ARS Pharmaceuticals (SPRY) 2025 Conference June 04, 2025 05:30 PM ET Speaker0 Thank you very much. So I'll present the beginning and I'll invite Eric Carras, our Chief Commercial Officer, up for the commercial part of the presentation so he can present that part. So very happy to be here and present. Next slide. Oh, I'm clicking or they didn't give me that. Okay. There we go. So forward looking statement. So this year has been a very active year for us. This is our first full year of launch of Nefi, which i ...

ARS Pharmaceuticals (SPRY) FY Conference June 03, 2025 12:20 PM ET Speaker0 Thank you very much. One sec. I'll just Speaker1 just briefly I'm Lachlan Henry Brown, one of the research analysts here at William Blair. Along with my colleague, Matt Phipps, we cover ARS Pharmaceuticals. Before I hand it over to Richard Lowenthal, the president and CEO of the company, did want to just mention, please visit WilliamBlair.com to see any and all relevant disclosures. And with that, I'll pass it on to Rich. Take it aw ...

SAN DIEGO, May 27, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, today announced that Richard Lowenthal, Co-Founder, President and CEO and Eric Karas, Chief Commercial Officer, will participate in presentations at the William Blair 45th Annual Growth Stock Conference and 2025 Jefferies Global Healthcare Conference ...

ARS Pharmaceuticals (SPRY) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Company Participants Justin Chakma - Chief Business OfficerRichard Lowenthal - Co Founder, President, CEO & DirectorEric Karas - Chief Commercial OfficerKathleen Scott - Chief Financial OfficerRyan Deschner - Vice President - Equity ResearchJosh Schimmer - Managing DirectorLouise Chen - Managing Director Conference Call Participants Roanna Ruiz - Senior Managing Director, Biotechnology AnalystLachlan Hanbury-Brown - Biotech Equity Res ...

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]

ARS Pharmaceuticals, Inc. (SPRY) came out with a quarterly loss of $0.35 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.11 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this company would post a loss of $0.04 per share when it actually produced earnings of $0.52, delivering a surprise of 1,400%.Over the last four quarters, the company has surpassed consensus EPS estimates just once.ARS Pharmaceuticals, Inc., whi ...

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]

"The expanded availability of neffy represents real progress for our community, especially for young children who may be more likely to speak up about symptoms of a serious allergic reaction when they know epinephrine can be given without a needle," said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research & Education), the leading nonprofit organization dedicated to food allergy. "This news means more families will have options that help them be ready to act and administer 'Epi first, Epi fast' when a ...

SAN DIEGO, May 05, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, today announced the company will host a conference call and webcast on Wednesday, May 14, 2025, at 5:30 a.m. PT / 8:30 a.m. ET to discuss its first quarter 2025 financial results and business highlights. Dial-in information for conference participants may b ...