Executive Summary](index=1&type=section&id=1.%20Executive%20Summary) Evoke Pharma reported strong Q1 2025 financial results with significant net product sales growth and improved net loss, alongside strengthening corporate governance and sustained GIMOTI commercial momentum [Q1 2025 Performance Highlights](index=1&type=section&id=1.1.%20Q1%202025%20Performance%20Highlights) Evoke Pharma reported strong Q1 2025 financial results, with net product sales increasing significantly year-over-year, driven by growing prescriber adoption and repeat patient use of GIMOTI. The company also saw an improvement in its net loss Q1 2025 Performance Metrics | Metric | Q1 2025 ($) | Q1 2024 ($) | YoY Change (%) | | :---------------- | :---------- | :---------- | :--------- | | Net Product Sales | $3.1 million | $1.7 million | +77% | | Net Loss | $(1.3) million | $(1.6) million | -18.75% | | Net Loss per Share | $(0.51) | $(2.09) | -75.6% | - Fill rate increased **73% year-over-year**, and the total prescriber base grew by **44%** compared to Q1 last year, indicating strong underlying demand drivers[2](index=2&type=chunk)[6](index=6&type=chunk) [Recent Business Developments](index=1&type=section&id=1.2.%20Recent%20Business%20Developments) The company strengthened its corporate governance with a new board appointment and highlighted sustained commercial momentum for GIMOTI, particularly among GLP-1 patient populations - Appointed Greg Pyszczymuka to the Board of Directors, bringing extensive experience in commercial strategy and revenue growth[3](index=3&type=chunk) - GIMOTI demonstrated solid momentum with strong repeat usage, increasing prescription depth, and stable conversion rates[6](index=6&type=chunk) - Maintained strategic emphasis on GLP-1 patient populations, where the need for effective non-oral options continues to grow[6](index=6&type=chunk) First Quarter 2025 Financial Review](index=1&type=section&id=2.%20First%20Quarter%202025%20Financial%20Review) Evoke Pharma's Q1 2025 financial review highlights substantial net product sales growth, increased operating expenses, a reduced net loss, and a stable cash position projected to fund operations into Q2 2026 [Net Product Sales](index=1&type=section&id=2.1.%20Net%20Product%20Sales) Evoke Pharma reported a substantial increase in net product sales for Q1 2025, reflecting strong commercial execution and market adoption of GIMOTI Net Product Sales Data | Metric | Q1 2025 ($) | Q1 2024 ($) | YoY Change (%) | | :---------------- | :---------- | :---------- | :--------- | | Net Product Sales | $3,080,158 | $1,735,490 | +77.4% | [Operating Expenses](index=2&type=section&id=2.2.%20Operating%20Expenses) Total operating expenses increased in Q1 2025, primarily driven by higher selling, general, and administrative (SG&A) costs due to increased professional fees and profit-sharing activities linked to higher net product sales Operating Expenses Breakdown | Metric | Q1 2025 ($) | Q1 2024 ($) | YoY Change (%) | | :-------------------------------- | :---------- | :---------- | :--------- | | Selling, General, and Administrative | $4,297,505 | $3,139,536 | +36.9% | | Total Operating Expenses | $4,381,901 | $3,236,710 | +35.4% | - The increase in SG&A was due to higher professional fees and reimbursement and profit-sharing activity with EVERSANA as a result of an increase in net product sales[7](index=7&type=chunk) [Net Loss and Earnings Per Share (EPS)](index=1&type=section&id=2.3.%20Net%20Loss%20and%20Earnings%20Per%20Share%20(EPS)) Evoke Pharma reduced its net loss in Q1 2025 compared to the prior year, despite increased operating expenses, leading to a significantly improved net loss per share Net Loss and EPS Summary | Metric | Q1 2025 ($) | Q1 2024 ($) | YoY Change (%) | | :-------------------------------- | :----------- | :----------- | :--------- | | Net Loss | $(1,306,178) | $(1,579,820) | -17.3% | | Net Loss per Share (basic & diluted) | $(0.51) | $(2.09) | -75.6% | - Weighted-average shares used to compute basic and diluted net loss per share increased to 2,548,684 in Q1 2025 from 756,808 in Q1 2024[23](index=23&type=chunk) [Liquidity and Cash Position](index=2&type=section&id=2.4.%20Liquidity%20and%20Cash%20Position) As of March 31, 2025, Evoke Pharma maintained a cash position of $12.6 million and projects its existing cash and future GIMOTI sales to fund operations into Q2 2026 Cash and Cash Equivalents | Metric | March 31, 2025 ($) | | :------------------------ | :------------- | | Cash and cash equivalents | $12,624,090 | - Existing cash and cash equivalents, along with future cash flows from GIMOTI net product sales, are believed to be sufficient to fund operations into the second quarter of 2026[8](index=8&type=chunk) Business Operations and Outlook](index=1&type=section&id=3.%20Business%20Operations%20and%20Outlook) Evoke Pharma's business operations in Q1 2025 showed strong GIMOTI adoption and commercial execution, a strengthened corporate governance, and a reiterated positive 2025 financial outlook [Commercial Execution and GIMOTI Adoption](index=1&type=section&id=3.1.%20Commercial%20Execution%20and%20GIMOTI%20Adoption) GIMOTI continued to demonstrate strong commercial momentum in Q1 2025, marked by increased prescriber confidence, expanded pharmacy partnerships, and a strategic focus on specific patient populations - GIMOTI showed solid momentum in Q1 with strong repeat usage, increasing prescription depth, and stable conversion rates[6](index=6&type=chunk) - Realized a **73% year-over-year** increase in fill rate, driven by expanded pharmacy partnerships and reduced fulfillment friction[6](index=6&type=chunk) - Grew the total prescriber base by **44%**, with increased provider confidence in GIMOTI's efficacy and convenience, and maintained strategic emphasis on GLP-1 patient populations[6](index=6&type=chunk) [Corporate Governance Update](index=1&type=section&id=3.2.%20Corporate%20Governance%20Update) Evoke Pharma strengthened its leadership team with the appointment of a new director to its Board, bringing valuable commercial strategy and revenue growth experience - Appointed Greg Pyszczymuka to the Board of Directors, whose extensive experience in commercial strategy and revenue growth is expected to be valuable[3](index=3&type=chunk) [2025 Financial Outlook](index=2&type=section&id=3.3.%202025%20Financial%20Outlook) Evoke Pharma reiterated its 2025 net product sales guidance, projecting significant growth based on current business momentum and expectations, while acknowledging potential external challenges - Reiterates 2025 net product sales guidance of approximately **$16 million**, reflecting a **60% increase over 2024**[9](index=9&type=chunk) - Confidence in continued growth is driven by focused execution, expanded provider engagement, and GIMOTI's ongoing relevance in a growing diabetic patient population[10](index=10&type=chunk) - Guidance is dependent on current business, growth rates, reimbursement, prescription fills, and external factors such as macroeconomic environment, supply chain constraints, and inflationary pressures[9](index=9&type=chunk) Company and Product Information](index=2&type=section&id=4.%20Company%20and%20Product%20Information) This section provides an overview of Evoke Pharma as a specialty pharmaceutical company and detailed information about its primary product, GIMOTI, including its indication and safety profile [About Evoke Pharma, Inc.](index=2&type=section&id=4.1.%20About%20Evoke%20Pharma,%20Inc.) Evoke Pharma is a specialty pharmaceutical company focused on developing and commercializing treatments for gastrointestinal disorders, with GIMOTI as its primary product for diabetic gastroparesis - Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases[10](index=10&type=chunk) - The company developed, commercialized, and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults[10](index=10&type=chunk) - Diabetic gastroparesis is a GI disorder affecting **millions**, where the stomach takes too long to empty, and metoclopramide remains the only FDA-approved drug in the United States to treat it[11](index=11&type=chunk) [About GIMOTI® (metoclopramide) nasal spray](index=2&type=section&id=4.2.%20About%20GIMOTI%C2%AE%20(metoclopramide)%20nasal%20spray) GIMOTI is a nasal spray formulation of metoclopramide indicated for acute and recurrent diabetic gastroparesis, but carries a serious warning for tardive dyskinesia and has several contraindications and potential adverse reactions [Indication and Mechanism](index=2&type=section&id=4.2.1.%20Indication%20and%20Mechanism) GIMOTI is a nasal spray formulation of metoclopramide indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis - GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis[12](index=12&type=chunk) - It is a nasal spray formulation of metoclopramide, which was previously only available in oral and injectable forms and is the only FDA-approved drug for gastroparesis in the US[10](index=10&type=chunk)[11](index=11&type=chunk) [Important Safety Information and Contraindications](index=2&type=section&id=4.2.2.%20Important%20Safety%20Information%20and%20Contraindications) GIMOTI carries a serious warning for tardive dyskinesia and is contraindicated in several patient populations, with common adverse reactions including dysgeusia, headache, and fatigue - WARNING: TARDIVE DYSKINESIA (TD) – Metoclopramide can cause TD, a serious, often irreversible movement disorder, with risk increasing with treatment duration and cumulative dosage. Treatment should be avoided for longer than **12 weeks**[12](index=12&type=chunk) - GIMOTI is contraindicated in pediatric patients, those with moderate/severe hepatic or renal impairment, history of TD, gastrointestinal hemorrhage/obstruction/perforation, pheochromocytoma, epilepsy, or hypersensitivity to metoclopramide[13](index=13&type=chunk)[17](index=17&type=chunk) - Most common adverse reactions (≥**5%**) for GIMOTI are dysgeusia, headache, and fatigue[13](index=13&type=chunk) Condensed Financial Statements](index=5&type=section&id=5.%20Condensed%20Financial%20Statements) The condensed financial statements for Q1 2025 reflect a decrease in total assets and stockholders' equity, significant growth in net product sales with a reduced net loss, and decreased cash usage from operations [Balance Sheets](index=5&type=section&id=5.1.%20Balance%20Sheets) The balance sheet shows a decrease in total assets and stockholders' equity from December 31, 2024, to March 31, 2025, primarily due to a reduction in cash and cash equivalents and an accumulated deficit Condensed Balance Sheet | Metric | March 31, 2025 ($) | December 31, 2024 ($) | Change ($) | | :-------------------------- | :------------- | :---------------- | :------- | | Cash and cash equivalents | $12,624,090 | $13,596,600 | $(972,510) | | Total current assets | $16,230,875 | $17,237,897 | $(1,007,022) | | Total assets | $16,375,945 | $17,519,007 | $(1,143,062) | | Total current liabilities | $10,451,513 | $10,380,039 | $71,474 | | Total liabilities | $10,534,730 | $10,480,997 | $53,733 | | Total stockholders' equity | $5,841,215 | $7,038,010 | $(1,196,795) | | Accumulated deficit | $(130,097,810) | $(128,791,632) | $(1,306,178) | [Statements of Operations](index=6&type=section&id=5.2.%20Statements%20of%20Operations) For Q1 2025, Evoke Pharma reported a significant increase in net product sales and a reduction in net loss compared to Q1 2024, despite higher operating expenses, leading to a substantially improved net loss per share Condensed Statements of Operations | Metric | 2025 ($) | 2024 ($) | YoY Change (%) | | :-------------------------------- | :----------- | :----------- | :--------- | | Net product sales | $3,080,158 | $1,735,490 | +77.4% | | Cost of goods sold | $41,613 | $92,529 | -55.0% | | Research and development | $42,783 | $4,645 | +821.1% | | Selling, general and administrative | $4,297,505 | $3,139,536 | +36.9% | | Total operating expenses | $4,381,901 | $3,236,710 | +35.4% | | Loss from operations | $(1,301,743) | $(1,501,220) | -13.2% | | Net loss | $(1,306,178) | $(1,579,820) | -17.3% | | Net loss per share (basic & diluted) | $(0.51) | $(2.09) | -75.6% | [Statements of Cash Flows](index=7&type=section&id=5.3.%20Statements%20of%20Cash%20Flows) In Q1 2025, net cash used in operating activities decreased significantly compared to Q1 2024, while net cash provided by financing activities was minimal, resulting in a net decrease in cash and cash equivalents for the period Condensed Statements of Cash Flows | Metric | 2025 ($) | 2024 ($) | Change ($) | | :------------------------------------ | :----------- | :----------- | :----------- | | Net cash used in operating activities | $(997,509) | $(2,579,390) | $(1,581,881) | | Net cash provided by financing activities | $24,999 | $7,542,719 | $(7,517,720) | | Net (decrease) increase in cash | $(972,510) | $4,963,329 | $(5,935,839) | | Cash and cash equivalents at end of period | $12,624,090 | $9,702,755 | $2,921,335 | - The significant decrease in net cash provided by financing activities in 2025 compared to 2024 is due to the absence of proceeds from offerings and warrant amendments that occurred in Q1 2024[25](index=25&type=chunk) Safe Harbor Statement](index=3&type=section&id=6.%20Safe%20Harbor%20Statement) This section provides a cautionary notice regarding forward-looking statements, highlighting inherent risks and uncertainties that could cause actual results to differ from projections [Forward-Looking Statements and Risks](index=3&type=section&id=6.1.%20Forward-Looking%20Statements%20and%20Risks) This section serves as a cautionary notice regarding forward-looking statements made in the press release, emphasizing that actual results may differ due to inherent risks and uncertainties in Evoke's business - Statements included in the press release that are not historical facts are forward-looking, identifiable by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplates,' 'believes,' 'estimates,' 'predicts,' 'potential' or 'continue'[15](index=15&type=chunk) - Forward-looking statements include guidance regarding 2025 net product sales, potential future provider engagement, GIMOTI's relevance, commercialization plans, and expected cash runway[16](index=16&type=chunk) - Actual results may differ due to risks such as inability to achieve guidance, decreased demand for GIMOTI, financing needs, potential termination of EVERSANA agreements, dependence on third-party manufacturers, and GIMOTI's sole product status[16](index=16&type=chunk)[18](index=18&type=chunk) Investor & Media Contact](index=4&type=section&id=7.%20Investor%20%26%20Media%20Contact) This section provides essential contact information for investor and media inquiries [Contact Information](index=4&type=section&id=7.1.%20Contact%20Information) This section provides the contact details for investor and media inquiries - Contact Person: Daniel Kontoh-Boateng, DKB Partners[19](index=19&type=chunk) - Contact Details: Tel: 862-213-1398, Email: dboateng@dkbpartners.net[19](index=19&type=chunk)

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]