Evoke Pharma Announces Q3 2024 Financial Results

Evoke Pharma, Inc., a pharmaceutical company specializing in gastrointestinal diseases, has reported significant financial growth and corporate developments in the third quarter of 2024. GIMOTI, their nasal spray for diabetic gastroparesis, achieved net product sales of $2.7 million, marking the highest quarterly revenue with a 70% increase compared to the previous year. The company has also seen a 45% rise in cumulative prescribers and a 52% increase in prescription fills year-over-year, with a 39% rise since the first quarter of 2024.

The company highlighted the effectiveness of GIMOTI through real-world data presented at the American College of Gastroenterology (ACG) 2024 meeting. The data demonstrated that GIMOTI significantly improved outcomes for patients undergoing GLP-1 therapy, showcasing its potential as a superior treatment option compared to oral metoclopramide.

CEO Matt D’Onofrio expressed optimism about the growth metrics for GIMOTI, noting the substantial year-over-year increases in sales and prescriber rates. He emphasized the product's value as a non-oral treatment for diabetic gastroparesis, particularly for patients on GLP-1 therapy. The real-world data presented at ACG 2024 underscored GIMOTI's ability to reduce healthcare visits, including hospitalizations, highlighting the need for better alternatives to traditional oral treatments.

Chief Commercial Officer Chris Quesenberry discussed the strategic initiatives to expand access to GIMOTI and engage more prescribers. He emphasized the positive feedback from both patients and providers, which bolsters the company's mission to reshape the care paradigm for gastroparesis. Quesenberry noted that many individuals with diabetic gastroparesis struggle with existing therapies, and a survey from IFFGD indicated that 65% of patients are dissatisfied with current treatments. He believes that patients could benefit from switching to GIMOTI, as it is directly absorbed into the bloodstream, bypassing the dysfunctional stomach.

In terms of commercial progress, Evoke Pharma has strengthened patient access and streamlined prescription processing by adding multiple pharmacy partners, which has expanded GIMOTI’s reimbursement coverage. Improved insurance reimbursement rates have reduced patient reliance on savings programs, with Medicare and Medicaid accounting for approximately 34% of filled GIMOTI prescriptions in the first nine months of 2024.

At the ACG 2024 meeting, Evoke Pharma presented compelling data showcasing statistically significant improvements in patient outcomes for GLP-1 users with diabetic gastroparesis while taking GIMOTI. A poster presentation featuring this data won the Presidential Poster Award, being recognized as one of the top 5% of data accepted by the conference and also receiving the Outstanding Research Award in the Stomach Category.

Financially, as of September 30, 2024, Evoke Pharma had cash and cash equivalents of approximately $11.3 million, which includes approximately $10.8 million from warrant exercise financing activities through the third quarter. Additionally, in October 2024, the company raised approximately $3.5 million through the exercise of warrants by existing investors. The company anticipates that its current cash on hand will fund its operations into the fourth quarter of 2025.

In terms of corporate governance, the company announced the appointment of Ben Smeal to its Board of Directors in October 2024, fulfilling a condition set by existing investor Nantahala Capital Management in connection with warrant financing that occurred in September.

For the third quarter of 2024, Evoke Pharma reported net product sales of approximately $2.7 million compared to $1.6 million during the third quarter of 2023. The net loss for the third quarter was approximately $1.3 million, or $0.94 per share, compared with $1.7 million, or $6.08 per share, for the same period in 2023. Selling, general, and administrative expenses were approximately $3.8 million, up from $3.1 million in the third quarter of 2023, due to higher professional fees and expanded marketing efforts. Total operating expenses for the third quarter of 2024 were approximately $3.9 million compared to $3.2 million for the same period in 2023.

Given the net sales generated in the first three quarters of 2024, Evoke Pharma has revised its 2024 guidance to $9.5-10.0 million from the previous range of $11-12 million, which still reflects an almost doubling from the previous year if achieved. The guidance is based on current business expectations and recent growth rates, as well as external factors such as the global macroeconomic environment and supply chain constraints.