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Mirati's (MRTX) Q4 Loss Narrows, Krazati Records First Sales
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Mirati Therapeutics reported a loss of $3.51 per share for fourth-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of $3.74 as well as the year-ago quarter’s loss of $3.72 per share.
Mirati reported $0.9 million in revenues for the fourth quarter, missing the Zacks Consensus Estimate of $3.76 million. Mirati had recorded revenues of $0.3 million in the year-ago quarter.
Fourth-quarter revenues included $0.7 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. Most of the product sales from Krazati were associated with inventory in the channel. A regulatory filing for Krazati is under review in Europe with potential approval expected in the third quarter. No product revenues were recorded in the year-ago quarter.
License and collaboration revenues were $0.2 million in the quarter compared with $0.3 million in the year-ago quarter
Mirati’s shares were up 2.5% on Tuesday after the results were announced. In the past year, the stock price of Mirati has plunged 48.6% compared with the industry’s decline of 11.4%.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses declined 8.2% from the prior-year quarter’s level to $141.2 million due to higher manufacturing costs incurred in the year-ago quarter, following the FDA filing for Krazati in 2021.
Selling, general and administrative expenses surged 62.8% from the year-ago quarter’s level to $70.8 million due to an increase in commercial readiness costs as the company prepared for the launch of Krazati and higher headcount-related costs.
Cash, cash equivalents and short-term investments as of Dec 31, 2022 were $1.1 billion, compared with $1.2 billion at the end of Sep 30, 2022.
Pipeline Update
Regarding Krazati’s launch, Mirati mentioned on the conference call that it is making strong initial progress in establishing broad reimbursement coverage. Krazati was added to the National Comprehensive Cancer Network (NCCN) guidelines within one week of approval.
Mirati is also 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 or CRC. In December, the FDA granted Breakthrough Therapy Designation (BTD) to Krazati plus Bristol Myers’ Erbitux (cetuximab) in patients with KRAS G12C mutated advanced colorectal cancer (CRC) whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy.
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.
In December 2022, Mirati announced preliminary data from the KRYSTAL-7 phase II study and a cohort of KRYSTAL-1 phase Ib study, evaluating Krazati plus Merck’s Keytruda in first-line NSCLC at ESMO. The data established the initial promising clinical activity of Krazati plus Merck’s Keytruda.
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 January, the FDA cleared the investigational new drug (IND) application of MRTX1133, a KRASG12D inhibitor, to begin clinical studies on the candidate, which is Mirati’s third program in the KRAS franchise. Mirati began a phase I/II study in February with plans to evaluate MRTX1133 in several cancers like pancreatic, colorectal, lung and other KRASG12D tumor types across multiple expansion cohorts.
Estimates for eFFECTOR Therapeutics’ 2023bottom line have narrowed from 96 cents to 88 cents in the past 60 days.
Earnings of eFFECTOR Therapeutics beat estimates in all the trailing four quarters. The average earnings surprise for EFTR is 104.56%. EFTR stock has declined 88.7% in the past year. eFFECTOR Therapeutics is expected to report its fourth-quarter results next month.
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Mirati's (MRTX) Q4 Loss Narrows, Krazati Records First Sales
Mirati Therapeutics reported a loss of $3.51 per share for fourth-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of $3.74 as well as the year-ago quarter’s loss of $3.72 per share.
Mirati reported $0.9 million in revenues for the fourth quarter, missing the Zacks Consensus Estimate of $3.76 million. Mirati had recorded revenues of $0.3 million in the year-ago quarter.
Fourth-quarter revenues included $0.7 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. Most of the product sales from Krazati were associated with inventory in the channel. A regulatory filing for Krazati is under review in Europe with potential approval expected in the third quarter. No product revenues were recorded in the year-ago quarter.
License and collaboration revenues were $0.2 million in the quarter compared with $0.3 million in the year-ago quarter
Mirati’s shares were up 2.5% on Tuesday after the results were announced. In the past year, the stock price of Mirati has plunged 48.6% compared with the industry’s decline of 11.4%.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses declined 8.2% from the prior-year quarter’s level to $141.2 million due to higher manufacturing costs incurred in the year-ago quarter, following the FDA filing for Krazati in 2021.
Selling, general and administrative expenses surged 62.8% from the year-ago quarter’s level to $70.8 million due to an increase in commercial readiness costs as the company prepared for the launch of Krazati and higher headcount-related costs.
Cash, cash equivalents and short-term investments as of Dec 31, 2022 were $1.1 billion, compared with $1.2 billion at the end of Sep 30, 2022.
Pipeline Update
Regarding Krazati’s launch, Mirati mentioned on the conference call that it is making strong initial progress in establishing broad reimbursement coverage. Krazati was added to the National Comprehensive Cancer Network (NCCN) guidelines within one week of approval.
Mirati is also 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 or CRC. In December, the FDA granted Breakthrough Therapy Designation (BTD) to Krazati plus Bristol Myers’ Erbitux (cetuximab) in patients with KRAS G12C mutated advanced colorectal cancer (CRC) whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy.
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.
In December 2022, Mirati announced preliminary data from the KRYSTAL-7 phase II study and a cohort of KRYSTAL-1 phase Ib study, evaluating Krazati plus Merck’s Keytruda in first-line NSCLC at ESMO. The data established the initial promising clinical activity of Krazati plus Merck’s Keytruda.
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 January, the FDA cleared the investigational new drug (IND) application of MRTX1133, a KRASG12D inhibitor, to begin clinical studies on the candidate, which is Mirati’s third program in the KRAS franchise. Mirati began a phase I/II study in February with plans to evaluate MRTX1133 in several cancers like pancreatic, colorectal, lung and other KRASG12D tumor types across multiple expansion cohorts.
Zacks Rank & Stock to Consider
Mirati currently has a Zacks Rank #3 (Hold).
Mirati Therapeutics, Inc. Price and Consensus
Mirati Therapeutics, Inc. price-consensus-chart | Mirati Therapeutics, Inc. Quote
A better-ranked stock in the biotech sector is eFFECTOR Therapeutics (EFTR - Free Report) , which sports a Zacks Rank of 1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for eFFECTOR Therapeutics’ 2023bottom line have narrowed from 96 cents to 88 cents in the past 60 days.
Earnings of eFFECTOR Therapeutics beat estimates in all the trailing four quarters. The average earnings surprise for EFTR is 104.56%. EFTR stock has declined 88.7% in the past year. eFFECTOR Therapeutics is expected to report its fourth-quarter results next month.