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Mirati (MRTX) Q1 Earnings & Revenues Beat Estimates, Stock Up
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Mirati Therapeutics reported a loss of $3.18 per share for first-quarter 2023, narrower than the Zacks Consensus Estimate of a loss of $3.47 and the year-ago quarter’s loss of $3.40 per share.
Mirati reported $7.2 million in revenues for the first quarter, beating the Zacks Consensus Estimate of $5 million. Mirati had recorded revenues of $1 million in the year-ago quarter.
Quarter in Detail
First-quarter revenues included $6.3 million as product revenues from Krazati/adagrasib, Mirati’s newly approved cancer drug. The FDA approved Krazati, a KRAS G12C inhibitor, to treat adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in December 2022. A regulatory filing for Krazati is under review in Europe, with potential approval expected in the third quarter of 2023. No product revenues were recorded in the year-ago quarter.
The first quarter of 2023 was the first full quarter of Krazati revenues. In the fourth quarter of 2022, Krazati recorded initial sales of $0.7 million, which was mostly associated with inventory in the channel.
Mirati’s shares gained 2% on Tuesday after the better-than-expected results were announced. In the past year, the stock price of Mirati has decreased 9.2% against the industry’s 2.7% rise.
Image Source: Zacks Investment Research
Regarding Krazati’s launch, Mirati mentioned on the conference call that it was witnessing a rapid acceptance of the drug, which was driven by Krazati’s differentiated profile and the company’s highly experienced lung cancer commercial team.
Krazati was included in the National Comprehensive Cancer Network guidelines within one week of approval, which is likely to have boosted sales having aided coverage and reimbursement decisions.
License and collaboration revenues were $0.9 million in the quarter compared with $0.7 million for the same period in 2022. License and collaboration revenues represent clinical supply revenues earned under Mirati’s agreement with Zai Lab Limited (ZLAB - Free Report) .
In May 2021, the company entered a collaboration and license agreement with Zai Lab, granting the latter the right to research, develop, manufacture and exclusively commercialize adagrasib in all indications in China, Macau, Hong Kong and Taiwan. Mirati retains exclusive rights for the development, manufacture and commercialization of adagrasib outside Zai Labs’ territory and certain co-commercialization, manufacture and development rights in the Zai Labs’ licensed territory.
Research and development expenses declined 3.3% from the prior-year quarter’s level to $126.7 million. This decrease was due to a reduction in clinical development costs for sitravatinib as enrollment was completed in the phase III SAPPHIRE study in the second quarter of 2022 and lower clinical manufacturing costs to support ongoing clinical studies.
Selling, general and administrative expenses rose 36.1% from the year-ago quarter’s level to $73.5 million due to an increase in commercial-related costs to support the marketing, and sales of Krazati and higher headcount-related costs.
Cash, cash equivalents and short-term investments as of Mar 31, 2023, were $902.3 million compared with $1.1 billion as of Dec 31, 2022.
Mirati expects the 2023 net cash burn to annualize within $525-$580 million. Mirati’s current cash runway is expected to fund operations into 2025.
Mirati Therapeutics, Inc. Price, Consensus and EPS Surprise
Mirati is evaluating adagrasib — both as monotherapy and combinations — in multiple cohorts of phase I/II KRYSTAL-1 study across multiple solid tumors that harbor KRAS G12C mutations. These include a combination of Krazati with Merck’s (MRK - Free Report) Keytruda in NSCLC, Krazati plus Boehringer Ingelheim’s Gilotrif (afatinib) in advanced NSCLC and Krazati with Bristol-Myers’ (BMY - Free Report) Erbitux (cetuximab) in advanced colorectal cancer (CRC). In December, the FDA granted Breakthrough Therapy Designation to Krazati plus Bristol Myers’ Erbitux (cetuximab) in patients with KRAS G12C mutated advanced CRC whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. Mirati is on track to complete supplemental new drug application for third-line and beyond CRC by year-end 2023.
A phase III registrational study is also ongoing in second-line CRC called KRYSTAL-10, which compares the efficacy of Krazati in combination with Bristol-Myers’ Erbitux versus standard-of-care chemotherapy. The company is currently enrolling patients in the phase III KRYSTAL-10 study and expects to complete enrollment by 2023 end, reporting top-line results in 2024, along with plans for regulatory submission based on study results.
Mirati is also planning to share updated first-line NSCLC data from its phase II KRYSTAL-7 study of the combination of adagrasib with Merck’s Keytruda and first-line development plans in the second half of 2023.
Another pipeline candidate, sitravatinib, is being evaluated in a pivotal phase III study (SAPPHIRE) combined with Bristol-Myers’ Opdivo for second-line or third-line non-squamous NSCLC. Final overall survival results from the study are expected in the second quarter of 2023.
In March 2023, Mirati began enrolling patients in its phase I/II study to evaluate MRTX1133 in several cancers like pancreatic, colorectal, lung and other KRASG12D tumor types across multiple expansion cohorts.
Image: Shutterstock
Mirati (MRTX) Q1 Earnings & Revenues Beat Estimates, Stock Up
Mirati Therapeutics reported a loss of $3.18 per share for first-quarter 2023, narrower than the Zacks Consensus Estimate of a loss of $3.47 and the year-ago quarter’s loss of $3.40 per share.
Mirati reported $7.2 million in revenues for the first quarter, beating the Zacks Consensus Estimate of $5 million. Mirati had recorded revenues of $1 million in the year-ago quarter.
Quarter in Detail
First-quarter revenues included $6.3 million as product revenues from Krazati/adagrasib, Mirati’s newly approved cancer drug. The FDA approved Krazati, a KRAS G12C inhibitor, to treat adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in December 2022. A regulatory filing for Krazati is under review in Europe, with potential approval expected in the third quarter of 2023. No product revenues were recorded in the year-ago quarter.
The first quarter of 2023 was the first full quarter of Krazati revenues. In the fourth quarter of 2022, Krazati recorded initial sales of $0.7 million, which was mostly associated with inventory in the channel.
Mirati’s shares gained 2% on Tuesday after the better-than-expected results were announced. In the past year, the stock price of Mirati has decreased 9.2% against the industry’s 2.7% rise.
Image Source: Zacks Investment Research
Regarding Krazati’s launch, Mirati mentioned on the conference call that it was witnessing a rapid acceptance of the drug, which was driven by Krazati’s differentiated profile and the company’s highly experienced lung cancer commercial team.
Krazati was included in the National Comprehensive Cancer Network guidelines within one week of approval, which is likely to have boosted sales having aided coverage and reimbursement decisions.
License and collaboration revenues were $0.9 million in the quarter compared with $0.7 million for the same period in 2022. License and collaboration revenues represent clinical supply revenues earned under Mirati’s agreement with Zai Lab Limited (ZLAB - Free Report) .
In May 2021, the company entered a collaboration and license agreement with Zai Lab, granting the latter the right to research, develop, manufacture and exclusively commercialize adagrasib in all indications in China, Macau, Hong Kong and Taiwan. Mirati retains exclusive rights for the development, manufacture and commercialization of adagrasib outside Zai Labs’ territory and certain co-commercialization, manufacture and development rights in the Zai Labs’ licensed territory.
Research and development expenses declined 3.3% from the prior-year quarter’s level to $126.7 million. This decrease was due to a reduction in clinical development costs for sitravatinib as enrollment was completed in the phase III SAPPHIRE study in the second quarter of 2022 and lower clinical manufacturing costs to support ongoing clinical studies.
Selling, general and administrative expenses rose 36.1% from the year-ago quarter’s level to $73.5 million due to an increase in commercial-related costs to support the marketing, and sales of Krazati and higher headcount-related costs.
Cash, cash equivalents and short-term investments as of Mar 31, 2023, were $902.3 million compared with $1.1 billion as of Dec 31, 2022.
Mirati expects the 2023 net cash burn to annualize within $525-$580 million. Mirati’s current cash runway is expected to fund operations into 2025.
Mirati Therapeutics, Inc. Price, Consensus and EPS Surprise
Mirati Therapeutics, Inc. price-consensus-eps-surprise-chart | Mirati Therapeutics, Inc. Quote
Pipeline Update
Mirati is evaluating adagrasib — both as monotherapy and combinations — in multiple cohorts of phase I/II KRYSTAL-1 study across multiple solid tumors that harbor KRAS G12C mutations. These include a combination of Krazati with Merck’s (MRK - Free Report) Keytruda in NSCLC, Krazati plus Boehringer Ingelheim’s Gilotrif (afatinib) in advanced NSCLC and Krazati with Bristol-Myers’ (BMY - Free Report) Erbitux (cetuximab) in advanced colorectal cancer (CRC). In December, the FDA granted Breakthrough Therapy Designation to Krazati plus Bristol Myers’ Erbitux (cetuximab) in patients with KRAS G12C mutated advanced CRC whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. Mirati is on track to complete supplemental new drug application for third-line and beyond CRC by year-end 2023.
A phase III registrational study is also ongoing in second-line CRC called KRYSTAL-10, which compares the efficacy of Krazati in combination with Bristol-Myers’ Erbitux versus standard-of-care chemotherapy. The company is currently enrolling patients in the phase III KRYSTAL-10 study and expects to complete enrollment by 2023 end, reporting top-line results in 2024, along with plans for regulatory submission based on study results.
Mirati is also planning to share updated first-line NSCLC data from its phase II KRYSTAL-7 study of the combination of adagrasib with Merck’s Keytruda and first-line development plans in the second half of 2023.
Another pipeline candidate, sitravatinib, is being evaluated in a pivotal phase III study (SAPPHIRE) combined with Bristol-Myers’ Opdivo for second-line or third-line non-squamous NSCLC. Final overall survival results from the study are expected in the second quarter of 2023.
In March 2023, Mirati began enrolling patients in its phase I/II study to evaluate MRTX1133 in several cancers like pancreatic, colorectal, lung and other KRASG12D tumor types across multiple expansion cohorts.
Zacks Rank
Mirati currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.