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Summary of Significant Accounting Policies
6 Months Ended
Jun. 30, 2025
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies
2.
Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

The condensed consolidated financial statements include the accounts of BridgeBio and its wholly-owned subsidiaries and controlled entities, substantially all of which are denominated in U.S. dollars. 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 loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests” on our condensed consolidated statements of operations equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties.

In determining whether an entity is considered a controlled entity, we applied the VIE and Voting Interest Entity (“VOE”) models. We assess whether we are the primary beneficiary of a 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. Entities that do not qualify as a VIE are assessed for consolidation under the VOE model. Under the VOE model, BridgeBio consolidates the entity if it determines that it has a controlling financial interest in the entity through its ownership of greater than 50% of the outstanding voting shares of the entity and that other equity holders do not have substantive voting, participating or liquidation rights. We assess whether we are the primary beneficiary of a VIE or whether we have a majority voting interest for entities consolidated under the VOE model at the inception of the arrangement and at each reporting date.

The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”) regarding interim financial reporting. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. Certain reclassifications have been made to prior period amounts to conform to current period presentations. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC.

The condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal and recurring adjustments, necessary for a fair statement of our financial position, our results of operations and comprehensive loss, stockholders’ deficit and our cash flows for the periods presented. The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other future annual or interim periods.

Concentration of Credit Risk and Other Risks and Uncertainties

Financial instruments that subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities, accounts receivable, and restricted cash. Amounts on deposit may at times exceed federally insured limits. Although management currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances as of June 30, 2025 and for the three and six months ended June 30, 2025.

During the three and six months ended June 30, 2025 and 2024, our revenues were generated primarily from license and collaboration agreements with strategic partners and from product sales to customers. As of June 30, 2025 and December 31, 2024, our gross accounts receivable balance was comprised of payments primarily due from license and collaboration agreements with strategic partners and from product sales to customers.

The following table summarizes customers that represent 10% or greater of our consolidated total gross revenues:

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

2025

 

2024

 

2025

 

2024

Bayer (as described in Note 11)

*

 

16.7%

 

30.1%

 

61.4%

Kyowa Kirin Co., Ltd

*

 

66.2%

 

*

 

33.8%

Alexion (as described in Note 11)

22.3%

 

14.7%

 

12.0%

 

*

Customer A

19.4%

 

*

 

15.2%

 

*

Customer B

17.5%

 

*

 

13.7%

 

*

Customer C

13.3%

 

*

 

*

 

*

Customer D

12.2%

 

*

 

10.1%

 

*

* Represents less than 10% and/or not a customer in the applicable period.

We are subject to credit risk from our accounts receivable. We have not experienced any material losses related to receivables from individual customers or groups of customers. We also do not require any collateral. Accounts receivable are recorded net of allowance for credit losses, if any. As of June 30, 2025, five customers each accounted for more than 10% of our consolidated gross accounts receivable balance, at 21.8%, 21.0%, 20.6%, 17.9%, and 11.3%. As of December 31, 2024, five customers each accounted for more than 10% of our consolidated gross accounts receivable balance, at 17.3%, 17.3%, 16.9%, 12.0% and 11.9%.

We are subject to certain risks and uncertainties and we believe that changes in any of the following areas could have a material adverse effect on future financial position or results of operations: ability to obtain future financing, regulatory approval and market acceptance of, and reimbursement for, product candidates, performance of third-party contract research organizations and manufacturers upon which we rely, development of sales channels, protection of our intellectual property, litigation or claims against us based on intellectual property, patent, product, regulatory, clinical or other factors, and our ability to attract and retain employees necessary to support our growth.

We are dependent on third-party manufacturers to supply products for Attruby and Beyonttra and for research and development activities in our programs. In particular, we rely and expect to continue to rely on a small number of manufacturers, and in some cases a single source manufacturer, to supply us with our requirements for the active pharmaceutical ingredients and formulated drugs related to the commercial sale of Attruby and the research and development of our other clinical product candidates. The commercial sale of Attruby and development of our other clinical product candidates could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients and formulated drugs.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and disclosure of contingent liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions made in the accompanying condensed consolidated financial statements include, but are not limited to:

accruals for research and development activities, such as clinical, development, regulatory, and sales-based milestone payments in our in-licensing agreements and asset acquisitions,
deferred royalty obligations, related embedded derivative liability and underlying assumptions,
revenue recognition for transactions accounted for under ASC 606, Revenue from Contracts with Customers (“ASC 606”), including estimating the impact of variable consideration and determining and allocating the transaction price to performance obligations,
accruals for performance-based milestone compensation arrangements,
the expected recoverability and estimated useful lives of our long-lived assets,
additional charges as a result of, or that are associated with, any restructuring initiative as well as impairment and related charges, and
allowance for credit losses.

We base our estimates on historical experience and on various other assumptions that are believed to be reasonable. Actual results may differ from those estimates or assumptions.

Cash, Cash Equivalents and Marketable Securities

We consider all highly liquid investments purchased with original maturities of 90 days or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market instruments, such as money market funds, U.S. treasury bills and securities issued by the U.S. government or its agencies.

Our marketable securities consist of high investment grade fixed income securities invested in U.S. treasury bills. We classify our marketable securities as available-for-sale securities and report them at fair value in cash equivalents or marketable securities on the consolidated balance sheets with related unrealized gains and losses included as a component of stockholders’ deficit. We classify our marketable securities as either short-term or long-term based on each instrument’s underlying contractual maturity date. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity which is included in interest income on the consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in “Other income (expense), net”. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income.

Our cash, cash equivalents, and marketable securities are exposed to credit risk in the event of default by the third parties that hold or issue such assets. Our cash, cash equivalents and marketable securities are held by financial institutions that management believes are of high credit quality. Our investment policy limits investments to fixed income securities denominated and payable in U.S. dollars such as commercial paper, U.S. government obligations, treasury bills, and money market funds, and places restrictions on maturities and concentrations by type and issuer.

Cash as reported in the accompanying condensed consolidated statements of cash flows includes the aggregate amounts of cash, cash equivalents and restricted cash as presented on the accompanying condensed consolidated balance sheets as follows:

 

 

 

June 30, 2025

 

 

December 31, 2024

 

 

 

(in thousands)

 

Cash and cash equivalents

 

$

748,953

 

 

$

681,101

 

Restricted cash — included in “Prepaid expenses and
other current assets”

 

 

449

 

 

 

126

 

Restricted cash, non-current — included in “Other assets

 

 

1,698

 

 

 

2,017

 

Total cash, cash equivalents and restricted cash

 

$

751,100

 

 

$

683,244

 

Restricted Cash

Restricted cash primarily represents certain letters of credit for lease agreements, of which we have pledged cash and cash equivalents as collateral. As of June 30, 2025, restricted cash related to such agreements was $0.4 million and $1.7 million, which is presented as part of “Prepaid expenses and other current assets” and “Other assets”, respectively, on the condensed consolidated balance sheet. As of December 31, 2024, restricted cash related to such agreements was $0.1 million and $2.0 million, which is presented as part of “Prepaid expenses and other current assets” and “Other assets”, respectively, on the condensed consolidated balance sheet.

Other Current Liabilities

Other current liabilities presented on the condensed consolidated balance sheets consisted of the following balances:

 

 

 

June 30, 2025

 

 

December 31, 2024

 

 

 

(in thousands)

 

Accrued rebates and other related costs

 

$

19,065

 

 

$

210

 

Accrued interest

 

 

14,411

 

 

 

11,056

 

Accrued commercial liabilities

 

 

11,326

 

 

 

11,267

 

Accrued professional services

 

 

7,135

 

 

 

3,673

 

Deferred royalty obligations, current portion

 

 

4,812

 

 

 

144

 

Milestone liabilities

 

 

2,400

 

 

 

1,595

 

Income taxes payable

 

 

2,100

 

 

 

1,153

 

Other accrued liabilities

 

 

4,667

 

 

 

3,973

 

Total other current liabilities

 

$

65,916

 

 

$

33,071

 

Segments

We are a single operating and reportable segment, which is in the business of identifying and advancing transformative medicines to treat patients. We operate in one segment because our business offerings have similar economics and other characteristics, including the nature of products, clinical and manufacturing processes, types of customers, distribution methods, and regulatory environments. We are managed in the aggregate as one business segment by the Chief Operating Decision Maker (“CODM”), which is our Chief Executive Officer.

While we operate as a single reportable segment, our research and development expenses for our significant programs are tracked and regularly reported to our CODM. Research and development costs consist primarily of external costs, such as fees paid to consultants, contractors, contract manufacturing organizations (“CMOs”), and contract research organizations (“CROs”), and purchase of active pharmaceutical ingredients (“APIs”), in connection with our preclinical, contract manufacturing and clinical development activities; as well as internal costs, such as personnel and facility costs, and are tracked on a program-by-program basis. License fees and other costs incurred after a product candidate has been designated and that are directly related to the product candidate are included in the specific program expense. License fees and other costs incurred prior to designating a product candidate are included in early-stage development and research programs, which are presented in the following table in “Other development programs” and “Other research programs”, respectively.

The following table summarizes our segment information for significant operating expenses and includes a reconciliation to net loss:

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

 

 

(in thousands)

 

 

(in thousands)

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

License and services revenue

 

$

37,440

 

 

$

2,168

 

 

$

117,130

 

 

$

213,288

 

Net product revenue

 

 

71,501

 

 

 

 

 

 

108,240

 

 

 

 

Royalty revenue

 

 

1,624

 

 

 

 

 

 

1,828

 

 

 

 

Total revenues, net

 

 

110,565

 

 

 

2,168

 

 

 

227,198

 

 

 

213,288

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of license, services and royalty revenue

 

 

805

 

 

 

598

 

 

 

1,410

 

 

 

1,196

 

Cost of goods sold

 

 

2,848

 

 

 

 

 

 

4,882

 

 

 

 

Total cost of revenues

 

 

3,653

 

 

 

598

 

 

 

6,292

 

 

 

1,196

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development by significant program:

 

 

 

 

 

 

 

 

 

 

 

 

Acoramidis for the treatment and primary prevention
     of ATTR-CM

 

 

28,269

 

 

 

36,798

 

 

 

52,661

 

 

 

76,540

 

Infigratinib for achondroplasia and hypochondroplasia

 

 

30,191

 

 

 

22,098

 

 

 

58,125

 

 

 

43,283

 

BBP-418 for LGMD2I/R9

 

 

11,243

 

 

 

10,773

 

 

 

25,452

 

 

 

20,791

 

Encaleret for ADH1

 

 

13,128

 

 

 

10,608

 

 

 

28,587

 

 

 

23,152

 

Other development programs

 

 

10,536

 

 

 

9,693

 

 

 

21,966

 

 

 

41,977

 

Other research programs

 

 

17,864

 

 

 

24,725

 

 

 

35,871

 

 

 

49,924

 

Total segment research and development

 

 

111,231

 

 

 

114,695

 

 

 

222,662

 

 

 

255,667

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

129,154

 

 

 

59,523

 

 

 

235,519

 

 

 

125,330

 

Restructuring, impairment and related charges

 

 

805

 

 

 

2,891

 

 

 

1,375

 

 

 

6,291

 

Total operating costs and expenses

 

 

244,843

 

 

 

177,707

 

 

 

465,848

 

 

 

388,484

 

Loss from operations

 

 

(134,278

)

 

 

(175,539

)

 

 

(238,650

)

 

 

(175,196

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

3,898

 

 

 

5,195

 

 

 

9,283

 

 

 

9,270

 

Interest expense

 

 

(37,637

)

 

 

(22,937

)

 

 

(79,778

)

 

 

(46,408

)

Gain on deconsolidation of a subsidiary

 

 

 

 

 

126,294

 

 

 

 

 

 

126,294

 

Losses on extinguishments of debt

 

 

 

 

 

 

 

 

(21,155

)

 

 

(26,590

)

Net loss from equity method investments

 

 

(20,189

)

 

 

(7,925

)

 

 

(35,745

)

 

 

(7,925

)

Other income (expense), net

 

 

6,548

 

 

 

(632

)

 

 

14,779

 

 

 

8,851

 

Total other income (expense), net

 

 

(47,380

)

 

 

99,995

 

 

 

(112,616

)

 

 

63,492

 

Loss before income taxes

 

 

(181,658

)

 

 

(75,544

)

 

 

(351,266

)

 

 

(111,704

)

Income tax expense

 

 

2,100

 

 

 

 

 

 

2,100

 

 

 

 

Net loss

 

 

(183,758

)

 

 

(75,544

)

 

 

(353,366

)

 

 

(111,704

)

Net loss attributable to redeemable convertible
   noncontrolling interests and noncontrolling interests

 

 

1,855

 

 

 

2,088

 

 

 

4,041

 

 

 

3,032

 

Segment net loss attributable to common stockholders
   of BridgeBio

 

$

(181,903

)

 

$

(73,456

)

 

$

(349,325

)

 

$

(108,672

)

 

There are no reconciling items or adjustments between segment “Total revenues, net” and “Net loss attributable to common stockholders of BridgeBio”, and condensed consolidated “Total revenues, net” and “Net loss attributable to common stockholders of BridgeBio”.

Total revenues, net is attributed to regions based on the location of our customers or partners.

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

2025

 

2024

 

2025

 

2024

U.S.

64.7%

 

17.2%

 

47.7%

 

4.8%

Europe, Middle East, and Africa (EMEA)

31.7%

 

16.7%

 

49.4%

 

61.4%

Asia-Pacific (APAC)

3.6%

 

66.1%

 

2.9%

 

33.8%

 

100.0%

 

100.0%

 

100.0%

 

100.0%

 

The CODM does not review assets at a different asset level or category than the amounts disclosed in the condensed consolidated balance sheets. As of June 30, 2025, our capitalized property and equipment located in the U.S., Canada and the rest of the world are approximately 46.7%, 49.3%, and 4.0%, respectively. As of December 31, 2024, our capitalized property and equipment located in the United States, Canada and the rest of the world are approximately 51.6%, 44.7% and 3.7%, respectively.

Revenue Recognition

For elements or transactions that we determine should be accounted for under ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy our performance obligation. We apply the five-step model to contracts when it is probable that we will collect the consideration to which we are entitled in exchange for the goods or services we transfer to the customer.

At inception of the arrangement, we assess the promised goods or services to identify the performance obligations within the contract. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation, on a relative standalone selling price basis, when (or as) the performance obligation is satisfied, either at a point in time or over time. If the performance obligation is satisfied over time, we recognize revenue based on the use of an input method. As part of the accounting for these arrangements, we develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include forecasted revenue or costs, development timelines, discount rates and probabilities of clinical and regulatory success.

License fees: For arrangements that include a grant of a license to our intellectual property, we consider whether the license grant is distinct from the other performance obligations included in the arrangement. Generally, we would conclude that the license is distinct if the customer is able to benefit from the license with the resources available to it. For licenses that are distinct, we recognize revenues from nonrefundable, upfront license fees and other consideration allocated to the license when the license term has begun and we have provided all necessary information regarding the underlying intellectual property to the customer, which generally occurs at or near the inception of the arrangement. For licenses that are bundled with other promises, we determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, we use judgment in determining the appropriate method of measuring progress for purposes of recognizing revenue from the up-front license fees. We evaluate the measure of progress for each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
Development and regulatory milestone payments: At the inception of each 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 using the most likely amount method. We generally include these milestone payments in the transaction price when they are achieved because there is considerable uncertainty in the research and development processes that trigger these payments under our agreements. Similarly, we include approval milestone payments in the transaction price once the product is approved by the applicable regulatory agency. At the end of each subsequent reporting period, we re-evaluate the probability of achieving such development and regulatory milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis.
Sales-based milestone payments and royalties: For arrangements that include sales-based royalties, including milestone payments based on the volume of sales, we will determine whether the license is deemed to be the predominant item to which the royalties or sales-based milestones relate and if such is the case, we will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Product supply services: Arrangements that include a promise for the future supply of drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. We will assess if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations and recognized when the future goods or services related to the option are provided or the option expires.
Research and development services: For arrangements that include research and development services, we will recognize revenue over time using an input method, representing the transfer of goods or services as we perform activities over the term of the arrangement.
Net product revenue: Revenue is recognized when our customers, primarily specialty pharmacies and specialty distributors, obtain control of the product and revenue is adjusted to reflect discounts, chargebacks, rebates, returns and other allowances associated with the respective sales as further described below. In addition, we offer a program that provides free drug products for a limited period of time or in perpetuity, which is based on specific patient eligibility criteria. We recognize the costs of the program, including the cost of the product, as “Selling, general, and administrative” expenses on our condensed consolidated statements of operations upon delivery to the specialty pharmacy.

For revenue recognized under collaboration and licensing arrangements, we identify the performance obligations and allocate the total consideration we expect to receive on a relative standalone selling price basis to each performance obligation. Variable consideration, such as performance-based milestones, will be included in the total consideration if we expect to receive such consideration and if it is probable that the inclusion of the variable consideration will not result in a significant reversal in the cumulative amount of revenue recognized under the arrangement. Our estimate of the total consideration we expect to receive under each collaboration and licensing arrangement is updated for each reporting period, and any adjustments to revenue are recorded on a cumulative catch-up basis.

Revenues from product sales are recorded at the net sales price, or “transaction price”, which includes estimates of variable consideration for which reserves are established that result from discounts, returns, chargebacks, rebates, co-pay assistance and other allowances that are offered within contracts between us and our customers, health care providers and other indirect customers relating to the sale of Attruby. These reserves are based on amounts earned or to be claimed on the related sale and are classified as reductions of accounts receivable (if the amount is payable to the customer) or accrued expenses and other current liabilities (if the amount is payable to a third-party other than a customer). We use the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts, or the most likely amount method, which is the single most likely amount in a range of possible considerations, to estimate variable consideration related to our product revenue. The estimates of reserves established for variable consideration reflect current contractual and statutory requirements, our historical experience, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The amount of variable consideration that is included in the transaction price may be constrained and is included in net product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results vary from our estimates, we will adjust these estimates prospectively in the period such change in estimate becomes known, which could affect net product revenue and earnings in the period of adjustment.

The following are the components of variable consideration related to “Net product revenue”:

Trade discounts and allowances: We provide customary invoice discounts on sales to our U.S. customers for prompt payment. The discounts are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue, and the establishment of a reserve that is offset against our accounts receivable balance on our condensed consolidated balance sheets.
Distribution fees: We receive and pay for various distribution services provided by our customers. These fees are generally accounted for as a reduction of revenue in the same period the related revenue is recognized, and the establishment of a reserve is offset against our accounts receivable balance on our condensed consolidated balance sheets. To the extent that the services received are distinct from the sale of products to our customers, we classify these payments as selling, general and administrative expenses.
Product returns: Consistent with industry practice, we offer our customers limited product return rights for damages, shipment errors, and expiring product; provided that the return is within a specified period around the product expiration date as set forth in the applicable individual distribution or customer agreement. In estimating for product returns, we consider historical product returns, the underlying product demand, and industry specific data. We estimate the amount of product sales that may be returned and record the estimate as a reduction of revenue and a refund liability included in accrued liabilities on our condensed consolidated balance sheets in the period the related product revenue is recognized.
Chargebacks: Chargebacks result from contractual commitments with the government and other entities to sell products to qualified healthcare providers at prices lower than the list prices charged to our customers. Our customers charge us for the difference between what they pay for the product and the selling price to the qualified healthcare providers. We record reserves and reduce our product revenue for these chargebacks related to product sold to our customers during the reporting period as well as our estimate of product that remains in the distribution channel at the end of the reporting period that we expect will be sold to qualified healthcare providers in future periods. Our established reserve for
chargebacks is included as an offset against our accounts receivable balance on our condensed consolidated balance sheets.
Government rebates: We are subject to discount obligations under government programs, including Medicare and Medicaid programs in the U.S. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements with payers or statutory requirements pertaining to Medicare and Medicaid benefit providers. The allowance for rebates is based on contractual or statutory discount rates, estimated payer mix, and expected utilization. Our estimates for the expected utilization of rebates are based on historical dispense data received from our customers and invoices received. We monitor sales trends and adjust the allowance on a quarterly basis to reflect the most recent rebate experience. Our reserve for these rebates is recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of the liability that is included in accrued liabilities on our condensed consolidated balance sheets.
Other incentives: Other incentives include co-payment assistance that we provide to patients with commercial insurance that have coverage and qualify for co-payment assistance. Co-payment assistance is accrued based on an estimate of the number of co-payment assistance claims and the cost per claim that we expect to receive associated with products that have been recognized as revenue. The estimate is recorded as a reduction of revenue in the same period that the related revenue is recognized and also results in the establishment of a liability which is included in accrued liabilities on our condensed consolidated balance sheets.

During the three and six months ended June 30, 2025, we recorded “Net product revenue” of $71.5 million and $108.2 million, respectively, related to product sales of Attruby. There were no significant changes in estimates of variable considerations during the three and six months ended June 30, 2025.

Inventories

Inventory is recorded at the lower of cost or net realizable value. The cost of raw materials, work in process and finished goods are determined using a standard cost approach, which approximates actual cost determined on a first-in first out basis. Raw and intermediate materials that may be used for either research and development or commercial purposes are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is used for research and development, it is expensed as research and development once that determination is made. We capitalize inventory costs that are expected to be sold commercially once we determine it is probable that the inventory costs will be recovered through commercial sales. Prior to regulatory approval of our product candidates, we record costs related to manufacturing and materials as “Research and development” expenses in the period incurred on the condensed consolidated statements of operations, and therefore such costs are not included in cost of revenue. Subsequent to the FDA approval of Attruby in November 2024, the costs directly related to Attruby manufacturing were capitalized as inventory. We reduce our inventory to net realizable value for potentially excess, dated or obsolete inventory based on our periodic assessment of the recoverability of our capitalized inventory. We periodically review inventory levels to identify what may expire prior to expected sale or have a cost basis in excess of its estimated realizable value and write-down of such inventories are charged to cost of revenues as appropriate. We regularly review our inventories for impairment and reserves are established when necessary.

Inventories presented on the condensed consolidated balance sheet as of June 30, 2025 consisted of the following balances:

 

 

 

June 30, 2025

 

 

 

(in thousands)

 

Raw materials

 

$

11,463

 

Work in progress

 

 

1,065

 

Finished goods

 

 

5,749

 

Total inventories

 

$

18,277

 

Cost of Revenues

Cost of revenues consists of the following two classifications, which are presented accordingly on our condensed consolidated statements of operations:

Cost of license, services and royalty revenue: Cost of license, services and royalty revenue consists of royalties owed to third-parties on the net sales of licensed products, as well as amortization of intangible assets associated with our license and collaboration agreements, which are amortized over the life of the underlying intellectual property.
Cost of goods sold: Cost of goods sold consists of manufacturing costs, transportation and freight-in, indirect overhead costs (including salary related and stock-based compensation expenses) associated with the commercial manufacturing and distribution of Attruby, and third-party royalties payable on our net product revenue. Cost of goods sold may also include period costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances.

Advertising Expense

Advertising expenses include costs incurred to market the Company’s branded product. Advertising production costs, which include costs incurred during production rather than when the advertising takes place, are expensed as incurred. Advertising communication costs, which include costs to run the ad campaign on digital or traditional marketing channels, such as on third-party websites, television, and social and print media, are expensed over the period of the campaign run. Deferred advertising costs primarily consist of vendor payments made in advance to secure media spots across various media channels. Deferred advertising costs are not expensed until the advertising is broadcast.

New Accounting Pronouncements Not Yet Adopted

In December 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which expands disclosures in an entity’s income tax rate reconciliation table and disclosures regarding cash taxes paid both in the U.S. and foreign jurisdictions. The update will be effective for annual periods beginning after December 15, 2024. We are currently evaluating the impact that this guidance will have on our annual consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40), which requires public companies to disclose, in interim and annual reporting periods, additional information about certain expenses in notes to financial statements, including purchases of inventory, employee compensation, depreciation, amortization of intangible assets, and selling expenses. This ASU is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. We plan to adopt this pronouncement and make the necessary updates to our disclosures for the year ending December 31, 2027, and, aside from these disclosure changes, we do not expect the amendments to have a material effect on our consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-04, Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments, which seeks to clarify the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion. This ASU is effective for fiscal years beginning after December 15, 2025. Early adoption is permitted. The Company does not expect the adoption of this ASU to have a material impact on its consolidated financial statements and related disclosures.