On November 5, 2015 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for its quarter ended September 30, 2015, and provided an update on the Company’s clinical development programs for 2015 (Press release, Clovis Oncology, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107598 [SID:1234508032]).
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"We are entering a new phase at Clovis, transitioning into becoming a commercial biopharmaceutical company," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Our U.S. commercial organization, including the sales force, is now fully in place. This team is highly experienced, enthusiastic and ready to go, following our U.S. launch meeting last week. We are now fully prepared to launch rociletinib upon a potential U.S. approval and we are actively building our E.U. commercial organization in preparation for a late 2016 launch in Europe. Additionally, having advanced our rucaparib NDA submission timeline to Q2 2016, we are planning for a potential U.S. launch of rucaparib for advanced ovarian cancer by the end of 2016. We are very enthusiastic about the prospect of having our commercial organization support sales for both rociletinib and rucaparib."
Third Quarter 2015 Financial Results
Net loss attributable to common shareholders was $98.6 million ($2.62 per share) for the third quarter of 2015 and $233.3 million ($6.62 per share) for the first nine months of 2015, compared to a net loss of $39.6 million ($1.17 per share) and $105.1 million ($3.10 per share) for the comparable periods of 2014.
Research and development expenses totaled $76.1 million for the third quarter of 2015 and $193.3 million for the first nine months of 2015, compared to $35.0 million and $87.6 million for the comparable periods in 2014. The increase in expenses for both the three- and nine-month periods is due to the significantly expanded clinical development activities for rociletinib and rucaparib, increased launch planning activities for rociletinib and increased personnel-related expenses associated with the hiring of additional staff to support the Company’s expanded activities.
General and administrative expenses totaled $8.3 million for the third quarter of 2015 and $22.3 million for the first nine months of 2015, compared to $5.3 million and $15.9 million for the comparable periods in 2014. The year over year increase is primarily due to higher share-based compensation and personnel expense for employees engaged in general and administrative activities, increased facility costs and higher professional service fees.
Acquired in-process research and development expenses totaled $12.0 million for both the third quarter of 2015 and the first nine months of 2015. There was no acquired in-process research and development expense for the third quarter of 2014 and $8.8 million for the first nine months of 2014. During the third quarter of 2015, the Company made milestone payments totaling $12.0 million to Celgene Corporation upon acceptance of the NDA and MAA submissions for rociletinib by the FDA and EMA, respectively.
Share-based compensation expense totaled $12.4 million for the third quarter of 2015 and $29.5 million for the first nine months of 2015.
Clovis had $605.9 million in cash, cash equivalents and available-for-sale securities and approximately 38.3 million outstanding shares of common stock as of September 30, 2015. Our net cash used in operations for the third quarter of 2015 was $71.7 million and $177.4 million for the first nine months of 2015, including $12.0 million in rociletinib milestone payments. In July 2015, the Company raised net proceeds of $298.5 million through an offering of 4.1 million shares of common stock.
2015 Key Milestones and Objectives
Highlights of planned or completed objectives for each product follows:
Rociletinib
Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. The U.S. Food and Drug Administration (FDA) has accepted Clovis’ New Drug Application (NDA) for rociletinib and has granted it priority review status with a Prescription Drug User Fee Act (PDUFA) action date of March 30, 2016. In addition, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for rociletinib.
The U.S. commercial and medical affairs organizations are now in place and efforts are currently underway to build out the E.U. commercial organization.
Rociletinib was the subject of several posters and presentations during the third quarter, including updates of data from the TIGER-X study in EGFR mutant, T790M-positive patients with a history of CNS involvement, as well as EGFR mutant, T790M-negative patients as determined by tissue as well as plasma testing. Posters and presentations for all Clovis products in development presented during the third quarter may be viewed at View Source
Rucaparib
During the third quarter, updated findings from ARIEL2 and Study 10, two ongoing studies evaluating the safety and activity of rucaparib in advanced ovarian cancer patients were presented at the 18th ECCO – 40th ESMO (Free ESMO Whitepaper) European Cancer Congress. Data from these studies demonstrated encouraging activity and safety in women with advanced, platinum-sensitive ovarian cancer with tissue BRCA (gBRCA and sBRCA) mutations. In addition, these data demonstrated that the application of Clovis’ proprietary BRCA-like tumor DNA signature to Foundation Medicine’s companion diagnostic assay successfully predicts the population of BRCA-like patients that are not gBRCA or sBRCA that respond to rucaparib therapy. Highlights of the data presented included the following (all response rates RECIST):
Data from ARIEL2 in 40 evaluable BRCA-mutant patients demonstrated an ORR of 75%, a median PFS of 12.8 months and a median duration of response of 9.5 months
Complete responses (CRs) observed in 15% of patients
Data from ARIEL2 in 77 evaluable patients with the BRCA-like signature demonstrated an ORR of 36%, a median PFS of 5.7 months and a median duration of response of 8.2 months
Data from Study 10 in 39 evaluable germline BRCA-mutant patients demonstrated an ORR of 67%, a disease control rate (DCR) of 87%, and median duration of response of 6.6 months
CRs observed in 8% of patients in this group
Rucaparib is well-tolerated with a manageable safety profile; the grade 3/4 treatment-related adverse events (AEs) observed in >15% of patients treated with the recommended 600mg BID dose were anemia/decreased hemoglobin (19%) in ARIEL2, and fatigue/asthenia (21%), and anemia (26%) in Study 10
Based on these compelling data, Clovis intends to submit an NDA to the FDA for rucaparib as treatment for advanced ovarian cancer patients with a tissue BRCA mutation in the second quarter of 2016, with the intention, pending data, to follow with a supplemental NDA for advanced ovarian cancer patients with a BRCA-like mutation. During the quarter, Clovis completed enrollment of the mutant BRCA population that will serve as the basis of its planned NDA submission.
Lucitanib
A Phase 2 program is ongoing to explore lucitanib in multiple indications, including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with advanced lung cancer with FGFR1 amplification, both of which are currently enrolling patients. In parallel with these Clovis-sponsored studies, a Servier-sponsored Phase 2 study of lucitanib in patients with advanced breast cancer is underway to identify the population of patients most likely to benefit from lucitanib therapy.
Management Update
Erle Mast, Clovis’ Executive Vice President, Chief Financial Officer and Clovis co-founder, has announced his plan to retire effective March 31, 2016. The Company is initiating a search for Erle’s successor, and intends to recruit a candidate prior to his departure date to enable a transition period during the first quarter.
"With great regret we announce today that Erle Mast, Chief Financial Officer and a co-founder of Clovis, and importantly, my friend and colleague for more than 14 years, has informed us of his plans to retire on March 31, 2016," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "While I am very sorry to see him go, I certainly understand his decision and can only add how much I have enjoyed working with him and appreciate all that he has done for Clovis. Obviously, we are confident that we will be able to recruit a highly qualified individual as a new CFO and appreciate very much Erle giving sufficient notice to allow a smooth transition."