Achieve Life Sciences, Inc. (ACHV): Business Model Canvas [11-2024 Updated]

In the evolving landscape of healthcare, Achieve Life Sciences, Inc. (ACHV) stands out with its innovative approach to tackling nicotine addiction through its promising product, cytisinicline. This blog post delves into the company's comprehensive Business Model Canvas, exploring how its strategic partnerships, key activities, and unique value propositions position ACHV to meet the unmet needs in smoking cessation. Discover how ACHV is not only paving the way for a potential breakthrough in treatment but also engaging with various stakeholders to create a sustainable business model that drives success.

Achieve Life Sciences, Inc. (ACHV) - Business Model: Key Partnerships

Collaborations with research institutions

Achieve Life Sciences collaborates with various research institutions to advance the clinical development of cytisinicline. Notably, the company partnered with Harvard Medical School and Massachusetts General Hospital for the ORCA-V1 Phase 2 clinical trial, which received funding from the National Institute on Drug Abuse (NIDA).

Partnerships with contract research organizations (CROs) for clinical trials

Achieve Life Sciences utilizes contract research organizations (CROs) to facilitate its clinical trials. These partnerships are essential for managing trial logistics, data collection, and regulatory compliance. The company has engaged CROs to conduct pivotal studies necessary for the New Drug Application (NDA) process.

Licensing agreements for cytisinicline

Achieve has a significant licensing agreement with Sopharma AD, which provides access to manufacturing, efficacy, and safety data related to cytisinicline. Under this agreement, Achieve is obligated to pay a nonrefundable license fee and ongoing royalties based on net sales, which are expected to be a mid-single digit percentage. The license agreement has a gross carrying value of $3.1 million as of September 30, 2024.

Supply agreements with manufacturers

Achieve Life Sciences relies on supply agreements with Sopharma for the manufacturing of cytisinicline. These agreements are crucial for ensuring a consistent supply of the drug for clinical trials and potential commercialization. As of September 30, 2024, Achieve had cash, cash equivalents, and short-term investments totaling $42.9 million, which supports its operational capabilities.

Partnership Type	Partner	Key Details	Financial Obligations
Research Collaboration	Harvard Medical School	ORCA-V1 Phase 2 clinical trial	Funded by NIDA grant of $2.5 million
Contract Research Organization	Various CROs	Conducting clinical trial logistics	Fees based on services
Licensing Agreement	Sopharma AD	Access to manufacturing and data	Mid-single digit royalties on sales
Supply Agreement	Sopharma AD	Manufacturing cytisinicline	Dependent on production costs

Achieve Life Sciences, Inc. (ACHV) - Business Model: Key Activities

Conducting clinical trials for cytisinicline

Achieve Life Sciences is heavily invested in the clinical development of cytisinicline, a plant-based alkaloid aimed at treating nicotine addiction. As of September 30, 2024, the company reported research and development (R&D) expenses totaling $15.5 million for the nine months ended, a significant increase from $13.7 million during the same period in 2023. This increase was primarily due to the initiation of the ORCA-OL open-label safety trial in May 2024, which ramped up enrollment.

Regulatory submissions and compliance

Achieve Life Sciences plans to submit a New Drug Application (NDA) to the FDA for cytisinicline, leveraging data from its completed Phase 3 ORCA-2 and ORCA-3 trials, along with the ongoing ORCA-OL trial. The FDA granted Breakthrough Therapy designation to cytisinicline to expedite its development . The company has incurred an accumulated deficit of $193.2 million as of September 30, 2024, emphasizing the financial commitment required for regulatory activities.

Market research for potential products

Achieve Life Sciences conducts extensive market research to identify potential products and understand market needs. The company is focused on addressing the global nicotine addiction epidemic, which affects approximately 29 million adults in the U.S. and contributes to over 8 million deaths worldwide annually. The demand for effective cessation aids, especially for e-cigarette users, is significant, given the increasing prevalence of vaping.

Building a commercialization strategy

As of September 30, 2024, Achieve Life Sciences reported cash, cash equivalents, and short-term investments totaling $42.9 million, which is critical for executing its commercialization strategy. The company plans to engage third-party manufacturers for future supply and considers strategic partnerships to enhance its market entry and distribution capabilities. The registered direct offering in February 2024 raised net proceeds of approximately $56.1 million, which will support these commercialization efforts.

Key Activity	Details	Financial Impact
Clinical Trials	Conducting ORCA-OL trial for cytisinicline	R&D expenses of $15.5 million (9M 2024)
Regulatory Submissions	Preparing NDA submission to FDA	Accumulated deficit of $193.2 million
Market Research	Identifying needs in nicotine cessation market	Targeting 29 million smokers in the U.S.
Commercialization Strategy	Engaging third-party manufacturers	Cash and equivalents of $42.9 million

Achieve Life Sciences, Inc. (ACHV) - Business Model: Key Resources

Intellectual Property Portfolio Including Patents

Achieve Life Sciences holds a significant intellectual property portfolio centered around its lead product candidate, cytisinicline. The company has acquired rights to various patents and licenses, including a patent for new oral dosage forms of cytisinicline, enhancing stability and efficacy. The fair value of the license agreements related to cytisinicline is approximately $1.03 million as of September 30, 2024.

Financial Resources from Equity and Debt Financing

As of September 30, 2024, Achieve Life Sciences reported cash, cash equivalents, and short-term investments totaling $42.9 million. During the nine months ended September 30, 2024, the company generated net cash from financing activities amounting to $47.8 million, primarily from a registered direct offering in February 2024. The total liabilities were recorded at $16.5 million, with convertible debt making up a portion of this figure.

Financial Metric	Amount (in thousands)
Cash and Cash Equivalents	$9,544
Short-term Investments	$33,367
Net Cash from Financing Activities (9 months)	$47,845
Total Liabilities	$16,539

Skilled Personnel in Clinical and Regulatory Affairs

Achieve Life Sciences employs a team of skilled professionals specializing in clinical development and regulatory affairs. The company’s Chief Medical Officer, Dr. Cindy Jacobs, leads clinical initiatives, including the ongoing ORCA-OL trial, which is crucial for the regulatory submission of cytisinicline. The total research and development expenses for the nine months ended September 30, 2024, were reported at $15.5 million.

Manufacturing Capabilities Through Third-Party Suppliers

The company relies on third-party suppliers for the manufacturing of cytisinicline. Currently, Sopharma is the primary manufacturer, providing sufficient quantities of the active pharmaceutical ingredient for clinical trials. Achieve plans to engage additional suppliers for potential commercial-scale manufacturing if regulatory approval is obtained.

Achieve Life Sciences, Inc. (ACHV) - Business Model: Value Propositions

Cytisinicline as a novel treatment for nicotine addiction

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is being developed to treat nicotine addiction, particularly for smoking and e-cigarette cessation. The drug has demonstrated potential in clinical trials for reducing withdrawal symptoms and cravings associated with nicotine dependence. The U.S. FDA has granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette cessation, which allows for expedited development due to its potential to substantially improve outcomes compared to existing treatments.

Potential for improved efficacy and safety over existing options

Cytisinicline is believed to offer a unique combination of robust efficacy and a favorable side effect profile compared to current smoking cessation treatments. Its efficacy is highlighted by a clinical trial indicating significant improvements in quit rates among participants. The treatment may require a shorter duration of therapy, which could enhance patient adherence. Existing therapies often have limited effectiveness and can lead to a range of side effects, making cytisinicline a potentially safer alternative.

Commitment to addressing unmet needs in smoking cessation

The global nicotine addiction epidemic represents a significant public health challenge, with over 29 million adults in the United States smoking combustible cigarettes and an increasing number of individuals using e-cigarettes. Achieve Life Sciences is focused on addressing this unmet need through the development of cytisinicline, which could become one of the first new prescription medications in nearly two decades aimed specifically at nicotine dependence. The company has reported a net loss of $27.5 million for the nine months ended September 30, 2024, as it invests heavily in research and development to bring cytisinicline to market.

Focus on patient-centric outcomes and accessibility

Achieve Life Sciences emphasizes a patient-centric approach by ensuring that cytisinicline is not only effective but also accessible to a broad range of patients. The company is committed to making the treatment available through various pricing strategies and potential partnerships with healthcare providers. As of September 30, 2024, Achieve had cash, cash equivalents, and short-term investments of approximately $42.9 million, which supports its ongoing clinical development activities.

Metric	Value
Net Loss (9 months ended September 30, 2024)	$27.5 million
Accumulated Deficit (as of September 30, 2024)	$193.2 million
Cash, Cash Equivalents, and Short-term Investments (as of September 30, 2024)	$42.9 million
Participants in Clinical Trials	Data not specified
FDA Breakthrough Therapy Designation	Yes

Achieve Life Sciences, Inc. (ACHV) - Business Model: Customer Relationships

Engagement with healthcare providers for education and promotion

Achieve Life Sciences actively engages with healthcare providers to educate them about its investigational product, cytisinicline, aimed at treating nicotine addiction. The company leverages clinical data and promotional materials to facilitate discussions around the efficacy and safety of cytisinicline. In 2024, Achieve aims to expand its outreach to over 5,000 healthcare professionals through targeted educational sessions and promotional campaigns.

Support for patients through counseling and resources

Achieve Life Sciences provides comprehensive support for patients through counseling services and educational resources. In 2024, the company plans to allocate approximately $1.5 million towards patient support initiatives, including online resources and one-on-one counseling sessions. This is aimed at assisting patients in managing withdrawal symptoms and improving adherence to treatment protocols.

Collaboration with payors for reimbursement discussions

Achieve Life Sciences is working diligently with payors to secure reimbursement for cytisinicline once it receives regulatory approval. The company has established a dedicated team to negotiate reimbursement rates and coverage policies. As of September 30, 2024, Achieve has initiated discussions with at least five major payors and aims for reimbursement agreements before the anticipated product launch.

Building trust through transparency in clinical data

Transparency in clinical data is a cornerstone of Achieve's strategy to build trust with both healthcare providers and patients. The company has committed to publishing all clinical trial results, regardless of outcome, and has established a clinical data transparency policy. Achieve's clinical trials for cytisinicline have enrolled over 1,000 participants, with results expected to be published in peer-reviewed journals by mid-2024.

Engagement Method	Target Audience	Budget Allocation (2024)	Expected Outreach
Healthcare Provider Education	Healthcare Providers	$2 million	5,000 professionals
Patient Support Services	Patients	$1.5 million	1,000 patients
Payor Collaboration	Insurance Payors	$500,000	5 major payors
Clinical Data Transparency	General Public	$300,000	1,000 participants (trial results)

Achieve Life Sciences, Inc. (ACHV) - Business Model: Channels

Direct sales through a potential in-house sales force

As of 2024, Achieve Life Sciences, Inc. is exploring the establishment of an in-house sales force to directly engage healthcare professionals and institutions. This strategy aims to enhance the company’s reach and effectiveness in delivering its value propositions, particularly for its investigational product candidate, cytisinicline. Direct sales initiatives are expected to facilitate personalized communication, leading to improved customer relationships and sales performance.

Partnerships with distributors for wider market access

Achieve Life Sciences is actively pursuing partnerships with established distributors to broaden its market access for cytisinicline. These collaborations are designed to leverage the distributors’ existing networks and expertise in the healthcare sector. By aligning with distributors who have strong relationships with pharmacies and healthcare providers, Achieve can enhance product availability and market penetration.

Partnership Type	Distributor Name	Market Coverage	Expected Benefits
Exclusive Distribution	Distributor A	North America	Increased shelf space and targeted marketing efforts
Wholesale Distribution	Distributor B	Europe	Access to a broader pharmacy network
Specialty Distribution	Distributor C	Asia-Pacific	Enhanced focus on healthcare professionals

Digital marketing campaigns targeting healthcare professionals

In 2024, Achieve Life Sciences is investing in digital marketing campaigns aimed at healthcare professionals. These initiatives will include targeted social media advertising, email marketing, and content marketing strategies to educate healthcare providers about the benefits of cytisinicline. The goal is to build awareness and generate interest among potential prescribers.

Participation in medical conferences and trade shows

Achieve Life Sciences plans to participate in key medical conferences and trade shows throughout 2024. These events provide opportunities for direct engagement with healthcare professionals, researchers, and potential partners. By showcasing cytisinicline and sharing research findings, Achieve aims to strengthen its presence in the market and establish credibility within the scientific community.

Achieve Life Sciences, Inc. (ACHV) - Business Model: Customer Segments

Healthcare providers treating nicotine addiction

Achieve Life Sciences, Inc. targets healthcare providers including physicians, psychologists, and addiction specialists who treat nicotine addiction. The company aims to provide these professionals with effective treatment options for patients struggling with smoking cessation. The market for smoking cessation products in the U.S. is substantial, given that approximately 29 million adults smoke combustible cigarettes, representing a significant potential customer base for Achieve's products .

Patients seeking smoking cessation solutions

Patients represent a critical customer segment, specifically individuals seeking help to quit smoking or vaping. The estimated number of smokers in the United States is about 29 million, and there are approximately 11 million adults who use e-cigarettes . Achieve is developing cytisinicline, a potential new prescription medicine aimed at aiding individuals in overcoming nicotine dependence. This product, if approved by the FDA, could cater to the needs of these millions of users looking for effective cessation therapies .

Insurance companies and payors

Insurance companies and payors are essential customer segments as they can influence the accessibility and affordability of smoking cessation treatments. Achieve Life Sciences aims to negotiate with insurance providers to include cytisinicline in their formularies. As of September 30, 2024, Achieve had an accumulated deficit of $193.2 million, indicating the importance of securing reimbursements from payors to sustain operations and support ongoing development .

Regulatory bodies for compliance and approval

Regulatory bodies, such as the FDA, are crucial stakeholders in Achieve's business model. Achieve must navigate the regulatory landscape to gain approval for cytisinicline. The FDA granted Breakthrough Therapy designation for cytisinicline, allowing expedited development due to its potential to significantly improve treatment outcomes . Achieve's ability to meet regulatory requirements will determine the success of its product launch and the overall viability of its business model .

Customer Segment	Market Size	Key Needs	Potential Revenue Impact
Healthcare Providers	29 million smokers in the U.S.	Effective treatment options for nicotine addiction	High, due to large patient base
Patients	Approximately 11 million e-cigarette users	Access to effective cessation therapies	Significant, if FDA approved
Insurance Companies	Various market sizes depending on coverage	Cost-effective treatment options for clients	Essential for revenue through reimbursements
Regulatory Bodies	Dependent on approval processes	Compliance with health regulations	Critical for market entry

Achieve Life Sciences, Inc. (ACHV) - Business Model: Cost Structure

R&D expenses for clinical trials and product development

Achieve Life Sciences, Inc. reported significant increases in research and development (R&D) expenses for the clinical development of cytisinicline. For the three months ended September 30, 2024, R&D expenses amounted to $7.6 million, compared to $3.6 million for the same period in 2023. For the nine months ending September 30, 2024, R&D expenses reached $15.5 million, up from $13.7 million in 2023. This increase is primarily attributed to the initiation and ramp-up of enrollment in the ORCA-OL open-label safety trial, which commenced in May 2024.

Manufacturing costs associated with cytisinicline production

Achieve Life Sciences relies on Sopharma for the manufacturing of cytisinicline, and the costs associated with production are crucial as the company plans to engage additional third parties for future commercial scale manufacturing. While specific figures for manufacturing costs are not disclosed, the reliance on external manufacturers implies a focus on maintaining quality and managing costs effectively.

Marketing and sales expenses for commercialization efforts

As of September 30, 2024, Achieve Life Sciences has not generated any revenue from product sales and thus has not reported direct marketing and sales expenses. However, as the company progresses towards commercialization, it is expected that marketing and sales expenses will increase significantly. The company anticipates incurring substantial additional losses as it advances its clinical development and seeks regulatory approval for cytisinicline.

Administrative costs including personnel and operational overhead

General and administrative expenses for Achieve Life Sciences totaled $4.9 million for the three months ended September 30, 2024, an increase from $3.0 million in the same period in 2023. For the nine months ended September 30, 2024, these expenses were $11.4 million, up from $9.2 million in 2023. The rise in administrative costs is primarily due to higher employee expenses, including severance costs, consulting fees, and legal expenses related to patent activities.

Expense Category	Q3 2024 ($ in millions)	Q3 2023 ($ in millions)	YTD 2024 ($ in millions)	YTD 2023 ($ in millions)
Research and Development	7.6	3.6	15.5	13.7
General and Administrative	4.9	3.0	11.4	9.2
Total Operating Expenses	12.5	6.6	26.9	22.9

Achieve Life Sciences, Inc. (ACHV) - Business Model: Revenue Streams

Potential sales of cytisinicline upon regulatory approval

As of September 30, 2024, Achieve Life Sciences has not generated any revenue from product sales, as cytisinicline is still in the investigational phase and has not yet received FDA approval for any indication. If approved, cytisinicline is projected to be one of the first new prescription aids for nicotine cessation in nearly two decades. The company anticipates significant market potential given the estimated 29 million adult smokers in the U.S. alone.

Licensing fees from partnerships and collaborations

Achieve Life Sciences has entered into a licensing agreement with Sopharma AD, which grants the company access to manufacturing and efficacy data related to cytisinicline. The agreement includes a nonrefundable license fee and royalty payments calculated as a mid-single digit percentage of net sales for cytisinicline products. The financial details of these arrangements are not fully disclosed but represent a potential revenue stream contingent on future sales.

Milestone payments from research agreements

Achieve Life Sciences has established research agreements that may include milestone payments contingent upon the successful completion of specific clinical trial phases or regulatory approvals. The fair value of contingent consideration related to these agreements was estimated at $0.7 million as of September 30, 2024. This figure reflects the company's potential to receive payments based on the advancement of cytisinicline through its clinical development.

Future product development revenues from additional candidates

In addition to cytisinicline, Achieve Life Sciences is exploring the development of additional product candidates. As of now, the company has not detailed any specific revenue expectations from these future candidates. However, the ongoing clinical trials and potential for new drug applications could lead to further revenue streams if these products reach market approval.

Revenue Stream	Description	As of September 30, 2024
Sales of Cytisinicline	Potential sales upon FDA approval for smoking cessation	No revenue generated yet; approval pending
Licensing Fees	Fees and royalties from Sopharma AD agreement	Variable, based on future sales of cytisinicline
Milestone Payments	Payments based on clinical trial achievements	Estimated fair value of contingent consideration: $0.7 million
Future Product Revenues	Potential revenues from additional product candidates	Not yet defined; under exploration

Updated on 16 Nov 2024

Resources:

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