Evoke Pharma Reports Fourth Quarter and Full Year 2023 Financial Results
- Fiscal year 2023 net product sales increased by 107% to $5.2M compared to 2022.
- Company projects $14M in net revenue for 2024.
- GIMOTI nasal spray saw a 66% rise in cumulative prescribers, totaling 1,689 by the end of 2023.
- Prescription fills and patient enrollments increased by 100% and 88% respectively, year-over-year.
- Reduced healthcare resource utilization data demonstrated cost savings benefits of GIMOTI over oral metoclopramide.
- Transitioned Pharmacy Service Partnership to ASPN Pharmacies to improve prescription processes and revenues.
- Issued two patents in 2023 for GIMOTI, strengthening intellectual property position.
- Closed a $7.5M public offering in February 2024, with potential for up to an additional $22.5M through common stock warrants.
- Real-world evidence showed GIMOTI's superiority over traditional treatments, leading to decreased hospitalizations and ER visits, saving over $15,000 per patient in six months.
- Strong market trust in GIMOTI was reinforced at major gastroenterology conferences like Digestive Disease Week 2023.
- None.
Insights
The reported 107% increase in net product sales to $5.2M for Evoke Pharma signifies a robust year-over-year growth, surpassing the biotech industry's average growth rate. This surge is indicative of effective commercial strategies and could be a positive signal to investors regarding the company's revenue-generating capabilities. The projection of $14M in net revenue for 2024 suggests a confident outlook on the company's part, potentially due to the increased adoption of GIMOTI. However, the reliance on a single product can be a risk factor, as it exposes the company to market volatility and competitive pressures.
From a financial perspective, the improved cash position through a $7.5M public offering extends the company's operational runway, which is crucial for maintaining R&D and marketing efforts. The availability of an additional $22.5M if warrants are exercised could provide further financial stability. However, investors should be aware of the potential for dilution.
It's also worth noting that cost savings of over $15,000 per patient could make GIMOTI an attractive option for payors, potentially leading to increased market penetration and sustained revenue growth. The partnership transition to ASPN Pharmacies could also be a strategic move to expand distribution channels and improve the prescription process, which may positively impact future sales.
The significant increase in prescription fills and patient enrollments for GIMOTI, along with the 66% rise in cumulative prescribers, reflects a growing acceptance of the product in the market. This data points to successful marketing efforts and the potential for GIMOTI to capture a larger share of the gastroparesis treatment market. The emphasis on operational excellence and the addition of new prescribers are key indicators of a company strategically positioning its product.
Furthermore, the presentation of healthcare resource utilization data at prominent gastroenterology conferences has likely contributed to the product's credibility among medical professionals. The evidence suggesting a decrease in healthcare resource burdens by using GIMOTI could lead to its endorsement as a standard of care for diabetic gastroparesis, which would significantly enhance its market potential.
The decision by Teva Pharmaceuticals not to pursue a paragraph 4 certification challenge against GIMOTI is a positive development, as it removes a potential barrier to market exclusivity. This fortification of Evoke's patent estate is an important aspect for investors, as it provides a more secure competitive advantage and could deter generic competition in the near term.
The real-world evidence presented regarding GIMOTI's effectiveness and cost savings for patients and payors is a strong endorsement of the product's value proposition in the healthcare market. The data presented at DDW 2023 and ACG 2023 could influence prescribing habits, especially in a healthcare environment increasingly focused on cost-effectiveness and outcomes.
Moreover, the transition to ASPN Pharmacies could improve access to GIMOTI, which is a positive development for patient care. The broader PBM agreements might streamline the prescription process, potentially improving treatment adherence and patient outcomes.
It is also significant that the company has secured additional patents and Orange Book listings for GIMOTI in 2023. These developments not only protect the product from generic competition but also signal to the market that the company is serious about defending its intellectual property, a key factor for long-term sustainability in the pharmaceutical industry.
Fiscal year 2023 net product sales from prescriptions totaled approximately
Company projects
SOLANA BEACH, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced its financial results for the fourth quarter and full year ended December 31, 2023, and recent corporate developments.
"In 2023, we focused on operational excellence to expand GIMOTI’s market share and ensure its availability for patients requiring an improved gastroparesis treatment. Our commercial team’s dedicated efforts yielded a
Fourth Quarter and Full Year 2023 Developments and Recent Highlights:
- Continued Advocacy for GIMOTI as the Standard of Care for Diabetic Gastroparesis Treatment
- Healthcare resource utilization data presented at DDW 2023 revealed that there is statistically signficantly less burden on healthcare resources and facilities such as hospitical admissions, emergency department and physician office visits with patients who are being prescirbed GIMOTI versus those on oral metoclopramide.
- Based on the reduced utilization data, additional compelling cost data presented in a distinguished plenary session at ACG 2023 demonstrated financial savings benefits of GIMOTI for patients and payors compared to oral metoclopramide.
- Abstract focused on the HCRU of diabetic gastroparesis care in women using nasal metoclopramide to be presented at DDW 2024.
- Transitioned Pharmacy Service Partnership to ASPN Pharmacies
- Aiming to enhance patient prescription process and enhance revenues through ASPN’s extensive network of partners with broader PBM agreements.
- Fortified Patent Estate for GIMOTI
- Two patents issued in 2023 covering the methods of use for GIMOTI including two Orange Book listings.
- Teva Pharmaceuticals determination not to pursue a paragraph 4 certification against Gimoti without financial or other consideration further enhanced Evoke’s intellectual property position and eliminated 180-day exclusivity opportunity for later possible generic seeking entities for the future.
- Improved Cash Position
- In February 2024, the Company closed a
$7.5M public offering with fundamental, healthcare-oriented institutional investors providing the company runway into the fourth quarter of 2024 with up to an additional$22.5M available if common stock warrants are exercised in full.
- In February 2024, the Company closed a
Mr. Gonyer concluded, “2023 was a milestone year for GIMOTI with new real-world evidence demonstrating its superiority over traditional treatments and data showing a marked decrease in hospitalization and ER visits for GIMOTI over oral metoclopramide which translated into savings of over
Fourth Quarter and Full Year 2023 Financial Review and Outlook
For the fourth quarter of 2023, net product sales were approximately
- Prescription sales through pharmacy service partnership with ASPN Pharmacy;
- Recapture of prescriptions sent to retail pharmacies without ability to order product; and
- Marketing of head-to-head real-world data comparing Gimoti to oral metoclopramide showing improvements in fewer hospitalizations and ER visits with GIMOTI.
Research and development expenses totaled approximately
For the fourth quarter of 2023 selling, general and administrative (SG&A) expenses were approximately
Total operating expenses for the fourth quarter of 2023 were approximately
As of December 31, 2023, cash and cash equivalents were approximately
Evoke projects net revenue in 2024 of 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.
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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 (≥
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, including the potential that GIMOTI could become the standard of care for gastroparesis; the potential for additional funds from the exercise of outstanding warrants 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 it’s 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 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.
Investor & Media Contact:
Daniel Kontoh-Boateng
DKB Partners
Tel: 862-213-1398
dboateng@dkbpartners.net
Financial Statements to Follow
Evoke Pharma, Inc.
Balance Sheet
Evoke Pharma, Inc.
Statement of Operations
The Financial Statements accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/1505239a-5694-4a7e-99c2-8d96e50a84a3
https://www.globenewswire.com/NewsRoom/AttachmentNg/b26e2618-665c-4966-acc6-c45d683cb7e0
FAQ
What was the percentage increase in net product sales for Evoke Pharma (EVOK) for fiscal year 2023?
How many cumulative prescribers did GIMOTI have by the end of 2023?
What was the increase in prescription fills for GIMOTI from 2022 to 2023?
What was the increase in patient enrollments for GIMOTI from 2022 to 2023?
What recent development aimed to enhance patient prescription processes for Evoke Pharma (EVOK)?
