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Clovis (CLVS) Q3 Loss Wider Than Expected, Revenues Lag
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Clovis Oncology reported third-quarter 2021 net loss of 56 cents per share, wider than the Zacks Consensus Estimate of a loss of 48 cents but narrower than the year-ago period’s loss of 89 cents.
Adjusted loss (excluding acquired in-process research and development as well as foreign currency loss) was 52 cents per share compared with 90 cents in the year-ago quarter.
Net revenues — entirely from Clovis’ only marketed drug, Rubraca — were down 2% year over year to $37.9 million for the quarter, missing the Zacks Consensus Estimate of $38.7 million.
Shares of Clovis have declined 2.3% in the year so far compared with the industry’s 8.2% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Sales of Rubraca — a PARP inhibitor — in the United States were $28.7 million, down 15.3% year over year. Ex-U.S. market sales were $9.2 million for the third quarter, up 87.8% year over year. Lower sales were due to COVID-19 impacts as fewer patients were treated for ovarian cancer amid the pandemic
For the third quarter, research & development expenses decreased 27% year over year to $46.2 million, primarily due to lower spending on Rubraca clinical studies.
Selling, general and administrative expenses declined 17% year over year to $32.2 million, driven by cost-saving initiatives and savings due to the COVID-19 situation globally.
Clovis ended the quarter with $171.9 million of cash equivalents and available-for-sale securities compared with $230.2million on Jun 30, 2021.
The company expects cash resources, and revenues and available financing sources to be enough to support its operations for at least the next 12 months.
Pipeline Updates
Label Expansion Studies on Rubraca
The phase III ATHENA study is evaluating Rubraca as monotherapy and in combination with Bristol-Myers‘ (BMY - Free Report) Opdivo in advanced ovarian cancer as first-line maintenance treatment. While top-line data from the combination arm of the study is anticipated in second-half 2022, top-line data from the monotherapy arm of the study is expected in first-quarter 2022.
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 for mCRPC.
FAP-2286
In June 2021, the company initiated enrolment in a phase I/II LuMIERE study to evaluate FAP-2286 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 expansion cohorts planned in multiple tumor types. The company anticipates presenting initial data from the phase I portion of the study later in 2022 at medical meetings.
Alkermes’ earnings per share estimates for 2021 have increased from $0.61 to $0.68 in the past 60 days. The same for 2022 has risen from $1.06 to $1.11 in the past 60 days. The stock has rallied 53.5% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $54.28 to $63.53 in the past 60 days. The same for 2022 has risen from $44.11 to $46.69 over the same period. The stock has rallied 35% in the year so far.
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Clovis (CLVS) Q3 Loss Wider Than Expected, Revenues Lag
Clovis Oncology reported third-quarter 2021 net loss of 56 cents per share, wider than the Zacks Consensus Estimate of a loss of 48 cents but narrower than the year-ago period’s loss of 89 cents.
Adjusted loss (excluding acquired in-process research and development as well as foreign currency loss) was 52 cents per share compared with 90 cents in the year-ago quarter.
Net revenues — entirely from Clovis’ only marketed drug, Rubraca — were down 2% year over year to $37.9 million for the quarter, missing the Zacks Consensus Estimate of $38.7 million.
Shares of Clovis have declined 2.3% in the year so far compared with the industry’s 8.2% decline.
Quarter in Detail
Sales of Rubraca — a PARP inhibitor — in the United States were $28.7 million, down 15.3% year over year. Ex-U.S. market sales were $9.2 million for the third quarter, up 87.8% year over year. Lower sales were due to COVID-19 impacts as fewer patients were treated for ovarian cancer amid the pandemic
For the third quarter, research & development expenses decreased 27% year over year to $46.2 million, primarily due to lower spending on Rubraca clinical studies.
Selling, general and administrative expenses declined 17% year over year to $32.2 million, driven by cost-saving initiatives and savings due to the COVID-19 situation globally.
Clovis ended the quarter with $171.9 million of cash equivalents and available-for-sale securities compared with $230.2million on Jun 30, 2021.
The company expects cash resources, and revenues and available financing sources to be enough to support its operations for at least the next 12 months.
Pipeline Updates
Label Expansion Studies on Rubraca
The phase III ATHENA study is evaluating Rubraca as monotherapy and in combination with Bristol-Myers‘ (BMY - Free Report) Opdivo in advanced ovarian cancer as first-line maintenance treatment. While top-line data from the combination arm of the study is anticipated in second-half 2022, top-line data from the monotherapy arm of the study is expected in first-quarter 2022.
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 for mCRPC.
FAP-2286
In June 2021, the company initiated enrolment in a phase I/II LuMIERE study to evaluate FAP-2286 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 expansion cohorts planned in multiple tumor types. The company anticipates presenting initial data from the phase I portion of the study later in 2022 at medical meetings.
Clovis Oncology, Inc. Price
Clovis Oncology, Inc. price | Clovis Oncology, Inc. Quote
Zacks Rank & Other Stocks to Consider
Clovis currently carries a Zacks Rank #2 (Buy).
Other top-ranked stocks in the same sector include Alkermes (ALKS - Free Report) and Regeneron Pharmaceuticals (REGN - Free Report) , each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings per share estimates for 2021 have increased from $0.61 to $0.68 in the past 60 days. The same for 2022 has risen from $1.06 to $1.11 in the past 60 days. The stock has rallied 53.5% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $54.28 to $63.53 in the past 60 days. The same for 2022 has risen from $44.11 to $46.69 over the same period. The stock has rallied 35% in the year so far.