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Clovis (CLVS) Q4 Loss Narrower than Expected, Revenues Lag
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Clovis Oncology reported fourth-quarter 2021 net loss of 50 cents per share, narrower than the year-ago period’s loss of $1.02.
Adjusted loss (excluding foreign currency loss) was 49 cents per share, narrower than the Zacks Consensus Estimate of a loss of 60 cents as well as the year-ago loss of $1.02.
Net revenues — entirely from Clovis’ only marketed drug PARP inhibitor Rubraca — were down 17% year over year to $36 million, missing the Zacks Consensus Estimate of $39.3 million.
Shares of Clovis fell 4.1% on Wednesday following the earnings announcement. The stock has plunged 73.9% in the trailing 12 months compared with the industry’s 40.7% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Sales of Rubraca in the United States were $27.6 million, down 24.2% year over year. Ex-U.S. market sales were $8.4 million for the fourth quarter, up 21.7% year over year. Lower sales were due to COVID-19 impacts as fewer patients were treated for ovarian cancer amid the pandemic.
For the fourth quarter, research & development expenses decreased 26% year over year to $41.8 million, primarily on lower spending on Rubraca clinical studies.
Selling, general and administrative expenses declined 18% year over year to $33.3 million, driven by cost-saving initiatives and savings owing to the COVID-19 situation, globally.
Clovis ended the quarter with $143.4 million of cash equivalents and available-for-sale securities compared with $171.9 million on Sep 30, 2021.
CLVS expects to raise additional capital to support its operations for at least next 12 months and ahead.
Full-Year Results
Clovis reported revenues of $148.8 million, down 10% year over year. CLVS incurred a loss of $2.29 per share in 2021, 47.7% narrower than the year-ago period’s figure.
Adjusted loss (excluding acquired in-process research and development as well as foreign currency loss) was $2.21 per share compared with $4.38 over a year ago.
Pipeline Updates
Label Expansion Studies on Rubraca
We note that Rubraca is approved for the treatment of patients with ovarian and prostate cancer. The phase III ATHENA study is evaluating Rubraca as a monotherapy and in combination with Bristol Myers’ (BMY - Free Report) Opdivo for advanced ovarian cancer as a first-line maintenance treatment. While top-line data from the combination arm of the study is anticipated in fourth-quarter 2022, the same from the monotherapy arm of the study is now expected in second-quarter 2022, indicating a delay by one quarter.
The ATHENA study is part of a broader clinical collaboration with Bristol Myers, formalized in 2017. Opdivo is one of the key drivers of Bristol Myers’s top line. For the fiscal year 2021, which ended on Dec 31, BMY recorded $7.5 billion from Opdivo sales.
A confirmatory phase III TRITON3 study is evaluating Rubraca in metastatic castration-resistant prostate cancer (mCRPC) patients with tumors associated with BRCA mutations and ATM mutations. Data from this study is expected in second-quarter 2022. This will serve as a confirmatory study for continued approval of Rubraca in mCRPC. It will also serve as a potential second-line label expansion for Rubraca to address mCRPC.
FAP-2286
In June 2021, Clovis initiated enrolment in a phase I/II LuMIERE study to evaluate FAP-2286, its peptide-targeted radionuclide therapy and imaging agent candidate, in multiple tumor types. While the phase I portion of the study will determine the dose and tolerability of the candidate, the phase II portion will consist of the expansion cohorts to be evaluated for multiple tumor types. CLVS expects to start the phase II portion in 2022.
During its earnings conference call, management said that it is exploring potential combinations of FAP-2286 with other oncology compounds like PD-1 or PDL-1 inhibitors, which are currently under preclinical development.
Adaptimmune Therapeutics’ loss per share estimates for 2022 have narrowed from 99 cents to 91 cents in the past 30 days. Earnings of Adaptimmune Therapeutics beat estimates in three of the last four quarters and missed the mark on a single occasion, the average surprise being 0.9%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $13.35 to $14.33 in the past 30 days. The same for 2023 has risen from $14.12 to $15.31 in the past 30 days. VRTX has risen 6.3% in the past year.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.
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Clovis (CLVS) Q4 Loss Narrower than Expected, Revenues Lag
Clovis Oncology reported fourth-quarter 2021 net loss of 50 cents per share, narrower than the year-ago period’s loss of $1.02.
Adjusted loss (excluding foreign currency loss) was 49 cents per share, narrower than the Zacks Consensus Estimate of a loss of 60 cents as well as the year-ago loss of $1.02.
Net revenues — entirely from Clovis’ only marketed drug PARP inhibitor Rubraca — were down 17% year over year to $36 million, missing the Zacks Consensus Estimate of $39.3 million.
Shares of Clovis fell 4.1% on Wednesday following the earnings announcement. The stock has plunged 73.9% in the trailing 12 months compared with the industry’s 40.7% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Sales of Rubraca in the United States were $27.6 million, down 24.2% year over year. Ex-U.S. market sales were $8.4 million for the fourth quarter, up 21.7% year over year. Lower sales were due to COVID-19 impacts as fewer patients were treated for ovarian cancer amid the pandemic.
For the fourth quarter, research & development expenses decreased 26% year over year to $41.8 million, primarily on lower spending on Rubraca clinical studies.
Selling, general and administrative expenses declined 18% year over year to $33.3 million, driven by cost-saving initiatives and savings owing to the COVID-19 situation, globally.
Clovis ended the quarter with $143.4 million of cash equivalents and available-for-sale securities compared with $171.9 million on Sep 30, 2021.
CLVS expects to raise additional capital to support its operations for at least next 12 months and ahead.
Full-Year Results
Clovis reported revenues of $148.8 million, down 10% year over year. CLVS incurred a loss of $2.29 per share in 2021, 47.7% narrower than the year-ago period’s figure.
Adjusted loss (excluding acquired in-process research and development as well as foreign currency loss) was $2.21 per share compared with $4.38 over a year ago.
Pipeline Updates
Label Expansion Studies on Rubraca
We note that Rubraca is approved for the treatment of patients with ovarian and prostate cancer. The phase III ATHENA study is evaluating Rubraca as a monotherapy and in combination with Bristol Myers’ (BMY - Free Report) Opdivo for advanced ovarian cancer as a first-line maintenance treatment. While top-line data from the combination arm of the study is anticipated in fourth-quarter 2022, the same from the monotherapy arm of the study is now expected in second-quarter 2022, indicating a delay by one quarter.
The ATHENA study is part of a broader clinical collaboration with Bristol Myers, formalized in 2017. Opdivo is one of the key drivers of Bristol Myers’s top line. For the fiscal year 2021, which ended on Dec 31, BMY recorded $7.5 billion from Opdivo sales.
A confirmatory phase III TRITON3 study is evaluating Rubraca in metastatic castration-resistant prostate cancer (mCRPC) patients with tumors associated with BRCA mutations and ATM mutations. Data from this study is expected in second-quarter 2022. This will serve as a confirmatory study for continued approval of Rubraca in mCRPC. It will also serve as a potential second-line label expansion for Rubraca to address mCRPC.
FAP-2286
In June 2021, Clovis initiated enrolment in a phase I/II LuMIERE study to evaluate FAP-2286, its peptide-targeted radionuclide therapy and imaging agent candidate, in multiple tumor types. While the phase I portion of the study will determine the dose and tolerability of the candidate, the phase II portion will consist of the expansion cohorts to be evaluated for multiple tumor types. CLVS expects to start the phase II portion in 2022.
During its earnings conference call, management said that it is exploring potential combinations of FAP-2286 with other oncology compounds like PD-1 or PDL-1 inhibitors, which are currently under preclinical development.
Clovis Oncology, Inc. Price
Clovis Oncology, Inc. price | Clovis Oncology, Inc. Quote
Zacks Rank & Stocks to Consider
Clovis currently carries a Zacks Rank #4 (Sell). Better-ranked stocks in the overall healthcare sector include Adaptimmune Therapeutics and Vertex Pharmaceuticals (VRTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Adaptimmune Therapeutics’ loss per share estimates for 2022 have narrowed from 99 cents to 91 cents in the past 30 days. Earnings of Adaptimmune Therapeutics beat estimates in three of the last four quarters and missed the mark on a single occasion, the average surprise being 0.9%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $13.35 to $14.33 in the past 30 days. The same for 2023 has risen from $14.12 to $15.31 in the past 30 days. VRTX has risen 6.3% in the past year.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.