Item 8. Financial Statements and Supplementary Data
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Page
Consolidated Balance Sheets as of December 31, 2024 and December 31, 2023
98
Consolidated Statements of Income for each of the three years in the period ended December 31, 2024
99
Consolidated Statements of Comprehensive Income for each of the three years in the period ended December 31, 2024
100
Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended December 31, 2024
101
Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2024
103
Notes to Consolidated Financial Statements
105
Report of Independent Registered Public Accounting Firm (PCAOB ID 34 )
150
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INNOVIVA, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
December 31,
December 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$
304,964
$
193,513
Accounts receivable
20,392
14,454
Receivable from collaboration arrangements
65,974
69,621
Inventory
33,725
40,737
Prepaid expenses
21,063
21,630
Current portion of ISP Fund investments (Note 5)
107,532
—
Other current assets
656
4,264
Total current assets
554,306
344,219
Property and equipment, net
514
483
Equity method investments
52,293
116,546
Equity and long-term investments
341,664
444,432
Capitalized fees paid, net
69,961
83,784
Right-of-use assets
2,453
2,536
Goodwill
17,905
17,905
Intangible assets
208,433
230,335
Deferred tax assets, net
12,054
—
Other assets
41,477
3,267
Total assets
$
1,301,060
$
1,243,507
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
2,132
$
6,717
Accrued personnel-related expenses
7,376
7,020
Accrued interest payable
3,422
3,422
Deferred revenue
1,126
1,277
Convertible notes, due 2025, net of issuance costs
192,028
—
Other accrued liabilities
29,999
19,698
Total current liabilities
236,083
38,134
Long-term debt, net of discount and issuance costs
256,316
446,234
Other long-term liabilities
64,275
71,870
Deferred tax liabilities, net
—
563
Income tax payable, long-term
53,227
11,751
Commitments and contingencies (Note 13)
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,
62,665 and 63,307 issued and outstanding as of
December 31, 2024 and 2023 respectively
627
633
Treasury stock: at cost, nil and, 32,005 shares as of December 31, 2024
and 2023, respectively
—
( 393,829
)
Additional paid-in capital
692,329
1,093,340
Accumulated deficit
( 1,797
)
( 25,189
)
Total stockholders’ equity
691,159
674,955
Total liabilities and stockholders’ equity
$
1,301,060
$
1,243,507
See accompanying notes to consolidated financial statements.
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INNOVIVA, INC.
CONSOLIDATED STATEMENTS OF INCOME
(In thousands, except per share data)
Year Ended December 31,
2024
2023
2022
Revenue:
Royalty revenue, net of amortization of
capitalized fees paid of $ 13,823 in
each of the years ended December 31,
2024, 2023 and 2022
$
241,733
$
238,846
$
311,645
Net product sales
97,492
60,617
19,694
License and other revenue
19,486
11,000
—
Total revenue
358,711
310,463
331,339
Expenses:
Cost of products sold (inclusive of
amortization of inventory fair value
adjustments, excluding amortization
of intangible assets)
36,598
41,040
13,793
Cost of license revenue
—
1,600
—
Selling, general and administrative
115,690
98,232
63,538
Research and development
13,654
33,922
41,432
Amortization of acquired intangible assets
25,902
21,784
5,581
Gain on sale of Theravance Respiratory
Company, LLC (“TRC”)
—
—
( 266,696
)
Loss on extinguishment of debt
—
—
20,662
Changes in fair values of equity method
investments, net
64,253
( 77,392
)
161,749
Changes in fair value of equity and
long-term investments, net
59,161
( 11,129
)
( 8,462
)
Interest and dividend income
( 19,141
)
( 15,818
)
( 6,369
)
Interest expense
22,209
19,157
15,789
Other expense, net
2,997
4,969
3,373
Total expenses, net
321,323
116,365
44,390
Income before income taxes
37,388
194,098
286,949
Income tax expense, net
13,996
14,376
66,687
Net income
23,392
179,722
220,262
Net income attributable to noncontrolling
interests
—
—
6,341
Net income attributable to Innoviva
stockholders
$
23,392
$
179,722
$
213,921
Basic net income per share attributable to
Innoviva stockholders
$
0.37
$
2.75
$
3.07
Diluted net income per share attributable to
Innoviva stockholders
$
0.36
$
2.20
$
2.37
Shares used to compute Innoviva
basic and diluted net income per share:
Shares used to compute basic
net income per share
62,726
65,435
69,644
Shares used to compute diluted
net income per share
74,187
86,876
95,248
See accompanying notes to consolidated financial statements.
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INNOVIVA, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands)
Year Ended December 31,
2024
2023
2022
Net income
$
23,392
$
179,722
$
220,262
Comprehensive income
23,392
179,722
220,262
Comprehensive income attributable to noncontrolling interests
—
—
6,341
Comprehensive income attributable to Innoviva stockholders
$
23,392
$
179,722
$
213,921
See accompanying notes to consolidated financial statements.
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INNOVIVA, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands)
Additional
Total
Common Stock
Paid-In
Accumulated
Treasury Stock
Noncontrolling
Stockholders’
Shares
Amount
Capital
Deficit
Shares
Amount
Interest
Equity
Balance as of January 1, 2022
69,566
$
696
$
1,264,024
$
( 456,148
)
32,005
$
( 393,829
)
$
111,192
$
525,935
Cumulative adjustment due to adoption of
ASU 2020-06
—
—
( 65,467
)
37,238
—
—
—
( 28,229
)
Distributions to noncontrolling interests
—
—
—
—
—
—
( 69,811
)
( 69,811
)
Recognition of noncontrolling interest upon
initial consolidation of Entasis
—
—
—
—
—
—
38,471
38,471
Equity activity of noncontrolling interests in
a consolidated variable interest entity
—
—
—
—
—
—
( 2
)
( 2
)
Derecognition of noncontrolling interests upon
sale of TRC
—
—
—
78
—
—
( 61,304
)
( 61,226
)
Derecognition of noncontrolling interests upon
acquisition of Entasis noncontrolling interest
—
—
( 14,153
)
—
—
—
( 28,009
)
( 42,162
)
Exercise of stock options and issuance of
common stock units and stock awards, net of
repurchase of shares to satisfy tax withholding
269
2
286
—
—
—
—
288
Capped call options associated with convertible
senior notes due 2028
—
—
( 16,585
)
—
—
—
—
( 16,585
)
Conversion of convertible subordinated notes
due 2023
—
—
3
—
—
—
—
3
Repurchase of common stock
( 647
)
( 6
)
( 8,497
)
—
—
—
—
( 8,503
)
Stock-based compensation
—
—
4,225
—
—
—
3,122
7,347
Net income
—
—
—
213,921
—
—
6,341
220,262
Balance as of December 31, 2022
69,188
$
692
$
1,163,836
$
( 204,911
)
32,005
$
( 393,829
)
$
—
$
565,788
Exercise of stock options and
issuance of common stock units
and stock awards, net of
repurchase of shares to satisfy
tax withholding
293
3
89
—
—
—
—
92
Repurchase of common stock, including accrued
excise tax
( 6,174
)
( 62
)
( 76,422
)
—
—
—
—
( 76,484
)
Stock-based compensation
—
—
5,837
—
—
—
—
5,837
Net income
—
—
—
179,722
—
—
—
179,722
Balance as of December 31, 2023
63,307
$
633
$
1,093,340
$
( 25,189
)
32,005
$
( 393,829
)
$
—
$
674,955
Exercise of stock options and
issuance of common stock units
and stock awards, net of
repurchase of shares to satisfy
tax withholding
345
3
1,321
—
—
—
—
1,324
Repurchase of common stock, including accrued
excise tax
( 987
)
( 9
)
( 14,916
)
—
—
—
—
( 14,925
)
Accrued excise tax on common stock repurchase
applied against tax liability
—
—
39
—
—
—
—
39
Stock-based compensation
—
—
6,374
—
—
—
—
6,374
Retirement of treasury stock
—
—
( 393,829
)
—
( 32,005
)
393,829
—
—
Net income
—
—
—
23,392
—
—
—
23,392
Balance as of December 31, 2024
62,665
$
627
$
692,329
$
( 1,797
)
—
$
—
$
—
$
691,159
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See accompanying notes to consolidated financial statements.
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INNOVIVA, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Year Ended December 31,
2024
2023
2022
Cash flows from operating activities
Net income
$
23,392
$
179,722
$
220,262
Adjustments to reconcile net income to net cash provided by operating activities:
Deferred income taxes
( 12,617
)
4,400
25,006
Amortization of capitalized fees and depreciation of property and equipment
13,951
13,921
13,931
Amortization of acquired intangible assets
25,902
21,784
5,581
Inventory fair value step-up adjustment included in cost of products sold
13,820
27,164
10,023
Stock-based compensation
6,374
5,837
7,347
Amortization of debt discount and issuance costs
2,110
2,065
2,055
Changes in fair values of equity method investments, net
64,253
( 77,392
)
161,749
Changes in fair values of equity and long-term investments, net
59,161
( 11,129
)
( 8,462
)
Loss on extinguishment of debt
—
—
20,662
Net gain on sale of TRC
—
—
( 266,696
)
Other non-cash items
( 722
)
( 517
)
3,402
Changes in operating assets and liabilities:
Accounts receivable
( 5,938
)
( 5,053
)
( 3,525
)
Receivables from collaboration arrangements
3,647
( 14,949
)
13,319
Inventory
( 6,808
)
( 12,004
)
280
Prepaid expenses
567
7,929
( 21,350
)
Other assets
( 38,186
)
( 2,965
)
( 3,341
)
Accounts payable
( 4,585
)
3,778
92
Accrued personnel-related expenses and other accrued liabilities
3,044
( 1,498
)
11,913
Accrued interest payable
—
( 937
)
207
Deferred revenue
( 151
)
( 817
)
( 755
)
Income tax payable
41,476
1,725
10,026
Net cash provided by operating activities
188,690
141,064
201,726
Cash flows from investing activities
Acquisition of intangible asset
( 4,000
)
—
—
Purchases of equity method investments
—
—
( 45,000
)
Purchases of trading securities
( 59,617
)
( 65,132
)
—
Purchases of equity and long-term investments
—
( 1,218
)
( 13,725
)
Purchases of equity investments managed by ISP Fund LP
( 32,270
)
( 31,164
)
( 60,910
)
Purchases of trading security managed by ISP Fund LP
—
—
( 50,000
)
Sales of equity investments managed by ISP Fund LP
75,756
72,500
24,281
Purchases and sales of other investments managed by ISP Fund LP, net
( 43,486
)
( 41,336
)
( 23,371
)
Purchases of property and equipment
( 270
)
( 411
)
( 67
)
Sale of property and equipment
101
—
—
Proceeds from sale of ownership interest in TRC, net
—
—
248,191
Cash acquired through the consolidation of Entasis
—
—
23,070
Cash paid for the acquisition of La Jolla, net of cash acquired
—
—
( 159,103
)
Net cash used in investing activities
( 63,786
)
( 66,761
)
( 56,634
)
Cash flows from financing activities
Distributions to noncontrolling interests
—
—
( 69,811
)
Purchase of Entasis noncontrolling interest
—
—
( 43,910
)
Repurchase of common stock
( 14,777
)
( 75,728
)
( 8,503
)
Repurchase of shares to satisfy tax withholding
( 142
)
( 77
)
( 82
)
Proceeds from issuances of common stock, net
1,466
170
370
Payment for repurchase of convertible subordinated notes due 2023
—
( 96,204
)
( 165,131
)
Purchases of capped call options associated with convertible senior notes due 2028
—
—
( 21,037
)
Proceeds from issuance of convertible senior notes due 2028, net of issuance costs
—
—
252,536
Net cash used in financing activities
( 13,453
)
( 171,839
)
( 55,568
)
Net increase (decrease) in cash and cash equivalents
111,451
( 97,536
)
89,524
Cash and cash equivalents at beginning of period
193,513
291,049
201,525
Cash and cash equivalents at end of period
$
304,964
$
193,513
$
291,049
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Year Ended December 31,
2024
2023
2022
Supplemental Disclosure of Cash Flow Information:
Cash paid for interest
$
10,359
$
11,381
$
11,736
Cash paid for income taxes
$
11,793
$
—
$
53,855
Supplemental Disclosure of Non-cash Investing and Financing Activities:
Accrued interest income converted to long-term investments
$
3,584
$
2,666
$
—
Adoption of ASU 2020-06
$
—
$
—
$
( 28,228
)
See accompanying notes to consolidated financial statements.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. DESCRIPTION OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Operations
Innoviva, Inc. (and where context requires, together with its subsidiaries referred to as “Innoviva”, the “Company”, or “we” and other similar pronouns) is a company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in other healthcare assets. Our royalty portfolio contains respiratory assets partnered with Glaxo Group Limited (“GSK”), including RELVAR ® /BREO ® ELLIPTA ® (fluticasone furoate/vilanterol, “FF/VI”) and ANORO ® ELLIPTA ® (umeclidinium bromide/vilanterol, “UMEC/VI”), and up until July 2022, TRELEGY ® ELLIPTA ® (the combination FF/UMEC/VI). We sold our 15 % ownership interest in Theravance Respiratory Company, LLC (“TRC”) on July 20, 2022, and are no longer entitled to receive royalties on sales of TRELEGY ® ELLIPTA ® products. 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 %.
We expanded our portfolio through the acquisition of Entasis Therapeutics Holdings Inc. (“Entasis”) on July 11, 2022 and the acquisition of La Jolla Pharmaceutical Company (“La Jolla”) on August 22, 2022. Our commercial and marketed products include GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Our new product, XACDURO ® (formerly known as sulbactam-durlobactam or SUL-DUR), was approved by the United States Food and Drug Administration (“FDA”) for the treatment of hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter in adults and we commenced commercial sales of XACDURO ® in the third quarter of 2023. On December 14, 2024, we entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd., (“Basilea”) for the commercialization of ZEVTERA ® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. We continue to further advance our pipeline and are on track to submit a New Drug Application (“NDA”) for zoliflodacin, potentially first in class, single dose oral drug for the treatment of uncomplicated gonorrhea, to the FDA in early 2025. Overall, we have a wholly owned robust critical care and infectious disease operating platform with a hospital focus anchored by four differentiated products with significant growth potential and a promising drug candidate.
In addition, we own other strategic healthcare assets, such as a large equity stake in Armata Pharmaceuticals, a leader in development of bacteriophages with potential use across a range of infectious and other serious diseases. We also have economic interests in other healthcare companies.
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of Innoviva, our wholly owned subsidiaries and certain variable interest entities (“VIE”) for which we are the primary beneficiary. All intercompany balances and transactions have been eliminated in consolidation. 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 consolidated statements of income equal to the percentage of the economic or ownership interest retained in such entity by the respective noncontrolling party.
Factors Affecting Comparability
Our historical financial condition and results of operations for the periods presented may not be comparable, either between periods or going forward due to the factors below and as discussed in Note 5, “Consolidated Entities and Acquisitions”.
• Accounting consolidation of Entasis on February 17, 2022 and purchase of remaining noncontrolling interest in Entasis on July 11, 2022;
• Sale of our 15 % ownership interest in TRC on July 20, 2022; and
• Acquisition of La Jolla on August 22, 2022.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Use of Management’s Estimates
The preparation of consolidated financial statements in conformity with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. Management evaluates its significant accounting policies and estimates on an ongoing basis. We base our estimates on historical experience and other relevant assumptions that we believe to be reasonable under the circumstances. These estimates also form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources.
Concentrations of Credit Risk and of Significant Suppliers and Partners
Our financial instruments that are exposed to concentrations of credit risk consist primarily of cash and cash equivalents and equity and long-term investments. Although we deposit our cash with multiple financial institutions, our deposits, at times, may exceed federally insured limits.
We are dependent on third-party manufacturers to supply active pharmaceutical ingredients (“API”) and drug products for commercial and research and development programs. These programs could be adversely affected by significant interruption in the supply of API or drug products.
Currently, we derive most of our revenues from GSK and our near-term success depends in large part on GSK’s ability to successfully develop and commercialize the products in the respiratory programs partnered with GSK. Our near-term success depends in large part upon the performance by GSK of its commercial obligations under the GSK Agreements and the commercial success of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . If GSK does not devote sufficient resources to the commercialization or development of these products, is unsuccessful in its efforts, or chooses to reprioritize its commercial programs, our business would be materially harmed. GSK is responsible for all clinical and other product development, regulatory, manufacturing and commercialization activities for products developed under the GSK Agreements, including RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Our royalty revenues may fluctuate due to a variety of factors, many of which are outside of our control. Our royalty revenues under the GSK Agreements may not meet our, analysts’ or investors’ expectations, due to a number of important factors.
Our revenue for the periods include product sales of GIAPREZA ® , XERAVA ® and XACDURO ® . Hospitals and other healthcare organizations generally purchase our products through a network of specialty distributors. These specialty distributors, which are located in the U.S., are considered our customers for accounting purposes. We do not believe that loss of one of these distributors would significantly impact our ability to distribute our products, as we expect that sales volume would be absorbed by new or remaining distributors. Three of our customers each account for approximately:
• 31 %, 24 % and 24 %, respectively, of our net product sales for the year ended December 31, 2024;
• 31 %; 27 % and 27 %, respectively, of our net product sales for the year ended December 31, 2023; and,
• 33 %, 29 % and 28 %, respectively, of our net product sales for the year ended December 31, 2022.
These same customers account for 31 %, 18 % and 15 %, respectively, of our receivables from net product sales, which are included in “Accounts receivables, net” in our consolidated balance sheet as of December 31, 2024. These same customers account for 29 %, 19 % and 15 %, respectively, of our receivables from net product sales, which are included in “Accounts receivables, net” in our consolidated balance sheet as of December 31, 2023.
Segment Reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is made available for evaluation by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. Refer to Note 15, “Segment Reporting”, for more segment information.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Variable Interest Entities
The primary beneficiary of a variable interest entity (“VIE”) is required to consolidate the assets and liabilities of the VIE. When we obtain a variable interest in another entity, we assess at the inception of the relationship and upon occurrence of certain significant events whether the entity is a VIE and, if so, whether we are the primary beneficiary of the VIE based on our power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and our obligation to absorb losses or the right to receive benefits from the VIE that could potentially be significant to the VIE.
To assess whether we have the power to direct the activities of a VIE that most significantly impact the VIE’s economic performance, we consider all the facts and circumstances, including our role in establishing the VIE and our ongoing rights and responsibilities. This assessment includes identifying the activities that most significantly impact the VIE’s economic performance and identifying which party, if any, has power over those activities. In general, the parties that make the most significant decisions affecting the VIE (management and representation on the Board of Directors) and have the right to unilaterally remove those decision-makers are deemed to have the power to direct the activities of a VIE.
To assess whether we have the obligation to absorb losses of the VIE or the right to receive benefits from the VIE that could potentially be significant to the VIE, we consider all of our economic interests that are deemed to be variable interests in the VIE. This assessment requires us to apply judgment in determining whether these interests, in the aggregate, are considered potentially significant to the VIE.
Business Combination
When we acquire an entity in a business combination, we recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establish the acquisition date as the fair value measurement point. We recognize and measure goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired. Acquisition-related expenses and related restructuring costs are expensed as incurred.
Several valuation methods may be used to determine the fair value of assets acquired and liabilities assumed. For intangible assets, we typically use the income method. This method starts with a forecast of all of the expected future net cash flows for each asset. These cash flows are then adjusted to present value by applying an appropriate discount rate that reflects the risk factors associated with the cash flow streams. Some of the more significant estimates and assumptions inherent in the income method or other methods include the amount and timing of projected future cash flows, the discount rate selected to measure the risks inherent in the future cash flows and the assessment of the asset’s life cycle and the competitive trends impacting the asset, including consideration of any technical, legal, regulatory, or economic barriers to entry. Determining the useful life of an intangible asset also requires judgment as different types of intangible assets will have different useful lives and certain assets may even be considered to have indefinite useful lives.
Cash and Cash Equivalents
We consider all highly liquid investments purchased with a maturity of three months or less on the date of purchase to be cash equivalents. Cash equivalents are carried at cost, which approximates fair value.
Accounts Receivable
Accounts receivable are recorded net of estimates for prompt-pay discounts, chargebacks, returns and rebates. Allowances for prompt-pay discounts and chargebacks are based on contractual terms. We estimate the allowance for credit losses based on existing contractual payment terms, actual payment patterns of customers and individual customer circumstances.
Inventory
Inventory is stated at the lower of cost or estimated net realizable value on a first-in, first-out basis. We periodically analyze inventory levels and write down inventory as cost of products sold when the following occurs: inventory has become obsolete, inventory has a cost basis in excess of its estimated net realizable value, or inventory quantities are in excess of expected product sales.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Property and Equipment
Property and equipment, which consist of laboratory equipment, computer equipment, software, office furniture and fixtures, and leasehold improvements, were not material as of December 31, 2024 and 2023, respectively.
Property and equipment are stated at cost less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the respective assets as follows:
Leasehold improvements
Shorter of remaining lease terms or useful life
Laboratory equipment, furniture and fixtures
5 – 7 years
Software and computer equipment
3 years
Equity and Long-Term Investments
We invest from time to time in equity and debt securities of private or public companies. If we determine that we have control over these companies under either voting or VIE models, we consolidate them in our consolidated financial statements. 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 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 method investments, net, and changes in fair values of equity and long-term investments, net, within 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 the security without a readily determinable fair value using the measurement alternative method under ASC 321, Investments – Equity Securities . This measurement alternative method 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.
We also invest in ISP Fund LP, which investments consist of money market funds and equity and debt securities in the healthcare, pharmaceutical and biotechnology industries. Pursuant to the Partnership Agreement entered in December 2020, we became a limited partner of this partnership, and our contributions were subject to a 36-month lock-up period, which restriction prevented us from having control over and access to the contributions and related investments. The lock-up period for a certain portion of our contributions expired in December 2023. Strategic Partners did not elect to make a withdrawal in 2023, thereby extending the lock-up period and withdrawal elections into subsequent years. These investments were classified as long-term investments in the consolidated balance sheet as of December 31, 2023. In October 2024, Strategic Partners made an election to unwind its capital accounts in the Partnership in accordance with the terms of the Partnership Agreement and we expect to receive distributions of our capital accounts through April 2026. Accordingly, a portion of these investments, which consist mainly of cash and money market funds that we expect to be distributed in the next 12 months, were classified as “Current portion of ISP Fund investments” in the consolidated balance sheet as of December 31, 2024.
Fair Value of Financial Instruments
We define fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
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Our valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. We classify these inputs into the following hierarchy:
Level 1 —Quoted prices for identical instruments in active markets.
Level 2 —Quoted prices for similar instruments in active markets; quoted prices for identical 3or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.
Level 3 —Unobservable inputs and little, if any, market activity for the assets.
Financial instruments include cash equivalents, accounts receivable, receivables from collaborative arrangements, accounts payable, and accrued liabilities, equity investments and convertible promissory notes. The carrying values of cash equivalents, receivables from collaborative arrangements, accounts payable, and accrued liabilities approximate their estimated fair values due to the relatively short-term nature of these instruments.
Capitalized Fees Paid
We capitalize fees paid to licensors related to agreements for approved products or commercialized products. We capitalize these fees as capitalized fees paid (“Capitalized Fees”) and amortize them on a straight-line basis over their estimated useful lives upon the commercial launch of the product, shortly after its regulatory approval. The estimated useful lives of these Capitalized Fees are determined on a country-by-country and product-by-product basis, as the later of the expiration or termination of the last patent right covering the compound in such product in such country and 15 years from first commercial sale of such product in such country, unless the Collaboration Agreement is terminated earlier. Consistent with our policy for classification of costs under the research and development collaborative arrangements, the amortization of these Capitalized Fees is recognized as a reduction of royalty revenue. We review our Capitalized Fees for impairment on a product-by-product basis for each major geographic area when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. The recoverability of Capitalized Fees is measured by comparing the asset’s carrying amount to the expected undiscounted future cash flows that the asset is expected to generate. The determination of recoverability typically requires various estimates and assumptions, including estimating the useful life over which cash flows will occur, their amount, and the asset’s residual value, if any. We derive the required cash flow estimates from near-term forecasted product sales and long-term projected sales in the corresponding market.
Goodwill and Intangible Assets
Goodwill is recognized as the excess of the purchase consideration of an acquired entity over the fair value assigned to assets acquired and liabilities assumed in a business combination. In addition to recognizing intangible assets acquired in a business combination, we capitalize milestone payments related to in-licensing agreements for approved products as an intangible asset when the contingency for the milestone is resolved and the consideration is issued or becomes issuable. Goodwill and intangible assets with indefinite useful life are not amortized and are tested for impairment at least annually on the first day of December of each year or more frequently if indicators for potential impairment exist or whenever events or changes in circumstances indicate that the asset’s carrying asset amount may not be recoverable. Intangible assets with definite useful lives are amortized on a straight-line basis over their respective remaining useful lives and are tested for impairment only if indicators for potential impairment exist or whenever events or changes in circumstances indicate that the asset’s carrying amount may not be recoverable. Significant judgment may be involved in determining if an indicator of impairment has occurred.
Operating Leases
Right-of-use assets represent our right to use an underlying asset over the lease term and include any lease payments made prior to the lease commencement date and are reduced by lease incentives. Lease liabilities represent the present value of the total lease payments over the lease term, calculated using an estimated incremental borrowing rate. Lease expense is recognized on a straight-line basis over the expected lease term.
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Revenue Recognition
We apply the guidance on principal versus agent considerations under ASC Topic 606, Revenue from Contracts with Customers , to determine the appropriate treatment for the transactions between us and third parties. The classification of transactions under our arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. Any consideration related to activities in which we are considered the principal, which includ es being in control of the good or service before such good or service is transferred to the customer, are accounted for as product sales.
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 the 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 as a performance obligation is satisfied.
Royalty Revenue
We recognize the royalty revenue on net sales of products with respect to which we have contractual royalty rights in the period in which the royalties are earned. The net sales reports provided by our partner are based on its methodology and assumptions to estimate rebates and returns, which it monitors and adjusts regularly in light of contractual and legal obligations, historical trends, past experience and projected market conditions. Our partner may make significant adjustments to its sales based on actual results recorded, which could cause our royalty revenue to fluctuate. We conduct periodic royalty audits to evaluate the information provided by our partner. Royalties are recognized net of amortization of capitalized fees associated with any approval and launch milestone payments made to GSK.
Revenue from Product Sales
Revenue from product sales is recognized when our customers obtain control of the product and is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, discounts, returns and rebates. Variable consideration is estimated using the expected-value amount method, which is the sum of probability-weighted amounts in a range of possible consideration amounts. Actual amounts of consideration ultimately received may differ from our estimates. If actual results vary materially from our estimates, we will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted. These items may include:
• Chargebacks: Chargebacks are discounts we provide to distributors in the event that the sales prices to end users are below the distributors’ acquisition price. This may occur due to a direct contract with a health system, a group purchasing organization (“GPO”) agreement or a sale to a government facility. Chargebacks are estimated based on known chargeback rates and recorded as a reduction of revenue on delivery to our customers.
• Discounts: We offer customers various forms of incentives and consideration, including prompt-pay and other discounts. We estimate discounts primarily based on contractual terms. These discounts are recorded as a reduction of revenue on delivery to our customers.
• Returns: We offer customers a limited right of return, generally for damaged or expired product. We estimate returns based on an internal analysis, which includes actual experience. The estimates for returns are recorded as a reduction of revenue on delivery to our customers.
• Rebates: We participate in Medicaid rebate programs, which provide assistance to certain low-income patients based on each individual state’s guidelines regarding eligibility and services. Under the Medicaid rebate programs, we pay a rebate to each participating state, generally within three months after the quarter in which product was sold. Additionally, we may offer customer incentives and consideration in the form of volume-based or other rebates. The estimates for rebates are recorded as a reduction of revenue on delivery to our customers.
We continue to assess our estimates of variable consideration as we accumulate additional historical data and will adjust these estimates accordingly.
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License Revenue
At the inception of a licensing arrangement that includes development and regulatory milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price. We generally recognize these milestone payments as revenues when they are achieved because there is considerable uncertainty in the research and development processes that trigger receipt of these payments under our agreements. Similarly, we recognize regulatory approval milestone payments as revenues once the product is approved by the applicable regulatory agency. For delivery of other goods or services related to a licensing arrangement, we determine whether the performance obligation is satisfied over time or at a point in time. If the performance obligation is satisfied over time, we use judgment in determining the appropriate method of measuring progress for purposes of recognizing revenue. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
Research and Development Expenses
Research and development expenses are recognized in the period that services are rendered or goods are received. Research and development expenses consist of salaries and benefits, laboratory supplies, facilities and other overhead costs, research-related manufacturing costs, contract service and clinical-related service costs performed by third party research organizations, research institutions and other outside service providers. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as an expense as the related goods are delivered or the related services are performed. We also utilize significant judgment and estimates to record accruals for estimated ongoing research costs based on the progress of the studies and progress of research manufacturing activities.
Interest Expense on Deferred Royalty Obligation
Interest expense related to the deferred royalty obligation is recognized over the expected repayment term of the deferred royalty obligation using the effective interest method. The assumptions used in determining the expected repayment term of the deferred royalty obligation require us to make estimates that could impact the effective interest rate. Each reporting period, we estimate the expected repayment term of the deferred royalty obligation based on forecasted net sales of GIAPREZA ® . Changes in interest expense resulting from changes in the effective interest rate, if any, are recorded on a prospective basis. Refer to Note 12, “Debt”, for more information.
Fair Value of Stock‑Based Compensation Awards
We use the Black-Scholes-Merton option pricing model to estimate the fair value of options granted under our equity incentive plans and rights to acquire stock granted under our employee stock purchase plan (“ESPP”). The Black-Scholes-Merton option valuation model requires the use of assumptions, including the expected term of the award and the expected stock price volatility. We use the “simplified” method as described in Staff Accounting Bulletin No. 107, “ Share-Based Payment ,” for the expected option term. We use our historical volatility to estimate expected stock price volatility.
Restricted stock units (“RSUs”) and restricted stock awards (“RSAs”) are measured based on the fair market values of the underlying stock on the dates of grant.
Stock-based compensation expense is calculated based on awards ultimately expected to vest and is reduced for estimated forfeitures at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differed from those estimates. Our estimated annual forfeiture rates for stock options, RSUs and RSAs are based on our historical forfeiture experience.
The estimated fair value of stock options, RSUs and RSAs is expensed on a ratable or straight-line basis over the expected term of the grant or expected term of the vesting. Compensation expense is recorded over the requisite service period based on management’s best estimate as to whether it is probable that the shares awarded are expected to vest.
Compensation expense for purchases under the ESPP is recognized based on the fair value of the common stock on the date of offering, less the purchase discount percentage provided for in the plan.
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Income Taxes
We utilize the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and the tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.
The recognition and measurement of tax benefits requires significant judgment. Our judgment might change as new information becomes available. We continue to evaluate our deferred tax assets each reporting period to determine whether adjustments to our valuation allowance are required and deferred tax assets will be realized based on the consideration of all available positive and negative evidence, including the differences between our anticipated and actual future operating results, using a “more likely than not” standard.
We assess all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than 50% likely to be realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and we determine whether the factors underlying the sustainability assertion have changed and whether the amount of the recognized tax benefit is still appropriate.
Related Parties
Sarissa Capital ow ned 11.6 % of o ur outstanding common stock as of December 31, 2024 . Transactions with Sarissa Capital are described in Note 5, “Consolidated Entities and Acquisitions”. Sarissa Capital is considered to be a related party because two of its principals are members of our board of directors.
Recently Adopted Accounting Pronouncement
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Improvements to Reportable Segment Disclosures (Topic 280). This ASU update requires enhanced segment disclosures, primarily related to significant segment expenses. The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. We adopted ASU 2023-07 for the 2024 fiscal year and provided the enhanced disclosures for the comparative years. The adoption of ASU 2023-07 did not have a material impact on the Company's financial statements. Enhanced disclosures related to significant segment expenses are included in Note 15, “Segment Reporting.”
Recently Issued Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures (Topic 740) . The ASU requires the disclosure of income taxes paid disaggregated by jurisdiction and enhanced disclosures for the entity’s effective tax rate reconciliation as well as other income tax related disclosures. The ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. The Company has not early adopted the ASU during 2024 and does not expect the adoption of the amendments to have a significant impact on its financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement — Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40) , which requires disclosures about specific types of expenses included in the expense captions presented on the face of the statement of income as well as disclosures about selling expenses. ASU 2024-03 is effective for the Company in annual reporting periods beginning after December 15, 2027, and interim reporting periods beginning after December 15, 2027. We are currently evaluating the potential impact that ASU 2024-03 may have on our financial statement disclosures.
In November 2024, the FASB issued ASU 2024-04, Debt — Debt with Conversion and Other Options (Subtopic 470-20), which clarifies the assessment of whether a transaction should be accounted for as an induced conversion or extinguishment of convertible debt when changes are made to conversion features as part of an offer to settle the instrument. ASU 2024-04 is effective for annual reporting periods beginning after December 15, 2025 and interim reporting periods within those annual reporting periods. We are currently evaluating the potential impact that ASU 2024-04 may have on our financial statements and related disclosures.
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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”) up until its maturity date on January 15, 2023, our convertible senior notes due 2025 (the “2025 Notes”), and our convertible senior notes due 2028 (the “2028 Notes”) using the if-converted method. If the results attributable to Innoviva stockholders are in a net loss position, diluted net loss per share attributable to Innoviva stockholders is computed by dividing the net loss attributable to Innoviva stockholders by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common stock equivalents.
The following table shows the computation of basic and diluted net income per share for the years ended December 31, 2024, 2023 and 2022:
Year Ended December 31,
(In thousands except per share data)
2024
2023
2022
Numerator:
Net income attributable to Innoviva stockholders, basic
$
23,392
$
179,722
$
213,921
Add: interest expense on 2023 Notes, net of tax effect
—
89
2,439
Add: interest expense on 2025 Notes, net of tax effect
3,468
5,116
4,583
Add: interest expense on 2028 Notes, net of tax effect
—
6,377
4,626
Net income attributable to Innoviva stockholders, diluted
$
26,860
$
191,304
$
225,569
Denominator:
Weighted-average shares used to compute basic net income
per share attributable to Innoviva stockholders
62,726
65,435
69,644
Dilutive effect of 2023 Notes
—
187
6,188
Dilutive effect of 2025 Notes
11,150
11,150
11,150
Dilutive effect of 2028 Notes
—
9,955
8,158
Dilutive effect of options and awards granted under equity
incentive plan and employee stock purchase plan
311
149
108
Weighted-average shares used to compute diluted net income
per share attributable to Innoviva stockholders
74,187
86,876
95,248
Net income per share attributable to Innoviva stockholders
Basic
$
0.37
$
2.75
$
3.07
Diluted
$
0.36
$
2.20
$
2.37
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 for the periods presented:
Year Ended December 31,
(In thousands)
2024
2023
2022
Outstanding options and awards granted under equity incentive
plan and employee stock purchase plan
1,196
1,333
648
Outstanding stock warrant
591
591
282
Outstanding 2028 Notes
9,955
—
—
Total
11,742
1,924
930
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3. REVENUE RECOGNITION
Net Revenue from Collaboration Arrangement
On July 13, 2022, Innoviva’s wholly owned subsidiary, Innoviva TRC Holdings, LLC (“ITH”) entered into an equity purchase agreement (“TRC Equity Purchase Agreement”) with Royalty Pharma Investments 2019 ICAV (“Royalty Pharma”) to sell our ownership interest in TRC. As a result of the sale of our ownership interest in TRC, which was consummated on July 20, 2022, we are no longer entitled to receive 15% of royalty payments made by GSK stemming from sales of TRELEGY ® ELLIPTA ® . We retained our royalty rights with respect to RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® .
Net revenue recognized under our GSK Agreements was as follows:
Year Ended December 31,
(In thousands)
2024
2023
2022
Royalties – RELVAR/BREO
$
207,925
$
208,042
$
215,034
Royalties – ANORO
47,631
44,627
38,405
Royalties – TRELEGY (1)
—
—
72,029
Total royalties
255,556
252,669
325,468
Less: amortization of capitalized
fees paid
( 13,823
)
( 13,823
)
( 13,823
)
Total royalty revenue
$
241,733
$
238,846
$
311,645
(1) The year ended December 31, 2022 represents the period from January 1, 2022 to July 20, 2022, the date of the sale of our ownership interest in TRC.
LABA Collaboration
As a result of the launch and approval of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® in the U.S., Japan and Europe, 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, which are being amortized over their estimated useful lives commencing upon the commercial launch of the product. The amortization is recorded as a reduction to the royalties from GSK.
We are entitled to receive annual 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. Sales of single‑agent LABA medicines and combination medicines would be combined for the purposes of this royalty calculation. For other products combined with a LABA from the LABA Collaboration, such as ANORO ® ELLIPTA ® , royalties are upward tiering and range from 6.5 % to 10 %.
We are also entitled to 15 % of royalty payments made by GSK under its agreements originally entered into with us, and since assigned to TRC in connection with the Spin-Off, including TRELEGY ® ELLIPTA ® through July 20, 2022, which royalties were upward tiering and ranged from 6.5 % to 10 %.
Net Product Sales
Total net product sales was as follows:
Year Ended December 31,
(In thousands)
2024
2023
2022
GIAPREZA®
$
55,037
$
41,294
$
14,214
XERAVA®
21,385
17,320
5,480
XACDURO®
21,070
2,003
—
Total net product sales
$
97,492
$
60,617
$
19,694
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We derived our net product sales:
• approximately 83 % from customers located in the U.S. and 17 % from the rest of the world for the year ended December 31, 2024;
• approximately 91 % from customers located in the U.S. and 9 % from the rest of the world for the year ended December 31, 2023; and,
• approximately 96 % from customers located in the U.S. and 4 % from the rest of the world from the date of acquisition of La Jolla, which occurred on August 22, 2022, to December 31, 2022.
License and Other Revenue
Refer to the out-license agreement with Zai Lab and Everest in Note 4, “License and Collaboration Arrangements”.
4. LICENSE AND COLLABORATION ARRANGEMENTS
Out-License Agreements
Zai Lab
Entasis entered into a license and collaboration agreement with Zai Lab (Shanghai) Co., Ltd. (“Zai Lab”) (Nasdaq: ZLAB), pursuant to which Zai Lab licensed exclusive rights to durlobactam and SUL-DUR, in the Asia-Pacific region (“the Zai Agreement”). Under the terms of the Zai Agreement, Zai Lab will fund most of the registrational clinical trial costs in China for SUL-DUR, with the exception of Phase 3 patient drug supply of licensed products. Zai Lab will conduct development activities and plan and obtain regulatory approval in a specified number of countries in the Asia-Pacific region beyond China after receipt of regulatory approval of a licensed product in China. Zai Lab is also solely responsible for commercializing licensed products in the Asia-Pacific region and will commercialize licensed products for which it has obtained regulatory approval. We are obligated to supply Zai Lab with the licensed products for clinical development and, if the licensed product is approved, for commercial use for a certain period unless Zai Lab notifies otherwise. Zai Lab may take over manufacturing responsibilities for its own commercialization activities within a specified time period following the effective date of the Zai Agreement.
We ar e eligible to receive up to an aggregate of $ 91.0 million in research and development support payments and development, regulatory and sales milestone payments related to SUL-DUR, imipenem and other combinations with the licensed products. Zai Lab will pay us a tiered royalty equal to from a high-single digit to low-double digit percentage based on annual net sales of licensed products in the territory, subject to specified reductions for the market entry of competing products, loss of patent coverage of licensed products and for payments owed to third parties for additional rights necessary to commercialize licensed products in the territory. Payments received for research support and reimbursable clinical trial costs are recorded as a reduction to research and development expense during the period in which the qualifying expenses are incurred. Such amounts recorded for the years ended December 31, 2024 and 2023 were not material. SUL-DUR was approved by China’s National Medical Products Administration in May 2024, and we recognized $ 8.0 million in license revenue for the year ended December 31, 2024 under this agreement. Following the approval of XACDURO ® by the FDA in May 2023, we recognized $ 3.0 million in license revenue for the year ended December 31, 2023.
In April 2024, we entered into an amendment to the Zai Agreement (the “Amended Zai Agreement”), pursuant to which Zai Lab shall share costs associated with certain new manufacturing and technology transfer activities for XACDURO ® (the “Services”), which were not contemplated under the Zai Agreement and are crucial for regulatory approval in the Asia-Pacific region. We determined that the Amended Zai Agreement falls within the scope of ASC 606 and Zai Lab is a customer in this arrangement as the Services are an output of our ordinary activities. We have determined that the Services represent the only performance obligation and are distinct from the performance obligations under the original Zai Agreement. In addition, the expenses we incur in performing the Services most accurately depict the transfer of value to Zai Lab and maximize the use of observable inputs for measuring progress, therefore, we recognize revenue from this arrangement as the expenses related to Services are incurred. We recognized $ 8.1 million in license and other revenue for the year ended December 31, 2024 under the Amended Zai Agreement, of which $ 1.6 million is included in “Accounts receivable” in our consolidated balance sheet as of December 31, 2024.
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In June 2024, we entered into an interim supply agreement with Zai Lab, under which Zai Lab shall purchase XACDURO ® inventory (the “Supplied Inventory”) for their commercial launch. We have determined that this agreement falls within the scope of ASC 606. Zai Lab is a customer and the Supplied Inventory is an output of our ordinary activities. We have also determined that the Supplied Inventory represents the only performance obligation and is distinct from the performance obligations under the Zai agreements discussed above. Furthermore, we evaluated that the performance obligation is satisfied over time and that a cost-to-cost measure of progress would be the measure of progress that most accurately depicts the transfer of value to Zai Lab and maximizes the use of observable inputs to measure progress. We recognized $ 6.3 million in net product sales for the Supplied Inventory for the year ended December 31, 2024, of which $ 0.6 million is included in “Accounts receivable” in our consolidated balance sheet as of December 31, 2024.
We also entered into a manufacturing stage transfer agreement with Zai Lab in June 2024, which was amended in September 2024 (the “Zai Manufacturing Stage Transfer Agreement”). Pursuant to this agreement, Entasis shall provide assistance to Zai Lab for building out Zai Lab’s manufacturing site for XACDURO ® and be compensated for Entasis' services and associated costs. We have determined this agreement falls within the scope of ASC 606. Zai Lab is a customer and the transfer service is an output of our ordinary activities and represents our only performance obligation, which is distinct from the performance obligations under the Zai agreements. Furthermore, we have evaluated that the performance obligation is satisfied over time and that the costs we incur in performing the transfer service most accurately depicts the transfer of value to Zai Lab and maximizes the use of observable inputs for measuring progress, therefore, we recognize revenue from this arrangement as the services are provided and the costs are incurred. We recognized $ 3.4 million in license and other revenue for the year ended December 31, 2024 under the Zai Manufacturing Stage Transfer Agreement, of which $ 0.1 million is included in “Accounts receivable” in our consolidated balance sheet as of December 31, 2024.
In October 2024, we entered into a letter agreement pursuant to which Zai Lab will purchase regulatory starting material (“RSM”) supply for use in the production of XACDURO ® for up to $ 10.9 million. We will supply the RSM while we continue to work on executing a commercial supply agreement with Zai Lab in accordance with the Zai Agreement. Based on our assessments, this agreement does not modify any of our existing contracts with Zai Lab discussed above and should be accounted for separately. We have also determined that this agreement falls within the scope of ASC 606. However, this does not meet the definition of a contract with a customer since the contract does not identify each party’s rights regarding goods or services. Accordingly, we deferred the consideration received amounting to $ 5.3 million as of December 31, 2024 in “Other accrued liabilities” until the execution of a commercial supply agreement, which will include all the required terms necessary for identifying each party’s rights regarding goods or services.
GARDP
Entasis entered into a collaboration agreement with the Global Antibiotic Research and Development Partnership (“GARDP”) for the development, manufacture and commercialization of the product candidate zoliflodacin in certain countries (“the GARDP Collaboration Agreement”). Under the terms of the GARDP Collaboration Agreement, GARDP will use commercially reasonable endeavors to perform and fully fund the Phase 3 registrational trial, including the manufacture and supply of the product candidate containing zoliflodacin, in uncomplicated gonorrhea. We recorded immaterial reimbursements from GARDP under this agreement as reduction to research and development expense during the periods presented.
In addition, under the GARDP Collaboration Agreement, GARDP was granted a worldwide, fully paid, exclusive and royalty-free license, with the right to sublicense, to use our zoliflodacin technology in connection with GARDP’s development, manufacture and commercialization of zoliflodacin in low-income and specified middle-income countries. We retained commercial rights in all other countries worldwide, including the major markets in North America, Europe and Asia-Pacific. We also retained the right to use and grant licenses to our zoliflodacin technology to perform our obligations under the GARDP Collaboration Agreement and for any purpose other than gonorrhea or community-acquired indications. If we believe that the results of the Phase 3 registrational trial of zoliflodacin would be supportive of an application for marketing approval, we are obligated to use our best efforts to file an application for marketing approval with the FDA within six months of the completion of the trial and to use commercially reasonable endeavors to file an application for marketing approval with the European Medicines Agency (“EMA”). Each party is responsible for using commercially reasonable efforts to obtain marketing authorizations for the product candidate in their respective territories.
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PAION Pharma GmbH
Pursuant to the PAION AG and PAION Deutschland GmbH (together and individually “PAION”) License, La Jolla granted PAION an exclusive license to commercialize GIAPREZA ® and XERAVA ® in the European Economic Area, the United Kingdom and Switzerland (collectively, the “PAION Territory”). We are entitled to receive potential commercial milestone payments of up to $ 109.5 million and double-digit tiered royalty payments. Royalties payable in a given jurisdiction under the PAION License will be subject to reduction on account of generic competition and after patent expiration in that jurisdiction. Pursuant to the PAION License, PAION will be solely responsible for the future development and commercialization of GIAPREZA ® and XERAVA ® in the PAION Territory. PAION is required to use commercially reasonable efforts to commercialize GIAPREZA® and XERAVA ® in the PAION Territory. We have not recognized any revenue from PAION related to commercial milestones from the date of acquisition of La Jolla to December 31, 2024. Royalty revenue recognized under this agreement for the year ended December 31, 2024 was $ 1.5 million . Royalty revenue recognized under this agreement for the year ended December 31, 2023 and from the date of acquisition of La Jolla to December 31, 2022 was no t material.
La Jolla also entered into the PAION commercial supply agreement (the “PAION Supply Agreement”) whereby La Jolla will supply PAION a minimum quantity of GIAPREZA ® and XERAVA ® through July 13, 2024. The PAION supply agreement will automatically renew until the earlier of July 13, 2027, or until a new supply agreement is executed. During the initial term of the supply agreement, we will be reimbursed for direct and certain indirect manufacturing costs at cost. We recognized $ 1.3 million in cost reimbursements under this agreement for the year ended December 31, 2023. Amounts recognized under this agreement for the year ended December 31, 2024 and from the date of acquisition of La Jolla to December 31, 2022 were not material.
PAION filed for insolvency in Germany on October 27, 2023 and the insolvency proceedings commenced on January 1, 2024. PAION announced on December 22, 2023 that it concluded negotiations with Humanwell Healthcare Group and entered into an agreement on the sale of the essential business operations of PAION with the approval of the insolvency administrator in both procedures. In early 2024, the sale of business operations of PAION was completed and starting February 2024, PAION has continued its business as a subsidiary of the Humanwell Healthcare Group as an independent company under the name PAION Pharma GmbH.
Everest Medicines Limited
Pursuant to the Everest Medicines Limited (“Everest”) License, La Jolla granted Everest an exclusive license to develop and commercialize XERAVA ® for the treatment of complicated intra-abdominal infections (“cIAI”) and other indications in mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines (collectively, the “Everest Territory”). Under the Everest License, we recognized $ 8.0 million in license revenue for the year ended December 31, 2023 as a result of an achievement of a regulatory milestone during the period. We are eligible to receive additional sales milestone payments of up to an aggregate of $ 20.0 million.
We are also entitled to receive tiered royalties from Everest at percentages in the low double digits on sales, if any, in the Everest Territory of products containing eravacycline. Royalties are payable with respect to each jurisdiction in the Everest Territory until the latest to occur of: (i) the last-to-expire of specified patent rights in such jurisdiction in the Everest Territory; (ii) expiration of marketing or regulatory exclusivity in such jurisdiction in the Everest Territory; or (iii) 10 years after the first commercial sale of a product in such jurisdiction in the Everest Territory. Royalty revenue recognized under this agreement for the years ended December 31, 2024 and 2023 was $ 4.7 million and $ 1.4 million, respectively. Royalty revenue recognized under this agreement from the date of acquisition of La Jolla to December 31, 2022 was no t material.
La Jolla also entered into the Everest commercial supply agreement (the “Everest Supply Agreement”) whereby La Jolla will supply Everest a minimum quantity of XERAVA ® and will transfer to Everest certain XERAVA ® -related manufacturing know-how. We were eligible to be reimbursed for direct and certain indirect manufacturing costs at 110 % of cost through December 31, 2023. W e recognized $ 3.2 million and $ 2.4 million in revenue under this agreement for the years ended December 31, 2024 and 2023, respectively. We recognized $ 0.8 million in revenue under this agreement from the acquisition of La Jolla to December 31, 2022.
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In-License Agreements
Basilea
In December 2024, we entered into an exclusive distribution and license agreement with Basilea under which we were granted exclusive marketing rights to ZEVTERA ® in the U.S. The agreement will remain in effect until the expiration of market exclusivity of ZEVTERA ® in the U.S. in 2034 (the “initial term”), subject to automatic renewal unless either party provides notice. We paid an upfront fee of $ 4.0 million, which we recognized as an intangible asset and will be amortized over the initial term of the agreement. We will exclusively purchase ZEVTERA ® (pre-packaging and labeling) from Basilea throughout the term. We are also obligated to pay Basilea tiered royalties ranging from the high-teens to mid-twenties, as well as tiered milestones, on annual net sales in the U.S. We anticipate commercializing ZEVTERA ® in mid-year 2025 and, therefore, have not incurred any royalties or sales milestone payments for the year ended December 31, 2024.
George Washington University
Pursuant to the George Washington University (“GW”) License, GW exclusively licensed to La Jolla certain intellectual property rights relating to GIAPREZA ® , including the exclusive rights to certain issued patents and patent applications covering GIAPREZA ® . Under the GW License, we are obligated to use commercially reasonable efforts to develop, commercialize, market and sell GIAPREZA ® . We are obligated to pay a 6 % royalty on net sales of GIAPREZA ® and 15 % on payments received from sublicensees. The obligation to pay royalties under this agreement extends through the last-to-expire patent covering GIAPREZA ® . We recognized $ 3.4 million and $ 2.5 million for the years ended December 31, 2024 and 2023, respectively, under this agreement. Amounts recognized from the date of acquisition of La Jolla to December 31, 2022 were no t material.
Harvard University
Pursuant to the Harvard University (“Harvard”) License, Harvard exclusively licensed to La Jolla certain intellectual property rights relating to tetracycline-based products, including XERAVA ® , including the exclusive rights to certain issued patents and patent applications covering such products. Under the Harvard License, we are obligated to use commercially reasonable efforts to develop, commercialize, market and sell tetracycline-based products, including XERAVA ® . For each product covered by the Harvard License, we are obligated to make certain payments for the following: (i) up to approximately $ 15.1 million upon the achievement of certain clinical development and regulatory milestones; (ii) a 5 % royalty on direct U.S. net sales of XERAVA ® ; (iii) a single-digit tiered royalty on direct ex-U.S. net sales of XERAVA ® , starting at a minimum royalty rate of 4.5 %, with step-ups to a maximum royalty of 7.5 % based on the achievement of annual net product sales thresholds; and (iv) 20 % on payments received from sublicensees. The obligation to pay royalties under this agreement extends through the last-to-expire patent covering tetracycline-based products, including XERAVA ® . We recognized $ 1.4 million for the year ended December 31, 2024 under this agreement. For the year ended December 31, 2023, we recognized $ 1.2 million as cost of license revenue under this agreement as a result of the license revenue we earned under the out-licensing agreement with Everest for the same period. For the years ended December 31, 2024 and 2023 and from the date of acquisition of La Jolla to December 31, 2022, royalties recognized under this agreement were no t material.
Paratek Pharmaceuticals, Inc.
Pursuant to the Paratek Pharmaceuticals, Inc. (“Paratek”) License, Paratek non-exclusively licensed to La Jolla certain intellectual property rights relating to XERAVA ® , including non-exclusive rights to certain issued patents and patent applications covering XERAVA ® . We were obligated to pay Paratek a 2.25 % royalty based on direct U.S. net sales of XERAVA ® . Our obligation to pay royalties with respect to the licensed product was retroactive to the date of the first commercial sale of XERAVA ® and continued until there are no longer any valid claims of the Paratek patents, which expired in October 2023 . For the year ended December 31, 2023, and from the date of acquisition of La Jolla to December 31, 2022, amounts recognized under this agreement were not material.
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Business Transfer and Subscription Agreement with AstraZeneca
Entasis entered into a Business Transfer and Subscription Agreement with AstraZeneca, AstraZeneca UK Limited and AstraZeneca Pharmaceuticals LP (collectively, “AstraZeneca”) (the “AstraZeneca Agreement”) in 2015, which was amended and restated through 2018, pursuant to which Entasis obtained, among other things, worldwide rights to durlobactam and zoliflodacin. Under the AstraZeneca Agreement, we are obligated to pay AstraZeneca a one-time milestone payment of $ 5.0 million within three months of achieving a specified cumulative net sales milestone for durlobactam. We are also obligated to pay AstraZeneca a one-time milestone payment of $ 10.0 million within two years of achieving the first commercial sale of zoliflodacin. Additionally, we are obligated to pay AstraZeneca tiered, single-digit royalties on the annual worldwide net sales of durlobactam and, the lesser of tiered, single-digit royalties on the worldwide annual net sales of zoliflodacin and a specified share of the royalties we receive from sublicensees of zoliflodacin. Royalties on sales of zoliflodacin do not include sales by GARDP in low-income and specified middle-income countries as discussed above. Our obligation to make these royalty payments expires with respect to each product on a country-by-country basis upon the later of (i) the 10-year anniversary of the first commercial sale of a product in each such country or (ii) when the last patent right covering a product expires in each such country.
Royalty expense on durlobactam arising from our net sales of XACDURO ® for the year ended December 31, 2024 and 2023 was no t material.
5. CONSOLIDATED ENTITIES AND ACQUISITIONS
Consolidated Entities
Theravance Respiratory Company, LLC
Up until July 20, 2022, we consolidated TRC under the VIE model as we determined that TRC was a VIE and we were the primary beneficiary of the entity because we had the power to direct the economically significant activities of TRC and the obligation to absorb losses of, or the right to receive benefits from, TRC. We held 15 % ownership interest of TRC. The primary source of revenue for TRC is the royalties generated from the net sales of TRELEGY ® ELLIPTA ® by GSK.
As discussed in Note 3, “Revenue Recognition”, on July 13, 2022, ITH entered into the TRC Equity Purchase Agreement to sell our ownership interest in TRC. Upon the closing of the transaction on July 20, 2022, we received $ 277.5 million in cash from Royalty Pharma. We are also entitled to receive up to $ 50.0 million in contingent sales-based milestone payments in the future. In connection with the closing of the transaction, we also received our portion of TRC’s remaining cash balance of $ 4.4 million from Royalty Pharma rather than through a cash distribution from TRC.
Prior to the closing of the transaction and as part of the agreement, TRC distributed its ownership interests and investments in InCarda Therapeutics (“InCarda”), Inc., ImaginAb, Inc. (“ImaginAb”), Gate and Nanolive SA (“Nanolive”), which had a total carrying value of $ 39.4 million, to ITH. We accounted for the transaction similar to an upstream sale between a parent and a VIE under ASC 810-10. As such, ITH recorded the transferred investments at their respective carrying values and no gain or loss was recognized in the consolidated statement of income.
The summarized financial information of TRC from January 1, 2022 to July 20, 2022, the date of the sale of our ownership interest in TRC, is presented as follows:
(In thousands)
Royalty revenue
$
72,029
Operating expenses
( 332
)
Income from operations
71,697
Other income, net
10
Realized loss
( 39,386
)
Income tax expense, net
1
Changes in fair values of equity and
long-term investments, net
( 8,884
)
Net income
$
23,438
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ISP Fund LP
In December 2020, Innoviva Strategic Partners LLC, our wholly owned subsidiary (“Strategic Partners”), contributed $ 300.0 million to ISP Fund LP (the “Partnership”) for investing in “long” positions in the healthcare, pharmaceutical and biotechnology sectors and became a limited partner. The general partner of the Partnership (“General Partner”) is an affiliate of Sarissa Capital.
The Partnership Agreement provides for Sarissa Capital to receive management fees from the Partnership, payable quarterly in advance, measured based on the Net Asset Value of Strategic Partners’ capital account in the Partnership. In addition, General Partner is entitled to an annual performance fee based on the Net Profits of the Partnership during the annual measurement period.
The Partnership Agreement includes a lock-up period of thirty-six months after which Strategic Partners is entitled to make withdrawals from the Partnership as of such lock-up expiration date and each anniversary thereafter, subject to certain limitations. The lock-up period for the initial contribution of $ 190.0 million, which excludes the amount discussed below, expired in December 2023 . Strategic Partners did not elect to make a withdrawal in 2023, thereby extending the lock-up period and withdrawal elections into subsequent years.
In May 2021, Strategic Partners received a distribution of $ 110.0 million from the Partnership to provide funding to Innoviva for a strategic repurchase of shares held by GSK. On March 30, 2022, Strategic Partners made an additional capital contribution of $ 110.0 million to the Partnership pursuant to the letter agreement entered into between Strategic Partners, the Partnership and Sarissa Capital Fund GP LP on May 20, 2021. The capital contribution is subject to a 36-month lock up period from the contribution date.
We consolidate ISP Fund LP under the VIE model as we have determined that ISP Fund LP is a VIE and we are the primary beneficiary of the entity via our related party relationships with Sarissa Capital entities. Our maximum exposure to loss is equal to the amount we invested in the entity.
ISP Fund LP is determined to be an investment company under ASC 946, Financial Services – Investment Companies , as it meets all fundamental characteristics of an investment company, and its activities are consistent with those of an investment company. Since ISP Fund LP is subject to investment company industry specific guidance, we have retained the industry-specific guidance applied by the Partnership. In addition, as our investment in the Partnership is a passive investment for the Company and is not part of our main operations, the investments are presented as part of “Equity and long-term investments” in our consolidated balance sheets. In October 2024, Strategic Partners made an election to unwind its capital accounts in the Partnership in accordance with the terms of the Partnership Agreement and we expect to receive distributions of our capital accounts through April 2026. Accordingly, a portion of our investments, which consist of cash and money market funds that we expect to be distributed in the next 12 months, were classified as ISP Fund investments in the consolidated balance sheet as of December 31, 2024, and the remaining equity investments managed by ISP Fund LP are expected to be distributed through April 2026. We report in our consolidated statements of income any investment gains and losses by the Partnership as part of “Changes in fair value of equity and long-term investments, net”, any interest and dividend income as part of “Interest and dividend income” and any investment expenses as part of “Other expense, net”.
As of December 31, 2024 , we continued to hold 100 % of the economic interest of Partnership. As of December 31, 2024 and 2023, total assets of the Partnership were $ 255.7 million and $ 311.8 million, respectively, of which the majority was attributable to equity and long-term investments. As of December 31, 2024 and 2023, total liabilities of the Partnership w ere $ 0.2 mill ion and $ 0.1 million, respectively. The Partnership ’s assets can only be used to settle its own obligations.
During the year ended December 31, 2024, the Partnership incurred $ 3.7 million in net investment-related expenses, generated $ 4.4 million interest income, recorded $ 5.3 million in net realized losses and $ 51.5 million in net unrealized losses as changes in fair values of equity and long-term investments, net, in the consolidated statement of income. During the year ended December 31, 2023, the Partnership incurred $ 4.3 million in net investment-related expenses, generated $ 6.3 million interest income, recorded $ 2.4 million in net realized losses and $ 6.7 million in net unrealized losses as changes in fair values of equity and long-term investments, net, in the consolidated statement of income. During the year ended December 31, 2022, the Partnership incurred $ 5.2 million in net investment-related expense, generated $ 2.0 million interest income, and recorded net $ 6.8 million realized gains and net $ 9.9 million unrealized losses as changes in fair values of equity and long-term investments, net, in the consolidated statement of income. We account for the long-term investments held by ISP Fund LP as of December 31, 2024 and 2023 and 2022 as equity investments measured at fair value.
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The following is a summary of individual investments held by ISP Fund at each balance sheet date:
December 31,
In thousands
2024
2023
Common stock - Publicly traded healthcare companies
United States
$
84,039
$
184,926
United Kingdom
1,989
2,942
Total common stock
86,028
187,868
Preferred stock - Privately held healthcare companies
United States
53,591
52,530
Warrants - Privately held healthcare companies
8,507
8,075
Money market fund and cash
107,532
63,339
Total investments held by ISP Fund LP
$
255,658
$
311,812
Acquisitions
Entasis Therapeutics Holdings Inc.
We started investing in Entasis in 2020 as part of our capital allocation strategy of deploying cash generated from royalty income and investing in different life sciences companies. Entasis at the time was an advanced, late clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products. Effective in June 2020, after certain conditions were met with respect to the sales of Entasis equity shares, Innoviva had the right to designate two members to Entasis’ board. Our investment in Entasis consisted of shares of common stock and warrants to purchase shares of Entasis common stock.
The fair value of Entasis’ common stock was measured based on its closing market price at each balance sheet date. We used the Black-Scholes-Merton pricing model to estimate the fair value of the warrants.
On February 17, 2022, Innoviva Strategic Opportunities, LLC (“ISO”) entered into a securities purchase agreement with Entasis pursuant to which ISO purchased a convertible promissory note for a total purchase price of $ 15.0 million. The note bore an annual interest rate of 0.59 % and was due to mature and become payable on August 18, 2022 unless it was converted at a conversion price of $ 1.48 before the maturity date. With this financing, we determined that we had both (i) the power to direct the economically significant activities of Entasis and (ii) the obligation to absorb the losses, or the right to receive the benefits, that could potentially be significant to Entasis and therefore, we were the primary beneficiary of Entasis. Accordingly, we consolidated Entasis’ financial position and results of operations effective on February 17, 2022. Our equity ownership interest remained at 59.9 % as of February 17, 2022, and the fair values of our holdings of Entasis common stock and warrants were remeasured and estimated at $ 64.5 million and $ 31.4 million, respectively.
The remeasurement resulted in a $ 7.8 million loss in the first quarter of 2022 which was included in changes in fair values of equity method investments, net, in the consolidated statement of income for the year ended December 31, 2022.
We completed our acquisition of Entasis’ noncontrolling interest on July 11, 2022. No payments were made toward the convertible promissory note through the date of acquisition of Entasis. In connection with the acquisition, all of the Entasis warrants were replaced with Innoviva warrants (the “Replacement Warrants”) of equivalent value and bearing the same terms. The Replacement Warrants were classified as equity.
We recognized the difference between the acquisition price and the carrying value of the acquired noncontrolling interest on July 11, 2022 in our additional paid-in capital.
The fair values assigned to assets acquired and liabilities assumed as of February 17, 2022 were based on management’s best estimates and assumptions. After the acquisition in July 2022, we adjusted the purchase price allocation based on new and additional information related to product sales forecast provided by Entasis and deferred tax liabilities.
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During the year ended December 31, 2022, we recorded measurement period adjustments of $ 4.7 million decrease in goodwill, primarily related to a decrease in estimated purchase price of $ 1.4 million, an increase in noncontrolling interests of $ 1.7 million, and an increase in intangible assets of $ 2.5 million. The cumulative impact of the measurement period adjustments included in the consolidated net income for the year ended December 31, 2022 was not material.
In February 2023, we recorded a measurement period adjustment of $ 1.2 million increase in goodwill, primarily related to a decrease in intangible assets of $ 0.8 million and an increase in deferred tax liabilities of $ 0.4 million. The measurement period adjustment did not impact the consolidated net income for the year ended December 31, 2023.
The following table represents the adjusted fair values of the assets acquired and liabilities assumed by us in the transaction:
(In thousands)
February 17, 2022
Cash and cash equivalents
$
23,070
Prepaid expenses
5,554
Other current assets
1,959
Property and equipment, net
185
Right-of-use assets
959
Goodwill
11,493
Intangible assets
106,700
Other assets
302
Total assets acquired
$
150,222
Accounts payable
$
1,583
Accrued personnel-related expenses
1,058
Other accrued liabilities
5,096
Deferred tax liabilities
7,769
Total liabilities assumed
$
15,506
Total assets acquired, net
$
134,716
The goodwill arising from the acquisition of Entasis is primarily attributable to Entasis’ assembled workforce and the value associated with growing our business more efficiently. The goodwill from this acquisition is not expected to be deductible for tax purposes.
Refer to Note 8, “Goodwill and Intangible Assets”, for more discussion on the intangible assets recognized as part of this acquisition.
As a result of the consolidation, we recognized a non-controlling interest of $ 38.5 million as of February 17, 2022. Our consolidated net income for the year ended December 31, 2022 included the net loss attributable to noncontrolling interest since the consolidation date until the date of acquisition of $ 13.6 million.
La Jolla Pharmaceutical Company
On August 22, 2022, ISO acquired La Jolla for a total consideration of $ 206.6 million. ISO acquired La Jolla at a price of $ 6.23 per share. La Jolla brought to Innoviva an established product portfolio, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAIs). We incurred approximately $ 5.3 million in acquisition-related costs in connection with this acquisition during the year ended December 31, 2022.
The fair values assigned to assets acquired and liabilities assumed as of August 22, 2022 were based on management’s best estimates and assumptions.
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During the year ended December 31, 2022, we recorded measurement period adjustments of $ 3.7 million increase in goodwill, primarily related to a decrease in inventory and intangible assets of $ 7.7 million and $ 1.5 million, respectively, and an increase in deferred tax liabilities of $ 2.6 million, partially offset by a decrease in other long-term liabilities of $ 8.3 million. The cumulative impact of the measurement period adjustments included in the consolidated net income for the year ended December 31, 2022 was not material.
In June 2023, we recorded a measurement period adjustment of $ 13.1 million decrease in goodwill, primarily related to an increase in deferred tax assets of $ 10.5 million and a decrease in deferred tax liabilities of $ 2.6 million. In August 2023, we recorded a measurement period adjustment of $ 3.0 million increase in goodwill, primarily related to a decrease in deferred tax assets of $ 2.4 million and an increase in deferred tax liabilities of $ 0.6 million. The cumulative impact of the measurement period adjustments included did not impact the consolidated net income for the year ended December 31, 2023.
The following table represents the adjusted fair values of assets acquired and liabilities assumed by us in the transaction:
(In thousands)
August 22, 2022
Cash and cash equivalents
$
47,415
Short-term marketable securities
471
Accounts receivable
5,876
Inventory
66,200
Prepaid expenses
1,261
Other current assets
907
Property and equipment, net
13
Right-of-use assets
226
Goodwill
6,411
Intangible assets
151,000
Deferred tax assets
7,461
Other assets
710
Total assets acquired
$
287,951
Accounts payable
$
1,237
Deferred revenue
2,849
Other accrued liabilities
11,362
Other long-term liabilities
65,944
Total liabilities assumed
$
81,392
Total assets acquired, net
$
206,559
The goodwill arising from the acquisition of La Jolla is primarily attributable to La Jolla’s assembled workforce and the value associated with leveraging the workforce to develop and commercialize new drug products in the future and growing our business more efficiently. The goodwill from this acquisition is not expected to be deductible for tax purposes.
Refer to Note 8, “Goodwill and Intangible Assets”, for more discussion on the intangible assets recognized as part of this acquisition.
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Pro Forma Financial Information
The following table presents certain unaudited pro-forma financial information for the year ended December 31, 2022 as if the consolidation of Entasis and La Jolla occurred on January 1, 2021. The unaudited pro forma financial information is presented for informational purposes only, and is not indicative of the results of operations that would have been achieved if the acquisitions had taken place on January 1, 2021, or of results that may occur in the future. The unaudited pro forma financial information combines the historical results of the Entasis and La Jolla with the Company’s consolidated historical results and includes certain adjustments including, but not limited to, fair value adjustments to equity investments in Entasis’ common stock and warrants, fair value adjustments to inventory, amortization of intangible assets, and interest expense on deferred royalty obligations and acquisition-related costs.
Year Ended December 31,
(In thousands)
2022
Revenue
$
357,880
Net income
$
204,987
Net income attributable to Innoviva stockholders
$
214,390
6. EQUITY AND LONG-TERM INVESTMENTS AND FAIR VALUE MEASUREMENTS
Equity and Other Investments in Armata
During the first quarter of 2020, Innoviva acquired 8,710,800 shares of common stock as well as warrants to purchase 8,710,800 additional shares of common stock of Armata Pharmaceuticals, Inc. (“Armata”) for approximately $ 25.0 million in cash. Armata is a clinical stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections.
During the first quarter of 2021, ISO entered into a securities purchase agreement with Armata to acquire 6,153,847 shares of Armata common stock and warrants to purchase 6,153,847 additional shares of Armata common stock for approximately $ 20.0 million. Armata also entered into a voting agreement with the Company and ISO, pursuant to which the Company and ISO agreed not to vote or take any action by written consent with respect to any common shares held by the Company and ISO that represent, in the aggregate, more than 49.5 % of the total number of shares of Armata’s common stock for voting on the matters related to election or removal of Armata’s board members. The voting agreement will expire on the earlier of the second anniversary of the agreement effective date and approval by the FDA of any of Armata’s product candidates for marketing and commercial distribution. During the fourth quarter of 2021, ISO also purchased an additional 1,212,122 shares of Armata common stock for approximately $ 4.0 million.
On February 9, 2022, ISO entered into a securities purchase agreement with Armata to acquire 9,000,000 shares of Armata common stock and warrants to purchase 4,500,000 additional shares of common stock with an exercise price of $ 5.00 per share for $ 45.0 million. The investment closed in two tranches on February 9, 2022 and March 31, 2022. The investment is intended to aid Armata in advancing its clinical pipeline and strengthening its bacteriophage platform.
On February 9, 2022, Armata also entered a second amended and restated voting agreement with the Company and ISO, pursuant to which the Company and ISO agreed not to vote or take any action by written consent with respect to any common shares held by the Company and ISO that represent, in the aggregate, more than 49.5 % of the total number of shares of Armata’s common stock for voting on the matters related to election or removal of Armata’s board members or amend the bylaws of Armata to reduce the maximum number of directors or set the number of directors who may serve on the board of Armata. The voting agreement will expire the earlier of the second anniversary of the agreement effective date and approval by the FDA of any of Armata’s product candidates for marketing and commercial distribution. In addition, as of February 9, 2022, Armata entered into an amended and restated investor rights agreement with the Company and ISO, pursuant to which for as long as the Company and ISO hold at least 12.5 % of the outstanding shares of Armata’s common stock on a fully-diluted, the Company and ISO shall have the right to designate two directors to Armata’s board of directors, and for so long as the Company and ISO hold at least 8 %, but less than 12.5 %, of the outstanding shares of Armata’s common stock on a fully-diluted basis, the Company and ISO shall have the right to designate one director to Armata’s board of directors, subject to certain conditions and qualifications set forth in the amended and restated investor rights agreement.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
On July 10, 2023, Armata entered into an amendment to the amended and restated investor rights agreement with the Company and ISO, pursuant to which the Company and ISO agreed that the voting agreement will expire on the earlier of the fifth anniversary of the original agreement’s effective date, January 26, 2021, or the approval by the FDA of any of Armata’s product candidates for marketing and commercial distribution.
As of December 31, 2024, three of the seven members of Armata’s board of directors are also members of the board of directors of Innoviva. As of December 31, 2024 and 2023, we owned approximately 69.3 % and 69.4 %, respectively, of Armata’s common stock.
On January 10, 2023, we entered into a Secured Convertible Credit Agreement (the “Credit Agreement”) with Armata, under which we invested in a one-year convertible note (the “Armata Convertible Note”) in an aggregate amount of $ 30.0 million at an interest rate of 8.0 % per annum. Pursuant to the Credit Agreement, the balance on the Armata Convertible Note, including all accrued and unpaid interest thereon, will convert into shares of Armata ’s common stock upon the occurrence of a qualified financing, as defined in the Credit Agreement. Any portion of the balance on the Armata Convertible Note, including all accrued and unpaid interest thereon, may also be converted into shares of Armata’ s common stock at our option once a registration statement covering the resale of such securities has been declared effective by the SEC. The Armata Convertible Note is secured by substantially all of the assets of Armata and its domestic and foreign material subsidiaries. On July 10, 2023, ISO and Armata executed an amendment to the Armata Convertible Note extending the maturity date from January 10, 2024 to January 10, 2025 . On November 12, 2024, ISO and Armata executed an amendment to the Armata Convertible Note extending the maturity date from January 10, 2025 to January 10, 2026 .
On July 10, 2023, ISO and Armata entered into a Credit and Security Agreement (the “July 2023 Credit and Security Agreement"), under which we extended a term loan to Armata (the “Armata July 2023 Term Loan”) in an aggregate amount of $ 25.0 million. The Armata July 2023 Term Loan is subject to an interest rate of 14 % per annum and is due to mature on January 10, 2025 . The July 2023 Credit and Security Agreement is secured by substantially all of the assets of Armata and its domestic and foreign material subsidiaries. On November 12, 2024, ISO and Armata executed an amendment to the Armata July 2023 Term Loan extending the maturity date from January 10, 2025 to January 10, 2026 .
On March 4, 2024, ISO and Armata entered into a Credit and Security Agreement (the “March 2024 Credit and Security Agreement”), under which we extended a term loan to Armata (the “Armata March 2024 Term Loan”) in an aggregate amount of $ 35.0 million. The Armata March 2024 Term Loan is subject to an interest rate of 14 % per annum and is due to mature on June 4, 2025 . The March 2024 Credit and Security Agreement is secured by substantially all of the assets of Armata and its domestic and foreign material subsidiaries.
The investments in Armata’s common stock and warrants provide Innoviva and ISO the ability to have significant influence, but not control, over Armata’s operations. Armata’s business and affairs are managed under the direction of its board of directors, which Innoviva and ISO do not control. Based on our evaluation, we determined that Armata is a VIE, but Innoviva and ISO are not the primary beneficiaries of the VIE. We have not provided financial or other support that we were not previously contractually required to provide during the periods presented. Our maximum exposure to loss is equal to the amount we invested in the entity.
We account for Armata’s common stock and warrants under the equity method using the fair value option. The fair value of Armata’s common stock is measured based on its closing market price. 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 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. We account for the Armata Convertible Note as a trading security, measured at fair value using a Monte Carlo simulation model with the probability of certain qualified events and the assumptions of risk-free rate, volatility of stock price and timing of certain qualified events. We account for the Armata July 2023 Term Loan and the Armata March 2024 Term Loan as trading securities, measured at fair value using income approach based on the discounted value of expected future cash flows.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
As of December 31, 2024, the fair values of our holdings of Armata common stock, warrants, the Armata Convertible Note, the Armata July 2023 Term Loan and the Armata March 2024 Term Loan were estimated at $ 46.4 million, $ 5.9 million, $ 42.1 million, $ 30.2 million and $ 39.3 million, respectively . As of December 31, 2023 the fair values of our holdings of Armata common stock, warrants, the Armata Convertible Note and Armata July 2023 Term Loan were estimated at $ 81.2 million, $ 35.3 million, $ 51.9 million and $ 27.0 million, respectively.
For the Armata common stock and warrants, we recorded $ 64.3 million unrealized losses, $ 77.4 million unrealized gains and $ 152.5 million unrealized losses as changes in fair values of equity method investments, net, in the consolidated statements of income for the years ended December 31, 2024, 2023 and 2022, respectively .
For the Armata Convertible Note, we recorded $ 9.8 million unrealized losses and $ 21.8 million unrealized gains as changes in fair values of equity and long-term investments, net, in the consolidated statements of income for the years ended December 31, 2024 and 2023, respectively.
For the Armata July 2023 Term Loan, we rec orded $ 3.2 million and $ 2.0 million unrealized gains as changes in fair values of equity and long-term investments, net, in the consolidated statements of income for the years ended December 31, 2024 and 2023, respectively.
For the Armata March 2024 Term Loan, we recorded $ 4.3 million unrealized gains as changes in fair values of equity and long-term investments, net, in the consolidated statements of income for the year ended December 31, 2024.
The summarized financial information, including the portion we do not own, is presented for Armata on a one quarter lag as follows:
Balance Sheet Information
September 30,
(In thousands)
2024
2023
Current assets
$
22,389
$
36,585
Noncurrent assets
$
75,848
$
76,176
Current liabilities
$
118,204
$
21,884
Noncurrent liabilities
$
31,006
$
103,263
Income Statement Information
Twelve Months Ended September 30,
(In thousands)
2024
2023
2022
Revenue
$
5,467
$
4,052
$
5,446
Loss from operations
$
( 38,476
)
$
( 41,639
)
$
( 32,666
)
Net loss
$
( 41,363
)
$
( 59,512
)
$
( 32,650
)
Equity Method Investment in Entasis
Prior to the consolidation of Entasis’ financial position and results of operations in February 2022, we accounted for Entasis as an equity method investment. Refer to Note 5, “Consolidated Entities and Acquisitions”, for more information.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Equity Investment in InCarda
During the third quarter of 2020, TRC purchased 20,469,432 shares of Series C preferred stock and a warrant to purchase 5,117,358 additional shares of Series C preferred stock of InCarda Therapeutics, Inc. (“InCarda”) (the “InCarda 2020 Warrant”) for $ 15.8 million, which included $ 0.8 million of transaction costs. InCarda is a privately held biopharmaceutical company focused on developing inhaled therapies for cardiovascular diseases. The investment is intended to fund the ongoing clinical development of InRhythm TM (flecainide for inhalation), InCarda’s lead program, for the treatment of a recent-onset episode of paroxysmal atrial fibrillation. On July 20, 2022, under the terms of the TRC Equity Purchase Agreement, TRC transferred to Innoviva’s wholly-owned subsidiary, Innoviva TRC Holdings, LLC (“ITH”) all of TRC’s ownership interests and investments in InCarda. ITH has the right to designate one member to InCarda’s board of directors. As of December 31, 2024, no ITH designee is serving on InCarda’s six -member board. We did not exercise the InCarda 2020 Warrant which expired in March 2023 and wrote off its carrying value of $ 0.1 million during 2023.
On March 9, 2022, TRC entered into a Note and Warrant Purchase Agreement (the “InCarda Agreement”) with InCarda to acquire a convertible promissory note (the “InCarda Convertible Note”) and warrants (the “InCarda 2022 Warrant”) for $ 0.7 million. The InCarda 2022 Warrant expires on March 9, 2027 and is measured at fair value.
On June 15, 2022, the principal amount and the accrued interest of the InCarda Convertible Note were converted into equity securities. In addition, TRC participated in InCarda’s Series D preferred stock financing by investing $ 2.3 million. In connection with the new round of financing, InCarda recapitalized its equity structure resulting in TRC owning 4,093,886 shares of InCarda’s common stock, 37,350 shares of its Series A-1 preferred stock, 20,469,432 shares of its Series C preferred stock, 8,771,780 shares of its Series D-1 preferred stock, 3,369,802 shares of its Series D-2 preferred stock, a warrant to purchase 5,117,358 shares of its Series C preferred stock at $ 0.73 per share and a warrant to purchase 2,490,033 shares of its Series D-1 preferred stock at $ 0.20 per share.
As of December 31, 2024 and 2023, we held 9.1 % and 8.1 % of InCarda equity ownership, respectively. Our investment in InCarda does not provide us with the ability to control or have significant influence over InCarda’s operations. Based on our evaluation, we determined that InCarda is a VIE, but we are not the primary beneficiary of the VIE. We have not provided financial or other support that we were not previously contractually required to provide during the periods presented. Our maximum exposure to loss is equal to the amount we invested in the entity.
With the exception of the InCarda Series D Warrants, which is measured at fair value, we account for the aforementioned investments in InCarda under the measurement alternative. Under the measurement alternative, the equity investment is initially recorded at its allocated cost, but the carrying value may be adjusted through earnings upon an impairment or when there is an observable price change involving the same or a similar investment with the same issuer. Due to InCarda’s equity recapitalization in the second quarter of 2022, TRC reassessed the value of its investments in InCarda using the Option Pricing Model Backsolve valuation methodology. Key assumptions used in the valuation model included an expected holding period of two years , a risk-free interest rate of 3.2 %, a dividend yield of 0.0 % and an estimated volatility of 122.0 %. The estimated volatility was calculated based on the historical volatility of a selected peer group of public companies comparable to InCarda. We recognized an impairment charge of $ 9.0 million during the second quarter of 2022.
Due to certain changes in InCarda’s business operations during the second quarter of 2023, ITH reassessed the value of its investments in InCarda using the Option Pricing Model methodology. Key assumptions used in the valuation model included an expected holding period of two years , a risk-free interest rate of 4.9 %, a dividend yield of 0.0 % and an estimated volatility of 114.2 %. The estimated volatility was calculated based on the historical volatility of a selected peer group of public companies comparable to InCarda. We recognized an impairment charge of $ 2.9 million during the second quarter of 2023.
On January 17, 2024, ITH purchased a secured convertible promissory note (the “InCarda Convertible Note”) from InCarda for a total purchase price of $ 0.4 million. The InCarda Convertible Note bears an annual interest rate of 8 % and shall be due and payable upon the earlier to occur of certain events defined in the InCarda Convertible Note. The InCarda Convertible Note will convert into equity securities or shadow equity securities of InCarda depending upon the occurrence of a qualified event or a qualified financing event as also defined in the InCarda Convertible Note. The InCarda Convertible Note is secured by certain intellectual property rights of InCarda. We account for the InCarda Convertible Note as a trading security, measured at fair value.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
As of December 31, 2024 and 2023, we recorded as equity and long-term investments in the consolidated balance sheets $ 4.8 million in carrying amount of InCarda’s Series C preferred stock and $ 0.1 million in fair value of the InCarda Series D Warrants. As of December 31, 2024 and 2023, we recognized as equity and long-term investments in the consolidated balance sheets $ 2.7 million, for InCarda’s Series D-1 preferred stock, Series D-2 preferred stock, and common stock using the measurement alternative. As of December 31, 2024, we recorded $ 0.4 million in fair value of the InCarda Convertible Note as equity and long-term investments in the consolidated balance sheet. During the year ended December 31, 2024, there were immaterial changes in the carrying amount of our investments. We recorded $ 3.1 million and $ 8.7 million in unrealized loss as changes in fair values of equity and long-term investments, net, in the consolidated statements of income for the years ended December 31, 2023 and 2022, respectively.
Equity Investment in ImaginAb
On March 18, 2021, TRC entered into a securities purchase agreement with ImaginAb, Inc. (“ImaginAb”) to purchase 4,051,724 shares of ImaginAb Series C preferred stock for $ 4.7 million. On the same day, TRC also entered into a securities purchase agreement with one of ImaginAb’s common stockholders to purchase 4,097,157 shares of ImaginAb common stock for $ 1.3 million. ImaginAb is a privately held biotechnology company focused on clinically managing cancer and autoimmune diseases via molecular imaging. $ 0.4 million was incurred for investment due diligence costs and execution and recorded as part of the equity investment in the consolidated balance sheets.
On July 20, 2022, under the terms of the TRC Equity Purchase Agreement, TRC transferred to ITH all of TRC’s ownership interests and investments in ImaginAb.
On March 14, 2023, ITH entered into a securities purchase agreement with ImaginAb to purchase 270,568 shares of ImaginAb Series C-2 preferred stock for $ 0.6 million. On September 14, 2023, ITH entered into a securities purchase agreement with ImaginAb to purchase another 405,852 shares of ImaginAb Series C-2 preferred stock for $ 0.6 million.
On February 23, 2024, ITH purchased a subordinated convertible promissory note (the “ImaginAb Convertible Note”) from ImaginAb for a total purchase price of $ 2.7 million. The ImaginAb Convertible Note bears an annual interest rate of 10 % and shall be due and payable upon the earlier to occur of January 31, 2025 and certain events defined in the ImaginAb Convertible Note. Under certain circumstances, the ImaginAb Convertible Note is convertible at the option of ITH into ImaginAb’s equity securities at defined conversion prices. The ImaginAb Convertible Note is subordinate to certain existing indebtedness of ImaginAb as defined in the ImaginAb Convertible Note. On October 31, 2024, ITH entered into an agreement with ImaginAb to amend the ImaginAb Convertible Note. Pursuant to the agreement, the principal amount of the ImaginAb Convertible Note was increased from $ 2.7 million to $ 4.8 million, which represents the principal as of February 23, 2024, accrued interest as of amendment date, commitment fees and an additional cash investment of $ 1.5 million. On January 13, 2025, ITH and ImaginAb executed an amendment to the ImaginAb Convertible Note extending the maturity date from January 31, 2025 to May 30, 2025. All other material terms of the ImaginAb Convertible Note were unchanged during the aforementioned amendments to the ImaginAb Convertible Note. As of December 31, 2024, one of ImaginAb’s six board members was designated by ITH. As of December 31, 2024 and 2023, we held 11.8 % and 12.4 %, respectively, of ImaginAb equity ownership.
Our investment in ImaginAb does not provide us with the ability to control or have significant influence over ImaginAb’s operations. Based on our evaluation, we determined that ImaginAb is a VIE, but we are not the primary beneficiary of the VIE. We have not provided financial or other support that we were not previously contractually required to provide during the periods presented. Our maximum exposure to loss is equal to the amount we invested in the entity.
Because ImaginAb’s equity securities are not publicly traded and do not have a readily determinable fair value, we account for our investment in ImaginAb’s Series C preferred stock, Series C-2 preferred stock and common stock using the measurement alternative. We account for the ImaginAb Convertible Note as a trading security, measured at fair value using a Monte Carlo simulation model with the probability of certain qualified events and the assumptions of risk-free rate, volatility of stock price and timing of certain qualified events. As of December 31, 2024 and 2023, our investment in ImaginAb’s Series C preferred stock, Series C-2 preferred stock and common stock amounted to $ 7.6 million and recorded as equity and long-term investments in the consolidated balance sheets. As of December 31, 2024, we recorded $ 5.0 million in fair value of the ImaginAb Convertible Note as equity and long-term investments in the consolidated balance sheets. During the year ended December 31, 2024, we recorded $ 0.1 million in net unrealized gain on the ImaginAb Convertible Note as changes in fair values of equity and long-term investments, net, in the consolidated statements of income. There was no change in the carrying amount of our equity investments in ImaginAb.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Convertible Promissory Note in Gate Neurosciences
On November 24, 2021, TRC entered into a Convertible Promissory Note Purchase Agreement with Gate to acquire a convertible promissory note (the “Gate Convertible Note”) with a principal amount of $ 15.0 million. Gate is a privately held biopharmaceutical company focused on developing the next generation of targeted nervous system therapies, leveraging precision medicine approaches to develop breakthrough drugs for psychiatric and neurologic diseases. The investment is intended to fund Gate ’ s ongoing development and research. The Gate Convertible Note bears an annual interest rate of 8 % and will convert into shares of common stock of Gate upon a qualified event or into shares of shadow preferred stock of Gate (“Shadow Preferred”) upon a qualified financing. A qualifying event can be a qualified initial price offering, a qualified merger, or a merger with a special-purpose acquisition company (“SPAC”). Shadow Preferred means preferred stock having identical rights, preferences and restrictions as the preferred stock that would be issued in a qualified financing.
The number of common stock shares to be issued in a qualified event shall be equal to the amount due on the conversion date divided by the lesser of a capped conversion price (the “Capped Conversion Price”) and the qualified event price (the “Qualified Event Price”). The Capped Conversion Price is calculated as $50.0 million divided by the number of shares of common stock outstanding at such time on a fully diluted basis. The Qualified Event Price is the price per share determined by the qualified event. A qualified financing is a sale or series of sales of preferred stock where (i) at least 50 percent of counterparties are not existing shareholders, (ii) net proceeds to Gate are at least $35.0 million, and (iii) the stated or implied equity valuation of Gate is at least $80.0 million.
On July 20, 2022, under the terms of the TRC Equity Purchase Agreement, TRC transferred to ITH all of TRC’s debt investments in Gate.
On February 2, 2023, ITH entered into a Note Amendment Agreement with Gate to amend the Gate Convertible Note. Pursuant to the Note Amendment Agreement, the principal amount of the Gate Convertible Note was increased from $ 15.0 million to $ 21.5 million, which represents the original principal, accrued interest as of the amendment date and an additional cash investment of $ 5.0 million. All other material terms of the Gate Convertible Note were unchanged.
On October 6, 2023, ITH entered into a Second Note Amendment Agreement with Gate to amend the Note Amendment Agreement. Pursuant to the Second Note Amendment Agreement, the principal amount of the Gate Convertible Note was increased from $ 21.5 million to $ 27.7 million, which represents the amended principal as of February 2, 2023, accrued interest as of the second amendment date and an additional cash investment of $ 5.0 million. All other material terms of the Gate Convertible Note were unchanged.
On February 13, 2024, ITH entered into a Third Note Amendment Agreement with Gate to amend the Gate Convertible Note. Pursuant to the Third Note Amendment Agreement, the principal amount of the Gate Convertible Note was increased from $ 27.7 million to $ 33.5 million, which represents the principal and accrued interest as of the third amendment date and an additional cash investment of $ 5.0 million. All other material terms of the Gate Convertible Note were unchanged.
On August 5, 2024, ITH entered into a Fourth Note Amendment Agreement with Gate to amend the Gate Convertible Note. Pursuant to the Fourth Note Amendment Agreement, the principal amount of the Gate Convertible Note was increased from $ 33.5 million to $ 39.8 million, which represents the principal and accrued interest as of the fourth amendment date and an additional cash investment of $ 5.0 million. All other material terms of the Gate Convertible Note were unchanged.
On November 13, 2024, ITH entered into a Fifth Note Amendment Agreement with Gate to amend the Gate Convertible Note. Pursuant to the Fifth Note Amendment Agreement, the principal amount of the Gate Convertible Note was increased from $ 39.8 million to $ 50.6 million, which represents the principal and accrued interest as of the fifth amendment date and an additional cash investment of $ 10.0 million. All other material terms, except for the conversion terms of the Gate Convertible Note, remained unchanged.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
We have accounted for the Gate Convertible Note as a trading security, measured at fair value using a Monte Carlo simulation model with the probability of certain qualified events and the assumptions of equity value of Gate, risk-free rate, expected stock price, volatility of its peer companies, and the time until a financing is raised. As of December 31, 2024 and 2023, the fair value of the Gate Convertible Note was estimated at $ 50.9 million and $ 28.0 million, respectively, and recorded as equity and long-term investments in the consolidated balance sheets. We recorded $ 0.4 million of unrealized loss and $ 0.6 million of unrealized gain as changes in fair values of equity and long-term investments, net, in the consolidated statements of income for the years ended December 31, 2023 and 2022, respectively. The change in fair value is not material for the year ended December 31, 2024.
Equity Investment in Nanolive
On February 18, 2022, TRC entered into an investment and shareholders agreement with Nanolive to purchase 18,750,000 shares of Nanolive Series C preferred stock for $ 9.8 million (equivalent to 9.0 million CHF). Nanolive SA is a Swiss privately held life sciences company focused on developing breakthrough imaging solutions that accelerate research in growth industries such as drug discovery and cell therapy. $ 0.7 million was incurred for investment due diligence costs and execution and recorded as part of the equity and long-term investment in the consolidated balance sheets. On July 20, 2022, under the terms of the TRC Equity Purchase Agreement, TRC transferred to ITH all of TRC’s ownership interests and investments in Nanolive. ITH has the right to designate one member to Nanolive’s board. ITH also has the right to designate another member, who will be mutually acceptable to ITH and another stockholder, to Nanolive’s board. As of December 31, 2024 , no Innoviva designee is serving on Nanolive’s six -member board. As of December 31, 2024 and 2023 , we held 13.0 % and 15.3 % of Nanolive equity ownership, respectively.
Our investment in Nanolive does not provide us with the ability to control or have significant influence over Nanolive’s operations. Based on our evaluation, we determined that Nanolive is a VIE, but we are not the primary beneficiary of the VIE. We have not provided financial or other support that we were not previously contractually required to provide during the periods presented. Our maximum exposure to loss is equal to the amount we invested in the entity.
Because Nanolive’s equity securities are not publicly traded and do not have a readily determinable fair value, we account for our investment in Nanolive’s Series C preferred stock using the measurement alternative. As of December 31, 2024 and 2023, $ 10.6 million of investment in Nanolive was recorded as equity and long-term investments in the consolidated balance sheets, and there was no change to the carrying amount of our investment.
Reconciliation of Equity and Long-Term Investments Balances
The following table reconciles the change in balances in “Equity and Long-Term Investments” as of each balance sheet date:
(In thousands)
Equity and long-term investments as of December 31, 2022
$
363,859
Purchases of trading securities
67,798
Purchases of equity and long-term investments
1,218
Changes in fair value, net
11,129
Other
428
Equity and long-term investments as of December 31, 2023
444,432
Purchases of trading securities
63,201
Changes in fair value, net
( 59,161
)
Reclassification of current portion
( 107,532
)
Other
724
Equity and long-term investments as of December 31, 2024
$
341,664
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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:
December 31, 2024
Gross
Gross
Amortized
Unrealized
Unrealized
Estimated
(In thousands)
Cost
Gains
Losses
Fair Value
Money market funds (1)
$
289,441
$
—
$
—
$
289,441
Total
$
289,441
$
—
$
—
$
289,441
(1) Money market funds are included in cash and cash equivalents in the consolidated balance sheets .
December 31, 2023
Gross
Gross
Amortized
Unrealized
Unrealized
Estimated
(In thousands)
Cost
Gains
Losses
Fair Value
Money market funds (1)
$
170,706
$
—
$
—
$
170,706
Total
$
170,706
$
—
$
—
$
170,706
(1) Money market funds are included in cash and cash equivalents in the consolidated balance sheets.
As of December 31, 2024 and 2023, all available-for-sale securities were money market funds, and there was no credit loss recognized.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Fair Value Measurements
Our available-for-sale securities, equity and long-term investments and contingent value rights are measured at fair value on a recurring basis and our debt is carried at amortized cost basis.
Estimated Fair Value Measurements as of December 31, 2024 Using:
Quoted Price
in Active
Markets for
Significant
Other
Significant
Identical
Observable
Unobservable
Types of Instruments
Assets
Inputs
Inputs
(In thousands)
Level 1
Level 2
Level 3
Total
Assets
Money market funds
$
289,441
$
—
$
—
$
289,441
Investments held by ISP Fund LP
193,560
—
62,098
255,658
Equity investment - Armata Common Stock
46,392
—
—
46,392
Equity investment - Armata Warrants
—
5,901
—
5,901
Equity investment - InCarda Warrants
—
—
59
59
Convertible debt investment - Armata Note
—
—
42,095
42,095
Term loan investment - Armata July 2023 Term Loan
—
—
30,197
30,197
Term loan investment - Armata March 2024 Term Loan
—
—
39,275
39,275
Convertible debt investment - InCarda Note
—
—
436
436
Convertible debt investment - ImaginAb Note
—
—
4,950
4,950
Convertible debt investment - Gate Note
—
—
50,881
50,881
Total assets measured at estimated fair value
$
529,393
$
5,901
$
229,991
$
765,285
Liabilities
Debt
2025 Notes
$
—
$
222,353
$
—
$
222,353
2028 Notes
—
251,213
—
251,213
Total fair value of debt
$
—
$
473,566
$
—
$
473,566
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Estimated Fair Value Measurements as of December 31, 2023 Using:
Quoted Price
in Active
Significant
Markets for
Other
Significant
Identical
Observable
Unobservable
Types of Instruments
Assets
Inputs
Inputs
(In thousands)
Level 1
Level 2
Level 3
Total
Assets
Money market funds
$
170,706
$
—
$
—
$
170,706
Investments held by ISP Fund LP
251,207
—
60,605
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 July 2023 Term Loan
—
—
27,044
27,044
Convertible debt investment - Gate Note
—
—
27,972
27,972
Total assets measured at estimated fair value
$
503,162
$
35,297
$
167,504
$
705,963
Debt
2025 Notes
$
—
$
200,407
$
—
$
200,407
2028 Notes
—
227,070
—
227,070
Total fair value of debt
—
427,477
—
427,477
Contingent value rights
—
—
359
359
Total liabilities at estimated fair value
$
—
$
427,477
$
359
$
427,836
There were no transfers between Level 1, Level 2 or Level 3 during the periods presented.
The fair values of our equity investments in Armata’s common stock and publicly traded investments held by ISP Fund LP are based on the quoted prices in active markets and are classified as Level 1 financial instruments. The fair values in the warrants in Armata classified within Level 2 are 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 Gate Convertible Note, the Armata Convertible Note, the Armata July 2023 Term Loan, the Armata March 2024 Term Loan, The Incarda Covertible Note, the InCarda Warrants, the ImaginAb Convertible Note, private placement positions and convertible notes held by ISP Fund LP, and contingent value rights are classified as Level 3 financial instruments as these securities are not publicly traded and the assumptions used in the valuation model for valuing these securities are based on significant unobservable and observable inputs including those of publicly traded peer companies.
The fair values of our 2025 Notes and 2028 Notes are based on recent trading prices of the respective instruments.
7. CAPITALIZED FEES PAID
Capitalized fees paid, which consist of registrational and launch-related milestone fees paid to GSK, were as follows:
December 31,
(In thousands)
Amortization period
2024
2023
United States
2013-2030
$
120,000
$
120,000
Europe
2013-2029
60,000
60,000
Japan
2013-2029
40,000
40,000
Gross carrying value
220,000
220,000
Accumulated amortization
( 150,039
)
( 136,216
)
Net carrying value
$
69,961
$
83,784
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
These milestone fees are amortized over their estimated useful lives commencing upon the commercial launch of the product in their respective regions with the amortization recorded as a reduction in revenue from collaborative arrangements. As of December 31, 2024, the weighted average remaining amortization period wa s 5.2 years.
Additional information regarding these milestone fees is included in Note 3, “Revenue Recognition”. Amortization for each of the years ended December 31, 2024, 2023 and 2022 was $ 13.8 million . The remaining estimated amortization is $ 13.8 million for each of the years from 2025 to 2027, $ 13.7 million for the year 2028, $ 9.4 million for the year 2029 and $ 5.4 million thereafter.
8. GOODWILL AND INTANGIBLE ASSETS
Goodwill and intangible assets acquired are recognized at fair value as of the acquisition date. The carrying amount of goodwill as of December 31, 2024 and 2023 was $ 17.9 million . We have no t recognized any impairment losses related to goodwill and intangible assets during the periods presented.
Intangible assets with definite lives are amortized over their estimated useful lives. The carrying basis and accumulated amortization of recognized intangible assets as of December 31, 2024 and 2023 were as follows:
December 31, 2024
Useful Life
Gross
Accumulated
Net Carrying
(In thousands)
(Years)
Amount
Amortization
Amount
Marketed products
8 - 10
$
223,700
$
( 47,559
)
$
176,141
In-process research and development
2,600
—
2,600
Collaboration agreement
10
35,400
( 5,708
)
29,692
Total
$
261,700
$
( 53,267
)
$
208,433
December 31, 2023
Useful Life
Gross
Accumulated
Net Carrying
(In thousands)
(Years)
Amount
Amortization
Amount
Marketed products
8 - 10
$
219,700
$
( 25,204
)
$
194,496
In-process research and development
2,600
—
2,600
Collaboration agreement
10
35,400
( 2,161
)
33,239
Total
$
257,700
$
( 27,365
)
$
230,335
Intangible assets recognized as a result of the acquisition of Entasis amounted to $ 106.7 million, which consisted of Entasis’ in-process research and development related to its antibacterial therapeutic product candidates and a collaboration agreement amounting to $ 71.3 million and $ 35.4 million, respectively. Following the FDA approval of XACDURO ® in May 2023, we started amortizing $ 68.7 million of the then in-process research and development as a marketed product, as well as the collaboration agreement, over their estimated useful lives. The useful life of the remaining in-process research and development of $ 2.6 million will be determined upon commercialization of the underlying product candidate; thus, no amortization expense for this intangible asset was recognized for the periods presented.
Intangible assets recognized as a result of the acquisition of La Jolla amounting to $ 151.0 million pertain to product rights and developed technologies on La Jolla’s currently marketed products. These are intangible assets with determinable lives and are amortized over their estimated useful lives.
As discussed in Note 4 “License and Collaboration Arrangements”, we capitalized the upfront fee of $ 4.0 million that we paid to Basilea under our exclusive distribution and license agreement as an intangible asset. This amount is included in marketed products in the table above and will be amortized over the term of the agreement.
We recognized amortization expense of $ 25.9 million, $ 21.8 million and $ 5.6 million for the years ended December 31, 2024, 2023 and 2022, respectively. Future amortization expense is expected to be $ 26.3 million for each of the years from 2025 to 2029 and $ 74.3 million thereafter.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
9. BALANCE SHEET COMPONENTS
Inventory
Inventory consisted of the following:
December 31,
(In thousands)
2024
2023
Raw materials
$
11,113
$
11,257
Work-in-process
20,529
15,670
Finished goods
2,083
13,810
Total inventory
$
33,725
$
40,737
As of December 31, 2024 and 2023, total inventory included net fair value adjustments resulting from the acquisition of La Jolla of approximately $ 9.2 million and $ 23.0 million, respectively , which will be recognized as cost of products sold when sales occur in future periods. The fair value adjustments recorded as part of cost of products sold amounted to $ 13.8 million, $27 .2 million and $ 10.0 million for the years ended December 31, 2024, 2023 and 2022, respectively.
Other Accrued Liabilities
Other accrued liabilities consisted of the following:
December 31,
(In thousands)
2024
2023
Accrued contract manufacturing expenses
$
1,071
$
1,966
Accrued clinical and research expenses
611
776
Accrued professional services
8,682
8,876
Current portion of lease liabilities
1,572
1,207
Royalty obligation payable
2,951
1,928
Current portion of deferred royalty obligation
6,438
—
Accrued license fees and royalties
1,727
1,575
Other
6,947
3,370
Total other accrued liabilities
$
29,999
$
19,698
Amount in “Other” as of December 31, 2024 includes $ 5.3 million in consideration received under a letter agreement we have entered into with Zai Lab as discussed in Note 4, “License and Collaboration Arrangements”.
Other Long-Term Liabilities
Other long-term liabilities consisted of the following:
December 31,
(In thousands)
2024
2023
Long-term portion of deferred royalty obligation
$
63,096
$
69,876
Long-term portion of lease liabilities
1,179
1,635
Contingent value rights liability
—
359
Total other long-term liabilities
$
64,275
$
71,870
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. STOCK‑BASED COMPENSATION
Equity Incentive Plans
In May 2012, we adopted the 2012 Equity Incentive Plan (the “2012 Plan”). The 2012 Plan provides for the grant of incentive stock options, nonstatutory stock options, RSAs, RSUs and Stock Appreciation Rights to employees, non-employee directors and consultants. As of December 31, 2024 , total shares remaining available for issuance under the 2012 Plan were 1,758,450 .
Employee Stock Purchase Plan
Under the 2004 Employee Stock Purchase Plan (the “2004 ESPP”), our employees may purchase common stock through payroll deductions at a price equal to 85 % of the lower of the fair market value of the stock at the beginning of the offering period or at the end of each applicable purchase period. The 2004 ESPP provided for consecutive and overlapping offering periods of 24 months in duration, with each offering period composed of four consecutive six-month purchase periods. The purchase periods ended on either May 15 or November 15. The 2004 ESPP contributions were limited to a maximum of 15 % of an employee’s eligible compensation. The maximum number of shares that an employee may purchase in any purchase period was 2,500 . An employee may not purchase shares with a value greater than $ 25,000 in any calendar year.
On April 13, 2023, the Board of Directors adopted the 2023 ESPP (the “2023 ESPP”). The 2023 ESPP, which supersedes the 2004 ESPP, was approved by the Company’s stockholders on May 22, 2023. Under the 2023 ESPP, eligible employees may purchase common stock through payroll deductions at a price equal to 85 % of the lower of the fair market value of the stock at the beginning or end of each applicable purchase period. The 2023 ESPP provides for offering periods of six months , which ends on either May 15 or November 15. The 2023 ESPP contributions are limited to a maximum of 15 % of an employee’s eligible compensation. The maximum number of shares that an employee may purchase in any purchase period is 2,500 . An employee may not purchase shares with a value greater than $ 25,000 in any calendar year. A total of 2.5 million shares of our common stock was reserved and available for issuance under the 2023 ESPP.
As of December 31, 2024 , total shares remaining available for issuance under the 2024 ESPP were 2,467,596 .
Director Compensation Program
Our non-employee directors receive compensation for services provided as a director. Each member of our board of directors who is not an employee receives both cash and equity compensation for services as a director, member of a committee of the board of directors, lead independent director and chairman, as applicable. In October 2017, both the cash and equity components of the compensation program were amended, effective immediately (the “October 2017 Amendments”).
Each of our independent directors receives periodic automatic grants of equity awards under a program implemented under the 2012 Plan. These grants are non‑discretionary. Only our independent directors or affiliates of such directors are eligible to receive automatic grants under the 2012 Plan. Under the program, each individual who first became a non-employee director will, on the date such individual joins the board of directors, automatically be granted a one‑time grant of RSUs covering a number of shares of our common stock calculated as $ 125,000 ($ 250,000 prior to the October 2017 Amendments) divided by our common stock closing share price on the date of grant as reported on The Nasdaq Global Select Market, rounded down to the nearest whole share (the “Initial RSUs”), plus a one‑time grant of RSUs covering a number of shares of our common stock calculated as $ 225,000 ($ 250,000 prior to the October 2017 Amendments) divided by our common stock closing share price on the date of grant as reported on The Nasdaq Global Select Market, which would be pro-rated for the number of whole months remaining until the anniversary of the prior year’s stockholders’ meeting, rounded down to the nearest whole share (the “Pro Rata RSUs”). The Initial RSUs vest in two equal annual installments, while Pro Rata RSUs vest in a single installment at the sooner of the next annual stockholder meeting or the one-year grant anniversary, in each case subject to the non-employee director’s continuous service through the applicable vesting date.
Annually, upon his or her re‑election to the board of directors at the Annual Meeting of Stockholders, each non-employee director is automatically granted an RSU covering a number of shares of our common stock calculated as $ 225,000 ($ 250,000 prior to the October 2017 Amendments) divided by our common stock closing share price on the date of grant as reported on The Nasdaq Global Select Market, rounded down to the nearest whole share. These RSUs will vest at the sooner of the next annual stockholder meeting or the one-year anniversary of grant, subject to the non-employee director’s continuous service through the applicable vesting date. Following the amendment to our non-employee director compensation program, both the annual RSUs and Initial RSUs described above remained unchanged with the exception that the number of shares of our common stock subject to each award has been reduced.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
These RSUs will vest in full upon the director’s death, the occurrence of a change in control or, with respect to awards made after the October 2017 Amendments, the director’s disability before the director’s service terminates. Director RSUs carry dividend equivalent rights to be credited with an amount equal to all cash dividends paid on the underlying shares of common stock while unvested. Dividend equivalents are subject to the same terms and conditions, including vesting, as the RSUs to which they attach and are paid in cash upon vesting.
Stock‑Based Compensation Expense
Stock‑based compensation expense is included in the consolidated statements of income as follows:
Year Ended December 31,
(In thousands)
2024
2023
2022
Selling, general and administrative
$
6,040
$
4,645
$
5,305
Research and development
334
1,192
2,042
Total
$
6,374
$
5,837
$
7,347
Stock‑based compensation expense included in the consolidated statements of income by award type is as follows:
Year Ended December 31,
(In thousands)
2024
2023
2022
Stock options
$
2,738
$
1,980
$
3,057
RSUs
3,348
3,663
4,053
RSAs
123
168
194
ESPP
165
26
43
Total stock-based compensation expense
$
6,374
$
5,837
$
7,347
As of December 31, 2024, the unrecognized stock-based compensation cost and the estimated weighted-average amortization period were as follows:
(In thousands)
Unrecognized Compensation Cost
Weighted-Average Amortization Period (Years)
Stock options
$
6,765
2.8
RSUs
6,996
2.5
RSAs
98
1.3
Total unrecognized compensation expense
$
13,859
Compensation Awards
The following table summarizes equity award activity under the 2012 Plan and prior plans and related information:
(In thousands, except per share data)
Number of outstanding options
Weighted-Average Exercise Price of Outstanding Options
Number of outstanding RSUs
Weighted-Average Fair Value per Share at Grant
Number of outstanding RSAs
Weighted-Average Fair Value per Share at Grant
Balance as of December 31, 2023
1,499
$
14.09
482
$
12.62
16
$
14.93
Granted
1,062
$
16.67
502
$
15.77
—
$
—
Exercised
( 80
)
$
12.88
—
$
—
—
$
—
Released RSUs and RSAs
—
$
—
( 241
)
$
12.52
( 9
)
$
14.46
Forfeited
( 414
)
$
15.24
( 145
)
$
13.86
—
$
—
Balance as of December 31, 2024
2,067
$
15.23
598
$
15.00
7
$
15.50
Vested and expected to vest
as of December 31, 2024
2,067
$
15.23
598
$
15.00
—
$
—
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
As of December 31, 2024 , the aggregate intrinsic value of options outstanding and options exercisable was $ 5.0 million and $ 2.4 million, respectively . As of December 31, 2023, the aggregate intrinsic value of options outstanding and options exercisable was $ 3.6 million and $ 0.8 million, respectively . As of December 31, 2024, 759,904 options were exercisable. The weighted average remaining contractual term of options outstanding was 8.04 years and 7.96 years as of December 31, 2024 and 2023, respectively.
The total intrinsic value of the options exercised was no t material for the year ended December 31, 2024, 2023 and 2022. The total estimated fair value of options vested was $ 2.5 million and $ 1.9 million for the years ended December 31, 2024 and 2023, respectively. The total estimated fair value of options vested was no t material for the year ended December 31, 2022.
The total estimated fair value of RSUs vested was $ 3.2 million, $ 3.9 million and $ 2.3 million for the years December 31, 2024, 2023 and 2022, respectively.
The total estimated fair value of RSAs vested was not material for the year ended December 31, 2024, 2023, and 2022.
Valuation Assumptions
Black-Scholes-Merton weighted-average assumptions used in calculating the estimated value of stock options granted by Innoviva on the dates of grant were as follows:
Year Ended December 31,
2024
2023
2022
Risk-free interest rate
4.2
%
4.0
%
3.6
%
Expected term (in years)
6.10
6.09
6.04
Volatility
35.5
%
37.8
%
38.6
%
Dividend yield
0.0
%
0.0
%
0.0
%
Weighted-average estimated fair value of stock options granted
$
8.17
$
5.57
$
6.43
11. Stockholders’ Equity
On October 31, 2022, our board of directors authorized a share repurchase program under which we may repurchase up to $ 100.0 million of our outstanding shares of common stock. The repurchase program authorized the repurchase by the Company of its common stock in open market transactions, including pursuant to a trading plan in accordance with Rule 10b-18 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), privately negotiated transactions, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination thereof or by other means in accordance with federal securities laws. The authorization permitted management to repurchase shares of the Company’s common stock from time to time at management’s discretion. Repurchases may also be made pursuant to a trading plan under Rule 10b5-1 under the Exchange Act, which would permit shares to be repurchased when the Company might otherwise be precluded from doing so because of self-imposed trading blackout periods or other regulatory restrictions. From program inception through December 31, 2022, we repurchased 647,394 shares in the open market at an average price of $ 13.13 per share for a total amount of approximately $ 8.5 million. For the year ended December 31, 2023, we repurchased 6,173,565 shares in the open market at an average price of $ 12.39 per share for a total amount of approximately $ 76.5 million. From January to April 2024, we repurchased 986,928 shares in the open market at an average price of $ 15.12 per share for a total amount of approximately $ 14.9 million. The share repurchase program was completed in April 2024. All of the repurchased shares were retired.
In April 2024, we retired all shares held in treasury resulting from our strategic buyback of GSK’s common shares in the Company in 2021. We recorded the corresponding cost of treasury stock of $ 393.8 million in additional paid-in capital.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
12. DEBT
Our debt consists of the following:
December 31,
(In thousands)
2024
2023
2025 Notes
$
192,500
$
192,500
2028 Notes
261,000
261,000
Total debt
453,500
453,500
Less: Unamortized debt discount and issuance costs
( 5,156
)
( 7,266
)
Total debt, net
448,344
446,234
Less: Current portion of long-term debt, net
( 192,028
)
—
Total long-term debt, net
$
256,316
$
446,234
Convertible Subordinated Notes Due 2023
In January 2013, we completed an underwritten public offering of $ 287.5 million aggregate principal amount of our 2023 Notes, which matured on January 15, 2023. The 2023 Notes bore interest at the rate of 2.125 % per year that is payable semi-annually in arrears in cash on January 15 and July 15 of each year, beginning on July 15, 2013.
The 2023 Notes were convertible, at the option of the holder, into shares of our common stock at an initial conversion rate of 35.9903 shares per $1,000 principal amount of the 2023 Notes, subject to adjustment in certain circumstances, which represented an initial conversion price of approximately $ 27.79 per share.
In connection with the offering of the 2023 Notes, we entered into two privately negotiated capped call option transactions with a single counterparty. The capped call option transaction was an integrated instrument consisting of a call option on our common stock purchased by us with a strike price equal to the initial conversion price of $ 27.79 per share for the underlying number of shares and a cap price of $ 38.00 per share, both of which were subject to adjustments consistent with the 2023 Notes. The cap component was economically equivalent to a call option sold by us for the underlying number of shares with an initial strike price of $ 38.00 per share. As an integrated instrument, the settlement of the capped call coincided with the due date of the convertible debt. Upon settlement, we would receive from our hedge counterparty a number of shares of our common shares that would range from zero , if the stock price was below $ 27.79 per share, to a maximum of 2,779,659 shares, if the stock price was above $38.00 per share. However, if the market price of our common stock, as measured under the terms of the capped call transactions, exceeded $38.00 per share, there was no incremental anti-dilutive benefit from the capped call.
As a result of the partial conversion by certain holders of the 2023 Notes in July 2014, and dividends declared and paid in 2014 and 2015, the conversion rate with respect to our 2023 Notes was adjusted in total to 50.5818 shares of our common stock per $1,000 principal amount of the 2023 Notes, which represented a conversion price of approximately $ 19.77 per share. As a result of the conversion rate adjustments, the capped call strike price and cap price were also adjusted to $ 19.77 and $ 27.04 , respectively.
For the year ended December 31, 2016, we retired a portion of our 2023 Notes with a face value of $ 14.1 million and carrying value of $ 13.9 million by way of purchase in the open market.
On March 7, 2022, we used $ 165.6 million from the sale of the 2028 Notes to repurchase 60 % of the 2023 Notes with a face value of $ 144.8 million. The carrying value of the repurchased 2023 Notes was $ 144.5 million. Accrued interest was $ 0.4 million and unamortized debt issuance costs were $ 0.3 million on the date of repurchase. We recognized a loss on the extinguishment of the 2023 Notes of $ 20.7 million in other expense, net, in the consolidated statement of operations. The repurchase reduced the outstanding principal balance to $ 96.2 million and unamortized debt issuance costs to $ 0.2 million. The annual effective interest rate of the 2023 Notes changed from 2.36 % to 2.37 %.
On April 18, 2022, certain 2023 Notes holders converted their notes of $ 3.0 thousand into Innoviva’s common stock. The outstanding principal balance was reduced slightly to $ 96.2 million. This remaining balance was fully paid upon the maturity date in January 2023.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table sets forth total interest expense recognized related to the 2023 Notes for the years ended December 31, 2023 and 2022:
Year Ended December 31,
(In thousands)
2023
2022
Contractual interest expense
$
85
$
2,617
Amortization of debt issuance costs
11
302
Total interest and amortization expense
$
96
$
2,919
Convertible Senior Notes Due 2025
On August 7, 2017, we completed a private placement of $ 192.5 million aggregate principal amount of our 2025 Notes. The proceeds include the 2025 Notes sold pursuant to the $ 17.5 million over-allotment option granted by us to the initial purchasers, which option was exercised in full. The 2025 Notes were sold in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The 2025 Notes are senior unsecured obligations and bear interest at a rate of 2.5 % per year, payable semi-annually in arrears on February 15 and August 15 of each year, beginning on February 15, 2018.
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. The initial conversion rate for the 2025 Notes is 57.9240 shares of our common stock per $1,000 principal amount of the 2025 Notes (which is equivalent to an initial conversion price of approximately $ 17.26 per share), representing a 30.0 % conversion premium over the last reported sale price of the Company’s common stock on August 1, 2017, which was $ 13.28 per share. The conversion rate is subject to customary anti-dilution adjustments in certain circumstances. The 2025 Notes will mature on August 15, 2025 , unless repurchased or converted in accordance with their terms prior to such date. Prior to February 15, 2025, the 2025 Notes will be convertible at the option of the holders only upon the occurrence of specified events and during certain periods, as described below. From, and including, February 15, 2025, until the close of business on the second scheduled trading day immediately preceding the maturity date, the 2025 Notes will be convertible at any time.
Holders of the 2025 Notes may convert all or a portion of their 2025 Notes prior to the close of business on February 15, 2025 only under the following circumstances:
• after September 30, 2017, if our closing common stock price for at least 20 days out of the most recent 30 consecutive trading days of the preceding quarter is greater than 130 % of the current conversion price of the 2025 Notes;
• for five consecutive business days, if the average trading price per $1,000 of Notes during the prior 10 consecutive trading days is less than 98 % of the product of our closing common stock price and the conversion rate of the 2025 Notes on such day; and,
• upon the occurrence of specified corporate events, including certain distributions, the occurrence of a fundamental changes (as defined in the indenture governing the 2025 Notes) or a transaction resulting in our common stock converting into other securities or property or assets.
On or after February 15, 2025, holders of the 2025 Notes may convert their 2025 Notes at any time until the close of business on the second scheduled trading day immediately preceding the maturity date of the 2025 Notes.
In the event of default or a fundamental change (as defined above), holders of the 2025 Notes may require us to repurchase all or a portion of their 2025 Notes at price equal to 100 % of the principal amount of the 2025 Notes, plus any accrued and unpaid interest.
Effective January 1, 2022, we adopted ASU 2020-06 using a modified retrospective method, under which financial results reported in prior periods were not adjusted.
Prior to the adoption of ASU 2020-06, we separately accounted 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 of $ 67.3 million 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
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
the 2025 Notes on the date of issuance. The excess of the principal amount of the liability component over its carrying amount (“debt discount”) was amortized to interest expense using the effective interest method over the term of the 2025 Notes. The equity component was not remeasured as long as it continued to meet the conditions for equity classification. Additionally, we separated the total issuance costs of $ 5.4 million incurred into liability and equity components in proportion to the allocation of the initial proceeds, resulting in liability issuance costs of $ 3.5 million and equity issuance costs of $ 1.9 million. Issuance costs attributable to the liability component were amortized on a straight-line basis, which approximated the effective interest rate method, to interest expense over the term of the 2025 Notes. The issuance costs attributable to the equity component were netted against the equity component in additional paid-in capital. The annual effective interest rate of the liability component of the 2025 Notes was 8.87 %.
Upon adoption of ASU 2020-06 on January 1, 2022, we combined the liability and equity components of the 2025 Notes assuming that the instrument was accounted for as a single liability from inception to the date of adoption. We similarly combined the liability and equity components of the issuance costs. The issuance costs are presented as a deduction from the outstanding principal balance of the 2025 Notes and are amortized on a straight-line basis over the term of the 2025 Notes under the effective interest rate method. Beginning January 1, 2022, the annual effective interest rate on the 2025 Notes is 2.88 %.
Our outstanding 2025 Notes balances consisted of the following:
December 31,
(In thousands)
2024
2023
Principal
$
192,500
$
192,500
Debt discount and issuance costs, net
( 472
)
( 1,205
)
Net carrying amount
$
192,028
$
191,295
The following table sets forth total interest expense recognized related to the 2025 Notes for the years ended December 31, 2024, 2023 and 2022:
Year Ended December 31,
(In thousands)
2024
2023
2022
Contractual interest expense
$
4,813
$
4,813
$
4,813
Amortization of debt issuance costs
733
712
692
Total interest and amortization expense
$
5,546
$
5,525
$
5,505
Convertible Senior Notes Due 2028
In March 2022, we completed a private placement of $ 261.0 million aggregate principal amount of our 2028 Notes, which will mature on March 15, 2028 . The proceeds include the 2028 Notes sold pursuant to the $ 45.0 million over-allotment option granted by us to the initial purchasers, of which $ 36.0 million was exercised. The 2028 Notes were sold in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act.
The net proceeds from the sale of the $ 261.0 million aggregate principal amount of 2028 Notes were approximately $ 252.6 million after deducting the initial purchasers’ discounts and commissions and our estimated offering expenses. We used approximately $ 21.0 million of the net proceeds from the offering to fund the cost of entering into the capped call transactions described below. In addition, we used $ 165.6 million of the remaining net proceeds to repurchase $ 144.8 million aggregate principal amount of the 2023 Notes in separate and individually negotiated transactions with certain holders of the 2023 Notes, which closed concurrently with the issuance of the 2028 Notes. We expect to use the remaining net proceeds for general corporate purposes.
The 2028 Notes bear interest at an annual rate of 2.125 % that is payable semi-annually in arrears in cash on March 15 and September 15 of each year, beginning on September 15, 2022.
The 2028 Notes are convertible, based on the applicable conversion rate, into cash, shares of our common stock or a combination thereof, at our election. The initial conversion rate was 38.1432 shares per $1,000 principal amount of the 2028 Notes, subject to customary anti-dilution adjustment in certain circumstances, which represented an initial conversion price of approximately $ 26.22 per share.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Prior to September 15, 2027, the 2028 Notes will be convertible at the option of the holders only upon the occurrence of specified events and during certain periods, and will be convertible on or after September 15, 2027, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date of the 2028 Notes.
Holders of the 2028 Notes may convert all or a portion of their 2028 Notes prior to the close of business on September 15, 2027, only under the following circumstances:
• after March 31, 2022, if our closing common stock price for at least 20 days out of the most recent 30 consecutive trading days of the preceding quarter is greater than 130 % of the current conversion price of the 2028 Notes;
• for five consecutive business days, if the average trading price per $1,000 of Notes during the prior 10 consecutive trading days is less than 98 % of the product of our closing common stock price and the conversion rate of the 2028 Notes on such day; and,
• upon the occurrence of specified corporate events, including certain distributions, the occurrence of a fundamental changes (as defined in the indenture governing the 2028 Notes) or a transaction resulting in our common stock converting into other securities or property or assets.
On or after September 15, 2027, holders of the 2028 Notes may convert their 2028 Notes at any time until the close of the business on the second day immediately preceding the maturity date of the 2028 Notes.
The 2028 Notes will be redeemable, in whole or in part, at our option at any time, and from time to time, on or after March 20, 2025, and on or before the 75th scheduled trading day immediately before the maturity date but only if the last reported sale price per share of our common stock exceeds 130% of the conversion price for a specified period of time. The redemption price will be equal to the principal amount of the 2028 Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. In addition, calling any 2028 Note for redemption will constitute a make-whole fundamental change (as defined in the indenture governing the 2028 Notes) with respect to that 2028 Note, in which case the conversion rate applicable to the conversion of that 2028 Note will be increased in certain circumstances if it is converted after it is called for redemption.
If we undergo a fundamental change, subject to certain conditions, holders may require us to purchase for cash all or any portion of their 2028 Notes. The fundamental change purchase price will be 100 % of the principal amount of the 2028 Notes to be purchased plus any accrued and unpaid interest to, but excluding, the fundamental change purchase date.
The indenture governing the 2028 Notes contains customary terms and covenants, including a merger covenant and that upon certain events of default occurring and continuing, either the Trustee or the holders of at least 25% of the aggregate principal amount of the outstanding Notes may declare 100% of the principal of, and accrued and unpaid interest, if any, on, all the Notes to be due and payable immediately.
In connection with the offering of the 2028 Notes, we entered into privately negotiated capped call transactions. The cap price of the capped call transaction is initially $ 33.9850 per share and is subject to certain adjustments under the terms of the capped call transactions. The capped call transactions cover, subject to customary adjustments, the number of shares of common stock initially underlying the 2028 Notes. The capped call transactions are expected generally to reduce potential dilution to our common stock upon conversion of the 2028 Notes or at our election (subject to certain conditions) offset any cash payments we are required to make in excess of the aggregate principal amount of converted 2028 Notes, as the case may be, with such reduction or offset subject to a cap.
The annual effective interest rate on the 2028 Notes is 2.70 %.
Our outstanding 2028 Notes balance consisted of th e following:
December 31,
(In thousands)
2024
2023
Principal
$
261,000
$
261,000
Debt discount and issuance costs, net
( 4,684
)
( 6,061
)
Net carrying amount
$
256,316
$
254,939
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table sets forth total interest expense recognized related to the 2028 Notes for the years ended December 31, 2024, 2023, and from the issuance through December 31, 2022:
Year Ended December 31,
Date of Issuance Through
(In thousands)
2024
2023
December 31, 2022
Contractual interest expense
$
5,546
$
5,546
$
4,514
Amortization of debt discount and issuance costs
1,377
1,342
1,061
Total interest and amortization expense
$
6,923
$
6,888
$
5,575
Debt Maturities
The aggregate scheduled maturities of our convertible debt as of December 31, 2024 are as follows:
(In thousands)
Amount
Year ending December 31,
2025
$
192,500
2026
—
2027
—
2028
261,000
Total
$
453,500
Deferred Royalty Obligation
As part of our acquisition of La Jolla, we recorded the fair value of its deferred royalty obligation in connection with La Jolla’s royalty financing agreement (“La Jolla Royalty Agreement”) with HealthCare Royalty Partners (“HCR”). Under the terms of the La Jolla Royalty Agreement, HCR is entitled to receive quarterly royalties on worldwide net sales of GIAPREZA ® until either January 1, 2031 or when the maximum aggregate royalty payments have been made, whichever occurs first. Quarterly payments to HCR under the Royalty Agreement start at a maximum royalty rate, with step-downs based on the achievement of annual net product sales thresholds. The maximum royalty rate through December 31, 2023 was 14 %. Starting January 1, 2024, the maximum royalty rate was increased to 18 % based on the terms of the Agreement. The La Jolla Royalty Agreement is subject to maximum aggr egate royalty payments to HCR of $ 225.0 million.
For the years ended December 31, 2024 and 2023, we recognized interest expense of $ 9.8 million and $ 6.5 million, respectively, on the deferred royalty obligation. From the date of our acquisition of La Jolla through December 31, 2022, we recognized interest expense of $ 1.8 million on the deferred royalty obligation. The carrying value of the deferred royalty obligation as of December 31, 2024 and 2023 was $ 69.5 million and $ 69.9 million, respectively, (refer to Note 9 “Balance Sheet Components ” ). During the years ended December 31, 2024 and 2023, we made royalty payments to HCR of $ 9.1 million and $ 5.4 million, respectively. From the date of acquisition of La Jolla through December 31, 2022, we made royalty payments to HCR of $ 1.0 million. The deferred royalty obligation was valued using Level 3 inputs, and its carrying value as of December 31, 2024 and 2023 approximates fair value. The fair
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
value of the deferred royalty obligation was calculated as the discounted deferred royalty obligations based on revenue projections for GIAPREZA ® . As of December 31, 2024, the annual effective interest rate of the deferred royalty obligation is 9.44 %.
Under the terms of the La Jolla Royalty Agreement, if we are unable to meet certain obligations, including the obligation to use commercially reasonable and diligent efforts to commercialize GIAPREZA ® , HCR would have the right to terminate the La Jolla Royalty Agreement and demand payment of either $ 125.0 million or $ 225.0 million (depending on which obligation we have failed to meet) less aggregate royalties already paid to HCR. As of December 31, 2024, inclusive of the aggregate royalties paid to HCR by La Jolla under the La Jolla Royalty Agreement prior to our acquisition, La Jolla paid $ 27.2 million of aggregate royalties to HCR. In the event that we fail to pay such amount if and when due in a timely manner, HCR would have the right to foreclose on the GIAPREZA ® -related assets. HCR has no recourse against any asset other than GIAPREZA ® .
Certain contract provisions within the La Jolla Royalty Agreement that could result in an acceleration of amounts due under the La Jolla Royalty Agreement are recognized as embedded derivatives that require bifurcation from the deferred royalty obligation and fair value recognition. We determined the fair value of each derivative by assessing the probability of each event occurring, as well as the potential repayment amounts and timing of such repayments that would result under various scenarios. As a result of this assessment, we determined that the fair value of the embedded derivatives is immaterial and, therefore, not recognized as of December 31, 2023 and 2022. We estimate the fair value of the embedded derivatives for each reporting period until either the features lapse or the La Jolla Royalty Agreement is terminated, whichever occurs first. Any material change in the fair value of the embedded derivatives will be recorded as either a gain or loss in the consolidated statements of income.
13. COMMITMENTS AND CONTINGENCIES
Operating Lease
We have operating leases for our corporate headquarters, office spaces and laboratory facilities.
In 2019, we entered into an operating lease for our headquarters in Burlingame, California for approximately 2,111 rentable square feet. The lease commenced in November 2019 with an initial term of thirty-six calendar months, which was subsequently amended to expire in December 2027 . Our operating leases include a facility lease consisting of 15,500 square feet of office space in Waltham, Massachusetts, which expires in March 2029 .
The components of lease costs are as follows:
Year Ended December 31,
(In thousands)
2024
2023
2022
Straight line operating lease costs
$
1,200
$
1,428
$
1,585
Variable lease costs
14
189
155
Total lease costs
$
1,214
$
1,617
$
1,740
Supplemental cash flow information related to leases are as follows:
Year Ended December 31,
(In thousands)
2024
2023
2022
Cash paid for amounts included in the measurement of
operating lease liabilities:
$
1,464
$
1,542
$
790
Operating lease right-of-use assets obtained in exchange
for operating lease obligations
1,156
—
3,323
Right-of-use assets obtained through acquisitions
—
—
1,185
As of December 31, 2024, our operating leases have weighted-average remaining term of approximately 2.6 years and the weighted-average discount rate on our operating lease liabilities was 7.0 %.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Future minimum lease payments on our operating leases as of December 31, 2024 are as follows:
(In thousands)
Amount
Year ending December 31,
2025
$
1,705
2026
435
2027
455
2028
326
2029
83
Total undiscounted lease payments
3,004
Less: imputed interest
( 253
)
Total operating lease liabilities
$
2,751
Purchase Commitments
In April 2024, we entered into a Commercial Supply Agreement with Corden Pharma CHENÔVE SAS (“Corden”), under which we engaged Corden to manufacture and supply certain products related to XACDURO ® and to perform certain services and studies. Under the agreement, we committed to minimum purchase commitments through December 31, 2027. As of December 31, 2024, we have approximately $ 6.7 million U.S. dollar equivalent in outstanding purchase commitments under the agreement for the year 2024, which will be utilized in early 2025. We also have approximately $ 6.5 million, $ 7.3 million and $ 5.9 million U.S. dollar equivalent in purchase commitments under the agreement for the years 2025, 2026 and 2027, respectively.
Legal Proceedings
From time to time, the Company is involved in legal proceedings in the ordinary course of its business. We are not currently a party to any material legal proceedings except as discussed below.
On February 15, 2022, La Jolla received a paragraph IV notice of certification (the “First Notice Letter”) from Gland Pharma Limited (“Gland”) advising that Gland had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to manufacture, use or sell a generic version of GIAPREZA ® in the U.S. prior to the expiration of U.S. Patent Nos.: 9,220,745; 9,572,856; 9,867,863; 10,028,995; 10,335,451; 10,493,124; 10,500,247; 10,548,943; 11,096,983; and 11,219,662 (the “GIAPREZA ® Patents”), which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). The First Notice Letter alleges that the GIAPREZA ® Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Gland’s ANDA.
On March 29, 2022, La Jolla filed a complaint for patent infringement of the GIAPREZA ® Patents against Gland and certain related entities in the United States District Court for the District of New Jersey in response to Gland’s ANDA filing. In accordance with the Hatch-Waxman Act, because GIAPREZA ® is a new chemical entity and La Jolla filed a complaint for patent infringement within 45 days of receipt of the First Notice Letter, the FDA cannot approve Gland’s ANDA any earlier than 7.5 years from the approval of the GIAPREZA ® NDA unless the District Court finds that all of the asserted claims of the patents-in-suit are invalid, unenforceable and/or not infringed.
On February 22, 2023, La Jolla received a paragraph IV notice of certification (the “Second Notice Letter”) from Gland advising that Gland had amended its ANDA filing to include a paragraph IV certification alleging that all claims of the newly-issued and Orange Book-listed U.S. Patent No. 11,559,559 (“the ’559 Patent”), which covers GIAPREZA®, are invalid, unenforceable and/or not infringed.
On March 22, 2023, La Jolla filed a First Amended Complaint in this litigation adding Gland’s marketing and distribution partners for its ANDA angiotensin II product, Fresenius Kabi USA LLC and Fresenius Kabi SwissBiosim GmbH (collectively, the “Fresenius Kabi Defendants”), as co-defendants. On April 7, 2023, La Jolla filed a Second Amended Complaint in response to the Second Notice Letter, adding claims that the manufacture, use, sale, offer for sale, or import of Gland’s ANDA angiotensin II product will infringe the ’559 Patent. On November 14, 2023, La Jolla filed a Third Amended Complaint adding additional infringement claims against the Fresenius Kabi Defendants.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
On February 18, 2025, La Jolla, as well as The George Washington University (collectively, with the La Jolla entities, the “Plaintiffs”) entered into a settlement agreement (the “Settlement Agreement”) with Gland and the Fresenius Kabi Defendants (collectively, “Defendants”) resolving the Hatch-Waxman Act concerning Gland’s ANDA filing. Under the terms of the Settlement Agreement, Plaintiffs granted Defendants a perpetual, royalty-free and fully paid-up, non-exclusive, non-sublicensable, non-transferable right and license solely to make, have made, use, sell, offer to sell, import, and/or distribute the product that is subject to Gland’s ANDA in the United States commencing in the early 2030s, subject to certain exceptions as is customary in these type of agreements.
As required by law, the settlement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Indemnifications and Other Contingencies
In the ordinary course of business, we may provide indemnifications of varying scope and terms to vendors, directors, officers, and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements, services to be provided by us, our negligence or willful misconduct, violations of law, or intellectual property infringement claims made by third parties. In addition, we have entered into indemnification agreements with directors and certain officers and employees that will require us, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors, officers, or employees. No material demands have been made upon us to provide indemnification under such agreements, and thus, there are no claims that we are aware of that could have a material effect in our consolidated financial statements. We also maintain director and officer insurance, which may cover certain liabilities arising from our obligation to indemnify our directors. To date, we have not incurred any material costs and, as of December 31, 2024, we have not accrued any liabilities in the consolidated financial statements as a result of these provisions.
14. INCOME TAXES
Income tax expense consists of the following:
Year Ended December 31,
(In thousands)
2024
2023
2022
Current
Federal
$
23,438
$
7,799
$
40,822
State
3,175
2,177
464
Total current
26,613
9,976
41,286
Deferred
Federal
( 12,606
)
6,594
26,026
State
( 11
)
( 2,194
)
( 625
)
Total deferred
( 12,617
)
4,400
25,401
Total income tax expense, net
$
13,996
$
14,376
$
66,687
The impacts of the differences between the expected U.S. federal statutory income tax to our income tax expense are as follows:
Year Ended December 31,
(In thousands)
2024
2023
2022
Expected tax at federal statutory rate
$
7,846
$
40,747
$
58,928
State income tax expense (benefit), net of federal benefit
1,864
1,433
( 1,414
)
Federal and state research credits
( 90
)
( 1,582
)
( 2,453
)
Foreign derived intangible income deduction
( 11,767
)
( 15,274
)
—
Noncontrolling interest
—
—
7,468
Impact of consolidation and deconsolidation of subsidiaries
—
—
( 8,897
)
Other
( 2,243
)
1,219
( 125
)
Change in valuation allowance
18,386
( 12,167
)
13,180
Total income tax expense, net
$
13,996
$
14,376
$
66,687
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of our deferred tax assets and deferred tax liabilities are as follows:
December 31,
(In thousands)
2024
2023
Deferred tax assets
Net operating loss carryforwards
$
176,989
$
182,013
Research and development tax credit carryforwards
21,359
21,357
Unrealized loss on investment, net
11,481
—
Deferred royalty obligation, net
17,452
18,084
Other
6,832
6,467
Total deferred tax assets before valuation allowance
234,113
227,921
Valuation allowance
( 187,635
)
( 169,249
)
Total deferred tax assets
46,478
58,672
Deferred tax liabilities
Depreciation and amortization
( 31,626
)
( 39,064
)
Unrealized gain on investment, net
—
( 13,747
)
Inventory fair value adjustment
( 2,798
)
( 6,424
)
Net deferred tax assets (liabilities)
$
12,054
$
( 563
)
We record deferred tax assets if the realization of such assets is more likely than not to occur. Significant management judgment is required in determining whether a valuation allowance against the deferred tax assets is required. We have considered all available evidence, both positive and negative, such as our historical operating results and predictability of future taxable income, in making such determination. We are also required to exercise significant management’s judgment in forecasting future taxable income. Specifically, we evaluate the following criteria when considering a valuation allowance:
• the history of tax net operating losses in recent years;
• predictability of operating results;
• profitability for a sustained period of time; and
• level of profitability on a quarterly basis.
As of December 31, 2024 , we had federal net operating loss carryforwards of approximately $ 520.6 million , $ 456.5 million of which do not expire. As of December 31, 2024, we also had state net operating loss carryforwards of approximately $ 1.0 billion , which will expire beginning 2030 and state research tax credits of approximately $ 33.3 million , which do not expire.
Utilization of net operating loss and tax credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations provided by the Internal Revenue Code and similar state provisions. Annual limitations may result in expiration of net operating loss and tax credit carryforwards before some or all of such amounts have been utilized.
We conducted an Internal Revenue Code of 1986, as amended, Section 382 (“Section 382”) analysis of the Company through December 31, 2024 to determine whether an ownership change had occurred since inception. The Section 382 study concluded that it is more likely than not that the Company did not experience an ownership change during the testing period. If we ever undergo an ownership change, the utilization of the pre-ownership change net operating loss carryforwards or pre-ownership change tax attributes, such as research tax credits, to offset the post-ownership change income may be subject to an annual limitation, pursuant to Sections 382 and 383 of the Internal Revenue Code of 1986, as amended. Similar rules may apply under state tax laws.
As of December 31, 2024, $ 154.8 million of Entasis’ federal net operating losses and $ 365.8 million of La Jolla’s federal operating losses from the acquisitions in 2022, both subject to annual limitations, were available for future utilization.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Our policy is to recognize interest and/or penalties related to income tax matters in income tax expense. As of December 31, 2024 and 2023, we had no accrued interest or penalties due to the Company ’s net operating losses available to offset any tax adjustments.
We do not have any tax positions for which a significant change in the total amount of gross unrecognized tax benefits is reasonably possible within 12 months of December 31, 2024.
Uncertain Tax Positions
A reconciliation of the beginning and ending balances of the total amounts of unrecognized tax benefits are as follows:
(In thousands)
Amount
Unrecognized tax benefits as of December 31, 2021
$
14,872
Net increase in tax portions for 2022
1,452
Unrecognized tax benefits as of December 31, 2022
16,324
Net increase in tax portions for 2023
3,119
Unrecognized tax benefits as of December 31, 2023
19,443
Net increase in tax portions for 2024
41,851
Unrecognized tax benefits as of December 31, 2024
$
61,294
The increase of $ 41.9 million in 2024 was primarily due to our strategic intercompany intellectual property alignment across different jurisdictions.
We are subject to taxation in the U.S. and various state and foreign jurisdictions. The tax years 2006 through 2013, 2015 and forward remain open to examination by the federal and most state tax authorities due to net operating loss and overall credit carryforward positions. We are not currently subject to any income tax audits by federal or state taxing authorities.
In December 2021, the Organization for Economic Cooperation and Development (“OECD”) enacted model rules for a new global minimum tax framework (“BEPS Pillar Two”), and various governments around the world have enacted, or are in the process of enacting legislation. We are in the process of evaluating whether and when these new rules may come into effect and apply to us, including the eligibility to qualify for safe harbor rules . We plan to treat the tax if any as a period cost. We do not believe that the Pillar Two rules apply to us yet. As such, the potential future quantitative impact of the enacted or substantively enacted legislation is not yet reasonably estimable.
15. SEGMENT REPORTING
We operate as a single operating and reportable segment, focused on creating value for our stockholders. We achieve this by maximizing the value of our respiratory royalty portfolio and growing our investments in innovative healthcare assets that address critical unmet medical needs.
Our Chief Executive Officer , as the chief operating decision-maker (“CODM”), evaluates the company’s financial performance and operational efficiency using consolidated net income. This helps guide decisions related to commercial operations, product development, and regulatory compliance, ensuring resources are allocated effectively to support growth initiatives. Consolidated net income also helps inform reinvestment strategies to strengthen our market position and drive innovation.
The accounting policies of the segment are the same as those described in Note 1, “Description of Operations and Summary of Significant Accounting Policies”.
Our revenues are generated primarily from our collaborative arrangements and royalty payments from GSK, located in Great Britain. We also generate revenue from net product sales of GIAPREZA ® , XERAVA ® , and XACDURO ® , as well as license and other revenues. Refer to Note 3, “Revenue Recognition”, for more information on our revenues for the periods presented.
Our long-term assets are located within the United States. The CODM does not review assets at a different level or category than the amounts disclosed in the consolidated balance sheets.
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INNOVIVA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The table below presents the financial information used by the CODM to assess performance, which reconcile to the consolidated net income:
Year Ended December 31,
(In thousands)
2024
2023
2022
Total revenue
$
358,711
$
310,463
$
331,339
Less:
Cost of products sold - U.S.
10,921
7,535
2,488
Cost of products sold - Rest of the world
11,857
6,341
1,282
Cost of products sold - Amortization of inventory fair value adjustments
13,820
27,164
10,023
Cost of license revenue
—
1,600
—
Selling and marketing
31,441
30,739
6,886
General and administrative
84,249
67,493
56,652
Research and development - External services
7,408
20,051
24,666
Research and development - Internal expenses
6,246
13,871
16,766
Amortization of acquired intangible assets
25,902
21,784
5,581
Changes in fair values of equity method investments, net
64,253
( 77,392
)
161,749
Changes in fair values of equity and long-term investments, net
59,161
( 11,129
)
( 8,462
)
Interest and dividend income
( 19,141
)
( 15,818
)
( 6,369
)
Interest expense
22,209
19,157
15,789
Gain on sale of TRC
—
—
( 266,696
)
Loss on extinguishment of debt
—
—
20,662
Other expense, net
2,997
4,969
3,373
Income tax expense, net
13,996
14,376
66,687
Consolidated net income
$
23,392
$
179,722
$
220,262
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REP ORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of Innoviva, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Innoviva, Inc. and subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of income, comprehensive income, stockholders’ equity, and cash flows, for each of the three years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 26, 2025, expressed an unqualified opinion on the Company's internal control over financial reporting.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Consolidated Entities and Equity and Long-term Investments—Primary Beneficiary Determination for Variable Interest Entities—Refer to Notes 1, 5, and 6 to the consolidated financial statements.
Critical Audit Matter Description
The Company invests in equity and debt securities of private and public companies. The Company evaluates its interests in these entities to determine whether they meet the definition of a variable interest entity (VIE) or a voting interest entity (VOE) and whether the Company is required to consolidate these entities. A VIE is consolidated by its primary beneficiary, which is the party that has both 1) the power to direct the activities that most significantly impact the economic performance of the VIE and 2) a variable interest that absorbs losses or receives benefits from the VIE that could potentially be significant to the VIE. To determine whether a variable interest that the Company holds could potentially be significant to the VIE, the Company considers both qualitative and quantitative factors regarding the nature, size and form of the Company’s involvement with the VIE. In general, the parties that make the most significant decisions affecting the VIE (management and representation on the Board of Directors) and have the right to unilaterally remove those decision-makers are deemed to have the power to direct the activities of a VIE. The Company will reconsider whether an entity is a VIE and whether the Company is the primary beneficiary of the entity upon the occurrence of certain types of events. The determination of the primary beneficiary of a VIE requires significant management judgment.
150
We identified the primary beneficiary determination for the Company’s VIEs as a critical audit matter due to the complexity of the accounting principles related to the determination of the primary beneficiary of a VIE and the significant judgment required by management in evaluating the Company’s role in establishing the VIE, their ongoing rights and responsibilities and identifying which party, if any, has power over those activities. This required a high degree of auditor judgment and an increased extent of effort, including the involvement of professionals with consolidation accounting expertise, when performing audit procedures to evaluate the Company’s determination of whether it is the primary beneficiary for its VIEs.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to the primary beneficiary determination for VIEs included the following, among others:
• We tested the effectiveness of controls over the Company’s primary beneficiary determination for its VIEs, including management’s determination of the party that has the power to direct the activities that most significantly impact the economic performance of the VIE and a variable interest that absorbs losses or receives benefits from the VIE that could potentially be significant to the VIE.
• We evaluated the appropriateness of the Company’s accounting conclusions for consolidated and unconsolidated VIEs through the following:
o Evaluated the investment structures and terms of the agreements, including reading the purchase agreements and other related documents which govern the formation and activities of the entity (the Contractual Arrangements).
o Tested whether the Company appropriately determined the primary beneficiary by evaluating the Contractual Arrangements of the entity to determine if the Company has the power to direct activities that most significantly impact the economic performance of the VIE, and if the Company has the obligation to absorb losses of the entity or the right to receive benefits from the entity that could be significant to the VIE.
o For certain VIEs, with the assistance of professionals with expertise in consolidation accounting, evaluated the appropriateness of the Company’s determination of the primary beneficiary of the VIE.
o Evaluated the Company’s disclosures related to the primary beneficiary determination of its consolidated entities and unconsolidated VIEs.
/s/ Deloitte & Touche LLP
San Jose, California
February 26, 2025
We have served as the Company’s auditor since 2022.
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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.