Axsome Therapeutics, Inc.

Previous wording

AUVELITY (dextromethorphan and bupropion) was developed by Axsome and approved by the FDA in August 2022 for the treatment of MDD (as defined below) in adults. We launched AUVELITY in the U.S. in October 2022 as the first and only oral, N-methyl-D-aspartate (NMDA) receptor antagonist approved for MDD in adults and the only oral antidepressant with rapid-acting efficacy reflected in the FDA label. In April 2026, the FDA approved AUVELITY for the treatment of agitation associated with dementia due to Alzheimer’s disease (AADDAD). We initiated the commercial launch of AUVELITY for the treatment of AADDAD in June 2026. AUVELITY utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components.

Current wording

AUVELITY (dextromethorphan and bupropion) was developed by Axsome and approved by the FDA in August 2022 for the treatment of MDD (as defined below) in adults. We launched AUVELITY in the U.S. in October 2022 as the first and only oral, N-methyl-D-aspartate (NMDA) receptor antagonist approved for MDD in adults and the only oral antidepressant with rapid-acting efficacy reflected in the FDA label. In April 2026, the FDA approved AUVELITY for the treatment of agitation associated with dementia due to Alzheimer’s disease (ADA). We initiated the commercial launch of AUVELITY for the treatment of ADA in June 2026. AUVELITY utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components.

Previous wording

SUNOSI (solriamfetol) is a novel, oral, dopamine and norepinephrine reuptake inhibitor (DNRI), trace amine-associated receptor 1 (TAAR1) agonist, and 5-HT1A agonist approved in the United States, the European Union, and Canada for the treatment of EDS in adult patients with obstructive sleep apnea or narcolepsy. We acquired the U.S. rights to SUNOSI from Jazz Pharmaceuticals plc, or Jazz, in May 2022, and the ex-U.S. rights (excluding certain Asian markets) from Jazz in November 2022. We have been commercializing SUNOSI since we completed these acquisitions. SK Biopharmaceuticals Co. Ltd., or SK, is the originator of SUNOSI and retains rights in 12 Asian markets, including China, Korea, and Japan. We refer to the acquisition of SUNOSI herein as the Acquisition. In February 2023, we entered into a licensing agreement, or the Pharmanovia License Agreement, with Atnahs Pharma UK Limited, or Pharmanovia, that granted to Pharmanovia the exclusive right to market SUNOSI in Europe and certain countries in the Middle East and North Africa, referred to as the Licensed Territory. Approximately 22 million adults and 185,000 people in the U.S. are affected by OSA and narcolepsy, respectively.

Current wording

SUNOSI (solriamfetol) is a novel, oral, dopamine and norepinephrine reuptake inhibitor (DNRI), trace amine-associated receptor 1 (TAAR1) agonist, and 5-HT1A agonist approved in the United States, the European Union, and Canada for the treatment of excessive daytime sleepiness, or EDS, in adult patients with obstructive sleep apnea or narcolepsy. We acquired the U.S. rights to SUNOSI from Jazz Pharmaceuticals plc, or Jazz, in May 2022, and the ex-U.S. rights (excluding certain Asian markets) from Jazz in November 2022. We have been commercializing SUNOSI since we completed these acquisitions. SK Biopharmaceuticals Co. Ltd., or SK, is the originator of SUNOSI and retains rights in 12 Asian markets, including China, Korea, and Japan. We refer to the acquisition of SUNOSI herein as the Acquisition. In February 2023, we entered into a licensing agreement, or the Pharmanovia License Agreement, with Atnahs Pharma UK Limited, or Pharmanovia, that granted to Pharmanovia the exclusive right to market SUNOSI in Europe and certain countries in the Middle East and North Africa, referred to as the Licensed Territory. Approximately 22 million adults and 185,000 people in the U.S. are affected by obstructive sleep apnea and narcolepsy, respectively.

Previous wording

AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist, sigma-1 receptor agonist, aminoketone, and CYP2D6 inhibitor being developed for smoking cessation. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components.

Current wording

AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist, sigma-1 receptor agonist, aminoketone, and CYP2D6 inhibitor being developed for smoking cessation. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components. In August 2026, we initiated the SUMMIT trial, a Phase 3 randomized, double-blind, active- and placebo-controlled, multicenter trial to assess the efficacy and safety of AXS-05 as a smoking cessation treatment in adults.

Previous wording

Solriamfetol is a novel, oral, investigational DNRI, TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (“ADHD”), binge eating disorder (“BED”), major depressive disorder (“MDD”) with EDS symptoms, and excessive sleepiness associated with shift work disorder (“SWD”). In March 2025, we announced positive topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD in adults. We recently announced the initiations of the FOCUS-2 and FOCUS-3 studies, Phase 3, randomized, double-blind, placebo-controlled, multicenter trials evaluating the efficacy and safety of solriamfetol in children and adolescents with ADHD, respectively. In February 2026, we initiated the CLARITY study, a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial of solriamfetol in patients with MDD with EDS symptoms. Enrollment for the ENGAGE and SUSTAIN Phase 3 trials of solriamfetol in BED and SWD, respectively, are ongoing.

Current wording

Solriamfetol is a novel, oral, investigational DNRI, TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (“ADHD”), binge eating disorder (“BED”), major depressive disorder (“MDD”) with EDS symptoms, and excessive sleepiness associated with shift work disorder (“SWD”). In March 2025, we announced positive topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD in adults. We recently announced the initiations of the FOCUS-2 and FOCUS-3 studies, Phase 3, randomized, double-blind, placebo-controlled, multicenter trials evaluating the efficacy and safety of solriamfetol in children and adolescents with ADHD, respectively. In February 2026, we initiated the CLARITY study, a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial of solriamfetol in patients with MDD with EDS symptoms. Enrollments for the ENGAGE and SUSTAIN Phase 3 trials of solriamfetol in BED and SWD, respectively, are ongoing.

Previous wording

AXS-12 (reboxetine) is a novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. We have completed three positive Phase 2 and Phase 3, placebo-controlled efficacy trials and a long-term safety trial. In July 2026, the FDA accepted for filing the Company’s New Drug Application (NDA) for AXS-12 for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. AXS-12 was previously granted FDA Orphan Drug Designation for narcolepsy.

Current wording

AXS-12 (reboxetine) is a novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. We have completed three positive Phase 2 and Phase 3, placebo-controlled efficacy trials and a long-term safety trial. In July 2026, the FDA accepted for filing our New Drug Application (NDA) for AXS-12 for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. AXS-12 was previously granted FDA Orphan Drug Designation for narcolepsy.

Previous wording

We have incurred significant operating and net losses since inception. We incurred net losses of $115.9 million and $107.4 million for the six months ended June 30, 2026 and 2025, respectively. Our accumulated deficit as of June 30, 2026 was $1,421.8 million, and we expect to incur significant expenses and continuing operating losses. We expect our expenses to increase in connection with our ongoing activities, as we continue the commercialization of our on-market products and the development and clinical trials of, and seek regulatory approval for, our current product candidates and any other product candidates that we develop or in-license and advance to clinical development. Further, we have incurred and will continue to incur additional costs associated with operating as a public company. Accordingly, we may need additional financing to support our continuing operations. We may seek to fund our operations through public or private equity, debt financings, or other sources. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.

Current wording

We have incurred significant operating and net losses since inception. We incurred net losses of $128.7 million and $154.6 million for the nine months ended September 30, 2026 and 2025, respectively. Our accumulated deficit as of September 30, 2026 was $1,434.7 million, and we expect to incur significant expenses and continuing operating losses. We expect our expenses to increase in connection with our ongoing activities, as we continue the commercialization of our on-market products and the development and clinical trials of, and seek regulatory approval for, our current product candidates and any other product candidates that we develop or in-license and advance to clinical development. Further, we have incurred and will continue to incur additional costs associated with operating as a public company. Accordingly, we may need additional financing to support our continuing operations. We may seek to fund our operations through public or private equity, debt financings, or other sources. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.

Previous wording

We generated total revenues of $218.4 million and $150.0 million in the three months ended June 30, 2026 and 2025, respectively, and $409.6 million and $271.5 million in the six months ended June 30, 2026 and 2025, respectively.

Current wording

We generated total revenues of $259.7 million and $171.0 million in the three months ended September 30, 2026 and 2025, respectively, and $669.3 million and $442.5 million in the nine months ended September 30, 2026 and 2025, respectively.

Previous wording

Additionally, in the first quarter of 2026, we recorded a milestone revenue of $0.5 million related to an achievement of a regulatory milestone for AUVELITY and in the second quarter of 2026, we recorded a milestone revenue of $0.5 million related to a developmental milestone for SUNOSI.

Current wording

Additionally, in the first quarter of 2026, we recorded milestone revenue of $0.5 million related to the achievement of a regulatory milestone for AUVELITY; in the second quarter of 2026, we recorded milestone revenue of $0.5 million related to the achievement of a developmental milestone for SUNOSI; and in the third quarter of 2026, we recorded milestone revenue of $8.5 million related to the achievement of a sales-based milestone under the Pharmanovia License Agreement.

Previous wording

In February 2023, we entered into the Pharmanovia License Agreement with Pharmanovia to commercialize and further develop SUNOSI in the Territory. Pharmanovia is a UK-based global life cycle management healthcare company that focuses on four core therapeutic areas – Oncology, Endocrinology, Neurology and Cardiovascular.

Current wording

In February 2023, we entered into the Pharmanovia License Agreement with Pharmanovia to commercialize and further develop SUNOSI in the Licensed Territory. Pharmanovia is a UK-based global life cycle management healthcare company that focuses on four core therapeutic areas – Oncology, Endocrinology, Neurology and Cardiovascular.

Previous wording

We are eligible to receive sales-based and other milestone payments totaling up to €94.5 million. We will receive a royalty percentage in the mid-twenties on net sales of the Licensed Products (as defined in the Pharmanovia License Agreement) in the Territory. We recognized royalty revenue of $1.5 million and $1.1 million for the three months ended June 30, 2026 and 2025, respectively, and $2.8 million and $2.2 million for the six months ended June 30, 2026 and 2025, respectively, related to Pharmanovia’s sales of SUNOSI.

Current wording

We are eligible to receive sales-based and other milestone payments totaling up to €94.5 million. We will receive a royalty percentage in the mid-twenties on net sales of the Licensed Products (as defined in the Pharmanovia License Agreement) in the Licensed Territory. We recognized royalty revenue of $1.2 million and $1.2 million for the three months ended September 30, 2026 and 2025, respectively, and $4.0 million and $3.4 million for the nine months ended September 30, 2026 and 2025, respectively, related to Pharmanovia’s sales of SUNOSI. During the three months ended September 30, 2026, we recognized milestone revenue of $8.5 million related to the achievement of a sales-based milestone under the Pharmanovia License Agreement.

Previous wording

Cost of revenue includes direct costs of formulating, manufacturing and packaging drug product, overhead costs consisting of labor, customs, stock-based compensation, shipping, outside inventory management, royalty expense, and other miscellaneous operating costs.

Current wording

Cost of revenue (excluding depreciation and amortization) includes direct costs of formulating, manufacturing and packaging drug product, overhead costs consisting of labor, customs, stock-based compensation, shipping, outside inventory management, royalty expense, and other miscellaneous operating costs.

Previous wording

Product sales, net. AUVELITY U.S. net sales were $180.3 million and $333.0 million for the three and six months ended June 30, 2026, respectively, as compared to $119.6 million and $215.9 million for the same periods in 2025. SUNOSI net sales were $33.8 million and $66.5 million for the three and six months ended June 30, 2026, respectively, as compared to $28.9 million and $53.0 million for the same periods in 2025. We began commercial sales of SYMBRAVO in June 2025 and had U.S. net sales of $2.3 million and $6.3 million for the three and six months ended June 30, 2026, respectively, as compared to $0.4 million for the three months ended June 30, 2025. There were no SYMBRAVO sales recorded during the three months ended March 31, 2025. The increases in product sales were primarily due to the increase in unit sales volume for both AUVELITY and SUNOSI.

Current wording

Product sales, net. AUVELITY U.S. net sales were $207.6 million and $540.6 million for the three and nine months ended September 30, 2026, respectively, as compared to $136.1 million and $352.0 million for the same periods in 2025. SUNOSI net sales were $38.5 million and $104.9 million for the three and nine months ended September 30, 2026, respectively, as compared to $31.6 million and $84.6 million for the same periods in 2025. We began commercial sales of SYMBRAVO in June 2025 and had U.S. net sales of $3.9 million and $10.2 million for the three and nine months ended September 30, 2026, respectively, as compared to $2.1 million and $2.5 million for the three and nine months ended September 30, 2025. The increases in product sales were primarily due to the increase in unit sales volume for AUVELITY, SUNOSI, and SYMBRAVO.

Previous wording

The following table summarizes the activity of our sales allowance and reserves as of and for the six months ended June 30, 2026 (in thousands):

Current wording

The following table summarizes the activity of our sales allowance and reserves as of and for the nine months ended September 30, 2026 (in thousands):

Previous wording

Royalty revenue and milestone revenue. Royalty revenue was $1.5 million and $2.8 million for the three and six months ended June 30, 2026, respectively, as compared to $1.1 million and $2.2 million for the same periods in 2025, attributable to Pharmanovia sales of SUNOSI in the out-licensed markets. The increase was in line with the increase in unit sales volume of SUNOSI in certain ex-U.S. markets. Further, we recognized milestone revenue of $0.5 million related to a regulatory milestone for AUVELITY in the first quarter of 2026 and $0.5 million related to a developmental milestone for SUNOSI in the second quarter of 2026.

Current wording

Royalty revenue and milestone revenue. Royalty revenue was $1.2 million and $4.0 million for the three and nine months ended September 30, 2026, respectively, as compared to $1.2 million and $3.4 million for the same periods in 2025, attributable to Pharmanovia sales of SUNOSI in the out-licensed markets. The increase was in line with the increase in unit sales volume of SUNOSI in certain ex-U.S. markets. Further, we recognized milestone revenue of $8.5 million related to a sales-based milestone under the Pharmanovia License Agreement in the third quarter of 2026, $0.5 million related to a developmental milestone for SUNOSI in the second quarter of 2026, and $0.5 million related to a regulatory milestone for AUVELITY in the first quarter of 2026.

Previous wording

Cost of revenue. Cost of revenue was $13.6 million and $28.3 million for the three and six months ended June 30, 2026, respectively, as compared to $13.4 million and $23.2 million for the same periods in 2025. The increase was in line with the increase in sales of AUVELITY and SUNOSI, the commercial launch of AUVELITY for the treatment of AADDAD in June 2026, and the commercial launch of SYMBRAVO in June 2025.

Current wording

Cost of revenue. Cost of revenue was $17.8 million and $46.1 million for the three and nine months ended September 30, 2026, respectively, as compared to $11.9 million and $35.1 million for the same periods in 2025. The increases in both comparable periods were in line with the increase in sales of AUVELITY and SUNOSI, the commercial launch of AUVELITY for the treatment of ADA in June 2026, and the commercial launch of SYMBRAVO in June 2025.

Previous wording

Research and development. The following table summarizes our research and development expenses for our primary products for the three and six months ended June 30, 2026 and 2025 (in thousands):

Current wording

Research and development. The following table summarizes our research and development expenses for our primary products for the three and nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

Research and development expenses decreased by $3.3 million and increased by $4.6 million for the three and six months ended June 30, 2026, respectively, as compared to the same periods in 2025. The decrease for the three months period was primarily due to lower spending on AXS-05, driven by the timing of clinical study activities, along with lower costs for AXS-14, reflecting regulatory costs incurred in the prior year period. This was partially offset by higher spending on solriamfetol. The increase for the six months period was primarily due to asset acquisition costs related to AXS-20, which were partially offset by lower spending on AXS-05, driven by the timing of clinical study activities. We expect research and development costs to moderately increase as our recently started clinical trials further enroll.

Current wording

Research and development expenses increased by $10.4 million and $15.0 million for the three and nine months ended September 30, 2026, respectively, as compared to the same periods in 2025. The increase for the three-month period was primarily due to higher spending on solriamfetol and AXS-14. The increase for the nine-month period was primarily due to asset acquisition costs related to AXS-20 and higher spending on solriamfetol and AXS-14, which were partially offset by lower spending on AXS-05, driven by the timing of clinical study activities. We expect research and development costs to moderately increase as our recently started clinical trials further enroll.

Previous wording

Selling, general and administrative. Selling, general and administrative expenses were $208.1 million and $393.1 million for the three and six months ended June 30, 2026, respectively, as compared to $130.3 million and $251.1 million for the same periods in 2025. The increases in both comparable periods were primarily related to pre-launch activities for AUVELITY for the treatment of AADDAD, higher commercial activities for AUVELITY including a national direct-to-consumer advertising campaign and sales force expansion, commercial activities for SYMBRAVO which was launched in June 2025, and higher personnel costs related to organizational growth. We anticipate SG&A expenses to marginally increase through the end of 2026 as we continue commercial activities for AUVELITY and SYMBRAVO.

Current wording

Selling, general and administrative. Selling, general and administrative expenses were $203.1 million and $596.2 million for the three and nine months ended September 30, 2026, respectively, as compared to $150.2 million and $401.3 million for the same periods in 2025. The increases in both comparable periods were primarily related to the launch of AUVELITY for the treatment of ADA, higher commercial activities for AUVELITY including a national direct-to-consumer advertising campaign and sales force expansion, commercial activities for SYMBRAVO which was launched in June 2025, and higher personnel costs related to organizational growth. We anticipate SG&A expenses to marginally increase through the end of 2026 as we continue commercial activities for AUVELITY and SYMBRAVO.

Previous wording

Gain in Fair Value of Contingent Consideration. The $1.5 million and $0.9 million changes for the three and six months ended June 30, 2026, respectively, as compared to $8.1 million and $6.6 million changes for the same periods in 2025, were primarily related to changes in significant assumptions, including future sales estimates, and significant unobservable inputs, including discount rates.

Current wording

Loss (Gain) in Fair Value of Contingent Consideration. The $2.4 million and $3.3 million changes for the three and nine months ended September 30, 2026, respectively, as compared to $13.2 million and $6.6 million changes for the same periods in 2025, were primarily related to changes in significant assumptions, including future sales estimates, and significant unobservable inputs, including discount rates.

Previous wording

Intangible asset amortization. We amortize the intangible asset, which we recognized as part of the Acquisition, over its useful life of 10 years. Intangible asset amortization was $1.6 million for both the three months ended June 30, 2026 and 2025 and $3.2 million for both the six months ended June 30, 2026 and 2025.

Current wording

Intangible asset amortization. We amortize the intangible asset, which we recognized as part of the Acquisition, over its useful life of 10 years. Intangible asset amortization was $1.6 million for both the three months ended September 30, 2026 and 2025 and $4.8 million for both the nine months ended September 30, 2026 and 2025.

Previous wording

Interest expense, net. Interest expense, net was $1.5 million and $2.7 million for the three and six months ended June 30, 2026, respectively, as compared to $1.8 million and $4.3 million for the same periods in 2025. The decrease was due to lower interest expense from the Blackstone Loan Agreement, which was partially offset by less interest income from lower interest rates.

Current wording

Interest expense, net. Interest expense, net was $1.7 million and $4.4 million for the three and nine months ended September 30, 2026, respectively, as compared to $1.1 million and $5.4 million for the same periods in 2025. The increase for the three-month period was primarily due to less interest income from lower interest rates. The decrease for the nine-month period was primarily due to lower interest expense from the Blackstone Loan Agreement, which was partially offset by less interest income from lower interest rates.

Previous wording

Income tax expense. We recorded an income tax expense of $0.1 million for the three and six months ended June 30, 2026. We recorded an income tax benefit of $1.0 million for the same periods in 2025.

Current wording

Income tax benefit (expense). We recorded an income tax expense of $0.1 million and $0.2 million for the three and nine months ended September 30, 2026, respectively, due to unfavorable return-to-provision adjustments attributable to certain foreign tax returns filed during the period. We did not record an income tax expense or benefit for the three months ended September 30, 2025. We recorded a tax benefit of $1.0 million for the nine months ended September 30, 2025 due to favorable return-to-provision adjustments attributable to certain foreign tax returns filed during July 2025 that were recorded as a discrete tax benefit in the second quarter of 2025.

Previous wording

Net loss. Net loss was $51.3 million and $115.9 million for the three and six months ended June 30, 2026, respectively, as compared to $48.0 million and $107.4 million for the same periods in 2025. The increase was primarily due to higher selling, general and administrative expenses from commercial activities for AUVELITY, including a national direct-to-consumer advertising campaign and sales force expansion, commercial activities for SYMBRAVO, and higher personnel costs related to organizational growth. This was partially offset by higher net product sales from AUVELITY, SUNOSI, and SYMBRAVO.

Current wording

Net loss. Net loss was $12.9 million and $128.7 million for the three and nine months ended September 30, 2026, respectively, as compared to $47.2 million and $154.6 million for the same periods in 2025. The decrease was primarily due to higher total revenues from AUVELITY, SUNOSI, and SYMBRAVO. This was partially offset by higher selling, general and administrative expenses from commercial activities for AUVELITY, including a national direct-to-consumer advertising campaign and sales force expansion, commercial activities for SYMBRAVO, and higher personnel costs related to organizational growth.

Previous wording

Under the March 2022 Sales Agreement, for the six months ended June 30, 2026, we received approximately $19.8 million in gross proceeds through the sale of 90,446 shares, of which net proceeds were approximately $19.5 million.

Current wording

Under the March 2022 Sales Agreement, for the nine months ended September 30, 2026, we received approximately $19.8 million in gross proceeds through the sale of 90,446 shares, of which net proceeds were approximately $19.5 million. We did not utilize the March 2022 Sales Agreement with Leerink during the three months ended September 30, 2026.

Previous wording

Operating Activities. Cash used in operating activities for the six months ended June 30, 2026 was $53.7 million, as compared to $75.8 million for the same period in 2025. The decrease of $22.1 million was primarily due to higher net product revenues from AUVELITY, SUNOSI, and SYMBRAVO, which was partially offset by increased cash used for commercial and clinical-related activities.

Current wording

Operating Activities. Cash used in operating activities for the nine months ended September 30, 2026 was $63.1 million, as compared to $74.8 million for the same period in 2025. The decrease of $11.7 million was primarily due to higher net product revenues from AUVELITY, SUNOSI, and SYMBRAVO, which was partially offset by increased cash used for commercial and clinical-related activities.

Previous wording

Investing Activities. Cash used in investing activities for the six months ended June 30, 2026 was $571 thousand, as compared to $351 thousand for the same period in 2025. The increase was due to higher purchases of equipment in the current year to support increased headcount.

Current wording

Investing Activities. Cash used in investing activities for the nine months ended September 30, 2026 was $768 thousand, as compared to $409 thousand for the same period in 2025. The increase was due to higher purchases of equipment in the current year to support increased headcount.

Previous wording

Financing Activities. Cash provided by financing activities was $51.1 million for the six months ended June 30, 2026, which primarily included proceeds of $51.9 million from the issuance of common stock upon the exercise of employee stock options and under the ESPP as well as net proceeds of $19.5 million from issuance of common stock for financing purposes, which was partially offset by payments of contingent consideration and tax withholdings on stock awards, for a total of $18.4 million. Financing activities also include $140.0 million in gross proceeds from the Blackstone revolving credit facilities and $140.0 million in repayments for the Blackstone revolving credit facilities. Cash provided by financing activities was $63.8 million for the six months ended June 30, 2025, which included net proceeds of $186.4 million from draw-downs related to the Blackstone Loans and net proceeds of $51.4 million from issuance of common stock for financing purposes as well as proceeds of $28.7 million from the issuance of common stock upon the exercise of employee stock options and under the ESPP, which was partially offset by the repayment of the Hercules Loan, for a total of $192.0 million, and payments of contingent consideration and tax withholdings on stock awards, for a total of $9.7 million.

Current wording

Financing Activities. Cash provided by financing activities was $54.8 million for the nine months ended September 30, 2026, which primarily included proceeds of $62.0 million from the issuance of common stock upon the exercise of employee stock options and under the ESPP as well as net proceeds of $19.5 million from issuance of common stock for financing purposes, which was partially offset by payments of contingent consideration and tax withholdings on stock awards, for a total of $23.4 million. Financing activities also include $210.0 million in gross proceeds from the Blackstone revolving credit facilities and $210.0 million in repayments for the Blackstone revolving credit facilities. Cash provided by financing activities was $85.1 million for the nine months ended September 30, 2025, which included net proceeds of $256.4 million from draw-downs related to the Blackstone Loans and net proceeds of $61.1 million from issuance of common stock for financing purposes as well as proceeds of $44.2 million from the issuance of common stock upon the exercise of employee stock options and under the ESPP, which was partially offset by the repayment of the Hercules Loan and revolving loan commitments under the Blackstone Loan Agreement, for a total of $262.0 million, and payments of contingent consideration and tax withholdings on stock awards, for a total of $13.1 million.

Previous wording

On the Closing Date, we entered into the Blackstone Loan Agreement with Blackstone, certain subsidiaries of the Company party thereto as guarantors, Wilmington Trust, and the Lenders, providing for loans in an aggregate principal amount of up to $570.0 million, consisting of (i) a first lien senior secured term loan in an aggregate principal amount of $120.0 million funded to us on the Closing Date, (ii) a $180.0 million senior secured term loan which is available to us at our option, of which $90.0 million was available to us until May 31, 2026, and of which the remaining $90.0 million is available until May 31, 2027 (the “Term Loans”) and (iii) a super senior revolving credit facility in an aggregate principal amount of up to $70.0 million available at our option (the “Revolver” and collectively with the Term Loans, the “Loans”). The Blackstone Loan Agreement also permits us, subject to the consent of the Lenders, to request incremental term loans in an aggregate principal amount of up to $200.0 million at any time and on the same terms as the initial Term Loans, except that any call protection will be determined at the time the incremental term loans are incurred.

Current wording

On the Closing Date, we entered into the Blackstone Loan Agreement with Blackstone, certain subsidiaries of the Company party thereto as guarantors, Wilmington Trust, and the Lenders, providing for loans in an aggregate principal amount of up to $570.0 million, consisting of (i) a first lien senior secured term loan in an aggregate principal amount of $120.0 million funded to us on the Closing Date, (ii) a $180.0 million senior secured term loan which is available to us at our option, of which $90.0 million was available to us until May 31, 2026, and of which the remaining $90.0 million is available until May 31, 2027 (the “Term Loans”) and (iii) a super senior revolving credit facility in an aggregate principal amount of up to $70.0 million available at our option (the “Revolver” and collectively with the Term Loans, the “Loans”). The Blackstone Loan Agreement also permits us, subject to the consent of the Lenders, to request incremental term loans in an aggregate principal amount of up to $200.0 million at any time and on the same terms as the initial Term Loans, except that any call protection will be determined at the time the incremental term loans are incurred. The proceeds of the Term Loans were used, together with cash on hand, to repay in full our obligations under the Hercules Loan Agreement, which resulted in a recording of a loss on debt extinguishment of $10.4 million in the consolidated statement of operations.

Previous wording

On June 26, 2026, the Company entered into a First Incremental Revolving Credit Commitment Supplement and Amendment to the Blackstone Loan Agreement (the “First Incremental Supplement”) with Blackstone, Wilmington Trust and the Lenders party thereto, pursuant to which the aggregate principal amount of Revolving Credit Commitments under the Blackstone Loan Agreement was increased by $20.0 million, from $70.0 million to $90.0 million, and the Company’s Permitted Indebtedness (as defined in the Loan Agreement) was increased by $10.0 million, from $10.0 million to $20.0 million. The proceeds of the Term Loans were used, together with cash on hand, to repay in full our obligations under the Hercules Loan Agreement, which resulted in a recording of a loss on debt extinguishment of $10.4 million in the consolidated statement of operations. The Term Loans bear interest at a variable SOFR plus 4.75%. The Revolver bears interest at SOFR plus 4.0%. The maturity date of the Loans is May 8, 2030. The Blackstone Loan Agreement provides for additional drawdowns at our option, subject to certain conditions, and includes customary covenants and a minimum liquidity covenant of $30.0 million. The obligations under the Blackstone Loan Agreement are secured by a first lien on certain assets of ours and our subsidiaries. The Company had allowed the Term Loan commitment of $90.0 million, which remained available to the Company at its option until May 31, 2026, to expire undrawn.

Current wording

On June 26, 2026, we entered into a First Incremental Revolving Credit Commitment Supplement and Amendment to the Blackstone Loan Agreement (the “First Incremental Supplement”) with Blackstone, Wilmington Trust and the Lenders party thereto, pursuant to which the aggregate principal amount of Revolving Credit Commitments under the Blackstone Loan Agreement was increased by $20.0 million, from $70.0 million to $90.0 million, and our Permitted Indebtedness (as defined in the Blackstone Loan Agreement) was increased by $10.0 million, from $10.0 million to $20.0 million. The Term Loans bear interest at a variable SOFR plus 4.75%. The Revolver bears interest at SOFR plus 4.0%. The maturity date of the Loans is May 8, 2030. The Blackstone Loan Agreement provides for additional drawdowns at our option, subject to certain conditions, and includes customary covenants and a minimum liquidity covenant of $30.0 million. The obligations under the Blackstone Loan Agreement are secured by a first lien on certain assets of ours and our subsidiaries. We allowed the Term Loan commitment of $90.0 million, which remained available to us at our option until May 31, 2026, to expire undrawn.

Previous wording

As of August 3, 2026, we had 1,346 full‑time employees. None of our employees are represented by a collective bargaining agreement and we have never experienced any work stoppage. We believe that we maintain good relations with our employees. Our employees are highly skilled, and many hold advanced degrees. Many of our employees have experience with drug commercialization or development. Our future performance depends significantly upon the continued service of our key scientific, technical and senior management personnel and our continued ability to attract and retain highly skilled employees. We provide our employees with competitive salaries and bonuses, opportunities for equity ownership, development programs that enable continued learning and growth and a robust employment package that promotes well-being across all aspects of their lives. In addition to salaries, these programs include potential annual discretionary bonuses, stock awards, healthcare and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, and flexible work schedules, among other benefits. We may take further actions, in compliance with all appropriate government regulations, that we determine to be in the best interest of our employees.

Current wording

As of October 26, 2026, we had 1,390 full‑time employees. None of our employees are represented by a collective bargaining agreement and we have never experienced any work stoppage. We believe that we maintain good relations with our employees. Our employees are highly skilled, and many hold advanced degrees. Many of our employees have experience with drug commercialization or development. Our future performance depends significantly upon the continued service of our key scientific, technical and senior management personnel and our continued ability to attract and retain highly skilled employees. We provide our employees with competitive salaries and bonuses, opportunities for equity ownership, development programs that enable continued learning and growth and a robust employment package that promotes well-being across all aspects of their lives. In addition to salaries, these programs include potential annual discretionary bonuses, stock awards, healthcare and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, and flexible work schedules, among other benefits. We may take further actions, in compliance with all appropriate government regulations, that we determine to be in the best interest of our employees.

Previous wording

On November 3, 2025, we filed an automatic shelf registration statement (File No. 333-291228), or the 2025 Shelf Registration Statement, with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities, and units up to an unlimited amount, which we refer to as the 2025 Shelf Registration Statement. In the future, we may conduct additional offerings of one or more of these securities utilizing the 2025 Shelf Registration Statement in such amounts, prices and terms to be announced when and if the securities are offered. At the time any of our securities covered by the 2025 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.

Current wording

On November 3, 2025, we filed an automatic shelf registration statement (File No. 333-291228), or the 2025 Shelf Registration Statement, with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities, and units up to an unlimited amount. In the future, we may conduct additional offerings of one or more of these securities utilizing the 2025 Shelf Registration Statement in such amounts, prices and terms to be announced when and if the securities are offered. At the time any of our securities covered by the 2025 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.