Clovis Oncology Announces First Quarter 2018 Operating Results
$18.5Min Rubraca® sales for the first quarter of 2018, based on limited third-line BRCA-mutant ovarian cancer treatment label in U.S.
- All-comers and earlier-line ovarian cancer maintenance treatment
indication approved in U.S. on
April 6, 2018
- CHMP adopted positive opinion for limited treatment indication in
March 23; Marketing Authorization by European Commissionanticipated later this month
- European maintenance treatment filing for ovarian cancer planned for Q2 2018, potential CHMP opinion by year-end
- Initiated potential registrational trial (ATLAS) of Rubraca in advanced bladder cancer during the quarter
- Robust Rubraca monotherapy and combination development program underway
- Gaining ex-US rights excluding
Chinafor lucitanib from Servier; combination studies with each of rucaparib and a PD(L)-1 inhibitor planned $850 millionin adjusted cash, cash equivalents and available for sale securities at March 31, 2018as adjusted for the April 2018financing proceeds of $386 million
“We were very pleased to receive the expanded maintenance treatment
indication for Rubraca in the U.S. in early April, and while it is early
days in the launch, we are receiving very positive feedback to the
broader and earlier-line label from clinicians,” said Patrick J.
Mahaffy, President and CEO of
First Quarter 2018 Financial Results
Clovis reported net product revenue for Rubraca of
Clovis reported a net loss for the first quarter of 2018 of
Cash used in operating activities was
Clovis had approximately 50.7 million shares of common stock outstanding
Research and development expenses totaled
Selling, general and administrative expenses totaled
Key Milestones and Objectives for Rubraca
U.S. Approval for Ovarian Cancer Maintenance Treatment Indication
In late March, the Company announced that the European Union’s (EU)
Also during the quarter, the Company initiated an early access program
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 Phase 3 ATHENA study in advanced ovarian cancer
in the first-line maintenance treatment setting evaluating Rubraca
plus Opdivo (PD-1 inhibitor), Rubraca, Opdivo and placebo in
newly-diagnosed patients who have completed platinum-based
chemotherapy. This study, as part of a broad clinical collaboration
Bristol-Myers Squibb, is expected to begin in the first half of 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 compares Rubraca to physician’s choice of AR-targeted therapy or chemotherapy in these patients. 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 ESMO in
October 2018, pending abstract acceptance.
- 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 currently enrolling patients.
The Phase 1 RUCA-J study, sponsored by Clovis, initiated during the
quarter 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.
- A Phase 2, open-label, multi-cohort study evaluating the combination of Rubraca and Opdivo in patients with relapsed, BRCA wild-type ovarian cancer and in patients with locally advanced or metastatic bladder carcinoma who are ineligible for treatment with cisplatin. This study is sponsored by Clovis and is expected to begin in the second half of 2018.
The Phase 3 pivotal study in advanced triple-negative breast cancer
(TNBC) to evaluate Opdivo and Rubraca in combination. This study is
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.
Exploratory studies in other tumor types are also underway.
Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity
of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3),
platelet-derived growth factor receptors alpha and beta (PDGFR α/β) and
fibroblast growth factor receptors 1 through 3 (FGFR1-3), which was
previously evaluated in breast and lung cancers in partnership with
Servier. Clovis has received notice from Servier that they will return
their ex-US rights (excluding
Lucitanib was originally developed by Clovis and Servier with the hypothesis of activity in FGFR driven tumors; data in breast and lung cancer were insufficient to move the program forward. Recent data for a similar drug that inhibits these same three pathways - when combined with a PD-1 inhibitor - are extremely encouraging and represent a validated and alternative hypothesis for the development of lucitanib in combination with a PD(L)-1 inhibitor, and a Clovis-sponsored combination study is now being planned. Clovis also intends to initiate a study of lucitanib in combination with rucaparib, based on encouraging data of VEGF and PARP inhibitors in combination. Each of these studies is expected to initiate before the end of Q1 2019.
Conference Call Details
Clovis will hold a conference call to discuss Q1 2018 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.
Rubraca is an unlicensed medical product outside of the U.S.
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 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, including those being planned or conducted in collaboration with partners, changes in drug supply costs and other expenses 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 development, 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 March 31,|
|Cost of sales - product||4,006||1,163|
|Cost of sales - intangible asset amortization||372||372|
|Research and development||43,543||32,447|
|Selling, general and administrative||39,274||29,224|
|Other income (expense):|
|Foreign currency loss||(81||)||(159||)|
|Legal settlement loss||(7,975||)||-|
|Other income (expense), net||(9,282||)||(2,386||)|
|Loss before income taxes||(77,954||)||(58,547||)|
|Income tax benefit||260||83|
|Basic and diluted net loss per common share||$||(1.54||)||$||(1.33||)|
|Basic and diluted weighted-average common shares outstanding||50,602||44,039|
|RECONCILIATION OF GAAP TO NON-GAAP|
|March 31, 2018|
|Cash, cash equivalents and available-for-sale securities||$||463,811|
|April 2018 financing proceeds||386,000|
The Company prepares its consolidated financial statements in accordance with U.S. GAAP. This press release also contains non-GAAP measurements of adjusted cash that the Company believes provide useful supplemental information relating to operating performance and trends and facilitates comparisons with other periods. These non-GAAP financial measures should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP.
|CONSOLIDATED BALANCE SHEET DATA|
|(Unaudited, in thousands)|
|March 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||374,114||$||464,198|
|Convertible senior notes||282,732||282,406|
|Common stock and additional paid-in capital||1,899,675||1,887,249|
|Total stockholders' equity||306,236||367,636|
|(Unaudited, in thousands)|
|Three Months Ended March 31,|
|Net cash used in operating activities||(100,635||)||$||(80,439||)|
|Share Based Compensation Expense||11,913||$||8,947|