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About Evoke Pharma Inc.
Evoke Pharma Inc. (NASDAQ: EVOK), headquartered in Solana Beach, California, is a specialty pharmaceutical company dedicated to the development and commercialization of innovative treatments for gastrointestinal (GI) disorders and diseases. With a primary focus on diabetic gastroparesis, Evoke addresses a critical unmet medical need by offering a novel, non-oral treatment option that improves patient outcomes and enhances quality of life.
Core Product: Gimoti
At the heart of Evoke Pharma's portfolio is Gimoti®, an FDA-approved nasal spray formulation of metoclopramide. Designed specifically for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults, Gimoti offers a unique solution for patients who struggle with oral medications due to delayed gastric emptying, a hallmark of gastroparesis. By bypassing the gastrointestinal tract, Gimoti ensures reliable drug absorption, addressing the core defect of the disease and providing a practical alternative to traditional oral and injectable formulations.
Market Position and Competitive Landscape
Diabetic gastroparesis is a debilitating condition affecting millions worldwide, with a disproportionate prevalence among women. Despite its widespread impact, treatment options remain limited. Metoclopramide is the only FDA-approved drug for gastroparesis in the United States, and Gimoti stands out as the sole non-oral formulation available. This positions Evoke Pharma as a key player in the GI treatment landscape, offering a differentiated product that meets the needs of a historically underserved patient population.
Innovative Approach and Strategic Partnerships
Evoke Pharma's commitment to innovation is evident in its development of Gimoti, which leverages intranasal drug delivery to overcome the challenges associated with oral medications in gastroparesis patients. The company has also established strategic partnerships, such as its collaboration with EVERSANA, to support the commercialization and market access of Gimoti. These partnerships enhance Evoke's ability to reach patients, streamline the prescription process, and ensure broad access to its groundbreaking therapy.
Real-World Evidence and Impact
Real-world data underscores the clinical and economic benefits of Gimoti. Studies have demonstrated significant reductions in emergency room visits and hospitalizations among patients treated with Gimoti compared to oral metoclopramide. Additionally, Gimoti has shown a substantial reduction in overall healthcare costs, highlighting its value to both patients and payers. These outcomes reinforce Evoke Pharma's role in improving patient care and reducing the burden on the healthcare system.
Commitment to Patients and Providers
Evoke Pharma is dedicated to addressing the challenges faced by gastroparesis patients and their healthcare providers. The company's patient assistance programs and efforts to expand pharmacy distribution networks reflect its mission to ensure that no patient goes untreated due to economic or access barriers. By prioritizing patient-centric solutions and leveraging strong clinical evidence, Evoke continues to set the standard for innovation in gastroparesis treatment.
Evoke Pharma (NASDAQ: EVOK) presented a study at Digestive Disease Week 2022 highlighting a 98.8 per 100,000 incidence of tardive dyskinesia (TD) among gastroparesis patients treated with metoclopramide, a significant reduction from earlier reports. This analysis, based on a database of 80 million patients from 2011-2020, supports the safety profile of GIMOTI®, the FDA-approved nasal spray formulation of metoclopramide for diabetic gastroparesis. The study received a “Poster of Distinction” award, emphasizing GIMOTI's potential in managing this condition.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced its participation in the H.C. Wainwright Global Investment Conference from May 23-26, 2022. The management team will present a virtual overview of the commercial progress of their flagship product, GIMOTI (metoclopramide nasal spray), on May 24, 2022, available on demand for registered attendees starting at 7:00 a.m. ET. Investors can also request one-on-one meetings with management during the event. GIMOTI addresses symptoms of acute and recurrent diabetic gastroparesis in adults, a condition affecting millions globally.
Evoke Pharma reported a net revenue of approximately $418,000 for Q1 2022, a 16% increase year-over-year, driven by higher sales of GIMOTI. The company saw a 41% rise in new prescribers and a 22% increase in prescriptions. Notably, GIMOTI received added state Medicaid programs in New York and Texas, expanding patient access. However, the net loss was approximately $2.2 million, an improvement from the $2.6 million loss in Q1 2021. Current cash reserves are about $7.7 million, projected to support operations into Q2 2023.
Evoke Pharma (NASDAQ: EVOK) plans to release its Q1 2022 financial results on May 10, 2022, after market close. A conference call will follow at 4:30 p.m. ET for discussion of the results. The company's flagship product, GIMOTI, is the only FDA-approved nasal spray for treating symptoms of diabetic gastroparesis. This GI disorder affects many worldwide and poses significant challenges in medication absorption. Investors can follow Evoke's updates on their official website and social media channels.
Evoke Pharma (NASDAQ: EVOK) announced on April 26, 2022, that the FDA granted new drug product exclusivity for GIMOTI (metoclopramide) nasal spray. This exclusivity allows Evoke to market GIMOTI solely for three years, shielding it from generic competition. Evoke holds two Orange Book-listed patents for GIMOTI, expiring in 2029 and 2030, along with additional gender-specific patents in the E.U., Japan, and Mexico, extending coverage until 2032. The company aims to deliver a non-oral treatment for diabetic gastroparesis, addressing a significant market need.
Evoke Pharma (NASDAQ: EVOK) announced that GIMOTI® (metoclopramide) nasal spray has been added to the Texas Medicaid Preferred Drug List as of April 12, 2022. This inclusion facilitates reimbursement for approximately 5 million Medicaid patients in Texas suffering from diabetic gastroparesis (DGP). The approval aligns with Evoke's commitment to increasing access to non-oral treatment options for DGP, following a similar approval in New York. The company aims to broaden accessibility and remains focused on its commercialization strategy.
Evoke Pharma (NASDAQ: EVOK) announced a virtual fireside chat on March 16, 2022, to discuss gastroparesis and GIMOTI, its nasal spray treatment for the condition, featuring Dr. Viplove Senadhi. The event aims to enhance understanding and awareness of this gastrointestinal disorder affecting millions. GIMOTI is the only FDA-approved drug for diabetic gastroparesis, offering a unique formulation compared to traditional oral and injectable options. Investors can register for the event through Evoke's investor relations site.
Evoke Pharma reported a 46% increase in fourth-quarter net product sales, reaching $361,000 compared to $247,000 in Q3 2021. The company also saw a 23% growth in the number of GIMOTI prescribers, totaling 425 by year-end 2021, with further growth to 499 by February 2022. For the year 2021, net product sales totaled $1.6 million versus $23,000 in 2020, reflecting a strong recovery post-COVID-19 restrictions. Despite a net loss of $8.5 million in 2021, a significant reduction from the previous year's loss of $13.2 million indicates improving financial health.
Evoke Pharma (NASDAQ: EVOK) is set to release its fourth quarter and full year 2021 financial results on March 8, 2022, after market close. The company, focused on gastrointestinal (GI) treatments, will host a conference call at 4:30 p.m. ET on the same day to discuss these results. Evoke Pharma is known for its GIMOTI product, a nasal spray formulation of metoclopramide for diabetic gastroparesis, a prevalent GI disorder. GIMOTI remains the only FDA-approved treatment specifically for this condition in the U.S.
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