Evoke Pharma(EVOK)

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Evoke Pharma(EVOK) - 2025 Q2 - Quarterly Results
2025-08-14 11:05
Evoke Pharma Reports Second Quarter 2025 Financial Results and Provides Business Update Q2 2025 Net Product Sales Increased 47% Year-over-Year to $3.8 Million SOLANA BEACH, Calif., August 14, 2025 (GLOBE NEWSWIRE) – Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI® (metoclopramide) nasal spray, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. " ...
Evoke Pharma(EVOK) - 2025 Q2 - Quarterly Report
2025-08-14 11:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR EVOKE PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-8447886 (State or other jurisdiction of incorporation) (IRS Employer Id ...
Evoke Pharma Announces Issuance of New U.S. Patent for GIMOTI With Extended Exclusivity to Late 2038
Globenewswire· 2025-08-06 10:30
Extends market exclusivity for GIMOTI® to November 2038, nearly two additional years beyond original 2036 projectionSOLANA BEACH, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced the official issuance of a new U.S. patent related to its product GIMOTI®. The patent, U.S. Patent No. 12,377,064, covers the use ...
Evoke Pharma Receives Notice of Allowance for U.S. Patent Application for GIMOTI Extending Orange Book listings to 2036
Globenewswire· 2025-07-09 12:16
Core Insights - Evoke Pharma, Inc. has received a Notice of Allowance from the USPTO for a patent application related to GIMOTI® nasal spray, extending patent exclusivity by an additional 6 years, expected to expire in December 2036 [1][2] Company Overview - Evoke Pharma is a specialty pharmaceutical company focused on developing treatments for gastrointestinal diseases, particularly through its product GIMOTI®, a nasal spray formulation of metoclopramide [6] - GIMOTI® is the only FDA-approved non-oral, self-administered formulation of metoclopramide, indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults [5][7] Product Significance - The new patent allowance enhances the GIMOTI® franchise by providing additional protection for its use in patients with moderate to severe symptoms of gastroparesis, a condition that complicates the absorption of oral medications [2][3] - GIMOTI® addresses a significant need in the market as gastroparesis affects millions globally, leading to serious gastrointestinal symptoms and complications [7] Market Commitment - The company is committed to supporting the gastroparesis community and will participate in Gastroparesis Awareness Month to improve treatment options and disease awareness [4]
Evoke Pharma(EVOK) - 2025 Q1 - Quarterly Report
2025-05-13 20:20
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited statements show sales growth but also net losses and substantial doubt about its going concern status [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Total assets and stockholders' equity decreased as of March 31, 2025, primarily due to a reduction in cash Condensed Balance Sheet Data (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $12,624,090 | $13,596,600 | | Total current assets | $16,230,875 | $17,237,897 | | Total assets | $16,375,945 | $17,519,007 | | Total current liabilities | $10,451,513 | $10,380,039 | | Total liabilities | $10,534,730 | $10,480,997 | | Total stockholders' equity | $5,841,215 | $7,038,010 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Net product sales grew significantly year-over-year, while the net loss per share improved Q1 2025 vs Q1 2024 Statement of Operations (Unaudited) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net product sales | $3,080,158 | $1,735,490 | | Loss from operations | $(1,301,743) | $(1,501,220) | | Net loss | $(1,306,178) | $(1,579,820) | | Net loss per share, basic and diluted | $(0.51) | $(2.09) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased significantly, though financing activities provided minimal cash in Q1 2025 Q1 2025 vs Q1 2024 Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(997,509) | $(2,579,390) | | Net cash provided by financing activities | $24,999 | $7,542,719 | | Net (decrease) increase in cash | $(972,510) | $4,963,329 | | Cash and cash equivalents at end of period | $12,624,090 | $9,702,755 | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes highlight a going concern risk, dependency on its sole product, and details of its partner agreement with Eversana - Management has concluded there is **substantial doubt about the Company's ability to continue as a going concern** for one year, due to recurring losses, negative cash flows, and the potential for its partner Eversana to terminate their agreement and demand repayment of a **$7.2 million loan** within 90 days[23](index=23&type=chunk) - A **1-for-12 reverse stock split** was effective on August 1, 2024, and all share and per-share data have been retroactively adjusted[26](index=26&type=chunk)[27](index=27&type=chunk) - Under the Eversana agreement, Evoke records sales for Gimoti and retains over **80% of net product profits** after both parties' costs are reimbursed, with unreimbursed commercialization costs owed to Eversana at approximately **$77.5 million** as of March 31, 2025[74](index=74&type=chunk) - The company has a **$5.0 million revolving credit facility** from Eversana, with **$7.2 million outstanding** including interest as of March 31, 2025, which is classified as a current liability due to the risk of accelerated repayment[23](index=23&type=chunk)[78](index=78&type=chunk)[80](index=80&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strong sales growth for Gimoti®, ongoing going concern risks, and its current liquidity position - The company's existing cash of **$12.6 million** is expected to fund operations into Q2 2026, but this forecast excludes the potential early repayment of the Eversana loan, leading to **substantial doubt about its ability to continue as a going concern**[97](index=97&type=chunk) - The company regained compliance with Nasdaq's minimum bid price and minimum stockholders' equity requirements but is subject to a **discretionary panel monitor through June 4, 2025**[98](index=98&type=chunk)[101](index=101&type=chunk) Gimoti Sales Metrics - Q1 2025 vs Q1 2024 | Metric | Change | Detail | | :--- | :--- | :--- | | Net Product Sales | +77% | $3.1M in Q1 2025 vs $1.7M in Q1 2024 | | New Inbound Prescriptions | +25% | 1,793 new prescriptions in Q1 2025 | | Refill Rate | ~70% | For patients who have completed their first fill | | New Prescribers | +9.6% | Cumulative increase during Q1 2025 | [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Q1 2025 saw a 77% increase in net product sales, offset by higher SG&A expenses tied to marketing and profit sharing Comparison of Operations for Three Months Ended March 31, (2025 vs 2024) | Item | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $3,080,158 | $1,735,490 | $1,344,668 | 77% | | Cost of goods sold | $41,613 | $92,529 | $(50,916) | -55% | | Research and development expenses | $42,783 | $4,645 | $38,138 | 821% | | Selling, general and administrative expenses | $4,297,505 | $3,139,536 | $1,157,969 | 37% | - The increase in SG&A was primarily due to a **$1.2 million rise in marketing and Eversana profit sharing** directly resulting from increased net product sales[121](index=121&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity risk from a potential loan acceleration by its partner, creating substantial going concern doubt - The company has a **$5.0 million revolving credit facility** from Eversana, with **$7.2 million outstanding** including interest as of March 31, 2025, and repayment could be accelerated if Eversana exercises its termination right (NPQTR)[124](index=124&type=chunk)[125](index=125&type=chunk) - Management believes there is **substantial doubt about the company's ability to continue as a going concern** for one year due to the risk of the Eversana loan acceleration and ongoing losses[125](index=125&type=chunk) Cash Flow Summary Change (Q1 2025 vs Q1 2024) | Cash Flow Activity | Q1 2025 | Q1 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) | [Quantitative and Qualitative Disclosures about Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exempt from this disclosure requirement as a smaller reporting company - The company is not required to provide information for this item as it qualifies as a **smaller reporting company**[131](index=131&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes to internal controls - Based on an evaluation as of March 31, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's **disclosure controls and procedures were effective** at a reasonable assurance level[134](index=134&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, internal controls[135](index=135&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no current legal proceedings - None[137](index=137&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor was added concerning potential impacts from U,S, tariff and import/export regulations - A new risk factor has been added regarding changes to **U.S. tariff and import/export regulations**, which could negatively affect the business due to reliance on international third-party manufacturers for Gimoti in Italy and France[138](index=138&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None[139](index=139&type=chunk) [Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted, modified, or terminated Rule 10b5-1 trading plans during the quarter - No officers or directors adopted, modified, or terminated any **Rule 10b5-1 trading plans** during the three months ended March 31, 2025[140](index=140&type=chunk) [Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including officer certifications and XBRL data
Evoke Pharma(EVOK) - 2025 Q1 - Quarterly Results
2025-05-13 20:15
Evoke Pharma Reports First Quarter 2025 Financial Results and Provides Business Update Q1 2025 Net Product Sales Increased 77% Year-over-Year to $3.1 Million Sustained Momentum Driven by Growing Prescriber Adoption and Repeat Patient Use SOLANA BEACH, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI ®, today announced financial results for the first quarter ended ...
Evoke Pharma Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-13 20:05
Q1 2025 Net Product Sales Increased 77% Year-over-Year to $3.1 Million Sustained Momentum Driven by Growing Prescriber Adoption and Repeat Patient Use SOLANA BEACH, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI®, today announced financial results for the first quarter ended March 31, 2025, and provided a business update. “We’re pleased to report continued stro ...
Evoke Pharma to Present New Data Comparing Tardive Dyskinesia Incidence in Continuous vs Intermittent Metoclopramide Use at DDW 2025
Globenewswire· 2025-04-28 12:30
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]
Evoke Pharma(EVOK) - 2024 Q4 - Earnings Call Presentation
2025-03-26 20:04
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]
Evoke Pharma(EVOK) - 2024 Q4 - Earnings Call Transcript
2025-03-14 03:33
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]