Financial Data and Key Metrics Changes - U.S. net product revenue for neffy reached $31.3 million in Q3 2025, a 2.5-fold increase from the prior quarter, exceeding consensus expectations of $28.3 million [3][20] - Total revenue for Q3 2025 was $32.5 million, with $1.1 million recognized in supply revenue and $0.1 million in royalties [20][21] - Net loss for Q3 2025 was $51.2 million or $0.52 per share [23] Business Line Data and Key Metrics Changes - The U.S. net product revenue from neffy was $31.3 million, reflecting strong growth in new patient starts and overall demand [3][20] - Gross-to-net retention improved, with cash prescriptions decreasing from about 20% to approximately 12% of total volume [13][21] - Approximately 19% of neffy patients were lapsed patients who had stopped filling prescriptions, indicating a new patient segment being reached [18] Market Data and Key Metrics Changes - Consumer awareness of neffy increased from 20% pre-campaign to 56% as of September 2025 [14] - The current U.S. epinephrine market is valued at $2 billion annually, growing at 6-8% organically prior to neffy's entry [18] - Market share among new prescribers reached 10.3%, indicating faster uptake compared to existing prescribers [17] Company Strategy and Development Direction - The company is focused on sustaining and accelerating neffy U.S. market share growth and enabling global expansion through multiple launches [25] - The "Get neffy on Us" program aims to simplify access to neffy and drive year-round sales growth [8][16] - The company plans to invest in direct-to-consumer initiatives and real-world evidence generation to support neffy's effectiveness [23][24] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a temporary pause in market share growth due to back-to-school seasonality but expects growth to resume in Q4 2025 [6][7] - The company anticipates Q4 sales will decrease from Q3 due to typical seasonality in the epinephrine market [7][19] - Management expressed confidence in the long-term growth and profitability of neffy, supported by a strong balance sheet and cash position [11][24] Other Important Information - The company secured a term loan facility of up to $250 million, drawing down $100 million initially to accelerate commercial growth [11][23] - Neffy received approval in Japan in September 2025, with launches anticipated in Canada and China in 2026 [10] Q&A Session Summary Question: How did Q3 performance stack up against internal expectations? - Management indicated that Q3 performance exceeded analysts' expectations and met internal expectations, despite challenges faced during the summer [32] Question: What is the market share growth among new prescribers? - New prescribers are trialing neffy, and while their market share is increasing, existing prescribers are also expanding their use [37] Question: What percentage of covered lives require prior authorization? - Approximately 50% of prescriptions require prior authorization, with 57% of commercial prescriptions not requiring it [46] Question: What are the inventory levels for neffy? - Distributors maintain inventory levels between 15-20 days, which may fluctuate based on market demand [49] Question: How is the virtual prescriber program expected to impact growth? - The virtual prescriber program is anticipated to streamline the prescription process, making it easier for patients to access neffy and potentially increasing adoption [70]

Neffy Sales Performance and Growth - Neffy US quarterly net sales showed strong growth throughout 2025, reaching $7.8 million in Q1, $12.8 million in Q2 (a 1.64x increase), and $31.3 million in Q3 (a 2.45x increase)[6] - ARS Pharmaceuticals anticipates further accelerated US growth with the addition of neffy to commercial formularies of CVS Caremark/Aetna (~23% of Rx) and Prime (~11%) by Spring 2026[8] - Direct-to-consumer (DTC) campaign significantly increased consumer awareness of neffy, with aided consumer awareness rising from 20% in May 2025 to 56% in September 2025, a 2.8x increase[11] Market Expansion and Patient Satisfaction - Approximately 26% of neffy patients are from market expansion segments, including those who have never had a prescription or are lapsed/non-fillers, representing a significant addressable market in the US[19] - Surveys indicate that 95% of neffy users are likely to refill their prescription, compared to 31% to 39% for epinephrine auto-injectors (EAIs)[22] - 87% of neffy users reported a positive impact on their daily and social life[22] Healthcare Professional (HCP) Engagement - The number of HCPs prescribing neffy has grown significantly, from 5,600 in April 2025 to 18,000 in November 2025[16] - ARS Pharmaceuticals has a total direct reach to approximately 20,000 HCPs, representing about 55% of epinephrine prescriptions from all HCPs[17] - 89% of HCPs prescribe neffy when asked by a patient[11] Financial Position - ARS Pharmaceuticals reported total revenue of $32.5 million and a net loss of $51.2 million for Q3 2025[24] - The company had $288.2 million in cash, cash equivalents, and short-term investments as of September 30, 2025[24] - A $100 million debt facility draw in September 2025 provides additional operational flexibility[24]

Financial Performance - ARS Pharmaceuticals, Inc. reported a quarterly loss of $0.52 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.45, representing an earnings surprise of -15.56% [1] - The company posted revenues of $32.5 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 14.08%, compared to revenues of $2.07 million in the same quarter last year [2] - Over the last four quarters, ARS Pharmaceuticals has surpassed consensus revenue estimates three times [2] Stock Performance - ARS Pharmaceuticals shares have declined approximately 16.1% since the beginning of the year, while the S&P 500 has gained 14.4% [3] - The current Zacks Rank for ARS Pharmaceuticals is 4 (Sell), indicating expectations of underperformance in the near future [6] Future Outlook - The consensus EPS estimate for the upcoming quarter is -$0.35 on revenues of $31.06 million, and for the current fiscal year, it is -$1.66 on revenues of $81.76 million [7] - The earnings outlook and estimate revisions trend for ARS Pharmaceuticals have been unfavorable leading up to the earnings release [6] Industry Context - The Medical - Drugs industry, to which ARS Pharmaceuticals belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a relatively strong industry performance [8]

Market Opportunity - nef y is the first FDA and European Commission-approved needle-free epinephrine product, targeting a market opportunity of approximately $3.5 billion in annual net sales from 6.5 million patients currently prescribed an epinephrine autoinjector in the U.S.[224] - The estimated annual net sales opportunity from an additional 13.5 million diagnosed patients who have not been prescribed an epinephrine product is approximately $7.0 billion[224] Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of $288.2 million[238] - Net losses for the nine months ended September 30, 2025, and 2024 were $130.0 million and $41.9 million, respectively, with an accumulated deficit of $253.3 million as of September 30, 2025[239] - Revenue for the three months ended September 30, 2025 was $32.5 million, a significant increase from $2.1 million in the same period of 2024, driven by $31.3 million in net product revenues from nef y sales in the U.S.[267] - Total operating expenses for the three months ended September 30, 2025 were $85.7 million, compared to $23.8 million in 2024, reflecting a substantial increase of $61.9 million[273] - Net loss for the three months ended September 30, 2025 was $51.2 million, compared to a net loss of $19.1 million in the same period of 2024, representing an increase of $32.0 million[267] - For the nine months ended September 30, 2025, total revenue was $56.2 million, compared to $2.6 million in the same period of 2024, with $51.9 million from net product revenues of nef y[274] - The cost of goods sold for the nine months ended September 30, 2025 was $14.3 million, a significant increase from $0.1 million in 2024, reflecting the transition of manufacturing costs from R&D to COGS[275] - Net cash used in operating activities for the nine months ended September 30, 2025 was $127.4 million, compared to $28.5 million in 2024, indicating increased operational cash burn[282] - Other income, net for the nine months ended September 30, 2025 was $8.0 million, slightly down from $8.3 million in 2024, primarily due to a decrease in net accretion of discounts on short-term investments[278] - Cash and cash equivalents provided by investing activities for the nine months ended September 30, 2025, was $32.7 million, compared to a usage of $4.3 million in the same period of 2024[284][285] - Financing activities generated $103.5 million in cash and cash equivalents during the nine months ended September 30, 2025, primarily from a term loan of $97.8 million[285] Product Development and Launch - The FDA approved nef y 2 mg on August 9, 2024, and the commercial launch began on September 23, 2024, with a direct sales force of approximately 107 individuals targeting high-volume prescribers[230] - The European Commission granted marketing authorization for EURnef y on August 22, 2024, with launches in Germany and the U.K. occurring in June and October 2025, respectively[235] - Approximately 90% of patients experiencing anaphylaxis symptoms were effectively treated with a single dose of nef y, comparable to historical outcomes for epinephrine injection[236] - The company initiated a Phase 2b clinical trial for chronic spontaneous urticaria patients in the second quarter of 2025, with topline data expected in mid-2026[237] Collaborations and Agreements - The ALK Collaboration Agreement allows ALK to develop and commercialize products containing intranasal epinephrine in territories outside the U.S., Japan, and China, with obligations for regulatory approvals and commercialization efforts[242] - ALK made an upfront payment of $145.0 million in November 2024, with potential additional milestone payments of up to $315.0 million[244] - The company expects to receive tiered royalty payments on net sales in the mid- to high-teens percentage range[244] - The ALK Co-Promotion Agreement allows for performance-based bonus payments equal to 30% of net sales generated from targeted prescribers in the second year, increasing to 50% in years three and four[250] - The ALK Supply Agreement ensures a five-year supply of products at a specified price, with termination clauses for material breaches[246] Expenses and Obligations - Selling, general and administrative expenses have increased due to the establishment of a sales force and marketing initiatives since Q3 2024[263] - Research and development expenses for the three months ended September 30, 2025 were $2.8 million, down 38% from $4.4 million in 2024, primarily due to decreases in product development-related expenses[269] - Selling, general and administrative expenses for the three months ended September 30, 2025 were $74.8 million, an increase of $55.5 million from $19.3 million in 2024, largely due to higher marketing and personnel-related expenses[271] - Total unconditional purchase obligations related to raw materials amounted to $56.9 million as of September 30, 2025, with estimated remaining payment obligations of $0.2 million in 2025 and $10.4 million in 2026[293] - The company has remaining payment obligations of $14.0 million under a corporate sponsorship agreement, with $7.0 million due as of September 30, 2025[295] - Under the Aegis Agreement, remaining payment obligations to OrbiMed are contingent upon achieving commercial milestones, reduced to $11.0 million as of September 30, 2025[296] - The company is required to make royalty payments of up to €5.0 million (approximately $5.7 million) under the Recordati Termination Agreement, with future amounts dependent on uncertain revenues[297] - The total remaining payment obligations under the ALK Co-Promotion Agreement are $26.8 million as of September 30, 2025, with payments deferred to the second year of the partnership[298] - Estimated interest payments on the outstanding principal of $100.0 million under the Credit Agreement are projected to total $48.1 million, with $2.5 million due in 2025[299] Future Outlook - The company anticipates that existing cash, cash equivalents, and revenues will be sufficient to meet cash requirements for at least the next three years, although actual results may vary[288]

Financial Performance - Total revenue for Q3 2025 was $32.5 million, with $31.3 million from neffy U.S. net product revenue and $1.1 million from supply revenue[5] - Total revenue for Q3 2025 was $32.5 million, a significant increase from $2.1 million in Q3 2024, representing a growth of 1,467%[29] - Product revenue for Q3 2025 reached $31.3 million, compared to only $568,000 in Q3 2024, indicating a substantial increase[29] - Net loss for Q3 2025 was $51.2 million, or $0.52 per share[5] - The net loss for Q3 2025 was $51.2 million, compared to a net loss of $19.1 million in Q3 2024, representing an increase in losses of 168%[29] Expenses - R&D expenses for Q3 2025 were $2.8 million, primarily for the ongoing Phase 2b clinical trial in urticaria and post-marketing registry study for anaphylaxis treatment[5] - SG&A expenses for Q3 2025 were $74.8 million, reflecting significant investment in national DTC marketing campaigns[5] - Operating expenses for Q3 2025 totaled $85.7 million, up from $23.8 million in Q3 2024, reflecting a rise of 260%[29] - Research and development expenses for the nine months ended September 30, 2025, were $9.7 million, down from $16.6 million in the same period of 2024[29] Cash and Assets - Cash position as of September 30, 2025, was $288.2 million, expected to fund operations through cash-flow breakeven[5] - Cash and cash equivalents as of September 30, 2025, were $59.6 million, up from $50.8 million at the end of 2024[28] - Total assets increased to $372.8 million as of September 30, 2025, compared to $351.2 million at the end of 2024[28] - Total liabilities rose to $225.1 million as of September 30, 2025, compared to $94.4 million at the end of 2024[28] - The company reported an accumulated deficit of $253.3 million as of September 30, 2025, compared to $123.3 million at the end of 2024[28] Market and Product Development - DTC campaign increased consumer awareness of neffy from approximately 20% to 56% as of September 2025[5] - Over 18,000 healthcare providers have prescribed neffy, an 86% increase since August 2025[6] - "Get neffy on Us" campaign launched to reduce cost barriers for patients, with over 70% of Type I allergy patients open to virtual prescribing options[6] - neffy approved in Japan in September 2025, with availability expected in Q4 2025[10] - Regulatory approvals for neffy in Canada and China anticipated in early to mid-2026[10] Share Information - The weighted-average shares outstanding for calculating net loss per share in Q3 2025 were approximately 98.8 million, compared to 97.0 million in Q3 2024[29]

Core Insights - ARS Pharmaceuticals reported a total revenue of $32.5 million for Q3 2025, with $31.3 million coming from U.S. net product revenue of neffy, the first FDA-approved needle-free epinephrine treatment for Type I allergic reactions [1][5] - The company has a strong cash position of $288.2 million, which is expected to support operations until cash-flow break-even [1][5] - The direct-to-consumer (DTC) marketing strategy has significantly increased consumer awareness of neffy from approximately 20% to 56% since its launch [5][11] Financial Performance - Total revenue for Q3 2025 was $32.5 million, including $31.3 million in net product revenue and $1.1 million in supply revenue [5][29] - Research and Development (R&D) expenses were $2.8 million, primarily for ongoing clinical trials and studies related to neffy [5][29] - Selling, General and Administrative (SG&A) expenses reached $74.8 million, reflecting substantial investment in DTC marketing and sales efforts [5][29] - The net loss for Q3 2025 was $51.2 million, or $0.52 per share [5][29] Commercial Launch and Strategy - The DTC campaign has been effective in increasing patient awareness and prescriber confidence in neffy's effectiveness [2][5] - Over 18,000 healthcare providers have prescribed neffy, marking an 86% increase since August 2025 [11] - The "Get neffy on Us" campaign aims to eliminate barriers for patients by offering a free virtual prescribing option and zero dollar co-pay [11] Market Expansion - neffy has received regulatory approval in Japan, with expectations for availability in Q4 2025 [11] - The launch of EURneffy in the U.K. occurred in October 2025, targeting the largest market outside the U.S. for adrenaline auto-injectors [11] - Additional regulatory approvals for neffy in Canada and China are anticipated in 2026 [11] Clinical Development - A Phase 2b trial for intranasal epinephrine technology is ongoing, with topline data expected in mid-2026 [7] - A post-marketing registry study for neffy is also underway in the U.S. [11]

Core Viewpoint - ARS Pharmaceuticals has launched a new program called "Get neffy on Us" to facilitate access to its needle-free epinephrine product, neffy, for patients with severe allergies, aiming to reduce barriers to treatment and improve convenience for patients [1][2][3] Company Overview - ARS Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on empowering at-risk patients and their caregivers to manage allergic reactions that could lead to anaphylaxis [15] - The company is commercializing neffy, an epinephrine nasal spray indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients aged 4 years and older who weigh at least 33 lbs [15] Program Details - The "Get neffy on Us" program offers eligible patients a free virtual visit with a healthcare provider to obtain a prescription for neffy, with a potential $0 co-pay for those with commercial insurance [1][8] - The program aims to eliminate the need for in-person office visits, making it easier for patients to access necessary medication [1][2] - The virtual consultation takes only five to ten minutes, saving time for patients and caregivers [8] Market Context - Approximately 40 million people in the U.S. live with severe allergies, but there is a limited number of allergists available to provide care [2] - Consumer surveys indicate that over 70% of Type 1 allergy patients are open to using virtual prescribing options, highlighting a demand for more accessible healthcare solutions [2] Previous Initiatives - Earlier in the year, ARS Pharmaceuticals launched the neffyInSchools program, providing eligible K-12 schools in the U.S. with neffy packs for treating severe allergic reactions, which has been distributed to over 6,600 schools across more than 20 states [3]

Core Insights - ARS Pharmaceuticals will present significant real-world data on the effectiveness of neffy® (epinephrine nasal spray) at the 2025 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology, showcasing its impact on treating anaphylaxis [1][2] Group 1: Presentation Details - One late-breaking oral presentation titled "Real World Data on the Effectiveness of Epinephrine Nasal Spray in Clinical Practice – Update" will be delivered on November 8, 2025 [3] - Six poster presentations will cover various aspects of neffy, including its effectiveness compared to autoinjectors, patient surveys, and case reports from clinical settings [5][6] Group 2: Expert Opinions - Dr. Jonathan Spergel emphasized that the real-world data supports intranasal epinephrine as a reliable alternative to injections, providing confidence to clinicians and patients [2] - Sarina Tanimoto, Co-founder and Chief Medical Officer of ARS Pharma, highlighted the breadth of research reinforcing the value of neffy in allergic emergencies [2] Group 3: Product Information - Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in patients aged 4 years and older who weigh at least 33 lbs [8] - The product aims to address limitations associated with traditional epinephrine auto-injectors, such as needle fear and portability issues [17]

Core Insights - ARS Pharmaceuticals, Inc. will host a conference call and webcast on November 10, 2025, to discuss its Q3 2025 financial results and business highlights [1] - The company is focused on empowering at-risk patients and caregivers to protect against allergic reactions that could lead to anaphylaxis [3] Company Overview - ARS Pharmaceuticals is commercializing neffy (EURneffy in the EU), an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients aged 4 years and older who weigh at least 15 kg in the U.S. and for patients weighing at least 30 kg in the EU [3] - The product is indicated for allergic reactions due to insect stings or bites, foods, medicinal products, and other allergens, as well as idiopathic or exercise-induced anaphylaxis [3]

Core Insights - ARS Pharmaceuticals is presenting real-world data on the effectiveness of neffy® (epinephrine nasal spray) at the 2025 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology, highlighting that approximately 90% of patients experiencing anaphylaxis were effectively treated with a single dose of neffy [1][2] - The presentations include one late-breaking oral presentation and six poster presentations, showcasing the treatment's value and effectiveness in various clinical settings [1][2] Company Overview - ARS Pharmaceuticals is focused on empowering at-risk patients and their caregivers to manage severe allergic reactions that could lead to anaphylaxis [1][18] - The company is commercializing neffy®, an epinephrine nasal spray indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients aged 4 years and older [1][18] Presentation Details - The oral presentation titled "Real World Data on the Effectiveness of Epinephrine Nasal Spray in Clinical Practice – Update" will take place on November 8, 2025 [3] - Six poster presentations will cover various topics, including the effectiveness of neffy in clinical settings and patient experiences with the nasal spray compared to autoinjectors [5][6][7] Clinical Evidence - Dr. Jonathan Spergel emphasized that the consistency of outcomes across diverse patient populations supports the reliability of intranasal epinephrine, asserting that it is as effective as injections [2] - Case reports presented during the meeting demonstrate the successful use of neffy in patients undergoing oral food challenges and allergy immunotherapy [2][7] Market Context - There are approximately 40 million people in the U.S. experiencing Type I allergic reactions, with a significant number diagnosed with severe reactions that may lead to anaphylaxis [17] - Despite the availability of epinephrine auto-injectors, many patients delay or do not administer treatment during emergencies due to various limitations, highlighting the need for alternatives like neffy [17]