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ARSA
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2026-08-14
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Earnings documents stored for SPRY.

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Investor releaseQuarter not tagged2026-08-14

ARS Pharmaceuticals, Inc. Q2 2026 Earnings Call Summary

Moby
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Transitioning from broad consumer awareness to a targeted provider-centric model to more efficiently address the 'prevention-based' nature of the epinephrine market. Performance data indicates field sales engagement is the primary driver of adoption, with 8% market share in targeted territories versus 1% in non-targeted areas. Management attributes the need for a strategic pivot to the high cost and lower conversion rates of broad digital and linear TV advertising in a market driven by status quo prescribing habits. The company is implementing a rigorous cost optimization framework, targeting a 40% reduction in cash-based SG&A expenses for the second half of 2026. Strategic positioning focuses on neffy as the solution to the 'clinical gap' caused by patient hesitation or fear regarding traditional needle-based injectors. New commercial leadership under Meg Smith is tasked with applying operational rigor and a disciplined investment playbook to change long-established prescriber behaviors. Projecting a path to cash flow breakeven by the end of 2027, underpinned by sustained SG&A reductions and steady market share gains. Guidance for H2 2026 total cash-based SG&A and R&D expenses is set at $100 million-$110 million, with these spending levels expected to persist through 2027. The Phase II-B interim readout for chronic spontaneous urticaria (CSU) is now expected in Q1 2027, delayed from late 2026 due to the real-world time required for patients to log three flare episodes. Future growth strategy assumes steady, incremental market share gains through repeated clinical interactions rather than overnight spikes from promotional events. Management expects gross margins to improve into 2027 as manufacturing scales and inefficiencies related to ex-U.S. launches and short-dated product reserves stabilize. Q2 2026 results included $12.8 million in cost of goods sold, impacted by manufacturing inefficiencies and reserves for short-dated product. Completed a full expansion of the field sales organization to cover 44% of the total market opportunity, focusing on high-value prescribers. Entered a new licensing agreement in July 2026 for worldwide IP rights to support potential future line extensions for the intranasal fran…Read full document

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Transitioning from broad consumer awareness to a targeted provider-centric model to more efficiently address the 'prevention-based' nature of the epinephrine market. Performance data indicates field sales engagement is the primary driver of adoption, with 8% market share in targeted territories versus 1% in non-targeted areas. Management attributes the need for a strategic pivot to the high cost and lower conversion rates of broad digital and linear TV advertising in a market driven by status quo prescribing habits. The company is implementing a rigorous cost optimization framework, targeting a 40% reduction in cash-based SG&A expenses for the second half of 2026. Strategic positioning focuses on neffy as the solution to the 'clinical gap' caused by patient hesitation or fear regarding traditional needle-based injectors. New commercial leadership under Meg Smith is tasked with applying operational rigor and a disciplined investment playbook to change long-established prescriber behaviors. Projecting a path to cash flow breakeven by the end of 2027, underpinned by sustained SG&A reductions and steady market share gains. Guidance for H2 2026 total cash-based SG&A and R&D expenses is set at $100 million-$110 million, with these spending levels expected to persist through 2027. The Phase II-B interim readout for chronic spontaneous urticaria (CSU) is now expected in Q1 2027, delayed from late 2026 due to the real-world time required for patients to log three flare episodes. Future growth strategy assumes steady, incremental market share gains through repeated clinical interactions rather than overnight spikes from promotional events. Management expects gross margins to improve into 2027 as manufacturing scales and inefficiencies related to ex-U.S. launches and short-dated product reserves stabilize. Q2 2026 results included $12.8 million in cost of goods sold, impacted by manufacturing inefficiencies and reserves for short-dated product. Completed a full expansion of the field sales organization to cover 44% of the total market opportunity, focusing on high-value prescribers. Entered a new licensing agreement in July 2026 for worldwide IP rights to support potential future line extensions for the intranasal franchise. Acknowledged that while commercial coverage is at 90%, the primary hurdle remains converting that access into prescriptions through provider conviction. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management is comfortable with a gross-to-net range approaching 50%, despite quarterly fluctuations based on segment mix. Gross margins (62% in Q2) were pressured by short-dated product reserves and ex-U.S. launch costs, but are expected to rise as production scales in 2027. ARS is moving away from high-cost linear and closed-circuit TV in favor of more efficient social media and search channels. The new digital strategy will target both consumers and providers more precisely to reduce SG&A overhead. The core challenge is overcoming decades of default behavior where providers prescribe needle-based injectors without considering the consequences of patient inaction. Success depends on high-frequency field engagement with the 'total office,' including nurses and medical assistants, to drive the value proposition of needle-free delivery.

Investor releaseQuarter not tagged2026-08-14

ARS Pharmaceuticals Inc (SPRY) (Q2 2026) Earnings Call Highlights: Market Share Doubles to 5% ...

GuruFocus.com
This article first appeared on GuruFocus. Total Revenue: $33.7 million in Q2 2026, reflecting a combination of net product, collaboration, and supply revenue. US Net Product Revenue: $26.2 million for the second quarter. Total Operating Expenses: $95.1 million in Q2 2026, including $12.8 million in cost of goods sold. SG&A Expense: Approximately $77.6 million for the second quarter. Cash and Investments: $143.8 million in cash equivalents and short-term investments at the end of Q2 2026. Market Share: Total US market share reached 5%, doubling from 2.5% in the same period last year; within the field-targeted universe, market share increased to 8%, up from 4% in the prior year quarter. Prescribers: Over 16,000 unique NEPHI prescribers in Q2 2026, a more than three-fold increase from the same period last year. Expense Guidance: Aggregate SG&A and R&D expenses for the second half of 2026 are expected to be in the range of $114 million to $126 million, including stock-based compensation of about $14 million to $60 million; cash-based SG&A and R&D expenses are expected to be in the range of $100 million to $110 million. Warning! GuruFocus has detected 5 Warning Signs with SPRY. Is SPRY fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Total US market share for NEPI doubled year-over-year to 5%, with field-targeted share reaching 8%. Over 16,000 unique NEPI prescribers in Q2, a three-fold increase from the prior year. Strategic shift to targeted provider engagement and reduced DTC spend is expected to cut cash-based SG&A by over 40% in H2 2026. Path to cash flow breakeven by end of 2027, supported by disciplined expense management and revenue growth. CSU program offers a significant pipeline expansion opportunity with no FDA-approved on-demand treatments for acute flares. Q2 net product revenue of $26.2 million reflects a slow adoption rate in a prevention-based market. Gross margin was lower than projected at 62% due to reserves for short-dated product and manufacturing inefficiencies. CSU phase 2b interim data readout delayed to Q1 2027, pushing back potential pipeline milestones. High SG&A spend of $77.6 million in Q2 highlights inefficiencies from the prior broad DTC strategy. Market share outside targeted field account…Read full document

This article first appeared on GuruFocus. Total Revenue: $33.7 million in Q2 2026, reflecting a combination of net product, collaboration, and supply revenue. US Net Product Revenue: $26.2 million for the second quarter. Total Operating Expenses: $95.1 million in Q2 2026, including $12.8 million in cost of goods sold. SG&A Expense: Approximately $77.6 million for the second quarter. Cash and Investments: $143.8 million in cash equivalents and short-term investments at the end of Q2 2026. Market Share: Total US market share reached 5%, doubling from 2.5% in the same period last year; within the field-targeted universe, market share increased to 8%, up from 4% in the prior year quarter. Prescribers: Over 16,000 unique NEPHI prescribers in Q2 2026, a more than three-fold increase from the same period last year. Expense Guidance: Aggregate SG&A and R&D expenses for the second half of 2026 are expected to be in the range of $114 million to $126 million, including stock-based compensation of about $14 million to $60 million; cash-based SG&A and R&D expenses are expected to be in the range of $100 million to $110 million. Warning! GuruFocus has detected 5 Warning Signs with SPRY. Is SPRY fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Total US market share for NEPI doubled year-over-year to 5%, with field-targeted share reaching 8%. Over 16,000 unique NEPI prescribers in Q2, a three-fold increase from the prior year. Strategic shift to targeted provider engagement and reduced DTC spend is expected to cut cash-based SG&A by over 40% in H2 2026. Path to cash flow breakeven by end of 2027, supported by disciplined expense management and revenue growth. CSU program offers a significant pipeline expansion opportunity with no FDA-approved on-demand treatments for acute flares. Q2 net product revenue of $26.2 million reflects a slow adoption rate in a prevention-based market. Gross margin was lower than projected at 62% due to reserves for short-dated product and manufacturing inefficiencies. CSU phase 2b interim data readout delayed to Q1 2027, pushing back potential pipeline milestones. High SG&A spend of $77.6 million in Q2 highlights inefficiencies from the prior broad DTC strategy. Market share outside targeted field accounts remains low at approximately 1%, indicating limited reach. Q: Can you discuss the gross-to-net in the quarter, how it's evolving, and the factors driving the product margins and cost of goods, which ticked up this quarter? What is the outlook going forward?A: Donn Casale (CEO) stated that gross-to-net will ebb and flow based on segment mix but remains comfortable in the range of 50% or approaching it. Kathleen Scott (CFO) added that gross margin was about 62% in Q2 and over 64% year-to-date, which was lower than projected due to reserves for short-dated product, manufacturing inefficiencies from scaling production, and costs for ex-US product launches. They expect gross margin to improve over time, particularly into 2027, as manufacturing streamlines and grows. Q: What is the path to cash flow breakeven into 2027, and what assumptions are baked into that goal? Are you considering the back-to-school tailwind for NEFI next year?A: Donn Casale (CEO) confirmed confidence in the cash flow breakeven statement, driven largely by a more efficient spend. SG&A was reduced by over 40% from the first half to the second half of 2026, a trend expected to continue through 2027. This, combined with continued revenue and market share gains quarter-over-quarter, underpins the path to profitability. Regarding back-to-school, the strategy remains the sameengaging providersbut Q3 offers more volume, so they anticipate more prescriptions in that quarter. Q: How are you thinking about the progression of payer access, and how critical is getting on Taremark's formulary in the next cycle? What will the new DTC strategy look like in terms of channel, media, and spend?A: Donn Casale (CEO) explained that access is a key first step, with 90% commercial coverage and 57% without prior authorization, but the focus is shifting to provider conviction. The strategy has moved from activating the consumer to activating the provider, which is more efficient. For DTC, the company is shifting away from broad-based linear and closed-circuit TV to more efficient channels like social media and search, which are also used for provider targeting, enabling significant SG&A savings. Q: You seem to be focusing on meaningfully changing provider prescribing habits. Can you elaborate on what particular habits you want to break and what education or detailing the new field force will focus on?A: Donn Casale (CEO) stated the goal is to break the entrenched, decades-long habit of using auto-injectors. In prevention-based markets, providers default to the status quo, so the field team's job is to get them to stop and think about the consequences of inaction. Once they appreciate the problem, the solution (NEFI) becomes obvious. This requires high-frequency, high-quality interactions with physicians, nurses, and MAs, leading to a methodical increase in revenue and share quarter-over-quarter. Q: Beyond scripts and revenue, what other metrics of prescriber engagement can you look at to evaluate the current strategy's progress?A: Donn Casale (CEO) noted that while scripts and market share are the best indicators and will be reported quarterly, the company will also monitor activity and frequency of calls on the total office (physician, nurse, MA). They will track which activities drive different behaviors and outcomes. The key blueprint is that where the field team is deployed, market share is 8% versus 1% in non-targeted areas, providing confidence in the execution-focused strategy. Q: Can you discuss the gross-to-net and gross margin in more detail, and what drove the increase in cost of goods this quarter?A: Kathleen Scott (CFO) clarified that the lower gross margin of 62% in Q2 was due to establishing reserves for short-dated product, manufacturing inefficiencies as they scale production, and costs associated with ex-US product launches. She reiterated that gross margin is expected to improve as they streamline and grow manufacturing, especially heading into 2027. Q: What is the company's strategy to increase the 8% market share in field-targeted accounts substantially higher?A: Donn Casale (CEO) highlighted that the expansion of the sales team is complete and fully deployed, which will support market share growth into Q3. The strategy involves evolving the messaging campaign to engage not only physicians but also nurses and MAs, emphasizing the consequences of inaction. The core approach is "blocking and tackling execution," provider by provider, in entrenched markets, which underpins confidence in NEFI profitability. Q: Can you provide more color on the license agreement entered into in July for worldwide rights to certain IP? Is it a potential pipeline expansion opportunity?A: Donn Casale (CEO) described it as an opportunity to think about a line extension for the franchise and provide options for the pipeline. He noted it is too early to comment on specifics, but it represents a potential opportunity for the intranasal epinephrine platform. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-14

ARS Pharmaceuticals Q2 Earnings Call Highlights

MarketBeat
Interested in ARS Pharmaceuticals, Inc.? Here are five stocks we like better. Neffy gained traction: ARS reported $26.2 million in second-quarter U.S. net product revenue, while total revenue reached $33.7 million. U.S. market share increased to 5% from 2.5% a year earlier, with more than 16,000 unique prescribers. Commercial and financial strategy reset: The company is shifting away from broad consumer advertising toward targeted healthcare-provider promotion and plans to cut second-half 2026 cash-based SG&A and R&D expenses by more than 40%. ARS expects to reach cash-flow breakeven by the end of 2027. CSU program timeline moved: The interim readout from neffy’s Phase IIb chronic spontaneous urticaria trial is now expected in the first quarter of 2027, later than previously anticipated, as patients complete the required flare episodes. ARS Pharmaceuticals (NASDAQ:SPRY) outlined a revised commercial and spending strategy during its second-quarter 2026 earnings call, with new President and CEO Donn Casale emphasizing provider-focused promotion for its neffy intranasal epinephrine product, lower operating expenses and an expected path to cash-flow breakeven by the end of 2027. Casale, hosting his first earnings call as CEO, said the company has established three priorities: targeted healthcare-provider commercial execution, financial discipline and pipeline expansion beginning with chronic spontaneous urticaria, or CSU. → Lumentum Just Delivered the AI Growth Investors Wanted ARS reported second-quarter U.S. net product revenue of $26.2 million. Total revenue, including net product, collaboration and supply revenue, was $33.7 million. Neffy’s total U.S. market share reached 5% during the quarter, compared with 2.5% a year earlier, according to Casale. In the company’s field-sales targeted universe, market share rose to 8% from 4% in the prior-year period. ARS also reported more than 16,000 unique neffy prescribers during the quarter, more than triple the prior-year level. → Joby’s Defense Pivot Accelerates With $500M Resonant Sciences Deal Casale said neffy is sold into what he described as a prevention-based market, because patients are prescribed the rescue therapy and carry it before an allergic event occurs. As a result, he said provider behavior is particularly important to adoption. “Closing the gap relies less on broad consumer awareness and far more on…Read full document

Interested in ARS Pharmaceuticals, Inc.? Here are five stocks we like better. Neffy gained traction: ARS reported $26.2 million in second-quarter U.S. net product revenue, while total revenue reached $33.7 million. U.S. market share increased to 5% from 2.5% a year earlier, with more than 16,000 unique prescribers. Commercial and financial strategy reset: The company is shifting away from broad consumer advertising toward targeted healthcare-provider promotion and plans to cut second-half 2026 cash-based SG&A and R&D expenses by more than 40%. ARS expects to reach cash-flow breakeven by the end of 2027. CSU program timeline moved: The interim readout from neffy’s Phase IIb chronic spontaneous urticaria trial is now expected in the first quarter of 2027, later than previously anticipated, as patients complete the required flare episodes. ARS Pharmaceuticals (NASDAQ:SPRY) outlined a revised commercial and spending strategy during its second-quarter 2026 earnings call, with new President and CEO Donn Casale emphasizing provider-focused promotion for its neffy intranasal epinephrine product, lower operating expenses and an expected path to cash-flow breakeven by the end of 2027. Casale, hosting his first earnings call as CEO, said the company has established three priorities: targeted healthcare-provider commercial execution, financial discipline and pipeline expansion beginning with chronic spontaneous urticaria, or CSU. → Lumentum Just Delivered the AI Growth Investors Wanted ARS reported second-quarter U.S. net product revenue of $26.2 million. Total revenue, including net product, collaboration and supply revenue, was $33.7 million. Neffy’s total U.S. market share reached 5% during the quarter, compared with 2.5% a year earlier, according to Casale. In the company’s field-sales targeted universe, market share rose to 8% from 4% in the prior-year period. ARS also reported more than 16,000 unique neffy prescribers during the quarter, more than triple the prior-year level. → Joby’s Defense Pivot Accelerates With $500M Resonant Sciences Deal Casale said neffy is sold into what he described as a prevention-based market, because patients are prescribed the rescue therapy and carry it before an allergic event occurs. As a result, he said provider behavior is particularly important to adoption. “Closing the gap relies less on broad consumer awareness and far more on changing long-established provider prescribing habits,” Casale said. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be The company has completed an expansion of its field sales organization and intends to focus the team on high-value prescribers representing 44% of the total market opportunity. Casale said neffy holds approximately 8% market share in the field-targeted universe, compared with about 1% in the non-targeted universe. ARS plans to begin reporting both total market share and share within its field-targeted call universe each quarter. Casale said the company expects steady share gains over successive quarters rather than an immediate increase. Casale said ARS invested heavily at launch in broad direct-to-consumer advertising, including linear and closed-circuit television. While those efforts built awareness, he said such advertising can be expensive and may not consistently convert into utilization in a prevention-oriented market. Going forward, ARS plans to emphasize provider engagement and use more targeted consumer and provider channels, including social media and search. The company said it will continue to pursue expanded commercial and Medicaid coverage, while focusing on provider conviction after formulary access is secured. ARS said commercial coverage currently stands at 90%, with 57% of covered lives not requiring prior authorization. Casale said the company’s strategy is now centered on helping providers recognize the clinical gap that neffy is intended to address rather than primarily activating consumers. The company also named Meg Smith as chief commercial officer. Casale said Smith brings more than 25 years of executive commercial experience and will lead the next stage of the neffy launch. Total operating expenses were $95.1 million in the second quarter, including $12.8 million in cost of goods sold. Selling, general and administrative expense was approximately $77.6 million, reflecting the company’s previous broad consumer-awareness strategy. ARS said it has adjusted aggregate SG&A and research and development expense expectations for the second half of 2026 to a range of $114 million to $126 million, including approximately $14 million to $16 million of stock-based compensation. Cash-based SG&A and R&D expenses are expected to be between $100 million and $110 million in the second half, representing more than a 40% reduction in cash-based SG&A expense from the first half of the year. Casale said the company expects the spending trend to continue through 2027. ARS ended the second quarter with $143.8 million in cash equivalents and short-term investments and said its revised expense base, combined with expected revenue and market-share growth, supports a goal of reaching cash-flow breakeven by the end of 2027. Chief Financial Officer Kathy Scott said gross margin was about 62% in the second quarter and slightly above 64% year to date. She attributed the level to reserves for short-dated product, manufacturing inefficiencies as production scales and costs associated with ex-U.S. product launches. Scott said the company expects gross margin to improve over time, particularly as it streamlines and expands manufacturing in 2027. ARS is also advancing neffy’s intranasal epinephrine platform in CSU, a condition for which Casale said there are no FDA-approved on-demand products to manage acute flares. The company views the program as a potential additional growth opportunity that could use existing commercial infrastructure and overlap with targeted prescribers for neffy. The interim data readout for the company’s Phase IIb CSU trial is now expected in the first quarter of 2027, rather than by the end of 2026. Casale said enrollment in the interim patient population has been completed, but the study design requires patients to experience and document three separate flare episodes and treat them with placebo and varying doses of intranasal epinephrine. Casale said the revised timing reflects the time needed for patients to complete those episodes and does not alter the company’s view of the program’s potential. ARS also disclosed that it entered a license agreement in July for worldwide rights to certain intellectual property, which Casale described as an early-stage opportunity to consider a franchise line extension. ARS Pharmaceuticals, Inc, a biopharmaceutical company, develops treatments for severe allergic reactions. The company is developing neffy, a needle-free and low-dose intranasal epinephrine nasal spray for the emergency treatment of Type I allergic reactions, including anaphylaxis. It serves healthcare professionals, patients, and caregivers. ARS Pharmaceuticals, Inc was founded in 2015 and is headquartered in San Diego, California. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "ARS Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-13

ARS Pharmaceuticals Outlines Strategic Priorities, including a Focused Commercial Strategy, and Reports Second Quarter 2026 Financial Results

GlobeNewswire
$26.2 million in U.S. neffy® net product revenue in Q2 2026; total U.S. epinephrine market share for Type 1 allergies of 5% and 8% share within field-targeted accounts Commercial investment realigned toward targeted provider engagement, significantly reducing total operating expenses for 2H 2026 and supporting an expected path to cash flow breakeven by the end of 2027 Commercial operations strengthened with appointment of Meg Smith as Chief Commercial Officer and completed expansion of field sales organization Interim data from Phase 2b trial in chronic spontaneous urticaria (CSU) expected in Q1 2027; no FDA-approved on-demand treatment currently exists for acute CSU flares Conference call to be held today, August 13, 2026, at 1:30 p.m. PT / 4:30 p.m. ET SAN DIEGO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect against allergic reactions that could lead to anaphylaxis, today outlined the strategic priorities and operating framework that will guide the Company going forward, its refined commercial strategy for neffy® (epinephrine nasal spray), and its financial results for the second quarter ended June 30, 2026. “It is a privilege to lead ARS Pharma at this pivotal time, and my conviction in the opportunity ahead has only grown since stepping into this role. As the first and only needle-free epinephrine option, neffy is well positioned to become the standard of care for patients and caregivers in this multi-billion-dollar market,” said Donn Casale, President and CEO of ARS Pharma. “Today, we are announcing a shift in focus to provider adoption, with a more efficient commercial strategy intended to drive market share growth without sacrificing revenue. We believe that provider awareness and recommendation will be the cornerstone to growing the neffy brand. Our confidence in continued revenue growth, along with a more efficient commercial model, is expected to provide the foundation for long-term value creation. Beyond neffy, advancing our intranasal epinephrine platform into CSU unlocks a potential major growth opportunity in an area of high unmet need built on top of our existing commercial infrastructure.” Updated Strategic Priorities Following a comprehensive assessment of ARS Pharma’s commercial, clinical, and business op…Read full document

$26.2 million in U.S. neffy® net product revenue in Q2 2026; total U.S. epinephrine market share for Type 1 allergies of 5% and 8% share within field-targeted accounts Commercial investment realigned toward targeted provider engagement, significantly reducing total operating expenses for 2H 2026 and supporting an expected path to cash flow breakeven by the end of 2027 Commercial operations strengthened with appointment of Meg Smith as Chief Commercial Officer and completed expansion of field sales organization Interim data from Phase 2b trial in chronic spontaneous urticaria (CSU) expected in Q1 2027; no FDA-approved on-demand treatment currently exists for acute CSU flares Conference call to be held today, August 13, 2026, at 1:30 p.m. PT / 4:30 p.m. ET SAN DIEGO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect against allergic reactions that could lead to anaphylaxis, today outlined the strategic priorities and operating framework that will guide the Company going forward, its refined commercial strategy for neffy® (epinephrine nasal spray), and its financial results for the second quarter ended June 30, 2026. “It is a privilege to lead ARS Pharma at this pivotal time, and my conviction in the opportunity ahead has only grown since stepping into this role. As the first and only needle-free epinephrine option, neffy is well positioned to become the standard of care for patients and caregivers in this multi-billion-dollar market,” said Donn Casale, President and CEO of ARS Pharma. “Today, we are announcing a shift in focus to provider adoption, with a more efficient commercial strategy intended to drive market share growth without sacrificing revenue. We believe that provider awareness and recommendation will be the cornerstone to growing the neffy brand. Our confidence in continued revenue growth, along with a more efficient commercial model, is expected to provide the foundation for long-term value creation. Beyond neffy, advancing our intranasal epinephrine platform into CSU unlocks a potential major growth opportunity in an area of high unmet need built on top of our existing commercial infrastructure.” Updated Strategic Priorities Following a comprehensive assessment of ARS Pharma’s commercial, clinical, and business operations, the Company has established a core set of strategic priorities intended to drive continued value creation from neffy and the intranasal epinephrine platform: Targeted commercial execution. ARS Pharma is shifting its focus from broad consumer-directed marketing to targeted engagement with high-volume prescribers, a strategy that has already demonstrated to grow field-targeted market share. Financial discipline aligned with neffy adoption rate. ARS Pharma has implemented a rigorous cost optimization framework, significantly reducing its SG&A expense, that focuses on building a profitable neffy franchise to drive shareholder value and provide financial support for platform expansion. Advance CSU clinical program. ARS Pharma is extending its intranasal epinephrine platform into CSU. With no FDA-approved, on-demand options currently available to manage acute flares, the Company’s intranasal epinephrine platform may address a critical unmet need in CSU and offer a compelling market expansion opportunity. Commercial Leadership and a Fully Deployed Field Organization ARS Pharma today announced the appointment of Meg Smith as Chief Commercial Officer, effective August 17, 2026. Ms. Smith is a commercial executive with more than 25 years of progressive leadership experience. Most recently, she led the commercial organization at Dynavax Technologies that successfully launched HEPLISAV-B®. “neffy is well positioned to become the new standard of care in a large, underserved market,” said Ms. Smith. “There is a solid foundation in place, growing prescriber momentum, and a talented field organization. I am excited to join the commercial leadership team at ARS where we will be relentlessly focused on provider-centered execution to convert that foundation into durable market share growth.” ARS Pharma also announced that the expansion of its field sales organization is now complete. Sales force efforts will focus primarily on the highest-value prescribers, which represent 44% of the total U.S. market opportunity. Mr. Casale added, “Executing our enhanced commercial strategy requires having the right leadership and footprint, and I am incredibly pleased to welcome Meg to the team. I am confident that she has the right capabilities and experience to drive this next chapter of the neffy launch, having seen her ability to inspire teams and drive operational rigor firsthand. The impact of our sales force is clear, and where we actively call on accounts, our share is meaningfully larger than our total market share. I am excited to see the compounding impact of a fully deployed, focused sales team under Meg’s leadership.” neffy U.S. commercial metrics as of the end of the second quarter of 2026 include: U.S. net product revenue of $26.2 million, bringing 2026 year-to-date net product revenue to $43.7 million; Total U.S. epinephrine market share of 5%, a doubling of the 2.5% total market share in the same period in 2025; Market share of 8% among field-targeted accounts compared with 4% share in the same period of 2025; and Over 16,000 unique prescribers in the second quarter, a nearly threefold increase over the same period in 2025. Enhanced Financial Discipline and Updated 2H 2026 Expense Guidance ARS Pharma announced the re-alignment of its operating expenses to support building a durable, profitable business. Going forward, the Company intends to direct its investments primarily to support healthcare provider education and field execution, with a particular focus on high-value prescribers. Consequently, the Company has significantly reduced spending, shifting resources away from broad consumer advertising and toward targeted provider engagement, without sacrificing revenue. The Company’s second quarter 2026 financial results are as follows: Total revenue: $33.7 million, comprised of $26.2 million in net product revenue from neffy sales in the United States, $0.1 million in collaboration revenue from international partners, and $7.4 million in supply revenue from partners. Total operating expenses, excluding cost of goods sold: $82.3 million. Net loss: $62.3 million, or ($0.63) per share basic and diluted. Cash balance: $143.8 million in cash, cash equivalents, and short-term investments as of June 30, 2026. ARS Pharma outlined the following guidance on its operating expense plan: Operating expense: ARS Pharma expects its aggregate SG&A and R&D expenses for the second half of 2026 to be in the range of $114 million to $126 million, which includes stock-based compensation expense of approximately $14 million to $16 million. As a result, total cash-based SG&A and R&D expenses for the second half of 2026 are expected to be in the range of $100 million to $110 million, driven by a more than 40% reduction in SG&A cash-based expenses from the first half of 2026, with a favorable trend planned to continue through full-year 2027. Path to cash flow breakeven: Based on its revised cash-based expense plan, ARS Pharma anticipates a path to reaching cash flow breakeven by the end of 2027. Expanding the Intranasal Epinephrine Platform, with Interim CSU Phase 2b Data in Q1 2027 Beyond neffy, ARS Pharma’s CSU program, ARS-2, represents a meaningful expansion opportunity built on its existing commercial infrastructure. The Company’s Phase 2b trial is underway, assessing rapid relief of acute flares with intranasal epinephrine compared to placebo, and enrollment is completed in the interim patient population. The trial design requires that each enrolled patient experience and log three separate CSU flare episodes, treated with placebo and varying doses of intranasal epinephrine. Given the time required for patients to complete all three episodes for data collection and reporting, ARS Pharma expects interim Phase 2b data in the first quarter of 2027. There are currently no FDA-approved, on-demand products to manage acute flares in patients with CSU. Epinephrine’s role in rapid, systemic symptom relief is well established; the historical challenge has been the needle delivery and the dose, which the Company’s intranasal technology is designed to address. Because the program can leverage our existing commercial infrastructure and overlapping targeted prescribers, the Company believes ARS-2 represents a high-margin growth driver, if approved. Conference Call Information ARS Pharma will host a conference call and webcast today, August 13, 2026, at 4:30 p.m. ET to discuss these results and the Company's strategic priorities. Dial-in information for conference participants may be obtained by registering for the event. To access the webcast and slides, please visit the Events & Presentations page in the Investors & Media section of the Company’s website. A replay of the webcast will be available for 30 days following the event. About neffy® neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children who weigh 33 lbs. or greater. INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray) INDICATION neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 33 lbs. or greater. IMPORTANT SAFETY INFORMATIONneffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only. Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy. Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed. Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works. neffy may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you use neffy. Common side effects of neffy include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting. Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy. These are not all of the possible side effects of neffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see the full Prescribing Information and Patient Information for neffy. About Type I Allergic Reactions Including Anaphylaxis Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are limitations — including fear of needles and needle-related safety concerns, lack of portability and reliability, and complexity of the devices — that may result in patients and caregivers delaying or not administering treatment in an emergency situation. There are approximately 40 million people in the United States who experience Type I allergic reactions, of whom only 3.3 million have an active epinephrine auto-injector prescription. Of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency. About ARS Pharmaceuticals, Inc. 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. The Company is commercializing neffy® (trade name EURneffy® in the EU and UK), an epinephrine nasal spray indicated in the United States for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients who weigh 33 lbs. or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children aged 4 years and older who weigh 15 kg or greater. For more information, visit www.ars-pharma.com and follow us on LinkedIn and X. Forward-Looking Statements Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: ARS Pharma’s updated strategic priorities and the anticipated benefits of their implementation, including a reduction in projected SG&A and R&D expenses for the second half of 2026 and expectations regarding operating expense trends into 2027; the anticipated path and timing to cash flow breakeven; the expected impact of the appointment of a new Chief Commercial Officer and the completed expansion of the field sales organization; the anticipated timing for interim data from the urticaria trial and the potential for ARS Pharma’s intranasal epinephrine technology to expand into the urticaria indication; the expectation that realigning commercial investment toward targeted provider engagement will expand market share and support a durable growth trajectory for neffy; the potential for the CSU program to leverage existing commercial infrastructure and overlapping targeted prescribers and to represent a high-margin growth driver, if approved; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “can,” “confident,” “could,” “expect,” “if,” “intend,” “may,” “potential,” “plan,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from neffy; the ability to maintain regulatory approval for neffy in its currently approved indications; the scope, progress and expansion of developing and commercializing neffy; the risk that personnel costs will be higher than anticipated; the scope, progress and expansion of developing our intranasal epinephrine technology; clinical trial results; the potential for governments and payors to delay, limit or deny coverage for neffy; the size and growth of the market for neffy and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; the adverse effects of pending litigation; and the impact of government laws, regulations and policies. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption 'Risk Factors' in ARS Pharma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission (SEC), and as updated by the 'Risk Factors' in ARS Pharma's Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, to be filed with the SEC today. These documents can also be accessed on ARS Pharma’s website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab. The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact: Monique Allaire, [email protected] Media Contact: Christy Curran, Sam Brown [email protected]

TranscriptFY2026 Q22026-08-13

FY2026 Q2 earnings call transcript

Earnings source - 48 paragraphs
Operator

Good afternoon, and welcome to ARS Pharma second-quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the company's prepared remarks, we will open the line for questions. Please be advised that today's conference is being recorded. I will now turn the call over to Monique Allaire, IR representative for the company. Please go ahead.

Monique Allaire

Good afternoon, and thank you for joining us. With me on the call today is Donn Casale, President and CEO of ARS Pharma. Kathy Scott, our Chief Financial Officer, will join us for the Q&A session. Earlier today, we issued a press release outlining ARS Pharma corporate priorities and commercial highlights and detailing its financial results for the second quarter of 2026. That press release can be found in the Investors and Media section of the company's website at ars-pharma.com. Before we begin, please note that today's remarks may contain forward-looking statements and actual results may differ materially. Please refer to our press release and SEC filings for further risk disclosures. With that, I'll turn the call over to Donn.

Donn Casale

Thank you, Monique, and good afternoon, everyone. It's an absolute honor to host my first earnings call as CEO. This is a pivotal time for ARS Pharmaceuticals, and I look forward to sharing my strategic vision today, along with the corporate priorities that will drive our next chapter of growth. Over the past month, I've conducted a deep review with our commercial, clinical, and corporate teams and met with many of our investors and shareholders. Those conversations confirm both the significant market opportunity ahead and the need for a disciplined operational approach going forward. Today, I want to walk you through how I see the business, what's working, what's changing, and what to expect from ARS. What I'm outlining is more than a shift in our commercial strategy. It is a fundamental change in how we manage our business and allocate capital.

Donn Casale

Against that backdrop, I'm laying out three strategic priorities that will guide our next phase. First, targeted provider commercial execution. We are prioritizing our resources and focus where they make the greatest immediate impact on neffy market share, the healthcare provider. Second, financial discipline. We are implementing a rigorous strategic cost optimization framework, significantly reducing SG&A expense with a focus on building a profitable neffy franchise with a predictable path to cash-flow breakeven. Third, pipeline expansion, starting with chronic spontaneous urticaria, or CSU. We are extending our intranasal epinephrine platform into a second large market, where we see significant opportunity to bring the first FDA-approved treatment for CSU acute flares. CSU addresses a critical unmet need and offers a compelling market expansion opportunity. Let me expand on the first strategic priority in more detail. Targeted provider commercial execution.

Donn Casale

Neffy should be the standard of care in this multi-billion dollar market. Our primary objective is to increase market share, which we believe is the best indicator of commercial success for a product like neffy. Starting this quarter, we will report on both total market share and share within our field-targeted call universe so you can track our progress directly. To level set where we are today, second quarter U.S. net product revenue was $26.2 million, and total U.S. market share reached 5%, doubling from 2.5% in the same period last year. Importantly, within our field sales targeted universe, market share increased to 8%, up from 4% in the prior year quarter. Additionally, we saw over 16,000 unique neffy prescribers in the second quarter, representing more than a threefold increase from the same period last year. Neffy is an acute, life-saving rescue therapy.

Donn Casale

Unlike a traditional product that a patient takes to treat a condition, neffy is prescribed, filled, and carried long before an event ever occurs. In commercial terms, this is more like a prevention-based market versus a treatment market. That distinction is critical. In a treatment market, a patient is symptomatic and actively seeks immediate relief. In a prevention market, patients and providers default to the status quo unless there's a compelling reason or need to change. At launch, ARS invested heavily in broad direct consumer digital advertising. While that builds brand awareness, consumer advertising in a prevention-based market carries a high cost and does not always convert to utilization. Today, millions of patients remain inadequately protected, either because they were never offered a prescription or due to the fear or hesitation of carrying traditional needle-based injectors. That is the exact clinical gap neffy solves.

Donn Casale

Closing the gap relies less on broad consumer awareness and far more on changing long-established provider prescribing habits. Going forward, we have an opportunity to drive market share growth with a more efficient commercial strategy, but not at the expense of revenue. We are prioritizing our investments where they deliver the highest return. Our sales team is calling on high-volume locations to build provider conviction office by office. Our data highlights the impact of field engagement. Where our sales team is deployed, neffy has an 8% market share compared to approximately 1% in the non-targeted universe. Growth in this market is won through repeated high-quality clinical interactions, not through a single promotional campaign or market event. On the topic of reimbursement, we will continue to aggressively work towards expanding commercial and Medicaid coverage. Securing formulary position is the first step.

Donn Casale

Beyond that, providers must appreciate and acknowledge the clinical gap neffy fills before coverage translates into prescriptions. Building that provider conviction is our highest operational priority. Executing this strategy requires leadership that understands the nature of a prevention-based market and what it takes to change prescriber behavior. That's why I'm thrilled to welcome Meg Smith to ARS as our new Chief Commercial Officer. A dynamic commercial leader with over 25 years of executive experience, Meg brings a proven track record of combining disciplined investment with deep operational accountability. Having worked closely with Meg during my time at Dynavax, I saw firsthand her inspirational leadership and operational rigor. She brings the exact playbook needed for this market, and I'm confident she'll hit the ground running, leading this next chapter of the neffy launch. In addition to strengthening our commercial leadership, we have completed the expansion of our field sales organization.

Donn Casale

Salesforce efforts will focus primarily on the highest-value prescribers, which represent 44% of the total market opportunity. I look forward to seeing what our now fully deployed, highly motivated, and focused sales team can do going forward. Looking ahead, we expect steady market share gains over successive quarters, not an overnight spike. We are focused on driving the next phase of growth with disciplined commercial execution, clear accountability, and prudent expense management. That brings me to our second strategic priority, financial discipline and greater OPEX control. Our total revenue in the second quarter was $33.7 million, reflecting a combination of net product, collaboration, and supply revenue. Total operating expenses were $95.1 million, which included $12.8 million in cost of goods sold. As discussed, our prior commercial strategy emphasized broad consumer awareness, which was costly, resulting in an SG&A spend of approximately $77.6 million for the second quarter.

Donn Casale

It is critical that we adjust our operating expenses to align with neffy adoption to build a durable, profitable business. To get there, we will plan and spend based on reasonable expectations and more efficient commercialization efforts. To give a clear baseline for our future runway, we've adjusted our aggregate SG&A and R&D expenses for the second half of 2026 to be in the range of $114 million-$126 million, which includes stock-based compensation of about $14 million-$16 million. As a result, total cash-based SG&A and R&D expenses for the second half of 2026 are expected to be in the range of $100 million-$110 million, driven by a more than 40% reduction in cash-based SG&A expenses from the first half of 2026. Importantly, we expect this spending trend to continue throughout 2027. We believe this operational rigor is what makes our outlook predictable.

Donn Casale

We ended the second quarter with $143.8 million in cash equivalents and short-term investments. With that capital, alongside our revised expense base, we see a path to cash flow breakeven by the end of 2027, which would position neffy to be a foundation for long-term optionality and future value unlock for our shareholders. Part of that value unlock will come from our third strategic priority, advancing our CSU program and maximizing the opportunities with our intranasal epinephrine platform. Beyond our foundational business with neffy, we believe we possess a compelling upside with our CSU program. Personally, I'm very excited about this opportunity. To start, we previously projected a data readout from our phase II-B trial by the end of this year.

Donn Casale

While enrollment in the interim patient population was recently completed, the design of this trial required a patient to experience and log three separate flare episodes, treating them with placebo and varying doses of intranasal epinephrine. Given the real-world time required for patients to complete all three episodes for valid data collection, the interim readout is now expected in Q1 2027. This modest change in timeline does not change the value of this program. CSU is a meaningful market with a major unmet public health need. There are currently no FDA-approved on-demand products to manage acute CSU flares, representing a clear expansion opportunity. Epinephrine's role in rapid systemic symptom relief is well established. The challenge in the past has never been the molecule. It's been the delivery mechanism and the dose. This is where our intranasal technology changes the dynamic, delivering rapid, non-invasive relief during acute flares.

Donn Casale

Because we can leverage our existing commercial infrastructure and overlapping targeted prescribers, this program could represent a high-margin growth driver built entirely on top of our neffy foundation. We look forward to updating you in the future on this exciting program. In closing, our strategic priorities for the next phase of ARS are established, and the baseline for how we operate will be defined by discipline, provider-targeted commercial strategy, and strong financial stewardship. We believe that doing this well yields a profitable company built on a durable, recurring neffy franchise with additional upside driven by our CSU program. That is the business we're out to build and why I'm excited about our future. I look forward to updating you on our progress in the quarters ahead. With that, we'll now open the line for your questions. Thank you.

Operator

Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Josh Schimmer of Cantor Fitzgerald. Your line is open.

Josh Schimmer

Great. Thanks for taking the questions and for articulating your views on the outlook for the franchise, Donn. A couple of quick questions. Maybe you can discuss both the gross-to-net in the quarter, how that's been evolving, as well as the product margins and the cost of goods that look like those ticked up this quarter, and what might have driven that and what you envision going forward. For the field-targeted accounts, maybe you can talk a little bit about what you think the company can do going forward to really get that 8% penetration up substantially higher. Thank you.

Donn Casale

Hey, Josh. Hey, thanks for your questions. I'll start with both gross to net and gross margin. I'll have maybe Kathy add a bit more color to that. But as it relates to gross to net, we anticipate ebbs and flows as it relates to gross to net, depending on the mix of different various segments each quarter. But that being said, we're comfortable in the range of 50% or approaching 50%. Importantly, though, when we look ahead in some of the forward-looking guidance as it relates to cash flow break-even, as well as net franchise profitability, we're really satisfied and comfortable with the gross-to-net that we have currently. In regard to gross margin, certainly, we anticipate that to continue to get more favorable over time. But, Kathy, would you mind maybe adding a little bit more color as it relates to the gross margin?

Kathy Scott

Sure. Hi, Josh. Our gross margin was about, excuse me, 62% in Q2 and a little over 64% year-to-date. That was lower than we project going forward for a few reasons. One is the establishment of some reserves for short-dated product, some manufacturing inefficiencies as we continue to scale production, and costs for the ex-U.S. product launches. We do expect our gross margin to improve over time, and really as we get into 2027, as we streamline and grow our manufacturing.

Josh Schimmer

Got it. Thank you.

Donn Casale

Josh, regarding the 8% market share and certainly the increase from a year ago of 4%, we are excited. One of the areas that we believe is going to continue to help support market share growth is we have completed the expansion of our sales team. It is fully deployed, and so we have an opportunity to leverage that moving forward into Q3. That is something that we are very excited about. Ultimately, at the end of the day, we know when we send in our field team, we can increase market share. That, coupled with, we will continue to evolve our messaging campaign. We think there is an opportunity to continue to engage not only the physician, but the nurses and the MAs to really get them to stop and think about the consequences of inaction. Our messaging campaign will continue to evolve.

Donn Casale

Ultimately, it is blocking and tackling execution provider by provider in these types of entrenched markets, which we believe will continue to drive market share, which ultimately underpins our confidence around neffy profitability.

Josh Schimmer

Thanks very much. Good luck.

Donn Casale

Thank you, Josh.

Operator

Thank you. Our next question comes from Ryan Deschner of Raymond James. Your line is open.

Ryan Deschner

Hi there. Thanks for the question. Two for me. The first, how are you thinking about the progression of payer access going forward, and how critical to your new strategy is getting on Caremark's formulary in the next cycle? Regarding DTC, can you give us a little more color on what specifically the new sort of strategy for DTC will look like going forward in terms of channels, media, and spend, and how this will be different from the previous strategy? Thanks.

Donn Casale

Sure. Thanks, Ryan, for the question. First, with access, we will continue to engage and work towards reducing friction. Obviously, access is important. It is a key first step. But we believe the second step, around provider conviction and ensuring that they essentially have the reason to change, and working with providers to change, is going to be critical as we move forward. There is coverage currently, 90% commercial coverage, 57% without a prior authorization.

Donn Casale

But with that, we do believe, again, we are going to have to continue to work on provider conviction because our strategy has shifted from consumer and activating the consumer to really activating the provider, which allows us to be much more efficient in our model. And we believe there is a recurring opportunity moving forward with that. As it relates to DTC, obviously when we launched, we had significant DTC, which is linear TV, closed-circuit TV.

Donn Casale

It drove a lot of awareness in the marketplace, and that awareness still exists today. But as we look ahead, we are looking towards more efficient consumer campaigns and media spend. That is going to be around traditional channels such as social media, search, those types of channels, which we believe are much more efficient. We will use those same channels, quite frankly, for providers as well, which allows us to be more targeted given the provider universe. But there is a pretty significant shift away from this broad-based DTC, which has enabled us to be much more efficient on our SG&A, which we reported today.

Operator

Thank you.

Ryan Deschner

Thank you very much.

Donn Casale

Thank you, Ryan.

Operator

Our next question comes from Roanna Ruiz of Leerink Partners. Your line is open.

Roanna Ruiz

Hi, everyone. A couple of questions from me. First, could you talk about the path to cash-flow breakeven into 2027? Maybe elaborate on what assumptions are baked into that goal. Are you also considering things like the back-to-school potential tailwind for neffy next year?

Donn Casale

Sure. Regarding the cash flow breakeven comment, we are certainly comfortable with that statement. A big part of that is being driven around our spend and being more efficient on our spend. As we shared, our SG&A was reduced by over 40% from the first semester to the second semester. Importantly, that trend continues throughout all of 2027. So we have a much more efficient, effective spend on SG&A. So that is certainly a big underpinning of that confidence around breakeven. Also, as we look at revenue, as I said earlier about gross-to-net and some of our other assumptions, we feel very comfortable in continued revenue gains and market share gains quarter-over-quarter, year-over-year, which will also underpin our path to profitability and cash flow breakeven moving forward.

Roanna Ruiz

Got it. A quick-

Donn Casale

On back-to-school, again, on back-to-school, obviously Q3 is the busiest quarter. The strategy stays the same. It is around engaging providers and driving awareness and conviction for change with those providers. Q3 just offers more volume relative to the other quarters, as we all know. Our strategy will stay the same, so obviously we anticipate more prescriptions in Q3 relative to other quarters because of back-to-school.

Roanna Ruiz

Makes sense. A quick follow-up. Also wanted to ask, you seem to be talking about meaningfully changing provider prescribing habits and that kind of your overarching strategy going forward. Could you elaborate a bit more, like what particular habits that you want to break? Any sort of education or detailing that your new field force might want to look at?

Donn Casale

Yeah. The habits we are trying to break is this entrenched behavior for decades long of using auto-injectors, and that takes time. In these prevention-type of markets where providers are doing the same thing over and over, we believe a high level of frequency with the right message at the right time will break those habits. Our job, quite frankly, is to get our providers to stop and think about the problem that is in front of them. Once there is an appreciation around the problem, the solution becomes obvious, and that is really the strategy. So when we talk about the habit of a provider, the fact is they are writing the same thing and not thinking about the consequences of that action.

Donn Casale

That's where the field team comes in to really tell the story and sell the story on the value proposition of neffy, as well as the problem that neffy solves for. That takes time, and that's why when we think about looking forward, we believe there's a very methodical increase quarter-over-quarter of both revenue and share gains, and it's going to be provider by provider. But we're really excited about the fact that we have the full team in place. Execution and fundamentals is what's going to be what changes this.

Roanna Ruiz

Makes sense. Thanks.

Donn Casale

Thanks, Roanna.

Operator

Thank you. Our next question comes from Lachlan Hanbury-Brown of William Blair. Your line is open.

Lachlan Hanbury-Brown

Yeah. Hey, thanks for taking the questions. Donn, you've talked about focusing on the prescriber engagement. The obvious outcome of that is scripts and revenue. I'm wondering if there are other metrics that you can look at in the interim. You just said that it takes time, obviously, to change these behaviors and grow market share. Are there other metrics of prescriber engagement you can look at beyond just scripts that may help you evaluate how the current strategy is going?

Donn Casale

We'll certainly look at, obviously, the best indicator is scripts and market share, and that's going to be an important metric. As I said earlier, we're going to share every quarter so you can track our progress from a year-over-year perspective. We're going to look at activity and where we look at frequency. Again, it's going to take multiple calls on not only the physician, but the nurse, the MA, the total office. We'll look at the types of activities we do that seem to drive different types of behaviors and outcomes from a script perspective. It is going to come down to, again, some of the basics around frequency, the right message with the right targets over time. We'll continue to monitor that.

Donn Casale

We have a blueprint, and we certainly have seen where we deploy the team, we see significant changes in market share. As I said in the prepared remarks, we have 8% share in that total field-targeted universe versus a 1% share where we don't send our team. That gives us a lot of confidence to continue with this strategy and focus on execution.

Lachlan Hanbury-Brown

Got it. Thanks. Maybe the second one, I did see in the 10-Q that you entered into a license agreement in July for worldwide rights to certain IP. Anything you can say on that? Is that a potential pipeline expansion opportunity?

Donn Casale

Yeah, it's really kind of an opportunity for us to think about a line extension and give us some opportunities for our pipeline. Too early right now to comment on it. But right now, it's an opportunity for us to think about line extension for the franchise.

Lachlan Hanbury-Brown

Got it. Thanks.

Operator

Thank you. This concludes our question-and-answer session and also today's conference call. Thank you for participating, and you may now disconnect.

Investor releaseQuarter not tagged2026-08-12

What To Expect From ARS Pharmaceuticals Inc (SPRY) Q2 2026 Earnings

GuruFocus.com

This article first appeared on GuruFocus. ARS Pharmaceuticals Inc (NASDAQ:SPRY) is set to release its Q2 2026 earnings on Aug 13, 2026. The consensus estimate for Q2 2026 revenue is 31.32 million, and the earnings are expected to come in at -0.49 per share. The full year 2026's revenue is expected to be $139.71 million and the earnings are expected to be $-1.78 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 5 Warning Signs with SPRY. Is SPRY fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for ARS Pharmaceuticals Inc (NASDAQ:SPRY) have declined from $146.99 million to $139.71 million for the full year 2026, and from $271.45 million to $245.67 million for 2027. During the same period, earnings estimates have declined from $-1.62 per share to $-1.78 per share for the full year 2026, and from $-0.78 per share to $-0.96 per share for 2027. In the previous quarter of 2026-03-31, ARS Pharmaceuticals Inc's (NASDAQ:SPRY) actual revenue was $22.68 million, which beat analysts' revenue expectations of $22.23 million by 2.03%. ARS Pharmaceuticals Inc's (NASDAQ:SPRY) actual earnings were $-0.61 per share, which missed analysts' earnings expectations of $-0.52 per share by -17.31%. After releasing the results, ARS Pharmaceuticals Inc (NASDAQ:SPRY) was down by -6.49% in one day. Based on the one-year price targets offered by 4 analysts, the average target price for ARS Pharmaceuticals Inc (NASDAQ:SPRY) is $29.75 with a high estimate of $33 and a low estimate of $24. The average target implies an upside of 399.16% from the current price of $5.96. Based on the consensus recommendation from 4 brokerage firms, ARS Pharmaceuticals Inc's (NASDAQ:SPRY) average brokerage recommendation is currently 1.3, indicating a "Buy" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-08-06

Cronos Group (CRON) Surpasses Q2 Earnings and Revenue Estimates

Zacks
Cronos Group (CRON) came out with quarterly earnings of $0.03 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to a loss of $0.1 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +200.00%. A quarter ago, it was expected that this cannabis company would post earnings of $0.01 per share when it actually produced earnings of $0.01, delivering no surprise. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Cronos, which belongs to the Zacks Medical - Drugs industry, posted revenues of $53.01 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 24.11%. This compares to year-ago revenues of $33.46 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Cronos shares have added about 3.4% since the beginning of the year versus the S&P 500's gain of 12.8%. While Cronos has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Cronos was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be in…Read full document

Cronos Group (CRON) came out with quarterly earnings of $0.03 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to a loss of $0.1 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +200.00%. A quarter ago, it was expected that this cannabis company would post earnings of $0.01 per share when it actually produced earnings of $0.01, delivering no surprise. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Cronos, which belongs to the Zacks Medical - Drugs industry, posted revenues of $53.01 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 24.11%. This compares to year-ago revenues of $33.46 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Cronos shares have added about 3.4% since the beginning of the year versus the S&P 500's gain of 12.8%. While Cronos has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Cronos was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.01 on $55.37 million in revenues for the coming quarter and $0.07 on $203.6 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, ARS Pharmaceuticals, Inc. (SPRY), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 13. This company is expected to post quarterly loss of $0.55 per share in its upcoming report, which represents a year-over-year change of -19.6%. The consensus EPS estimate for the quarter has been revised 4.7% lower over the last 30 days to the current level. ARS Pharmaceuticals, Inc.'s revenues are expected to be $31.89 million, up 102.9% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Cronos Group Inc. (CRON) : Free Stock Analysis Report ARS Pharmaceuticals, Inc. (SPRY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-03

ARS Pharmaceuticals Announces Conference Call and Webcast on August 13 Outlining its Updated Strategic Priorities and Reporting Second Quarter 2026 Financial Results

GlobeNewswire

SAN DIEGO, Aug. 03, 2026 (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 Thursday, August 13, 2026, at 1:30 p.m. PT / 4:30 p.m. ET. During the call, Donn Casale, President and Chief Executive Officer, will outline the Company’s updated strategic priorities and report second quarter 2026 financial results. Dial-in information for conference participants may be obtained by registering for the event. To access the webcast and slides, please visit the Events & Presentations page in the Investors & Media section of the Company’s website. A replay of the webcast will be available for 30 days following the event. About ARS Pharmaceuticals, Inc.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. The Company is commercializing neffy® (trade name EURneffy® in the EU and 优敏速® in China), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients who weigh 33 lbs. or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com. ARS Investor Contact:Monique Allaire, [email protected] ARS Media Contact:Christy Curran, Sam Brown [email protected]

Investor releaseQuarter not tagged2026-05-16

ARS Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary

Moby
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Generated $22.7 million in total revenue, with U.S. net product revenue for neffy growing 3x in volume year-over-year despite seasonal deductible resets. Identified prior authorization (PA) requirements and perceived out-of-pocket costs as the primary barriers to broader prescriber adoption. Shifted commercial strategy to prioritize 'ease of prescribing' alongside product differentiation to capture high-volume electronic refill markets. Expanded the sales force to 148 representatives to deepen reach within the highest-volume prescribing practices and support office staff with PA workflows. Achieved 90% commercial coverage, with 57% of those lives currently covered without requiring prior authorization. Leveraged the 'neffyinSchools' program to build real-world evidence and familiarity, reporting over 200 successful uses by school nurses. Anticipates a final formulary decision from CVS Caremark by July 1, which would align neffy's access with traditional auto-injectors. Expects revenue to be weighted toward the second half of 2026, driven by the back-to-school season and the maturation of refill cycles. Projects reaching cash flow breakeven by mid-2027 through disciplined spending and reallocation of resources toward high-return commercial activities. Aims to achieve unrestricted Medicaid coverage in the majority of U.S. states by early 2027, targeting a segment that represents 25% of the market. Plans to optimize SG&A spend by shifting focus from infrastructure building to targeted direct-to-consumer and field execution. Launched a new retail conversion program that automatically applies a $199 cash price for denied commercial claims at the point of sale to prevent script abandonment. Removed minimum age restrictions from the neffy label, expanding the addressable market to pediatric patients over 33 pounds and under 4 years of age. Noted that PBM focus on new legislation and FTC interactions has extended the timeline for some formulary approval processes. Recognized $2.5 million in collaboration revenue from ALK following the EU approval of neffy 1 milligram. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expressed high confidence based on a…Read full document

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Generated $22.7 million in total revenue, with U.S. net product revenue for neffy growing 3x in volume year-over-year despite seasonal deductible resets. Identified prior authorization (PA) requirements and perceived out-of-pocket costs as the primary barriers to broader prescriber adoption. Shifted commercial strategy to prioritize 'ease of prescribing' alongside product differentiation to capture high-volume electronic refill markets. Expanded the sales force to 148 representatives to deepen reach within the highest-volume prescribing practices and support office staff with PA workflows. Achieved 90% commercial coverage, with 57% of those lives currently covered without requiring prior authorization. Leveraged the 'neffyinSchools' program to build real-world evidence and familiarity, reporting over 200 successful uses by school nurses. Anticipates a final formulary decision from CVS Caremark by July 1, which would align neffy's access with traditional auto-injectors. Expects revenue to be weighted toward the second half of 2026, driven by the back-to-school season and the maturation of refill cycles. Projects reaching cash flow breakeven by mid-2027 through disciplined spending and reallocation of resources toward high-return commercial activities. Aims to achieve unrestricted Medicaid coverage in the majority of U.S. states by early 2027, targeting a segment that represents 25% of the market. Plans to optimize SG&A spend by shifting focus from infrastructure building to targeted direct-to-consumer and field execution. Launched a new retail conversion program that automatically applies a $199 cash price for denied commercial claims at the point of sale to prevent script abandonment. Removed minimum age restrictions from the neffy label, expanding the addressable market to pediatric patients over 33 pounds and under 4 years of age. Noted that PBM focus on new legislation and FTC interactions has extended the timeline for some formulary approval processes. Recognized $2.5 million in collaboration revenue from ALK following the EU approval of neffy 1 milligram. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expressed high confidence based on an updated April proposal and ongoing discussions, noting CVS Zinc represents approximately 24% of covered lives. The July 1 target is strategically timed to capture the peak back-to-school prescribing surge. Refill contributions are expected to scale significantly starting this summer as initial launch lots reach expiration and parents renew for the school year. Refills are viewed as a key driver for establishing a self-sustaining, durable patient base into 2027. The program uses three major vendors covering 90% of pharmacies to instantaneously convert rejected claims to a $199 price at the point of sale. This initiative aims to eliminate 'negative noise' from high retail price quotes (up to $1,000) that previously deterred physicians from prescribing. Management confirmed a target of mid-2027 for breakeven, supported by a $201 million cash position and plans to reallocate DTC marketing funds based on ROI data.

Investor releaseQuarter not tagged2026-05-16

ARS Pharmaceuticals Inc (SPRY) Q1 2026 Earnings Call Highlights: Strong Revenue Growth and ...

GuruFocus.com
This article first appeared on GuruFocus. Total Revenue: $22.7 million in Q1 2026. US Net Product Revenue for Neffy: $17.5 million. Collaboration Revenue: $2.5 million from international partners. Supply Revenue: $2.7 million from international partners. R&D Expenses: $4.3 million. SG&A Expenses: $72.2 million. Gross to Net Range: Low to mid 50% range, targeting approximately 50% at steady state. Cash Equivalents and Short-term Investments: $201 million at the end of Q1 2026. Warning! GuruFocus has detected 5 Warning Signs with SPRY. Is SPRY fairly valued? Test your thesis with our free DCF calculator. Release Date: May 15, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. ARS Pharmaceuticals Inc (NASDAQ:SPRY) reported a strong start to 2026 with $22.7 million in total revenue, including $17.5 million in US net product revenue for neffy. The company achieved three times the volume of neffy prescriptions year-over-year and more than doubled the revenue. Approximately 90% of commercial coverage was achieved, with 57% without prior authorization, improving access for patients. The introduction of a $199 retail pharmacy cash option for neffy aims to reduce out-of-pocket costs and improve affordability. Health Canada and the European Commission have approved neffy, expanding its market presence internationally. The prior authorization process remains a barrier to prescriber adoption, creating friction that can delay or deter prescribing. High retail prices for neffy, sometimes exceeding $1,000, have created confusion and impacted prescribing decisions. SG&A expenses were high at $72.2 million, reflecting significant commercialization investments. The CVS Caremark proposal process has been delayed due to new legislation and ongoing FTC-related interactions. The company is still working to achieve unrestricted Medicaid coverage in the majority of states, which is crucial for market expansion. Q: Can you talk more about your level of conviction regarding the CVS coverage and the goal of removing prior authorizations by the July 1 effective date? How does this tie in with the back-to-school surge expectation later this summer? A: Eric Karas, Chief Commercial Officer: We are nearing the approval process with CVS Caremark, which represents a significant portion of covered lives. We feel confident based on our conv…Read full document

This article first appeared on GuruFocus. Total Revenue: $22.7 million in Q1 2026. US Net Product Revenue for Neffy: $17.5 million. Collaboration Revenue: $2.5 million from international partners. Supply Revenue: $2.7 million from international partners. R&D Expenses: $4.3 million. SG&A Expenses: $72.2 million. Gross to Net Range: Low to mid 50% range, targeting approximately 50% at steady state. Cash Equivalents and Short-term Investments: $201 million at the end of Q1 2026. Warning! GuruFocus has detected 5 Warning Signs with SPRY. Is SPRY fairly valued? Test your thesis with our free DCF calculator. Release Date: May 15, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. ARS Pharmaceuticals Inc (NASDAQ:SPRY) reported a strong start to 2026 with $22.7 million in total revenue, including $17.5 million in US net product revenue for neffy. The company achieved three times the volume of neffy prescriptions year-over-year and more than doubled the revenue. Approximately 90% of commercial coverage was achieved, with 57% without prior authorization, improving access for patients. The introduction of a $199 retail pharmacy cash option for neffy aims to reduce out-of-pocket costs and improve affordability. Health Canada and the European Commission have approved neffy, expanding its market presence internationally. The prior authorization process remains a barrier to prescriber adoption, creating friction that can delay or deter prescribing. High retail prices for neffy, sometimes exceeding $1,000, have created confusion and impacted prescribing decisions. SG&A expenses were high at $72.2 million, reflecting significant commercialization investments. The CVS Caremark proposal process has been delayed due to new legislation and ongoing FTC-related interactions. The company is still working to achieve unrestricted Medicaid coverage in the majority of states, which is crucial for market expansion. Q: Can you talk more about your level of conviction regarding the CVS coverage and the goal of removing prior authorizations by the July 1 effective date? How does this tie in with the back-to-school surge expectation later this summer? A: Eric Karas, Chief Commercial Officer: We are nearing the approval process with CVS Caremark, which represents a significant portion of covered lives. We feel confident based on our conversations and the updated proposal submitted in April. This aligns well with our marketing initiatives and field force efforts targeting top prescribers, which should support the back-to-school surge. Q: What magnitude of lift might we expect from refills going into later this year, and how should we think about that trend in 2027? A: Richard Lowenthal, President and CEO: We expect renewal prescriptions over the summer as parents prepare for the school year, contributing to peak season sales. This trend should continue into 2027 as the patient base matures and refill cycles become more established. Q: When do you expect more broadening of prescribing to lower decile accounts, considering your current initiatives? A: Richard Lowenthal, President and CEO: We are already seeing broadening with the expansion of our prescriber base. Typically, physicians trial the product before becoming frequent prescribers. Eric Karas added that over 28,000 physicians have prescribed neffy, and we are seeing traction in both high and lower decile accounts. Q: How should we think about market share growth into the summer, especially with the expanded sales force? A: Richard Lowenthal, President and CEO: We expect meaningful market share growth, aligning with current consensus even without Caremark. Our streamlined prescribing processes and well-trained sales team should support this growth, particularly as we approach the back-to-school season. Q: Can you explain the automated conversion process for denied claims and its expected impact on script volumes? A: Richard Lowenthal, President and CEO: The process has been implemented at the pharmacy level to convert denied claims to a $199 cash price, reducing negative feedback to doctors. Eric Karas added that this covers about 90% of pharmacies and should simplify the prescribing process, reducing abandonment rates and improving script volumes. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-05-16

ARS Pharmaceuticals Q1 Earnings Call Highlights

MarketBeat
Interested in ARS Pharmaceuticals, Inc.? Here are five stocks we like better. ARS Pharmaceuticals reported $22.7 million in first-quarter 2026 revenue, with U.S. net product revenue for neffy reaching $17.5 million as prescriptions tripled year over year and revenue more than doubled. The company is prioritizing access and affordability, including a push for broader commercial coverage without prior authorization and a new retail cash-price program that caps rejected claims at $199. ARS said neffy is gaining commercial traction, with about 120,000 U.S. patients using the product and more than 28,000 health care providers prescribing it, while management expects growth to accelerate through back-to-school season and better refill dynamics. ARS Pharmaceuticals (NASDAQ:SPRY) reported first-quarter 2026 revenue of $22.7 million as executives said the company is working to expand access, reduce prescribing friction and build momentum for neffy, its needle-free epinephrine treatment for allergic reactions including anaphylaxis. Co-founder, President and Chief Executive Officer Richard Lowenthal said the company generated $17.5 million in U.S. net product revenue for neffy during the quarter, with prescription volume tripling year over year and revenue more than doubling. He characterized the quarter as a “strong start” to 2026, particularly because the first two months of the year are typically the lowest-volume period for epinephrine products due to the reset of health insurance deductibles. → Micron Investors Face a High-Stakes Moment After the Latest Rally Lowenthal said ARS is focused on three priorities for neffy: access, affordability and adoption. He noted that epinephrine is a mature, refill-driven market, with about half of prescriptions typically coming from renewals that may be written electronically without an office visit. As a newer entrant, neffy has relied more heavily on new in-office prescriptions, but Lowenthal said improved payer access, reduced prescribing friction and the maturation of refill cycles should support more scalable growth over time. Lowenthal said ARS ended the first quarter with about 90% commercial coverage for neffy, with 57% of covered lives having access without prior authorization. He said the company views prior authorization requirements and misperceptions about out-of-pocket costs as key barriers to prescriber adoption.…Read full document

Interested in ARS Pharmaceuticals, Inc.? Here are five stocks we like better. ARS Pharmaceuticals reported $22.7 million in first-quarter 2026 revenue, with U.S. net product revenue for neffy reaching $17.5 million as prescriptions tripled year over year and revenue more than doubled. The company is prioritizing access and affordability, including a push for broader commercial coverage without prior authorization and a new retail cash-price program that caps rejected claims at $199. ARS said neffy is gaining commercial traction, with about 120,000 U.S. patients using the product and more than 28,000 health care providers prescribing it, while management expects growth to accelerate through back-to-school season and better refill dynamics. ARS Pharmaceuticals (NASDAQ:SPRY) reported first-quarter 2026 revenue of $22.7 million as executives said the company is working to expand access, reduce prescribing friction and build momentum for neffy, its needle-free epinephrine treatment for allergic reactions including anaphylaxis. Co-founder, President and Chief Executive Officer Richard Lowenthal said the company generated $17.5 million in U.S. net product revenue for neffy during the quarter, with prescription volume tripling year over year and revenue more than doubling. He characterized the quarter as a “strong start” to 2026, particularly because the first two months of the year are typically the lowest-volume period for epinephrine products due to the reset of health insurance deductibles. → Micron Investors Face a High-Stakes Moment After the Latest Rally Lowenthal said ARS is focused on three priorities for neffy: access, affordability and adoption. He noted that epinephrine is a mature, refill-driven market, with about half of prescriptions typically coming from renewals that may be written electronically without an office visit. As a newer entrant, neffy has relied more heavily on new in-office prescriptions, but Lowenthal said improved payer access, reduced prescribing friction and the maturation of refill cycles should support more scalable growth over time. Lowenthal said ARS ended the first quarter with about 90% commercial coverage for neffy, with 57% of covered lives having access without prior authorization. He said the company views prior authorization requirements and misperceptions about out-of-pocket costs as key barriers to prescriber adoption. → How Bad Could Tesla’s Cybertruck Recall Be for Shares? The company is awaiting a potential formulary decision from CVS Health, which Lowenthal said includes Caremark, Aetna and Anthem. ARS submitted an updated proposal in late April seeking to add neffy to commercial formularies without a prior authorization requirement, targeting a July 1 effective date. Lowenthal said the proposal is in the final stages of the formulary approval process and that the company expects to provide a more definitive update in the coming weeks. Chief Commercial Officer Eric Karas said during the question-and-answer session that CVS represents about 15% of covered lives, Anthem about 5% and Aetna about 4%. He said ARS feels confident based on its conversations with CVS Caremark and that a July 1 start would align with the company’s back-to-school marketing and field-force plans. → How Berkshire’s New York Times Bet Looks Today On Medicaid, ARS said Florida has added neffy to its unrestricted formulary effective July 1, bringing the total to nine states covering the product under Medicaid. Karas said Florida is among the top five states in the epinephrine market and that ARS is in active discussions with multiple states and state pooling groups. He said the company expects to achieve unrestricted coverage in the majority of Medicaid programs by early 2027. ARS also launched a program designed to ensure patients whose commercial insurance claims are rejected at retail pharmacies can access neffy for no more than $199. Lowenthal said the $199 cash price had previously been available through specialty pharmacy and telehealth channels, but patients filling prescriptions at retail pharmacies could sometimes be quoted the wholesale acquisition cost plus pharmacy markup, resulting in out-of-pocket costs above $1,000 in some cases. Lowenthal said the new retail program is intended to reduce confusion for patients and prescribers and align provider perception with the company’s stated maximum cash price. During the Q&A, he said the program was implemented at the pharmacy level during the week of the call and should automatically convert certain rejected commercial claims to the $199 price. Karas said three vendors involved in the process cover about 90% of pharmacies and already work with ARS on its copay program. He said about 55% of neffy prescriptions are currently going through retail, with the remaining 45% going through the company’s patient assistance program. He also said abandonment in the category is similar to neffy, at roughly 22% to 23%. ARS said approximately 120,000 patients are using neffy in the U.S., including 29,500 patients added during the first quarter. Karas said more than 28,000 health care providers have prescribed neffy, with about half demonstrating repeat use. He said prescribing is concentrated among the highest-decile accounts, where adoption is most meaningful for volume. The company expanded its sales organization in May to 148 representatives and area sales managers. Karas said the larger field team is focused on high-volume practices, prior authorization support, electronic refill requests and back-to-school preparation. ARS is also increasing direct-to-consumer media aimed at parents, including linear and connected TV, digital platforms, social media and testimonials. Lowenthal said refill activity should begin contributing more meaningfully during the summer, as families seek prescriptions that will last through the full school year. He said initial launch lots expire around the end of the year and beginning of next year, but many parents are expected to renew prescriptions earlier to avoid having product expire during the school year. Lowenthal said the Food and Drug Administration removed the minimum age restriction from the neffy label at the end of March, enabling pediatric patients who weigh more than 33 pounds and are under 4 years old to access treatment. He said ARS believes pediatric adoption will accelerate as the broadened label takes hold. The company also highlighted its neffyinSchools program, saying more than 200 successful uses of neffy in anaphylactic episodes have been reported by school nurses, with positive feedback. Lowenthal said these reports may help build familiarity among patients, caregivers, school nurses and prescribers. Outside the U.S., Lowenthal said Health Canada approved neffy in April as the first and only needle-free emergency treatment for allergic reactions, including anaphylaxis. Commercial launch in Canada by partner ALK is expected later in 2026. In March, the European Commission granted marketing authorization for neffy 1 mg, expanding access for younger children in Europe. Chief Financial Officer Kathleen Scott said first-quarter revenue consisted of $17.5 million in U.S. neffy net product revenue, $2.5 million in collaboration revenue and $2.7 million in supply revenue from international partners. The collaboration revenue was tied to a $5 million milestone payment from ALK triggered by approval of neffy 1 mg in the European Union, with most of the remaining balance recorded as a financing liability. Research and development expenses were $4.3 million, while selling, general and administrative expenses were $72.2 million, reflecting commercialization investments across direct-to-consumer marketing and field execution. Scott said the company expects its 2026 SG&A run rate to be slightly higher than the run rate in the second half of 2025, while shifting spending toward higher-return commercial activities. ARS ended the quarter with $201 million in cash equivalents and short-term investments. Scott said the company remains focused on progress toward cash flow breakeven. In response to an analyst question, Lowenthal said current company projections call for cash breakeven by mid-2027, with losses expected to decline over time as revenue becomes more weighted toward the second half of 2026. Lowenthal said ARS expects neffy prescription growth to expand as new initiatives reduce provider and patient friction. He said a favorable CVS Caremark decision would further accelerate the company’s trajectory. ARS Pharmaceuticals, Inc, a biopharmaceutical company, develops treatments for severe allergic reactions. The company is developing neffy, a needle-free and low-dose intranasal epinephrine nasal spray for the emergency treatment of Type I allergic reactions, including anaphylaxis. It serves healthcare professionals, patients, and caregivers. ARS Pharmaceuticals, Inc was founded in 2015 and is headquartered in San Diego, California. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "ARS Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Investor releaseQuarter not tagged2026-05-15

Eton Pharmaceuticals, Inc. (ETON) Misses Q1 Earnings Estimates

Zacks
Eton Pharmaceuticals, Inc. (ETON) came out with quarterly earnings of $0.05 per share, missing the Zacks Consensus Estimate of $0.1 per share. This compares to earnings of $0.07 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -50.00%. A quarter ago, it was expected that this company would post earnings of $0.12 per share when it actually produced earnings of $0.05, delivering a surprise of -58.33%. Over the last four quarters, the company has not been able to surpass consensus EPS estimates. Eton Pharmaceuticals, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $24.27 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 8.48%. This compares to year-ago revenues of $17.28 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Eton Pharmaceuticals shares have added about 82.3% since the beginning of the year versus the S&P 500's gain of 8.8%. While Eton Pharmaceuticals has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Eton Pharmaceuticals was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. Yo…Read full document

Eton Pharmaceuticals, Inc. (ETON) came out with quarterly earnings of $0.05 per share, missing the Zacks Consensus Estimate of $0.1 per share. This compares to earnings of $0.07 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -50.00%. A quarter ago, it was expected that this company would post earnings of $0.12 per share when it actually produced earnings of $0.05, delivering a surprise of -58.33%. Over the last four quarters, the company has not been able to surpass consensus EPS estimates. Eton Pharmaceuticals, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $24.27 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 8.48%. This compares to year-ago revenues of $17.28 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Eton Pharmaceuticals shares have added about 82.3% since the beginning of the year versus the S&P 500's gain of 8.8%. While Eton Pharmaceuticals has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Eton Pharmaceuticals was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.15 on $25.03 million in revenues for the coming quarter and $0.83 on $110.76 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 41% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the broader Zacks Medical sector, ARS Pharmaceuticals, Inc. (SPRY), has yet to report results for the quarter ended March 2026. The results are expected to be released on May 15. This company is expected to post quarterly loss of $0.53 per share in its upcoming report, which represents a year-over-year change of -51.4%. The consensus EPS estimate for the quarter has been revised 12.4% lower over the last 30 days to the current level. ARS Pharmaceuticals, Inc.'s revenues are expected to be $22.24 million, up 179% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Eton Pharmaceuticals, Inc. (ETON) : Free Stock Analysis Report ARS Pharmaceuticals, Inc. (SPRY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

As of 2026-08-22 • Updated weeklySource: Earnings sourceIngestion runbook