ARS Pharmaceuticals(SPRY) - 2025 Q2 - Quarterly Results

Executive Summary & Business Highlights ARS Pharmaceuticals reported strong Q2 2025 financial results, driven by neffy U.S. net product revenue and global expansion Q2 2025 Key Highlights ARS Pharmaceuticals achieved strong Q2 2025 financial results, driven by $15.7 million total revenue from neffy U.S. sales and successful global expansion Q2 2025 Financial Metrics | Metric | Q2 2025 Value (Millions) | | :----- | :----------------------- | | Total Revenue | $15.7 | | neffy U.S. Net Product Revenue | $12.8 | | EURneffy® Germany Milestone Revenue | $2.6 | | Supply Revenue | $0.3 | - neffy U.S. growth is driven by increased payor access (93% commercial coverage achieved), anticipated growth from a national direct-to-consumer (DTC) campaign, and a pediatric co-promote partnership[1] - Global expansion for neffy includes EURneffy® approval in the United Kingdom and its launch in Germany, marking a significant global footprint[1] Second Quarter 2025 Financial Performance This section details ARS Pharmaceuticals' Q2 2025 financial performance, including revenue breakdown, operating expenses, net loss, and cash position Revenue Breakdown ARS Pharmaceuticals' Q2 2025 total revenue of $15.7 million was primarily driven by neffy U.S. net product sales and EURneffy® milestone revenue Q2 2025 Revenue Breakdown | Revenue Type | Amount (Millions) | | :-------------------------- | :---------------- | | Total Revenue | $15.7 | | neffy U.S. Net Product Revenue | $12.8 | | ALK Milestone Revenue (Germany) | $2.6 | | Supply Revenue | $0.3 | Operating Expenses Q2 2025 operating expenses included $4.0 million in R&D and $54.3 million in SG&A, reflecting significant investment in neffy's commercialization Q2 2025 Operating Expenses | Expense Type | Amount (Millions) | | :-------------------------------- | :---------------- | | Research and Development (R&D) | $4.0 | | Selling, General and Administrative (SG&A) | $54.3 | Net Loss and Cash Position ARS Pharma reported a Q2 2025 net loss of $44.9 million, maintaining a strong cash position of $240.1 million to support operations for at least three years Q2 2025 Net Loss | Metric | Value | | :---------- | :---------------- | | Net Loss | $44.9 million | | Net Loss Per Share | $0.46 | Cash Position as of June 30, 2025 | Metric | Amount (Millions) | | :------------------------------------ | :---------------- | | Cash, Cash Equivalents, and Short-term Investments (as of June 30, 2025) | $240.1 | - The company reiterates its guidance that its financial position is expected to support its operating plans for at least the next three years[3] neffy Commercial and Clinical Development Updates This section details neffy's U.S. commercial launch progress, global expansion, and ongoing clinical development initiatives U.S. Commercial Launch Progress neffy's U.S. commercial launch showed significant momentum with a 180% increase in prescription volumes, 93% commercial coverage, and enhanced consumer awareness - neffy two-pack unit weekly volumes increased approximately 180% from the end of Q1 2025 to the end of Q2 2025[5] - The national DTC campaign, rolled out in two stages, significantly increased consumer awareness of neffy from a baseline of approximately 20% pre-campaign to 49% in late July[5] - Achieved 93% commercial coverage, including 57% without prior authorization, with approval rates across major PBMs consistent with the overall epinephrine market (over 80% success rate for required PAs under Zinc)[5] Q2 2025 Commercial Metrics | Metric | Q2 2025 Value (Percentage) | | :-------------------- | :------------------------- | | Gross-to-Net Retention | 52% | - Over 9,700 HCPs have prescribed neffy to date, representing a 73% increase from April 2025, with about 70% being among the highest decile prescribing HCPs[5] - More than 3,200 schools have opted into the neffyinSchools program, receiving free doses for emergency use[5] Global Expansion and Clinical Development ARS Pharma is expanding neffy's global footprint with EURneffy® approvals and launches, advancing clinical trials, and anticipating further regulatory approvals by H1 2026 - Initiated a Phase 2b clinical trial in June 2025 to evaluate intranasal epinephrine for acute flares in chronic spontaneous urticaria, with topline data anticipated in H1 2026[8] - EURneffy® was approved in the U.K. by MHRA in July 2025 for emergency treatment of allergic reactions in adults and children >30 kg, with product availability expected late H2 2025[9] - EURneffy® 2 mg successfully launched in Germany in June 2025, triggering a $5.0 million milestone payment[9] - EURneffy® 1 mg for children (15 to <30 kg) is under regulatory review by the European Medicines Agency (EMA), with approval anticipated in H1 2026[9] - Regulatory approvals for neffy are expected by the end of 2025 in Canada, Japan, and Australia (with commercial rollouts in H1 2026), and in H1 2026 in China[9] Product and Disease Information This section provides essential information about neffy, its safety profile, and the critical nature of Type I allergic reactions including anaphylaxis About neffy neffy is an FDA and European Commission-approved needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions - neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater[12] - neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater[12] Important Safety Information Important safety information for neffy highlights its use for life-threatening allergic emergencies, proper administration, and potential interactions or side effects - neffy contains epinephrine, a medicine used to treat life-threatening allergic emergencies (anaphylaxis); always carry two neffy nasal sprays as a second dose may be needed if symptoms continue or return, and seek emergency medical help if symptoms persist or worsen after the first dose[13][14][15] - Patients should inform their healthcare provider about underlying nasal conditions, all medications, and medical conditions due to potential serious side effects or interactions[16][17] - Common side effects of neffy include nasal discomfort, headache, throat irritation, chest and nasal congestion, anxiety, nose bleed, and dizziness[18] About Type I Allergic Reactions Including Anaphylaxis Type I allergic reactions, including anaphylaxis, are life-threatening events requiring immediate epinephrine, with current auto-injectors facing limitations that neffy aims to address - Type I allergic reactions are serious, potentially life-threatening events requiring immediate epinephrine treatment, occurring within minutes of allergen exposure[20] - Limitations of epinephrine auto-injectors, such as fear of needles, lack of portability, and complexity, often lead to delayed or non-administration in emergencies[20] - Approximately 40 million people in the U.S. experience Type I allergic reactions, yet only 3.2 million filled auto-injector prescriptions in 2023, with over half delaying or not administering when needed[20] Corporate Information and Disclosures This section provides an overview of ARS Pharmaceuticals, outlines forward-looking statements, and includes contact information About ARS Pharmaceuticals, Inc. ARS Pharmaceuticals is a biopharmaceutical company focused on empowering patients against anaphylaxis by commercializing neffy, an epinephrine nasal spray - ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis[21] - The Company is commercializing neffy® (trade name EURneffy® in the EU), an epinephrine nasal spray indicated for emergency treatment of Type I allergic reactions, including anaphylaxis[21] Forward Looking Statements This section contains forward-looking statements about ARS Pharma's future expectations, subject to risks and uncertainties that could materially alter actual results - Statements in this press release that are not purely historical are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, based on current expectations and assumptions[22] - Actual results could differ materially due to various risks and uncertainties, including potential safety complications, regulatory approval, commercialization scope, clinical trial results, market acceptance, and intellectual property protection[23] Contact Information This section provides contact information for ARS Pharmaceuticals' investor relations and media inquiries - Investor Contact: Justin Chakma, ARS Pharma, justinc@ars-pharma.com[25] - Media Contact: Christy Curran, Sam Brown Inc., christycurran@sambrown.com, 615.414.8668[25] Condensed Consolidated Financial Statements This section presents ARS Pharmaceuticals' condensed consolidated balance sheets and statements of operations and comprehensive loss Condensed Consolidated Balance Sheets The condensed consolidated balance sheets detail ARS Pharmaceuticals' financial position as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (Amounts in Thousands) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :-------------- | :---------------- | | Assets | | | | Cash and cash equivalents | $51,540 | $50,817 | | Short-term investments | $188,590 | $263,205 | | Accounts receivable, net | $25,126 | $8,175 | | Total current assets | $281,436 | $334,295 | | Total assets | $313,472 | $351,153 | | Liabilities & Stockholders' Equity | | | | Accounts payable and accrued liabilities | $44,264 | $22,841 | | Total current liabilities | $45,599 | $23,440 | | Financing liability | $71,959 | $69,383 | | Total liabilities | $121,151 | $94,355 | | Total stockholders' equity | $192,321 | $256,798 | Condensed Consolidated Statements of Operations and Comprehensive Loss The condensed consolidated statements summarize revenues, operating expenses, and net loss for the three and six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss (Amounts in Thousands, Except Per Share Data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue: | | | | | | Product revenue, net | $12,800 | $0 | $20,563 | $0 | | Revenue under collaboration agreements | $2,594 | $500 | $2,804 | $500 | | Revenue under supply agreements | $323 | $0 | $323 | $0 | | Total revenue | $15,717 | $500 | $23,690 | $500 | | Operating Expenses: | | | | | | Cost of goods sold | $4,984 | $0 | $6,078 | $0 | | Research and development | $4,035 | $6,896 | $6,987 | $12,130 | | Selling, general and administrative | $54,312 | $8,944 | $95,416 | $16,902 | | Total operating expenses | $63,331 | $15,840 | $108,481 | $29,032 | | Loss from operations | $(47,614) | $(15,340) | $(84,791) | $(28,532) | | Other income, net | $2,731 | $2,824 | $5,968 | $5,724 | | Net loss | $(44,883) | $(12,516) | $(78,823) | $(22,808) | | Net loss per share, basic and diluted | $(0.46) | $(0.13) | $(0.80) | $(0.24) |