ARS Pharmaceuticals(US:SPRY)2023-11-09 21:04PART I FINANCIAL INFORMATION Financial Statements This section presents the unaudited condensed consolidated financial statements for the nine months ended September 30, 2023, detailing a $47.2 million net loss, $241.9 million in cash and equivalents, and key operational changes Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $60,532 | $210,518 | | Short-term investments | $181,370 | $63,863 | | Total Current Assets | $244,466 | $277,700 | | Total Assets | $248,556 | $281,435 | | Liabilities & Equity | | | | Total Liabilities | $11,272 | $8,549 | | Accumulated Deficit | ($124,135) | ($76,938) | | Total Stockholders' Equity | $237,284 | $272,886 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $189 | $30 | $1,316 | | Research and development | $3,002 | $3,893 | $16,862 | $13,666 | | General and administrative | $14,976 | $2,926 | $40,462 | $7,723 | | Loss from operations | ($17,978) | ($6,630) | ($57,294) | ($20,073) | | Net loss | ($14,866) | ($6,583) | ($47,197) | ($20,253) | | Net loss per share | ($0.16) | ($0.21) | ($0.50) | ($0.66) | Condensed Consolidated Statements of Cash Flows (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($41,861) | ($19,581) | | Net cash used in investing activities | ($113,219) | ($73) | | Net cash provided by (used in) financing activities | $5,094 | ($3,087) | | Net change in cash and cash equivalents | ($149,986) | ($22,741) | - In September 2023, the company initiated a 20% reduction in force to conserve cash, incurring $0.6 million in termination benefits32 - As of September 30, 2023, the company's $241.9 million in cash, cash equivalents, and short-term investments are deemed sufficient for at least the next 12 months33 - In February 2023, the company terminated its Recordati agreement, reacquiring European rights for a €3.0 million upfront payment recorded as IPR&D expense8586 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's sole product candidate, nefy, the FDA's Complete Response Letter delaying its launch, and significant increases in operating expenses for pre-commercialization, affirming sufficient capital for three years Overview This overview details the company's focus on nefy, the FDA's Complete Response Letter requesting an additional study, and the revised timeline for NDA resubmission in H1 2024 and potential U.S. launch in H2 2024 - The FDA issued a Complete Response Letter (CRL) for the nefy NDA, requesting a repeat-dose study under allergen-induced allergic rhinitis conditions135 - The company plans to complete the requested study and resubmit the NDA in H1 2024, targeting a PDUFA action date in H2 2024137147 - As of September 30, 2023, the company held $241.9 million in cash, cash equivalents, and short-term investments, with an accumulated deficit of $124.1 million139140 Results of Operations Operating expenses significantly increased for both three and nine-month periods ended September 30, 2023, primarily driven by higher General & Administrative costs for nefy's pre-commercial launch activities Comparison of Three Months Ended September 30, 2023 and 2022 (in thousands) | Expense Category | 2023 | 2022 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $3,002 | $3,893 | ($891) | Decrease in device component purchases | | General & Administrative | $14,976 | $2,926 | $12,050 | $6.0M increase in pre-commercial launch activities, plus higher payroll and stock-based compensation | Comparison of Nine Months Ended September 30, 2023 and 2022 (in thousands) | Expense Category | 2023 | 2022 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $16,862 | $13,666 | $3,196 | Increase in product materials, stock-based compensation, and payroll | | General & Administrative | $40,462 | $7,723 | $32,739 | $14.9M increase in pre-commercial launch activities, plus higher payroll and stock-based compensation | Liquidity and Capital Resources The company's operations are funded by merger proceeds and stock sales, holding $241.9 million in cash and equivalents as of September 30, 2023, deemed sufficient for at least the next three years - Net cash used in operating activities increased to $41.9 million for the nine months ended September 30, 2023, from $19.6 million in 2022, driven by a higher net loss167168169 - The company believes existing cash and cash equivalents are sufficient to meet anticipated cash requirements for at least the next three years, including funding nefy's commercial launch if approved172 Quantitative and Qualitative Disclosures About Market Risk As a "smaller reporting company," ARS Pharmaceuticals is exempt from providing quantitative and qualitative disclosures about market risk - The company is exempt from this disclosure requirement due to its status as a "smaller reporting company"184 Controls and Procedures Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes in internal control over financial reporting - As of September 30, 2023, the CEO and CFO concluded the company's disclosure controls and procedures were effective185 - No material changes occurred during the quarter affecting the company's internal control over financial reporting186 PART II OTHER INFORMATION Legal Proceedings The company is involved in patent-related legal proceedings, including an appeal by Amphastar Pharmaceuticals regarding U.S. Patent No. 10,682,414 and an opposition by Aera A/S against European Patent EP 3678649 - Amphastar Pharmaceuticals appealed a USPTO decision upholding claims of the company's '414 patent covering nefy, with a Federal Circuit decision expected in 202498 - Aera A/S filed an opposition with the European Patent Office against the company's EP '649 patent for a nasal spray epinephrine formulation99 Risk Factors This section outlines significant risks, including dependence on nefy, the FDA's Complete Response Letter, future capital needs, reliance on third parties, market acceptance and reimbursement challenges, and ongoing patent litigation Risks Related to Financial Position and Capital Needs The company, a clinical-stage entity, faces ongoing losses with a $124.1 million accumulated deficit, and while current cash is sufficient for three years, additional capital for commercialization may be needed, risking dilution - The company has incurred significant losses since inception, with a $47.2 million net loss for the nine months ended September 30, 2023, and an accumulated deficit of $124.1 million190 - The company's business depends entirely on the success of its sole product candidate, nefy; failure to gain regulatory approval and commercialize it would materially harm the business195207 - While current cash is expected to fund operations for at least three years, significant additional capital may be required for nefy's launch and commercialization, potentially on unfavorable terms197201 Risks Related to Product Development Primary development risks include regulatory approval uncertainty, highlighted by the FDA's CRL for nefy, potential clinical trial delays or failures, non-acceptance of the 505(b)(2) pathway, and the emergence of undesirable side effects - The FDA issued a Complete Response Letter (CRL) for the nefy NDA, requesting an additional study, which will delay potential commercialization and offers no guarantee of approval upon resubmission206 - Reliance on the Section 505(b)(2) regulatory pathway is a risk; a different FDA-required pathway would significantly increase approval time and cost221223 - Potential competitors, including Bryn Pharma, Nasus Pharma, and Amphastar, are developing intranasal epinephrine products, which could reduce nefy's commercial opportunity246 Risks Related to Dependence on Third Parties The company relies entirely on third parties for manufacturing (e.g., Renaissance), clinical trials (CROs), and international commercialization (e.g., Alfresa Pharma, Pediatrix), creating risks of supply shortages, development delays, and limited control over partner performance - The company relies on third parties, primarily Renaissance Lakewood LLC, for nefy's manufacturing and supply, creating dependence on a single source due to its lack of internal capabilities267268 - The company depends on Contract Research Organizations (CROs) for clinical trials; their failure to perform could delay or jeopardize development programs270 - International commercialization outside the U.S. relies on partners like Alfresa Pharma (Japan) and Pediatrix Therapeutics (China), whose non-performance could adversely affect the business273 Risks Related to Commercialization Commercialization risks include the company's lack of experience, the uncertainty of market acceptance for nefy, challenges in securing adequate reimbursement from payors, and compliance with complex healthcare laws - The company has limited marketing, sales, and distribution infrastructure, requiring expensive and time-consuming development to commercialize nefy successfully if approved279 - Even if approved, nefy may fail to gain market acceptance from physicians, patients, and payors, who might prefer established injectable products293 - Commercial success depends heavily on obtaining favorable coverage and adequate reimbursement from third-party payors, which is uncertain and subject to pricing pressures305 Risks Related to Intellectual Property Commercial success depends on defending intellectual property, as nefy's patents face ongoing legal challenges in the U.S. and Europe, potentially inadequate patent terms, and risks of costly third-party infringement lawsuits - The company's patents face ongoing legal challenges, including a U.S. Inter Partes Review appeal and a European opposition proceeding, risking loss of patent protection345373 - Nefy's co-owned or licensed patents are expected to expire as early as 2038, and if approved via the 505(b)(2) pathway, they will not be eligible for patent term restoration, risking earlier generic competition360 - The company may face costly litigation for infringing third-party intellectual property rights, potentially preventing or delaying nefy's commercialization368 Unregistered Sales of Equity Securities and Use of Proceeds This section details the use of $255.3 million net proceeds from the December 2020 IPO, with $143.3 million utilized by September 30, 2023, for product development, merger costs, and general corporate purposes - The December 2020 IPO generated $255.3 million in net proceeds432 - As of September 30, 2023, approximately $143.3 million of IPO proceeds have been used, including an estimated $34.8 million for nefy's development and pre-commercial launch activities434 Other Information No information is reported under this item for the period - None Exhibits This section lists exhibits filed with the Form 10-Q, including corporate governance documents, officer certifications, and Inline XBRL data files - Exhibits include key corporate governance documents and certifications from the Principal Executive Officer and Principal Financial Officer as required by Sarbanes-Oxley Act Sections 302 and 906441