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We are a clinical-stage pharmaceutical company with a mission to develop novel therapies for communities with high unmet medical needs.
−Removed: We have preclinical and clinical development programs underway in neurodegenerative diseases and endocrine conditions.
−Removed: We are advancing a pipeline in which we have matched investigational therapies with diseases where they can make the greatest impact, based on well-defined mechanistic rationale, clear clinical outcomes and biomarkers, and rigorous preclinical data, agnostic of modality.
−Removed: We are currently developing three investigational therapies for potential impact across several diseases:
−Removed: avexitide in PBH and congenital HI, AMX0035 in Wolfram syndrome and PSP, and AMX0114 in ALS.
+Added: We have preclinical and clinical development programs underway in endocrine conditions and neurodegenerative diseases.
+Added: We are advancing a pipeline in which we have matched investigational therapies with diseases where we believe they can make the greatest impact, based on well-defined mechanistic rationale, clear clinical outcomes and biomarkers, and rigorous preclinical data, agnostic of modality.
+Added: We are currently developing four investigational therapies for potential impact across several diseases:
+Added: avexitide in PBH, AMX0035 in Wolfram syndrome, AMX0114 in ALS, and AMX0318 in PBH and other rare diseases.
As of December 31, 2025, we had cash, cash equivalents and marketable securities of $317.0 million.
−Removed: In January 2025, we received net proceeds of $65.5 million from the January 2025 Offering.
−Removed: We believe our existing cash, cash equivalents and marketable securities as of December 31, 2024, along with the proceeds from the January 2025 Offering, will be sufficient to meet our anticipated operating and capital expenditure requirements through 2026.
+Added: We believe our existing cash, cash equivalents and marketable securities as of December 31, 2025 will be sufficient to fund our operations into 2028.
We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
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Components of Our Results of Operations
−Removed: Product Revenue, Net
−Removed: Product revenue, net recognized during the years ended December 31, 2024 and 2023 relates to units of ALBRIOZA and RELYVRIO sold in Canada and the U.S., respectively.
−Removed: In April 2024, we announced we had started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO®/ALBRIOZA (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine];
−Removed: also known as AMX0035) for the treatment of ALS and remove the product from the market in the U.S.
−Removed: and Canada, or the “RELYVRIO®/ALBRIOZA Discontinuation.
−Removed: This decision was informed by topline results from the global Phase 3 PHOENIX trial, which failed to meet its prespecified primary and secondary endpoints, engagement with regulatory authorities, and discussions with the ALS community.
−Removed: As a result, we do not expect to generate revenue from the sale of RELYVRIO®/ALBRIOZA in future periods.
−Removed: As of April 4, 2024, RELYVRIO/ALBRIOZA was no longer available for new patients.
−Removed: Patients who were currently on therapy in the U.S.
−Removed: and Canada who, in consultation with their physician, wished to stay on treatment had the option to be transitioned to a free drug program.
−Removed: Patients and their physicians were informed that final shipments of free drug were made to allow treatment through early 2025.
−Removed: The NDA is now on the Discontinued Drug Product List of the Orange Book and we have filed a formal request to withdraw the NDA.
−Removed: We have completed the collection of data on survival and we will continue to share any learnings from PHOENIX to help inform future ALS research.
−Removed: We wound down the Open Label Extension as planned.
Operating Expenses
−Removed: Cost of Sales
−Removed: Cost of sales consists primarily of costs associated with the manufacturing of RELYVRIO, ALBRIOZA and certain period costs and losses on purchase commitments with contract manufacturing organizations.
−Removed: Following our announcement of a process to discontinue the marketing authorizations for RELYVRIO®/ALBRIOZA and remove the product from the market in the U.S.
−Removed: and Canada, we did not report product cost of sales following the discontinuation of these products.
−Removed: Acquired In-process Research and Development Expenses
−Removed: Acquired in-process research and development, or IPR&D, expenses relate to upfront or other payments pursuant to our business development transactions, including the Eiger Acquisition (as defined below).
Research and Development Expenses
−Removed: Research and development expenses consist primarily of costs incurred in connection with the research and development of avexitide, AMX0035, AMX0114 and other potential future product candidates.
+Added: Research and development expenses consist primarily of costs incurred in connection with the research and development of avexitide, AMX0035, AMX0114, AMX0318 and other potential future product candidates.
We expense research and development costs as incurred.
These expenses include:
−Removed: • expenses incurred under agreements with CROs, contract manufacturing organizations, or CMOs, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;
+Added: • expenses incurred under agreements with CROs, CMOs, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;
• manufacturing scale-up expenses and the cost of acquiring and manufacturing drug product for our preclinical studies and clinical trials, including manufacturing registration and validation batches, as well as pre-commercial manufacturing activities;
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Research and development activities are central to our business model.
−Removed: Product candidates such as avexitide and AMX0035 in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, such as AMX0114, primarily due to the increased size and duration of later-stage clinical trials and related product manufacturing expenses.
+Added: Product candidates such as avexitide and AMX0035 in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, such as AMX0114 and AMX0318, primarily due to the increased size and duration of later-stage clinical trials and related product manufacturing expenses.
Despite a decline in research and development expenses in 2025 compared to 2024, we expect that our research and development expenses will increase in connection with our planned clinical development activities in the near term and in the future.
−Removed: At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of avexitide, AMX0035 and any future product candidates.
+Added: At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of avexitide, AMX0035, AMX0114, AMX0318 and any future product candidates.
Our clinical development costs may vary significantly based on factors such as:
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• the number of product candidates we are developing.
−Removed: The successful development and commercialization of avexitide, AMX0035 and any other current or future product candidates is highly uncertain, due to the numerous risks and uncertainties associated with product development and commercialization, including the following:
+Added: The successful development and commercialization of avexitide, AMX0035, AMX0114, AMX0318 and any other current or future product candidates is highly uncertain, due to the numerous risks and uncertainties associated with product development and commercialization, including the following:
• the timing and progress of preclinical and clinical development activities;
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• a continued acceptable safety profile of our therapies in pre-approval market access programs or in commercial access following approval.
−Removed: A change in the outcome of any of these variables with respect to the development of avexitide, AMX0035 or any other current or future product candidates could have a significant impact on the cost and timing associated with the development of our product candidates.
−Removed: We may never succeed in obtaining or maintaining, as applicable, regulatory approval for avexitide, AMX0035 or any other current or future product candidates.
+Added: A change in the outcome of any of these variables with respect to the development of avexitide, AMX0035, AMX0114, AMX0318 or any other current or future product candidates could have a significant impact on the cost and timing associated with the development of our product candidates.
+Added: We may never succeed in obtaining or maintaining, as applicable, regulatory approval for avexitide, AMX0035, AMX0114, AMX0318 or any other current or future product candidates.
Selling, General and Administrative Expenses
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However, we expect that general and administrative expenses will increase in future periods as we advance our clinical pipeline.
−Removed: Restructuring Expenses
−Removed: Restructuring expenses consists primarily of employee severance and termination benefits, contract termination costs, impairment of long-lived assets and other costs.
−Removed: Such costs are based on estimates of fair value in the period liabilities are incurred.
−Removed: We evaluate and adjust these costs as appropriate for changes in circumstances as additional information becomes available.
We have historically not incurred significant income taxes.
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Total operating expenses
−Removed: (Loss) income from operations
+Added: Loss from operations
Other income, net:
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Total other income, net
−Removed: (Loss) income before income taxes
−Removed: (Benefit) provision for income taxes
−Removed: Net (loss) income
−Removed: * NM - not meaningful
−Removed: Product revenue, net
−Removed: Product revenue, net was $87.4 million for the year ended December 31, 2024, compared to $380.8 million for the year ended December 31, 2023.
−Removed: Product revenue, net was related to units of RELYVRIO and ALBRIOZA sold in the U.S.
−Removed: and Canada, respectively, prior to the RELYVRIO®/ALBRIOZA Discontinuation.
−Removed: Cost of sales
−Removed: Cost of sales were $124.6 million for the year ended December 31, 2024, compared to $25.4 million for the year ended December 31, 2023.
−Removed: Cost of sales consisted of costs to procure, manufacture and distribute our marketed products, RELYVRIO and ALBRIOZA.
+Added: Loss before income taxes
+Added: Provision (benefit) for income taxes
+Added: Product revenue, net and Cost of sales
+Added: In April 2024, we announced we had started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO®/ALBRIOZA (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine];
+Added: also known as AMX0035) for the treatment of ALS and remove the product from the market in the U.S.
+Added: and Canada, or the “RELYVRIO®/ALBRIOZA Discontinuation.
+Added: As a result of the RELYVRIO®/ALBRIOZA Discontinuation, we did not generate revenue from product sales for the year ended December 31, 2025.
+Added: For the year ended December 31, 2024, product revenue, net was primarily related to units of RELYVRIO and ALBRIOZA previously sold in the U.S.
+Added: and Canada during the first quarter of 2024.
+Added: As a result of the RELYVRIO®/ALBRIOZA Discontinuation, we did not generate cost of sales for the year ended December 31, 2025.
+Added: For the year ended December 31, 2024, cost of sales consisted of costs to procure, manufacture and distribute our marketed products, RELYVRIO and ALBRIOZA.
As a result of the RELYVRIO®/ALBRIOZA Discontinuation, we recorded approximately $118.7 million of charges associated with the write-down of inventory and losses on firm purchase commitments for the year ended December 31, 2024.
Acquired In-process Research and Development Expenses
−Removed: On July 9, 2024, we completed the acquisition of substantially all the assets and interests in the development, manufacture and commercialization of avexitide, an investigational, first-in-class GLP-1 receptor antagonist, from Eiger, or the Seller, or the Eiger Acquisition.
+Added: In July 2024, we completed the acquisition of substantially all the assets and interests in the development, manufacture and commercialization of avexitide, an investigational, first-in-class GLP-1 receptor antagonist, from Eiger, or the Eiger Acquisition.
During the year ended December 31, 2024, we recorded a charge of approximately $36.2 million associated with the acquired in-process research and development assets of avexitide with no alternative future use.
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Direct research and development expenses by program:
−Removed: AMX0035 - ALS
AMX0035 - PSP
+Added: AMX0035 - ALS
Other programs
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Personnel-related research and development
−Removed: * NM - not meaningful
Research and development expenses were $90.4 million for the year ended December 31, 2025, compared to $104.1 million for the year ended December 31, 2024.
−Removed: The decrease of $24.1 million was primarily due to a $24.1 million decrease in spending on AMX0035 for the treatment of ALS following topline data from the PHOENIX trial in April 2024, an $8.1 million decrease in payroll and personnel-related costs due to a decrease in the number of employees following the completion of our Restructuring Plan, and a $5.2 million decrease in other costs due to an decrease in preclinical development activities.
−Removed: The decrease in research and development expenses was offset by a $10.5 million increase in spending on AMX0035 for the treatment of PSP, and a $2.8 million increase in expenses for the development of avexitide following the Eiger Acquisition.
−Removed: The increase in spending on AMX0035 for the treatment of PSP was primarily related to costs to support the continuation of the ORION Phase 2b/3 global clinical trial.
+Added: The decrease of $13.7 million was primarily due to a $35.0 million decrease in spending on AMX0035 for the treatment of ALS following topline data from the PHOENIX trial and a $6.7 million decrease in payroll and personnel-related costs due to a decrease in the number of employees following the completion of our Restructuring Plan.
+Added: The decrease in research and development expenses was offset by a $21.3 million increase in expenses related to the pivotal Phase 3 LUCIDITY clinical trial in PBH and other costs related to avexitide, and a $6.3 million increase in other research and development activities.
Selling, General and Administrative Expenses
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The decrease in consulting and professional services was primarily due to a decrease in commercial sales and marketing activity as a result of the RELYVRIO®/ALBRIOZA Discontinuation.
−Removed: The decrease in other expenses is primarily due to a decrease in charitable contributions.
+Added: The decrease in other expenses is primarily due to a decrease in charitable contributions, lower facilities and IT-related expenses, and a decrease in activity to wind down commercial operations.
Restructuring Expenses
−Removed: In April 2024, we announced a restructuring to focus our financial resources on upcoming clinical milestones.
−Removed: Under the restructuring, we reduced our workforce by approximately 70% and decreased external financial commitments outside of our priority areas.
−Removed: Restructuring expenses were approximately $22.9 million for the year ended December 31, 2024 which includes employee severance and termination benefits of approximately $21.9 million, contract termination costs, impairment of long-lived assets and other costs of $1.0 million.
−Removed: We completed the Restructuring Plan in 2024.
+Added: We did not recognize restructuring expenses for the year ended December 31, 2025.
+Added: During the year ended December 31, 2024, restructuring expenses were approximately $22.9 million, which includes employee severance and termination benefits of approximately $21.9 million, contract termination costs, impairment of long-lived assets and other costs of $1.0 million.
+Added: We substantially completed the Restructuring Plan in the second quarter of 2024.
Liquidity and Capital Resources
Sources of Liquidity
−Removed: In the second half of 2022, we began generating revenue from the sale of our approved drug product RELYVRIO, known as ALBRIOZA in Canada.
−Removed: In April 2024, we announced the RELYVRIO®/ALBRIOZA Discontinuation.
−Removed: We also announced the Restructuring Plan, which was designed to focus our resources on key clinical and preclinical programs and included a reduction in force which reduced our workforce by approximately 70% and decreased external financial commitments outside of our priority areas.
−Removed: We completed the Restructuring Plan in the second half of 2024.
−Removed: In January 2025, we entered into an underwriting agreement with Leerink Partners LLC, as representative of the several underwriters named therein, relating to the issuance and sale of an aggregate of 19,714,285 shares of our common stock, which includes the exercise in full by the underwriters of their option to purchase an additional 2,571,428 shares, or the January 2025 Offering.
−Removed: The offering price per share was $3.50.
−Removed: The January 2025 Offering resulted in estimated proceeds of approximately $65.5 million, net of underwriting discounts and estimated offering expenses (see Note 18 Subsequent events).
+Added: In January 2025, we entered into an underwriting agreement with Leerink Partners LLC, as representative of the several underwriters named therein, relating to the issuance and sale of an aggregate of 19,714,285 shares of our common stock, which includes the exercise in full by the underwriter of its option to purchase an additional 2,571,428 shares, or the January 2025 Offering.
+Added: The public offering price per share was $3.50.
+Added: The January 2025 Offering resulted in proceeds of approximately $65.5 million, net of underwriting discounts and offering expenses.
+Added: In September 2025, we entered into an underwriting agreement with Leerink Partners LLC and Guggenheim Securities LLC, as representatives of the several underwriters named therein, relating to the issuance and sale of an aggregate of 20,150,000 shares of our common stock, which includes the exercise in full by the underwriters of their option to purchase an additional 2,625,000 shares, or the September 2025 Offering.
+Added: The public offering price per share was $10.00.
+Added: The September 2025 Offering resulted in proceeds of approximately $190.7 million, net of underwriting discounts and offering expenses.
As of December 31, 2025, we had cash, cash equivalents and marketable securities of $317.0 million and an accumulated deficit of $751.4 million.
−Removed: We believe our existing cash, cash equivalents and marketable securities as of December 31, 2024, along with the proceeds from the January 2025 Offering, will be sufficient to meet our anticipated operating and capital expenditure requirements through 2026.
+Added: We believe our existing cash, cash equivalents and marketable securities as of December 31, 2025 will be sufficient to fund our operations into 2028.
We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
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There can be no assurances that our current operating plan will be achieved or that additional funding, if required, will be available on terms acceptable to us, or at all.
−Removed: Capital Resources
−Removed: Despite the decline in research and development and general administrative expenses in 2024 as compared to 2023, we expect our expenses to increase in connection with our ongoing activities, particularly as we advance the preclinical activities, manufacturing and clinical trials of avexitide, AMX0035 and any other current or future product candidates or acquire or in-license additional product candidates or products.
+Added: Capital Resources and Uses
+Added: Despite the decline in research and development and general administrative expenses in 2025 as compared to 2024, we expect our expenses to increase in connection with our ongoing activities, particularly as we advance the preclinical activities, manufacturing and clinical trials of avexitide, AMX0035, AMX0114 and any other current or future product candidates or acquire or in-license additional product candidates or products.
We may also incur expenses related to business development activities, such as in-licensing or acquisition of product candidates.
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• continue our research and development efforts of avexitide in PBH, or any other indications, and conduct clinical trials of avexitide;
−Removed: • continue our research and development efforts of AMX0035, including our ongoing Phase 2b/3 trial of AMX0035 in PSP and our ongoing Phase 2 trial of AMX0035 for the treatment of Wolfram syndrome;
−Removed: • continue to develop AMX0114, our antisense oligonucleotide, for the treatment of people living ALS;
+Added: • continue our research and development efforts of AMX0035, including our ongoing Phase 2 trial of AMX0035 for the treatment of Wolfram syndrome and winding down of the Phase 2b/3 trial of AMX0035 in PSP;
+Added: • continue our research and development efforts of AMX0114, including our ongoing Phase 1 clinical trial of AMX0114 for the treatment of ALS;
• pursue INDs of AMX0035 for additional indications;
• conduct preclinical studies and clinical trials for AMX0035 for additional indications and for potential future product candidates;
+Added: • continue our preclinical efforts of AMX0318, including advancing into IND-enabling studies in 2026;
• seek to identify and develop, acquire or in-license additional product candidates;
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Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
−Removed: • the scope, progress, results and costs of drug discovery, laboratory testing, preclinical and clinical development for avexitide, AMX0035 and any future product candidates;
+Added: • the scope, progress, results and costs of drug discovery, laboratory testing, preclinical and clinical development for avexitide, AMX0035, AMX0114, AMX0318 and any future product candidates;
• the costs, timing and outcome of any future commercialization activities, including manufacturing, marketing, sales and distribution costs;
−Removed: • the costs, timing and outcome of regulatory review of avexitide, AMX0035 and any future product candidates;
+Added: • the costs, timing and outcome of regulatory review of avexitide, AMX0035, AMX0114, AMX0318 and any future product candidates;
• our ability to establish and maintain collaborations, marketing, distribution and license agreements on favorable terms, if at all;
• our ability to enroll clinical trials in a timely manner and to quickly resolve any delays or clinical holds that may be imposed on our development activities;
−Removed: • timing delays with respect to preclinical and clinical development of avexitide, AMX0035 and any future product candidates, including as result of any future outbreak of any highly infectious or contagious diseases;
+Added: • timing delays with respect to preclinical and clinical development of avexitide, AMX0035, AMX0114, AMX0318 and any future product candidates, including as result of any future outbreak of any highly infectious or contagious diseases;
• costs associated with identifying and developing, acquiring or in-licensing additional product candidates or products;
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(in thousands)
−Removed: Net cash (used in) provided by operating activities
+Added: Net cash used in operating activities
Net cash provided by investing activities
2 unchanged sentences
and restricted cash equivalents
−Removed: Net (decrease) increase in cash, cash equivalents and restricted cash equivalents
+Added: Net increase (decrease) in cash, cash equivalents and restricted cash equivalents
Operating Activities
+Added: During the year ended December 31, 2025, operating activities used $123.3 million of cash, primarily resulting from our net loss of $144.7 million, $5.5 million in accretion of discounts on investments, and $1.1 million of net cash used by changes in our operating assets and liabilities, offset by $27.6 million of non-cash stock-based compensation expense.
+Added: Net cash used by changes in our operating assets and liabilities primarily consisted of a $6.6 million decrease in accrued expenses, a $1.2 million decrease in operating lease liabilities, and a $2.0 million increase in other assets, offset by a $6.0 million decrease in prepaid expenses and other current assets and a $1.7 million decrease in operating right-of-use (ROU) assets.
During the year ended December 31, 2024, operating activities used $167.6 million of cash, primarily resulting from our net loss of $301.7 million, offset by non-cash items totaling $179.9 million including $118.7 million of inventory impairment and loss on firm purchase commitments, $33.0 million of non-cash stock-based compensation expense, $9.9 million in accretion of discounts on investments and $36.2 million of acquired IPR&D assets, which are classified as investing activities.
Changes in working capital totaled $45.8 million, primarily consisting of a $59.8 million decrease in accrued expenses, a $19.1 million decrease in accounts payable, a $9.3 million decrease in inventories and partially offset by a $39.6 million decrease in accounts receivable, net.
−Removed: During the year ended December 31, 2023, operating activities provided $11.9 million of cash, primarily resulting from our net income of $49.3 million, non-cash stock-based compensation expense of $37.2 million and $1.1 million of depreciation expense, offset by an increase of $65.7 million in net cash used in our operating assets and liabilities and net amortization of premiums and discounts on investments of $9.9 million.
−Removed: Net cash used in our operating assets and liabilities in 2023 primarily consisted of a $21.6 million increase in accrued expenses, a $15.9 million increase in accounts payable and a $1.8 million decrease in operating lease right-of-use assets.
−Removed: This was offset by a $73.1 million increase in inventories, a $24.7 million increase in accounts receivable, a $4.8 million increase in prepaid expenses and other current assets and a $2.0 million decrease in operating lease liabilities.
Investing Activities
+Added: During the year ended December 31, 2025, net cash provided by investing activities was $14.0 million resulting primarily from $246.0 million of investments that matured, offset by $231.8 million in purchases of marketable securities.
During the year ended December 31, 2024, net cash provided by investing activities was $75.7 million resulting from $344.0 million of investments that matured during the period offset by $232.0 million in purchases of marketable securities and a $36.2 million cash outflow to acquire IPR&D assets related to the Eiger Acquisition.
−Removed: During the year ended December 31, 2023, net cash provided by investing activities was $92.1 million resulting from $394.1 million of investments matured during the period offset by $300.8 million in purchases of marketable securities and $1.2 million in purchases of property and equipment.
Financing Activities
During the year ended December 31, 2025, net cash provided by financing activities was $257.0 million.
−Removed: This amount consisted of $2.1 million of proceeds from exercises of stock options, offset by $1.8 million of withholding taxes paid on stock-based awards.
+Added: This amount consisted primarily of $65.6 million in proceeds from the January 2025 Offering, net of offering costs paid, and $190.7 million in proceeds from the September 2025 Offering, net of offering costs paid.
During the year ended December 31, 2024, net cash provided by financing activities was $0.3 million.
−Removed: This amount consisted of $7.0 million of proceeds from exercises of stock options, offset by $3.3 million of withholding taxes paid on stock-based awards and $0.1 million in payments of deferred offering costs.
+Added: This amount consisted of $2.1 million of proceeds from exercises of stock options, offset by $1.8 million of withholding taxes paid on stock-based awards.
Contractual Obligations and Commitments
We enter into agreements in the normal course of business with contract manufacturing organizations for raw material purchases and manufacturing services.
−Removed: As of December 31, 2024, the amounts committed under these agreements are not material.
+Added: As of December 31, 2025, there are no amounts committed under these agreements.
Critical Accounting Policies and Significant Judgments and Estimates
Our consolidated financial statements are prepared in accordance with U.S.
+Added: generally accepted accounting principles, or U.S.
The preparation of our consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our consolidated financial statements.
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While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements appearing at the end of this Annual Report, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
−Removed: Revenue Recognition
−Removed: Prior to the RELYVRIO®/ALBRIOZA Discontinuation, our accounting policy for revenue recognition had a substantial impact on reported results and relied on certain estimates.
−Removed: Specifically, revenue was reduced by variable consideration related to certain gross-to-net, or GTN.
−Removed: These GTN adjustments involve significant estimates and judgment, considering historical experience, payer channel mix (e.g., Medicare or Medicaid), current contract prices under applicable programs, unbilled claims and processing time lags and inventory levels in the distribution channel.
−Removed: Estimates were assessed each period and adjusted as required to revise information or actual experience.
−Removed: To date, actual GTN activity has not differed materially from our estimates.
−Removed: Because of the time elapsed since the RELYVRIO®/ALBRIOZA Discontinuation the remaining estimates and judgments related to revenue recognition are not considered significant as of December 31, 2024.
Accrued Research and Development Expenses
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses.
−Removed: This process involves reviewing open contracts and purchase orders, communicating
−Removed: with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs.
+Added: This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs.
The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met;
however, some require advance payments.
−Removed: We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time.
+Added: We make estimates of our accrued expenses as of
+Added: each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time.
We periodically confirm the accuracy of these estimates with the service providers and make adjustments if necessary.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.