We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Clovis (CLVS) Q1 Earnings and Revenues Surpass Estimates
Read MoreHide Full Article
Clovis Oncology incurred loss of $1.28 per share for the first quarter of 2020, narrower than the Zacks Consensus Estimate of a loss of $1.29 and the year-ago loss of $1.63 per share.
Net revenues, entirely from Clovis’ only marketed drug, Rubraca, were up almost 28.5% year over year to $42.6 million in the quarter, beating the Zacks Consensus Estimate of $41.8 million. Sales were up 8.4% sequentially.
Shares of Clovis were up almost 9.7% in after-market trading on May 5, following the earnings release. The stock has plunged 26% so far this year against the industry’s increase of 3.7%.
Quarter in Details
Sales of Rubraca, a PARP inhibitor, in the United States were $39.3 million, compared with $31.9 million in the first quarter of 2019. Ex-U.S. market sales were $3.3 million in the first quarter compared with $3.2 million in the fourth quarter of 2019.
In February, the company successfully negotiated a reimbursement agreement for the drug in France.
On its first-quarter earnings call, the company also stated that Rubraca is well-positioned as an oncology treatment option in the COVID-19 era. The drug, which can be administered orally, requires less physician visits than immunosuppressive chemotherapy as well as Glaxo’s (GSK - Free Report) Zejula. The company anticipates that, although Rubraca sales may have an adverse impact over the near-term, the drug has significant advantages as a maintenance option in an environment in which physicians are trying to reduce patient visits to their clinics.
In the first quarter, research & development expenses increased 10% year over year to $68.2 million, mainly due to higher costs related to Rubraca’s label expansion studies. Selling, general and administrative expenses declined 10.9% year over year to $42.6 million, primarily driven by lower commercialization expenses for Rubraca in the United States and Europe
Clovis ended the quarter with $228.4 million of cash equivalents and available-for-sale securities compared with $296.7 million as of Dec 31, 2019.
The company expects its cash resources to be enough to support its operations in the second half of 2021.
Update on Rubraca
In January, the FDA granted priority review to the supplemental new drug application (sNDA), seeking label expansion of Rubraca as monotherapy for BRCA-mutant recurrent, metastatic castrate-resistant prostate cancer (mCRPC). A decision from the FDA is expected by May 15, 2020.
Clovis is currently in the process of launching the drug in European countries for the recurrent ovarian cancer maintenance indication. It is also preparing for the U.S. launch of the drug in mCRPC, following a potential approval.
A phase III TRITON3 study evaluating Rubraca in mCRPC patients with BRCA mutation and ATM mutation, and who have not received chemotherapy is currently enrolling patients.
The company has a collaboration with Bristol-Myers (BMY - Free Report) to develop Rubraca and pipeline candidate, lucitanib, in combination with the latter’s PD-L1 inhibitor, Opdivo, for several cancer indications. The phase III ATHENA study evaluating Rubraca plus Opdivo as first-line maintenance treatment in advanced ovarian cancer is currently enrolling patients. A phase II study —FRACTION-GC —to evaluate doublet and triplet combination of Rubraca and Bristol-Myers’ Yervoy and Opdivo in patients with advanced gastric cancer is also enrolling patients.
A phase II LODESTAR study is evaluating Rubraca in patients with recurrent solid tumors associated with the deleterious homologous recombination repair or HRR gene mutations. Based on the company’s interaction with FDA, it stated that data from the study may be used to file a regulatory application in 2021 seeking approval for Rubraca in HRR patients.
Our Take
Clovis reported encouraging first-quarter results. The company’s cancer drug, Rubraca, showed continued strength in the first quarter of 2020. A successful launch following potential approval in the mCRPC indication should drive sales higher in 2020. The company remains committed to expand the drug’s label into earlier-line setting in ovarian cancer as well in new cancer indications.
However, Rubraca faces stiff competition in the PARP inhibitor segment, especially from AstraZeneca’s (AZN - Free Report) Lynparza and Glaxo’s Zejula. While Lynparza is approved for treating ovarian, breast and pancreatic cancer, Rubraca and Zejula are available only to ovarian cancer patients. Moreover, the FDA approved Zejula as first-line monotherapy maintenance treatment for platinum-responsive advanced ovarian cancer regardless of biomarker status last month. The drug gained an edge over Rubraca, which is approved as second-line maintenance treatment. Competition is set to rise with several other pharma companies marketing/developing PARP inhibitors.
Clovis Oncology, Inc. Price, Consensus and EPS Surprise
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2019, while the S&P 500 gained and impressive +53.6%, five of our strategies returned +65.8%, +97.1%, +118.0%, +175.7% and even +186.7%.
This outperformance has not just been a recent phenomenon. From 2000 – 2019, while the S&P averaged +6.0% per year, our top strategies averaged up to +54.7% per year.
Image: Bigstock
Clovis (CLVS) Q1 Earnings and Revenues Surpass Estimates
Clovis Oncology incurred loss of $1.28 per share for the first quarter of 2020, narrower than the Zacks Consensus Estimate of a loss of $1.29 and the year-ago loss of $1.63 per share.
Net revenues, entirely from Clovis’ only marketed drug, Rubraca, were up almost 28.5% year over year to $42.6 million in the quarter, beating the Zacks Consensus Estimate of $41.8 million. Sales were up 8.4% sequentially.
Shares of Clovis were up almost 9.7% in after-market trading on May 5, following the earnings release. The stock has plunged 26% so far this year against the industry’s increase of 3.7%.
Quarter in Details
Sales of Rubraca, a PARP inhibitor, in the United States were $39.3 million, compared with $31.9 million in the first quarter of 2019. Ex-U.S. market sales were $3.3 million in the first quarter compared with $3.2 million in the fourth quarter of 2019.
In February, the company successfully negotiated a reimbursement agreement for the drug in France.
On its first-quarter earnings call, the company also stated that Rubraca is well-positioned as an oncology treatment option in the COVID-19 era. The drug, which can be administered orally, requires less physician visits than immunosuppressive chemotherapy as well as Glaxo’s (GSK - Free Report) Zejula. The company anticipates that, although Rubraca sales may have an adverse impact over the near-term, the drug has significant advantages as a maintenance option in an environment in which physicians are trying to reduce patient visits to their clinics.
In the first quarter, research & development expenses increased 10% year over year to $68.2 million, mainly due to higher costs related to Rubraca’s label expansion studies. Selling, general and administrative expenses declined 10.9% year over year to $42.6 million, primarily driven by lower commercialization expenses for Rubraca in the United States and Europe
Clovis ended the quarter with $228.4 million of cash equivalents and available-for-sale securities compared with $296.7 million as of Dec 31, 2019.
The company expects its cash resources to be enough to support its operations in the second half of 2021.
Update on Rubraca
In January, the FDA granted priority review to the supplemental new drug application (sNDA), seeking label expansion of Rubraca as monotherapy for BRCA-mutant recurrent, metastatic castrate-resistant prostate cancer (mCRPC). A decision from the FDA is expected by May 15, 2020.
Clovis is currently in the process of launching the drug in European countries for the recurrent ovarian cancer maintenance indication. It is also preparing for the U.S. launch of the drug in mCRPC, following a potential approval.
A phase III TRITON3 study evaluating Rubraca in mCRPC patients with BRCA mutation and ATM mutation, and who have not received chemotherapy is currently enrolling patients.
The company has a collaboration with Bristol-Myers (BMY - Free Report) to develop Rubraca and pipeline candidate, lucitanib, in combination with the latter’s PD-L1 inhibitor, Opdivo, for several cancer indications. The phase III ATHENA study evaluating Rubraca plus Opdivo as first-line maintenance treatment in advanced ovarian cancer is currently enrolling patients. A phase II study —FRACTION-GC —to evaluate doublet and triplet combination of Rubraca and Bristol-Myers’ Yervoy and Opdivo in patients with advanced gastric cancer is also enrolling patients.
A phase II LODESTAR study is evaluating Rubraca in patients with recurrent solid tumors associated with the deleterious homologous recombination repair or HRR gene mutations. Based on the company’s interaction with FDA, it stated that data from the study may be used to file a regulatory application in 2021 seeking approval for Rubraca in HRR patients.
Our Take
Clovis reported encouraging first-quarter results. The company’s cancer drug, Rubraca, showed continued strength in the first quarter of 2020. A successful launch following potential approval in the mCRPC indication should drive sales higher in 2020. The company remains committed to expand the drug’s label into earlier-line setting in ovarian cancer as well in new cancer indications.
However, Rubraca faces stiff competition in the PARP inhibitor segment, especially from AstraZeneca’s (AZN - Free Report) Lynparza and Glaxo’s Zejula. While Lynparza is approved for treating ovarian, breast and pancreatic cancer, Rubraca and Zejula are available only to ovarian cancer patients. Moreover, the FDA approved Zejula as first-line monotherapy maintenance treatment for platinum-responsive advanced ovarian cancer regardless of biomarker status last month. The drug gained an edge over Rubraca, which is approved as second-line maintenance treatment. Competition is set to rise with several other pharma companies marketing/developing PARP inhibitors.
Clovis Oncology, Inc. Price, Consensus and EPS Surprise
Clovis Oncology, Inc. price-consensus-eps-surprise-chart | Clovis Oncology, Inc. Quote
Zacks Rank
Clovis currently has a Zacks Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2019, while the S&P 500 gained and impressive +53.6%, five of our strategies returned +65.8%, +97.1%, +118.0%, +175.7% and even +186.7%.
This outperformance has not just been a recent phenomenon. From 2000 – 2019, while the S&P averaged +6.0% per year, our top strategies averaged up to +54.7% per year.
See their latest picks free >>