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Correspondence 0001193125-24-226938 from Innoviva, Inc. (INVA)

Innoviva, Inc.
Date: Sept. 26, 2024 · CIK: 0001080014 · Accession: 0001193125-24-226938

AI Filing Summary & Sentiment

File numbers found in text: 000-30319

Referenced dates: September 13, 2024

Date
September 26, 2024
Author
/s/ Stephen Basso
Form
CORRESP
Company
Innoviva, Inc.

Letter

VIA EDGAR Division of Corporation Finance Office of Life Sciences Re: Innoviva, Inc. Form 10-K for the fiscal year ended December 31, 2023 Filed February 29, 2024 File No. 000-30319

Dear Mr. Wyman and Mr. Gordon:

On behalf of Innoviva, Inc. (the “Company” or “we”), we are responding to the comments of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) pertaining to the Company’s Form 10-K for the fiscal year ended December 31, 2023, filed February 29, 2024 (the “Form 10-K”), as contained in the letter, dated September 13, 2024 (the “Comment Letter”).

We have set forth each of the Staff’s comments italicized below with the Company’s corresponding response and have numbered the items to correspond to the Comment Letter.

Form 10-K for the Fiscal Year Ended December 31, 2023

Management’s Discussion and Analysis of Financial Condition and Results of Operations Changes in Fair Value of Equity Method Investments and Equity and Long-Term Investments, page 87

1. Please provide an analysis that reconciles the increase in Equity and Long-Term Investments of $80.57 million presented on your consolidated Balance Sheet to the corresponding change in fair value of $11.12 million presented on your Consolidated Statement of Income. Also, reconcile related fair value amounts as of December 31, 2023 on page 121 to corresponding amounts on your consolidated balance sheet and provide a summary of individual investments held by the ISP Fund at each balance sheet date. Revise your disclosure accordingly.

Response to Comment 1: We acknowledge the Staff’s comment, and in response to the Staff’s request for an analysis that reconciles the increase in Equity and Long-Term Investments of $80.57 million presented on our consolidated Balance Sheet to the corresponding change in fair value of $11.12 million presented on our Consolidated Statement of Income, the reconciliation is presented as follows:

(In thousands)

Year Ended December 31, 2023

Activities in equity and long term investments:

Purchases of trading securities (1)

$ 67,798

Purchases of equity and long-term investments (2)

1,218

Changes in fair values, net

11,129

Other (3)

Net increase in equity and long term investments

80,573

Equity and long term investments at beginning of period

363,859

Equity and long term investments at end of period

$ 444,432

(1) Purchases of trading securities included an Armata Convertible Note of $30.0 million in January 2023, an Armata Term Loan of $25.0 million in July 2023, $0.1 million closing costs associated with Armata investments, and an additional Gate Convertible Note totaling $12.7 million (comprising $10.0 million in cash and $2.7 million in accrued interest) in February and October 2023. These investments are disclosed in footnote 6, ‘Equity and Long-term Investments and Fair Value Measurements,’ on pages 116 and 120, respectively.

(2) Equity and long-term investment purchases included ImaginAb Series C-2 preferred stock, with a total investment of $1.2 million made in March and September 2023. These investments are disclosed in footnote 6, ‘Equity and Long-term Investments and Fair Value Measurements,’ on page 119.

(3) Other items included net cash generated from the operations of ISP Fund LP, whose assets can only be used to settle its own obligations. During 2023, the partnership generated $6.3 million in interest income, incurred $4.3 million in investment-related expenses, and made net cash payments of $1.6 million. ISP Fund LP’s activities are disclosed in footnote 5, ‘Consolidated Entities and Acquisitions,’ on pages 111 and 112.

- 2 -

In response to the Staff’s request to reconcile the related fair value amounts as of December 31, 2023 on page 121 to corresponding amounts on our consolidated balance sheet and to provide a summary of individual investments held by ISP Fund at each balance sheet date, we provide the following reconciliation and summary:

Reconciliation of fair value amounts of assets as of December 31, 2023

Types of Instruments

(In thousands)

Cash and cash equivalents

Equity method investments

Equity and long-term investments

Total

Assets

Money market funds (1)

$ 170,706

$ —

$ —

$ 170,706

Investments held by ISP Fund LP

311,812

311,812

Equity investment - Armata Common Stock

81,249

81,249

Equity investment - Armata Warrants

35,297

35,297

Convertible debt investment - Armata Note

51,883

51,883

Term loan investment - Armata Term Loan

27,044

27,044

Convertible debt investment - Gate Note

27,972

27,972

Equity investment - InCarda Series D Warrants (2)

Total assets measured using fair value method

$ 170,706

$ 116,546

$ 418,787

$ 706,039

Equity investment - InCarda Series C Preferred Stock

$ —

$ —

$ 4,773

$ 4,773

Equity investment - InCarda Series D-1 Preferred Stock, Series D-2

Preferred Stock, and Common Stock

2,717

2,717

Equity investment - ImaginAb Series C Preferred Stock, Series C-2

Preferred Stock, and Common Stock

7,590

7,590

Equity investment - Nanolive Series C Preferred Stock

10,565

10,565

Total assets measured using measurement alternative method

$ —

$ —

$ 25,645

$ 25,645

Total assets

$ 170,706

$ 116,546

$ 444,432

$ 731,684

(1) Money market funds are included in the $193.5 million of cash and cash equivalents on the consolidated balance sheets.

(2) This investment is not reflected in the fair value measurement table due to its immateriality.

- 3 -

Summary of individual investments held by ISP Fund at each balance sheet date:

December 31,

(In thousands)

Common stock - publicly traded healthcare companies

United States

$ 184,926

$ 174,770

Ireland

64,729

United Kingdom

2,942

1,339

Total common stock

187,868

240,838

Preferred stocks - privately held healthcare companies

United States

52,530

2,032

Warrants - privately held healthcare companies

United States

8,075

Convertible note - privately held healthcare companies

United States

52,546

Money market fund and cash

63,339

25,144

Total investments held by ISP Fund LP

$ 311,812

$ 320,560

We will revise the disclosures prospectively, to include the Equity and Long-Term Investments Reconciliation to our consolidated balance sheet and the Summary of individual investments held by ISP Fund consistent with the above, starting with our Form 10-Q for the third quarter of 2024.

Notes to Consolidated Financial Statements

6. Equity and Long-term Investments and Fair Value Measurements

Equity and Other Investments in Armata, page 116

2. You state that Armata Pharmaceuticals is a VIE but Innoviva and ISO are not the primary beneficiaries and as a result you have reported its common stock and warrants under the equity method using the fair value option. In this regard, fair values for your holdings of Armata common stock, warrants, a convertible note and term loan totaled $195.4 million as of December 31, 2023. Please describe and quantify the methods and assumptions used to value your investments in Armata, including your consideration of Armata’s market capitalization. Refer us to the technical guidance upon which you relied.

- 4 -

Response to Comment 2:

We respectfully acknowledge the Staff’s request to describe the methods and assumptions used to value our investments in Armata, including the consideration of Armata’s market capitalization. We maximize the use of observable inputs when estimating the fair values for our investments in accordance with the fair value measurement standard, ASC 820-10-35-24. The following valuation techniques and assumptions are used for each of the investments in Armata:

Common stock – under the fair value option, the investment is measured based on Armata’s closing market price at the end of each reporting period. As of December 31, 2023, 25,076,769 shares of common stock were valued at $81.2 million based on the closing market price of $3.24 per share. We base this measurement in accordance with ASC 820-10-35-36B, which states, in part, that “if there is a quoted price in an active market (that is, a Level 1 input) for an asset or a liability, a reporting entity shall use that quoted price without adjustment when measuring fair value.” The fair value is not adjusted for a control premium since each individual share of Armata common stock is a separate unit of account classified as Level 1 within the fair value hierarchy. At December 31, 2023, Armata’s market capitalization was approximately $117.0 million, based on the outstanding shares of its common stock.

Warrants – a Black-Scholes-Merton pricing model is used to estimate the fair value of the warrants. The warrants purchased in 2020, 2021 and 2022 have an exercise price of $2.87, $3.25 and $5.00 per share, respectively. All warrants totaling 19,364,647 are exercisable immediately within five years from the issuance date of the warrants. At December 31, 2023, the warrants were valued at $35.3 million using the following inputs in the model:

Armata’s closing market price of $3.24 per share

Risk-free interest rates between 3.9% and 4.5% computed based on the published U.S. Treasury yield

Expected terms between 1.1 and 3.3 years based on when the Company expects the warrants to be exercised, which corresponds to the remaining contractual period

Estimated volatilities between 96.8% and 124.4% based on the historical volatility of Armata’s common stock.

Convertible note – this trading security is measured at fair value using a Monte Carlo simulation model, which incorporates estimates of the probability of certain qualified events. As of December 31, 2023, the note, purchased for $30.0 million in January 2023, was valued at $51.9 million using the following inputs in the model:

Armata’s closing market price of $3.24 per share

Risk-free interest rate of 4.8% based on the published U.S. Treasury yield

A discount rate of 50.0%, estimated based on the implied transaction date yield, adjusted for changes in market yields of the instruments with comparable credit risks

Estimated volatility of 65%, calculated using Armata’s own historical stock price volatility of 127% and adjusted downward to account for the illiquidity of the conversion feature

Estimates of the timing and probability of certain qualified events between 0.8 to 1.0 years.

Term loan – this trading security is measured at fair value using an income approach. As of December 31, 2023, the loan, purchased for $25.0 million in July 2023, was valued at $27.0 million based on the discounted value of expected future cash flows, using a discount rate of 11.5%, which was estimated based on the implied transaction date yield, adjusted for changes in market yields of the instruments with comparable credit risks.

- 5 -

The Company does not have a controlling financial interest in Armata due to its limited voting rights under the voting agreement entered with Armata. Additionally, the Company will not acquire a controlling financial interest upon exercise of the warrants and conversion of the note. As such, a control premium is not considered in the valuation of the warrants and the note in accordance with the fair value measurement standard, ASC 820-10-35-36B.

ITEM 9A. Controls and Procedures

Changes in Internal Control over Financial Reporting, page 142

3. Please explicitly state that no changes were made to your internal control over financial reporting.

Response to Comment 3: The Company acknowledges the Staff’s comment and notes that there was a typographical error in the Form 10-K, which resulted in the inaccurate conveyance on page 142, that there have been no more material changes to our internal controls over financial reporting, other than those related to the integration of acquired operations from our acquisitions of Entasis and La Jolla. The Company regrets that error and will ensure that this is correctly disclosed in future filings.

* * * * *

- 6 -

Should you have any questions concerning this letter please call the undersigned at (339)526-4927.

Very truly yours,
/s/ Stephen Basso

Show Raw Text
CORRESP
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filename1.htm

CORRESP

 September 26, 2024

VIA EDGAR

 Mr. Frank Wyman

Mr. Daniel Gordon

 Division of Corporation Finance

Office of Life Sciences

 U.S. Securities and Exchange Commission

 100 F Street, NE

 Washington, D.C. 20549

Re:
 Innoviva, Inc.

Form 10-K for the fiscal year ended December 31, 2023

Filed February 29, 2024

File
No. 000-30319               

Dear Mr. Wyman and Mr. Gordon:

 On behalf of Innoviva,
Inc. (the “Company” or “we”), we are responding to the comments of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) pertaining to the Company’s Form 10-K for the fiscal year ended December 31, 2023, filed February 29, 2024 (the “Form 10-K”), as contained in the letter, dated September 13, 2024 (the
“Comment Letter”).

 We have set forth each of the Staff’s comments italicized below with the Company’s corresponding response and have
numbered the items to correspond to the Comment Letter.

 Form 10-K for the Fiscal Year Ended
December 31, 2023

 Management’s Discussion and Analysis of Financial Condition and Results of Operations Changes in Fair Value of
Equity Method Investments and Equity and Long-Term Investments, page 87

1.
 Please provide an analysis that reconciles the increase in Equity and Long-Term Investments of
$80.57 million presented on your consolidated Balance Sheet to the corresponding change in fair value of $11.12 million presented on your Consolidated Statement of Income. Also, reconcile related fair value amounts as of December 31,
2023 on page 121 to corresponding amounts on your consolidated balance sheet and provide a summary of individual investments held by the ISP Fund at each balance sheet date. Revise your disclosure accordingly.

 Response to Comment 1: We acknowledge the Staff’s comment, and in response to the Staff’s
request for an analysis that reconciles the increase in Equity and Long-Term Investments of $80.57 million presented on our consolidated Balance Sheet to the corresponding change in fair value of $11.12 million presented on our
Consolidated Statement of Income, the reconciliation is presented as follows:

 (In thousands)

Year Ended
December 31, 2023

 Activities in equity and long term investments:

 Purchases of trading securities (1)

$
67,798

 Purchases of equity and long-term investments (2)

1,218

 Changes in fair values, net

11,129

 Other (3)

428

 Net increase in equity and long term investments

80,573

 Equity and long term investments at beginning of period

363,859

 Equity and long term investments at end of period

$
444,432

(1)
 Purchases of trading securities included an Armata Convertible Note of $30.0 million in January 2023, an
Armata Term Loan of $25.0 million in July 2023, $0.1 million closing costs associated with Armata investments, and an additional Gate Convertible Note totaling $12.7 million (comprising $10.0 million in cash and $2.7 million
in accrued interest) in February and October 2023. These investments are disclosed in footnote 6, ‘Equity and Long-term Investments and Fair Value Measurements,’ on pages 116 and 120, respectively.

(2)
 Equity and long-term investment purchases included ImaginAb Series C-2
preferred stock, with a total investment of $1.2 million made in March and September 2023. These investments are disclosed in footnote 6, ‘Equity and Long-term Investments and Fair Value Measurements,’ on page 119.

(3)
 Other items included net cash generated from the operations of ISP Fund LP, whose assets can only be used to
settle its own obligations. During 2023, the partnership generated $6.3 million in interest income, incurred $4.3 million in investment-related expenses, and made net cash payments of $1.6 million. ISP Fund LP’s activities are
disclosed in footnote 5, ‘Consolidated Entities and Acquisitions,’ on pages 111 and 112.

 - 2 -

 In response to the Staff’s request to reconcile the related fair value amounts as of December 31,
2023 on page 121 to corresponding amounts on our consolidated balance sheet and to provide a summary of individual investments held by ISP Fund at each balance sheet date, we provide the following reconciliation and summary:

Reconciliation of fair value amounts of assets as of December 31, 2023

 Types of Instruments

(In thousands)

Cash and cash
equivalents

Equity method
investments

Equity and
long-term
investments

Total

 Assets

 Money market funds (1)

$
170,706

$
— 

$
— 

$
170,706

 Investments held by ISP Fund LP

— 

— 

311,812

311,812

 Equity investment - Armata Common Stock

— 

81,249

— 

81,249

 Equity investment - Armata Warrants

— 

35,297

— 

35,297

 Convertible debt investment - Armata Note

— 

— 

51,883

51,883

 Term loan investment - Armata Term Loan

— 

— 

27,044

27,044

 Convertible debt investment - Gate Note

— 

— 

27,972

27,972

 Equity investment - InCarda Series D Warrants (2)

— 

— 

76

76

 Total assets measured using fair value method

$
170,706

$
116,546

$
418,787

$
706,039

 Equity investment - InCarda Series C Preferred Stock

$
— 

$
— 

$
4,773

$
4,773

 Equity investment - InCarda Series D-1 Preferred Stock,
Series D-2

 Preferred Stock, and Common Stock

— 

— 

2,717

2,717

 Equity investment - ImaginAb Series C Preferred Stock, Series
C-2

 Preferred Stock, and Common Stock

— 

— 

7,590

7,590

 Equity investment - Nanolive Series C Preferred Stock

— 

— 

10,565

10,565

 Total assets measured using measurement alternative method

$
— 

$
— 

$
25,645

$
25,645

 Total assets

$
170,706

$
116,546

$
444,432

$
731,684

(1)
 Money market funds are included in the $193.5 million of cash and cash equivalents on the consolidated
balance sheets.

(2)
 This investment is not reflected in the fair value measurement table due to its immateriality.

 - 3 -

 Summary of individual investments held by ISP Fund at each balance sheet date:

December 31,

 (In thousands)

2023

2022

 Common stock - publicly traded healthcare companies

 United States

$
184,926

$
174,770

 Ireland

— 

64,729

 United Kingdom

2,942

1,339

 Total common stock

187,868

240,838

 Preferred stocks - privately held healthcare companies

 United States

52,530

2,032

 Warrants - privately held healthcare companies

 United States

8,075

— 

 Convertible note - privately held healthcare companies

 United States

— 

52,546

 Money market fund and cash

63,339

25,144

 Total investments held by ISP Fund LP

$
311,812

$
320,560

 We will revise the disclosures prospectively, to include the Equity and Long-Term Investments Reconciliation to our
consolidated balance sheet and the Summary of individual investments held by ISP Fund consistent with the above, starting with our Form 10-Q for the third quarter of 2024.

Notes to Consolidated Financial Statements

6. Equity and Long-term Investments and Fair Value Measurements

Equity and Other Investments in Armata, page 116

2.
 You state that Armata Pharmaceuticals is a VIE but Innoviva and ISO are not the primary beneficiaries and as
a result you have reported its common stock and warrants under the equity method using the fair value option. In this regard, fair values for your holdings of Armata common stock, warrants, a convertible note and term loan totaled
$195.4 million as of December 31, 2023. Please describe and quantify the methods and assumptions used to value your investments in Armata, including your consideration of Armata’s market capitalization. Refer us to the technical
guidance upon which you relied.

 - 4 -

 Response to Comment 2:

We respectfully acknowledge the Staff’s request to describe the methods and assumptions used to value our investments in Armata, including the
consideration of Armata’s market capitalization. We maximize the use of observable inputs when estimating the fair values for our investments in accordance with the fair value measurement standard, ASC 820-10-35-24. The following valuation techniques and assumptions are used for each of the investments in Armata:

•

 Common stock – under the fair value option, the investment is measured based on Armata’s closing market
price at the end of each reporting period. As of December 31, 2023, 25,076,769 shares of common stock were valued at $81.2 million based on the closing market price of $3.24 per share. We base this measurement in accordance with ASC 820-10-35-36B, which states, in part, that “if there is a quoted price in an active market (that is, a Level 1 input) for an
asset or a liability, a reporting entity shall use that quoted price without adjustment when measuring fair value.” The fair value is not adjusted for a control premium since each individual share of Armata common stock is a separate unit of
account classified as Level 1 within the fair value hierarchy. At December 31, 2023, Armata’s market capitalization was approximately $117.0 million, based on the outstanding shares of its common stock.

•

 Warrants – a Black-Scholes-Merton pricing model is used to estimate the fair value of the warrants. The
warrants purchased in 2020, 2021 and 2022 have an exercise price of $2.87, $3.25 and $5.00 per share, respectively. All warrants totaling 19,364,647 are exercisable immediately within five years from the issuance date of the warrants. At
December 31, 2023, the warrants were valued at $35.3 million using the following inputs in the model:

•

 Armata’s closing market price of $3.24 per share

•

 Risk-free interest rates between 3.9% and 4.5% computed based on the published U.S. Treasury yield

•

 Expected terms between 1.1 and 3.3 years based on when the Company expects the warrants to be exercised, which
corresponds to the remaining contractual period

•

 Estimated volatilities between 96.8% and 124.4% based on the historical volatility of Armata’s common stock.

•

 Convertible note – this trading security is measured at fair value using a Monte Carlo simulation model,
which incorporates estimates of the probability of certain qualified events. As of December 31, 2023, the note, purchased for $30.0 million in January 2023, was valued at $51.9 million using the following inputs in the model:

•

 Armata’s closing market price of $3.24 per share

•

 Risk-free interest rate of 4.8% based on the published U.S. Treasury yield

•

 A discount rate of 50.0%, estimated based on the implied transaction date yield, adjusted for changes in market
yields of the instruments with comparable credit risks

•

 Estimated volatility of 65%, calculated using Armata’s own historical stock price volatility of 127% and
adjusted downward to account for the illiquidity of the conversion feature

•

 Estimates of the timing and probability of certain qualified events between 0.8 to 1.0 years.

•

 Term loan – this trading security is measured at fair value using an income approach. As of
December 31, 2023, the loan, purchased for $25.0 million in July 2023, was valued at $27.0 million based on the discounted value of expected future cash flows, using a discount rate of 11.5%, which was estimated based on the implied
transaction date yield, adjusted for changes in market yields of the instruments with comparable credit risks.

 - 5 -

 The Company does not have a controlling financial interest in Armata due to its limited voting rights under
the voting agreement entered with Armata. Additionally, the Company will not acquire a controlling financial interest upon exercise of the warrants and conversion of the note. As such, a control premium is not considered in the valuation of the
warrants and the note in accordance with the fair value measurement standard, ASC 820-10-35-36B.

ITEM 9A. Controls and Procedures

Changes in Internal Control over Financial Reporting, page 142

3.
 Please explicitly state that no changes were made to your internal control over financial reporting.

 Response to Comment 3: The Company acknowledges the Staff’s comment and notes that there was a typographical error in the
Form 10-K, which resulted in the inaccurate conveyance on page 142, that there have been no more material changes to our internal controls over financial reporting, other than those related to the
integration of acquired operations from our acquisitions of Entasis and La Jolla. The Company regrets that error and will ensure that this is correctly disclosed in future filings.

* * * * *

 - 6 -

 Should you have any questions concerning this letter please call the undersigned at (339)526-4927.

Very truly yours,

/s/ Stephen Basso

 Stephen Basso

 Chief Financial
Officer

cc:
 Pavel Raifeld (Innoviva, Inc.)

Marianne Zhen (Innoviva, Inc.)

Katherine Dorris, Esq. (Innoviva, Inc.)

Jared Fertman, Esq. (Willkie Farr & Gallagher LLP)

 - 7 -