4Q/FY 2024 Earnings Call March 13, 2025 Disclaimers Evoke cautions you that statements included in this presentation that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. Th ...

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]

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]

Core Viewpoint - Evoke Pharma has received notices of allowance for two U.S. patent applications, enhancing its intellectual property for GIMOTI® (metoclopramide) nasal spray, which is the only FDA-approved non-oral therapy for diabetic gastroparesis in the U.S. [1][2] Group 1: Patent Applications - The two patent applications, U.S. 17/366,839 and U.S. 17/366,818, focus on "Nasal Formulations of Metoclopramide," providing additional claims for intranasal administration of metoclopramide for treating gastroparesis [2] - These patents are expected to be Orange Book listable and will expire at the end of 2029, further solidifying the company's market position [2] Group 2: Product Efficacy - GIMOTI offers a reliable treatment option by bypassing the gastrointestinal tract, addressing the challenge of effective drug absorption in patients with gastroparesis [3] - The CEO of Evoke Pharma emphasized that GIMOTI is a groundbreaking therapy, with data showing that many patients find relief with this nasal spray compared to oral medications [4] Group 3: Market Context - Diabetic gastroparesis affects millions globally, leading to delayed stomach emptying and serious gastrointestinal symptoms, which can compromise the efficacy of orally administered medications [6] - Prior to GIMOTI's FDA approval, metoclopramide was only available in oral and injectable forms, making GIMOTI the only approved drug in the U.S. for treating gastroparesis [6]

Financial Performance - Gimoti net product sales for the quarter ended September 30, 2024, were approximately $2.7 million, reflecting a $0.1 million increase compared to the previous quarter[64]. - Net product sales for the three months ended September 30, 2024, increased by approximately $1.1 million, a 70% change compared to the same period in 2023, totaling $2,654,186[79]. - For the nine months ended September 30, 2024, net product sales reached $6,941,042, representing a 98% increase compared to $3,504,636 in 2023[80]. - Net product sales increased by approximately $3.4 million for the nine months ended September 30, 2024, compared to the same period in 2023, driven by increased product adoption and a larger pharmacy network[82]. Expenses and Financial Challenges - The company incurred losses since inception, with ongoing operating losses expected until revenues from Gimoti exceed expenses[60]. - Selling, general and administrative expenses for the three months ended September 30, 2024, increased by approximately $692,753, totaling $3,824,142, a 22% change compared to 2023[79]. - Selling, general and administrative expenses increased by approximately $2.0 million for the nine months ended September 30, 2024, with significant costs in wages, marketing, and legal expenses[82]. - Research and development expenses for the three months ended September 30, 2024, were $11,677, compared to no expenses in the same period in 2023[79]. - Research and development expenses decreased by approximately $0.1 million for the nine months ended September 30, 2024, due to reduced ongoing stability testing costs[82]. - The company anticipates needing to raise additional funds to continue operations, as existing cash may not be sufficient beyond 12 months from the report date[60]. - The company anticipates needing to raise additional funds through various financing methods to support ongoing operations and achieve profitability[83]. Cash and Financing - As of September 30, 2024, the company had cash and cash equivalents of approximately $11.3 million, expected to fund operations into the fourth quarter of 2025[60]. - Cash provided by financing activities was $10.8 million for the nine months ended September 30, 2024, primarily from stock sales and warrant exercises[86]. - The company raised approximately $6.2 million from a public offering of common stock units in February 2024[84]. Compliance and Corporate Actions - The company received a notice from Nasdaq regarding non-compliance with the minimum stockholders' equity requirement, with stockholders' equity reported at $3.5 million as of March 31, 2024[61]. - A reverse stock split was executed on August 1, 2024, combining every twelve shares into one to regain compliance with Nasdaq's minimum bid price requirement[62]. - The company entered into a lease amendment extending the office lease term to March 31, 2027, with an initial monthly base rent of approximately $6,500[86]. Product Development and Market Strategy - The company launched commercial sales of Gimoti in October 2020, with modest sales generated to date[60]. - Future product development and commercialization strategies are critical for the company's financial sustainability and growth[58]. - The company is in discussions with the FDA regarding a post-marketing commitment clinical trial for Gimoti to assess dose proportionality for a lower dose strength[74]. - The company expects to incur expenses related to the commercialization of Gimoti, including a post-marketing PK clinical trial[87]. Market Impact and Patient Outcomes - A study indicated that diabetic gastroparesis patients using Gimoti had reduced healthcare costs by approximately $15,000 over six months compared to those using oral metoclopramide[59]. - A study presented at ACG 2024 showed that all-cause emergency department visits decreased by 55% for patients using nasal metoclopramide compared to those using oral metoclopramide[67]. - Approximately 34% of filled prescriptions for Gimoti were covered by Medicare and Medicaid programs for the nine months ended September 30, 2024[66]. - The ASPN platform has improved the proportion of prescriptions covered by insurance payors through enhanced patient communication and electronic automation[65]. - New prescribers increased by 8% during the quarter ended September 30, 2024[65]. Cost of Goods Sold - The cost of goods sold for the three months ended September 30, 2024, increased by approximately $69,116, a 198% change compared to the same period in 2023[79]. - Cost of goods sold rose by approximately $0.1 million for the nine months ended September 30, 2024, primarily due to stability testing completion timing[82].

Core Insights - Evoke Pharma, Inc. is set to present two posters at the American College of Gastroenterology Annual Scientific Meeting, highlighting the use of its product Gimoti® (metoclopramide) nasal spray in treating gastrointestinal diseases [1] - One of the posters, P3339, has received the ACG's Outstanding Research Award and the Presidential Poster Award, indicating its high impact and excellence in research [1] Company Overview - Evoke Pharma is a specialty pharmaceutical company focused on developing treatments for gastrointestinal disorders, particularly diabetic gastroparesis [2] - Gimoti is a nasal spray formulation of metoclopramide, specifically designed for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults [2] - Diabetic gastroparesis affects millions globally, causing delayed gastric emptying and serious gastrointestinal symptoms, with Gimoti being the only FDA-approved treatment for this condition in the U.S. [2]