Company Overview - ADARx Pharmaceuticals, Inc. is a late-stage clinical biotechnology company focused on developing next-generation RNA therapeutics across various therapeutic areas [3] - The company aims to transform cutting-edge science into RNA medicines that address urgent unmet medical needs [3] Leadership Appointment - Laura Shawver, Ph.D., has been appointed as Chair of the Board of Directors, bringing 25 years of experience in the biopharma industry [1][2] - Dr. Shawver's leadership is expected to drive strategic growth and innovation in RNA therapeutics as the company advances its pipeline [2] Strategic Focus - ADARx is advancing a deep pipeline of RNA-targeted therapeutic candidates for diseases such as complement-mediated, genetic, cardiovascular, thrombosis, central nervous system, and metabolic diseases [3] - The company has a collaboration and license option agreement with AbbVie to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology, and oncology [3]

Core Insights - ARS Pharmaceuticals, Inc. has published findings indicating that approximately 90% of patients experiencing anaphylaxis were effectively treated with a single dose of neffy, a nasal spray formulation of epinephrine [1][2][4] - The real-world effectiveness of neffy aligns closely with historical data for epinephrine injections, suggesting clinical interchangeability between the two treatment methods [2][4] Group 1: Clinical Performance of Neffy - A total of 545 patients were treated with neffy during oral food challenges and allergen immunotherapy, with a success rate of 89.2% for a single dose administered by healthcare providers [2][9] - Meta-analyses show a similar success rate of 88.9% for epinephrine injections, reinforcing the effectiveness of neffy in real-world settings [2][4] - Previous clinical studies, including a Phase 3 trial, indicated that no patients required a second dose of neffy for initial anaphylactic reactions [3][10] Group 2: Neffy Experience Program - The neffy experience program involved healthcare providers administering neffy to patients experiencing anaphylaxis symptoms, with data collected from 301 providers [8][9] - The program provided six doses of neffy for emergency use, with the labeling indicating that a second dose may be necessary if symptoms persist after five minutes [8][9] - The ongoing program now includes both 2 mg and 1 mg doses of neffy, expanding treatment options for patients [9] Group 3: Company Overview - ARS Pharmaceuticals is focused on empowering at-risk patients and caregivers to manage allergic reactions that could lead to anaphylaxis [21] - Neffy is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients aged 4 years and older who weigh at least 33 lbs [11][12] - The company aims to address limitations associated with traditional epinephrine auto-injectors, such as needle fear and portability issues, by offering a needle-free alternative [20][21]

Summary of ARS Pharmaceuticals Conference Call Company Overview - **Company**: ARS Pharmaceuticals - **Product**: Nefi, a needle-free epinephrine delivery device aimed at displacing injectable epinephrines [1][2] Key Points and Arguments Launch and Market Strategy - **Launch Timeline**: Nefi was launched approximately ten months ago, focusing on access and awareness [1] - **Direct-to-Consumer (DTC) Campaign**: Initiated in May/June, with linear TV ads starting in July, expected to drive uptake [2] - **Physician Adoption**: Approximately 10,000 doctors have prescribed Nefi, with early adopters showing increased prescription rates over time [6][7] Market Dynamics - **Patient Education**: High awareness among doctors (98%-100% would prescribe if patients request Nefi) is crucial for adoption [5] - **Market Research**: Aided awareness of Nefi increased from 20% to 49% in recent surveys, indicating effective campaign reach [17][18] - **Prescription Trends**: The company anticipates a natural decline in overall market share post back-to-school season but expects recovery as awareness grows [21][30] Financial and Operational Insights - **GoodRx Program Discontinuation**: The decision to discontinue the GoodRx program was made due to financial losses from pharmacists using multiple coupons, resulting in a drop in cash pay from 20% to nearly 10% [21][22] - **Market Share Goals**: To sustain revenue, the company aims to increase market share from 3.5% to 5% by leveraging awareness and patient demand [41][42] Legislative and Advocacy Efforts - **Advocacy Group Support**: Advocacy groups are pushing for legislation to encourage restaurants to stock epinephrine, with Nefi seen as a safer alternative to auto-injectors [58][59] - **California Legislation**: New bills are being considered in California to mandate epinephrine availability in restaurants and schools, with support from the California Restaurant Association [60] Future Outlook - **Market Share Growth**: The company expects to build market share through new patient prescriptions and increased awareness, particularly among children [34][39] - **Formulary Inclusion**: Anticipation of Nefi being included in formularies by January 1, which could enhance market access [43][44] Additional Important Insights - **Consumer Preferences**: The preference for Nefi over injections is high, particularly among parents and caregivers [20][34] - **Real-World Data**: The Nefi Experience Program is expected to provide valuable data to build trust and confidence in the product [51][54] - **Economic Considerations**: The company is focusing on reducing copays and improving access for patients with commercial coverage [35][36] This summary encapsulates the key discussions and insights from the ARS Pharmaceuticals conference call, highlighting the company's strategies, market dynamics, and future outlook.

Financial Data and Key Metrics Changes - The company reported total revenue of $15.7 million for Q2 2025, with U.S. net product revenue for NEFI at $12.8 million, reflecting a 64% increase compared to Q1 2025 [18][19] - Gross to net retention improved from about 70% in 2024 to the low 50% range in Q2 2025, indicating successful payer access strategies [22] Business Line Data and Key Metrics Changes - NEFI prescriptions increased by 180% in weekly two-pack unit volume from the end of Q1 to the end of Q2 2025, with 35,000 two-packs shipped in Q2 compared to 19,000 in Q1 [5][29] - The company achieved 93% commercial coverage for NEFI, with 57% of commercial payers not requiring prior authorization for prescriptions [11][12] Market Data and Key Metrics Changes - NEFI is gaining traction globally, with successful launches in Germany and the UK, and expected regulatory decisions in Canada, Australia, Japan, and China by 2026 [7][8] - The direct-to-consumer (DTC) campaign has significantly increased brand awareness, with nearly 50% of respondents recognizing the NEFI advertisement [15] Company Strategy and Development Direction - The company aims to sustain and accelerate market share growth through DTC investments and global expansion of NEFI [25] - The focus is on changing the treatment landscape for type one allergies by addressing barriers such as needle fear and device complexity with NEFI [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth in NEFI prescriptions, driven by the DTC campaign and seasonal demand [58] - The company anticipates a positive impact from the DTC campaign during the back-to-school season, which is a peak period for epinephrine prescriptions [58] Other Important Information - The company maintains a strong cash position with over $240 million in cash and short-term investments, providing a solid foundation for commercial efforts [23] - Significant investments in sales and marketing, particularly in the DTC campaign, are expected to continue through 2026 [20][50] Q&A Session Summary Question: Can you confirm the number of prescriptions written during the quarter? - The company reported approximately 35,000 two-packs shipped in Q2, compared to 19,000 in Q1 [29] Question: Are there early signs that the DTC campaign is translating into prescribing behavior? - Feedback indicates that many patients are inquiring about NEFI after seeing the ads, suggesting a potential uptick in prescriptions in the near future [31] Question: What is the realistic ceiling for coverage without prior authorization? - Currently, about 25% of CVS Caremark's coverage is without prior authorization, and there is no indication of a ceiling for further coverage improvements [39][40] Question: What factors are driving growth in the second half of the year? - Major drivers include the DTC campaign, expanded sales force, and seasonal increases in prescriptions [46] Question: How long will the DTC campaign last? - The DTC campaign is expected to continue at a similar pace through 2026, with potential budget increases based on effectiveness [50] Question: Are patients ordering multiple packs during the back-to-school season? - The company is seeing an increase in orders for multiple packs, indicating strong demand as parents prepare for the school year [51][52]

Company Performance - ARS Pharmaceuticals, Inc. reported a quarterly loss of $0.46 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.41, and compared to a loss of $0.13 per share a year ago, indicating a significant decline [1] - The company posted revenues of $15.72 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 3.98%, and showing a substantial increase from year-ago revenues of $0.5 million [2] - Over the last four quarters, ARS Pharmaceuticals has surpassed consensus EPS estimates just once, but has topped consensus revenue estimates two times [2] Stock Performance - ARS Pharmaceuticals shares have increased approximately 57.9% since the beginning of the year, significantly outperforming the S&P 500's gain of 9.6% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.41 on revenues of $29.98 million, and for the current fiscal year, it is -$1.44 on revenues of $84.04 million [7] Industry Outlook - The Medical - Drugs industry, to which ARS Pharmaceuticals belongs, is currently ranked in the top 34% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that the industry outlook can materially impact stock performance [5][8]

PART I FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and detailed notes [Item 1. Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) This section provides the company's unaudited condensed consolidated financial statements and comprehensive notes [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents a snapshot of the company's assets, liabilities, and equity at specific points in time | Metric | Dec 31, 2024 (in thousands) | Jun 30, 2025 (in thousands) | Change (in thousands) | | :----------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Cash and cash equivalents | $50,817 | $51,540 | $723 | | Short-term investments | $263,205 | $188,590 | $(74,615) | | Accounts receivable, net | $8,175 | $25,126 | $16,951 | | Inventories | $10,519 | $22,112 | $11,593 | | Total assets | $351,153 | $313,472 | $(37,681) | | Total liabilities | $94,355 | $121,151 | $26,796 | | Total stockholders' equity | $256,798 | $192,321 | $(64,477) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net loss over specific reporting periods | Metric (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | Change | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | Change | | :-------------------- | :-------------------------- | :-------------------------- | :----- | :-------------------------- | :-------------------------- | :----- | | Total revenue | $15,717 | $500 | $15,217 | $23,690 | $500 | $23,190 | | Cost of goods sold | $4,984 | $0 | $4,984 | $6,078 | $0 | $6,078 | | R&D expenses | $4,035 | $6,896 | $(2,861) | $6,987 | $12,130 | $(5,143) | | SG&A expenses | $54,312 | $8,944 | $45,368 | $95,416 | $16,902 | $78,514 | | Loss from operations | $(47,614) | $(15,340) | $(32,274) | $(84,791) | $(28,532) | $(56,259) | | Net loss | $(44,883) | $(12,516) | $(32,367) | $(78,823) | $(22,808) | $(56,015) | | Net loss per share | $(0.46) | $(0.13) | $(0.33) | $(0.80) | $(0.24) | $(0.56) | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in the company's equity, including net loss and additional paid-in capital | Metric (in thousands) | Dec 31, 2024 | Mar 31, 2025 | Jun 30, 2025 | | :-------------------- | :----------- | :----------- | :----------- | | Total Stockholders' Equity | $256,798 | $228,974 | $192,321 | | Accumulated Deficit | $(123,305) | $(157,245) | $(202,128) | | Additional Paid-in Capital | $379,873 | $386,137 | $394,485 | | Net loss and comprehensive loss (3 months ended Mar 31, 2025) | N/A | $(34,088) | N/A | | Net loss and comprehensive loss (3 months ended Jun 30, 2025) | N/A | N/A | $(45,001) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities | Cash Flow Activity (in thousands) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(80,334) | $(13,989) |\n| Net cash provided by (used in) investing activities | $77,635 | $(21,159) |\n| Net cash provided by financing activities | $3,422 | $803 |\n| Net increase (decrease) in cash and cash equivalents | $723 | $(34,345) |\n| Cash and cash equivalents at end of period | $51,540 | $36,626 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Nature of Business](index=11&type=section&id=1.%20Nature%20of%20Business) This note describes the company's core business, financial status, and liquidity outlook - ARS Pharmaceuticals is a biopharmaceutical company focused on the commercialization and development of nef y (EURnef y in EU), the first FDA and European Commission-approved needle-free epinephrine product for Type I allergic reactions[26](index=26&type=chunk) - The company has an **accumulated deficit of $202.1 million** as of June 30, 2025, and has not generated positive cash flows from operations in most years since inception[28](index=28&type=chunk) - Current cash, cash equivalents, and short-term investments of **$240.1 million** as of June 30, 2025, are sufficient to meet anticipated cash requirements for at least the next 12 months[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and estimates used in preparing the financial statements - The financial statements are prepared in conformity with U.S. GAAP and presented on a condensed consolidated basis, including ARS Pharmaceuticals, Inc. and its subsidiaries[30](index=30&type=chunk) - Significant estimates are made for revenue under collaboration agreements, variable components of product revenue, R&D accruals, and valuation of equity awards[33](index=33&type=chunk) - Inventories are stated at the lower of cost or net realizable value, determined on a first-in, first-out basis, and capitalized after regulatory approval when commercialization is probable[42](index=42&type=chunk)[43](index=43&type=chunk) - Revenue is recognized in accordance with ASC Topic 606, requiring identification of performance obligations, determination of transaction price, allocation, and recognition upon satisfaction of obligations[50](index=50&type=chunk) [3. Revenue](index=17&type=section&id=3.%20Revenue) This note details the company's revenue recognition policies and models for product and collaboration revenues - Product revenue from nef y began in September 2024 after FDA approval in August 2024[70](index=70&type=chunk) - Revenue is recognized under two models: a title model (when title transfers from Title Agent to wholesale distributor/pharmacy) and a consignment model (when sold to a patient)[71](index=71&type=chunk)[72](index=72&type=chunk) - Product revenue is recorded net of Gross-to-Net Adjustments, including distribution service fees, commercial pharmacy discounts, prompt pay discounts, chargebacks, rebates, and co-payment assistance[73](index=73&type=chunk) [4. Inventories](index=18&type=section&id=4.%20Inventories) This note provides a breakdown of inventory categories and the company's capitalization policy - Inventory capitalization for nef y began in August 2024 upon FDA approval[83](index=83&type=chunk) | Inventory Category (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Raw materials | $17,784 | $4,674 | | Finished goods | $6,488 | $5,826 | | Inventory reserve | $(2,160) | $0 | | Total inventories, net | $22,112 | $10,519 | - The company held **$9.8 million in zero-cost inventory** as of June 30, 2025, and expects to fully utilize it in future periods, with depletion anticipated by mid-2026[85](index=85&type=chunk)[239](index=239&type=chunk) [5. Fair Value Measurements](index=19&type=section&id=5.%20Fair%20Value%20Measurements) This note presents fair value measurements for financial assets, including cash and short-term investments | Asset Category (in thousands) | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :---------------------------- | :----------------------- | :--------------------------- | | Cash and cash equivalents | $51,248 | $48,893 | | Short-term investments | $188,590 | $263,205 | | Total | $239,838 | $312,098 | - Net unrealized loss on available-for-sale securities was **$0.1 million** for the three months and **$0.3 million** for the six months ended June 30, 2025[89](index=89&type=chunk) [6. Balance Sheet Details](index=20&type=section&id=6.%20Balance%20Sheet%20Details) This note provides specific details on selected balance sheet accounts, including prepaid and accrued items | Account (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------- | :------------ | :---------------- | | Prepaid marketing | $3,447 | $3,169 | | Accounts payable | $15,559 | $9,870 | | Accrued gross-to-net adjustments | $11,341 | $2,179 | | Accrued marketing related expenses | $6,374 | $1,855 | [7. Intangible assets, net](index=20&type=section&id=7.%20Intangible%20assets,%20net) This note details the company's intangible assets, including capitalized milestone payments and amortization - Capitalized milestone payments for intangible assets increased by **$5.9 million** in June 2025 due to the first commercial sale of EURnef y in the Recordati Territory[93](index=93&type=chunk)[115](index=115&type=chunk) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Capitalized milestone payments | $13,360 | $7,500 | | Less accumulated depreciation | $(388) | $(129) | | Total intangible assets, net | $12,972 | $7,371 | - Amortization expense for intangible assets was **$0.1 million** for the three months and **$0.3 million** for the six months ended June 30, 2025[95](index=95&type=chunk) [8. Collaboration, Out-Licensing and Related Agreements](index=21&type=section&id=8.%20Collaboration,%20Out-Licensing%20and%20Related%20Agreements) This note describes key collaboration and licensing agreements, including revenue recognition and milestone payments - The company's collaboration agreements typically involve upfront license fees, clinical/regulatory/commercial milestone payments, and royalties or transfer prices on net sales[97](index=97&type=chunk) - Milestone payments are included in the transaction price only when achievement is probable and a significant revenue reversal is unlikely[100](index=100&type=chunk) - The ALK Collaboration Agreement resulted in a **$145.0 million upfront payment** in November 2024 and a **$5.0 million commercial milestone** earned in June 2025 for the first commercial sale of EURnef y in the ALK Territory[127](index=127&type=chunk)[138](index=138&type=chunk) - The transaction price allocated to the EEA License under the ALK Collaboration Agreement (**$69.4 million**) is accounted for as a financing liability due to the company's repurchase option[135](index=135&type=chunk) - The ALK Co-Promotion Agreement, entered in May 2025, involves ALK U.S. co-promoting nef y in the U.S. to pediatricians and other prescribers, with the company paying a base fee and potential performance-based bonuses[142](index=142&type=chunk)[146](index=146&type=chunk) [9. Commitments and Contingencies](index=28&type=section&id=9.%20Commitments%20and%20Contingencies) This note outlines the company's contractual obligations, lease payments, and ongoing legal proceedings - The company's future minimum non-cancelable operating lease payments total **$1.864 million** as of June 30, 2025, with an annualized payment of **$0.6 million** for the new office space[151](index=151&type=chunk)[155](index=155&type=chunk) - Legal proceedings include an EPO opposition to EP 3678649 (nasal spray patent) and a lawsuit by Aptar alleging trade secret misappropriation and breach of contract[157](index=157&type=chunk)[158](index=158&type=chunk) | Obligation Category | Total Amount (as of Jun 30, 2025) | 2025 (remaining) | 2026 | 2027 | 2028 | 2029 | | :------------------ | :-------------------------------- | :--------------- | :--- | :--- | :--- | :--- | | Raw materials supply | $57.6 million | $0.9 million | $10.5 million | $11.8 million | $13.8 million | N/A (then $2.9M/yr through 2035) | | ALK Co-Promotion Agreement | $26.8 million | $0 | $4.4 million | $14.2 million | $4.6 million | $3.6 million | | Corporate sponsorship | $10.0 million | $4.0 million | $5.0 million | $1.0 million | $0 | $0 | | Hosted software license | $2.5 million | $0.6 million | $1.5 million | $0.4 million | $0 | $0 | [10. In-Licensing and Supply](index=30&type=section&id=10.%20In-Licensing%20and%20Supply) This note details in-licensing agreements and reliance on third-party manufacturers for product supply - Under the Aegis Agreement, the company licensed exclusive worldwide rights to proprietary technology for epinephrine products, including nef y[169](index=169&type=chunk) - Milestone payments under Aegis Agreement: **$2.5 million** for FDA approval (Aug 2024) and **$5.0 million** for first commercial sale of nef y (Sep 2024) were capitalized as intangible assets[170](index=170&type=chunk) - The company relies on Renaissance Lakewood, LLC for drug product manufacturing and final packaging, and Nuova Ompi S.r.l. for glass microvials, with committed annual minimum quantities for microvials[176](index=176&type=chunk)[178](index=178&type=chunk) [11. Common Stock and Stockholders' Equity](index=32&type=section&id=11.%20Common%20Stock%20and%20Stockholders'%20Equity) This note provides information on common stock, shares reserved, and equity offerings - As of June 30, 2025, **98,697,658 shares of common stock** were issued and outstanding[16](index=16&type=chunk) | Reserved for (shares) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Common stock options | 17,271,990 | 15,161,180 | | Future awards/grants | 8,062,484 | 5,905,773 | | ESPP issuances | 2,811,182 | 2,223,100 | | Warrants | 45,456 | 45,456 | | Total | 28,192,494 | 23,338,272 | - An automatic shelf registration statement on Form S-3ASR was filed in January 2025, allowing for the offer and sale of up to **$200.0 million** in common stock through an Equity Sales Agreement, though no securities have been sold as of June 30, 2025[184](index=184&type=chunk) [12. Stock-Based Compensation](index=32&type=section&id=12.%20Stock-Based%20Compensation) This note details stock-based compensation expenses and unrecognized compensation for employee options | Expense Category (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :------------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $664 | $913 | $1,327 | $1,824 | | Selling, general and administrative | $4,707 | $2,452 | $9,342 | $4,856 | | Total | $5,371 | $3,365 | $10,669 | $6,680 | - Total unrecognized stock-based compensation expense for outstanding employee options was **$53.9 million** as of June 30, 2025, to be recognized over approximately 2.6 years[186](index=186&type=chunk) - The weighted-average grant date fair value per share of option grants increased to **$8.60** for the six months ended June 30, 2025, from **$4.52** in the prior year[193](index=193&type=chunk) [13. Employee Benefit Plans](index=34&type=section&id=13.%20Employee%20Benefit%20Plans) This note describes the company's 401(k) plan and associated matching contribution expenses - The company matches up to **5%** of employee contributions to its 401(k) plan[198](index=198&type=chunk) | Metric (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Matching contribution expenses | $400 | $100 | $800 | $200 | [14. Related-Party Transactions](index=34&type=section&id=14.%20Related-Party%20Transactions) This note discloses transactions with related parties, including consulting and royalty expenses - Consulting expenses of **$0.6 million** (3 months) and **$1.3 million** (6 months) were incurred with an entity owned by the CEO/CMO[199](index=199&type=chunk) - Royalty expense of **$0.9 million** (3 months) and **$1.4 million** (6 months) was incurred payable to OrbiMed, a related party, for nef y sales[202](index=202&type=chunk) [15. Segment Information](index=34&type=section&id=15.%20Segment%20Information) This note clarifies that the company operates as a single segment and provides a breakdown of operating expenses - The company operates and manages its business as a single operating segment[203](index=203&type=chunk) | Segment Operating Expenses (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :-------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Cost of goods sold | $4,984 | $0 | $6,078 | $0 | | Clinical | $1,250 | $1,226 | $2,454 | $4,042 | | Development | $2,151 | $2,591 | $3,252 | $4,099 | | Medical affairs | $1,073 | $421 | $2,018 | $754 | | Sales and marketing | $40,925 | $2,694 | $67,682 | $4,145 | | General and administrative | $7,118 | $5,505 | $15,837 | $9,195 | | Stock-based compensation | $5,371 | $3,365 | $10,669 | $6,680 | | Total segment operating expenses | $63,331 | $15,840 | $108,481 | $29,032 | [16. Subsequent Events](index=35&type=section&id=16.%20Subsequent%20Events) This note reports significant events occurring after the balance sheet date, such as new legislation - The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025, bringing significant changes to federal tax law and regulatory provisions[207](index=207&type=chunk) - The company is evaluating the potential impact of OBBBA on its financial statements, with certain provisions effective in 2025 and others through 2027[207](index=207&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operational results, liquidity, and capital resources [Overview](index=36&type=section&id=Overview) This section provides a high-level summary of nef y's market position, commercialization efforts, and financial performance - nef y is the first and only FDA and European Commission-approved needle-free epinephrine product for Type I allergic reactions, including anaphylaxis[210](index=210&type=chunk) - Commercial launch of nef y 2 mg in the U.S. began in September 2024, and nef y 1 mg in May 2025[216](index=216&type=chunk) - The estimated U.S. addressable market for nef y is approximately **$3 billion** in annual net sales for currently prescribed patients and an additional **$7 billion** for undiagnosed patients[210](index=210&type=chunk) - The company had an **accumulated deficit of $202.1 million** as of June 30, 2025, and incurred net losses from operations of **$47.6 million** for the six months ended June 30, 2025[223](index=223&type=chunk) [ALK Collaboration Agreement](index=39&type=section&id=ALK%20Collaboration%20Agreement) This section details the collaboration agreement with ALK, including licensing terms, upfront payments, and milestone eligibility - ALK Collaboration Agreement grants ALK exclusive worldwide license (excluding specific territories) for intranasal epinephrine products[227](index=227&type=chunk) - ALK made a **$145.0 million upfront payment** in November 2024, and the company earned a **$5.0 million commercial milestone** in June 2025[229](index=229&type=chunk) - The company is eligible for up to **$15.0 million** in additional regulatory milestones and up to **$300.0 million** in sales-based milestones, plus tiered royalties in the mid-to-high teens[229](index=229&type=chunk) [ALK Supply Agreement](index=39&type=section&id=ALK%20Supply%20Agreement) This section outlines the company's obligations to supply ALK's product requirements under a five-year agreement - The ALK Supply Agreement obligates the company to supply ALK's Product requirements for five years at a specified supply price[231](index=231&type=chunk) [ALK Co-Promotion Agreement](index=39&type=section&id=ALK%20Co-Promotion%20Agreement) This section describes the co-promotion agreement with ALK U.S. for nef y in the U.S., including fees and performance terms - ALK U.S. will co-promote nef y to up to **9,000** specified pediatricians and other prescribers in the U.S[232](index=232&type=chunk) - The company will pay ALK U.S. a base fee, with first-year payments deferred to the second year, and performance-based bonuses starting in the second year[235](index=235&type=chunk) - The ALK Co-Promotion Agreement expires on the fourth anniversary of promotion activities, with termination clauses for material breach, insolvency, or failure to meet performance thresholds[236](index=236&type=chunk) [Financial Overview](index=40&type=section&id=Financial%20Overview) This section provides a general overview of the company's financial performance, including revenue and expense trends [Revenues](index=40&type=section&id=Revenues) This section discusses the company's revenue sources, including product sales and collaboration agreements - Limited net product sales recognized since nef y's commercial launch in September 2024[238](index=238&type=chunk) - Future revenues are expected to fluctuate based on nef y's commercial launch, regulatory and commercial milestones from collaboration agreements, and supply agreements[238](index=238&type=chunk) [Cost of Goods Sold](index=40&type=section&id=Cost%20of%20Goods%20Sold) This section explains the components of cost of goods sold and the impact of zero-cost inventory - Cost of goods sold includes product costs, inventory reserve, and royalties[239](index=239&type=chunk) - Initial cost of goods sold is lower due to the use of zero-cost inventory, which is expected to be depleted by mid-2026[239](index=239&type=chunk) [Research and Development Expenses](index=41&type=section&id=Research%20and%20Development%20Expenses) This section details R&D expenses, their primary drivers, and future expectations - R&D expenses are primarily for clinical development, process development, and manufacturing of nef y and other intranasal epinephrine product candidates[242](index=242&type=chunk) - R&D expenses are expected to remain relatively consistent in 2025, but are subject to unpredictability due to clinical development and manufacturing activities[244](index=244&type=chunk) - Key components of R&D expenses include personnel costs, external CRO/CMO fees, manufacturing for clinical trials, regulatory compliance, and indirect expenses[243](index=243&type=chunk)[245](index=245&type=chunk) [Selling, General and Administrative Expenses](index=42&type=section&id=Selling,%20General%20and%20Administrative%20Expenses) This section outlines SG&A expenses and anticipated increases due to commercialization efforts - SG&A expenses include salaries, stock-based compensation, marketing, legal, and professional fees[247](index=247&type=chunk) - SG&A expenses are expected to increase substantially in 2025 due to sales force expansion, marketing campaigns, the ALK Co-Promotion Agreement, and commercialization infrastructure[248](index=248&type=chunk) [Other Income, net](index=43&type=section&id=Other%20Income,%20net) This section describes the sources of other income, primarily from interest and short-term investments - Other income, net, is mainly derived from interest income on cash, cash equivalents, and short-term investments, and net amortization/accretion on short-term investments[250](index=250&type=chunk) [Results of Operations](index=43&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of the company's financial performance over different reporting periods [Comparison of the Three Months Ended June 30, 2025 and 2024](index=43&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares the company's financial results for the three-month periods ended June 30, 2025 and 2024 | Metric (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | Dollar Change | % Change | | :-------------------- | :-------------------------- | :-------------------------- | :------------ | :------- | | Total revenue | $15,717 | $500 | $15,217 | * | | Product revenue, net | $12,800 | $0 | $12,800 | * | | Revenue under collaboration agreements | $2,594 | $500 | $2,094 | * | | Cost of goods sold | $4,984 | $0 | $4,984 | * | | R&D expenses | $4,035 | $6,896 | $(2,861) | (41%) | | SG&A expenses | $54,312 | $8,944 | $45,368 | * | | Net loss | $(44,883) | $(12,516) | $(32,367) | * | - The **$45.4 million increase in SG&A expenses** was primarily due to **$28.2 million** in marketing-related expenses, **$9.0 million** in personnel-related expenses, and **$2.3 million** in stock-based compensation[255](index=255&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=44&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares the company's financial results for the six-month periods ended June 30, 2025 and 2024 | Metric (in thousands) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | Dollar Change | % Change | | :-------------------- | :-------------------------- | :-------------------------- | :------------ | :------- | | Total revenue | $23,690 | $500 | $23,190 | * | | Product revenue, net | $20,563 | $0 | $20,563 | * | | Revenue under collaboration agreements | $2,804 | $500 | $2,304 | * | | Cost of goods sold | $6,078 | $0 | $6,078 | * | | R&D expenses | $6,987 | $12,130 | $(5,143) | (42%) | | SG&A expenses | $95,416 | $16,902 | $78,514 | * | | Net loss | $(78,823) | $(22,808) | $(56,015) | * | - The **$78.5 million increase in SG&A expenses** was primarily due to **$45.7 million** in marketing-related expenses, **$18.0 million** in personnel-related expenses, and **$4.5 million** in stock-based compensation[262](index=262&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its short-term and long-term financial obligations [Sources of Liquidity and Capital](index=45&type=section&id=Sources%20of%20Liquidity%20and%20Capital) This section identifies the primary funding sources and available capital for the company's operations - The company's primary funding sources include merger proceeds, equity offerings, licensing agreements, bank debt, and limited product sales[264](index=264&type=chunk) - As of June 30, 2025, cash, cash equivalents, and short-term investments totaled **$240.1 million**[264](index=264&type=chunk) [Cash flows](index=45&type=section&id=Cash%20flows) This section provides a summary of cash flows from operating, investing, and financing activities | Cash Flow Activity (in thousands) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(80,334) | $(13,989) | | Net cash provided by (used in) investing activities | $77,635 | $(21,159) | | Net cash provided by financing activities | $3,422 | $803 | | Net increase (decrease) in cash and cash equivalents | $723 | $(34,345) | [Operating Activities](index=46&type=section&id=Operating%20Activities) This section details cash flows generated from or used in the company's core business operations - Net cash used in operating activities was **$80.3 million** for the six months ended June 30, 2025, driven by a **$78.8 million net loss** and increases in operating assets (**$14.4 million** in accounts receivable, **$13.2 million** in inventories)[266](index=266&type=chunk) - Non-cash charges included **$10.7 million** in stock-based compensation and **$2.2 million** for inventory reserve[266](index=266&type=chunk) [Investing Activities](index=46&type=section&id=Investing%20Activities) This section describes cash flows related to the purchase and sale of long-term assets and investments - Net cash provided by investing activities was **$77.6 million** for the six months ended June 30, 2025[268](index=268&type=chunk) - This was primarily due to **$143.5 million** in maturities of short-term investments, offset by **$65.7 million** in purchases[268](index=268&type=chunk) [Financing Activities](index=46&type=section&id=Financing%20Activities) This section outlines cash flows from debt, equity, and dividend transactions - Net cash provided by financing activities was **$3.4 million** for the six months ended June 30, 2025[269](index=269&type=chunk) - Funds were primarily from stock option exercises and common stock issuance under the employee stock purchase plan[269](index=269&type=chunk) [Future Funding Requirements](index=46&type=section&id=Future%20Funding%20Requirements) This section discusses anticipated capital needs and potential funding strategies for future operations - Existing cash, cash equivalents, short-term investments, and revenues are expected to fund operations for at least the next three years[270](index=270&type=chunk) - Future funding requirements depend on R&D scope and costs, commercialization activities, regulatory approvals, and intellectual property protection[272](index=272&type=chunk)[275](index=275&type=chunk) - Additional funding may be sought through equity offerings (potentially dilutive), debt financings (with restrictive covenants), or collaborations (relinquishing rights)[272](index=272&type=chunk) [Material Cash Requirements](index=47&type=section&id=Material%20Cash%20Requirements) This section details significant contractual obligations and contingent payments requiring future cash outlays | Obligation Category | Total Amount (as of Jun 30, 2025) | 2025 (remaining) | 2026 | 2027 | 2028 | 2029 | | :------------------ | :-------------------------------- | :--------------- | :--- | :--- | :--- | :--- | | Raw materials supply | $57.6 million | $0.9 million | $10.5 million | $11.8 million | $13.8 million | N/A (then $2.9M/yr through 2035) | | ALK Co-Promotion Agreement | $26.8 million | $0 | $4.4 million | $14.2 million | $4.6 million | $3.6 million | | Corporate sponsorship | $10.0 million | $4.0 million | $5.0 million | $1.0 million | $0 | $0 | | Hosted software license | $2.5 million | $0.6 million | $1.5 million | $0.4 million | $0 | $0 | - Remaining contingent milestone payments to OrbiMed (under Aegis Agreement) are **$11.0 million**, plus indeterminate mid-single-digit royalties on net product sales[277](index=277&type=chunk) - Remaining milestone payments to Recordati are **€5.0 million ($5.9 million)**, plus royalties up to **€5.0 million ($5.9 million)** in aggregate from sales in the Recordati Territory[278](index=278&type=chunk) [Critical Accounting Policies and Estimates](index=48&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section highlights key accounting policies and estimates that require significant management judgment - Key estimates and judgments include revenue, accrued expenses, stock-based compensation, and valuation allowances for deferred tax assets[281](index=281&type=chunk) - No material changes to critical accounting policies or estimates occurred during the six months ended June 30, 2025[282](index=282&type=chunk) [Recent Accounting Pronouncements](index=48&type=section&id=Recent%20Accounting%20Pronouncements) This section refers to disclosures regarding recently adopted and issued accounting standards - Refer to Note 2 for information on recently adopted and issued accounting pronouncements[283](index=283&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=49&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) This section explains the company's status as an EGC and SRC and its implications for reporting requirements - The company is an Emerging Growth Company (EGC) and a Smaller Reporting Company (SRC), utilizing exemptions from certain public company reporting requirements[284](index=284&type=chunk)[287](index=287&type=chunk) - Effective December 31, 2025, the company will be considered a "large accelerated filer" due to its market value exceeding **$700 million**, but can use scaled disclosures until Q1 2026[288](index=288&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not required for the company due to its status as a smaller reporting company - Not required for a "smaller reporting company"[289](index=289&type=chunk) [Item 4. Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) This section evaluates the effectiveness of disclosure controls and reports on changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=49&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section assesses the effectiveness of the company's disclosure controls and procedures - Disclosure controls and procedures were evaluated as effective at the reasonable assurance level as of June 30, 2025[290](index=290&type=chunk) [Changes in Internal Control over Financial Reporting](index=49&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on any material changes to the company's internal control over financial reporting - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[291](index=291&type=chunk) PART II OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and equity sales [Item 1. Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) This section details the company's involvement in various legal proceedings and claims, with further information in Note 9 - The company is involved in various legal proceedings and claims, with details provided in Note 9 – Commitments and Contingencies[294](index=294&type=chunk) [Item 1A. Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors) This section outlines various risks that could materially impact the company's business, financial condition, and operational results [Risks Related to Our Business](index=50&type=section&id=Risks%20Related%20to%20Our%20Business) This section identifies key business risks, including commercialization challenges and market acceptance of nef y - High dependence on successful commercialization of nef y in the U.S. and EU; failure would materially adversely affect business and stock price[296](index=296&type=chunk)[297](index=297&type=chunk) - nef y may fail to achieve market acceptance by physicians, patients, and payors, especially against established injectable products, limiting revenue[305](index=305&type=chunk) - Inability to achieve and maintain adequate third-party payor coverage and reimbursement for nef y on reasonable pricing terms could severely hinder commercial success[307](index=307&type=chunk) - Competitive products, including established epinephrine autoinjectors and other intranasal candidates, may reduce or eliminate nef y's commercial opportunity[313](index=313&type=chunk) [Risks Related to Our Results of Operations and Financial Position](index=68&type=section&id=Risks%20Related%20to%20Our%20Results%20of%20Operations%20and%20Financial%20Position) This section details risks associated with financial performance, including operating losses and funding requirements - Operating results are expected to fluctuate significantly due to the ongoing commercial launch of nef y, making future performance difficult to predict[386](index=386&type=chunk) - The company has incurred significant losses since inception, with an **accumulated deficit of $202.1 million** as of June 30, 2025, and expects continued losses[389](index=389&type=chunk) - Additional funding may be required, and if unavailable on favorable terms, could force delays or reductions in product development or commercialization efforts[391](index=391&type=chunk) - Raising additional capital through equity could dilute stockholders, while debt financing may impose restrictive covenants[397](index=397&type=chunk) [Risks Related to our Legal and Regulatory Environment](index=72&type=section&id=Risks%20Related%20to%20our%20Legal%20and%20Regulatory%20Environment) This section outlines risks stemming from ongoing regulatory review, healthcare laws, and data privacy regulations - nef y is subject to ongoing regulatory review and post-marketing obligations, with potential for restrictions, withdrawal, or penalties for non-compliance[402](index=402&type=chunk)[403](index=403&type=chunk) - Business activities are subject to federal and state healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA), with potential for significant penalties for violations[428](index=428&type=chunk)[430](index=430&type=chunk) - The company is subject to stringent and evolving U.S. and foreign data privacy and security laws (e.g., GDPR, CCPA), with non-compliance risking regulatory actions, fines, litigation, and reputational harm[431](index=431&type=chunk)[436](index=436&type=chunk)[437](index=437&type=chunk)[444](index=444&type=chunk) - Recent and future legislative changes, such as the IRA and potential "Most-Favored-Nation" pricing policies, could increase costs and adversely affect product commercialization and pricing[406](index=406&type=chunk)[411](index=411&type=chunk)[412](index=412&type=chunk) [Risks Related to Our Dependence on Third Parties](index=82&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This section highlights risks associated with reliance on third parties for manufacturing, supply, and commercialization - Complete reliance on third parties for manufacturing and warehousing nef y and product candidates, creating risks of supply shortages, interruptions, and price fluctuations[450](index=450&type=chunk)[452](index=452&type=chunk) - Dependence on third-party manufacturers for cGMP compliance and quality control; failure could impact sales and regulatory approvals[454](index=454&type=chunk) - Dependence on international third-party licensees for ex-U.S. development and commercialization; their failure to perform could adversely affect business and results of operations[456](index=456&type=chunk) - Reliance on third parties to conduct nonclinical studies and clinical trials; their failure to meet deadlines or comply with regulations could delay development programs[460](index=460&type=chunk) [Risks Related to Our Intellectual Property](index=86&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section discusses risks concerning patent protection, potential infringement, and marketing exclusivity - Commercial success depends on obtaining and maintaining patent protection for nef y and product candidates; failure would materially harm the business[465](index=465&type=chunk)[466](index=466&type=chunk) - Patent protection may not be sufficiently broad, or may be lost, adversely affecting the ability to prevent competitors from commercializing similar products[470](index=470&type=chunk) - Litigation for infringing third-party IP rights could be costly, time-consuming, and prevent or delay commercialization[501](index=501&type=chunk) - The company has not received U.S. non-patent marketing exclusivity for nef y, potentially leading to earlier generic competition[515](index=515&type=chunk) - In the EU, EURnef y received **eight years of data protection** and **ten years of marketing protection**[516](index=516&type=chunk) [Risks Related to Employee Matters and Managing Growth](index=98&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Growth) This section addresses risks related to attracting talent, managing organizational growth, and employee misconduct - Success is highly dependent on the ability to attract and retain highly skilled executive officers and employees in a competitive industry[530](index=530&type=chunk)[531](index=531&type=chunk)[532](index=532&type=chunk) - Rapid expansion of the organization and headcount (from **23 to 162 full-time employees** between July 2024 and June 2025) presents difficulties in managing growth[535](index=535&type=chunk) - Misconduct by employees, contractors, or partners (e.g., fraudulent conduct, non-compliance with regulations) could lead to significant liability and reputational harm[534](index=534&type=chunk) [Risks Related to the Securities Markets and Ownership of Our Common Stock](index=100&type=section&id=Risks%20Related%20to%20the%20Securities%20Markets%20and%20Ownership%20of%20Our%20Common%20Stock) This section covers risks related to stock price volatility, corporate governance, and dividend policy - The market price of common stock is subject to significant fluctuations due to various factors, including financial performance, regulatory approvals, competition, and macroeconomic conditions[538](index=538&type=chunk) - Delaware law and provisions in the company's certificate of incorporation and bylaws could make a merger, tender offer, or proxy contest difficult, potentially depressing the stock price[542](index=542&type=chunk)[544](index=544&type=chunk) - The company does not anticipate paying any cash dividends in the foreseeable future, with capital appreciation being the sole source of gain for stockholders[550](index=550&type=chunk) [General Risk Factors](index=103&type=section&id=General%20Risk%20Factors) This section includes broader risks such as geopolitical events impacting global trade and supply chains - Geo-political events (e.g., Russia-Ukraine war, Middle East conflict) could adversely impact global trade, currency exchange rates, inflation, and supply chains, affecting the company's business and stock price[552](index=552&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=103&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item reports no unregistered sales of equity securities or use of proceeds for the period - No unregistered sales of equity securities or use of proceeds to report[557](index=557&type=chunk) [Item 5. Other Information](index=104&type=section&id=Item%205.%20Other%20Information) This section provides other information, including Rule 10b5-1 trading arrangements adopted or modified by directors and officers [Rule 10b5-1 Trading Arrangements](index=104&type=section&id=Rule%2010b5-1%20Trading%20Arrangements) This section details Rule 10b5-1 trading plans adopted or modified by company directors and officers - Several directors and officers adopted or modified Rule 10b5-1 trading plans during Q2 2025[559](index=559&type=chunk) | Name and Position | Action | Adoption/Termination Date | Type of Trading Arrangement | Total Shares of Common Stock to be Sold | Expiration Date | | :---------------- | :----- | :------------------------ | :-------------------------- | :-------------------------------------- | :-------------- | | Richard Lowenthal, CEO (on behalf of trusts) | Adoption | May 21, 2025 | Rule 10b5-1 | 2,100,000 | May 14, 2027 | | Sarina Tanimoto, CMO (on behalf of trusts) | Adoption | May 21, 2025 | Rule 10b5-1 | 2,100,000 | May 14, 2027 | | Laura Shawver, Director | Adoption | May 21, 2025 | Rule 10b5-1 | 128,562 | Dec 31, 2025 | | Kathleen Scott, CFO | Adoption | May 22, 2025 | Rule 10b5-1 | 50,000 | May 22, 2026 | | Alexander Fitzpatrick, CLO | Termination/Adoption | May 29, 2025 | Rule 10b5-1 | 100,000 | Jan 30, 2026 | [Item 6. Exhibits](index=105&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including key agreements and certifications - Key exhibits include the Co-Promotion Agreement with ALK-Abelló Inc., the Third Amendment to the Manufacturing Agreement with Renaissance Lakewood, LLC, and certifications from the Principal Executive and Financial Officers[564](index=564&type=chunk)

[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) ARS Pharmaceuticals reported strong Q2 2025 financial results, driven by neffy U.S. net product revenue and global expansion [Q2 2025 Key Highlights](index=1&type=section&id=Q2%202025%20Key%20Highlights) ARS Pharmaceuticals achieved strong Q2 2025 financial results, driven by $15.7 million total revenue from neffy U.S. sales and successful global expansion Q2 2025 Financial Metrics | Metric | Q2 2025 Value (Millions) | | :----- | :----------------------- | | Total Revenue | $15.7 | | neffy U.S. Net Product Revenue | $12.8 | | EURneffy® Germany Milestone Revenue | $2.6 | | Supply Revenue | $0.3 | - neffy U.S. growth is driven by increased payor access (**93% commercial coverage achieved**), anticipated growth from a national direct-to-consumer (DTC) campaign, and a pediatric co-promote partnership[1](index=1&type=chunk) - Global expansion for neffy includes EURneffy® approval in the United Kingdom and its launch in Germany, marking a significant global footprint[1](index=1&type=chunk) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section details ARS Pharmaceuticals' Q2 2025 financial performance, including revenue breakdown, operating expenses, net loss, and cash position [Revenue Breakdown](index=2&type=section&id=Revenue%20Breakdown) ARS Pharmaceuticals' Q2 2025 total revenue of $15.7 million was primarily driven by neffy U.S. net product sales and EURneffy® milestone revenue Q2 2025 Revenue Breakdown | Revenue Type | Amount (Millions) | | :-------------------------- | :---------------- | | Total Revenue | $15.7 | | neffy U.S. Net Product Revenue | $12.8 | | ALK Milestone Revenue (Germany) | $2.6 | | Supply Revenue | $0.3 | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Q2 2025 operating expenses included $4.0 million in R&D and $54.3 million in SG&A, reflecting significant investment in neffy's commercialization Q2 2025 Operating Expenses | Expense Type | Amount (Millions) | | :-------------------------------- | :---------------- | | Research and Development (R&D) | $4.0 | | Selling, General and Administrative (SG&A) | $54.3 | [Net Loss and Cash Position](index=2&type=section&id=Net%20Loss%20and%20Cash%20Position) ARS Pharma reported a Q2 2025 net loss of $44.9 million, maintaining a strong cash position of $240.1 million to support operations for at least three years Q2 2025 Net Loss | Metric | Value | | :---------- | :---------------- | | Net Loss | $44.9 million | | Net Loss Per Share | $0.46 | Cash Position as of June 30, 2025 | Metric | Amount (Millions) | | :------------------------------------ | :---------------- | | Cash, Cash Equivalents, and Short-term Investments (as of June 30, 2025) | $240.1 | - The company reiterates its guidance that its financial position is expected to support its operating plans for at least the next three years[3](index=3&type=chunk) [neffy Commercial and Clinical Development Updates](index=3&type=section&id=neffy%20Commercial%20Launch%20Progress%20in%20the%20United%20States%20and%20Global%20Expansion) This section details neffy's U.S. commercial launch progress, global expansion, and ongoing clinical development initiatives [U.S. Commercial Launch Progress](index=3&type=section&id=U.S.%20Commercial%20Launch%20Progress) neffy's U.S. commercial launch showed significant momentum with a **180% increase** in prescription volumes, **93% commercial coverage**, and enhanced consumer awareness - neffy two-pack unit weekly volumes increased approximately **180%** from the end of Q1 2025 to the end of Q2 2025[5](index=5&type=chunk) - The national DTC campaign, rolled out in two stages, significantly increased consumer awareness of neffy from a baseline of approximately **20%** pre-campaign to **49%** in late July[5](index=5&type=chunk) - Achieved **93%** commercial coverage, including **57%** without prior authorization, with approval rates across major PBMs consistent with the overall epinephrine market (over **80%** success rate for required PAs under Zinc)[5](index=5&type=chunk) Q2 2025 Commercial Metrics | Metric | Q2 2025 Value (Percentage) | | :-------------------- | :------------------------- | | Gross-to-Net Retention | 52% | - Over **9,700** HCPs have prescribed neffy to date, representing a **73%** increase from April 2025, with about **70%** being among the highest decile prescribing HCPs[5](index=5&type=chunk) - More than **3,200** schools have opted into the neffyinSchools program, receiving free doses for emergency use[5](index=5&type=chunk) [Global Expansion and Clinical Development](index=4&type=section&id=Global%20Expansion%20and%20Clinical%20Development) ARS Pharma is expanding neffy's global footprint with EURneffy® approvals and launches, advancing clinical trials, and anticipating further regulatory approvals by H1 2026 - Initiated a Phase 2b clinical trial in June 2025 to evaluate intranasal epinephrine for acute flares in chronic spontaneous urticaria, with topline data anticipated in H1 2026[8](index=8&type=chunk) - EURneffy® was approved in the U.K. by MHRA in July 2025 for emergency treatment of allergic reactions in adults and children >30 kg, with product availability expected late H2 2025[9](index=9&type=chunk) - EURneffy® 2 mg successfully launched in Germany in June 2025, triggering a **$5.0 million** milestone payment[9](index=9&type=chunk) - EURneffy® 1 mg for children (15 to <30 kg) is under regulatory review by the European Medicines Agency (EMA), with approval anticipated in H1 2026[9](index=9&type=chunk) - Regulatory approvals for neffy are expected by the end of 2025 in Canada, Japan, and Australia (with commercial rollouts in H1 2026), and in H1 2026 in China[9](index=9&type=chunk) [Product and Disease Information](index=5&type=section&id=About%20neffy%20and%20Anaphylaxis) This section provides essential information about neffy, its safety profile, and the critical nature of Type I allergic reactions including anaphylaxis [About neffy](index=5&type=section&id=About%20neffy) neffy is an FDA and European Commission-approved needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions - neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater[12](index=12&type=chunk) - neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater[12](index=12&type=chunk) [Important Safety Information](index=5&type=section&id=Important%20Safety%20Information) Important safety information for neffy highlights its use for life-threatening allergic emergencies, proper administration, and potential interactions or side effects - neffy contains epinephrine, a medicine used to treat life-threatening allergic emergencies (anaphylaxis); always carry two neffy nasal sprays as a second dose may be needed if symptoms continue or return, and seek emergency medical help if symptoms persist or worsen after the first dose[13](index=13&type=chunk)[14](index=14&type=chunk)[15](index=15&type=chunk) - Patients should inform their healthcare provider about underlying nasal conditions, all medications, and medical conditions due to potential serious side effects or interactions[16](index=16&type=chunk)[17](index=17&type=chunk) - Common side effects of neffy include nasal discomfort, headache, throat irritation, chest and nasal congestion, anxiety, nose bleed, and dizziness[18](index=18&type=chunk) [About Type I Allergic Reactions Including Anaphylaxis](index=6&type=section&id=About%20Type%20I%20Allergic%20Reactions%20Including%20Anaphylaxis) Type I allergic reactions, including anaphylaxis, are life-threatening events requiring immediate epinephrine, with current auto-injectors facing limitations that neffy aims to address - Type I allergic reactions are serious, potentially life-threatening events requiring immediate epinephrine treatment, occurring within minutes of allergen exposure[20](index=20&type=chunk) - Limitations of epinephrine auto-injectors, such as fear of needles, lack of portability, and complexity, often lead to delayed or non-administration in emergencies[20](index=20&type=chunk) - Approximately **40 million** people in the U.S. experience Type I allergic reactions, yet only **3.2 million** filled auto-injector prescriptions in 2023, with over half delaying or not administering when needed[20](index=20&type=chunk) [Corporate Information and Disclosures](index=7&type=section&id=Corporate%20Information%20and%20Disclosures) This section provides an overview of ARS Pharmaceuticals, outlines forward-looking statements, and includes contact information [About ARS Pharmaceuticals, Inc.](index=7&type=section&id=About%20ARS%20Pharmaceuticals%2C%20Inc.) ARS Pharmaceuticals is a biopharmaceutical company focused on empowering patients against anaphylaxis by commercializing neffy, an epinephrine nasal spray - ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis[21](index=21&type=chunk) - The Company is commercializing neffy® (trade name EURneffy® in the EU), an epinephrine nasal spray indicated for emergency treatment of Type I allergic reactions, including anaphylaxis[21](index=21&type=chunk) [Forward Looking Statements](index=7&type=section&id=Forward%20Looking%20Statements) This section contains forward-looking statements about ARS Pharma's future expectations, subject to risks and uncertainties that could materially alter actual results - Statements in this press release that are not purely historical are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, based on current expectations and assumptions[22](index=22&type=chunk) - Actual results could differ materially due to various risks and uncertainties, including potential safety complications, regulatory approval, commercialization scope, clinical trial results, market acceptance, and intellectual property protection[23](index=23&type=chunk) [Contact Information](index=9&type=section&id=Contact%20Information) This section provides contact information for ARS Pharmaceuticals' investor relations and media inquiries - Investor Contact: Justin Chakma, ARS Pharma, justinc@ars-pharma.com[25](index=25&type=chunk) - Media Contact: Christy Curran, Sam Brown Inc., christycurran@sambrown.com, 615.414.8668[25](index=25&type=chunk) [Condensed Consolidated Financial Statements](index=10&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents ARS Pharmaceuticals' condensed consolidated balance sheets and statements of operations and comprehensive loss [Condensed Consolidated Balance Sheets](index=10&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets detail ARS Pharmaceuticals' financial position as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (Amounts in Thousands) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :-------------- | :---------------- | | **Assets** | | | | Cash and cash equivalents | $51,540 | $50,817 | | Short-term investments | $188,590 | $263,205 | | Accounts receivable, net | $25,126 | $8,175 | | Total current assets | $281,436 | $334,295 | | Total assets | $313,472 | $351,153 | | **Liabilities & Stockholders' Equity** | | | | Accounts payable and accrued liabilities | $44,264 | $22,841 | | Total current liabilities | $45,599 | $23,440 | | Financing liability | $71,959 | $69,383 | | Total liabilities | $121,151 | $94,355 | | Total stockholders' equity | $192,321 | $256,798 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The condensed consolidated statements summarize revenues, operating expenses, and net loss for the three and six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss (Amounts in Thousands, Except Per Share Data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | **Revenue:** | | | | | | Product revenue, net | $12,800 | $0 | $20,563 | $0 | | Revenue under collaboration agreements | $2,594 | $500 | $2,804 | $500 | | Revenue under supply agreements | $323 | $0 | $323 | $0 | | Total revenue | $15,717 | $500 | $23,690 | $500 | | **Operating Expenses:** | | | | | | Cost of goods sold | $4,984 | $0 | $6,078 | $0 | | Research and development | $4,035 | $6,896 | $6,987 | $12,130 | | Selling, general and administrative | $54,312 | $8,944 | $95,416 | $16,902 | | Total operating expenses | $63,331 | $15,840 | $108,481 | $29,032 | | Loss from operations | $(47,614) | $(15,340) | $(84,791) | $(28,532) | | Other income, net | $2,731 | $2,824 | $5,968 | $5,724 | | Net loss | $(44,883) | $(12,516) | $(78,823) | $(22,808) | | Net loss per share, basic and diluted | $(0.46) | $(0.13) | $(0.80) | $(0.24) |

Core Insights - ARS Pharmaceuticals reported $15.7 million in total revenue for Q2 2025, with $12.8 million coming from neffy U.S. net product revenue, indicating strong growth driven by increased payor access and a national DTC campaign [1][5][6] - The company achieved 93% commercial coverage for neffy, with a streamlined prior authorization process leading to high approval rates, positioning neffy as a preferred option for allergic reactions [1][6][8] - neffy has expanded its global footprint with EURneffy approved in the U.K. and launched in Germany, marking significant milestones in the company's international strategy [1][9][10] Financial Performance - Total revenue for Q2 2025 was $15.7 million, including $12.8 million from neffy sales, $2.6 million in milestone revenue from ALK-Abelló A/S, and $0.3 million in supply revenue [5][32] - R&D expenses were $4.0 million, primarily for clinical trials and development expenses related to neffy [5][32] - SG&A expenses reached $54.3 million, reflecting significant investment in marketing and commercialization efforts for neffy [5][32] - The net loss for Q2 2025 was $44.9 million, or $0.46 per share, with cash reserves of $240.1 million as of June 30, 2025, supporting operations for at least the next three years [5][32] Commercial Launch and Growth - neffy prescription growth increased approximately 180% from Q1 to Q2 2025, driven by effective sales execution and marketing strategies [4][6] - The DTC campaign significantly raised consumer awareness of neffy from 20% to 49% by late July 2025, with expectations for continued momentum [8] - Over 9,700 healthcare providers have prescribed neffy, a 73% increase since April 2025, indicating strong adoption among high-prescribing HCPs [6][8] Global Expansion - EURneffy was approved in the U.K. in July 2025 and launched in Germany in June 2025, with further regulatory approvals anticipated in Canada, Japan, Australia, and China by 2026 [9][10][11] - The company is also pursuing a Phase 2b clinical trial for neffy in treating chronic spontaneous urticaria, expanding its product's indications [11]

Media Contact: Christy Curran, Sam Brown Inc. christycurran@sambrown.com 615.414.8668 SAN DIEGO, Aug. 04, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, today announced the company will host a conference call and webcast on Wednesday, August 13, 2025, at 5:30 a.m. PT / 8:30 a.m. ET to discuss its second quarter 2025 f ...

Wall Street expects a year-over-year decline in earnings on higher revenues when ARS Pharmaceuticals, Inc. (SPRY) reports results for the quarter ended June 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the ...