Here are 1-2 brief analogies for ARS Pharmaceuticals (SPRY):

1. SPRY is like the 'nasal spray Mylan' for emergency allergic reactions, offering a needle-free alternative to the EpiPen.

2. SPRY is like an Abbott (known for FreeStyle Libre) for anaphylaxis, providing a less invasive, user-friendly alternative to injectable epinephrine.

• SPY001: An investigational monoclonal antibody targeting TL1A, currently in clinical development for Inflammatory Bowel Disease (IBD).
• SPY002: An investigational monoclonal antibody targeting P40, currently in clinical development for Inflammatory Bowel Disease (IBD).

ARS Pharmaceuticals (SPRY) Major Customers

• McKesson Corporation (MCK)
• AmerisourceBergen Corporation (ABC)
• Cardinal Health, Inc. (CAH)

• Lonza Group AG (LONN)
• Catalent, Inc. (CTLT)
• Sanofi S.A. (SNY)

Richard Lowenthal, President and Chief Executive Officer

Richard Lowenthal is a co-founder of ARS Pharmaceuticals and has served as its President and CEO, and a member of its Board of Directors since the company's inception in 2015. He also previously served as Chairman. Mr. Lowenthal holds an M.S. and MSEL degree.

Kathleen Scott, Chief Financial Officer

Kathleen Scott has served as the Chief Financial Officer of ARS Pharmaceuticals since 2022. She is a Certified Public Accountant (CPA).

Sarina Tanimoto, Chief Medical Officer

Sarina Tanimoto is a co-founder of ARS Pharmaceuticals and serves as its Chief Medical Officer. She holds an M.D. and an M.B.A.

Brian T. Dorsey, Chief Operating Officer

Brian T. Dorsey has been the Chief Operating Officer of ARS Pharmaceuticals since December 2022. Prior to this role, he served as the Senior Vice President of Operations and Project Management from 2018 to December 2022. Mr. Dorsey holds an MSc.

Justin Chakma, Chief Business Officer

Justin Chakma has served as the Chief Business Officer of ARS Pharmaceuticals since June 2019. Before joining ARS Pharmaceuticals, he was the Vice President, Head of Business Development and Strategy at Vedanta Biosciences from 2018 to May 2019.

The key risks to ARS Pharmaceuticals (SPRY) primarily revolve around the commercial success and market acceptance of its sole approved product, Neffy, an epinephrine nasal spray for allergic reactions.

1. Commercialization and Market Acceptance of Neffy: The most significant risk for ARS Pharmaceuticals is the successful commercialization of Neffy in a highly competitive market. The success of Neffy is uncertain due to potential market acceptance issues, pricing challenges, and competition from established injectable epinephrine devices like EpiPen and emerging intranasal products. Convincing patients and healthcare providers that Neffy is as effective as conventional injections is critical for its adoption. Additionally, securing adequate third-party payor coverage and reimbursement for Neffy is crucial; inadequate coverage could severely hinder its commercial success. The company also has limited experience in product commercialization, which could impede its ability to effectively market and distribute Neffy.
2. Regulatory Challenges: While Neffy has received FDA approval, ARS Pharmaceuticals faces ongoing regulatory risks. The company must maintain existing approvals and seek new ones for additional indications and jurisdictions. Any negative developments in post-approval trials or regulatory processes could adversely impact Neffy's commercial potential. Past regulatory hurdles, such as a Complete Response Letter from the FDA, have demonstrated the potential for delays and significant impacts on the company's stock price.
3. Financial Performance and Operational Dependence: ARS Pharmaceuticals has a history of operational losses and expects expenses to continue to significantly outpace revenues in the near term. The company reported an accumulated deficit of $157.2 million as of March 31, 2025. While the company currently has sufficient cash reserves, continued high selling, general, and administrative costs, along with significant cash burn, could necessitate additional capital. Furthermore, ARS Pharmaceuticals relies on third-party contract manufacturing organizations (CMOs) for manufacturing, supply, and distribution of Neffy; any failures in this network could disrupt commercialization efforts.

The primary clear emerging threat for ARS Pharmaceuticals (SPRY) is the development and potential market entry of alternative needle-free epinephrine delivery systems by competitors.

Specifically, Aquestive Therapeutics (NASDAQ: AQST) is developing Anaphylm (epinephrine sublingual film), a needle-free epinephrine product that has completed Phase 3 trials with positive data. Aquestive plans to submit a New Drug Application (NDA) for Anaphylm to the FDA in late 2024 or early 2025. If approved, Anaphylm would directly compete with SPRY's neffy™ (epinephrine nasal spray) for market share in the non-injectable emergency anaphylaxis treatment segment.

ARS Pharmaceuticals' (SPRY) primary product, Neffy, targets a significant addressable market for the emergency treatment of Type I allergic reactions, including anaphylaxis.

For the United States, the initial addressable market for Neffy is estimated at approximately $3 billion in annual net sales, focusing on the 6.5 million patients currently prescribed an epinephrine auto-injector. Additionally, there is an estimated $7 billion opportunity for an extra 13.5 million diagnosed patients who are not currently prescribed epinephrine. This brings the total potential addressable market in the U.S. to approximately $10-10.5 billion.

Beyond the U.S., Neffy has been launched in Europe, and is anticipated to be launched in other regions, including the UK, Canada, China, Japan, and Australia. The UK is noted as the largest market outside of the United States for adrenaline (epinephrine) auto-injector sales.

The broader global market for epinephrine for anaphylaxis treatment was valued at approximately $1.56 billion in 2023 and is projected to reach around $3.32 billion by 2032. Similarly, other sources indicate the global anaphylaxis treatment market was valued at approximately $3.38 billion in 2024 and is expected to reach about $6.14 billion by 2031. North America held the largest share of this global market, accounting for 67.95% in 2023.

Expected Drivers of Future Revenue Growth for ARS Pharmaceuticals (SPRY)

ARS Pharmaceuticals (SPRY) is anticipated to drive significant revenue growth over the next 2-3 years through several key initiatives, primarily centered around its novel epinephrine nasal spray, neffy.

• Expanding U.S. Market Penetration and Payer Coverage for neffy: The ongoing commercial launch of neffy in the U.S. is a primary revenue driver. The company has been actively expanding its sales force and implementing direct-to-consumer (DTC) marketing campaigns to increase awareness and adoption among healthcare providers and patients. ARS Pharmaceuticals anticipates continued growth in product revenue, supported by increased prescription numbers and an improved payer access environment. The company aims for over 80% commercial lives coverage by early Q3 2025 and is working to reduce prior authorization requirements. This expanded access and increased patient demand are expected to accelerate sales throughout 2025 and beyond.
• Approval and Commercialization of neffy for Pediatric Use: The FDA approval of neffy 1 mg for children aged four and older weighing 15-30 kg significantly expands the addressable market by approximately 2 million younger children. This pediatric indication, which became available in May 2025, is a crucial catalyst for increasing net product revenue. A pediatric co-promotion with ALK is also in place to support this expansion.
• International Expansion through Partnerships: ARS Pharmaceuticals is actively pursuing global expansion for neffy through strategic licensing agreements. The company has an exclusive licensing agreement with ALK-Abelló to commercialize neffy in Europe, Canada, and certain other geographies outside the U.S. Regulatory approvals and launches are anticipated in key international markets, including Japan (approval in September 2025, launch anticipated in 2025), the United Kingdom (EURneffy launched in October 2025, regulatory decisions anticipated by mid-2025), and Canada and China (approvals expected by 2026). These international commercialization efforts, along with milestone payments from partners, will contribute to future revenue.
• Potential Label Expansion into New Indications (e.g., Urticaria): ARS Pharmaceuticals initiated a Phase 2b clinical trial in June 2025 to evaluate its intranasal epinephrine technology as a treatment for acute flares in patients with chronic spontaneous urticaria. This program expansion represents a significant opportunity to extend the utility of neffy to a new indication, potentially impacting approximately two million people in the U.S. alone. Topline data from this trial are anticipated in the first half of 2026, and a successful outcome could lead to further label expansion and a new revenue stream.

Share Issuance

• In 2020, ARS Pharmaceuticals issued $153 million in preferred equity and $258 million in common equity.
• The company issued $55 million in preferred equity and $0.17 million in common equity in 2021.
• Common equity issuances continued with $0.57 million in 2022, $6.90 million in 2023, and $3.02 million in 2024.

Inbound Investments

• ARS Pharmaceuticals secured a term loan facility of up to $250 million with RA Capital Management and OMERS Life Sciences to accelerate the U.S. commercialization of neffy.
• As of September 30, 2025, the company had drawn $100 million from this facility, contributing to cash, cash equivalents, and short-term investments totaling $288.2 million.

Capital Expenditures

• Annual capital expenditures were reported as $0.92 million in 2020, $0.06 million in 2021, $0.20 million in 2022, $0.18 million in 2023, and $0.56 million in 2024.
• For June 2025, quarterly capital expenditures amounted to $5.8 million.