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EURneffy® (adrenaline nasal spray) Approved in the U.K. as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis)
Globenewswire· 2025-07-18 13:25
Core Viewpoint - The approval of EURneffy as the first needle-free adrenaline treatment in the U.K. represents a significant advancement for patients with severe allergies, addressing the need for a more accessible emergency treatment option [2][4]. Group 1: Product Overview - EURneffy is an epinephrine nasal spray approved for emergency treatment of allergic reactions, including anaphylaxis, in adults and children over 30 kg [1][5]. - The product is expected to be available in the U.K. by late Q3 2025, with the U.K. being the largest market outside the U.S. for adrenaline auto-injectors [1][4]. Group 2: Company Partnerships and Financials - ARS Pharmaceuticals entered an exclusive licensing agreement with ALK-Abelló A/S in November 2024, granting ALK rights to commercialize neffy outside the U.S. [2][4]. - ARS Pharma received a $145 million upfront payment and is eligible for up to an additional $320 million in milestone payments, along with tiered royalties on net sales in licensed territories [2][4]. Group 3: Market Strategy and Promotion - A co-promotion agreement was initiated between ARS Pharma and ALK in May 2025 to reach nearly 20,000 healthcare providers, particularly targeting pediatricians during the back-to-school season [3]. - ALK successfully launched EURneffy in Germany in late June 2025, with further regulatory approvals expected in Canada, Japan, Australia, and China by the end of 2025 and into 2026 [4].
ARS Pharmaceuticals, Inc. (SPRY) is a Great Momentum Stock: Should You Buy?
ZACKS· 2025-07-15 17:01
Group 1 - The core concept of momentum investing involves following a stock's recent price trends, with the aim of buying high and selling even higher [1] - ARS Pharmaceuticals, Inc. (SPRY) currently holds a Momentum Style Score of B and a Zacks Rank of 2 (Buy), indicating potential for outperformance [2][3] - SPRY shares have increased by 7.08% over the past week, significantly outperforming the Zacks Medical - Drugs industry, which rose by 1.75% during the same period [5] Group 2 - Over the past quarter, SPRY shares have risen by 25%, and over the last year, they have increased by 53.52%, while the S&P 500 has only moved 16.27% and 12.91%, respectively [6] - The average 20-day trading volume for SPRY is 1,516,745 shares, which is a bullish indicator when combined with rising stock prices [7] - In the last two months, one earnings estimate for SPRY has moved higher, increasing the consensus estimate from -$1.49 to -$1.44, with two upward revisions for the next fiscal year [9] Group 3 - Given the positive momentum indicators and earnings outlook, SPRY is positioned as a promising stock for near-term gains, making it a candidate for investors' short lists [11]
Wall Street Analysts See a 78.77% Upside in ARS Pharmaceuticals, Inc. (SPRY): Can the Stock Really Move This High?
ZACKS· 2025-07-15 14:56
ARS Pharmaceuticals, Inc. (SPRY) closed the last trading session at $17.9, gaining 18.1% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $32 indicates a 78.8% upside potential.The average comprises five short-term price targets ranging from a low of $28.00 to a high of $40.00, with a standard deviation of $4.69. While the lowest estimate indicates an increase of 56.4% from the curr ...
What Makes ARS Pharmaceuticals, Inc. (SPRY) a Good Fit for 'Trend Investing'
ZACKS· 2025-07-15 13:50
While "the trend is your friend" when it comes to short-term investing or trading, timing entries into the trend is a key determinant of success. And increasing the odds of success by making sure the sustainability of a trend isn't easy. A solid price increase over a period of 12 weeks reflects investors' continued willingness to pay more for the potential upside in a stock. SPRY is quite a good fit in this regard, gaining 25% over this period. However, it's not enough to look at the price change for around ...
ARS Pharmaceuticals (SPRY) Earnings Call Presentation
2025-06-23 11:40
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]
ARS Pharmaceuticals (SPRY) 2025 Conference Transcript
2025-06-04 22:30
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 Transcript
2025-06-03 17:20
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 ...
ARS Pharmaceuticals to Participate in Upcoming Investor Conferences
Globenewswire· 2025-05-27 12:00
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]
ARS Pharmaceuticals(SPRY) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:32
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 ...
ARS Pharmaceuticals(SPRY) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:30
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]