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Evoke Pharma(EVOK) - 2025 Q2 - Quarterly Results
Evoke PharmaEvoke Pharma(US:EVOK)2025-08-14 11:05

Executive Summary & Business Update Second Quarter 2025 Highlights Evoke Pharma reported strong Q2 2025 results, with GIMOTI net product sales increasing significantly year-over-year, driven by expanded pharmacy access and increased physician adoption Q2 2025 Net Product Sales | Metric | Q2 2025 ($M) | Q2 2024 ($M) | YoY Change (%) | | :---------------- | :-------- | :-------- | :--------- | | Net Product Sales | $3.8M | $2.6M | +47% | - New prescribers increased 20% year-over-year2 CEO Commentary The CEO highlighted GIMOTI's commercial strength and execution, noting accelerating demand from physicians and patients, improving fill rates, and broadening prescriber adoption, positioning GIMOTI as an essential treatment option for diabetic gastroparesis - CEO Matt D'Onofrio stated, "This quarter's results demonstrate the commercial strength of GIMOTI and the precision of our execution."2 - Demand is accelerating from both physicians and patients, with improving fill rates and broadening prescriber adoption across GI practices2 Financial Results Overview Second Quarter 2025 Financial Performance Evoke Pharma reported a net loss of $1.6 million for Q2 2025, an increase from $1.3 million in Q2 2024, despite a significant increase in net product sales Q2 2025 Key Financials | Metric | Q2 2025 (USD) | Q2 2024 (USD) | | :---------------- | :-------- | :-------- | | Net Product Sales | $3.8M | $2.6M | | Net Loss | $1.6M | $1.3M | | EPS | ($0.62) | ($0.93) | Operating Expenses Total operating expenses increased to $5.3 million in Q2 2025 from $3.8 million in Q2 2024, primarily due to higher selling, general, and administrative (SG&A) expenses driven by increased profit-sharing with EVERSANA and professional fees Q2 2025 Operating Expenses | Expense Category | Q2 2025 ($M) | Q2 2024 ($M) | | :----------------------- | :-------- | :-------- | | Selling, General, & Admin | $5.1M | $3.7M | | Total Operating Expenses | $5.3M | $3.8M | - Increase in SG&A was due to higher profit-sharing activity with EVERSANA and higher professional fees5 Cash Position and Runway As of June 30, 2025, Evoke Pharma had $12.1 million in cash and cash equivalents, which is projected to fund operations into the third quarter of 2026 Cash and Cash Equivalents | Metric | As of June 30, 2025 (USD) | | :---------------------- | :------------------ | | Cash and Cash Equivalents | ~$12.1 million | - Existing cash and future cash flows from GIMOTI net product sales are believed to be sufficient to fund operations into the third quarter of 20266 2025 Outlook and Business Developments 2025 Revenue Outlook Evoke Pharma confirmed its full-year 2025 net product sales guidance of approximately $16 million, representing up to a 60% increase over 2024, based on current business outlook, prescription growth, refill rates, and expanded pharmacy access Full-Year 2025 Net Product Sales Guidance | Metric | Guidance | | :------------------------ | :------------- | | Full-Year 2025 Net Product Sales | ~$16 million | | Projected YoY Increase over 2024 | Up to 60% | - Guidance reflects current business outlook, including recent trends in prescription growth and refill rates, expanded pharmacy access, and continued adoption of GIMOTI78 Key Business Developments Recent business developments include a 20% year-over-year growth in new prescribers, steady refill rates of approximately 70%, and the presentation of real-world safety data for GIMOTI at Digestive Disease Week (DDW) 2025 - New prescribers grew 20% year-over-year, continuing a positive trend of clinical adoption7 - Refill rates held steady at approximately 70%, reflecting consistent therapeutic benefit7 - Presented real-world safety data at Digestive Disease Week (DDW) 2025, comparing incidence of tardive dyskinesia among continuous versus intermittent metoclopramide use7 Company and Product Information About Evoke Pharma, Inc. Evoke Pharma is a specialty pharmaceutical company focused on developing and commercializing drugs for gastrointestinal (GI) disorders, with GIMOTI, a nasal spray formulation of metoclopramide, being its primary product for diabetic gastroparesis - Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases9 - Evoke developed, commercialized, and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults9 - Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, where the stomach takes too long to empty its contents10 About GIMOTI® (metoclopramide) nasal spray GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis, but carries a WARNING for tardive dyskinesia (TD) and has several contraindications and potential adverse reactions Indication and Important Safety Information GIMOTI is indicated for symptom relief in adults with acute and recurrent diabetic gastroparesis, but comes with a significant warning regarding tardive dyskinesia - GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis11 - WARNING: TARDIVE DYSKINESIA (TD), a serious movement disorder that is often irreversible, is associated with metoclopramide use1112 Warnings and Contraindications GIMOTI is not recommended for use in pediatric patients, those with moderate to severe hepatic or renal impairment, or concurrent use of strong CYP2D6 inhibitors. It is contraindicated in patients with a history of TD, conditions where GI motility stimulation is dangerous, pheochromocytoma, epilepsy, or hypersensitivity to metoclopramide - GIMOTI is not recommended for use in pediatric patients, or patients with moderate/severe hepatic or renal impairment, or those concurrently using strong CYP2D6 inhibitors12 - Contraindications include a history of tardive dyskinesia, gastrointestinal hemorrhage/obstruction/perforation, pheochromocytoma, epilepsy, or hypersensitivity to metoclopramide1213 - Treatment with metoclopramide (all dosage forms) should be avoided for longer than 12 weeks due to increased risk of developing TD12 Potential Adverse Reactions Potential adverse reactions include tardive dyskinesia, other extrapyramidal effects, parkinsonism symptoms, neuroleptic malignant syndrome, depression, hypertension, and hyperprolactinemia. The most common adverse reactions (≥5%) are dysgeusia, headache, and fatigue - Potential adverse reactions include Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, and hyperprolactinemia13 - Most common adverse reactions (≥5%) for GIMOTI are dysgeusia, headache, and fatigue13 Financial Statements Balance Sheets As of June 30, 2025, total assets decreased to $16.06 million from $17.52 million at December 31, 2024, primarily due to a decrease in cash and cash equivalents. Total liabilities increased to $11.69 million from $10.48 million, while total stockholders' equity decreased Balance Sheet Data (in USD) | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $12,059,072 | $13,596,600 | -$1,537,528 | | Total current assets | $15,931,078 | $17,237,897 | -$1,306,819 | | Total assets | $16,060,328 | $17,519,007 | -$1,458,679 | | Total current liabilities | $11,620,808 | $10,380,039 | +$1,240,769 | | Total liabilities | $11,685,836 | $10,480,997 | +$1,204,839 | | Total stockholders' equity | $4,374,492 | $7,038,010 | -$2,663,518 | Statements of Operations For the three months ended June 30, 2025, net product sales increased by 47% year-over-year, but the net loss widened to $1.57 million from $1.27 million in the prior year, primarily due to increased operating expenses, particularly selling, general, and administrative costs Statements of Operations (Three Months Ended June 30, in USD) | Metric | 2025 | 2024 | YoY Change | | :-------------------------- | :----------- | :----------- | :--------- | | Net product sales | $3,752,142 | $2,551,366 | +47.06% | | Cost of goods sold | $167,679 | $41,478 | +304.26% | | Selling, general and administrative | $5,134,902 | $3,733,450 | +37.55% | | Total operating expenses | $5,310,994 | $3,774,928 | +40.67% | | Net loss | $(1,570,976) | $(1,267,218) | +24.00% | | Net loss per share (basic and diluted) | $(0.62) | $(0.93) | -33.33% | Statements of Operations (Six Months Ended June 30, in USD) | Metric | 2025 | 2024 | YoY Change | | :-------------------------- | :----------- | :----------- | :--------- | | Net product sales | $6,832,300 | $4,286,856 | +59.40% | | Net loss | $(2,877,154) | $(2,847,038) | +1.06% | | Net loss per share (basic and diluted) | $(1.13) | $(2.69) | -57.99% | Statements of Cash Flows For the six months ended June 30, 2025, net cash used in operating activities decreased significantly to $1.56 million from $3.40 million in the prior year, primarily due to changes in operating assets and liabilities. Net cash provided by financing activities was minimal in 2025 compared to substantial proceeds in 2024 from offerings and warrant exercises Statements of Cash Flows (Six Months Ended June 30, in USD) | Metric | 2025 | 2024 | | :---------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(1,562,527) | $(3,400,005) | | Net cash provided by financing activities | $24,999 | $7,838,415 | | Cash and cash equivalents at end of period | $12,059,072 | $9,177,836 | Legal and Contact Information Safe Harbor Statement This section serves as a cautionary statement regarding forward-looking statements in the press release, emphasizing that actual results may differ due to inherent risks and uncertainties in Evoke's business, including market demand for GIMOTI, financing needs, dependence on third parties, and intellectual property protection - Forward-looking statements include guidance regarding 2025 net product sales, demand for GIMOTI, its ongoing relevance, and Evoke's expected cash runway16 - Actual results may differ due to risks such as decreased demand for GIMOTI, ability to drive market demand, need for additional financing, potential termination of EVERSANA agreement, dependence on third parties for manufacturing, and intellectual property protection16 Investor & Media Contact Provides contact information for investor and media inquiries - Investor & Media Contact: Daniel Kontoh-Boateng, DKB Partners, Tel: 862-213-1398, dboateng@dkbpartners.net17