Evoke Pharma(EVOK)

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Evoke Pharma(EVOK) - 2022 Q2 - Quarterly Report
2022-08-09 16:00
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed financial statements for the period ended June 30, 2022, show increased net product sales but continued net losses, with cash and equivalents at **$13.5 million** and a going concern uncertainty [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2022, cash and cash equivalents increased to **$13.5 million**, total assets grew to **$14.4 million**, and stockholders' equity rose to **$7.2 million** due to financing activities Condensed Balance Sheet Data (Unaudited) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $13,450,949 | $9,144,710 | | Total current assets | $14,404,396 | $10,560,734 | | **Total assets** | **$14,404,396** | **$10,573,162** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $1,353,146 | $1,405,773 | | Total liabilities | $7,213,386 | $7,018,068 | | Total stockholders' equity | $7,191,010 | $3,555,094 | | **Total liabilities and stockholders' equity** | **$14,404,396** | **$10,573,162** | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) For the three and six months ended June 30, 2022, net product sales significantly grew, and net loss narrowed to **$2.2 million** for Q2 2022 and **$4.4 million** for the six-month period Statement of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $461,795 | $236,635 | $880,175 | $327,056 | | Loss from operations | ($2,112,632) | ($2,168,996) | ($4,163,805) | ($4,759,445) | | Net loss | ($2,233,380) | ($2,290,643) | ($4,407,045) | ($4,896,138) | | Net loss per share | ($0.71) | ($0.85) | ($1.50) | ($1.85) | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2022, net cash used in operating activities improved to **$3.0 million**, with **$7.3 million** provided by financing activities, resulting in a **$4.3 million** net increase in cash Cash Flow Summary (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,988,737) | ($4,463,608) | | Net cash provided by financing activities | $7,294,976 | $13,115,608 | | Net increase in cash and cash equivalents | $4,306,239 | $8,652,000 | | Cash and cash equivalents at end of period | $13,450,949 | $16,720,939 | - The company has incurred recurring losses and negative cash flows since inception, raising substantial doubt about its ability to continue as a going concern for one year, requiring additional funding[18](index=18&type=chunk) - In May 2022, the company effected a **1-for-12 reverse stock split** to regain compliance with Nasdaq's minimum bid price requirement, successfully achieved in June 2022[22](index=22&type=chunk) - The company is in litigation with Teva Pharmaceuticals, alleging patent infringement after Teva submitted an Abbreviated New Drug Application (ANDA) for a generic version of Gimoti[30](index=30&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Gimoti's commercialization, noting an **11% quarter-over-quarter sales increase** in Q2 2022, but acknowledges a history of losses and substantial doubt about going concern, with current cash projected to last only into Q2 2023 - The company believes its existing cash of approximately **$13.5 million** as of June 30, 2022, will be sufficient to fund operations into the second quarter of 2023, but substantial doubt exists about its ability to continue as a going concern[41](index=41&type=chunk)[53](index=53&type=chunk) - Gimoti net product sales were approximately **$462,000** in Q2 2022, an **11% increase** from Q1 2022, with new inbound prescriptions growing **24%** and a patient refill rate of approximately **67%**[46](index=46&type=chunk) Comparison of Operations (Six Months Ended June 30) | Metric | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $880,175 | $327,056 | +$553,119 | | Research and development expenses | $233,194 | $473,054 | -$239,860 | | Selling, general and administrative expenses | $4,720,251 | $4,480,443 | +$239,808 | - During the six months ended June 30, 2022, the company sold **621,697 shares** of common stock under its ATM Sales Agreement, receiving net proceeds of approximately **$7.3 million**[53](index=53&type=chunk)[56](index=56&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Evoke Pharma, Inc. is not required to provide the information for this item - The company is not required to provide information for this item as it qualifies as a smaller reporting company[58](index=58&type=chunk) [Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2022, the Chief Executive Officer and Chief Business Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[59](index=59&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[59](index=59&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in patent litigation against Teva Pharmaceuticals, alleging infringement after Teva submitted an ANDA for a generic version of Gimoti - On February 25, 2022, Teva Pharmaceuticals submitted an ANDA for a generic version of Gimoti, with Paragraph IV certifications alleging that two of Evoke's patents are invalid or will not be infringed[60](index=60&type=chunk) - In April 2022, Evoke initiated litigation against Teva in the U.S. District Court for the District of New Jersey, alleging patent infringement, which Teva has denied and counterclaimed[62](index=62&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) The primary risk factor is the company's need for substantial additional funding to continue operations, with existing cash projected to last only into Q2 2023, risking liquidation if capital cannot be raised - The company requires substantial additional funding and may be unable to raise capital when needed, which would force it to liquidate, dissolve, or wind down operations[63](index=63&type=chunk) - Cash and cash equivalents of **$13.5 million** as of June 30, 2022, are expected to fund operations only into the second quarter of 2023[63](index=63&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[63](index=63&type=chunk) [Defaults Upon Senior Securities](index=24&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[63](index=63&type=chunk) [Mine Safety Disclosures](index=25&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[64](index=64&type=chunk) [Other Information](index=25&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - None[64](index=64&type=chunk) [Exhibits](index=26&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed with this Quarterly Report on Form 10-Q, including corporate governance documents, certifications, and XBRL data files
Evoke Pharma(EVOK) - 2022 Q1 - Earnings Call Transcript
2022-05-10 23:11
Evoke Pharma, Inc. EVOK Q1 2022 Earnings Conference Call May 10, 2022 4:30 PM ET Company Participants David Gonyer – Chief Executive Officer Chris Quesenberry – Chief Commercial Officer, EVERSANA Matthew D'Onofrio – Chief Business Officer Daniel Kontoh-Boateng – Investor Relations Conference Call Participants Yale Jen – Laidlaw and Company Mitchell Kapoor – H.C. Wainwright & Co., LLC Operator Please stand by. Your program is about to begin. [Operator Instructions] Good afternoon and welcome to the Evoke Pha ...
Evoke Pharma(EVOK) - 2022 Q1 - Quarterly Report
2022-05-09 16:00
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited Q1 2022 financials show increased sales, continued net loss, negative cash flow, and substantial doubt about going concern [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to $9.0 million by March 31, 2022, primarily due to reduced cash, with total equity declining to $1.9 million Condensed Balance Sheet Data (in USD) | Financial Metric | March 31, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $7,701,201 | $9,144,710 | | Total current assets | $9,026,270 | $10,560,734 | | Total assets | $9,026,270 | $10,573,162 | | Total current liabilities | $1,356,676 | $1,405,773 | | Total liabilities | $7,092,259 | $7,018,068 | | Total stockholders' equity | $1,934,011 | $3,555,094 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Net product sales significantly increased to $418,380 in Q1 2022, narrowing the net loss to $2.17 million from $2.61 million year-over-year Condensed Statement of Operations (in USD) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net product sales | $418,380 | $90,421 | | Total operating expenses | $2,469,552 | $2,680,871 | | Loss from operations | ($2,051,172) | ($2,590,450) | | Net loss | ($2,173,665) | ($2,605,495) | | Net loss per share | ($0.07) | ($0.08) | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased to $1.93 million by March 31, 2022, primarily due to a $2.17 million net loss, partially offset by stock-based compensation - The net loss for the quarter of **$2,173,665** was the primary driver for the reduction in total stockholders' equity[13](index=13&type=chunk) - In contrast, for the three months ended March 31, 2021, stockholders' equity increased significantly from a deficit of **($3.2 million)** to **$7.8 million**, mainly due to the issuance of common stock that raised net proceeds of approximately **$13.1 million**[13](index=13&type=chunk)[47](index=47&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations improved to $1.6 million in Q1 2022, but minimal financing activities led to a $1.4 million net cash decrease for the quarter Condensed Statement of Cash Flows (in USD) | Cash Flow Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,615,030) | ($2,953,119) | | Net cash provided by financing activities | $171,521 | $13,070,154 | | Net (decrease) increase in cash | ($1,443,509) | $10,117,035 | | Cash at end of period | $7,701,201 | $18,185,974 | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes disclose Gimoti® as the sole product, substantial doubt about going concern, a Nasdaq delisting notice, and patent litigation against Teva Pharmaceuticals - The company has incurred recurring losses and negative cash flows, leading to **substantial doubt about its ability to continue as a going concern** for one year[22](index=22&type=chunk) - In February 2022, Teva Pharmaceuticals submitted an ANDA for a generic version of Gimoti, leading Evoke to initiate patent infringement litigation in April 2022[45](index=45&type=chunk) - The company has a commercial services agreement with Eversana to commercialize Gimoti, with unreimbursed commercialization costs to Eversana approximately **$32.7 million** as of March 31, 2022[56](index=56&type=chunk) - The company received a delisting notice from Nasdaq in December 2021 for its stock price closing below **$1.00** for 30 consecutive days, and plans a **1-for-12 reverse stock split** to regain compliance[26](index=26&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Gimoti commercialization, significant Q1 2022 sales growth, and ongoing 'going concern' issues, with cash projected to last only into Q2 2023 [Overview](index=15&type=section&id=Overview) Evoke Pharma, focused on Gimoti®, faces substantial doubt about its going concern status, with current cash funding operations only into Q2 2023, necessitating additional financing - The company's sole product is **Gimoti (metoclopramide) nasal spray**, the first and only nasally-administered product for acute and recurrent diabetic gastroparesis[62](index=62&type=chunk) - The company has a commercialization agreement with Eversana, amended in February 2022 to extend the term to **December 31, 2026**, and increase the net product profit retained by Evoke[62](index=62&type=chunk) - Based on the current operating plan, existing cash of **$7.7 million** as of March 31, 2022, plus subsequent ATM proceeds, is expected to fund operations into the **second quarter of 2023**, raising substantial doubt about its ability to continue as a going concern[64](index=64&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Q1 2022 saw a $328,000 increase in net product sales due to enhanced promotional activities, while R&D expenses decreased and SG&A slightly rose Comparison of Operations (in USD) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $418,380 | $90,421 | +$327,959 | | Research and development expenses | $41,717 | $277,825 | -$236,108 | | Selling, general and administrative expenses | $2,405,075 | $2,338,295 | +$66,780 | - The increase in net product sales was primarily driven by increased educational and promotional activities of the Eversana sales force[79](index=79&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) With $7.7 million cash, the company raised $7.3 million via ATM but faces a 'going concern' warning, with cash only into Q2 2023, and plans a reverse stock split - From January 1, 2022, through May 6, 2022, the company sold **7,460,397 shares** of common stock under its ATM Sales Agreement, receiving net proceeds of approximately **$7.3 million**[82](index=82&type=chunk) - Management concluded there is **substantial doubt about the company's ability to continue as a going concern**, with cash sufficient to fund operations only into the **second quarter of 2023**[84](index=84&type=chunk) - The company received a Nasdaq delisting notice for its stock price being below **$1.00** and intends to effect a **1-for-12 reverse stock split** on May 23, 2022, to regain compliance[84](index=84&type=chunk) - The company has a **$5 million revolving credit facility** from Eversana, from which it borrowed the full **$5 million** in 2020[84](index=84&type=chunk) [Item 3. Quantitative and Qualitative Disclosure about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20about%20Market%20Risk) As a smaller reporting company, Evoke Pharma is exempt from providing this specific market risk disclosure - The company is not required to provide information for this item as it qualifies as a smaller reporting company[90](index=90&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal controls - Based on an evaluation as of March 31, 2022, the Chief Executive Officer and Chief Business Officer concluded that the company's disclosure controls and procedures were **effective at the reasonable assurance level**[92](index=92&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter ended March 31, 2022, that materially affected, or are reasonably likely to materially affect, internal controls[93](index=93&type=chunk) [PART II. OTHER INFORMATION](index=25&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company initiated patent infringement litigation against Teva Pharmaceuticals in April 2022 after Teva filed an ANDA for a generic Gimoti - On February 25, 2022, Teva Pharmaceuticals submitted an ANDA for a generic version of Gimoti, challenging U.S. Patent Nos. **8,334,281** and **11,02,0361**[94](index=94&type=chunk) - In April 2022, Evoke Pharma initiated litigation against Teva in the U.S. District Court for the District of New Jersey over the validity and infringement of the patents covering Gimoti[94](index=94&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces a critical need for substantial additional funding, as existing cash is only sufficient into Q2 2023, risking liquidation without new capital - The company requires **substantial additional funding** and may be unable to raise capital when needed, which could force it to liquidate or wind down operations[95](index=95&type=chunk) - Cash on hand as of March 31, 2022, plus subsequent ATM proceeds, is projected to be sufficient to fund operations only into the **second quarter of 2023**[95](index=95&type=chunk) - The business is entirely dependent on the success of Gimoti, and failure to secure financing or successfully commercialize the product could lead to a **complete loss of investment**[95](index=95&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists various exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications
Evoke Pharma(EVOK) - 2021 Q4 - Earnings Call Transcript
2022-03-09 01:58
Evoke Pharma, Inc. (NASDAQ:EVOK) Q4 2021 Earnings Conference Call March 8, 2022 4:30 PM ET Company Participants Dave Gonyer – Chief Executive Officer Matt D’Onfrio – Chief Business Officer Chris Quesenberry – Gimoti’s Chief Commercial Officer from EVERSANA Conference Call Participants Yale Jen – Laidlaw Mitchell Kapoor – Wainwright Operator Gentlemen, today's conference will resume momentarily. Please hold. And we now have today's management on the call. Please go ahead. Daniel Kontoh-Boateng Good afternoo ...
Evoke Pharma(EVOK) - 2021 Q4 - Annual Report
2022-03-08 21:42
| --- | --- | --- | |-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------| | Evoke (Exact Name of \nDelaware (State or Other Jurisdiction of Incorporation or Organization) | Pharma, Inc. Registrant as Specified in its Charter) | 20-8447886 (I.R.S. Employer Identification No.) | | 420 Stevens Avenue, Suite 370 Solana Beach, ...
Evoke Pharma(EVOK) - 2021 Q3 - Earnings Call Transcript
2021-11-11 01:15
Evoke Pharma, Inc. (NASDAQ:EVOK) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Daniel Kontoh-Boateng – Investor Relations Dave Gonyer – Chief Executive Officer Matt D'Onofrio – Chief Business Officer Chris Quesenberry – Chief Commercial Officer-GIMOTI, EVERSANA Conference Call Participants Mitchell Kapoor – H.C. Wainwright Yale Jen – Laidlaw and Company Daniel Kontoh-Boateng Good afternoon and welcome to Evoke Pharma's Third Quarter 2021 Earnings Conference Call and Audi ...
Evoke Pharma(EVOK) - 2021 Q3 - Quarterly Report
2021-11-10 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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 September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 | --- | --- | |--------------------------------------------------------------------------------------------------|-------------------------------------- ...
Evoke Pharma(EVOK) - 2021 Q2 - Earnings Call Transcript
2021-08-13 01:05
Evoke Pharma, Inc. (NASDAQ:EVOK) Q2 2021 Results Conference Call August 12, 2021 4:30 PM ET Company Participants Christine Petraglia - The Ruth Group David Gonyer - Chief Executive Officer Matt D'Onofrio - Chief Business Officer Chris Quesenberry - Chief Commercial Officer, Gimoti Conference Call Participants Yale Jen - Laidlaw & Company Operator Good day and thank you for standing by. Welcome to the Evoke Pharma's Q2 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A ...
Evoke Pharma(EVOK) - 2021 Q2 - Quarterly Report
2021-08-12 20:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 | --- | --- | |--------------------------------------------------------------------------------------------------|---------------------------------------| | ...
Evoke Pharma(EVOK) - 2021 Q1 - Earnings Call Transcript
2021-05-13 02:42
Evoke Pharma, Inc. (NASDAQ:EVOK) Q1 2021 Earnings Conference Call May 12, 2021 4:30 PM ET Company Participants Christine Petraglia - The Ruth Group David Gonyer - Co-Founder, CEO, President & Director Christopher Quesenberry - Chief Commercial Officer, Gimoti Matthew D'Onofrio - Co-Founder, Chief Business Officer, Executive VP, Treasurer & Secretary Conference Call Participants Yale Jen - Laidlaw & Company Operator Good afternoon, and thank you for joining Evoke Pharma's First Quarter 2021 Earnings Conferen ...