Summary of ARS Pharmaceuticals FY Conference Call Company Overview - **Company**: ARS Pharmaceuticals (NasdaqGM:SPRY) - **Product**: Neffy, a needle-free epinephrine rescue product Key Industry Insights - **Epinephrine Market**: The company is focused on expanding the epinephrine market, particularly through the introduction of neffy, which is positioned as a safer and more user-friendly alternative to traditional auto-injectors [1][25]. Core Points and Arguments 1. **Early Adoption and Prescriber Engagement**: - Over 20,000 prescribers have prescribed neffy, with this number doubling in the last three months, indicating strong early adoption [2][4]. - The company has seen a two to threefold higher market share among physicians who have participated in their experience program [5]. 2. **Insurance Coverage and Access**: - The company has made significant progress in payer access, with major payers like UnitedHealth Group covering neffy quickly due to its medical necessity [6][8]. - Challenges remain with certain payers like CVS and some Blue Cross plans, which have delayed coverage [7][10]. 3. **Get Neffy on Us Program**: - This program lowers the copay for patients to zero, facilitating easier access to neffy through virtual prescribers [3][12]. - The program aims to reduce barriers for patients and caregivers, making it easier to obtain prescriptions without the need for in-person doctor visits [13][15]. 4. **Direct-to-Consumer (DTC) Marketing**: - Awareness of neffy has increased from under 20% to over 50% among patients and caregivers, which is crucial for driving adoption [20]. - The DTC campaign targets not only patients but also healthcare providers, particularly those who may not frequently prescribe epinephrine [21][28]. 5. **Market Expansion Metrics**: - Approximately 80% of neffy prescriptions are from switchers (patients who previously used auto-injectors), while 20% are from new market expansion [26]. - There are 3.2 million patients who have auto-injectors but did not fill their prescriptions, indicating a significant opportunity for neffy [27]. 6. **Real-World Outcomes Data**: - Data shows that neffy has a similar efficacy to traditional injections, with 90% of patients responding to a single dose [33][35]. - The company has published data supporting neffy's effectiveness, which is expected to enhance physician confidence in prescribing the product [36][37]. 7. **International Market Opportunities**: - The company is exploring international markets, with pricing in countries like Germany and Japan being more than double that of EpiPen, indicating strong market potential [41][42]. - Japan is expected to launch neffy by early January, with favorable pricing established [42]. 8. **Chronic Spontaneous Urticaria (CSU) Opportunity**: - The company is conducting a phase 2B study for CSU, targeting an unmet medical need for patients experiencing acute exacerbations [44][48]. - The product for CSU will have a lower dose than neffy, focusing on at-home use for rapid symptom relief [48]. Additional Important Insights - The company is addressing the challenges faced by healthcare providers in prescribing new medications, aiming to streamline the process and reduce the burden on doctors [16][18]. - There is a significant portion of the population at high risk for anaphylactic reactions who are not currently seeing doctors, highlighting a substantial market opportunity for neffy [29][30]. This summary encapsulates the key points discussed during the ARS Pharmaceuticals FY Conference Call, focusing on the company's strategies, market dynamics, and product positioning within the epinephrine rescue space.

Core Insights - ARS Pharmaceuticals, Inc. is participating in the Piper Sandler 37th Annual Healthcare Conference from December 2-4, 2025, in New York [1] - The company's management will engage in a fireside chat and one-on-one meetings with investors during the conference [2] Company Overview - ARS Pharmaceuticals is focused on empowering at-risk patients and their caregivers to manage allergic reactions that may lead to anaphylaxis [3] - The company is commercializing neffy® (EURneffy® in the EU), an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, for patients aged 4 years and older in the U.S. and for various allergic reactions in the EU [3]

Core Insights - The article discusses ARS Pharmaceuticals, Inc. (SPRY), which markets Neffy, a needle-free intranasal delivery system for epinephrine aimed at treating Type I allergic reactions, including anaphylaxis [1] Company Overview - ARS Pharmaceuticals is focused on innovative delivery methods for emergency treatments in the biotech sector [1] - Neffy is positioned as a significant product for the company, targeting a critical need in emergency allergy treatment [1] Industry Context - The article emphasizes the importance of staying updated on stocks within the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - The investing group Haggerston BioHealth provides insights and forecasts for major pharmaceutical companies, indicating a comprehensive approach to market analysis [1]

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]