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Summary of Significant Accounting Policies (Policies)
 3 Months Ended
Mar. 31, 2026
Accounting Policies [Abstract]  
Use of Estimates

Use of Estimates

 

The preparation of interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the interim condensed consolidated financial statements and the notes thereto.

 

Significant estimates affecting amounts reported or disclosed in the interim condensed consolidated financial statements include, but are not limited to: the assumptions used in measuring the revenue gross-to-net variable consideration items; the allowance for expected credit losses estimate; the assumptions used in estimating the notes carried at fair value, preferred stock, and purchase rights issued; and the assumptions used in the valuation of inventory, the intangible asset, and contingent liabilities; the useful lives and recoverability of long-lived assets; and the valuation of deferred tax assets. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances and adjusts when facts and circumstances dictate. These estimates are the basis for making judgments about the carrying values of assets, liabilities and recorded expenses that are not readily apparent from other sources. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.

 
Segment Reporting

Segment Reporting

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker (CODM), the Chief Executive Officer of the Company, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. The Company’s CODM assesses performance and decides how to allocate resources for the Company’s one operating segment based on consolidated net income or loss that is reported on the interim condensed consolidated statements of operations. The Company has also evaluated the significant segment expenses incurred by the single segment that are regularly provided to the CODM. The significant segment expenses regularly provided to the CODM are consistent with those reported on the interim condensed consolidated statements of operations and include cost of goods sold, research and development, net, selling and marketing, and general and administrative. The CODM uses these expense categories, along with data on product sales, net, to make key operating decisions such as: the strategic direction of the Company, pursuing and/or approving product acquisitions, decisions about key personnel, and approving annual operating budgets. The Company manages assets on a consolidated basis as reported on the interim condensed consolidated balance sheets.

 

 
Concentrations of Credit Risk

Concentrations of Credit Risk

 

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents and restricted cash and cash equivalents. Deposits in the Company’s checking, time deposit and investment accounts are maintained in federally insured financial institutions and are subject to federally insured limits or limits set by Securities Investor Protection Corporation. The Company invests in funds through a major U.S. bank and is exposed to credit risk in the event of default to the extent of amounts recorded on the condensed consolidated balance sheets.

 

The Company has not experienced any losses in such accounts and believes it is not exposed to significant concentrations of credit risk on its cash, cash equivalents and restricted cash balances on amounts in excess of federally insured limits due to the financial position of the depository institutions in which these deposits are held.

 

The Company is also subject to credit risk related to its trade accounts receivable from product sales. Its customers are located in the U.S. and, starting in the fourth quarter of 2025, in the United Arab Emirates (UAE), and consist of wholesale distributors, retail pharmacies, mail-order specialty pharmacies and, in the UAE, its licensee, Pharma 1.

 

In the U.S., products are distributed primarily through three major distributors and mail-order pharmacies, which receive service fees calculated as a percentage of the gross sales and a fee-per-unit shipped or sold, respectively. These entities are not obligated to purchase any set number of units; they distribute products on demand as orders are received.

 

For the three months ended March 31, 2026 and 2025, the Company’s three largest customers combined made up approximately 63% and 75% of its gross product sales, respectively. As of March 31, 2026 and December 31, 2025, the Company’s three largest customers combined made up 69% and 91%, respectively, of its trade accounts receivable balance.

 
Significant Accounting Policies

Significant Accounting Policies

 

There have been no changes to the significant accounting policies that were described in Note 2 – Summary of Significant Accounting Policies of the 2025 Audited Financial Statements in the Company’s Annual Report.

 
Cash and Cash Equivalents and Restricted Cash and Cash Equivalents

Cash and Cash Equivalents and Restricted Cash and Cash Equivalents

 

Cash and cash equivalents and restricted cash and cash equivalents consist of readily available cash in checking accounts and money market funds. Restricted cash and cash equivalents consists of cash held in monthly time deposit accounts as well as an immaterial letter of credit.

 
Net Income (Loss) Per Share

Net Income (Loss) Per Share

 

Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (loss) by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. The net income (loss) available to common stockholders is adjusted for amounts in accumulated deficit related to the deemed dividends triggered for certain financial instruments. Such adjustment was immaterial in each of the three months ended March 31, 2026 and 2025. Diluted net income (loss) per share is computed by dividing the net income (loss) by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for the three months ended March 31, 2026. Potentially dilutive securities excluded from the calculation of diluted net loss per share are summarized in the table below. Common shares were calculated for the convertible preferred stock and the convertible debt using the if-converted method.

 

 

The schedule of potentially dilutive securities excluded from the calculation of diluted net income (loss) per share is included below:

 

   2026   2025 
   Three Months Ended
March 31,		 
   2026   2025 
Options to purchase Common Stock   3,324    3,372 
Warrants to purchase Common Stock   258,254,405    20,807,539 
Series E-1 Shares   168,080,419    - 
Series F-1 Shares   1,706,493,507    - 
Series G-1 Shares   101,343,389    - 
Purchase rights to purchase Common Stock   1,505,819,328    - 
Convertible debt   3,036,800,486    - 
Total(1)   

6,776,794,858

    20,810,911 

 

(1) The potentially dilutive securities in the table above include all potentially dilutive securities that are not included in the diluted net income (loss) per share as per U.S. GAAP, whereas the total Common Stock reserved for future issuance in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit includes the shares that must legally be reserved based on the applicable instruments’ agreements.

 

The following table sets forth the computation of net income attributable to common stockholders, weighted average common shares outstanding for diluted net income per share, and diluted net income per share attributable to common stockholders for the three months ended March 31, 2025 (in thousands, except share and per share amounts).

 

   Three Months Ended
March 31, 2025		 
Numerator:     
Net income attributable to common stockholders  $953 
Adjustments:     
Noncash interest expense on convertible debt, net of tax   577 
Change in fair value of purchase rights   (1,221)
Net income attributable to common stockholders  $309 
Denominator:     
Weighted average shares used to compute net income attributable to common stockholders, basic   118,164,046 
Add:     
Pro forma adjustments to reflect assumed conversion of convertible debt   2,673,516,392 
Pro forma adjustments to reflect assumed exercise of outstanding purchase rights   1,519,148,899 
Pro forma adjustments to reflect assumed conversion of Series E-1 Shares   137,712,447 
Pro forma adjustments to reflect assumed conversion of Series F-1 Shares   1,706,493,507 
      
Weighted average shares used to compute net income attributable to common stockholders, diluted   6,155,035,291 
Net income per share attributable to common stockholders, diluted  $0.00 

 

 
Correction of Previously Issued Interim Condensed Consolidated Financial Statements and Prior Period Errors

Correction of Previously Issued Interim Condensed Consolidated Financial Statements and Prior Period Errors

 

In the fourth quarter of 2025, the Company identified issues with the disclosure of the weighted-average shares outstanding and the basic and diluted earnings per share calculations. First, the prefunded warrants should have been included in the weighted-average shares outstanding in the disclosure of basic and diluted earnings per share for the three months ended March 31, 2025. While correcting this calculation resulted in an increase in the weighted-average shares outstanding of 4,807,692, there was no change to net income per share attributable to common shareholders for the three months then ended. Secondly, the Company discovered in the calculation of the diluted net income per share attributable to common stockholders that (1) the adjustment related to the noncash interest expense on convertible debt, net of tax, was incorrectly calculated at the statutory tax rate instead of the Company’s effective tax rate and (2) the pro forma adjustment to reflect assumed conversion of convertible debt was calculated incorrectly. As a result of these corrections, for the three months ended March 31, 2025, net income attributable to common stockholders increased by $0.2 million and the weighted average shares used to compute net income attributable to common stockholders increased by 115,137,250 (inclusive of the change to the weighted-average shares outstanding as described above). There was no impact to net income per share attributable to common stockholders, diluted. The Company has concluded that the impact to the previously issued interim condensed consolidated financial statements is not material.

 
Recently Adopted Accounting Pronouncements

Recently Adopted Accounting Pronouncements

 

In November 2024, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2024-04, Debt - Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments, designed to clarify the requirements for accounting for the settlement of a debt as an induced conversion versus as an extinguishment. This guidance was effective for the Company on January 1, 2026 and the Company will apply the guidance on any future induced debt conversions.

 

In July 2025, the FASB issued ASU 2025-05, Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, to provide a practical expedient related to the estimation of expected credit losses for current accounts receivable and current contract assets that arise from transactions accounted for under Accounting Standards Codification (ASC) 606 whereby companies are allowed to assume that current economic conditions will not change over the remaining life of current accounts receivable. The Company adopted ASU 2024-05 on January 1, 2026, but because the Company does not currently expect any credit losses for accounts receivable and does not have any contract assets, there was no impact to the Company’s unaudited condensed consolidated financial statements.

 

No other significant new standards have been adopted during the three months ended March 31, 2026.

 

Recently Issued Accounting Pronouncements — Not Yet Adopted

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standards setting bodies that are adopted as of the specified effective date.

 

In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative, designed to clarify or improve disclosure and presentation requirements on a variety of topics and align the requirements in the FASB ASC with the SEC regulations. This guidance is effective for the Company no later than June 30, 2027. The Company is still evaluating the impact of ASU 2023-06.

 

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, which primarily requires disaggregation of specific expense categories in disclosures within the footnotes on an annual and interim basis. ASU 2024-03 is effective for the Company’s annual period ending December 31, 2027 and interim periods thereafter. Early adoption is permitted. In January 2025, the FASB issued ASU 2025-01 to clarify the effective date of ASU 2024-03. The Company is still evaluating the impacts of ASU 2024-03 and ASU 2025-01.

 

In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, to improve the guidance in ASC 270 related to interim reporting and also to clarify when it applies. This guidance is effective for the Company no later than January 1, 2028. The Company is still evaluating the impact of ASU 2025-11.

 

In December 2025, the FASB issued ASU 2025-12, Codification Improvements, to update the FASB ASC for a broad range of topics arising from technical corrections, unintended application of the ASC, clarifications, and other minor improvements. This guidance is effective for the Company no later than January 1, 2027. The Company is still evaluating the impact of ASU 2025-12.

 

In April 2026, the FASB issued ASU 2026-01, Equity (Topic 505): Initial Measurement of Paid-in-Kind Dividends on Equity-Classified Preferred Stock, to add guidance on how Companies should measure paid-in-kind dividends on equity-classified preferred stock. The guidance is effective for the Company no later than January 1, 2027. The Company is still evaluating the impact of ASU 2026-01.

 

The Company does not believe the impact of any other recently issued standards and any issued but not yet effective standards will have a material impact on its unaudited condensed consolidated financial statements upon adoption.