$26.2 million in U.S. neffy$(R)$ 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(R) (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:
1. 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.
2. 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.
3. 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(R).
"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.
-- SG&A expenses: $77.6 million, primarily driven by
consumer-targeted media activities, which were incurred prior to
the Company's updated operating plan, as well as its sales force
expansion and one-time personnel-related expenses related to its
July leadership transition.
-- R&D expenses: $4.7 million, primarily related to clinical costs
for the Company's ongoing Phase 2b trial in CSU and registry study
and continuing development and regulatory expenses.
-- 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.
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