Mirati Therapeutics, Inc.

Revenue for the second quarter of 2023 was $13.7 million, including $13.4 million of KRAZATI sales and $0.3 million of license and collaboration revenue, versus $5.4 million in the second quarter of 2022, when results included a $5 million Zai Lab milestone. Gross-to-net discount remained within the expected 20% to 25% range. Cost of product revenue was $1 million; R&D expense was $124.2 million versus $128.3 million a year ago; SG&A was $75.5 million versus $54.2 million a year ago; and net loss was $176.9 million, or $3.04 per share, versus $176.4 million, or $3.18 per share, last year. Ending cash and investments were approximately $780 million at June 30, 2023. Management now expects 2023 net cash burn to annualize in a range of $560 million to $580 million and said it intends to reduce 2024 cash burn. Forward plans include a Phase 3 frontline study in TPS >50% with pembrolizumab as comparator, FDA discussion in 3Q, and enrollment by year-end; for TPS <50%, a decision on Phase 3 registrational plans is expected in 2024 after KRYSTAL-17 data. In colorectal cancer, they remain on track to file an sNDA for accelerated approval in 4Q, expect KRYSTAL-10 enrollment completion this year, and plan PFS/OS updates in 2024. For MRTX1719, the goal is to identify a recommended Phase II dose this year.

Chuck Baum framed the quarter as a continuation of Mirati’s mission despite the CEO transition, emphasizing gratitude for David Meek and confidence in the company’s R&D engine. He highlighted three strategic pillars: advancing adagrasib into pivotal frontline lung development, growing KRAZATI as a commercial product, and developing earlier-stage assets such as MRTX1719 and MRTX1133. His tone was upbeat and forward-looking, with repeated references to long-term sustainable growth and shareholder value creation.

Laurie Stelzer said Mirati ended the quarter with approximately $780 million in cash and investments and launched a proposed $250 million common stock offering, plus a 30-day option for underwriters to buy up to an additional $37.5 million. She reiterated that 2023 net cash burn is expected to annualize between $560 million and $580 million and said the company will look for operational efficiencies in 2024 without hurting its highest-value programs. On the income statement, she cited $13.7 million of revenue, $124.2 million of R&D, $75.5 million of SG&A, and a net loss of $176.9 million, while noting a gross-to-net discount in the expected 20% to 25% range.

Analysts focused on the frontline adagrasib strategy, especially whether Mirati might pursue accelerated approval and how the company plans to position TPS <50% patients. Management said it is taking a more traditional Phase 3 path with PFS as the primary endpoint, while acknowledging that KRYSTAL-7 suggests the doublet likely will not beat KEYNOTE-189 in TPS <50%, making a chemo-immunotherapy triplet approach more likely. Questions on MRTX1719 centered on depth and durability of responses, safety, and whether it should be viewed as a monotherapy or combination drug; management said the data are early, responses have deepened over time, and combinations will be evaluated if the monotherapy activity supports further development. There were also questions about the CHMP negative opinion in Europe, with management saying the agency acknowledged positive benefit-risk but did not grant CMA, and that Mirati has requested reexamination.