Press Release
Evoke Pharma, Inc. Reports Second Quarter 2024 Financial Results
GIMOTI second quarter net product sales grew 47% quarter-over-quarter and 126% year-over-year, indicating an annual run-rate in excess of
Achieved record-high prescription fills during Q2
75% year-over-year prescription fill increase; 32% growth compared to Q1 2024
Two abstracts submitted and accepted by the
Matt D’Onofrio, CEO of
“We are continuing to see growth in all phases of our business with increases in HCPs prescribing, patients taking GIMOTI, improvements in covered prescriptions with each showing our best performance in quarter over quarter growth in Q2. As of
Second Quarter 2024 Developments and Recent Highlights:
Strong Commercial Progress with GIMOTI
- Achieved positive momentum with transition to ASPN Pharmacies’ comprehensive servicing platform.
- Expanded access by increasing our filling pharmacy network with four additional pharmacies in prioritized states and sales territories.
Unveiled Further Benefits of GIMOTI at Medical Meetings and Webinars
- Presented data at the 2024 Digestive Disease Week (DDW) in May, demonstrating a significant reduction in physician office visits, inpatient hospitalizations, and emergency department visits in women who had diabetic gastroparesis compared to those taking oral metoclopramide.
- Held virtual webinar in April featuring
Michael Cline , DO., Medical Director Gastroparesis Clinic at theCleveland Clinic in April to discuss compelling healthcare resource utilization data showing improved hospitalization rates, and his view on patient experience with GIMOTI. Video link here. - Two abstracts submitted and accepted by the
American College of Gastroenterology (ACG) focusing on use of GIMOTI in patients on GLP-1 analogs.
Leadership Appointments
- Promoted former COO,
Matt D’Onofrio , to Chief Executive Officer. - Promoted former VP of Finance,
Mark Kowieski , to Chief Financial Officer.
Implemented Reverse Stock Split
- Evoke Pharma Board of Directors approved a 1-for-12 reverse stock split of the company’s common stock, which began trading on a split-adjusted basis on
August 1, 2024 .
"Our commitment remains steadfast in amplifying and emphasizing the benefits and practical applications of GIMOTI to reach as many patients as possible and grow revenues, thus doing well by doing good. We continue to receive inbound questions from physicians regarding diabetic gastroparesis and patients on GLP-1 analogs and have submitted two abstracts to ACG in response. We remain energized by the encouraging results generated to date and look forward to building on this momentum throughout the rest of the year,” Mr. D’Onofrio concluded.
Second Quarter 2024 Financial Review and Outlook
For the second quarter of 2024, net product sales were approximately
For the second quarter of 2024, selling, general and administrative expenses were approximately $3.7 million compared to $2.8 million for the second quarter of 2023. The increases were due to higher professional fees and reimbursement for expanded marketing efforts and profit-sharing activity with EVERSANA.
Total operating expenses for the second quarter of 2024 were approximately $3.8 million compared to $2.9 million for the same period in 2023.
As of
Based on net sales generated in the first two quarters of 2024, Evoke is revising its 2024 guidance to a range of
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
Visit www.EvokePharma.com for more information.
Follow GIMOTI on Facebook
Follow Evoke Pharma on LinkedIn
Follow Evoke Pharma on 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: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, the potential market opportunity for GIMOTI, Evoke’s partnership with ASPN Pharmacies, growth in prescriptions, patients taking GIMOTI and the conversion of prescriptions to fills, and Evoke’s expected cash runway. 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 may not be able to achieve its guidance for 2024 including as a result of decreased demand for GIMOTI; 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; Evoke may use its capital resources sooner than expected; warrant holders may choose not to exercise any of the outstanding warrants; 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
Investor & Media Contact:
Tel: 862-213-1398
dboateng@dkbpartners.net
Condensed Balance Sheets |
||||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,177,836 | $ | 4,739,426 | ||||
| Accounts receivable, net of allowance for credit losses of |
2,003,003 | 673,071 | ||||||
| Prepaid expenses | 382,936 | 885,040 | ||||||
| Inventories | 544,765 | 481,840 | ||||||
| Other current assets | 27,675 | 47,532 | ||||||
| Total current assets | 12,136,215 | 6,826,909 | ||||||
| Deferred offering costs | — | 241,637 | ||||||
| Total assets | $ | 12,136,215 | $ | 7,068,546 | ||||
| Liabilities and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 2,183,850 | $ | 1,711,778 | ||||
| Accrued compensation | 425,797 | 1,324,010 | ||||||
| Note payable | 5,000,000 | 5,000,000 | ||||||
| Accrued interest payable | 1,861,610 | 1,612,295 | ||||||
| Total current liabilities | 9,471,257 | 9,648,083 | ||||||
| Total liabilities | 9,471,257 | 9,648,083 | ||||||
| Commitments and contingencies | ||||||||
| Stockholdersʼ equity (deficit): | ||||||||
| Preferred stock, as of zero as of |
— | — | ||||||
| Common stock, 50,000,000 as of and outstanding shares — 734,836 and 278,558 as of |
73 | 28 | ||||||
| Additional paid-in capital | 128,951,361 | 120,859,873 | ||||||
| Accumulated deficit | (126,286,476 | ) | (123,439,438 | ) | ||||
| Total stockholdersʼ equity (deficit) | 2,664,958 | (2,579,537 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 12,136,215 | $ | 7,068,546 | ||||
Condensed Statement of Operations (unaudited) |
||||||||
| Three Months Ended |
||||||||
| 2024 | 2023 | |||||||
| Net product sales | $ | 2,551,366 | $ | 1,131,368 | ||||
| Operating expenses: | ||||||||
| Cost of goods sold | 41,478 | 57,357 | ||||||
| Research and development | — | 92,357 | ||||||
| Selling, general and administrative | 3,733,450 | 2,766,077 | ||||||
| Total operating expenses | 3,774,928 | 2,915,791 | ||||||
| Loss from operations | (1,223,562 | ) | (1,784,423 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 81,001 | 41,164 | ||||||
| Interest expense | (124,657 | ) | (124,658 | ) | ||||
| Total other expense | (43,656 | ) | (83,494 | ) | ||||
| Net loss | $ | (1,267,218 | ) | $ | (1,867,917 | ) | ||
| Net loss per share of common stock, basic and diluted | $ | (0.93 | ) | $ | (6.71 | ) | ||
| Weighted-average shares used to compute basic and diluted net loss per share |
1,363,525 | 278,558 | ||||||
Source: Evoke Pharma, Inc.