Evoke Pharma Reports Commercial Strategy Progress & Positive Momentum for GIMOTI
Evoke Pharma reports significant progress in its commercial strategy and positive momentum for its GI treatment product, GIMOTI. The company achieved its highest monthly GIMOTI prescription fills in May 2024 and expanded state Medicaid access. Evoke transitioned its pharmacy distribution to ASPN Pharmacies in November 2023, improving prescription conversion rates. Through Eversana, Evoke also broadened its pharmacy network to include four additional regional pharmacies, improving access in states like Arkansas and Illinois.
Leadership changes include the promotion of Mark Kowieski to Chief Financial Officer. The company focuses on enhancing operational efficiency and plans to continue its growth trajectory throughout 2024.
- Achieved highest monthly GIMOTI prescription fills in May 2024.
- Expanded state Medicaid access for GIMOTI.
- Improved prescription conversion rates through ASPN Pharmacies partnership.
- Expanded pharmacy network to include four additional regional pharmacies.
- Improved access to GIMOTI in states like Arkansas, Connecticut, Georgia, Illinois, and Michigan.
- Leadership change with the promotion of Mark Kowieski to CFO.
- Focus on enhancing operational efficiency and reducing overhead costs.
- No specific financial performance data provided in the PR.
- Potential risks associated with dependency on new pharmacy partnerships.
- Uncertainty regarding the sustainability of the reported growth.
Insights
Evoke Pharma's latest updates indicate several strategic moves aimed at enhancing market access and boosting sales of GIMOTI, their flagship product for diabetic gastroparesis. From a financial perspective, the expanded Medicaid access and the highest-ever monthly prescription fills in May 2024 are significant. These developments suggest that Evoke's efforts to streamline distribution through the ASPN Pharmacy Platform are paying off, leading to increased sales and market penetration.
The partnership with ASPN and Eversana is particularly noteworthy. By leveraging ASPN's comprehensive servicing platform and expanding to four additional regional pharmacies, Evoke is improving coverage and reimbursement, which can translate to sustained revenue growth. The implications for the company's financial health and long-term viability are positive, as improved market access directly correlates with higher sales volumes and expanded insurance coverage.
However, investors should stay cautious about the impact on the bottom line. While top-line growth appears promising, the costs associated with distribution expansion and marketing could weigh on short-term profits. Monitoring the company's operating margins and expense management will be important in upcoming quarters. Overall, these updates position Evoke Pharma favorably in the competitive pharmaceutical market, particularly within the niche of GI diseases.
From a market research perspective, Evoke Pharma’s ongoing efforts to expand market access for GIMOTI illustrate a well-planned and executed strategy to capture a larger share of the diabetic gastroparesis treatment market. The transition to ASPN Pharmacies and the subsequent rise in prescription fills highlight successful operational adjustments that streamline the prescription process and enhance the patient experience.
The strategic expansion of the pharmacy network to include four additional regional pharmacies is critical for better geographical penetration. This move not only improves accessibility for patients across multiple states but also bolsters the brand's presence and reliability in the market. Evoke’s focus on Medicaid accessibility is particularly significant, as it targets a broader patient base, including those who might have faced reimbursement challenges previously. This expanded access can potentially result in a more diverse customer base and increased prescription volumes.
Additionally, the company’s efforts to demonstrate GIMOTI's value to different stakeholders reinforce its market stance. By generating strong evidence of efficacy and ensuring smooth delivery through advanced distribution partnerships, Evoke builds trust among healthcare providers and patients, which can lead to higher adoption rates and long-term loyalty. The positive momentum in prescription fills reflects a growing acceptance and demand for GIMOTI.
In conclusion, these developments suggest a robust market strategy with promising growth prospects for Evoke Pharma, positioning it strongly within its niche market.
Evoke Pharma's updates demonstrate a strategic push towards improving patient access and prescription fills for GIMOTI, a nasal spray used to treat diabetic gastroparesis. The transition to ASPN Pharmacies has enhanced the efficiency of the prescription process, thus improving patient outcomes by ensuring quicker access to treatment. This is particularly relevant in the treatment of gastroparesis, where managing symptoms promptly can significantly impact patient quality of life.
The expansion into additional regional pharmacies through Eversana is another step forward for Evoke. This move addresses several logistical and coverage-related barriers, making GIMOTI more readily available to a wider patient population. By increasing Medicaid access in states like Arkansas, Georgia and Illinois, Evoke is tapping into regions with high demand for diabetic treatments, potentially increasing prescription rates among underserved communities.
However, it's important to note that such expansions require meticulous management to ensure consistent supply and effective communication with healthcare providers. Any disruption or inefficiency in this expanded network could adversely affect patient trust and prescription volumes. Monitoring the implementation of these distribution strategies will be important to sustaining the positive momentum reported.
Overall, these updates signal a well-coordinated effort to optimize patient access and drive GIMOTI's market penetration, which is essential for long-term success in the competitive pharmaceutical landscape.
Expanded State Medicaid Access for GIMOTI
Achieved highest ever monthly GIMOTI prescription fills in May 2024
Promoted former VP of Finance, Mark Kowieski to Chief Financial Officer
SOLANA BEACH, Calif., June 17, 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, announced updates regarding their business and commercial growth strategy. With a determined focus to ensure maximum market access for GIMOTI, Evoke continues to execute on its plan to expand net product sales throughout 2024. This update outlines the key areas of Evoke’s strategic blueprint and positive updates regarding its implementation.
ASPN Pharmacy Platform
In November 2023, Evoke transitioned its pharmacy distribution partnership from vitaCare to ASPN Pharmacies. This strategic move has streamlined the prescription process for healthcare providers, ensuring that patients receive GIMOTI promptly. Over two quarters of collaboration with ASPN, Evoke has improved percentages of GIMOTI prescriptions converted to fills, and initial data show record-high prescription fills in April and May. ASPN's comprehensive servicing platform provides holistic advantages for our business, healthcare providers, and patients, reinforcing Evoke’s mission to reach as many patients as possible.
“We continue to make inroads into the diabetic gastroparesis market and believe we are well positioned to improve the health and daily life of patients suffering with symptoms of this debilitating disease. We have invested significantly in generating evidence to demonstrate the value of GIMOTI to patients, providers and payers. Partnering with ASPN affords Evoke access to state of the art tools and capabilities and allows us to ensure we can deliver GIMOTI quickly, improve patient and provider experience and ramp up for future demand,” said Chris Quesenberry, Chief Commercial Officer for GIMOTI.
Medicaid access through Pharmacy Partnerships
In May 2024, Evoke, through Eversana, began expanding our filling pharmacy network from a single central organization to an additional four regional pharmacies. This is intended to allow for improved coverage, reimbursement and speed to deliver GIMOTI to patients in need. Some of the states where access to GIMOTI will improve based on expanded distribution include: Arkansas, Connecticut, Georgia, Illinois, and Michigan, Mississippi, Rhode Island and Tennessee. In our first full month with these additional pharmacies, Evoke is already realizing additional GIMOTI covered prescriptions through insurers, especially Medicaid patients. Evoke anticipates further expansion of our pharmacy distribution in the coming months.
“Halfway into 2024, as prescriptions continue to grow, we are executing on our distribution expansion strategy and are seeing improved growth trajectory of access and sales for GIMOTI. The combination of the shift to ASPN and the expansion of additional regional pharmacies is yielding results to help unlock GIMOTI's true market potential,” stated Matt D’Onofrio, Chief Executive Officer of Evoke Pharma.
Leadership Changes and Operational Enhancements
In alignment with Evoke’s growth objectives, we are pleased to announce the promotion of Mark Kowieski, formerly our VP of Finance, to the role of Chief Financial Officer in May 2024. Mark brings a wealth of financial and public accounting experience and a deep understanding of Evoke Pharma’s operations to the role, which are instrumental in enhancing our operational efficiency and driving excellence.
Evoke is committed to maintaining a lean business model to maximize value for our stakeholders. Mark’s promotion is a key part of our plan to streamline operations and reduce overhead costs while accelerating growth.
Mark Kowieski, newly appointed Chief Financial Officer of Evoke Pharma, commented, “I am thrilled to assume the role of CFO at Evoke Pharma during this pivotal time in our company’s commercial journey. With the robust support from Eversana and the expertise of our leadership team and board, I am confident that we have all the necessary tools to drive significant business growth. Our focus remains on accelerating revenue growth, ensuring GIMOTI is accessible to all patients in need, and ultimately generating substantial value for our shareholders.”
The company will report full results for sales in the second quarter in August 2024.
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 (≥
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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.
About EVERSANA
EVERSANA™ is the leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle 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 sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.
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: Evoke’s strategy of adding pharmacies to its prescribing platform to drive additional sales; Evoke’s commercialization plans, including the initial data showing that the prescription fills in April and May 2024 are record-highs for the company; and that Evoke is successfully executing on its commercial strategy and may generate stockholder value. 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 increased revenues for 2024; Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke may not be able to regain compliance with Nasdaq’s minimum bid price requirement or maintain compliance with Nasdaq’s minimum stockholders’ equity requirements which may result in the Evoke’s common stock being delisted from Nasdaq; 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
FAQ
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