On February 28, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported financial results for the fourth quarter and full year of 2022 along with recent corporate updates (Press release, Mirati, FEB 28, 2023, View Source [SID1234627863]).
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"2022 was a momentous year for Mirati, culminating in the approval and launch of KRAZATI as a treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRASG12C mutation. We believe this is the first of several potentially best-in-class products on the horizon for Mirati," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "In addition to the approval of KRAZATI in 2022 we advanced MRTX1719 and MRTX0902 into clinical trials and filed an Investigational New Drug application for MRTX1133. These accomplishments bring us closer to realizing our vision to unlock the promise of a life beyond cancer. We look ahead to 2023 with excitement as the company enters a new phase of commercialization from a strong financial position."
Pipeline Updates
Adagrasib (Potent and selective KRASG12C inhibitor)
•In December 2022, the Company announced the U.S. Food and Drug Administration (FDA) granted accelerated approval of KRAZATI (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.
•In December 2022, the Company announced the FDA granted Breakthrough Therapy Designation (BTD) for adagrasib in combination with cetuximab in patients with KRASG12C-mutated advanced colorectal cancer (CRC) whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. The New England Journal of Medicine published these findings, which demonstrate promising clinical activity and a favorable tolerability profile. Based on recent FDA discussions, the Company expects to move forward with an application for Accelerated Approval in third-line or later KRASG12C-mutated advanced CRC.
•In December 2022, the Company announced preliminary results from the KRYSTAL-7 Phase 2 study and KRYSTAL-1 Phase 1b cohort evaluating adagrasib concurrently combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRASG12C mutation at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Annual Congress. The data demonstrated the combinability of KRAZATI with pembrolizumab as well as initial promising clinical activity.
•In November 2022, the Company announced a clinical study collaboration and supply agreement with Incyte to evaluate the combination of adagrasib and INCB099280, an oral PD1 inhibitor, in patients with KRASG12C-mutant solid tumors.
•In October 2022, the Company announced a clinical collaboration with Aadi Bioscience to evaluate the combination of adagrasib and nab-sirolimus, an mTOR inhibitor complexed with human albumin, in KRASG12C-mutant NSCLC and other solid tumors.
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Sitravatinib (Potent TAM receptor inhibitor)
•The Company expects to provide topline final overall survival results from the global, registration-enabling Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC in the second quarter of 2023.
MRTX1719 (MTA cooperative PRMT5 inhibitor)
•A Phase 1/2 clinical study to evaluate MRTX1719, an MTA cooperative PRMT5 inhibitor, in patients with solid tumors harboring MTAP-gene deletions is ongoing. The study continues to enroll, and the Company expects to share the initial clinical data in the second half of 2023.
MRTX0902 (Potent SOS1 inhibitor)
•The Company initiated a Phase 1/2 clinical study initially evaluating MRTX0902, a selective KRAS signal modifying SOS1 inhibitor, in an escalating dose cohort as a monotherapy and expects to initiate dose escalation cohorts combining MRTX0902 and adagrasib in the second half of 2023.
MRTX1133 (Potent and selective KRASG12D inhibitor)
•In December 2022, the Company submitted the IND application for MRTX1133, a potent and selective KRASG12D inhibitor, which was cleared by the FDA in January 2023. The Company initiated a Phase 1/2 clinical study in February 2023 with plans for multiple expansion cohorts in pancreatic, colorectal, lung and other tumor types with KRASG12D mutations.
Recent Corporate Updates
•In November 2022, the Company announced the appointment of Alan Sandler, M.D., as Chief Medical Officer and the planned retirement of Charles Baum, M.D., Ph.D., president, founder and head of research and development in the second quarter of 2023.
•The Company published the 2022 Corporate Sustainability Report, the Company’s second annual report, which provides information describing investments and resources based on the biotechnology and pharmaceuticals framework of the Sustainability Accounting Standards Board.
Fourth Quarter and Full-Year 2022 Financial Results
•Cash, cash equivalents, and short-term investments of approximately $1.1 billion as of December 31, 2022.
•Net product revenue for both the fourth quarter 2022 and the twelve months ended December 31, 2022 was $0.7 million and was driven by sales of KRAZATI, which received approval by the FDA and launched commercially in the U.S. in December 2022. There was no product revenue for the same periods in 2021.
•License and collaboration revenue for the fourth quarter 2022 was $0.2 million, compared to $0.3 million for the same period in 2021. License and collaboration revenues for the twelve months ended December 31, 2022 were $11.7 million, primarily driven by milestone payments received from Zai Lab in connection with the initiation of pivotal clinical studies of adagrasib for the first and second indications in the Zai Lab designated territories during 2022. This compares to license and collaboration revenues of $72.1 million for the same period in 2021, primarily driven by $66.6 million of revenue associated with the transfer of the license and know-how of adagrasib as part of our agreement with Zai
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Lab, and a $5.0 million milestone payment from BeiGene, associated with the start of the first pivotal sitravatinib clinical study in the BeiGene designated territories.
•Cost of product revenue for both the fourth quarter 2022 and the twelve months ended December 31, 2022 was $0.6 million and was primarily due to non-recurring, launch-related product distribution costs for KRAZATI following FDA approval in December 2022. There was no cost of product revenue for the same periods in 2021.
•Research and development expenses for the fourth quarter 2022 were $141.2 million, compared to $153.8 million for the same period in 2021. Research and development expenses for the twelve months ended December 31, 2022 were $531.6 million, compared to $508.6 million for the same period in 2021. The decrease in research and development expenses for the fourth quarter 2022 compared to the same period in 2021 was primarily due to the manufacturing costs incurred in 2021 to support our New Drug Application (NDA) and commercial launch, partially offset by an increase in headcount-related costs, including share-based compensation and salaries, due to the growth of our headcount to support our growing portfolio. The increase in research and development expenses for the twelve months ended December 31, 2022 compared to the same period in 2021 was primarily driven by an increase in development costs to advance our preclinical and clinical development programs, and an increase in headcount-related costs, including share-based compensation and salaries, offset primarily by a reduction in manufacturing costs for adagrasib to support our NDA and commercial launch. The Company recognized research and development-related share-based compensation expenses of $36.2 million during the fourth quarter 2022, compared to $21.8 million for the same period in 2021, and $113.5 million during the twelve months ended December 31, 2022, compared to $68.5 million for the same period in 2021.
•Selling, general and administrative expenses for the fourth quarter 2022 were $70.8 million, compared to $43.5 million for the same period in 2021. Selling, general and administrative expenses for the twelve months ended December 31, 2022 were $239.8 million, compared to $136.7 million for the same period in 2021. The increases were primarily due to an increase in headcount-related costs, including share-based compensation and salaries, and commercial readiness costs as we prepared for the commercial launch of KRAZATI. The Company recognized selling, general and administrative-related share-based compensation expenses of $25.4 million in the fourth quarter 2022, compared to $12.1 million for the same period in 2021, and $72.6 million during the twelve months ended December 31, 2022, compared to $45.0 million for the same period in 2021.
•Net loss for the fourth quarter 2022 was $202.5 million, or $3.51 per share basic and diluted, compared to a net loss of $199.6 million, or $3.72 per share basic and diluted for the same period in 2021. Net loss for the twelve months ended December 31, 2022 was $740.9 million, or $13.18 per share basic and diluted, compared to a net loss of $581.8 million, or $11.21 per share basic and diluted for the same period in 2021.
Conference Call Information
There will be a conference call on February 28, 2023 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the fourth quarter and full year of 2022 and provide corporate updates.
Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 773-305-6853 or international +1 888-394-8218, confirmation code: 2312901.
A replay of the call will be available approximately 2 hours after the event has ended at the same website.