Product Approvals and Developments - Auvelity (dextromethorphan-bupropion) was approved by the FDA for major depressive disorder in August 2022 and commercial sales began in October 2022[12]. - Sunosi (solriamfetol) was approved for excessive daytime sleepiness in 2019 in the U.S. and 2022 in Europe, with U.S. rights acquired in May 2022 and worldwide rights in November 2022[13]. - AXS-05 achieved its primary endpoint in the ADVANCE-1 trial for Alzheimer's disease agitation, with 366 patients participating in the study[32]. - AXS-07 completed two Phase 3 trials (MOMENTUM and INTERCEPT) for migraine treatment, achieving co-primary endpoints in both trials[15]. - AXS-12 has received FDA Orphan Drug Designation for narcolepsy and is currently in a Phase 3 trial[17]. - AXS-05 is being developed for smoking cessation and has shown positive results in a Phase 2 trial in collaboration with Duke University[14]. Clinical Trial Results - AXS-05 demonstrated a mean reduction of 15.4 points in the CMAI total score compared to 11.5 points for placebo, representing a 48% reduction for AXS-05 versus 38% for placebo (p=0.010) [33]. - A statistically significant 73% of patients achieved a clinical response with AXS-05, defined as a 30% or greater improvement from baseline, compared to 57% for placebo (p=0.005) [34]. - AXS-05 significantly delayed time to relapse of Alzheimer's disease agitation versus placebo (p=0.014) and prevented relapse (p=0.018) in the ACCORD Phase 3 trial [36]. - In the MOMENTUM study, AXS-07 achieved pain freedom in 19.9% of patients compared to 6.7% for placebo (p<0.001) and absence of most bothersome symptom in 36.9% versus 24.4% (p=0.002) [49]. - AXS-07 provided sustained pain relief from 2 to 24 hours for 53.3% of patients compared to 33.5% for placebo (p<0.001) and 43.9% for rizatriptan (p=0.006) [50]. - AXS-07 demonstrated rapid pain relief with 60.5% of patients achieving pain relief at 1.5 hours compared to 52.5% for rizatriptan (p=0.019) [51]. - AXS-12 significantly reduced the mean weekly number of cataplexy attacks by 14.6 attacks for AXS-12 compared to 2.6 for placebo, representing reductions of 48.8% and 8.6% respectively (p=0.002) [66]. - AXS-12 treatment resulted in a 31.8% mean reduction in the average weekly number of inadvertent naps compared to 5.3% for placebo (p<0.001) [67]. - AXS-12 improved sleep quality, with 45.0% of patients reporting improvement versus 5.3% for placebo (p=0.007) [69]. Intellectual Property and Licensing - The intellectual property portfolio includes patents extending to 2034 and 2040 for AXS-05, AXS-07, and AXS-12, ensuring protection for product candidates[19]. - The exclusive license agreement with Pfizer includes a cash payment of $3 million and potential milestones up to $323 million [77]. - The company announced a licensing transaction with Pharmanovia to market Sunosi in European and certain Middle East/North Africa countries[81]. - As of February 21, 2023, the company holds 300 issued patents and over 400 pending applications globally, with significant coverage for AXS-05, AXS-07, and AXS-12 extending through 2034, 2036, and 2039 respectively[84]. Regulatory and Compliance - The regulatory approval process for the company's product candidates involves substantial time and financial resources, with stringent compliance requirements[94]. - The FDA requires satisfactory completion of an NDA submission, including preclinical studies and clinical trials, to permit commercial marketing of a product[97]. - Clinical trials are conducted in three phases, with Phase 3 requiring two adequate and well-controlled trials for FDA approval[106]. - The approval process involves inspections of manufacturing facilities and clinical trial sites to ensure compliance with cGMP and GCP requirements[118]. - The FDA may require additional clinical trials post-approval, known as Phase 4 studies, to confirm effectiveness and safety[107]. - User fees for NDA submissions are mandated under the Prescription Drug User Fee Act, with fees paid at the time of application submission[112]. - The Pediatric Research Equity Act requires pediatric data to assess safety and effectiveness for relevant subpopulations in NDA submissions[113]. - The FDA may refer applications to advisory committees for recommendations, although it is not bound by these recommendations[117]. - The approval process can be lengthy and may involve additional data requests, with the FDA having discretion in interpreting clinical trial data[119]. - The FDA may issue a Complete Response Letter (CRL) if the NDA is not ready for approval, detailing specific deficiencies that must be addressed for approval[120]. Financial and Market Considerations - The company plans to increase research and development expenses to complete the development of AXS-05, AXS-07, AXS-12, AXS-14, and solriamfetol[207]. - The commercial success of the company's products depends on adequate coverage and reimbursement from governmental and private payors, which are increasingly limiting prices[175]. - Legislative proposals to reform healthcare could result in lower reimbursement rates or exclusion of the company's products from coverage, impacting revenue[184]. - The company may need to conduct expensive pharmacoeconomic studies to demonstrate the cost-effectiveness of its products to secure reimbursement[181]. - Third-party payors are demanding discounted fee structures, which could reduce the company's revenue and profitability[182]. - The reimbursement process is complex and may involve delays, affecting market acceptance and utilization of the company's products[182]. Employee and Operational Insights - As of February 21, 2023, the company had 383 full-time employees, with no collective bargaining agreements in place[208]. - The company emphasizes competitive salaries, bonuses, and a robust employment package to attract and retain skilled employees[208]. - The company has taken proactive steps to protect employee health and safety during the COVID-19 pandemic[208]. Company Overview - The company was incorporated in Delaware in January 2012, with its offices located in New York City[209]. - The company files reports with the SEC, including annual reports on Form 10-K and quarterly reports on Form 10-Q, which are available on its website[210].

Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was generated solely from Sunosi, amounting to U.S. net sales of $16.8 million, marking the first full quarter of sales for the product [14] - R&D expenses increased to $14.9 million from $13.2 million in Q3 2021, driven by personnel expenses and ongoing clinical trials [15] - SG&A expenses rose significantly to $40.9 million from $20.2 million in the comparable period, primarily due to commercial activities for Sunosi and pre-launch activities for Auvelity [15] - The net loss for Q3 2022 was $44.8 million or $1.07 per share, compared to a net loss of $34.9 million or $0.93 per share in Q3 2021 [16] - Cash and equivalents at the end of the quarter stood at $227.5 million, a substantial increase from $86.5 million at the end of 2021 [16] Business Line Data and Key Metrics Changes - Sunosi's total prescriptions grew 15% year-over-year, significantly outpacing the wake-promoting agent market, which grew only 1% [18] - The current prescription split for Sunosi is approximately 70% for obstructive sleep apnea (OSA) and 30% for narcolepsy [66] Market Data and Key Metrics Changes - Sunosi currently holds a 2% share of drug-treated OSA patients and a 7% share in drug-treated narcolepsy patients, indicating substantial growth potential [19] - Payer coverage for Sunosi remains robust, with 96% of commercial lives covered and 83% of total lives covered [19] Company Strategy and Development Direction - The company is focused on expanding the commercialization of Sunosi and has recently launched Auvelity for major depressive disorder (MDD), addressing a significant public health concern [9][10] - The pipeline includes several late-stage CNS products, with plans for NDA submissions for AXS-07, AXS-12, and AXS-14 in 2023 [11][12][13] - The company aims to leverage its Digital Centric Commercialization platform to enhance sales force productivity and market engagement for both Sunosi and Auvelity [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential for Sunosi and the early interest in Auvelity, despite it being only 12 days post-launch [10][20] - The company anticipates continued significant value creation from its pipeline and is preparing for clinical trial readouts and NDA filings in the near future [11][13] Other Important Information - The company utilized its ATM facility to realize net proceeds of $175 million during the third quarter [16] - The FDA approval of Auvelity allows access to up to $100 million under a $300 million term loan facility [16] Q&A Session Summary Question: What do you think is most attractive to prescribers regarding Auvelity's clinical profile? - Management indicated that the attractiveness lies in a combination of differentiated mechanism, onset, and limited side effects [25][26] Question: What feedback have you received from the FDA regarding the randomized withdrawal study? - Management noted that the design provides clear evidence of drug efficacy relative to control, and products have been approved based on such studies [27][28] Question: Can you provide insights on gross to net inventory changes for Sunosi? - Management expects gross to net to be around 50%, with no significant inventory impact during the quarter [33][35] Question: What is the current payer coverage for Auvelity? - Coverage is expected to evolve, with commercial payers typically blocking new therapies for clinical reviews post-launch [42][43] Question: What metrics will be reported regularly on earnings calls? - Management confirmed that they will report on scripts, HCP adoption, and payer coverage as they progress [72][74]

Call Start: 08:00 January 1, 0000 8:58 AM ET Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q2 2022 Earnings Conference Call August 9, 2022 08:00 ET Company Participants Mark Jacobson - Chief Operating Officer Herriot Tabuteau - Founder, Chairman, Chief Executive Officer & President Lori Englebert - Executive Vice President of Commercial & Business Development Nick Pizzie - Chief Financial Officer Conference Call Participants Charles Duncan - Cantor Fitzgerald Yatin Suneja - Guggenheim Partners Jason Gerberry - Ba ...

[Financial Information](index=4&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) This section provides a comprehensive overview of the company's financial performance, condition, and related disclosures [Financial Statements](index=4&type=section&id=ITEM%201%20Financial%20Statements) The unaudited consolidated financial statements for Axsome Therapeutics, Inc. as of and for the three and six months ended June 30, 2022, are presented, including balance sheets, statements of operations, stockholders' equity, cash flows, and explanatory notes [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of June 30, 2022, and December 31, 2021 Consolidated Balance Sheet Highlights (Unaudited) (in millions USD) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $73.4 | $86.5 | | Total current assets | $104.0 | $86.5 | | Goodwill | $11.9 | $— | | Intangible asset, net | $62.9 | $— | | **Total assets** | **$180.6** | **$87.8** | | **Liabilities & Equity** | | | | Total current liabilities | $42.6 | $23.1 | | Contingent consideration, non-current | $29.3 | $— | | Loan payable, long-term | $93.5 | $49.1 | | **Total liabilities** | **$165.4** | **$72.2** | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) This section details the company's revenues and expenses, presenting net loss and loss per common share for the three and six months ended June 30, 2022 and 2021 Consolidated Statements of Operations (Unaudited) (in millions USD, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $8.8 | $— | $8.8 | $— | | Research and development | $15.8 | $14.5 | $28.4 | $31.1 | | Selling, general and administrative | $31.2 | $16.3 | $56.9 | $27.6 | | Loss from operations | ($39.2) | ($30.8) | ($77.5) | ($58.7) | | Net loss | ($41.4) | ($32.3) | ($81.1) | ($61.5) | | Net loss per common share | ($1.06) | ($0.86) | ($2.09) | ($1.64) | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section outlines the company's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2022 and 2021 Cash Flow Summary for the Six Months Ended June 30 (Unaudited) (in millions USD) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($66.2) | ($52.6) | | Net cash used in investing activities | ($53.5) | ($0.049) | | Net cash provided by financing activities | $106.6 | $10.0 | | **Net (decrease) increase in cash** | **($13.1)** | **($42.7)** | | Cash at end of period | $73.4 | $141.2 | [Notes to Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Detailed notes explain the company's accounting policies and financial data, covering business nature, the Sunosi acquisition, goodwill, debt, stock-based compensation, and contingencies - In May 2022, the Company acquired the U.S. rights to Sunosi® from Jazz Pharmaceuticals, which is now a key part of its CNS portfolio[21](index=21&type=chunk) - The company has incurred operating losses since inception, with an accumulated deficit of **$490.3 million** as of June 30, 2022, and expects losses to continue for the foreseeable future[24](index=24&type=chunk) - The acquisition of Sunosi was accounted for as a business combination with a total preliminary purchase consideration of **$89.1 million**, including **$53 million** in cash and **$36.1 million** in fair value of contingent consideration[79](index=79&type=chunk)[82](index=82&type=chunk) - The company amended its loan agreement with Hercules Capital, increasing its term loan facility to **$300 million** and drawing down an additional **$45.0 million** in May 2022 to finance the Sunosi acquisition[106](index=106&type=chunk)[107](index=107&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=ITEM%202%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operational results for the quarter ended June 30, 2022, including business overview, recent developments, financial analysis, and liquidity [Company Overview](index=30&type=section&id=Overview) This section provides an overview of Axsome's biopharmaceutical focus on central nervous system conditions and its product portfolio, including commercial and clinical-stage candidates - Axsome is a biopharmaceutical company focused on developing and delivering therapies for central nervous system (CNS) conditions[156](index=156&type=chunk) - The company's portfolio includes the commercial product Sunosi® (acquired from Jazz Pharmaceuticals in May 2022) and four clinical-stage candidates: AXS-05 (MDD, AD agitation), AXS-07 (migraine), AXS-12 (narcolepsy), and AXS-14 (fibromyalgia)[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk) - The NDA for AXS-05 for MDD is under review by the FDA. The NDA for AXS-07 for migraine received a Complete Response Letter (CRL) from the FDA related to chemistry, manufacturing, and controls (CMC) issues[158](index=158&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) This section analyzes the company's operational performance, comparing product sales, research and development, and selling, general, and administrative expenses for the three and six months ended June 30, 2022 and 2021 Comparison of Operating Results (Three Months Ended June 30) (in millions USD) | Item | 2022 | 2021 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $8.8 | $0 | +$8.8 | Launch of Sunosi sales post-acquisition | | R&D Expenses | $15.8 | $14.5 | +$1.3 | Increased personnel expense and ongoing clinical trial costs | | SG&A Expenses | $31.2 | $16.3 | +$14.9 | Pre-commercial and commercial activities for Sunosi, increased personnel, and stock compensation | Comparison of Operating Results (Six Months Ended June 30) (in millions USD) | Item | 2022 | 2021 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $8.8 | $0 | +$8.8 | Launch of Sunosi sales post-acquisition | | R&D Expenses | $28.4 | $31.1 | -$2.7 | Decrease driven by NDA fees incurred in the prior period | | SG&A Expenses | $56.9 | $27.6 | +$29.3 | Pre-commercial and commercial activities for Sunosi, increased personnel, and stock compensation | [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, primary funding sources, and management's assessment of future funding requirements and sufficiency of capital - As of June 30, 2022, the company had **$73.4 million** in cash and cash equivalents[231](index=231&type=chunk) - Primary funding sources have been equity offerings and debt borrowings. In H1 2022, financing activities provided **$106.6 million**, primarily from a **$45.0 million** debt draw, **$56.8 million** from an at-the-market stock offering, and a **$5.0 million** stock purchase by Hercules[198](index=198&type=chunk)[210](index=210&type=chunk) - Management believes current cash and committed capital from its **$300 million** term loan facility are sufficient to fund operations into 2024, assuming the potential launch of AXS-05 in MDD[205](index=205&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=43&type=section&id=ITEM%203%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) This section details the company's exposure to market risks, including interest rate, foreign currency, and inflation, none of which are currently deemed to have a material financial impact - The company is exposed to interest rate risk from its debt borrowings, but does not believe a **100 basis point** increase would have a material effect due to the nature of its debt and investment portfolio[231](index=231&type=chunk) - Foreign currency exchange risk exists due to contracts with vendors in Europe, but to date, the effects have not been material[232](index=232&type=chunk) - Inflation is not believed to have had a material effect on the business during the six months ended June 30, 2022[232](index=232&type=chunk) [Controls and Procedures](index=43&type=section&id=ITEM%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting other than those related to the Sunosi acquisition - Management concluded that the company's disclosure controls and procedures were effective as of the end of the quarter[233](index=233&type=chunk) - No material changes to internal control over financial reporting were identified during the quarter, apart from those related to the integration of the Sunosi acquisition[234](index=234&type=chunk) [Other Information](index=44&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This section provides additional disclosures beyond financial statements, including legal proceedings, risk factors, and a list of exhibits filed with the report [Legal Proceedings](index=44&type=section&id=ITEM%201%20Legal%20Proceedings) This section discloses a securities class action lawsuit and a shareholder derivative action filed against the company, both alleging false statements regarding AXS-07's CMC practices - A securities class action lawsuit was filed against the company in May 2022, alleging false statements and omissions concerning the Chemistry Manufacturing and Controls (CMC) practices for its product candidate, AXS-07[236](index=236&type=chunk) - A shareholder derivative action was filed in July 2022 against the company's directors and certain officers, arising from similar allegations as the securities class action[237](index=237&type=chunk) [Risk Factors](index=44&type=section&id=ITEM%201A%20Risk%20Factors) This section comprehensively outlines significant risks and uncertainties that could adversely affect the company's business, financial condition, and operations, categorized across various critical areas - The company has a history of significant losses (**$490.3 million** accumulated deficit) and may never achieve profitability[239](index=239&type=chunk)[252](index=252&type=chunk) - The business is substantially dependent on the success of its products, particularly the commercialization of Sunosi and the regulatory approval and launch of its pipeline candidates like AXS-05[241](index=241&type=chunk)[275](index=275&type=chunk) - The company relies heavily on third parties for clinical trial conduct, manufacturing, and other essential services, and failure by these parties to perform could significantly harm the business[243](index=243&type=chunk)[403](index=403&type=chunk) - Significant competition exists from major pharmaceutical companies, and the company faces risks related to intellectual property protection, potential infringement lawsuits, and reliance on licensed IP[242](index=242&type=chunk)[438](index=438&type=chunk)[452](index=452&type=chunk) [Exhibits](index=99&type=section&id=ITEM%206%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including warrant agreements, share transfer agreements, and required certifications from executive officers List of Filed Exhibits | Exhibit Number | Description | | :--- | :--- | | 10.1 | Form of Warrant Agreement with Hercules Capital, Inc. | | 10.2 | Share Transfer Agreement with Hercules Capital, Inc. and related entities | | 31.1 / 31.2 | Certifications of Principal Executive Officer and Principal Financial Officer (Section 302) | | 32.1 / 32.2 | Certifications of Principal Executive Officer and Principal Financial Officer (Section 906) | | 101 / 104 | Inline XBRL documents | [Signatures](index=100&type=section&id=Signatures) This section confirms the official signing of the report by the company's President and Chief Executive Officer and Chief Financial Officer - The report was duly signed on August 9, 2022, by Herriot Tabuteau, M.D., President and Chief Executive Officer, and Nick Pizzie, Chief Financial Officer[560](index=560&type=chunk)

Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q1 2022 Earnings Conference Call May 2, 2022 8:00 AM ET Company Participants Mark Jacobson - Chief Operating Officer Herriot Tabuteau - Chief Executive Officer Lori Englebert - Senior Vice President of Commercial and Business Development Nick Pizzie - Chief Financial Officer Amanda Jones - Senior Vice President, Clinical Development Conference Call Participants Charles Duncan - Cantor Fitzgerald Joon Lee - Truist Securities Vikram Purohit - Morgan Stanley Marc Goodman ...

Financial Data and Key Metrics Changes - The company ended 2021 with approximately $87 million in cash, down from roughly $115 million at the end of Q3 2021, representing a net decrease of approximately $28 million [16] - R&D expenses for Q4 2021 were $13.8 million, a decrease from $17.4 million in Q4 2020, primarily due to the conclusion of several clinical trials [17] - G&A expenses for Q4 2021 were $18.8 million, up from $10.4 million in Q4 2020, mainly due to pre-commercial activities and increased stock compensation [18] - The net loss for Q4 2021 was $34 million, or $0.90 per share, compared to a net loss of $29.2 million, or $0.78 per share, in Q4 2020 [18] - For the full year, the net loss was $130.4 million, or $3.47 per share, compared to a net loss of $102.9 million, or $2.77 per share, in 2020 [18] Business Line Data and Key Metrics Changes - AXS-05 is undergoing NDA review for major depressive disorder (MDD) and is also being developed for Alzheimer’s Disease Agitation, with enrollment in the Phase 3 ACCORD trial progressing [9] - AXS-07, an acute treatment for migraine, has its NDA accepted for review with a PDUFA target action date of April 30, 2022 [10] - AXS-12 for narcolepsy is in the SYMPHONY Phase III trial, with top-line results expected in the first half of 2023 [10] - AXS-14 for fibromyalgia is expected to have its NDA submitted in 2023 [10] Market Data and Key Metrics Changes - The migraine market shows a 70% dissatisfaction rate with current therapies, indicating a high unmet need for new treatments [14] - The company’s commercialization strategy for AXS-07 will be strategic and highly targeted, addressing the significant dissatisfaction in the migraine treatment landscape [15] Company Strategy and Development Direction - The company is preparing for the potential launch of two investigational medicines for depression and migraine, with a focus on innovative commercialization strategies [8][12] - The Digital Centric Commercialization (DCC) platform is designed to enhance engagement with physicians and patients through technology and data analytics [15][96] - The company aims to leverage the unmet needs in the depression and migraine markets to position its products effectively [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential launch of AXS-05 and AXS-07, emphasizing the urgent need for new treatment options in depression and migraine [12][14] - The company is actively engaging with the FDA regarding the NDA reviews and is prepared to respond to any further inquiries [24][41] - Management acknowledged the resource constraints at the FDA, which may be contributing to delays in the review process [41] Other Important Information - The company expanded its term loan facility with Hercules Capital to $300 million, providing additional financial flexibility for anticipated commercial launches [18] - The proforma cash position at year-end is approximately $106 million, which is expected to fund operations into 2024 [19] Q&A Session Summary Question: Next steps with the FDA for AXS-05 - The company confirmed that they responded to two deficiencies related to the NDA and are awaiting further feedback from the FDA [24] Question: Enrollment progress for AXS-05 in Alzheimer's agitation - Enrollment is proceeding well, and the company is on track to meet guidance for reporting results in the first half of 2023 [26] Question: Unmet need and product positioning for AXS-07 - The company highlighted a 70% dissatisfaction rate with current migraine therapies, indicating a significant unmet need for AXS-07 [18] Question: Timeline for approval and launch of AXS-05 and AXS-07 - The company anticipates launching within one quarter after receiving regulatory approval for both products [45] Question: Insights on FDA delays - Management noted that resource constraints at the FDA could be contributing to the delays, but they are focused on responding promptly to the FDA's requests [41] Question: Commercial preparations and payer discussions - The company has engaged with payers since April 2021 and is encouraged by the recognition of unmet needs in MDD [66]

Financial Data and Key Metrics Changes - The company ended Q3 2021 with approximately $115 million in cash, a decrease of about $26 million from roughly $141 million at the end of Q2 2021 [18] - R&D expenses were $13.2 million for Q3 2021, down from $14.8 million in the same period of 2020, attributed to the completion of NDA-enabling clinical trials [19] - G&A expenses increased to $20.2 million in Q3 2021 from $6.3 million in Q3 2020, primarily due to pre-commercial activities and personnel expenses [19] - The net loss for Q3 2021 was $34.9 million, or $0.93 per share, compared to a net loss of $22.9 million, or $0.61 per share, in Q3 2020 [19] Business Line Data and Key Metrics Changes - AXS-05 is under NDA review for major depressive disorder (MDD), with the FDA identifying two deficiencies related to analytical methods that need to be addressed before action can be taken [9][10] - AXS-07, an acute treatment for migraine, has an NDA accepted for review with a PDUFA target action date of April 30, 2022 [11] - AXS-12 for narcolepsy has initiated a Phase III trial, with top-line results expected in the first half of 2023 [12] - AXS-14 for fibromyalgia is in the process of NDA submission, now expected in 2023 [12] Market Data and Key Metrics Changes - The U.S. is experiencing a mental health crisis, with a global study indicating a 28% increase in depression rates in 2020 due to the COVID-19 pandemic [14] - AXS-05 is positioned to address the urgent need for new treatment options for depression, especially given the increased awareness of mental health issues [14][15] Company Strategy and Development Direction - The company is focused on advancing its late-stage CNS product candidates to improve patient lives, with a strong emphasis on the commercial launch readiness for AXS-05 and prelaunch activities for AXS-07 [9][11] - The digital-centric commercialization platform is fully implemented and ready for execution, aimed at enhancing marketing efficiency and effectiveness [15] - The company is preparing for potential launches of AXS-05 and AXS-07, targeting high-value prescribers and ensuring comprehensive patient support services [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in addressing the FDA's deficiencies and emphasized the importance of AXS-05 in the treatment landscape for MDD, particularly for patients with inadequate responses to current therapies [28][29] - The company is optimistic about the potential of AXS-05 and AXS-07 to meet significant unmet needs in their respective markets [17][29] - Management highlighted the ongoing discussions with payers and the encouraging feedback received regarding the clinical profile of AXS-05 [88] Other Important Information - The company expanded its term loan facility with Hercules Capital to $300 million, providing additional financial flexibility for anticipated commercial launches [19][20] - The company aims to ensure that patients have access to its products while capturing the value they bring to the market [88] Q&A Session Summary Question: Can you provide more details on the analytical deficiencies related to AXS-05? - Management confirmed they are actively working on addressing the deficiencies and are in communication with the FDA to understand the specifics [24][25] Question: How do you view the treatment landscape for MDD with AXS-05? - Management expressed excitement about AXS-05's potential to improve treatment outcomes for patients with MDD, particularly those who are treatment-resistant [28][29] Question: What is the status of the NDA review process and potential CRL for AXS-05? - Management indicated that the FDA has not yet issued a CRL and is awaiting the company's response to the deficiencies before making a decision [42][45] Question: What are the next steps regarding the smoking cessation program? - The company received positive pre-IND meeting guidance from the FDA and plans to proceed to a pivotal Phase II/III trial, with timing to be provided next year [50][49] Question: Can you clarify the timeline for addressing the FDA's deficiencies? - Management stated that the timeline for addressing the deficiencies is weeks to months, depending on further feedback from the FDA [52][54] Question: What is the size and strategy of the sales force for the upcoming launches? - The sales force is designed to cover over 25,000 high-value prescribers, with a focus on ensuring effective promotion of AXS-05 and AXS-07 [78][79]