Evoke Pharma Reports First Quarter 2022 Financial Results
“We are encouraged by the incremental improvement in net GIMOTI sales and prescriptions and continue to receive positive feedback from patients and physicians. Working closely with our strategic commercial partner, Eversana, we continue to implement and execute strategies as we seek continued improvement in the quarters ahead,” said
First Quarter 2022 Developments and Recent Progress:
GIMOTI was added to two state Medicaid Programs
- New York Medicaid; Coverage allows for more rapid utility of GIMOTI
- Texas Medicaid Preferred Drug List (PDL); Effective
April 12, 2022, approximately 5 million additional patients are able to quickly access GIMOTI
- Medicaid and Medicare made up approximately 51% of the filled prescriptions for GIMOTI in the first quarter of 2022
New drug product exclusivity granted by the FDA for GIMOTI nasal spray
- Company now has Hatch-Waxman Act exclusive marketing rights for three years from approval date
Piloted strategic collaboration with vitaCare (subsidiary of GoodRx.com)
- Quick and convenient electronic submission of prescriptions by doctors to pharmacies online
- More effective and accelerated insurance approval of prescriptions by pharmacies, state Medicaid agencies and private insurance companies
- Commercial patients may receive trial samples while awaiting insurance reimbursement
Abstract on association between tardive dyskinesia (TD) and potential risk factors accepted as poster of distinction at Digestive Disease Week (DDW) on
- Data will update TD incidence in metoclopramide which may have been previously overestimated
- Additional medical subgroups analyzed to inform physicians of possible additional treatment factors
Extends cash runway into Q2, 2023
- ATM program accessed for additional sales runway
First Quarter 2022 Financial Review
For the first quarter of 2022, net product sales were approximately
For the first quarter of 2022, selling, general and administrative expenses were approximately
Total operating expenses for the first quarter of 2022 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
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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 and sales 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
(Financial Statements to Follow)
Condensed Balance Sheets
|Cash and cash equivalents||$||7,701,201||$||9,144,710|
|Accounts receivable, net||418,910||295,193|
|Other current assets||11,551||11,551|
|Total current assets||9,026,270||10,560,734|
|Operating lease right-of-use asset||—||12,428|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||944,478||$||874,028|
|Operating lease liability||—||12,428|
|Total current liabilities||1,356,676||1,405,773|
|Accrued interest payable||735,583||612,295|
|Total long-term liabilities||5,735,583||5,612,295|
|Additional paid-in capital||111,527,397||110,974,841|
|Total stockholders' equity||1,934,011||3,555,094|
|Total liabilities and stockholders' (deficit) equity||$||9,026,270||$||10,573,162|
Condensed Statements of Operations
|Three Months Ended
|Net product sales||$||418,380||$||90,421|
|Cost of goods sold||22,760||64,751|
|Research and development||41,717||277,825|
|Selling, general and administrative||2,405,075||2,338,295|
|Total operating expenses||2,469,552||2,680,871|
|Loss from operations||(2,051,172||)||(2,590,450||)|
|Other income (expense):|
|Forgiveness of paycheck protection loan and accrued interest||—||105,130|
|Total other income (expense)||(122,493||)||(15,045||)|
|Net loss per share of common stock, basic and diluted||$||(0.07||)||$||(0.08||)|
|Weighted-average shares used to compute basic and diluted net loss per share||32,777,294||31,158,065|
Source: Evoke Pharma, Inc.