Full Press Release Details
Evoke Pharma Reports Fourth Quarter and Full Year 2021 Financial Results
Fourth-quarter net product sales from prescriptions increased by 46% to $361,000 versus Q3
Easing of COVID-19 restrictions helped fuel higher sales, increased face-to-face meetings with healthcare professionals
SOLANA BEACH, Calif., March 8, 2022 (GLOBE NEWSWIRE) - Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2021, and recent corporate developments.
"We are happy to report that, by several key metrics, we showed encouraging progress over the course of 2021-especially during the fourth quarter-and continuing into 2022 by calling attention to GIMOTI's value proposition," said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. "Our net product sales from prescriptions increased sequentially by 46%, to $361,000 in the fourth quarter of 2021 from $247,000 in the third quarter. In addition, the number of GIMOTI prescribers increased by approximately 23%, to 425 healthcare providers (HCPs) through December 31, 2021, from 345 through September 30, 2021. This metric continues to increase reaching 499 prescribers as of the end of February. We are encouraged by the positive trends we are seeing in these future revenue indicators for GIMOTI and look forward to continued success in the market. Together with Eversana, we look forward to employing more strategies to ensure GIMOTI is reaching the patients who need it most."
Fourth Quarter 2021 Developments and Recent Progress:
Fourth Quarter and Full Year 2021 Financial Review
For the fourth quarter of 2021, net product sales were approximately $361,000 compared with $23,000 during the fourth quarter of 2020, the first quarter of Gimoti's launch, and the net loss was approximately $1.7 million, or $0.05 cents per share compared with $2.3 million, or $0.09 per share, for the fourth quarter of 2020. For the year ended December 31, 2021, net product sales were approximately $1.6 million compared with approximately $23,000 for the year ended December 31, 2020, and the net loss was approximately $8.5 million, or $0.27 per share, compared with a net loss of $13.2 million, or $0.52 per share, for the year ended December 31, 2020. The year-over-year increase in revenue and reduction in net loss were due to higher net product sales in 2021, including approximately $718,000 of GIMOTI sold to third parties for research purposes, and, to a lesser extent, higher prescription sales in the second half of 2021. In addition, during 2020, we incurred a $5 million milestone expense upon receiving FDA's approval of Gimoti in June 2020.
Total operating expenses for the fourth quarter of 2021 were approximately $1.9 million compared with $2.2 million for the same period of 2020. For the year ended December 31, 2021, total operating expenses were approximately $9.8 million compared with approximately $13.1 million for the full year of 2020.
As of December 31, 2021, cash and cash equivalents were approximately $9.1 million. We believe, based on our current operating plan, that our existing cash and cash equivalents, as well as future cash flows from net product sales of GIMOTI, will be sufficient to fund our operations into the first quarter of 2023.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. 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.
Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.
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EVERSANA is a leading provider of global services to the life science industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product lifecycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies to advance life science solutions for a healthier world. To learn more about EVERSANA, visit www.eversana.com or connect through LinkedIn and Twitter.
About Gimoti (metoclopramide) nasal spray
GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Important Safety Information
WARNING: TARDIVE DYSKINESIA
GIMOTI is not recommended for use in:
GIMOTI is contraindicated:
Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions ( 5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: potential future prescribing trends for GIMOTI based on Evoke's or EVERSANA's marketing efforts; Evoke's commercialization plans, including its plans to increase awareness of and access to GIMOTI; and
Evoke's future capital requirements. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke's business, including, without limitation: Evoke's and EVERSANA's ability to successfully drive market demand for GIMOTI; Evoke's ability to obtain additional financing as needed to support its operations; the COVID-19 pandemic may continue to disrupt Evoke's and EVERSANA's business operations impairing the ability to commercialize GIMOTI and Evoke's ability to generate product revenue; Evoke's dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke's ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke's prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
(Financial Statements to Follow)
| Evoke Pharma, Inc. Balance Sheet | ||||||||
| December 31, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 9,144,710 | $ | 8,068,939 | ||||
| Accounts receivable, net | 295,193 | 23,311 | ||||||
| Prepaid expenses | 923,746 | 921,762 | ||||||
| Inventory | 185,534 | 236,480 | ||||||
| Other current assets | 11,551 | 30,300 | ||||||
| Total current assets | 10,560,734 | 9,280,792 | ||||||
| Operating lease right-of-use asset | 12,428 | 141,705 | ||||||
| Other assets | - | 11,551 | ||||||
| Total assets | $ | 10,573,162 | $ | 9,434,048 | ||||
| Liabilities and stockholders' equity (deficit) | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 874,028 | $ | 1,273,572 | ||||
| Accrued compensation | 519,317 | 1,016,232 | ||||||
| Operating lease liability | 12,428 | 141,705 | ||||||
| Paycheck protection program loan | - | 104,168 | ||||||
| Milestone payable | - | 5,000,000 | ||||||
| Total current liabilities | 1,405,773 | 7,535,677 | ||||||
| Long-term liabilities | ||||||||
| Note payable | 5,000,000 | 5,000,000 | ||||||
| Accrued interest payable | 612,295 | 112,994 | ||||||
| Total long-term liabilities | 5,612,295 | 5,112,994 | ||||||
| Total liabilities | 7,018,068 | 12,648,671 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock | 3,266 | 2,662 | ||||||
| Additional paid-in capital | 110,974,841 | 95,667,776 | ||||||
| Accumulated deficit | (107,423,013 | ) | (98,885,061 | ) | ||||
| Total stockholders' equity (deficit) | 3,555,094 | (3,214,623 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 10,573,162 | $ | 9,434,048 |
| Evoke Pharma, Inc. Statement of Operations | ||||||||
| Year Ended | ||||||||
| 2021 | 2020 | |||||||
| Net product sales | $ | 1,618,076 | $ | 23,020 | ||||
| Operating expenses: | ||||||||
| Cost of goods sold | 328,118 | 86,712 | ||||||
| Research and development | 590,476 | 6,554,825 | ||||||
| Selling, general and administrative | 8,851,129 | 6,428,832 | ||||||
| Total operating expenses | 9,769,723 | 13,070,369 | ||||||
| Loss from operations | (8,151,647 | ) | (13,047,349 | ) | ||||
| Other income (expense): | ||||||||
| Forgiveness of paycheck protection loan and accrued interest | 105,130 | - | ||||||
| Interest income | 8,615 | 5,672 | ||||||
| Interest expense | (500,050 | ) | (112,994 | ) | ||||
| Total other income (expense) | (386,305 | ) | (107,322 | ) | ||||
| Net loss | $ | (8,537,952 | ) | $ | (13,154,671 | ) | ||
| Net loss per share of common stock, basic and diluted | $ | (0.27 | ) | $ | (0.52 | ) | ||
| Weighted-average shares used to compute basic and diluted net loss per share | 32,185,758 | 25,492,169 |