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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 September 30, 2020

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.)

1350 Old Bayshore Highway Suite 400

Burlingame, CA 94010

(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

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 October 19, 2020 was 101,391,634.

TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Consolidated Balance Sheets as of September 30, 2020 (Unaudited) and December 31, 2019

3

Unaudited Consolidated Statements of Income for the Three and Nine Months ended September 30, 2020 and 2019

4

Unaudited Consolidated Statements of Comprehensive Income for the Three and Nine Months ended September 30, 2020 and 2019

5

Unaudited Consolidated Statements of Stockholders’ Equity for the Three and Nine Months ended September 30, 2020 and 2019

6

Unaudited Consolidated Statements of Cash Flows for the Nine Months ended September 30, 2020 and 2019

8

Notes to Unaudited Consolidated Financial Statements

9

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

18

Item 3. Quantitative and Qualitative Disclosures About Market Risk

25

Item 4. Controls and Procedures

25

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

26

Item 1A. Risk Factors

26

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

26

Item 3. Defaults Upon Senior Securities

26

Item 4. Mine Safety Disclosure

27

Item 5. Other Information

27

Item 6. Exhibits

27

Signatures

28

Exhibits

2

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

INNOVIVA, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except per share data)

September 30, 

December 31, 

    

2020

    

2019

(unaudited)

*

Assets

Current assets:

Cash and cash equivalents

$

479,193

$

278,096

Short-term marketable securities

 

 

72,749

Related party receivables from collaborative arrangements

 

92,150

 

79,427

Prepaid expenses and other current assets

 

698

 

962

Total current assets

 

572,041

 

431,234

Property and equipment, net

 

33

 

33

Equity investments

111,745

Capitalized fees paid to a related party, net

 

128,708

 

139,076

Deferred tax assets, net

109,490

154,171

Other assets

 

239

 

312

Total assets

$

922,256

$

724,826

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

623

$

10

Accrued personnel-related expenses

 

384

 

647

Accrued interest payable

 

1,668

 

4,152

Other accrued liabilities

 

1,223

 

562

Total current liabilities

 

3,898

 

5,371

Long-term debt, net of discount and issuance costs

 

383,350

 

377,120

Other long-term liabilities

136

219

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, 101,391 and 101,288 issued and outstanding as of September 30, 2020 and December 31, 2019, respectively

 

1,014

 

1,013

Additional paid-in capital

 

1,260,447

 

1,258,859

Accumulated other comprehensive income

 

 

27

Accumulated deficit

 

(775,905)

 

(946,404)

Total Innoviva stockholders’ equity

485,556

313,495

Noncontrolling interest

49,316

28,621

Total stockholders’ equity

 

534,872

 

342,116

Total liabilities and stockholders’ equity

$

922,256

$

724,826

* Consolidated balance sheet as of December 31, 2019 has been derived from audited consolidated financial statements.

See accompanying notes to consolidated financial statements.

3

INNOVIVA, INC.

CONSOLIDATED STATEMENTS OF INCOME

(In thousands, except per share data)

(Unaudited)

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2020

    

2019

    

2020

    

2019

Revenue:

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 September 30, 2020 and 2019, and $10,368 in the nine months ended September 30, 2020 and 2019

$

88,694

$

65,755

$

236,318

$

185,045

Revenue from collaborative arrangements with a related party

10,000

Total net revenue

88,694

65,755

246,318

185,045

Operating expenses:

Research and development

 

1,010

 

 

1,569

 

General and administrative

 

3,254

 

4,962

 

8,413

 

12,324

Total operating expenses

 

4,264

 

4,962

 

9,982

 

12,324

Income from operations

 

84,430

 

60,793

 

236,336

 

172,721

Other income (expense), net

(13)

(115)

85

(122)

Interest income

 

41

 

1,624

 

1,501

 

4,002

Interest expense

 

(4,603)

 

(4,693)

 

(13,680)

 

(13,971)

Changes in fair values of equity investments

(29,368)

39,245

Income before income taxes

50,487

57,609

263,487

162,630

Income tax expense, net

8,866

10,558

44,689

29,499

Net income

41,621

47,051

218,798

133,131

Net income attributable to noncontrolling interest

13,403

7,242

48,299

21,792

Net income attributable to Innoviva stockholders

$

28,218

$

39,809

$

170,499

$

111,339

Basic net income per share attributable to Innoviva stockholders

$

0.28

$

0.39

$

1.68

$

1.10

Diluted net income per share attributable to Innoviva stockholders

$

0.26

$

0.36

$

1.53

$

1.01

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

Shares used to compute basic net income per share

101,358

101,191

101,306

101,134

Shares used to compute diluted net income per share

113,572

113,415

113,543

113,394

See accompanying notes to consolidated financial statements.

4

INNOVIVA, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(In thousands)

(Unaudited)

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2020

    

2019

    

2020

    

2019

Net income

$

41,621

$

47,051

$

218,798

$

133,131

Unrealized gain (loss) on marketable securities, net

2

(8)

(27)

28

Comprehensive income

41,623

47,043

218,771

133,159

Comprehensive income attributable to noncontrolling interest

13,403

7,242

48,299

21,792

Comprehensive income attributable to Innoviva stockholders

$

28,220

$

39,801

$

170,472

$

111,367

See accompanying notes to consolidated financial statements.

5

INNOVIVA, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands)

(Unaudited)

Nine Months Ended September 30, 2020

Accumulated

Additional

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

Equity activity of noncontrolling interest from a consolidated variable interest entity

8

8

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

 

(1)

 

(1)

 

(11)

 

 

 

 

(12)

Stock-based compensation

 

 

 

441

 

 

 

 

441

Net income

 

 

 

 

 

28,218

 

13,403

 

41,621

Other comprehensive income

 

 

 

 

2

 

 

 

2

Balance as of September 30, 2020

 

101,391

$

1,014

$

1,260,447

$

$

(775,905)

$

49,316

$

534,872

6

Nine Months Ended September 30, 2019

Accumulated

Additional

Other

Total

Common Stock

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

Distributions to noncontrolling interest

(10,553)

(10,553)

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

7

82

82

Stock-based compensation

489

489

Net income

39,809

7,242

47,051

Other comprehensive income

(8)

(8)

Balance as of September 30, 2019

101,279

$

1,013

$

1,258,370

$

25

$

(992,353)

$

16,708

$

283,763

See accompanying notes to consolidated financial statements.

7

INNOVIVA, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

Nine Months Ended September 30, 

    

2020

    

2019

  

Cash flows from operating activities

Net income

$

218,798

$

133,131

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

Deferred income taxes

44,689

29,499

Depreciation and amortization

 

10,382

 

10,400

Stock-based compensation

 

1,251

 

1,568

Amortization of debt discount and issuance costs

6,230

5,789

Amortization of discount on short-term investments

(343)

(1,739)

Amortization of lease guarantee

135

(243)

Loss on write-off of property and equipment

104

Changes in fair values of equity investments

(39,245)

Other non-cash items

14

Changes in operating assets and liabilities:

Receivables from collaborative arrangements

 

(12,723)

 

14,075

Prepaid expenses and other current assets

 

264

 

466

Other assets

 

 

(11)

Accounts payable

 

613

 

24

Accrued personnel-related expenses and other accrued liabilities

 

252

 

107

Accrued interest payable

 

(2,484)

 

(2,491)

Other long-term liabilities

 

 

(126)

Net cash provided by operating activities

 

227,833

190,553

Cash flows from investing activities

Maturities of marketable securities

 

86,000

 

160,925

Purchases of marketable securities

 

(12,943)

 

(230,922)

Purchases of equity investments

 

(72,500)

 

Purchases of property and equipment

 

(13)

 

Net cash provided by (used in) investing activities

 

544

 

(69,997)

Cash flows from financing activities

Repurchase of shares to satisfy tax withholding

(83)

(81)

Payments of cash dividends to stockholders

 

 

(11)

Proceeds from issuances of common stock, net

421

618

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

344

Distributions to noncontrolling interest

(27,962)

(10,553)

Net cash used in financing activities

 

(27,280)

 

(10,027)

Net increase in cash and cash equivalents

 

201,097

 

110,529

Cash and cash equivalents at beginning of period

 

278,096

 

62,417

Cash and cash equivalents at end of period

$

479,193

$

172,946

Supplemental disclosure of cash flow information

Cash paid for interest

$

9,933

$

10,674

See accompanying notes to consolidated financial statements.

8

INNOVIVA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Description of Operations and Summary of Significant Accounting Policies

Description of Operations

Innoviva Inc. (referred to as "Innoviva", the "Company", or "we" and other similar pronouns) is a company with a portfolio of royalties that includes respiratory assets partnered with Glaxo Group Limited (“GSK”), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/ vilanterol, “FF/VI”), ANORO® ELLIPTA® (umeclidinium bromide/ vilanterol, “UMEC/VI”) and TRELEGY® ELLIPTA® (the combination FF/UMEC/VI). Under the Long-Acting Beta2 Agonist (“LABA”) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® 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”), 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 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 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, 2020 or any other period.

The accompanying unaudited consolidated 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, 2019 filed with the Securities and Exchange Commission (“SEC”) on February 19, 2020, and as amended on February 21, 2020 (“2019 Form 10-K”).

Variable Interest Entities

We evaluate our ownership, contractual and other interest in the entities that we invest in to determine if they are variable interest entities (“VIEs”), whether we have a variable interest in those entities and the nature and extent of those interests. Such evaluation is performed continually throughout the entire period when we stay involved with these entities. Based on our evaluation, if we determine we are the primary beneficiary of a VIE, we consolidate the entity’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 VIEs, because we have the power to direct the economically significant activities of these entities and the obligation to absorb losses of, or the right to receive benefits from them, and we are the primary beneficiary of the entities.

9

Equity Investments

We invest from time to time in equity securities of private or public companies. If we determine that we do not have 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 equity investments where we exercise significant influence using either an equity method of accounting 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 equity 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 influence over an investee, we may elect to account for an equity security without a readily determinable fair value using a measurement alternative. This measurement alternative allows us to measure the equity investment 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 September 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 permitted. We adopted Topic 326 effective January 1, 2020. The adoption did not have a material impact on our consolidated financial statements.

Recently Issued Accounting Standards or Updates Not Yet Adopted

In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes”, which is intended to simplify various aspects related to accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. We are currently in the process of evaluating the effects of the provisions of ASU 2019-12 on our financial statements.

In August 2020, the FASB issued ASU 2020-06, "Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity", which is intended to simplify the accounting for convertible instruments by removing certain separation models in Subtopic 470-20, Debt-Debt with Conversion and Other Options, for convertible instruments. The pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2021, with early adoption permitted. We are currently in the process of evaluating the effects of the provisions of ASU 2020-06 on 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 converted method.

10

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 was lower than the initial conversion price of $17.26 per share, there was no dilutive effect of the assumed conversion premium for the three and nine months ended September 30, 2020 and 2019, respectively.

The following table shows the computation of basic and diluted net income per share for the three and nine months ended September 30, 2020 and 2019:

Three Months Ended September 30, 

Nine Months Ended September 30, 

(In thousands except per share data)

     

2020

     

2019

     

2020

     

2019

   

Numerator:

Net income attributable to Innoviva stockholders, basic

$

28,218

$

39,809

 

$

170,499

 

$

111,339

Add: interest expense on 2023 Notes

 

1,171

 

1,157

 

3,535

 

3,482

Net income attributable to Innoviva stockholders, diluted

$

29,389

$

40,966

 

$

174,034

 

$

114,821

Denominator:

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

 

101,358

 

101,191

 

101,306

 

101,134

Dilutive effect of 2023 Notes

 

12,189

 

12,189

 

12,189

 

12,189

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

 

25

 

35

 

48

 

71

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

 

113,572

 

113,415

 

113,543

 

113,394

Net income per share attributable to Innoviva stockholders

Basic

$

0.28

$

0.39

 

$

1.68

 

$

1.10

Diluted

$

0.26

$

0.36

 

$

1.53

 

$

1.01

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 September 30, 

Nine Months Ended September 30, 

(In thousands)

    

2020

    

2019

    

2020

    

2019

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

1,268

 

1,144

 

1,172

 

1,128

11

3. Revenue Recognition and Collaborative Arrangements

Net Revenue from Collaborative Arrangements

Net revenue recognized under our GSK Agreements was as follows:

Three Months Ended September 30, 

Nine Months Ended September 30, 

(In thousands)

    

2020

    

2019

    

2020

    

2019

Royalties from a related party — RELVAR/BREO

$

63,893

$

46,433

$

165,612

$

136,259

Royalties from a related party — ANORO

 

11,882

 

11,548

 

32,931

 

30,753

Royalties from a related party — TRELEGY

16,375

11,230

48,143

28,401

Total royalties from a related party

 

92,150

 

69,211

 

246,686

 

195,413

Less: amortization of capitalized fees paid to a related party

 

(3,456)

 

(3,456)

 

(10,368)

 

(10,368)

Royalty revenue

 

88,694

 

65,755

 

236,318

 

185,045

Strategic alliance  — MABA program

10,000

Total net revenue from GSK

$

88,694

$

65,755

$

246,318

$

185,045

During the nine months ended September 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 in June 2020.

4. Consolidated Entities

Theravance Respiratory Company, LLC

As of September 30, 2020, and December 31, 2019, $16.4 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 September 30, 2020 was $41.4 million. Total revenue for TRC related to TRELEGY® ELLIPTA® was $16.4 million and $11.2 million for the three months ended September 30, 2020 and 2019, respectively, and $48.1 million and $28.4 million for the nine months ended September 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 nine months ended September 30, 2020. Total operating expenses were $0.6 million and $1.4 million for the three and nine months ended September 30, 2020, respectively, compared to $2.8 million and $2.9 million 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 (excluding unvested restricted 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 September 30, 2020, total assets attributable to Pulmoquine were $4.6 million, including $4.3 million in cash and cash equivalents and $0.3 million in other current assets. Pulmoquine does not currently generate revenue. Total operating expense was $1.1 million and $1.7 million for the three and nine months ended September 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 two tranches on February 12, 2020 and March 27, 2020. Two of our board members joined Armata’s board. After the second closing, we owned approximately 46.7% of Armata’s common stock.

12

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. 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 and its peer companies.

As of September 30, 2020, the fair values of Armata’s common stock and warrants were estimated at $27.8 million and $20.2 million, respectively. The total fair value of both financial instruments in the amount of $48.0 million was recorded as equity investments on the consolidated balance sheets as of September 30, 2020. We recorded $12.4 million in unrealized loss and $23.0 million in unrealized gain from 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 nine months ended September 30, 2020, respectively.

Equity Investment in Entasis

On April 12, 2020, we entered into a securities purchase agreement with Entasis (“April 2020 Entasis Agreement”) 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 development 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 two tranches on April 22, 2020 and June 11, 2020. Innoviva has a right to designate two members to Entasis's board. After the second closing, we owned approximately 51.3% of Entasis's common stock.

On August 27, 2020, we entered into another securities purchase agreement with Entasis ("August 2020 Entasis Agreement") to purchase 4,672,897 shares of Entasis common stock as well as warrants to purchase 4,672,897 additional shares of its common stock for approximately $12.5 million in cash. On September 1, 2020, we completed the purchase and increased our ownership in Entasis's common stock to 52.6%.

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 under the April 2020 Entasis Agreement and an exercise price of $2.675 under the August 2020 Entasis Agreement. The warrants 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 and its peer companies.

As of September 30, 2020, the fair values of Entasis's common stock and warrants were estimated at $38.1 million and $25.7 million, respectively. The total fair value of both financial instruments in the amount of $63.8 million was recorded as equity investments on the consolidated balance sheets. We recorded $17.0 million in unrealized loss and $16.3 million in unrealized gain from 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 nine months ended September 30, 2020, respectively.

13

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:

September 30, 2020

Gross

Gross

Unrealized

Unrealized

Estimated

(In thousands)

    

Amortized Cost

    

Gains

    

Losses

    

Fair Value

Money market funds

$

430,144

$

$

$

430,144

Total

$

430,144

$

$

$

430,144

December 31, 2019

Gross

Gross

Unrealized

Unrealized

Estimated

(In thousands)

    

Amortized Cost

    

Gains

    

Losses

    

Fair Value

U.S. government securities

$

53,799

$

35

$

$

53,834

U.S. commercial paper

 

18,915

 

 

 

18,915

Money market funds

 

233,992

 

 

 

233,992

Total

$

306,706

$

35

$

$

306,741

As of September 30, 2020, all investments were money market funds. There was no credit loss as of September 30, 2020.

14

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 September 30, 2020 Using:

Quoted Price

Significant

in Active 

Other

Significant

Markets for 

Observable

Unobservable

Types of Instruments

Identical Assets

Inputs

Inputs

(In thousands)

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets

Money market funds

$

430,144

$

$

$

430,144

Equity investment - Armata Common Stock

27,787

27,787

Equity investment - Armata Warrants

20,167

20,167

Equity investment - Entasis Common Stock

38,093

38,093

Equity investment - Entasis Warrants

25,698

25,698

Total assets measured at estimated fair value

$

496,024

$

45,865

$

$

541,889

Debt

2023 Notes

$

$

230,494

$

$

230,494

2025 Notes

191,491

191,491

Total fair value of debt

$

$

421,985

$

$

421,985

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

Quoted Price

Significant

in Active 

Other

Significant

Markets for 

Observable

Unobservable

Types of Instruments

Identical Assets

Inputs

Inputs

(In thousands)

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets

U.S. government securities

$

$

53,834

$

$

53,834

U.S. commercial paper

 

18,915

 

 

18,915

Money market funds

233,992

233,992

Total assets measured at estimated fair value

$

233,992

$

72,749

$

$

306,741

Debt

2023 Notes

$

$

243,394

$

$

243,394

2025 Notes

208,976

208,976

Total fair value of debt

$

$

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.

15

6. Stock-Based Compensation

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

Three Months Ended September 30, 

Nine Months Ended September 30, 

(In thousands)

    

2020

    

2019

    

2020

    

2019

General and administrative

$

441

$

489

$

1,251

$

1,568

7. Debt

Our debt consists of:

September 30, 

December 31, 

(In thousands)

    

2020

    

2019

2023 Notes

$

240,984

$

240,984

2025 Notes

192,500

192,500

Total debt

433,484

433,484

Unamortized debt discount and issuance costs

(50,134)

(56,364)

Net long-term debt

$

383,350

$

377,120

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.

Our outstanding 2025 Notes balances consisted of the following:

September 30, 

December 31, 

(In thousands)

    

2020

    

2019

Liability component

 

  

Principal

$

192,500

$

192,500

Debt discount and issuance costs, net

 

(48,788)

 

(54,597)

Net carrying amount

$

143,712

$

137,903

Equity component, net

$

65,361

$

65,361

The following table sets forth total interest expense recognized related to the 2025 Notes for the three and nine months ended September 30, 2020 and 2019:

Three Months Ended September 30, 

Nine Months Ended September 30, 

(In thousands)

    

2020

    

2019

    

2020

    

2019

Contractual interest expense

$

1,203

$

1,203

$

3,609

$

3,609

Amortization of debt issuance costs

 

152

 

139

 

446

 

408

Amortization of debt discount

 

1,828

 

1,673

 

5,363

 

4,909

Tot