Neffy Approval and Indication - Neffy (epinephrine nasal spray) has been approved for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children weighing ≥30kg[4, 65] - The available dose strength is a 2 mg nasal spray device[8] - A supplemental regulatory application (sNDA) for a 1 mg dose for children 15 kg to <30 kg is expected to be filed with the FDA in Q3 2024[2, 22] Addressing Unmet Needs and Market Opportunity - Only 10%-20% of patients with active prescriptions use them as indicated, highlighting significant limitations with current treatment options[5] - Approximately 40 million patients have type 1 allergic reactions, with ~20 million diagnosed and under physician care[25] - The US severe allergic reaction market has shown consistent growth, with a +6.5% Compound Annual Growth Rate (CAGR) since 2010 and +12.7% Year-over-Year (YoY) growth in 2023[25] - Market research indicates a 45% reduction in time to use with neffy compared to current devices, suggesting faster administration[30] Clinical Trial Data and Safety - Registrational studies demonstrate comparable pharmacodynamic (PD) surrogates for efficacy and pharmacokinetic (PK) with approved products[19] - In clinical trials, 100% of patients responded to a single dose of neffy within the first 15 minutes, and did not require a second dose of epinephrine per treatment guidelines in an oral food challenge induced anaphylaxis study[41] - The most common adverse events (>2%) with a single dose of neffy were mild nasal discomfort (9.7%) and mild headache (6%)[12, 19] Commercialization and Market Access - A commercial force of 110 sales representatives and area sales managers will target 12,500 allergy specialists and high decile prescribers[38] - The company anticipates at least 80% unrestricted access in the US by mid-2025[62] - A co-pay buy-down program will reduce the patient co-pay to $25 for commercially insured patients[48, 49] Global Expansion and Future Development - Filings by partners in Australia, China, and Japan are expected in 2024, with filings planned in Canada and other regions[22, 62] - Phase 2b trial results for treating acute urticaria exacerbations in CSU patients on antihistamine therapy are expected in 2025[23, 62] - The company has a strong balance sheet of $218.7 million and an expected operating runway of at least 3 years to support US commercialization[62]

Summary of Conference Call Company and Industry - The conference call discusses **Nefi**, a needle-free epinephrine product launched by the company, targeting the **anaphylaxis treatment market**. Core Points and Arguments 1. **Product Launch and Market Potential** - Nefi is the first needle-free epinephrine product, approved for type one allergic reactions including anaphylaxis, with both 1 mg and 2 mg versions available for ages four and above [2][3] - The current market size for generic epinephrine is approximately **$1 billion**, with potential growth to **$3 billion** or more [5][23] 2. **Sales Performance** - The company reported **$7.8 million** in net sales for the first quarter following the launch, indicating strong traction in the market [4] - The one milligram product represents about **23%** of the market, contributing to sales growth [4][65] 3. **Market Demographics** - Approximately **40 million** people in the U.S. have type one allergic reactions, with **20 million** potentially benefiting from epinephrine [18][19] - Only **6.5 million** are prescribed epinephrine, with about **50%** of prescriptions not being filled, often due to the aversion to injections [20][21] 4. **Product Advantages** - Nefi offers a non-injection method, addressing the fear and inconvenience associated with auto-injectors, which are carried less than **50%** of the time [10][12][14] - The product is designed for ease of use, requiring no training, and has better stability at high temperatures compared to traditional injectors [17][18] 5. **Commercial Strategy** - The company has a strategic plan focusing on driving adoption and educating prescribers, with **92%** commercial coverage achieved [31][48] - A direct-to-consumer (DTC) campaign was launched to increase awareness, with a budget of **$45 million** for various advertising channels [56][58] 6. **International Expansion** - Nefi is expected to launch in Europe, with approvals anticipated in Germany and the UK, and potential expansion into Canada and China [26][27][28] 7. **Future Studies and Market Expansion** - The company is initiating a phase 2b study for Nefi in treating urticaria, which could represent an additional **$2 to $3 billion** market [68][70] Other Important Content 1. **Consumer Awareness and Engagement** - Initial consumer awareness of Nefi was low, with only **16%** of patients aware of the product, indicating significant growth potential through marketing efforts [53] - The DTC campaign aims to engage caregivers, with **81%** likely to ask healthcare providers about Nefi after exposure to the campaign [53] 2. **Sales Force and Physician Engagement** - The sales team consists of **95 sales reps** targeting **12,000 physicians**, with a focus on allergists and pediatricians [34][35] - A co-promotion agreement with ALK expands the reach to an additional **8,000 pediatricians** [35] 3. **Regulatory and Coverage Challenges** - The company is working to reduce barriers related to prior authorization (PA) requirements, with a **65%** success rate in PA approvals [49] 4. **Market Research Insights** - Market research indicates that **two out of three physicians** would offer Nefi to patients, and **nine out of ten** will prescribe it if asked [46][53] 5. **Product Stability and Reliability** - Nefi has been tested for stability at high temperatures, remaining effective even after storage at **122°F** for three months [18] This summary encapsulates the key points from the conference call, highlighting the company's strategic direction, market potential, and product advantages in the context of the anaphylaxis treatment industry.

Summary of ARS Pharmaceuticals (SPRY) FY Conference Call - June 03, 2025 Company Overview - **Company**: ARS Pharmaceuticals - **Product**: Nefi, an epinephrine nasal spray designed to treat emergency type one allergic reactions, including anaphylaxis [2][3] Market Opportunity - **Market Size**: The existing prescription market consists of approximately 6.5 million patients, representing a market value of about $3 billion [4][18] - **Potential Expansion**: There is a significant population that has not received prescriptions, estimated to be around 13.5 million, which presents a substantial opportunity for market growth [19][20] - **Institutional Use**: Nefi's needle-free design allows for broader institutional use, which is currently limited by the need for training associated with auto-injectors [5][21] Product Features and Advantages - **Administration Method**: Nefi is a needle-free solution, making it less intimidating and easier to use compared to traditional auto-injectors [10][12] - **Patient Compliance**: Only 10-20% of patients use auto-injectors correctly, and about 50% do not carry them at all. Nefi's design aims to improve patient compliance and reduce delays in treatment [10][12][14] - **Device Reliability**: The device used for Nefi is the same as that for Narcan, known for its reliability and ease of use [14][15] Sales and Marketing Strategy - **Sales Performance**: Nefi reported net sales of $7.8 million in the first quarter, just two quarters post-launch [3] - **Insurance Coverage**: Currently, 92% of commercial insurance plans cover Nefi, with 57% not requiring prior authorization [26][38] - **Direct-to-Consumer Campaign**: A significant investment of $45 million is planned for the DTC campaign to raise awareness and drive demand [28][42] Regulatory and Approval Status - **Global Approvals**: Nefi has received approval in Europe and is pending approval in the UK, Japan, and China [22][24] - **Patent Protection**: Strong patent protection is in place, with recent challenges to patents being upheld, providing confidence in market exclusivity [5][66] Future Outlook - **Market Growth Potential**: The company anticipates a potential market size exceeding $3 billion, with additional opportunities in chronic therapy markets [56][57] - **Expansion of Sales Force**: A partnership with ALK will enhance the sales force's reach, particularly among pediatricians [52][54] - **Clinical Studies**: Ongoing studies for urticaria treatment are expected to yield results in the second quarter of next year, potentially expanding the product's indications [55] Key Challenges - **Awareness and Education**: Only 16% of patients were aware of Nefi prior to the DTC campaign, indicating a need for increased education and outreach [43][44] - **Cost and Coverage Concerns**: Some doctors cite cost and coverage as barriers to prescribing Nefi, although these issues are improving [36][38] Conclusion - **Strategic Focus**: The company is focused on expanding awareness, improving insurance coverage, and enhancing the comfort of doctors in prescribing Nefi, with expectations for accelerated growth in the coming years [56][57]

Core Insights - ARS Pharmaceuticals, Inc. is focused on empowering at-risk patients and caregivers to manage allergic reactions that may lead to anaphylaxis [1][6] - The company will have key presentations at the William Blair 45 Annual Growth Stock Conference and the 2025 Jefferies Global Healthcare Conference in June [1][4] Event Details - **William Blair 45 Annual Growth Stock Conference** - Presentation Date: June 3, 2025 - Time: 11:20 a.m. CT - Location: Chicago [3] - **2025 Jefferies Global Healthcare Conference** - Presentation Date: June 4, 2025 - Time: 5:30 p.m. ET - Location: New York City [4] - The company will also engage in one-on-one meetings with investors at the Scotiabank Third Annual Healthcare Canadian Investor Day on June 17, 2025, in Toronto [4] Product Information - ARS Pharmaceuticals is commercializing neffy (trade name EURneffy in the EU), an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis [6] - In the U.S., neffy is indicated for adult and pediatric patients aged 4 years and older who weigh 15 kg or more [6] - In the EU, it is indicated for emergency treatment of allergic reactions due to various allergens in adults and children who weigh 30 kg or more [6]

Financial Data and Key Metrics Changes - For Q1 2025, the company recorded total revenue of $8 million, with $7.8 million coming from U.S. net product revenue for Nefi, indicating a strong start to the year [20][24] - The company reported a net loss of $33.9 million or $0.35 per share for the first quarter [24] - Cash, cash equivalents, and short-term investments stood at $275.7 million as of March 31, 2025, providing an operating runway of at least three years [25] Business Line Data and Key Metrics Changes - Nefi generated $7.8 million in U.S. net product revenue in Q1 2025, reflecting growing demand among healthcare providers and patients [6][20] - The company has expanded commercial insurance coverage from 27% to 57% during the quarter, with ongoing discussions for further coverage [7][15] Market Data and Key Metrics Changes - The U.S. market potential for Nefi is estimated at $3 billion, with 6.5 million patients prescribed epinephrine in the past three years and an additional 13.5 million diagnosed patients without prescriptions [6] - The company aims to achieve 80% commercial lives coverage by Q3 2025, with current coverage at 57% without prior authorization [48] Company Strategy and Development Direction - The company is focused on deepening physician engagement, expanding access, and establishing a global commercial footprint for Nefi [12] - A comprehensive direct-to-consumer campaign titled "Hello Nefi, Goodbye Needles" is set to launch, aimed at raising awareness and driving prescription growth [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum from early revenue and physician testimonials, reinforcing the belief that Nefi is a transformative product [26] - The company anticipates an inflection point in sales during Q3 2025, particularly with the launch of the one-milligram dose and the DTC campaign [65] Other Important Information - The company plans to invest $40 million to $50 million in the DTC campaign for the remainder of 2025, with expectations of seeing benefits starting in Q3 [22][23] - The co-promotion agreement with ALK will allow the company to retain full control over U.S. commercialization while expanding its promotional network [21][75] Q&A Session Summary Question: How much of the Q1 sales figure is attributed to inventory? - Management indicated that Q1 numbers were minimally influenced by inventory, with steady inventories observed [30] Question: What would the gross to net discount look like in Q1? - The gross to net discount was around 60% for Q1, expected to decrease to closer to 50% as payer coverage improves [33] Question: Can you confirm that there are no prior auth requirements for access to Nefi for 57% of commercial lives? - Management confirmed that 57% have coverage without prior authorization, while about 90% have coverage when including those requiring prior authorization [38] Question: What is the expected cost of goods sold (COGS) as inventory is worked through? - COGS is expected to increase slightly as no-cost inventory is utilized over the next 18 months [40] Question: How is the Nefi Experience Program helping convert physicians into prescribers? - The program has enrolled over 2,500 physicians, with positive feedback and high prescription rates among participants [44] Question: How are payer negotiations tracking against the goal of 80% commercial lives by Q3? - Management is still negotiating with several payers, including Caremark and Aetna, to achieve the target [47] Question: What is the current market share and where do you hope to be by the end of the year? - The company currently holds about 1.3% market share overall, with higher shares among targeted physicians [73]

Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $8 million, with $7.8 million from U.S. net product revenue for Nefi and $200,000 from collaboration revenue [19][20] - The company reported a net loss of $33.9 million or $0.35 per share for the first quarter [23] - Cash, cash equivalents, and short-term investments stood at $275.7 million as of March 31, 2025, indicating a runway of at least three years [24] Business Line Data and Key Metrics Changes - Nefi generated $7.8 million in U.S. net product revenue in Q1 2025, reflecting strong demand among healthcare providers and patients [5][19] - The company has expanded commercial insurance coverage from 27% to 57% during the year, with ongoing discussions for further coverage [6][14] Market Data and Key Metrics Changes - The U.S. market potential for Nefi is estimated at $3 billion, with 6.5 million patients prescribed epinephrine and an additional 13.5 million diagnosed patients without prescriptions [5] - The company aims to achieve 80% commercial lives coverage by Q3 2025, with current coverage at 57% without prior authorization [45][68] Company Strategy and Development Direction - The company is focused on deepening physician engagement, expanding access, and establishing a global commercial footprint for Nefi [11] - A comprehensive direct-to-consumer campaign titled "Hello Nefi, Goodbye Needles" is set to launch, aimed at raising awareness and driving adoption [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum of Nefi, citing strong early revenue and positive physician testimonials [25] - The company anticipates an inflection point in sales during Q3 2025, particularly with the launch of the one-milligram dose and the DTC campaign [62] Other Important Information - The company plans to invest $40 million to $50 million in the DTC campaign for the remainder of 2025, with expected benefits starting in Q3 [21][22] - The co-promotion agreement with ALK will allow the company to retain full control over U.S. commercialization while benefiting from ALK's sales force [20] Q&A Session Summary Question: How much of the Q1 sales figure is attributed to inventory? - Management indicated that Q1 numbers were minimally influenced by inventory, with steady inventories at that point [28][29] Question: What would the gross to net discount look like in Q1? - The gross to net discount was around 60% for Q1, expected to decrease to closer to 50% as payer coverage improves [30][31] Question: Can you confirm that there are no prior auth requirements for access to Nefi for 57% of commercial lives? - Management confirmed that 57% have coverage without prior authorization, while about 90% have coverage when including those requiring prior authorization [35][36] Question: What is the strength of the Nefi experience program? - The Nefi experience program has enrolled over 2,500 physicians, with positive feedback and high prescription rates among participants [41][42] Question: How is the company tracking towards the goal of 80% commercial lives by Q3? - Management noted ongoing negotiations with several payers, with a high approval rate for prior authorizations, indicating positive progress towards the goal [44][46] Question: What is the current market share and where does the company hope to be by the end of the year? - The company currently holds about 1.3% market share overall, with higher shares among targeted physicians, and expects to see growth with upcoming catalysts [70][72]

Core Insights - ARS Pharmaceuticals, Inc. reported a quarterly loss of $0.35 per share, which aligns with the Zacks Consensus Estimate, compared to a loss of $0.11 per share a year ago [1] - The company posted revenues of $7.97 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 0.03%, and this is a significant increase from zero revenues a year ago [2] - The stock has increased approximately 26.5% since the beginning of the year, outperforming the S&P 500's gain of 0.1% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.38 on revenues of $15.45 million, and for the current fiscal year, it is -$1.28 on revenues of $89.27 million [7] - The estimate revisions trend for ARS Pharmaceuticals is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Drugs industry, to which ARS Pharmaceuticals belongs, is currently in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, ProPhase Labs, Inc., is expected to report a quarterly loss of $0.18 per share, reflecting a year-over-year change of -157.1% [9]

Product Overview - nef y is the first and only FDA and EC-approved needle-free epinephrine product, with an estimated initial addressable market opportunity of approximately $3 billion in annual net sales in the U.S. for 6.5 million patients currently prescribed an epinephrine autoinjector [198]. - The FDA approved nef y 2 mg on August 9, 2024, and the commercial launch began on September 23, 2024, targeting high-volume prescribers accounting for approximately 55% of prescriptions [204][207]. - The design of nef y aims to eliminate needle-related apprehension and pain, improving portability and ease of use, which is expected to increase prescriptions for epinephrine [201]. - The company estimates that up to 90% of patients prescribed an epinephrine device are not achieving optimal treatment outcomes with current injectable formulations [200]. Market and Regulatory Environment - Approximately 20 million people in the U.S. have been diagnosed with severe Type I allergic reactions, with only 3.2 million filling their active epinephrine autoinjector prescriptions in 2023 [199]. - Regulatory review for nef y is ongoing in Canada, the U.K., China, Japan, and Australia, with decisions anticipated by mid-2025 in the U.K. and the second half of 2025 in Japan [208]. Financial Performance - The company reported a net loss from operations of $37.2 million for the three months ended March 31, 2025, compared to a net loss of $13.2 million for the same period in 2024, with an accumulated deficit of $157.2 million [212]. - Product revenue for the three months ended March 31, 2025, was $7.8 million, compared to $0 for the same period in 2024 [240]. - Total revenue for the three months ended March 31, 2025, was $8.0 million, reflecting a significant increase from $0 in the prior year [240]. - The net loss for the three months ended March 31, 2025, was $33.9 million, a 230% increase from the net loss of $10.3 million in the same period in 2024 [240]. Expenses and Cash Flow - Selling, general and administrative expenses surged to $41.1 million for the three months ended March 31, 2025, compared to $8.0 million in the prior year, an increase of 413% [240]. - Research and development expenses decreased to $3.0 million for the three months ended March 31, 2025, down from $5.2 million in the same period in 2024, a reduction of 44% [242]. - Net cash used in operating activities was $40.7 million in Q1 2025, compared to $6.7 million in Q1 2024, reflecting a significant increase in operational losses [247][248]. - Cash and cash equivalents as of March 31, 2025, amounted to $275.7 million, providing liquidity for future operations [245]. Collaborations and Agreements - The ALK Collaboration Agreement includes an upfront payment of $145 million and potential regulatory and commercialization milestones of up to $320 million, with tiered royalty payments on net sales in the mid- to high-teens [215][217]. - The ALK Co-Promotion Agreement obligates ALK U.S. to promote nef y to up to 9,000 pediatricians starting in May 2025 [219]. - ALK U.S. is eligible for performance-based bonuses starting in the second year of the partnership, equal to 30% of net sales exceeding a specified market share threshold [222]. Future Outlook and Funding - The company expects zero-cost inventory of $10.9 million to be depleted by mid-2026, impacting future cost of goods sold [227]. - The company expects existing cash and revenues to meet anticipated cash requirements for at least the next three years, supporting commercial manufacturing and clinical trials [252]. - Future funding requirements will depend on various factors, including the costs of clinical trials and commercialization activities for new products [254]. - The company has contingent payment obligations of $11.0 million under the Aegis Agreement, based on achieving certain commercial milestones [260]. - The remaining milestone payment obligations to Recordati are approximately $5.4 million, contingent upon achieving regulatory and commercial milestones [261]. Reporting Status - The company is classified as a "smaller reporting company" under the Exchange Act, which may allow it to continue relying on certain disclosure exemptions [269]. - The market value of the company's stock held by non-affiliates must be less than $250 million to maintain its status as a smaller reporting company [269]. - The company can present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K due to its smaller reporting company status [269]. - The company has reduced disclosure obligations regarding executive compensation and other matters as a smaller reporting company [269]. - Quantitative and qualitative disclosures about market risk are not required for smaller reporting companies [270].

Financial Performance - Total revenue for Q1 2025 was $8.0 million, with $7.8 million from neffy U.S. net product revenue and $0.2 million from collaboration revenue[2] - Total revenue for Q1 2025 was $7.973 million, with product revenue of $7.763 million and collaboration agreement revenue of $210,000[30] - Net loss for Q1 2025 was $33.9 million, or $0.35 per share[2] - Net loss for Q1 2025 was $33.940 million, compared to a net loss of $10.292 million in Q1 2024, resulting in a net loss per share of $0.35[30] - The company reported a comprehensive loss of $34.088 million for Q1 2025, compared to a comprehensive loss of $10.465 million in Q1 2024[30] Expenses - R&D expenses for Q1 2025 were $3.0 million, primarily for neffy clinical and development expenses[2] - Operating expenses for Q1 2025 totaled $45.150 million, significantly higher than $13.192 million in Q1 2024, driven by increased selling, general and administrative expenses[30] - SG&A expenses for Q1 2025 were $41.1 million, mainly for personnel-related and sales and marketing expenses for neffy commercialization[2] - Research and development expenses for Q1 2025 were $2.952 million, down from $5.234 million in Q1 2024[30] Cash and Assets - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled $275.7 million, supporting operating plans for at least the next three years[2] - Cash and cash equivalents decreased to $39.864 million as of March 31, 2025, down from $50.817 million at the end of 2024[29] - Total current assets decreased to $303.860 million from $334.295 million at the end of 2024[29] - Total assets decreased to $327.318 million as of March 31, 2025, compared to $351.153 million at the end of 2024[29] - Total liabilities increased to $98.344 million as of March 31, 2025, up from $94.355 million at the end of 2024[29] Market and Product Development - Over 5,000 physicians have prescribed neffy, indicating strong demand for the product[1] - The co-promotion agreement with ALK-Abelló Inc. expands neffy's promotional reach to nearly 20,000 healthcare providers[1] - 57% commercial coverage has been secured, with ongoing negotiations aiming for over 80% access by early Q3 2025[6] - A national direct-to-consumer marketing campaign is set to launch on May 15, 2025, to increase brand awareness[5] - ARS Pharma plans to initiate a Phase 2b clinical trial for intranasal epinephrine technology in Q2 2025, with topline data expected in early 2026[9]

Core Insights - ARS Pharmaceuticals reported total revenue of $8.0 million for Q1 2025, with $7.8 million coming from neffy sales and $0.2 million from collaboration revenue with ALK-Abelló [5][21] - The company is focused on the U.S. commercial launch of neffy, a needle-free epinephrine nasal spray approved for treating severe allergic reactions, including anaphylaxis [1][10] - A co-promotion agreement with ALK-Abelló has expanded neffy's promotional reach to nearly 20,000 healthcare providers, enhancing market access [1][5] Financial Performance - Total revenue for Q1 2025 was $8.0 million, with net product revenue from neffy sales at $7.8 million and collaboration revenue at $0.2 million [5][27] - R&D expenses were $3.0 million, primarily for neffy's clinical and development costs [5] - SG&A expenses totaled $41.1 million, mainly for personnel and marketing related to neffy's commercialization [5] - The net loss for Q1 2025 was $33.9 million, equating to $0.35 per share [5][27] - As of March 31, 2025, the company had cash and short-term investments totaling $275.7 million, supporting operations for at least the next three years [5][21] Commercial Launch Progress - neffy 1 mg is now available nationwide for children aged four and older, with the 2 mg dose available for adults and older children [5][10] - Over 5,000 physicians have prescribed neffy, indicating strong demand for this treatment option [1][6] - The company is launching a national direct-to-consumer marketing campaign to increase brand awareness and drive demand [5][6] Market Access and Engagement - The sales force has engaged over 10,000 healthcare providers, with more than 50% having prescribed neffy [11] - Approximately 57% commercial coverage has been secured, with ongoing discussions to achieve over 80% access by early Q3 2025 [11][12] - More than 1,000 schools have opted into the neffyinSchools program, receiving free doses for emergency use [11][12] Clinical Development - ARS Pharma plans to initiate a Phase 2b clinical trial in Q2 2025 to evaluate intranasal epinephrine for chronic spontaneous urticaria [8] - Regulatory reviews for neffy are ongoing in the U.K. and Canada, with expected decisions by mid-2025 [12]