Latest news with #Neffy
Yahoo
15-05-2025
- Business
- Yahoo
ARS Pharmaceuticals Inc (SPRY) Q1 2025 Earnings Call Highlights: Strong Launch of Neffy Amid ...
Total Revenue: $8 million for Q1 2025. US Net Product Revenue for neffy: $7.8 million. Collaboration Revenue: $0.2 million from ALK agreement. Cost of Goods Sold: $1.1 million for Q1 2025. R&D Expenses: $3 million for Q1 2025. SG&A Expenses: $41.1 million for Q1 2025. Planned DTC Campaign Investment: $40 million to $50 million for the remainder of 2025. Projected 2025 Operating Expenses: $210 million to $220 million, excluding stock-based compensation and COGS. Net Loss: $33.9 million, or $0.35 per share, for Q1 2025. Cash, Cash Equivalents, and Short-term Investments: $275.7 million as of March 31, 2025. Warning! GuruFocus has detected 4 Warning Signs with SPRY. Release Date: May 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. ARS Pharmaceuticals Inc (NASDAQ:SPRY) successfully launched neffy, the first needle-free epinephrine treatment, with $7.8 million in US net product revenue in Q1 2025. The company expanded commercial insurance coverage for neffy from 27% to 57%, with ongoing payer discussions to further increase coverage. Neffy 1-milligram dose was approved by the FDA for children, representing a significant portion of the pediatric market. A strategic collaboration with ALK-Abello expanded ARS Pharmaceuticals Inc (NASDAQ:SPRY)'s promotional network to over 20,000 healthcare providers, including 9,000 pediatricians. The company is launching a comprehensive direct-to-consumer campaign to increase patient awareness and drive prescription growth for neffy. ARS Pharmaceuticals Inc (NASDAQ:SPRY) reported a net loss of $33.9 million for Q1 2025, indicating financial challenges despite revenue growth. The cost of goods sold is expected to increase as the company uses up its zero-cost inventory. Prior authorization requirements remain a barrier for some patients, with only 57% of commercial lives having access to neffy without prior authorization. The company anticipates significant operating expenses of $210 million to $220 million for 2025, driven by marketing and commercialization efforts. Market share for neffy is currently low at 1.3% overall, though higher among targeted high-prescribing physicians. Q: How much of the first-quarter sales figure is attributed to inventory, and what are your expectations for inventory contribution over the next two quarters? A: Richard Lowenthal, President and CEO, stated that the first-quarter numbers were minimally influenced by inventory. The sales were primarily from 2-milligram doses, and inventory levels are steady. They do not expect inventory to significantly impact sales in the upcoming quarters. Q: What is the current gross-to-net discount, and how has it changed from the fourth quarter to the first quarter? A: Kathleen Scott, CFO, explained that the gross-to-net discount was higher in Q4 than in Q1. With increasing insurance coverage, the gross-to-net is expected to decrease to around 50% as the year progresses. Q: What do you expect the cost of goods sold (COGS) to be once the current inventory is used up? A: Kathleen Scott noted that some inventory was expensed prior to FDA approval, which currently benefits COGS. As this inventory is used, COGS will increase slightly, but the zero-cost inventory primarily involves raw materials, with manufacturing costs still being incurred. Q: Can you discuss the impact of the neffy Experience Program on physician adoption and any feedback received? A: Richard Lowenthal highlighted that the neffy Experience Program has been successful, with over 2,500 physicians enrolled. Feedback has been positive, with results similar to injections, where about 90% of patients respond to a single dose. Plans are in place to expand the program and potentially publish the results. Q: How are you tracking against your goal of 80% commercial insurance coverage by the third quarter? A: Richard Lowenthal mentioned ongoing negotiations with major insurers like Caremark and Aetna. Currently, 57% of patients have coverage without prior authorization, and efforts are underway to increase this percentage to meet the 80% goal. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
31-03-2025
- Health
- Yahoo
Here's why school nurses need Texas law change to give new epi nasal spray to students
Children who have an allergy that could cause anaphylaxis symptoms such throat swelling and other severe reactions have long had to carry an epinephrine injectable pen with them or have one stored at school. Those pens, known under the brand name EpiPen, can become unusable if subjected to heat like in a hot car in a Texas summer. They also have a one-year shelf life, which means families have to fill a new prescription each school year for hundreds of dollars and then supply it to the school nurse's office. Last year, the U.S. Food and Drug Administration approved Neffy, a nasal spray form of epinephrine for people who weigh 66 pounds or more, and this month it approved a lower dose spray for children ages 4 and older who are between 33 pounds and 66 pounds. This is great news, but families can't just hand over the nasal spray form to their school nurse. The Texas law allowing school nurses to give epinephrine uses the phrase "auto-injectors" when referring to delivering the drug to students who have a prescription for it. That means only the pen form. Senate Bill 1619 and House Bill 2283 both aim to rectify that by simply taking out the phrase "auto-injector" and changing it to "delivery devices." Allergy treatment takes girl from fear of cashews to no-worry birthday cake "This is a happy bill," said Dr. Allen Lieberman of Austin Family Allergy and Asthma. "There is no downside to it." This new nasal spray delivers medicine the same way as a nasal allergy spray like Flonase or the same way as Narcan for people experiencing an opioid overdose. You put the nozzle into one nostril and push down on the plunger to spray the medicine into the nose. It's easy to use, and people are less intimidated by it than by the idea of giving someone a shot. The nasal spray offers the same medical results as the auto-injectors, but it has some other advantages, Lieberman said. If you want to buy the nasal spray without insurance, a two-pack is about $200, Lieberman said, compared with $600 for one auto-injector. Neffy comes in a two-pack because if a first dose doesn't improve the symptoms, you can give a second dose. With the traditional pen, it's just one dose. The sprays also remain effective for two years instead of one, and they don't have heat restrictions like the injectables do. Lieberman is now prescribing the nasal sprays and getting it approved by insurance about 50% of the time, and "the more we write for it, the more insurance sees it, and will approve it," he said. He encourages people, especially in Texas, who have a prescription for an EpiPen to consider the Neffy instead. He has had many patients with auto-injectors accidentally leave them in a bag in the trunk of a car for days or weeks in the Texas heat and then have to throw the auto-injector away and get a new one. With the nasal spray, that spray would still be effective. It's going to be "a game-changer," Lieberman said. This article originally appeared on Austin American-Statesman: Texas law keeps school nurses from using new epi nasal spray
Reuters
05-03-2025
- Health
- Reuters
US FDA expands use of allergic reaction nasal spray in people between 15-30 kilograms
March 5 (Reuters) - The U.S. Food and Drug Administration approved the expanded use of ARS Pharmaceuticals' (SPRY.O), opens new tab nasal spray for severe allergic reactions in patients who weigh between 15 and 30 kilograms, the company said on Wednesday. Shares of the company were up 4.5% in extended trading. The spray, sold under the brand name neffy, will be dosed at 1 milligram (mg) for the new patient population, compared to the previously approved dose of 2 mg for people who weigh above 30 kilograms. Neffy, which was first approved by the FDA in August, is seen as an alternative to EpiPen and other autoinjectors that are filled with epinephrine. It is designed to be given at the first sign of a severe allergic reaction to prevent life-threatening conditions such as anaphylaxis. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here.
