Clovis Oncology Announces 2017 Operating Results
- First full year of Rubraca® (rucaparib)
U.S. sales totaled
$55.5M, including $17.0Mfor the fourth quarter of 2017, with limited third-line BRCA-mutant ovarian cancer treatment label
- U.S. maintenance treatment indication under review, with
April 6, 2018PDUFA date
- CHMP positive trend vote communicated for limited treatment
indication; formal CHMP vote anticipated in
- Maintenance variation to MAA planned following potential Q2 approval for treatment indication
- Robust Clovis-sponsored Rubraca development program in place; clinical studies in ovarian, prostate and bladder cancers open for enrollment or initiating 1H2018
- Broad clinical collaboration with
Bristol-Myers Squibbunderway to evaluate Rubraca in combination with Opdivo® (nivolumab) in several late-stage clinical trials in multiple tumor types; prostate study underway, ovarian and breast cancer studies expected to begin 1H2018 $563.7Min cash, cash equivalents and available for sale securities at December 31, 2017
“2017 provided us strong momentum for 2018, with a potential all-comers
maintenance approval in the U.S. coming soon, and a potential positive
Fourth Quarter and Year-End 2017 Financial Results
Clovis reported net product revenue for Rubraca of
Clovis reported a net loss for the fourth quarter of 2017 of
The net loss for the year ended
Research and development expenses totaled
Selling, general and administrative expenses totaled
Key Milestones and Objectives for Rubraca
U.S. sNDA for Ovarian Cancer Maintenance Treatment Indication based on ARIEL3 Dataset
The first presentation of the comprehensive dataset from the Phase 3
ARIEL3 study of Rubraca took place at the 2017
ARIEL3 is a double-blind, placebo-controlled, Phase 3 trial of Rubraca that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) tumor BRCA mutant (tBRCAmut) patients, inclusive of germline and somatic mutations of BRCA (n=196); 2) HRD patients, including BRCA-mutant patients (n=354), and, finally, 3) the intent-to-treat population, or all patients treated in ARIEL3 (n=564). The study achieved its primary endpoint of improved PFS by investigator review in each of three populations. PFS was also improved in the Rubraca group compared with placebo by BICR, a key secondary endpoint, in all three populations. In addition, Rubraca improved objective response rate vs placebo among evaluable trial participants in all three study populations.
Treatment emergent adverse events (TEAEs) in the ARIEL3 Rubraca group were generally managed with dose modifications and not associated with increased mortality or morbidity compared with the placebo group. Safety data from ARIEL3 demonstrate consistency with prior Rubraca studies.
Last week Clovis announced that the
Clinical Collaboration with
Initiation of TRITON Prostate Clinical Development Program
Beyond its ovarian cancer development program, the Company is focused on development of Rubraca in multiple tumor types, including prostate cancer. Prostate cancer is the second most diagnosed cancer in men, with 1.1 million new cases diagnosed worldwide in 2012. Men with disease that has advanced to castration-resistant prostate cancer (CRPC) have a high likelihood of having or developing metastases, and metastatic CRPC remains an incurable disease usually associated with poor prognosis and short survival time. Germline and somatic mutations in BRCA, ATM or other homologous recombination (HR) DNA-repair genes are present in patients with advanced prostate cancer (including metastatic CRPC) at frequencies of 20-25 percent and higher. These markers may be used to select metastatic CRPC patients for targeted treatment with Rubraca. Rucaparib has demonstrated cytotoxicity in prostate cancer cells lines with reduced levels of BRCA1, BRCA2, or ATM. In addition, another PARP inhibitor has demonstrated preliminary evidence of anti-tumor activity in mCRPC patients with HR deficiencies.
Clovis has a robust clinical development program underway in multiple tumor types, including Clovis-sponsored, partner-sponsored and investigator-initiated trials. The following clinical studies are open for enrollment or are anticipated to open during the next several months:
- The Clovis-sponsored ARIEL4 confirmatory study in the treatment setting is a Phase 3 multicenter, randomized study of Rubraca versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of therapy. This study is currently enrolling patients.
- The Clovis-sponsored TRITON2 study in mCRPC, a Phase 2 single-arm study enrolling patients with BRCA mutations and ATM mutations (both inclusive of germline and somatic) or other deleterious mutations in other homologous recombination (HR) repair genes. All patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of androgen-receptor (AR) targeted therapy. This study is currently enrolling patients. The Company plans to present initial data from the ongoing TRITON2 study at a medical meeting in Fall 2018.
- The Clovis-sponsored TRITON3 study, a Phase 3 comparative study in mCRPC enrolling BRCA mutant and ATM mutant (both inclusive of germline and somatic) patients who have progressed on AR-targeted therapy and who have not yet received chemotherapy in the castrate-resistant setting is also open for enrollment. TRITON3 will compare Rubraca to physician’s choice of AR-targeted therapy or chemotherapy in these patients. This study is currently enrolling patients.
The Clovis-sponsored ATHENA study in advanced ovarian cancer in the
first-line maintenance treatment setting evaluating Rubraca plus
Opdivo (anti-PD1), Rubraca, Opdivo and placebo in newly-diagnosed
patients who have completed platinum-based chemotherapy. This study,
as part of a broad clinical collaboration with
Bristol-Myers Squibb, is expected to begin in the first half of 2018.
- A Clovis-sponsored single-arm Phase 2 open-label monotherapy study of Rubraca in recurrent, metastatic bladder cancer titled ATLAS: A Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. This study is open for enrollment.
The Phase 3 pivotal study in advanced triple-negative breast cancer
(TNBC) to evaluate Opdivo and Rubraca in combination. This study is
Bristol-Myers Squibband is expected to begin in the first half of 2018.
The Phase 2 combination study of Opdivo with Rubraca for the treatment
of mCRPC. This study, sponsored by
Bristol-Myers Squibb, is being conducted as an arm of a larger sponsored prostate cancer study. This study is currently enrolling patients.
The Phase 1b combination study of the cancer immunotherapy Tecentriq
(atezolizumab; anti-PDL1) and Rubraca for the treatment of ovarian and
triple-negative breast cancers. This study is sponsored by
Rocheand is currently enrolling patients.
The Phase 1 RUCA-J study, sponsored by Clovis, initiated last week
with the first patient dosed with rucaparib in
Japan. The Phase 1 study seeks to identify the recommended dose of rucaparib in Japanese patients, which will enable development of a bridging strategy and potential inclusion of Japanese sites in planned or ongoing global studies.
Exploratory studies in other tumor types are also underway.
Conference Call Details
Clovis will hold a conference call to discuss Q4/FY 2017 results this
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.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectation of timing for review and approval of the sNDA for the maintenance treatment indication and review and approval of the MAA for rucaparib for the treatment and the maintenance treatment indications, our plans to present final or interim data on ongoing clinical trials, the timing and pace of commencement of and enrollment in our clinical trials and statements regarding our expectations of the supply of free drug distributed to eligible patients.Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the market potential of our approved drug, including the performance of our sales and marketing efforts and the success of competing drugs, the performance of our third-party manufacturers, our clinical development programs for our drug candidates and those of our partners, the corresponding development pathways of our companion diagnostics, the timing of availability of data from our clinical trials and the results, the initiation, enrollment and timing of our planned clinical trials, actions by the FDA, the EMA or other regulatory authorities regarding whether to approve drug applications that may be filed, as well as their decisions regarding drug labeling, reimbursement and pricing, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.
|CLOVIS ONCOLOGY, INC|
|CONSOLIDATED FINANCIAL RESULTS|
|(Unaudited, in thousands, except per share amounts)|
Three Months Ended December 31,
Twelve Months Ended December 31,
|Product revenue, net||$||17,040||$||78||$||55,511||$||78|
|Cost of sales - product||3,332||70||10,251||70|
|Cost of sales - intangible asset amortization||370||-||1,486||-|
|Research and development||38,019||54,454||142,498||251,129|
|Selling, general and administrative||38,523||12,190||138,907||40,731|
|Acquired in-process research and development||-||500||-||1,300|
|Impairment of intangible asset||-||-||-||104,517|
|Change in fair value of contingent purchase consideration||-||-||-||(24,936||)|
|Other income (expense):|
|Foreign currency gain (loss)||45||(146||)||(82||)||(580||)|
|Legal settlement loss||11,523||-||(105,477||)||-|
|Other income (expense)||1,404||160||3,643||633|
|Other income (expense), net||10,341||(2,159||)||(112,344||)||(8,438||)|
|Loss before income taxes||(52,863||)||(69,295||)||(349,975||)||(381,171||)|
|Income tax benefit||980||(1,433||)||3,578||32,034|
|Basic and diluted net loss per common share||$||(1.04||)||$||(1.83||)||$||(7.36||)||$||(9.07||)|
|Basic and diluted weighted-average common shares outstanding||49,973||38,624||47,047||38,478|
|RECONCILIATION OF GAAP TO NON-GAAP|
|NET LOSS AND NET LOSS PER SHARE|
|(Unaudited, in thousands, except per share amounts)|
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|GAAP net loss||$||(51,883||)||$||(70,728||)||$||(346,397||)||$||(349,137||)|
|Legal settlement loss (1)||(11,523||)||-||105,477||-|
|Impairment of intangible asset (2)||-||-||-||104,517|
|Change in fair value of contingent purchase consideration (3)||-||-||-||(25,452||)|
|Income tax benefit (2)||-||-||-||(29,160||)|
|Non-GAAP net loss||$||(63,406||)||$||(70,728||)||$||(240,920||)||$||(299,232||)|
|GAAP net loss per common share||$||(1.04||)||$||(1.83||)||$||(7.36||)||$||(9.07||)|
|Non-GAAP net loss per common share||$||(1.27||)||$||(1.83||)||$||(5.12||)||$||(7.78||)|
|The Company prepares its consolidated financial statements in accordance with U.S. GAAP. This press release also contains non-GAAP measurements ofnet loss and net loss per common share that the Company believes provide useful supplemental information relating to operating performance and trendsand facilitates comparisons with other periods. These non-GAAP financial measures should be considered in addition to, but not as a substitute for, theinformation prepared in accordance with U.S. GAAP.|
|Explanation of adjustments:|
|(1) During the twelve months ended December 31, 2017, the Company recorded a $105.5 million legal settlement loss related to a stipulation and agreement of settlement entered into between the Clovis Defendants and the plaintiffs to the Consolidated Complaint. During the three months ended December 31, 2017, the Company recorded an $11.5 million decrease to the legal settlement loss due to the difference in the volume weighted average price of the Company's stock over the 10 trading days immediately preceding the October 26, 2017 hearing date and the closing stock price on November 2, 2017, the date the Company issued the shares related to the legal settlement.|
(2) During the three months ended June 30, 2016, the Company recorded a $104.5 million non-cash impairment charge to the intangible asset related to the lucitanib product rights initially recorded in 2013 in connection with the acquisition of Ethical Oncology Science, S.p.A. (EOS). The Company also recorded a $29.2 million tax benefit associated with this charge. This adjustment removes the net of tax effect of this charge from our net loss.
|(3) During the three months ended June 30, 2016, the Company recorded a $25.5 million non-cash credit to operating expenses to reflect the reduction in the fair value of the contingent purchase consideration liability, also associated with the Company's acquisition of EOS. This adjustment, which excludes the normal accretion of the liability, removes the effect of this expense credit from our net loss.|
|CONSOLIDATED BALANCE SHEET DATA|
|(Unaudited, in thousands)|
|December 31, 2017||
December 31, 2016
|Cash and cash equivalents||$||464,198||$||216,186|
|Convertible senior notes||282,406||281,126|
|Common stock and additional paid-in capital||1,887,249||1,174,989|
|Total stockholders' equity (deficit)||367,636||(3,634||)|
|(Unaudited, in thousands)|
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|Net cash used in operating activities||(65,578||)||$||(54,675||)||(260,904||)||$||(266,680||)|
|Share Based Compensation Expense||12,506||$||10,052||44,707||$||39,796|