Mirati Therapeutics, Inc. (MRTX): Business Model Canvas [10-2024 Updated]

Mirati Therapeutics, Inc. (MRTX) is at the forefront of oncology innovation, developing targeted therapies aimed at improving outcomes for patients with specific genetic mutations. With a robust business model centered around strategic partnerships, cutting-edge research, and a commitment to personalized medicine, Mirati is poised to make significant strides in the fight against cancer. Dive into the details of their Business Model Canvas to understand how they are shaping the future of oncology treatment.

Mirati Therapeutics, Inc. (MRTX) - Business Model: Key Partnerships

Collaboration with BeiGene for sitravatinib development in Asia

Mirati Therapeutics has a significant partnership with BeiGene Ltd. established through a Collaboration and License Agreement dated January 7, 2018. Under this agreement, Mirati granted BeiGene an exclusive license to develop, manufacture, and commercialize sitravatinib in Asia (excluding Japan) and certain other territories. BeiGene paid a non-refundable upfront fee of $10.0 million for these rights. Additionally, BeiGene is obligated to make milestone payments of up to $123.0 million based on the achievement of specific clinical, regulatory, and sales milestones. The agreement also includes tiered royalties on annual net sales of licensed products ranging from mid-single digits to 20%, subject to certain reductions.

Partnerships with contract manufacturers for drug production

Mirati engages with contract manufacturers to ensure the production of its therapeutics, particularly for sitravatinib. The company has initial supply obligations for sitravatinib, which were recognized as revenues amounting to $0.5 million as of December 31, 2020. These obligations are part of the broader collaboration with BeiGene, enabling efficient access to manufacturing capabilities.

Licensing agreements for intellectual property and know-how

Mirati has established various licensing agreements that enhance its intellectual property portfolio. One notable agreement is with ORIC Pharmaceuticals, which was signed on August 3, 2020. Under this agreement, Mirati granted ORIC an exclusive, worldwide license to develop and commercialize allosteric PRC2 inhibitors. In exchange, ORIC issued 588,235 shares of its common stock to Mirati, valued at approximately $11.4 million in non-cash consideration recognized as license and collaboration revenues.

Engagement with research institutions for clinical trials

Mirati collaborates with various research institutions to conduct clinical trials for its drug candidates. As of September 30, 2023, Mirati reported a net product revenue of $36.1 million from KRAZATI, its first commercial product, which is targeted at patients with KRAS G12C mutations. The company continues to engage with clinical research organizations (CROs) to facilitate the development and trial phases of its investigational drugs, ensuring a robust pipeline and adherence to regulatory standards.

Partnership	Type	Financial Terms	Purpose
BeiGene	Collaboration and License	Upfront fee: $10.0 million Milestone payments: Up to $123.0 million Royalties: 20% on net sales	Development and commercialization of sitravatinib in Asia
Contract Manufacturers	Manufacturing	Initial supply obligation: $0.5 million	Production of sitravatinib
ORIC Pharmaceuticals	Licensing	Shares issued: 588,235 Value: $11.4 million	Development of PRC2 inhibitors
Research Institutions	Clinical Trials	Net product revenue: $36.1 million (KRAZATI)	Conducting clinical trials for drug candidates

Mirati Therapeutics, Inc. (MRTX) - Business Model: Key Activities

Conducting clinical trials for various oncology drug candidates.

Mirati Therapeutics has focused its research and development efforts on several clinical programs. As of September 30, 2023, the company reported research and development expenses totaling $114.8 million for the third quarter of 2023, compared to $131.1 million for the same period in 2022. The trials include:

• Adagrasib: $43.8 million in R&D expenses for Q3 2023.
• MRTX1133: Initiated a Phase 1 clinical trial in Q1 2023.
• MRTX0902: Phase 1/2 multiple expansion cohort trial initiated in Q4 2022.

Regulatory submissions for drug approvals (e.g., KRAZATI).

KRAZATI (adagrasib) received FDA approval in December 2022, marking a significant milestone for Mirati. The product revenue, net for KRAZATI for the three months ended September 30, 2023, was $16.4 million, and for the nine months ended September 30, 2023, it was $36.1 million. The company continues to engage in regulatory submissions for other drug candidates as part of its strategy to expand its oncology portfolio.

Market research and analysis for targeted cancer therapies.

Mirati conducts extensive market research to identify unmet needs in oncology. The company’s strategic partnerships, such as the agreement with BeiGene for sitravatinib, highlight its focus on developing targeted therapies in specific markets. The collaboration with BeiGene includes milestone payments of up to $123 million based on clinical, regulatory, and sales milestones.

Development of companion diagnostics for patient selection.

Companion diagnostics are essential for patient selection in targeted therapies. Mirati has been involved in the development of diagnostics that align with its drug candidates. The company aims to enhance treatment efficacy through precise patient stratification. As of September 30, 2023, the company has incurred $365.6 million in total research and development expenses for the nine months ended.

Clinical Program	R&D Expenses Q3 2023 (in millions)	FDA Approval Status
Adagrasib	$43.8	Approved
MRTX1133	—	Phase 1 trial initiated
MRTX0902	—	Phase 1/2 trial ongoing
KRAZATI	—	FDA approved December 2022

Mirati Therapeutics, Inc. (MRTX) - Business Model: Key Resources

Proprietary drug candidates, including KRAZATI and MRTX1719

Mirati Therapeutics has developed several proprietary drug candidates, with KRAZATI (adagrasib) being a leading product. KRAZATI received FDA approval in December 2022, generating product revenue of $16.4 million for the three months ended September 30, 2023, and $36.1 million for the nine months ended the same date. MRTX1719 is another drug candidate in the pipeline, focusing on specific cancer treatments.

Experienced research and development team

The research and development (R&D) efforts at Mirati Therapeutics have been substantial. For the three months ended September 30, 2023, R&D expenses totaled $114.8 million, down from $131.1 million in the same period of 2022. The team is skilled in navigating complex clinical trials, with a focus on innovative cancer therapies. Salaries and related expenses for personnel account for a significant portion of the R&D budget, which was $22.4 million for the three months ended September 30, 2023.

Financial resources from recent funding rounds

As of September 30, 2023, Mirati Therapeutics had $976.4 million in cash, cash equivalents, and short-term investments. In August 2023, the company completed a public offering of common stock and warrants, generating net proceeds of $332.5 million. The total shareholders' equity as of September 30, 2023, was $946.5 million. This financial backing is crucial for ongoing clinical trials and potential commercialization of drug candidates.

Intellectual property portfolio, including patents

Mirati Therapeutics has established a robust intellectual property portfolio, which includes exclusive licenses and patents for its drug candidates. Notably, under the BeiGene Agreement, Mirati retains exclusive rights for the development and commercialization of sitravatinib outside specified regions, with potential milestone payments up to $123 million. The company has also incurred approximately $10.5 million in development milestone payments related to its collaborations.

Key Resource	Description	Financial Impact
KRAZATI	FDA-approved drug for KRAS G12C mutations	$16.4M Q3 2023 revenue
MRTX1719	In development for cancer treatment	Potential future revenue
R&D Team	Experienced personnel in drug development	$114.8M R&D expenses Q3 2023
Cash Reserves	Available capital for operations	$976.4M as of Sept 2023
Intellectual Property	Patents and licenses for drug candidates	Milestone payments potential of $123M

Mirati Therapeutics, Inc. (MRTX) - Business Model: Value Propositions

Innovative treatments targeting specific genetic mutations in cancer

Mirati Therapeutics focuses on developing innovative treatments that specifically target genetic mutations associated with various cancers. The company's lead product, KRAZATI (adagrasib), is designed for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). Since its FDA approval in December 2022, KRAZATI has generated significant revenue, with net product revenue of $16.4 million for Q3 2023 and $36.1 million for the nine months ended September 30, 2023.

Potential for improved patient outcomes in hard-to-treat cancers

Mirati's commitment to addressing hard-to-treat cancers is evident in its clinical pipeline, which includes multiple candidates targeting various genetic mutations. The company reported a total research and development expense of $114.8 million for Q3 2023, reflecting its ongoing investment in clinical trials aimed at improving patient outcomes. The focus on specific genetic targets enhances the potential effectiveness of treatments, thereby aiming for better patient outcomes compared to traditional therapies.

Focus on personalized medicine through companion diagnostics

Mirati emphasizes personalized medicine by integrating companion diagnostics with its therapeutic offerings. This approach allows for tailored treatment plans based on individual genetic profiles, enhancing the efficacy of treatments. The company’s companion diagnostics initiatives are designed to identify patients who are most likely to benefit from its targeted therapies, thereby optimizing treatment outcomes and resource allocation.

Commitment to addressing significant unmet medical needs in oncology

Mirati Therapeutics is dedicated to addressing unmet medical needs in oncology, focusing on cancers with high morbidity and mortality rates. The company’s strategic partnerships, such as those with BeiGene and Zai Labs, facilitate broader access to its innovative therapies across different markets, furthering its mission to meet significant healthcare challenges.

Value Proposition	Details	Financial Impact
Innovative treatments	KRAZATI targeting KRAS G12C mutations	$16.4 million in Q3 2023 revenue
Improved patient outcomes	Focus on hard-to-treat cancers	$114.8 million R&D expense in Q3 2023
Personalized medicine	Integration of companion diagnostics	Enhanced treatment efficacy potential
Addressing unmet needs	Strategic partnerships with BeiGene and Zai Labs	Broader market access for therapies

Mirati Therapeutics, Inc. (MRTX) - Business Model: Customer Relationships

Building relationships with oncologists and healthcare providers

Mirati Therapeutics emphasizes the importance of establishing strong, collaborative relationships with oncologists and healthcare providers. This is crucial for the adoption of its FDA-approved product, KRAZATI, which was launched in December 2022. As of September 30, 2023, the product revenue from KRAZATI reached $16.4 million for the third quarter of 2023, indicating a growing acceptance among healthcare professionals.

Engaging patients through educational initiatives

To enhance patient engagement, Mirati has implemented educational initiatives aimed at raising awareness of its products and the conditions they treat. These initiatives are designed to equip patients with the necessary knowledge to make informed decisions about their treatment options. The company’s product revenue for KRAZATI included $3.0 million from sales to third-party commercial customers for clinical trials during the nine months ended September 30, 2023.

Utilizing specialty pharmacies for product distribution

Mirati utilizes specialty pharmacies and distributors for the distribution of KRAZATI. This strategy not only ensures that the product reaches patients efficiently but also allows for better management of the complex logistics involved in specialty drug distribution. As of September 30, 2023, the company reported that its accounts receivable from KRAZATI product sales totaled $14.7 million, reflecting the company's growing sales through these channels.

Distribution Channel	Revenue (Q3 2023)	Accounts Receivable (as of Sept 2023)
Specialty Pharmacies	$16.4 million	$14.7 million
Third-party Commercial Customers	$3.0 million	N/A

Establishing partnerships with healthcare payors for reimbursement

Mirati recognizes the significance of establishing partnerships with healthcare payors to facilitate reimbursement for its products. The company has engaged in discussions with various payors to ensure that KRAZATI is included in their formularies, which is vital for patient access. The company’s accrued liabilities related to government and commercial rebates totaled $2.8 million as of September 30, 2023.

Mirati Therapeutics, Inc. (MRTX) - Business Model: Channels

Direct sales through specialty pharmacies and distributors

Mirati Therapeutics primarily generates revenue through direct sales of its product, KRAZATI, which received FDA approval in December 2022. As of September 30, 2023, the total product revenue, net, was $16.4 million for the third quarter and $36.1 million for the nine months ended September 30, 2023. The company sells KRAZATI through specialty pharmacies and distributors, ensuring that it reaches the appropriate patient populations effectively.

Clinical trial sites for patient recruitment and education

Mirati engages with clinical trial sites to facilitate patient recruitment and education regarding its drug offerings. The company’s clinical development programs are crucial for advancing its pipeline and include studies for KRAZATI and other investigational products. As of September 30, 2023, Mirati had invested approximately $114.8 million in research and development for the third quarter. This investment supports the infrastructure needed to recruit patients for clinical trials and educate them about the therapeutic options available.

Digital platforms for outreach and patient engagement

Mirati leverages digital platforms to enhance outreach and engage with patients and healthcare providers. The company utilizes online resources to provide information about KRAZATI and its mechanism of action, as well as updates on clinical trials. This digital engagement is part of a broader strategy to build awareness and facilitate access to its products, especially as it seeks to establish a foothold in the competitive oncology market.

Partnerships with healthcare institutions for research collaboration

Mirati has established partnerships with various healthcare institutions to foster research collaboration. Notably, under the BeiGene Agreement, Mirati granted an exclusive license to BeiGene to develop and commercialize sitravatinib in certain territories, which includes milestone payments potentially totaling up to $123 million. These collaborations not only enhance research capabilities but also expand the distribution channels for Mirati's products, facilitating broader market penetration.

Channel Type	Description	Financial Impact
Direct Sales	Sales of KRAZATI through specialty pharmacies	$16.4 million (Q3 2023)
Clinical Trials	Investment in R&D for patient recruitment and education	$114.8 million (R&D expense Q3 2023)
Digital Platforms	Online resources for patient and provider engagement	Not quantified; part of marketing strategy
Partnerships	Collaborations with healthcare institutions	Potential milestone payments of up to $123 million (BeiGene Agreement)

Mirati Therapeutics, Inc. (MRTX) - Business Model: Customer Segments

Patients with KRAS G12C-mutated non-small cell lung cancer

Mirati Therapeutics focuses on patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), a significant subgroup of lung cancer cases. As of 2024, approximately 13% of NSCLC patients are estimated to have the KRAS G12C mutation, representing a patient population of around 40,000 in the U.S. annually. The FDA approved KRAZATI (adagrasib) in December 2022, specifically for this indication, with product revenue netting $16.4 million and $36.1 million for the three and nine months ended September 30, 2023, respectively.

Oncologists and healthcare providers specializing in cancer treatment

Oncologists and healthcare providers are critical customer segments for Mirati, as they prescribe KRAZATI to eligible patients. The oncology market continues to expand, with oncology drug sales projected to reach approximately $300 billion globally by 2025. Mirati’s sales strategy includes direct engagement with oncologists to educate them on the benefits and administration of KRAZATI, enhancing its market penetration.

Research institutions and clinical trial networks

Mirati collaborates with research institutions and clinical trial networks to advance its drug development pipeline. These partnerships are vital for conducting clinical trials for new therapies. The company has initiated several clinical trials, including MRTX1133, which began Phase 1 trials in early 2023. The investment in R&D was $114.8 million for Q3 2023, reflecting continuous commitment to developing innovative treatments.

Pharmaceutical companies seeking collaboration in oncology

Mirati also targets partnerships with other pharmaceutical companies. Notable collaborations include agreements with BeiGene and Pfizer. The BeiGene agreement includes milestone payments of up to $123 million and royalties on net sales. As of September 30, 2023, Mirati had an accumulated deficit of $2.976 billion, highlighting the importance of strategic collaborations to bolster financial stability and expand its research capabilities.

Customer Segment	Key Statistics	Revenue Impact
Patients with KRAS G12C-mutated NSCLC	Approx. 40,000 patients annually in the U.S.	$16.4 million (Q3 2023)
Oncologists and healthcare providers	Projected oncology drug sales: $300 billion globally by 2025	Growing market engagement through education
Research institutions and clinical trial networks	R&D investment: $114.8 million (Q3 2023)	Pipeline advancement and trial initiation
Pharmaceutical companies	Milestone payments up to $123 million (BeiGene)	Strategic collaborations for financial support

Mirati Therapeutics, Inc. (MRTX) - Business Model: Cost Structure

High R&D expenditure for drug development and clinical trials

Research and development expenses for the three months ended September 30, 2023, were $114.8 million, compared to $131.1 million for the same period in 2022. For the nine months ended September 30, 2023, R&D expenses totaled $365.6 million, down from $390.4 million in 2022. This decrease is attributed to reduced costs associated with sitravatinib clinical development, as the company completed enrollment in the SAPPHIRE Phase 3 clinical trial.

Expense Category	Q3 2023 (in thousands)	Q3 2022 (in thousands)	9M 2023 (in thousands)	9M 2022 (in thousands)
Research and Development	$114,766	$131,076	$365,636	$390,391
Third-party R&D Expenses	$64,514	$68,663	$199,520	$209,925
Salaries and Employee-related Expenses	$22,415	$26,511	$77,832	$75,289
Share-based Compensation	$19,480	$28,276	$62,518	$77,343

Manufacturing and production costs for drug candidates

Cost of product revenue for the three and nine months ended September 30, 2023, was $1.4 million and $3.0 million, respectively. This includes manufacturing and distribution costs for KRAZATI. Additionally, had previously expensed inventory been capitalized, total cost of product revenue would have increased by approximately $1.7 million and $4.5 million for the respective periods.

Regulatory compliance and submission costs

Regulatory compliance costs are embedded within the R&D expenses, particularly in the fees paid to external service providers like Clinical Research Organizations (CROs). These costs are essential for obtaining FDA approval and maintaining compliance during clinical trials. While specific dollar amounts for compliance costs are not detailed, they are a significant aspect of the overall R&D budget, which reached $114.8 million in Q3 2023.

Marketing and sales expenses for KRAZATI and other products

Selling, general and administrative expenses, which include marketing and sales costs, were $72.0 million for the three months ended September 30, 2023, compared to $60.8 million for the same period in 2022. For the nine months ended September 30, 2023, these expenses totaled $221.0 million, an increase from $169.0 million in 2022. This increase is primarily due to higher headcount-related costs and commercial activities to support KRAZATI's marketing and sales.

Expense Category	Q3 2023 (in thousands)	Q3 2022 (in thousands)	9M 2023 (in thousands)	9M 2022 (in thousands)
Selling, General and Administrative	$72,001	$60,798	$220,981	$168,977

Mirati Therapeutics, Inc. (MRTX) - Business Model: Revenue Streams

Product sales from KRAZATI and potential future drugs

Mirati Therapeutics has generated significant revenue from the sales of KRAZATI, which was approved by the FDA in December 2022. For the three months ended September 30, 2023, the company recognized $16.4 million in product revenue, net, related to KRAZATI. For the nine months ended September 30, 2023, the total product revenue was $36.1 million. Additionally, $1.3 million and $3.0 million of this revenue for the respective periods were attributed to sales of KRAZATI to a third-party commercial customer for clinical trials.

Milestone payments from licensing agreements

Mirati has entered into several licensing agreements that include milestone payments. Notably, under the BeiGene Agreement, the company is entitled to milestone payments totaling up to $123 million upon the achievement of specified clinical, regulatory, and sales milestones. As of September 30, 2023, no milestone payments were earned during the current year, but previously, the company recognized milestone payments of $5 million for the initiation of pivotal trials related to adagrasib in prior periods.

Royalties from collaborations with pharmaceutical partners

Mirati also earns royalty revenue from its collaborations. Under the BeiGene Agreement, the company is entitled to receive tiered royalties ranging from mid-single digits to 20% on annual net sales of licensed products in the BeiGene Licensed Territory. However, no royalty revenue was recognized during the three and nine months ended September 30, 2023.

Potential revenue from companion diagnostics once commercialized

While specific figures for potential revenue from companion diagnostics are not yet available, the commercialization of these diagnostics could provide an additional revenue stream for Mirati. The development of companion diagnostics is a strategic focus, enhancing the value proposition of their therapeutic offerings, particularly KRAZATI.

Revenue Source	Amount (USD)	Notes
Product Sales (KRAZATI)	$16.4 million (Q3 2023)	Net revenue from KRAZATI sales
Product Sales (KRAZATI)	$36.1 million (9M 2023)	Total net revenue from KRAZATI
Milestone Payments (BeiGene Agreement)	Up to $123 million	Total potential milestone payments
Royalties (BeiGene Agreement)	Up to 20%	Royalty percentage on net sales
Companion Diagnostics	Not yet quantified	Potential future revenue stream