Evoke Pharma Reports Fourth Quarter and Full Year 2021 Financial Results
Fourth-quarter net product sales from prescriptions increased by 46% to
Easing of COVID-19 restrictions helped fuel higher sales, increased face-to-face meetings with healthcare professionals
“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
Fourth Quarter 2021 Developments and Recent Progress:
- Conducted higher number of in-person meetings with HCPs in many areas of the
- Eased COVID-19 restrictions on HCPs in many areas of
U.S.allowed for more face-to-face meetings with gastroenterologists, primary care physicians, physician’s assistants and nurse practitioners
- Eased COVID-19 restrictions on HCPs in many areas of
- Judicious increases in GIMOTI samples distributed to HCPs to allow for greater trial which has led to higher prescription sales
- Recent national sales meeting provided valuable insights in gaining additional physician and patient experience with GIMOTI
- Extended strategic collaboration with EVERSANA to commercialize and distribute GIMOTI within the
- Amended agreement extends term and increases the percentage of the net product profit retained by Evoke
- Accelerates the reimbursement of commercialization costs to EVERSANA after the product breaks even on a monthly basis
- Expanding strategic outreach to state pharmacy programs and specialty pharmacy.
New York StateMedicaid approval of GIMOTI with confirmation of diabetes diagnosis only
- Initial pilot program for automated Electronic Medical Record (EMR) prescription submission showing impressive follow through with increase in prescriptions and reimbursement
Fourth Quarter and Full Year 2021 Financial Review
For the fourth quarter of 2021, net product sales were approximately
Research and development expenses totaled approximately
For the fourth quarter of 2021, selling, general and administrative expenses were approximately
Total operating expenses for the fourth quarter of 2021 were approximately
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
- Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.
- Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.
- Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.
GIMOTI is not recommended for use in:
- Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.
- Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions.
GIMOTI is contraindicated:
- In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
- When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation).
- In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
- In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.
- In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.
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.
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|Cash and cash equivalents||$||9,144,710||$||8,068,939|
|Accounts receivable, net||295,193||23,311|
|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|
|Liabilities and stockholders' equity (deficit)|
|Accounts payable and accrued expenses||$||874,028||$||1,273,572|
|Operating lease liability||12,428||141,705|
|Paycheck protection program loan||—||104,168|
|Total current liabilities||1,405,773||7,535,677|
|Accrued interest payable||612,295||112,994|
|Total long-term liabilities||5,612,295||5,112,994|
|Stockholders' equity (deficit):|
|Additional paid-in capital||110,974,841||95,667,776|
|Total stockholders' equity (deficit)||3,555,094||(3,214,623||)|
|Total liabilities and stockholders' equity (deficit)||$||10,573,162||$||9,434,048|
|Net product sales||$||1,618,076||$||23,020|
|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||—|
|Total other income (expense)||(386,305||)||(107,322||)|
|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|
Source: Evoke Pharma, Inc.