Core Insights - Evoke Pharma, Inc. reported a 77% year-over-year increase in net product sales for Q1 2025, reaching approximately $3.1 million, driven by growing prescriber adoption and repeat patient use of GIMOTI [1][5][9] - The company achieved a 73% increase in fill rate and a 44% increase in its total prescriber base compared to Q1 2024, indicating strong commercial execution and provider engagement [2][9] - Evoke maintains its 2025 net product sales guidance of approximately $16 million, reflecting a 60% increase over 2024 [8] Financial Performance - For Q1 2025, net product sales were approximately $3.1 million compared to $1.7 million in Q1 2024, while the net loss decreased to approximately $1.3 million ($0.51 per share) from $1.6 million ($2.09 per share) in the prior year [5][22] - Selling, general, and administrative expenses rose to approximately $4.3 million from $3.1 million in Q1 2024, attributed to higher professional fees and reimbursement activities [6] - As of March 31, 2025, cash and cash equivalents were approximately $12.6 million, expected to fund operations into Q2 2026 [7] Business Developments - The company appointed Greg Pyszczymuka to the Board of Directors, enhancing its commercial strategy and revenue growth capabilities [3] - GIMOTI demonstrated solid momentum with strong repeat usage and increased prescription depth, supported by expanded pharmacy partnerships [9][10] - The company emphasizes its strategic focus on GLP-1 patient populations, where the demand for effective non-oral treatment options is growing [9]

Core Viewpoint - Evoke Pharma, Inc. announced the acceptance of a new abstract for presentation at Digestive Disease Week 2025, focusing on the incidence of tardive dyskinesia in patients treated with metoclopramide [1][3] Company Overview - Evoke Pharma is a specialty pharmaceutical company that develops treatments for gastrointestinal disorders, particularly known for GIMOTI, a nasal spray formulation of metoclopramide for diabetic gastroparesis [6][7] - GIMOTI is the only FDA-approved treatment for diabetic gastroparesis, addressing a significant need in the market [3][7] Research and Findings - The upcoming presentation will compare the incidence rates of tardive dyskinesia in patients receiving continuous versus intermittent oral metoclopramide treatment, utilizing real-world data from over 100 million U.S. patients [2][4] - The research aims to clarify the long-term safety profile of metoclopramide, particularly regarding tardive dyskinesia, to support informed prescribing decisions [3][4] Event Details - The abstract titled "Comparison of the Incidence of Tardive Dyskinesia in Patients Receiving Continuous vs Intermittent Oral Metoclopramide" will be presented by Pierantonio Russo, MD, during a session on gastroparesis and small intestinal dysmotility on May 5, 2025 [4] - The abstract will be accessible to attendees via the DDW ePosters site and mobile app starting May 4, 2025 [4] Industry Context - Digestive Disease Week (DDW) is a major international event for professionals in gastroenterology, showcasing advancements in GI research and medicine [8]

Financial Performance - Full-year revenue reached $10.2 million, a 97% year-over-year increase, exceeding the prior guidance of $10 million[8] - Q4 revenue was $3.3 million, a 24.6% increase from Q3 2024[8] - The company raised $14.3 million, ensuring Nasdaq compliance and providing a cash runway into Q1 2026[8] - Cash and cash equivalents as of December 31, 2024, were $13.6 million[47] Commercial Growth - The cumulative prescriber base grew by 46% year-over-year[8] - Fills grew by 72% year-over-year[8] - Prescriptions grew by 22% year-over-year[8] Market Position and Strategy - GIMOTI has a unique market advantage as the first and only FDA-approved nasal spray for gastroparesis[10] - The company's conversion rate in 2024 was 51% on average, with steady improvement seen over the year[20] Cost Savings - Total healthcare costs in the GIMOTI arm were $15,227 lower compared to oral metoclopramide[30] Sales and Marketing - Over 40,000 healthcare professionals were reached through email, with over 60% of targets reached via email and a ~16% email open rate[34]

Financial Data and Key Metrics Changes - For Q4 2024, net product sales were approximately $3.3 million, compared to $1.7 million in Q4 2023, representing a significant increase [47] - The net loss for Q4 2024 was approximately $1.2 million or $0.49 per share, an improvement from a net loss of $2 million or $7.13 per share in Q4 2023 [47] - For the full year 2024, net product sales were approximately $10.2 million, up from $5.2 million in 2023, with a net loss of approximately $5.4 million or $2.81 per share compared to $7.8 million or $27.97 per share in 2023 [47][48] Business Line Data and Key Metrics Changes - The growth in revenue was driven by enhanced prescription fulfillment through the Aspen Pharmacy network and increased provider awareness [48] - The cumulative prescriber base increased by 46% year-over-year, reaching a total of 2,553 prescribers [12] - Fill rates increased by 72% year-over-year, and patient enrollments grew by 22% [12] Market Data and Key Metrics Changes - Medicaid prescriptions increased from about 2% of the business at the beginning of 2024 to between 5% and 7% by year-end [62] - The transition to Aspen pharmacies significantly accelerated delivery times and improved insurance authorization processes [12][30] Company Strategy and Development Direction - The company aims to expand pharmacy partnerships, improve access, and increase provider awareness to drive broader adoption of Gimoti [66] - The strategy includes leveraging real-world data to strengthen payer discussions and reinforce Gimoti's value [66] - The company is focused on maintaining a disciplined approach to capital allocation to maximize returns on investments in commercialization [66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to execute and deliver strong results despite external factors like macroeconomic conditions and supply chain constraints [51] - The company projects net revenue guidance of approximately $16 million for 2025, representing a 60% increase over 2024 [51] Other Important Information - The company raised $14.3 million in capital through equity financings and warrant exercises, extending its cash runway into Q1 2026 [50] - The company has six listed patents related to Gimoti, extending into 2030 [13] Q&A Session Summary Question: Impact of Vanda's drug and FDA's compassionate use of Domperidone on competitive landscape - Management noted uncertainty regarding the volume of Domperidone but acknowledged that its discontinuation would likely lead patients to seek alternatives like Gimoti [56][58] Question: Update on increasing Medicaid and private Medicaid pharmacy partnerships - Management reported that Medicaid prescriptions have increased significantly due to the addition of seven dispensing pharmacies, growing from 2% to between 5% and 7% of the business [60][62]

Financial Data and Key Metrics Changes - For Q4 2024, net product sales were approximately $3.3 million, compared to $1.7 million in Q4 2023, representing a significant increase [47] - For the full year 2024, net product sales reached approximately $10.2 million, up from approximately $5.2 million in 2023, indicating strong growth [47] - The net loss for Q4 2024 was approximately $1.2 million or $0.49 per share, compared to a net loss of $2 million or $7.13 per share in Q4 2023 [47] - The net loss for the full year 2024 was approximately $5.4 million or $2.81 per share, down from a net loss of $7.8 million or $27.97 per share in 2023 [47] Business Line Data and Key Metrics Changes - The growth in revenue was driven by enhanced prescription fulfillment through the Aspen Pharmacy network and increased provider awareness [48] - The fill rates increased by 72% year over year, and patient enrollments grew by 22% [12] - The prescriber base increased by 46% year over year, totaling 2,553 prescribers [12] Market Data and Key Metrics Changes - Medicaid prescriptions increased from about 2% of the business at the beginning of 2024 to between 5% and 7% by year-end [62] - The transition to Aspen pharmacies significantly accelerated delivery times and improved insurance authorization processes [12] Company Strategy and Development Direction - The company aims to expand pharmacy partnerships, improve access, and increase provider awareness to drive broader adoption of Gimoti [66] - The strategy includes leveraging real-world data to strengthen payer discussions and reinforce Gimoti's value [66] - The company plans to maintain a disciplined approach to capital allocation to maximize returns on investments in commercialization [66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a projected net revenue of approximately $16 million for 2025, representing a 60% increase over 2024 [51] - The company acknowledged external factors such as macroeconomic conditions and supply chain constraints but remains optimistic about executing its plans [51] Other Important Information - The company raised $14.3 million in capital through equity financings and warrant exercises, extending its cash runway into Q1 2026 [50] - The company has six listed patents related to Gimoti, extending into 2030 [13] Q&A Session Summary Question: Impact of Vanda's drug and FDA's compassionate use of Domperidone - Management noted uncertainty regarding the volume of Domperidone but recognized that its discontinuation would likely lead patients to seek alternatives like Gimoti [56][58] Question: Update on increasing Medicaid and private Medicaid pharmacy - The company reported growth in Medicaid prescriptions, which increased from about 2% to between 5% and 7% of the business due to the addition of new dispensing pharmacies [62]

Product Launch and Market Potential - Gimoti, the first nasally-administered product for diabetic gastroparesis, was launched in the U.S. in October 2020 after FDA approval in June 2020[19]. - The GI pharmaceutical market in the U.S. is projected to reach $22–$28 billion in prescription drug spending by 2024, driven by increased awareness of gastroparesis[33]. - The company plans to develop a lower dosage strength of Gimoti to expand market potential, pending FDA feedback[34]. - The growing use of GLP-1 agonists may increase the number of patients affected by gastroparesis, highlighting a significant market opportunity[23]. - Approximately 2.3 million diabetic patients with moderate or severe gastroparesis symptoms are seeking treatment in the U.S.[46]. - The market for diabetic gastroparesis treatments is currently served by approximately 3.0 million prescriptions annually for metoclopramide in various formulations[47]. Financial Performance and Projections - The company has incurred significant operating losses since inception and expects to continue incurring losses until revenues exceed expenses[31]. - The Eversana Agreement allows the company to retain more than 80% of net product profits from Gimoti after reimbursing costs[56]. - As of December 31, 2024, there were approximately $75.4 million in unreimbursed commercialization costs under the Eversana Agreement[56]. - The company anticipates needing to raise additional funds through debt, equity, or other financing methods to continue operations[151]. - As of December 31, 2024, the company had approximately $13.6 million in cash and cash equivalents, which is expected to fund operations into the first quarter of 2026[151]. Clinical Studies and Efficacy - A study showed that patients taking Gimoti had approximately $15,000 lower health resource utilization over six months compared to those on oral metoclopramide[21]. - In an October 2022 patient ATU study, Gimoti outperformed comparators in symptom improvement, with 100% of respondents reporting symptom improvement compared to 23% to 32% for oral metoclopramide and others[72][73]. - Patients using Gimoti experienced a 55% reduction in all-cause emergency department visits compared to pre-treatment, and a 91% reduction in visits compared to those using oral metoclopramide[76]. Regulatory Environment - FDA approval is required before any new unapproved drug can be marketed in the U.S., involving extensive regulatory processes[99]. - The FDA has a goal of completing Standard Review NDAs within ten months and Priority Review NDAs within six months[106]. - Post-approval, the product will be subject to ongoing FDA regulation, including requirements for periodic reporting and potential post-approval studies[111]. - The company is subject to strict FDA regulations regarding manufacturing processes, requiring prior approval for changes and compliance with cGMP standards[112]. - The company must report average manufacturer prices (AMP) and best prices for drugs under the Medicaid Drug Rebate Program, with potential civil penalties for incorrect submissions[134]. Competition and Market Landscape - The competitive landscape includes metoclopramide oral, erythromycin, and domperidone, with metoclopramide being the only FDA-approved treatment for gastroparesis in the U.S.[85]. - The company faces substantial competition from established products like metoclopramide, erythromycin, and domperidone, which are available under various trade names[187]. Partnerships and Commercialization - The company aims to seek partnerships to enhance the development and commercialization of Gimoti, including potential regulatory approval outside the U.S.[34]. - The company relies on Eversana for the commercialization of Gimoti, which poses risks related to sales team management and market demand development[151]. - The company has no intent to terminate the Eversana Agreement, which could impact its financial obligations if terminated[151]. Legal and Compliance Risks - The company may face significant legal challenges if it does not comply with the Anti-Kickback Statute and False Claims Act, which can result in multi-million dollar settlements[127]. - The company is required to submit annual reports on payments made to healthcare providers, with significant penalties for non-compliance[131]. - The company must comply with the Physician Payment Sunshine Act, requiring annual reporting of payments to healthcare providers[217]. Operational Challenges - The company relies on third-party contract manufacturers for Gimoti production and has a Manufacturing Services Agreement with Patheon UK Limited until December 31, 2025[79][80]. - The company is entirely dependent on the success of its product, Gimoti, which may never generate sufficient sales to become profitable[150]. - The company faces significant risks related to the marketing and distribution of Gimoti, including the potential inability to hire and retain qualified sales personnel[158]. Future Outlook and Challenges - Legislative changes may increase the difficulty and cost of commercializing Gimoti, affecting pricing and profitability[199]. - Future healthcare reforms may impose more rigorous coverage criteria and downward pressure on product pricing, impacting revenue generation[210]. - The company operates in a dynamic environment with numerous risks that could adversely affect its business prospects and financial condition[149].

Core Insights - Evoke Pharma reported a significant revenue increase of 97.8% year-over-year for 2024, reaching approximately $10.2 million, with Q4 2024 revenue up 24.6% from Q3 2024 at $3.3 million [1][4][6] - The company successfully expanded its prescriber base by 46%, achieving a total of 2,553 prescribers, and improved fill rates by 72% year-over-year [4][6] - Evoke raised $14.3 million in net proceeds through financings, ensuring compliance with Nasdaq requirements and extending its cash runway into Q1 2026 [1][4][9] Revenue Growth and Market Expansion - The transition to ASPN Pharmacies significantly enhanced prescription fulfillment rates and patient access to GIMOTI [3][4] - Patient enrollments increased by 22% year-over-year, indicating strong demand for GIMOTI [4] - The company presented compelling healthcare resource utilization data at key gastroenterology conferences, including an award-winning study on GLP-1 users with diabetic gastroparesis [1][4] Financial Position - As of December 31, 2024, cash and cash equivalents stood at approximately $13.6 million, a substantial increase from $4.7 million in 2023 [9][22] - The net loss for Q4 2024 was approximately $1.2 million, a significant reduction from $2.0 million in Q4 2023, while the full-year net loss decreased to approximately $5.4 million from $7.8 million [6][7][24] - Selling, general and administrative expenses rose to approximately $15.1 million for the year, up from $12.2 million in 2023, primarily due to increased marketing costs [7][8] Clinical Validation and Awareness - The company received two new U.S. patent allowances in December 2024, enhancing its intellectual property estate [4] - GIMOTI remains the only FDA-approved product for diabetic gastroparesis in over a decade, especially critical following the discontinuation of domperidone access in the U.S. [4][16] Future Outlook - Evoke projects net revenue of approximately $16 million for 2025, representing a 60% increase from 2024 [11] - The company plans to expand pharmacy partnerships and enhance commercialization efforts, including hiring field reimbursement managers [5][11]

Company Overview - Evoke Pharma, Inc. is a specialty pharmaceutical company focused on treatments for gastrointestinal diseases, particularly with its product Gimoti, a nasal spray formulation of metoclopramide [4] - Gimoti is specifically developed for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults [4] Upcoming Financial Results - The company is scheduled to release its fourth quarter and full year 2024 financial results on March 13, 2025, after market close [1] - A conference call and webcast will be held on the same day at 4:30 p.m. ET to discuss the results, with specific dial-in numbers provided for participants [2] Product Information - Diabetic gastroparesis is a gastrointestinal disorder affecting millions globally, characterized by delayed stomach emptying, which can lead to serious symptoms and complications [5] - Prior to the FDA approval of Gimoti, metoclopramide was only available in oral and injectable forms, making Gimoti the only approved drug in the U.S. for treating gastroparesis [5]

Core Insights - Evoke Pharma, Inc. has appointed Greg Pyszczymuka to its Board of Directors, effective February 20, 2025, marking the second board member appointment by Nantahala Capital Management, indicating confidence in Evoke's commercial strategy and growth potential [1][3] Company Overview - Evoke Pharma is a specialty pharmaceutical company focused on developing treatments for gastrointestinal diseases, particularly GIMOTI, a nasal spray formulation of metoclopramide for diabetic gastroparesis [4][5] - GIMOTI is the only drug currently approved in the United States for treating gastroparesis, which affects millions of patients globally [5] Leadership Background - Greg Pyszczymuka has extensive experience in pharmaceutical sales and market access, currently serving as Chief Commercial Officer at Aytu BioPharma, where he has driven operational profitability and sustainable revenue growth [2][3] - His previous roles include senior commercial leadership positions at Neos Therapeutics and other pharmaceutical companies, contributing to his expertise in commercial strategy and revenue optimization [3] Strategic Goals - The appointment of Pyszczymuka is expected to enhance Evoke's market presence and shareholder value as the company aims to expand access to GIMOTI [3] - Pyszczymuka expressed enthusiasm about joining Evoke at a pivotal time, highlighting opportunities for further adoption and growth of GIMOTI [4]

Core Insights - The FDA has announced that the supply of unapproved domperidone is expected to be exhausted by early 2025, highlighting the urgent need for alternative treatments for gastroparesis [2][4] - GIMOTI, a nasal spray formulation of metoclopramide, is the only FDA-approved treatment for acute and recurrent diabetic gastroparesis, positioning it as a critical option for patients [1][6] - Real-world evidence indicates that GIMOTI significantly reduces emergency room visits by 60% and hospitalizations by 68% compared to oral metoclopramide, demonstrating its clinical effectiveness [4][5] Company Overview - Evoke Pharma, Inc. is a specialty pharmaceutical company focused on developing treatments for gastrointestinal diseases, with GIMOTI being its primary product [5][6] - The company emphasizes its commitment to providing innovative solutions for patients suffering from gastroparesis, particularly as alternative treatments become less accessible [5][6] Market Context - Gastroparesis is a debilitating condition that leads to delayed stomach emptying, causing severe symptoms and complications, which makes effective treatment options essential [3][6] - The discontinuation of domperidone supply underscores the need for safe and effective therapies like GIMOTI, which bypasses the gastrointestinal tract and addresses the core issues of delayed gastric emptying [2][4]