing pricing pressure in the U.S., offset by the volume growth in both U.S. and non-U.S. markets. ANORO® ELLIPTA® maintained its steady volume growth, offset by the increasing pricing pressure in the U.S. GrowthRoyalties for TRELEGY® ELLIPTA® were higher due to the continued growth in prescriptions and market shareshare.

Research & Development

Research and development expenses of $0.6 million for TRELEGY® ELLIPTA® continued quarter over quarter.the three and six months ended June 30, 2020 were attributable to Pulmoquine’s product development efforts.

General & Administrative

General and administrative expenses, as compared to the prior year period,periods, were as follows:

Three Months Ended June 30, 

Change

 

Six Months Ended June 30, 

Change

 

Three Months Ended June 30, 

Change

 

Six Months Ended June 30, 

Change

 

(In thousands)

    

2019

    

2018

    

$

    

%

 

    

2019

    

2018

    

$

    

%

 

    

2020

    

2019

    

$

    

%

 

2020

    

2019

    

$

    

%

 

General and administrative expenses

$

4,347

$

4,411

$

(64)

(1)

%

$

7,362

$

13,396

$

(6,034)

(45)

%

$

2,596

$

4,347

$

(1,751)

(40)

%

$

5,159

$

7,362

$

(2,203)

(30)

%

General and administrative expenses - related party

 

 

 

 

2,700

(2,700)

General and administrative expenses for the three months ended June 30, 2019 were slightly lower, compared to the same period in 2018.

General and administrative expenses for the six months ended June 30, 2019 were $7.4 million2020 decreased compared with $13.4 millionto the same periods in the six months ended June 30, 2018, a decrease of $6.0 million mainly2019, attributable to overall lower personnel-relatedoperating expenses as a result of lower headcount. The amount for the six months ended June 30, 2018 included $3.2 million cash severance payments in connection with certain members of senior management’s separation from the Company and payment of $2.7 million to Sarissa to partially reimburse expenses pursuant to a settlement agreement in February 2018.incurred.

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Other Income, (Expense), net and Interest Income

Other income, (expense), net and interest income, as compared to the prior year period,periods, were as follows:

Three Months Ended June 30, 

Change

Six Months Ended June 30, 

Change

Three Months Ended June 30, 

Change

Six Months Ended June 30, 

Change

(In thousands)

    

2019

    

2018

    

$

    

2019

    

2018

    

$

    

2020

    

2019

    

$

    

%

2020

    

2019

$

%

Other income (expense), net

$

(8)

$

39

$

(47)

$

(7)

$

(3,060)

$

3,053

$

30

$

(8)

$

38

*

$

98

$

(7)

$

105

*

Interest income

 

1,403

 

380

1,023

 

2,378

 

771

1,607

 

158

$

1,403

(1,245)

(89)

%

 

1,460

$

2,378

(918)

(39)

%

Other income (expense), net for the six months ended June 30, 2018, mainly consists of the loss on the extinguishment of debt of $3.1 million in relation to the $120.0 million prepayment of our Term B Loan.* Not Meaningful

Interest income increaseddecreased for the three and six months ended June 30, 2019,2020, as compared to the same periods a year ago primarily due to higher cash and investment balances.lower interest rates impacted by the COVID-19 pandemic.

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Interest Expense

Interest expense, as compared to the prior year period,periods, was as follows:

Three Months Ended June 30, 

Change

 

Six Months Ended June 30, 

Change

 

Three Months Ended June 30, 

Change

 

Six Months Ended June 30, 

Change

 

(In thousands)

    

2019

    

2018

    

$

    

%

 

    

2019

    

2018

    

$

    

%

 

    

2020

    

2019

    

$

    

%

 

2020

    

2019

    

$

    

%

 

Interest expense

$

4,661

$

6,478

$

(1,817)

(28)

%

$

9,278

$

14,135

$

(4,857)

(34)

%

$

4,561

$

4,661

$

(100)

(2)

%

$

9,077

$

9,278

$

(201)

(2)

%

Interest expense decreased slightly for the three and six months ended June 30, 2019,2020, compared to the same periods a year ago primarily due to the lower average outstanding debt balance. See “Liquidity” section below

Changes in Fair Values of Equity Investments

During the quarter ended June 30, 2020, Innoviva invested $35.0 million in 14,000,000 shares of Entasis’s common stock as well as warrants to purchase up to an additional 14,000,000 shares of the common stock at $2.50 per share. As a result of this initial investment, Innoviva owned approximately 51% of Entasis’s common stock as of June 30, 2020. The total fair value of Entasis’s common stock and warrants was estimated at $68.3 million. We recorded $33.3 million as unrealized gains and fair value changes and presented it in the changes in fair values of equity investments on the consolidated statements of income for further information.the three and six months ended June 30, 2020, respectively.

As of June 30, 2020, the total fair value of Armata’s common stock and warrants was estimated at $60.3 million. We recorded $13.4 million and $35.3 million as unrealized gains and fair value changes and presented it in the changes in fair values of equity investments on the consolidated statements of income for the three and six months ended June 30, 2020, respectively.

Provision for Income Taxes

The provisional income tax expense for the three and six months ended June 30, 20192020 was $19.9 million and $35.8 million with an effective income tax rate of 17%, respectively, compared to $10.4 million and $18.9 million, respectively, with an effective interest rate of 18% in the same period a year ago. The difference between the Company's effective income tax rate and the U.S. federal statutory income tax rate of 18%, compared21% is primarily attributable to immaterial amounts in the same periods a year ago as a full valuation allowance was maintained on our gross deferred taxes.state income tax, non-deductible expenses and noncontrolling interests.

Net Income Attributable to Noncontrolling Interest

Net income attributable to noncontrolling interest, as compared to the prior period,periods, was as follows:

Three Months Ended June 30, 

Six Months Ended June 30, 

Three Months Ended June 30, 

Change

Six Months Ended June 30, 

Change

(In thousands)

    

2019

    

2018

    

Change

    

2019

    

2018

    

Change

    

2020

    

2019

    

$

    

%

    

2020

    

2019

$

    

%

Net income attributable to noncontrolling interest

$

8,321

$

1,990

$

6,331

$

14,550

$

2,739

$

11,811

$

21,381

$

8,321

$

13,060

*

$

34,896

$

14,550

$

20,346

*

* Not Meaningful

This represents the 85% share of net income in Theravance Respiratory Company, LLC for Theravance Biopharma for the three and six months ended June 30, 20192020 and 2018.2019. The increase was primarily due to the increase in the growth in prescriptions and market share for TRELEGY® ELLIPTA®.

Liquidity and Capital Resources

Liquidity

Since our inception, we have financed our operations primarily through private placements and public offerings of equity and debt securities and payments received under collaborative arrangements. For the six months ended June 30, 2019,2020, we generated gross royalty revenues from GSK of $126.2 million.$154.5 million and a $10.0 million fee from the termination of the MABA program. Net cash and cash equivalents, short term investments and marketable securities totaled $249.7$417.1 million, and royalties receivablereceivables from GSK totaled $67.6$82.4 million as of June 30, 2019.2020.

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On August 18, 2017, we entered into a Credit Agreement and completed a financing of the $250.0 million Term B Loan. The Term B Loan will mature on August 18, 2022. Two and a half percent (2.5%) of the initial principal amount was originally due quarterly beginning December 31, 2017. The remaining outstanding balance is due at maturity. Prepayments, in whole or in part, can be made at any time without a penalty. The Credit Agreement also provides us the ability to request one or more additional tranches of term loans (or increase an existing term loan) at any time prior to maturity. In December 2017, February 2018 and August 2018, we repaid the principal balance of the Term B Loan by $6.3 million, $120.0 million and $110.0 million, respectively. The outstanding principal balance of the Term B Loan as of June 30, 2019 was $13.8 million.

Adequacy of Cash Resources to Meet Future Needs

We believe that cash from projected future royalty revenues and our cash, cash equivalents and marketable securities will be sufficient to meet our anticipated debt service and operating needs for at least the next 12 months based upon current operating plans and financial forecasts. If our current operating plans and financial forecasts change, we may require additional funding sooner in the form of public or private equity offerings or debt financings. Furthermore, if in our view favorable financing opportunities arise, we may seek additional funding at any time. However, future financing may not be available in amounts or on terms acceptable to us, if at all. This could leave us without adequate financial resources to fund our operations as currently planned. In addition, from time to time we may restructure or reduce our debt, including through tender offers, redemptions, amendments, repurchases or otherwise, all consistentallowable with the terms of our debt agreements.

Cash Flows

Cash flows, as compared to the prior year period, were as follows:

Six Months Ended June 30, 

Six Months Ended June 30, 

(In thousands)

    

2019

    

2018

    

Change

    

2020

    

2019

    

Change

Net cash provided by operating activities

$

133,151

$

101,639

$

31,512

$

153,275

$

133,151

$

20,124

Net cash provided by (used in) investing activities

 

(54,060)

 

35,591

 

(89,651)

 

9,044

 

(54,060)

 

63,104

Net cash provided by (used in) financing activities

 

444

 

(123,340)

 

123,784

 

(27,268)

 

444

 

(27,712)

Cash Flows from Operating Activities

CashNet cash provided by operating activities for the six months ended June 30, 2020 was $153.3 million, consisting primarily of our net income of $177.2 million, adjusted for net non-cash items such as $35.8 million of deferred income taxes, $7.0 million of depreciation and amortization and $68.6 million increase in the fair values of our equity investments.

Net cash provided by operating activities for the six months ended June 30, 2019 was $133.2 million, consisting primarily of our net income of $86.1 million, adjusted for non-cash items such as $18.9 million of deferred income taxes, $7.1 million of depreciation and amortization and $3.8 million amortization of debt discount and issuance costs, as well as a decrease in receivables from collaborative arrangements of $15.7 million.

Cash Flows from Investing Activities

Net cash provided by operatinginvesting activities for the six months ended June 30, 20182020 of $9.0 million was $101.6primarily due to $82.0 million consisting primarilyreceived from maturities of our net income of $86.9 million, adjusted for non-cash items such as $6.9 million of depreciation and amortization, $4.0 million amortization of debt discount and issuance costs, $3.6 million of stock-based compensation expense and $3.1 million of loss on extinguishment of debt,marketable securities, partially offset by a reduction$12.9 million in accrued personnel-related expensespurchases of marketable securities and other accrued liabilities of $1.5 million.

Cash Flows from Investing Activities$60.0 million for our investments in Armata and Entasis.

Net cash flows used in investing activities for the six months ended June 30, 2019 of $54.1 million was primarily due to $111.9 million in purchases of marketable securities, partially offset by $57.9 million proceeds received from maturities of marketable securities.

Cash Flows from Financing Activities

Net cash flows from investingused in financing activities for the six months ended June 30, 20182020 of $35.6$27.3 million was primarily due to $54.9$28.0 million proceeds received from maturities of marketable securities, partially offset by $19.3 million in purchases of marketable securities.

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Table of Contents

Cash Flows from Financing Activitiesdistributions to noncontrolling interest.

Net cash provided by financing activities for the six months ended June 30, 2019 of $0.4 million was primarily due to $0.5 million net proceeds from issuance of common stock.

Net cash used in financing activities for the six months ended June 30, 2018 of $123.3 million was primarily due to $120.0 million prepayment on our Term B Loan and $2.8 million paid for the repurchase of shares to satisfy tax withholding.

Off-Balance Sheet Arrangements

In June 2014, our facility leases in South San Francisco, California were assigned to Theravance Biopharma, Inc. (“Theravance Biopharma”) in connection with the spin-off of Theravance Biopharma. However, if Theravance Biopharma were to default on its lease obligations, we would be held liable by the landlord and thus, we have in substance guaranteed the lease payments for these facilities. We would also be responsible for lease-related payments including utilities, property taxes, and common area

21

Table of Contents

maintenance, which may be as much as the actual lease payments. As of June 30, 2019, the total remainingThis lease paymentsconcluded in May 2020, and we have no further obligations for the duration of the lease, which runs through May 2020, were $6.0 million. The carrying value of this lease guarantee was $0.3 million as of June 30, 2019 and is reflected in other long-term liabilities in our condensed consolidated balance sheet.

Contractual Obligations and Commercial Commitments

In the table below, we set forth our significant enforceable and legally binding obligations and future commitments as of June 30, 2019.lease.

    

    

Payment Due by Period

Less Than

More Than

(In thousands)

    

Total

    

1 Year

    

1 - 3 Years

    

3 - 5 Years

    

5 Years

2023 Notes

$

261,468

$

5,121

$

10,242

$

246,105

$

2025 Notes

 

223,781

 

4,813

 

9,625

 

9,625

 

199,718

Term B Loan*

 

13,750

 

 

��

 

13,750

 

Facility lease

 

1,690

 

409

 

856

 

425

 

Total

$

500,689

$

10,343

$

20,723

$

269,905

$

199,718

*The Term B Loan balances reflect the principal repayment obligations and do not include the interest payments as the loan bears interest at a varying rate of three-month LIBOR plus 4.5% margin.

Item 3. Quantitative and Qualitative Disclosure about Market Risk

There have been no significant changes in our market risk or how our market risk is managed compared to those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2018.2019.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures.

We conducted an evaluation as of June 30, 2019,2020, under the supervision and with the participation of our management, of the effectiveness of the design and operation of our disclosure controls and procedures, which are defined under SEC rules as controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files under the Securities Exchange Act of 1934 (“Exchange Act”) is recorded, processed, summarized and reported within required time periods. Based upon that evaluation, our Interim PrincipalChief Executive Officer and Chief Accounting Officer, concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance levels.

24

Table of Contents

Limitations on the Effectiveness of Controls

Our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all frauds. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefit of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within Innoviva have been detected. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Changes in Internal Control over Financial Reporting

There were no material changes in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the quarter ended June 30, 20192020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1. LegalProceedings

In May 2019, Theravance Biopharma, who is the owner of 85% of the economic interests in TRC, initiated arbitration against the Company and TRC, relating to a dispute as to the determination by Innoviva (as manager of TRC) to cause TRC to explore potential reinvestment opportunities for the royalty proceeds received by GSK into initiatives that Innoviva believes will increase the value of TRC and TRELEGY® ELLIPTA®. Theravance Biopharma allegesalleged that in causing TRC to not distribute substantially all royalty proceeds received from GSK, Innoviva breached the limited liability company operating agreement governing TRC (the “Operating Agreement”), as well as the fiduciary duties applicable to Innoviva as manager of TRC. The hearing in respect of the arbitration commenced onwas conducted from July 23, 2019 through July 25, 2019. Post-arbitration oral argument was heard on August 14, 2019. On September 26, 2019, the arbitrator issued a final decision. The arbitrator ruled that Innoviva did not breach the Operating Agreement or its fiduciary duties by withholding royalties or pursuing reinvestment opportunities. Accordingly, the Company is permitted to continue to pursue development and is expected to last several days. Whilecommercialization initiatives. The arbitrator did conclude that Innoviva believes that it has complied with all applicable duties and is not in breachbreached a provision of the Operating Agreement requiring Innoviva to deliver quarterly financial plans to Theravance Biopharma. However, the arbitrator concluded that this technical breach did not cause any damages to Theravance Biopharma is alleging such breach and is seeking material damagesthe arbitrator awarded limited injunctive relief to expand and there is no certaintyclarify the disclosure obligations under the Operating Agreement related to the delivery of financial plans and the pursuit of investment opportunities (if those opportunities related to TRELEGY® ELLIPTA®). Finally, the arbitrator ruled that the arbitrator will ruleCompany is entitled to indemnification from TRC for 95% of its fees and expenses incurred in favorconnection with the arbitration.

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Table of Innoviva.Contents

On September 30, 2019, the Company and TRC filed a Verified Complaint in the Court of Chancery of the State of Delaware to confirm the arbitration award. The award was confirmed by the Court of Chancery on May 4, 2020.

Item 1A. Risk Factors

Our business is subject to a number of risks, including those identified in Item 1A of Part I of our 20182019 Form 10-K. Except as set forth under “Item 1. Legal Proceedings” above and as discussed below, there have been no other material changes to the risk factors described in our 20182019 Form 10-K,, which is incorporated by reference herein.

The widespread outbreak of an illness or any other communicable disease, or any other public health crisis, could adversely affect our business, results of operations and financial condition.

In December 2019, an outbreak of COVID-19 began in Wuhan, Hubei Province, China. In March 2020, the World Health Organization declared COVID-19 a pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains, and created significant volatility and disruption of financial markets. At this time, based on the information available to us, we can not predict the extent of the impact, if any, of the COVID-19 pandemic on our royalty revenues derived from GSK upon which we significantly rely, or on the operations of our equity and other investments. It is possible that an extended period of global supply chain and economic disruption could materially affect our results of operations and financial condition.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3: Defaults Upon Senior Securities

None.

Item 4: Mine Safety Disclosures

None.

Item 5: Other Information

None.

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Table of Contents

Item 6. Exhibits

(a)Index to Exhibits

Exhibit
Number

Description

Form

Exhibit

Incorporated
by Reference
Filing
Date/Period
End Date

31.1

Certification of Principal Executive Officer pursuant to Rules 13a14 pursuant to the Securities Exchange Act of 1934

31.2

Certification of Principal Financial Officer pursuant to Rules 13a14 pursuant to the Securities Exchange Act of 1934

32

Certifications Pursuant to 18 U.S.C. Section 1350

101

Interactive Data File (Quarterly Report on Form 10-Q, for the quarterly period ended June 30, 2019) formatted in iXBRL (Inline eXtensible Business Reporting Language).

Exhibit
Number

    

Description

    

Form

    

Exhibit

    

Incorporated
by Reference
Filing
Date/Period
End Date

10.1

Offer Letter between Innoviva, Inc. and Pavel Raifeld, dated May 20, 2020

8-K

10.1

05/26/2020

10.2

Transition Agreement between Innoviva, Inc. and Geoffrey L. Hulme, dated June 11, 2020

8-K

10.1

06/12/2020

31.1

Certification of Principal Executive Officer pursuant to Rules 13a-14 pursuant to the Securities Exchange Act of 1934

31.2

Certification of Principal Financial Officer pursuant to Rules 13a-14 pursuant to the Securities Exchange Act of 1934

32

Certifications Pursuant to 18 U.S.C. Section 1350

99.1

Form of Indemnification Agreement between Innoviva, Inc. and its executive officers

8-K

99.1

05/26/2020

101

Interactive Data File (Quarterly Report on Form 10-Q, for the quarterly period ended June 30, 2020) formatted in iXBRL (Inline eXtensible Business Reporting Language).

104

Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101).

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Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Innoviva, Inc.

Date: July 24, 201929, 2020

/s/ Geoffrey HulmePavel Raifeld

Geoffrey HulmePavel Raifeld

Interim PrincipalChief Executive Officer

(Principal Executive Officer)

Date: July 24, 201929, 2020

/s/ Marianne Zhen

Marianne Zhen

Chief Accounting Officer

(Principal Financial Officer)

2725