Evoke Pharma, Inc. (EVOK): Business Model Canvas [11-2024 Updated]

In the rapidly evolving pharmaceutical landscape, Evoke Pharma, Inc. (EVOK) stands out with its innovative approach to treating diabetic gastroparesis through its flagship product, Gimoti. This blog post delves into the company's comprehensive Business Model Canvas, highlighting key aspects such as partnerships, value propositions, and revenue streams that drive its success. Discover how Evoke Pharma is reshaping patient care and enhancing medication accessibility in the healthcare market.

Evoke Pharma, Inc. (EVOK) - Business Model: Key Partnerships

Collaboration with Eversana for commercialization

Evoke Pharma has a significant partnership with Eversana, established through a commercial services agreement signed on January 21, 2020. This agreement allows Eversana to commercialize and distribute Evoke's primary product, Gimoti, in the United States. Eversana is responsible for marketing to healthcare providers and managing sales and distribution efforts.

Under the terms of the Eversana Agreement, Evoke retains ownership of the Gimoti NDA and is responsible for legal, regulatory, and manufacturing aspects. For the three months ended September 30, 2024, Evoke allocated approximately $2.2 million in profit-sharing costs to Eversana, compared to $1.3 million for the same period in 2023. For the nine months ended September 30, 2024, these costs rose to approximately $5.9 million from $3.0 million year-over-year. As of September 30, 2024, unreimbursed commercialization costs to Eversana stood at approximately $72.8 million.

Metrics	Q3 2024	Q3 2023	9M 2024	9M 2023
Eversana Profit Sharing Costs	$2.2 million	$1.3 million	$5.9 million	$3.0 million
Unreimbursed Commercialization Costs	$72.8 million	N/A	N/A	N/A

Partnerships with healthcare providers

Evoke Pharma collaborates with healthcare providers to enhance the adoption and prescription rates of Gimoti. The partnership strategy has focused on targeting larger gastroenterology teams, which has resulted in increased prescribing activity. As of September 30, 2024, the number of new prescribers increased by 8% during the quarter. The increased engagement with healthcare providers has been instrumental in improving patient outcomes and reducing healthcare costs associated with diabetic gastroparesis.

Agreements with pharmacies for product distribution

To facilitate the distribution of Gimoti, Evoke Pharma has established agreements with various pharmacies. The transition of pharmacy services to ASPN Pharmacy from vitaCare Prescription Services in late 2023 has improved the efficiency of prescription processing and insurance coverage. During the quarter ended September 30, 2024, there were approximately 1,602 new inbound prescriptions processed through the ASPN reimbursement center. The ASPN platform has contributed to enhancing communication between providers and payors, leading to a higher proportion of prescriptions covered by insurance.

Metrics	Q3 2024	Q2 2024
New Inbound Prescriptions	1,602	N/A
Prescription Refill Rate	71%	N/A

Evoke Pharma, Inc. (EVOK) - Business Model: Key Activities

Development and marketing of Gimoti

Evoke Pharma is primarily focused on the development and commercialization of Gimoti, a nasal spray formulation of metoclopramide indicated for the treatment of gastroparesis in women. As of September 30, 2024, the net product sales of Gimoti reached approximately $6.94 million, a significant increase of 98% compared to the $3.50 million reported for the same period in 2023.

The increase in sales can be attributed to enhanced commercialization efforts, including an expanded pharmacy network and a growing number of physicians prescribing Gimoti. The transition of Gimoti pharmacy services to ASPN Pharmacy has improved prescription processing and reimbursement, contributing to better sales performance.

Conducting clinical trials and research

Research and development (R&D) expenditures for Evoke Pharma have been focused on ongoing clinical trials to support Gimoti. For the nine months ended September 30, 2024, R&D expenses were $16,322, a significant decrease of 90% from $159,347 in the corresponding period of 2023. This reduction reflects the shift from initial development to commercialization, with fewer ongoing clinical trials post-FDA approval of Gimoti in June 2020.

The company is currently in discussions with the FDA regarding a post-marketing commitment trial to evaluate a lower dose strength of Gimoti. This trial is expected to incur substantial costs, which may significantly increase future R&D expenses.

Managing sales and distribution channels

Evoke Pharma has established a commercial services agreement with Eversana for the distribution and marketing of Gimoti in the U.S. Under this agreement, Evoke retains ownership of the Gimoti NDA, while Eversana manages marketing, sales, and distribution. For the three months ended September 30, 2024, Eversana profit-sharing costs included in selling, general, and administrative expenses amounted to approximately $2.2 million, compared to $1.3 million for the same period in 2023.

As of September 30, 2024, unreimbursed commercialization costs to Eversana totaled $72.8 million, which will be payable from the net product profits of Gimoti. The agreement allows Evoke to retain more than 80% of net product profits after reimbursement of costs, thus incentivizing both parties to maximize sales.

Key Financial Metrics	2024 (YTD)	2023 (YTD)	Change ($)	Change (%)
Net Product Sales	$6,941,042	$3,504,636	$3,436,406	98%
Cost of Goods Sold	$238,031	$142,855	$95,176	67%
Research and Development Expenses	$16,322	$159,347	($143,025)	-90%
Selling, General and Administrative Expenses	$10,697,128	$8,745,407	$1,951,721	22%
Eversana Profit Sharing Costs	$5,900,000	$3,000,000	$2,900,000	97%

Evoke Pharma, Inc. (EVOK) - Business Model: Key Resources

Intellectual property for Gimoti

The primary intellectual property asset for Evoke Pharma, Inc. is its product, Gimoti® (metoclopramide), which is the first and only nasally-administered product approved for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The New Drug Application (NDA) for Gimoti was approved by the FDA in June 2020. Evoke retains ownership of the Gimoti NDA, as well as legal, regulatory, and manufacturing responsibilities for the product.

Financial resources from stock offerings

As of September 30, 2024, Evoke Pharma reported cash and cash equivalents of approximately $11.3 million, an increase from $4.7 million at the end of 2023. The company has raised funds through various stock offerings, including:

• Proceeds from the February 2024 Offering, net of issuance costs: $6.7 million.
• Proceeds from the March 2024 Warrant Amendment, net of issuance costs: $1.2 million.
• Proceeds from the June 2024 Warrant Amendment, net of issuance costs: $0.3 million.
• Proceeds from the September 2024 Exercise Price Warrant Amendment, net of issuance costs: $2.5 million.

The company also has a universal shelf registration statement filed in August 2024 that covers the offering of up to $50 million in various securities.

Experienced management team

Evoke Pharma is led by an experienced management team with a strong background in the pharmaceutical industry. The management team is responsible for the commercialization efforts for Gimoti, which include marketing, distribution, and sales. The company has partnered with Eversana Life Science Services, LLC, which provides commercialization services for Gimoti. For the nine months ended September 30, 2024, Evoke incurred approximately $5.9 million in profit-sharing costs with Eversana, indicating a robust collaboration to drive sales.

Financial Metrics	2024 (Nine Months Ended September 30)	2023 (Nine Months Ended September 30)	Change ($)	Change (%)
Net Product Sales	$6,941,042	$3,504,636	$3,436,406	98%
Cost of Goods Sold	$238,031	$142,855	$95,176	67%
Research and Development Expenses	$16,322	$159,347	($143,025)	-90%
Selling, General and Administrative Expenses	$10,697,128	$8,745,407	$1,951,721	22%

Evoke Pharma, Inc. (EVOK) - Business Model: Value Propositions

First nasal spray for diabetic gastroparesis

Evoke Pharma has developed Gimoti® (metoclopramide), the first and only nasally-administered product indicated for the relief of symptoms in adults with diabetic gastroparesis. Since its launch in October 2020, Gimoti has been positioned as a novel treatment option that addresses the unique needs of patients suffering from this condition. As of September 30, 2024, the net product sales for Gimoti reached approximately $6.94 million for the nine-month period, representing a 98% increase from $3.50 million during the same period in 2023.

Reduced healthcare resource utilization

Clinical studies have shown that patients using Gimoti experience significant reductions in healthcare resource utilization. For instance, a retrospective study presented at the American College of Gastroenterology 2024 Annual Meeting indicated a 55% decrease in all-cause emergency department visits and a 28% reduction in gastroparesis-related visits for patients treated with Gimoti compared to those on oral metoclopramide. This reduction in healthcare visits can lead to lower overall treatment costs for both patients and healthcare systems.

Improved patient compliance and outcomes

Gimoti's unique formulation as a nasal spray allows for improved patient compliance compared to traditional oral medications. This is particularly significant for diabetic gastroparesis patients who may struggle with oral medication due to nausea. Data indicates that approximately 71% of patients who have the opportunity to refill their prescriptions do so. Furthermore, the transition of Gimoti pharmacy services to ASPN Pharmacy has enhanced prescription processing, leading to better insurance coverage and patient communication.

Metric	Q3 2024	Q3 2023	Change (%)
Net Product Sales	$2,654,186	$1,562,860	70%
Cost of Goods Sold	$104,024	$34,908	198%
Research and Development Expenses	$11,677	$0	—
Selling, General and Administrative Expenses	$3,824,142	$3,131,389	22%

In conclusion, Evoke Pharma's value propositions through innovative treatment options like Gimoti, the reduction in healthcare resource utilization, and enhanced patient compliance significantly differentiate it from competitors in the specialty pharmaceuticals market.

Evoke Pharma, Inc. (EVOK) - Business Model: Customer Relationships

Direct engagement with healthcare providers

Evoke Pharma focuses on building strong relationships with healthcare providers through targeted marketing and educational efforts. The company utilizes its commercial partner, Eversana, to effectively reach gastroenterologists and other relevant specialists. This engagement includes direct sales efforts, participation in medical conferences, and providing educational materials. As of September 30, 2024, approximately 1,602 new inbound prescriptions were processed through the ASPN reimbursement center, highlighting the effectiveness of their outreach strategies.

Patient support programs for medication access

Evoke Pharma has established various patient support programs to facilitate access to its product, Gimoti. These initiatives include co-payment assistance programs for commercially insured and uninsured patients, which help alleviate the financial burden of medication costs. The company records co-payment assistance as an offset to gross revenue, utilizing prescribing data to estimate liabilities. For the nine months ended September 30, 2024, net product sales reached $6,941,042, which represents a significant increase of 98% compared to the same period in 2023.

Metric	Q3 2024	Q3 2023	Change
Net Product Sales	$2,654,186	$1,562,860	$1,091,326 (70%)
Co-payment Coverage Expenses	Flat	—	—
New Inbound Prescriptions	1,602	—	—

Feedback mechanisms for continuous improvement

To ensure continuous improvement in its customer relationships, Evoke Pharma employs feedback mechanisms that include surveys and direct communications with healthcare providers and patients. This approach allows the company to gather insights on the effectiveness of its support programs and make necessary adjustments. The transition to the ASPN platform for pharmacy services has also improved patient communication and streamlined processes, contributing to a higher percentage of prescriptions covered by insurance.

Feedback Mechanism	Description	Impact
Surveys	Collecting feedback from healthcare providers and patients	Identifies areas for improvement and enhances service delivery
Direct Communication	Engaging with prescribers for insights on Gimoti	Improves prescription rates and patient adherence
Transition to ASPN	Streamlined prescription processing and patient support	Increased efficiency and improved patient capture

Evoke Pharma, Inc. (EVOK) - Business Model: Channels

Distribution through Eversana-managed channels

Evoke Pharma has partnered with Eversana for the commercialization of its product, Gimoti. Eversana is responsible for the marketing, distribution, and commercialization of Gimoti in the United States. Under the terms of their agreement, Evoke retains ownership of the Gimoti New Drug Application (NDA), while Eversana manages the sales and marketing efforts directed towards healthcare providers. For the three months ended September 30, 2024, Evoke recognized approximately $2.2 million in profit-sharing costs related to Eversana, compared to $1.3 million during the same period in 2023.

The profit-sharing model indicates that Evoke retains more than 80% of net product profits after reimbursing Eversana for costs incurred. As of September 30, 2024, unreimbursed commercialization costs to Eversana were approximately $72.8 million.

Direct sales to healthcare facilities

Evoke Pharma also engages in direct sales to healthcare facilities, leveraging its sales force to promote Gimoti directly to healthcare professionals. As of September 30, 2024, net product sales reached $6.9 million for the nine-month period, significantly up from $3.5 million during the same period in 2023, reflecting a 98% increase. This growth can be attributed to enhanced product adoption and an increased number of prescribers, which has expanded the market reach of Gimoti within gastroenterology teams.

Online platforms for patient education

Evoke Pharma utilizes online platforms to educate patients about Gimoti and its applications. This approach aims to improve patient understanding and adherence to therapy. The company has transitioned its pharmacy services to ASPN Pharmacy, enhancing the efficiency of prescription processing and patient communication. In the quarter ended September 30, 2024, there were approximately 1,602 new inbound prescriptions processed through the ASPN reimbursement center. This transition has reportedly improved the proportion of prescriptions covered by insurance and facilitated faster communication between providers and payors.

In addition, Evoke's marketing efforts have focused on providing resources and support for patients, which is critical for maintaining engagement and ensuring that patients are aware of their treatment options.

Channel	Details	Financial Impact (Q3 2024)
Eversana-managed channels	Marketing, distribution, and commercialization of Gimoti	$2.2 million profit-sharing costs
Direct sales	Sales to healthcare facilities	$6.9 million in net product sales
Online platforms	Patient education and prescription processing	1,602 new inbound prescriptions

Evoke Pharma, Inc. (EVOK) - Business Model: Customer Segments

Adults with diabetic gastroparesis

As of September 30, 2024, Evoke Pharma's primary customer segment consists of adults suffering from diabetic gastroparesis (DGP), a condition that affects approximately 30% of individuals with diabetes. The company’s product, Gimoti® (metoclopramide nasal spray), is specifically indicated for the relief of symptoms associated with this condition. The market for DGP treatments has been growing, driven by an increasing prevalence of diabetes and the need for effective management of gastrointestinal symptoms. The demographic data indicates that the majority of patients are between the ages of 31 and 65 years old, with a significant proportion being female.

Gastroenterologists and healthcare professionals

Another critical customer segment for Evoke Pharma includes gastroenterologists and healthcare professionals. These practitioners are essential in diagnosing and managing patients with DGP and are responsible for prescribing Gimoti. The company has focused on building relationships with gastroenterology teams, which has resulted in a cumulative increase of 8% in new prescribers during the quarter ended September 30, 2024. The increased engagement with healthcare professionals is reflected in the growing number of prescriptions, with approximately 1,602 new inbound prescriptions processed during the same quarter.

Patients seeking alternative medication delivery methods

Patients looking for alternative medication delivery methods also represent a crucial segment. Gimoti's unique nasal spray delivery system addresses the needs of patients who may have difficulty with traditional oral medications due to nausea or vomiting associated with their condition. This delivery method has been particularly beneficial for patients who require more immediate relief from gastroparesis symptoms. The transition to ASPN Pharmacy for processing prescriptions has improved patient access and insurance coverage, demonstrating a commitment to enhancing patient experience and outcomes.

Customer Segment	Characteristics	Market Size (2024)	Key Products
Adults with diabetic gastroparesis	Affects 30% of diabetes patients	Approx. 2 million patients in the U.S.	Gimoti® (metoclopramide nasal spray)
Gastroenterologists and healthcare professionals	Primary prescribers of DGP treatments	Approx. 10,000 gastroenterologists in the U.S.	Gimoti®
Patients seeking alternative medication delivery methods	Prefer non-oral delivery due to nausea	Growing segment due to increasing DGP cases	Gimoti®

Evoke Pharma, Inc. (EVOK) - Business Model: Cost Structure

Research and Development Expenses

Research and development (R&D) expenses for Evoke Pharma, Inc. for the nine months ended September 30, 2024, totaled $16,322, a significant decrease of 90% from $159,347 during the same period in 2023. For the quarter ended September 30, 2024, R&D expenses were $11,677, compared to $0 in the same quarter of 2023 .

Period	R&D Expenses	Year-over-Year Change
Q3 2024	$11,677	N/A
9 Months 2024	$16,322	-90%
9 Months 2023	$159,347	N/A

Marketing and Sales Costs

Selling, general and administrative expenses (SG&A), which encompass marketing and sales costs, amounted to $10,697,128 for the nine months ended September 30, 2024, marking an increase of 22% from $8,745,407 in the same period of 2023. For the quarter ended September 30, 2024, SG&A expenses were $3,824,142, up from $3,131,389 in Q3 2023, reflecting a 22% increase .

Period	SG&A Expenses	Year-over-Year Change
Q3 2024	$3,824,142	+22%
9 Months 2024	$10,697,128	+22%
9 Months 2023	$8,745,407	N/A

Administrative Overhead and Compliance Expenses

Administrative overhead, including compliance expenses, during the nine months ended September 30, 2024, totaled approximately $1,600,000, which includes costs associated with legal, accounting, directors and officers liability insurance, and other public company operational expenses. This reflected a rise compared to the $1,900,000 incurred in the same period of 2023 .

Period	Administrative Expenses	Year-over-Year Change
Q3 2024	$500,000	N/A
9 Months 2024	$1,600,000	-15.79%
9 Months 2023	$1,900,000	N/A

Evoke Pharma, Inc. (EVOK) - Business Model: Revenue Streams

Sales Revenue from Gimoti

The primary revenue stream for Evoke Pharma, Inc. comes from the sales of its product, Gimoti, a nasal spray indicated for the treatment of diabetic gastroparesis. For the nine months ended September 30, 2024, net product sales of Gimoti were approximately $6,941,042, representing a 98% increase from $3,504,636 during the same period in 2023.

Additionally, for the quarter ended September 30, 2024, net product sales were reported at $2,654,186, up 70% from $1,562,860 in the same quarter of 2023. The increase in sales is attributed to enhanced product adoption and a broader pharmacy network, alongside an increase in the number of prescribers within gastroenterology teams.

Period	Net Product Sales	Percentage Change
Q3 2024	$2,654,186	70%
9 Months 2024	$6,941,042	98%
9 Months 2023	$3,504,636	-

Potential Licensing Agreements

Evoke Pharma is exploring potential licensing agreements to expand its revenue streams. While specific financial figures related to these agreements have not been disclosed, such arrangements may provide additional funds through upfront payments, milestones, and royalties on future sales. The company is actively seeking partnerships that can leverage Gimoti's unique delivery mechanism and therapeutic benefits to tap into broader markets.

Reimbursements from Insurance and Medicare/Medicaid

Evoke Pharma also generates revenue through reimbursements from insurance providers, Medicare, and Medicaid. The company has implemented programs to assist with co-pay liabilities and ensure patients can access Gimoti. The reimbursement process is critical, as it influences the net revenue received by the company after accounting for sales-related adjustments, including rebates and discounts associated with these programs.

As of September 30, 2024, the company reported approximately $2,022,518 in accounts receivable, indicating pending payments from insurance and government programs for Gimoti sales. This figure reflects the ongoing need for effective management of receivables to maintain liquidity.

Type of Reimbursement	Estimated Accounts Receivable
Insurance Providers	$2,022,518
Medicare/Medicaid	Included in total accounts receivable

Updated on 16 Nov 2024

Resources:

1. Evoke Pharma, Inc. (EVOK) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Evoke Pharma, Inc. (EVOK)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Evoke Pharma, Inc. (EVOK)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.