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Evoke Pharma(EVOK) - 2025 Q1 - Quarterly Results
Evoke PharmaEvoke Pharma(US:EVOK)2025-05-13 20:15

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 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) | $(2.09) | -75.6% | - Fill rate increased 73% year-over-year, and the total prescriber base grew by 44% compared to Q1 last year, indicating strong underlying demand drivers26 Recent Business Developments The company strengthened its corporate governance with a new board appointment and highlighted sustained commercial momentum for GIMOTI, particularly among GLP-1 patient populations - Appointed Greg Pyszczymuka to the Board of Directors, bringing extensive experience in commercial strategy and revenue growth3 - GIMOTI demonstrated solid momentum with strong repeat usage, increasing prescription depth, and stable conversion rates6 - Maintained strategic emphasis on GLP-1 patient populations, where the need for effective non-oral options continues to grow6 First Quarter 2025 Financial Review](index=1&type=section&id=2.%20First%20Quarter%202025%20Financial%20Review) Evoke Pharma's Q1 2025 financial review highlights substantial net product sales growth, increased operating expenses, a reduced net loss, and a stable cash position projected to fund operations into Q2 2026 Net Product Sales Evoke Pharma reported a substantial increase in net product sales for Q1 2025, reflecting strong commercial execution and market adoption of GIMOTI Net Product Sales Data | Metric | Q1 2025 ($) | Q1 2024 ($) | YoY Change (%) | | :---------------- | :---------- | :---------- | :--------- | | Net Product Sales | $3,080,158 | $1,735,490 | +77.4% | Operating Expenses Total operating expenses increased in Q1 2025, primarily driven by higher selling, general, and administrative (SG&A) costs due to increased professional fees and profit-sharing activities linked to higher net product sales Operating Expenses Breakdown | Metric | Q1 2025 ($) | Q1 2024 ($) | YoY Change (%) | | :-------------------------------- | :---------- | :---------- | :--------- | | Selling, General, and Administrative | $4,297,505 | $3,139,536 | +36.9% | | Total Operating Expenses | $4,381,901 | $3,236,710 | +35.4% | - The increase in SG&A was due to higher professional fees and reimbursement and profit-sharing activity with EVERSANA as a result of an increase in net product sales7 Net Loss and Earnings Per Share (EPS) Evoke Pharma reduced its net loss in Q1 2025 compared to the prior year, despite increased operating expenses, leading to a significantly improved net loss per share Net Loss and EPS Summary | Metric | Q1 2025 ($) | 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 202423 Liquidity and Cash Position 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 20268 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 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 rates6 - Realized a 73% year-over-year increase in fill rate, driven by expanded pharmacy partnerships and reduced fulfillment friction6 - 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 populations6 Corporate Governance Update 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 valuable3 2025 Financial Outlook 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 20249 - Confidence in continued growth is driven by focused execution, expanded provider engagement, and GIMOTI's ongoing relevance in a growing diabetic patient population10 - Guidance is dependent on current business, growth rates, reimbursement, prescription fills, and external factors such as macroeconomic environment, supply chain constraints, and inflationary pressures9 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. 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 diseases10 - 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 adults10 - 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 it11 About GIMOTI® (metoclopramide) nasal spray 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 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 gastroparesis12 - 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 US1011 Important Safety Information and Contraindications 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 weeks12 - 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 metoclopramide1317 - Most common adverse reactions (≥5%) for GIMOTI are dysgeusia, headache, and fatigue13 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 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) | $(1,306,178) | Statements of Operations For Q1 2025, Evoke Pharma reported a significant increase in net product sales and a reduction in net loss compared to Q1 2024, despite higher operating expenses, leading to a substantially improved net loss per share Condensed Statements of Operations | Metric | 2025 ($) | 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) | $(2.09) | -75.6% | Statements of Cash Flows In Q1 2025, net cash used in operating activities decreased significantly compared to Q1 2024, while net cash provided by financing activities was minimal, resulting in a net decrease in cash and cash equivalents for the period Condensed Statements of Cash Flows | Metric | 2025 ($) | 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 202425 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 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 - Forward-looking statements include guidance regarding 2025 net product sales, potential future provider engagement, GIMOTI's relevance, commercialization plans, and expected cash runway16 - 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 status1618 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 This section provides the contact details for investor and media inquiries - Contact Person: Daniel Kontoh-Boateng, DKB Partners19 - Contact Details: Tel: 862-213-1398, Email: dboateng@dkbpartners.net19