Clovis Oncology, Inc. (NASDAQ: CLVS) is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe, and additional international markets.
On October 30th, 2018, the company reported its financial results for the fourth quarter and full year of 2017 and its outlook for 2018.
- $22.8M in Rubraca ® sales for the third quarter of 2018 compared to $16.8M for Q3 2017.
- Free drug increased to 30 percent of overall commercial supply, equivalent to $9.6 million in commercial value.
- Initial TRITON2 data for Rubraca in mCRPC presented at ESMO include 44% confirmed ORR and 51% confirmed PSA response rate in 25 RECIST-evaluable and 45 PSA-evaluable patients with a BRCA1/2 alteration; preliminary safety data are consistent with those observed in other Rubraca studies.
- $604.4 million in cash, cash equivalents and available for sale securities at September 30, 2018.
“As discussed last quarter, growth remains challenging in the second-line maintenance ovarian cancer setting, but we have efforts underway to address this, and we are aggressively moving forward to grow this market and grow our share of this market,” said Patrick J. Mahaffy, CEO and President of Clovis Oncology. “In addition, our development team continues to make significant progress in moving Rubraca beyond its initial ovarian cancer indications. In particular, we were very pleased with the data from the TRITON studies presented at ESMO and at the Prostate Cancer Foundation Scientific Retreat, which also served as the basis for Breakthrough Therapy designation, and we are committed to developing Rubraca in the prostate setting as rapidly as possible to support men with this difficult-to-treat disease.”
Turning to the expectations for 2018, Based on current trends in PARP inhibitor adoption, the Company anticipates Q4 2018 revenues to be consistent with or slightly higher than Q3 2018 reported revenues of $22.8 million. Clovis anticipates providing full-year 2019 guidance in early January.
Overall, the company continues the momentum during 2018, and with a positive maintenance indication, from the EMA’s Committee for Medicinal Products for Human Use (CHMP) by the end of 2018, and, a potential formal European Commission approval in early 2019, Clovis is well poised to establish its EU organization to support the planned launch of Rubraca in Europe.
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Analyst tracking the stock believes that Clovis has a robust clinical development program underway in multiple tumor types, including Clovis-sponsored, partner-sponsored and investigator-initiated trials. Moreover, from the liquidity and financial standpoint, the company only has one drug in development. Therefore, existing cash and equivalents should provide a decent runway to the company.
Analyst views and brokerage actions:
Per www.marketbeat.com, their average twelve-month price target is $57.0520, suggesting that the stock has a possible upside of 298.97%. The high price target for CLVS is $110.00, and the low-price target for CLVS is $16.00. There are currently 5 hold ratings, and 9 buy ratings for the stock, resulting in a consensus rating of “Buy.”
Below are the excerpts of recent ratings by brokerage house:
Upcoming Presentation: The company is scheduled to present at the 27th Annual Healthcare Conference on Wednesday, November 14, 2018, at 11:30 AM Mountain Time. The conference will be held at the Phoenician in Scottsdale.
Description & about the Company: Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe, and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California, and Cambridge, UK.
About Rubraca® (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2, and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.
In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.
Rubraca is an unlicensed medical product outside of the U.S. and EU.
Pipeline: Clovis sponsored studies
Key Milestones and Objectives:
- European Union (EU) Maintenance Treatment Variation Under Review: Following the receipt of the initial Marketing Authorization for Rubraca in late May 2018, Clovis submitted a variation to include the maintenance indication, which was validated by the European Medicines Agency (EMA) in early July. The review is underway, and opinion for the maintenance indication is anticipated from the EMA’s Committee for Medicinal Products for Human Use (CHMP) by the end of 2018, and, if positive, a potential formal European Commission approval could follow in early 2019. Clovis continues to establish its EU organization to support the planned launch of Rubraca in Europe.
- TRITON Datasets at ESMO and Breakthrough Therapy Designation: Initial data from the Company’s ongoing TRITON studies of Rubraca in advanced prostate cancer were presented at the ESMO 2018 Congress (European Society for Medical Oncology) during October 2018.
- The TRITON2 results were the basis for Breakthrough Therapy designation for Rubraca as a monotherapy treatment of adult patients with BRCA1/2mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy, which was granted on October 2, 2018, by the U.S. Food and Drug Administration (FDA). The TRITON2 study continues to enroll patients.
- Also, a TRITON screening poster presented at ESMO provided initial genomic profiling data from the TRITON clinical program. Plasma samples identified alterations in BRCA1or BRCA2 in approximately 12% of mCRPC patients screened for the TRITON2 study, and data demonstrated that plasma cell-free circulating tumor DNA (cfDNA) samples were highly consistent with tumor tissue in identifying BRCA1 or BRCA2
- Rubraca Clinical Development: Clovis has a robust clinical development program underway in multiple tumour types, including Clovis-sponsored, partner-sponsored and investigator-initiated trials.
Revenue: Product revenue for the quarter and first nine months ended September 30, 2018, was $22.8 million and $65.0 million, compared to $16.8 million and $38.5 million for the comparable periods in 2017. The supply of free drug distributed to eligible patients through the Rubraca patient assistance program for the three months ended September 30, 2018, was approximately 30 percent of the overall commercial supply or the equivalent of $9.6 million in commercial value.
Following the receipt of the initial Marketing Authorization for Rubraca in late May 2018, Clovis submitted a variation to include the maintenance indication, which was validated by the European Medicines Agency (EMA) in early July. The review is underway, and opinion for the maintenance indication is anticipated from the EMA’s Committee for Medicinal Products for Human Use (CHMP) by the end of 2018, and, if positive, a potential formal European Commission approval could follow in early 2019. Clovis continues to establish its EU organization to support the planned launch of Rubraca in Europe.
Profitability: Clovis reported a net loss for the third quarter of 2018 of $89.9 million, or ($1.71) per share, and $268.8 million, or a net loss of ($5.18) per share for the first nine months of 2018. Net loss was $60.7 million, or a net loss of ($1.24) per share for the third quarter of 2017, and $294.5 million, or a net loss of ($6.39) per share for the first nine months of 2017.
Liquidity: Clovis had $604.4 million in cash, cash equivalents and available-for-sale securities as of September 30, 2018. Cash used in operating activities was $72.5 million for the third quarter of 2018 and $283.3 million for the first nine months of 2018, compared with $45.8 million for the third quarter of 2017 and $195.3 million for the first nine months of 2017. T
Key Stock Influences:
Successful completion of the upcoming milestones would lead future direction for the company. Any adversities related to these future milestones might adversely impact the overall investor sentiments.
The company’ business profile is constrained due to risk related to product concentration. CLVS is a single-asset commercial-stage biopharma company, and the only marketed product is Rubraca (rucaparib)
If CLVS fails in securing acceptance for EU market, this would significantly constrain the business and financial risk profile of the company.
CLVS is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it.
The company is exposed to Regulatory risk as approvals are not guaranteed. Furthermore, ongoing clinical trials may fail or could face time and cost overruns, which would negatively impact the overall performance.
On Friday, November 9th, 2018, CLVS closed at $15.65 (down by 0.25%) on an above average volume of 2.04 million shares exchanging hands. Market capitalization is $824.84 million. The current RSI is 33.41
In the past 52 weeks, shares of CLVS have traded as low as $11.50 and as high as $69.02
At $15.65, shares of CLVS are below its 50-day moving average (MA) at $26.99 and below its 200-day MA at $43.48
The present support and resistance levels for the stock are at $14.24 & $17.38 respectively.