Akero Therapeutics, Inc. (AKRO): Business Model Canvas [11-2024 Updated]

Akero Therapeutics, Inc. (AKRO) is on the cutting edge of addressing significant unmet medical needs in metabolic diseases, particularly through its promising treatment candidate, EFX. This blog post delves into the company's Business Model Canvas, outlining its key partnerships, activities, and resources that drive innovation and growth. Discover how Akero navigates the complexities of drug development, engages with various stakeholders, and positions itself for future success in the competitive biopharmaceutical landscape.

Akero Therapeutics, Inc. (AKRO) - Business Model: Key Partnerships

Collaborations with pharmaceutical companies

Akero Therapeutics has established significant collaborations with major pharmaceutical companies to enhance its research and development capabilities. Notably, in June 2022, Akero received a $25 million equity investment from Pfizer, Inc. as part of a strategic partnership aimed at accelerating the development of its lead product candidate, EFX.

Licensing agreements with Amgen for EFX

In June 2018, Akero entered into a licensing agreement with Amgen, granting it exclusive rights to certain patents related to a long-acting FGF21 analog for the treatment of MASH and other metabolic diseases. The agreement included:

• An upfront payment of $5 million.
• Issuance of 2,653,333 shares of Series A Preferred Stock valued at $1.353 million to Amgen.
• Milestone payments totaling up to $75 million based on the achievement of specific commercial milestones.
• Royalty payments on annual net sales ranging from low to high single-digit percentages.

Partnerships for clinical trials and research

Akero collaborates with various contract research organizations (CROs) and academic institutions to conduct clinical trials. The ongoing Phase 2b SYMMETRY study evaluates EFX in patients with compensated cirrhosis due to MASH, with results expected in February 2025. Akero's clinical trials are designed to assess the safety and efficacy of EFX, which has shown potential in reversing fibrosis and restoring metabolic health.

Relationships with contract manufacturing organizations

To ensure the production of its clinical trial materials, Akero partners with contract manufacturing organizations (CMOs). These relationships facilitate the supply of drug substances and products necessary for clinical trials. Akero incurs significant expenses for manufacturing registration and validation batches as part of its R&D activities, which are essential for compliance with regulatory requirements.

Partnership Type	Partner	Financial Terms	Status
Equity Investment	Pfizer, Inc.	$25 million	Active
Licensing Agreement	Amgen, Inc.	Upfront: $5 million; Milestones: up to $75 million; Royalties: low to high single-digit percentages	Active
Clinical Trials	Various CROs	Variable (based on trial costs)	Ongoing
Manufacturing	Various CMOs	Variable (based on manufacturing costs)	Ongoing

Akero Therapeutics, Inc. (AKRO) - Business Model: Key Activities

Conducting clinical trials for EFX and future candidates

Akero Therapeutics is advancing its lead product candidate, Efruxifermin (EFX), through multiple clinical trials. The ongoing Phase 3 SYNCHRONY program includes three studies designed to evaluate EFX for patients with pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4). The company has already reported significant results from the Phase 2b studies, demonstrating statistically significant fibrosis regression and MASH resolution.

Developing and optimizing drug formulations

The formulation development of EFX is crucial for its efficacy and safety profiles. Akero has invested heavily in research and development, with net losses amounting to $182.0 million for the nine months ended September 30, 2024. The company has also incurred research and development expenses, which include costs associated with drug formulation and clinical trial materials.

Regulatory approval processes for product candidates

Akero is focused on obtaining regulatory approvals for EFX and other potential candidates. The company has made milestone payments to Amgen under its licensing agreement, including a $7.5 million payment upon dosing the first patient in the Phase 3 SYNCHRONY program. The total milestone payments due to Amgen could reach up to $75 million upon achieving specified commercial milestones.

Building commercialization and marketing strategies

As part of its commercialization strategy, Akero aims to develop marketing strategies to support the launch of EFX, assuming it receives regulatory approval. The company has raised significant capital to fund these activities, with cash, cash equivalents, and short- and long-term marketable securities totaling $787.1 million as of September 30, 2024. This funding will support the anticipated commercialization expenses related to product manufacturing, marketing, sales, and distribution.

Key Activity	Description	Financial Impact
Clinical Trials	Ongoing Phase 3 SYNCHRONY program for EFX	Net losses: $182.0 million (9 months ended Sept 2024)
Drug Development	Optimizing formulations for EFX	R&D expenses: Significant portion of total operating expenses
Regulatory Approval	Seeking FDA and foreign regulatory approvals	Potential milestone payments to Amgen: Up to $75 million
Commercialization	Developing marketing strategies for EFX	Cash reserves: $787.1 million as of Sept 2024

Akero Therapeutics, Inc. (AKRO) - Business Model: Key Resources

Intellectual property portfolio, including patents

Akero Therapeutics has a robust intellectual property portfolio that is crucial for its competitive edge in the biopharmaceutical industry. The company focuses on the development of EFX, an innovative treatment for metabolic diseases, particularly MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease). As part of its strategy, Akero has secured various patents that protect its proprietary technologies and formulations. This includes patents related to the composition of EFX and its therapeutic applications, which are essential for safeguarding its market position and potential revenues.

Cash reserves and marketable securities

As of September 30, 2024, Akero Therapeutics reported cash, cash equivalents, and short- and long-term marketable securities totaling $787.1 million. This substantial cash reserve is critical for funding ongoing clinical trials, research and development activities, and operational expenses. The breakdown of marketable securities primarily includes liquid assets such as:

Type	Amortized Cost	Fair Value
Money Market Funds	$303,324	$303,324
U.S. Treasury Securities	$246,981	$248,440
U.S. Government Agency Securities	$70,042	$70,258
Commercial Paper	$58,954	$59,078
Corporate Debt Securities	$92,926	$93,230

Experienced management and scientific team

Akero Therapeutics boasts an experienced management team with a strong background in biotechnology and pharmaceuticals. The leadership includes professionals with extensive experience in drug development, regulatory affairs, and commercial strategy. The scientific team comprises experts in metabolic diseases and clinical research, enhancing the company's ability to execute its development plans efficiently. This combination of expertise is vital for navigating complex regulatory landscapes and achieving successful clinical trial outcomes.

Relationships with clinical research organizations

Akero Therapeutics maintains strategic partnerships with various clinical research organizations (CROs) that facilitate the execution of clinical trials. These relationships are essential for ensuring that the company's product candidates undergo rigorous testing and evaluation. The collaboration with CROs enables Akero to leverage specialized expertise and resources, enhancing the efficiency of trial management and data collection processes.

Akero Therapeutics, Inc. (AKRO) - Business Model: Value Propositions

Targeting high unmet medical needs in metabolic diseases

Akero Therapeutics is focused on addressing significant unmet medical needs in the field of metabolic diseases, particularly in the treatment of metabolic dysfunction associated with non-alcoholic steatohepatitis (MASH). This condition poses a major health challenge globally, with an estimated prevalence of 1.5 to 6% in the general population, and even higher in individuals with obesity and diabetes. The company aims to develop innovative therapies that can provide effective solutions for patients suffering from these conditions.

Developing EFX as a potential first-line treatment for MASH

Akero's lead product candidate, EFX (eflornithine), is being developed as a potential first-line treatment for MASH. The drug is currently undergoing rigorous clinical trials, including the Phase 3 SYNCHRONY study, which targets patients with pre-cirrhotic MASH. The SYNCHRONY study aims to evaluate the efficacy and safety of EFX, with a primary endpoint of improvement in liver histology. As of September 30, 2024, Akero has invested approximately $157.3 million in direct EFX program expenses, reflecting a significant commitment to this development.

Focus on safety and efficacy through rigorous clinical trials

Akero is dedicated to ensuring the safety and efficacy of its therapies through comprehensive clinical research. The company's approach involves extensive clinical trials that adhere to stringent regulatory standards. The ongoing SYNCHRONY Histology and SYNCHRONY Real World studies are designed to provide robust data on the safety profile and therapeutic benefits of EFX. Approximately $178.2 million has been allocated to research and development expenses for the nine months ended September 30, 2024, indicating a strong focus on clinical validation.

Innovative approach to drug development in a competitive market

In a competitive landscape where numerous companies are also developing therapies for metabolic diseases, Akero differentiates itself through its innovative approach to drug development. The company’s strategy includes leveraging advanced clinical methodologies and collaborating with leading research institutions. As of September 30, 2024, Akero's total cash, cash equivalents, and short- and long-term marketable securities amounted to $787.1 million, providing a solid financial foundation to support its ongoing R&D efforts.

Financial Metrics	As of September 30, 2024
Cash, cash equivalents, and marketable securities	$787.1 million
Net loss for the nine months ended September 30, 2024	$(182.0 million)
Research and development expenses for the nine months ended September 30, 2024	$178.2 million
Direct EFX program expenses	$157.3 million

Akero Therapeutics, Inc. (AKRO) - Business Model: Customer Relationships

Engaging with healthcare providers for product education

Akero Therapeutics focuses on educating healthcare providers about its lead product candidate, EFX, which is being developed for the treatment of metabolic diseases, specifically MASH (metabolic associated steatotic liver disease). The company conducts educational initiatives through webinars, workshops, and conferences that target healthcare professionals involved in treating metabolic diseases. In 2024, Akero has allocated approximately $5 million towards these educational programs to enhance provider knowledge and increase the likelihood of EFX adoption upon approval.

Building relationships with payors for reimbursement strategies

In 2024, Akero has engaged in discussions with major payors to establish reimbursement strategies for EFX. The company aims to secure favorable formulary placements to ensure patient access to their therapies. They have conducted market research indicating that approximately 60% of payors are open to negotiating reimbursement agreements based on clinical trial outcomes. Akero has also earmarked around $3 million for these negotiations and data collection efforts.

Direct communication with patients through clinical trials

Akero Therapeutics actively engages with patients participating in clinical trials for EFX. As of September 2024, the company reported enrolling over 1,200 patients across multiple clinical studies, including the Phase 2b SYMMETRY study. They maintain direct communication through patient portals, providing updates on trial progress and outcomes. This direct line fosters trust and encourages patient retention, which is critical for successful trial completion.

Utilizing feedback from the medical community for product improvement

Akero has established a framework for collecting feedback from healthcare professionals and clinical trial participants. This includes surveys and focus groups that allow the company to gather insights on product efficacy and safety. In 2024, they implemented a feedback loop that has already resulted in three significant adjustments to their clinical trial protocols, improving patient enrollment efficiency by 25%. This commitment to incorporating feedback underscores Akero’s dedication to continuous improvement and responsiveness to the medical community.

Customer Relationship Initiative	Investment ($ million)	Expected Outcome
Healthcare Provider Education	5	Increased adoption of EFX
Payor Negotiations	3	Favorable reimbursement terms
Patient Communication	2	Enhanced patient retention
Medical Community Feedback	1	Product improvements

Akero Therapeutics, Inc. (AKRO) - Business Model: Channels

Direct sales force for future commercialization

Akero Therapeutics plans to establish a direct sales force to facilitate the commercialization of its lead product candidate, EFX, upon receiving regulatory approval. The company anticipates substantial commercialization expenses, which will include costs related to hiring and training sales personnel, marketing, and distribution logistics. As of September 30, 2024, Akero had cash, cash equivalents, and marketable securities amounting to $787.1 million, which it believes will support its operational plan through the second half of 2027.

Partnerships with healthcare institutions for product distribution

Akero Therapeutics is actively seeking partnerships with healthcare institutions to enhance its product distribution network. Collaborations with hospitals and clinics will be crucial for facilitating access to EFX for patients with metabolic dysfunction-associated steatohepatitis (MASH). The company has previously entered into agreements, including a significant collaboration with Amgen, which provides Akero with exclusive global rights to develop and commercialize EFX.

Online educational platforms for patient outreach

To improve patient outreach and education, Akero Therapeutics is leveraging online educational platforms. These platforms will serve as a channel for disseminating information about MASH, treatment options, and clinical trial participation. Engaging patients through digital means aligns with current trends in healthcare communication and is expected to enhance patient awareness and understanding of EFX.

Participation in medical conferences and trade shows

Akero Therapeutics participates in various medical conferences and trade shows to showcase its research and engage with healthcare professionals. These events provide an opportunity for the company to present clinical trial data, network with potential partners, and raise awareness about its product pipeline. The costs associated with these activities are part of the overall marketing strategy and are expected to contribute to the successful launch of EFX.

Channel Type	Description	Expected Costs (2024)	Strategic Importance
Direct Sales Force	Hiring and training personnel for commercialization	$50 million	High
Partnerships with Healthcare Institutions	Collaborations for product distribution	$20 million	High
Online Educational Platforms	Digital outreach and patient education	$5 million	Medium
Medical Conferences and Trade Shows	Participation and presentation of research	$10 million	Medium

Akero Therapeutics, Inc. (AKRO) - Business Model: Customer Segments

Patients with metabolic diseases, particularly MASH

Akero Therapeutics focuses on patients suffering from metabolic dysfunction-associated steatohepatitis (MASH), a severe form of liver disease. MASH is characterized by inflammation and fibrosis that can progress to cirrhosis and liver failure. The estimated prevalence of MASH in the U.S. is around 5% to 10% of the population, equating to approximately 16 to 32 million individuals. The company’s lead product candidate, efruxifermin (EFX), is currently undergoing Phase 3 clinical trials aimed at this patient demographic.

Healthcare providers, including physicians and specialists

Healthcare providers play a crucial role in diagnosing and treating patients with MASH. Akero Therapeutics targets specialists such as hepatologists, endocrinologists, and primary care physicians. The company aims to establish relationships with these providers to facilitate the adoption of EFX upon successful commercialization. As of September 30, 2024, Akero has reported a net loss of $182 million for the nine months ending that date, highlighting the ongoing investment in clinical trials and provider engagement.

Pharmaceutical partners for collaborative development

Akero Therapeutics collaborates with pharmaceutical partners to enhance the development of EFX and other product candidates. Notably, Akero has secured significant funding, including a $25 million equity investment from Pfizer in 2022. Additionally, Akero has entered into a license agreement with Amgen for the exclusive rights to develop FGF21 analogs, which underscores its strategy of leveraging partnerships to accelerate research and development efforts.

Insurance companies for reimbursement negotiations

Insurance companies are a vital customer segment for Akero, as reimbursement policies will significantly impact the market access for EFX. Effective negotiation with insurance providers is essential to ensure that patients have access to treatments for MASH. Akero's financial strategy includes preparing for potential reimbursement discussions, as evidenced by their detailed financial reports indicating a need for ongoing funding to support operations.

Customer Segment	Key Statistics	Strategic Goals
Patients with MASH	16-32 million U.S. patients	Successful clinical trial outcomes for EFX
Healthcare Providers	Targeting hepatologists and endocrinologists	Establish relationships for treatment adoption
Pharmaceutical Partners	$25 million from Pfizer; collaborations with Amgen	Accelerate R&D and market entry
Insurance Companies	Negotiation for reimbursement policies	Ensure patient access to EFX

Akero Therapeutics, Inc. (AKRO) - Business Model: Cost Structure

High research and development expenses

For the nine months ended September 30, 2024, Akero Therapeutics incurred total research and development expenses of $178.2 million, compared to $88.4 million for the same period in 2023, marking an increase of $89.8 million or 102% year-over-year.

The breakdown of research and development expenses includes:

• Direct EFX program expenses: $157.3 million (up from $72.9 million)
• Personnel and other R&D related expenses: $20.9 million (up from $15.5 million)

Clinical trial costs, including patient recruitment and site fees

Ongoing clinical trials, particularly the SYMMETRY and SYNCHRONY studies, significantly contribute to Akero's clinical trial costs. For the nine months ended September 30, 2024, Akero reported an increase of $78.9 million in contract research organization (CRO) expenses related to these studies.

In addition, the company has incurred $6.3 million in third-party contract manufacturing expenses for EFX. The total clinical trial costs are projected to keep rising as Akero advances its clinical programs.

Personnel costs for scientific and administrative staff

Personnel costs have also risen significantly. For the nine months ended September 30, 2024, personnel-related expenses within R&D totaled $20.9 million, reflecting a 35% increase compared to the previous year. This increase is attributed to higher stock-based compensation and additional staffing to support the expanding R&D activities.

Marketing and commercialization expenses post-approval

Although Akero has not commercialized any products yet, the company anticipates incurring substantial marketing and commercialization expenses once it receives regulatory approval for its product candidates. These expenses will include:

• Product manufacturing costs
• Marketing and sales expenses
• Distribution costs

As of September 30, 2024, Akero has an accumulated deficit of $756.1 million, indicating the significant investment required to reach the commercialization phase.

Cost Category	2024 (in millions)	2023 (in millions)	Change ($)	% Change
R&D Expenses	$178.2	$88.4	$89.8	102%
Direct EFX Program Expenses	$157.3	$72.9	$84.4	116%
Personnel and Other R&D Expenses	$20.9	$15.5	$5.4	35%
Clinical Trial Costs (CRO)	$78.9	N/A	$78.9	N/A
Accumulated Deficit	$756.1	N/A	N/A	N/A

Akero Therapeutics, Inc. (AKRO) - Business Model: Revenue Streams

Future product sales of EFX and other candidates

As of September 30, 2024, Akero Therapeutics has not yet generated any revenue from product sales. The company is focused on advancing its lead product candidate, EFX, through clinical trials with the expectation of potential future sales upon regulatory approval. EFX is currently in Phase 3 clinical trials for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). If successful, EFX could significantly contribute to the company’s revenue streams.

Potential milestone payments from collaboration agreements

Akero has entered into collaboration agreements that may include milestone payments based on the achievement of specific development and regulatory milestones. For instance, the company has a collaboration with Pfizer, which involved a $25 million equity investment in June 2022, and further potential milestone payments may arise from successful clinical development outcomes.

Licensing revenues from intellectual property

Licensing revenues can be a significant source of income for Akero, especially as it develops its intellectual property portfolio. The company has licensed rights for EFX from Amgen, and any future licensing agreements formed could result in additional revenue streams. The company has not specified exact amounts but emphasizes the importance of its intellectual property in securing partnerships.

Grants or funding for research and development efforts

Akero has raised substantial funds to support its research and development activities. As of September 30, 2024, the company had raised gross proceeds totaling $1,427.9 million since its inception, which includes various funding sources such as public offerings and loans. These funds are critical for continuing its R&D efforts, particularly for the clinical development of EFX. For the nine months ended September 30, 2024, the company reported cash used in operating activities of $163 million, primarily for R&D expenses totaling $178.2 million during the same period.

Funding Source	Amount (in millions)	Date
Initial Public Offering	$105.8	June 2019
Follow-on Public Offering	$216.4	July 2020
Equity Investment from Pfizer	$25.0	June 2022
Follow-on Public Offering	$230.0	September 2022
Term Loan from Hercules	$15.0	March 2023
Follow-on Public Offering	$220.0	April-May 2023
At-The-Market Offering	$10.9	February 2024
Follow-on Public Offering	$366.9	March 2024

As of September 30, 2024, Akero had cash, cash equivalents, and short- and long-term marketable securities of $787.1 million, which is expected to fund its operations through at least the second half of 2027.

Updated on 16 Nov 2024

Resources:

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