Clovis Oncology Announces 2015 Operating Results
-
Rociletinib NDA scheduled for discussion at ODAC panel on
April 12 with aJune 28 PDUFA date - Rucaparib NDA submission for treatment of advanced ovarian cancer expected to complete Q2 2016
“2016 has the potential to be a very transformational year for Clovis,”
said
2015 Financial Results
Clovis had
Clovis reported a net loss for the fourth quarter of 2015 of
Research and development expenses totaled
General and administrative expenses totaled
As noted above, in the fourth quarter of 2015 Clovis recorded a non-cash
impairment charge of
In connection with its acquisition of EOS, Clovis is obligated to pay
additional consideration to the former EOS shareholders if certain
future regulatory and sales milestones for lucitanib are achieved. The
estimated fair value of these contingent payments is recorded as a
liability on the Company’s balance sheet. During the fourth quarter of
2015, Clovis recorded a
There was no acquired in-process research and development expense for
the fourth quarter of 2015, and
Operating expenses for the fourth quarter of 2015 and year ended
2016 Key Milestones and Objectives
Highlights of planned or completed objectives for each product follow:
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 Company is preparing for its scheduled
During the first quarter the Company initiated a Phase 1b/2 trial of rociletinib in combination with investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PD-L1 antibody). The Clovis-sponsored study is designed to assess the safety and activity of the combination in patients with activating EGFR mutation-positive (EGFRm) advanced or metastatic NSCLC.
Rucaparib
During the second quarter of 2016, Clovis intends to complete its
rolling NDA submission to the
During the second half of 2016, the Company intends to initiate a study of rucaparib in metastatic castrate-resistant BRCA mutant (inclusive of germline and somatic) prostate cancer patients. In addition, the Company expects to initiate the ARIEL4 confirmatory study in advanced ovarian cancer, including both tumor BRCA mutant and, potentially, BRCA-like patients.
Lucitanib
A Phase 2 program is ongoing to explore lucitanib in patients with treatment-refractory breast cancer. In parallel with Clovis’ sponsored study, 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.
Conference Call Details
Clovis will hold a conference call to discuss fiscal year 2015 results
this afternoon,
About Rociletinib
Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal
growth factor receptor (EGFR) under investigation for the treatment of
EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the
activating mutations of EGFR (L858R and Del19), while also inhibiting
the dominant acquired resistance mutation, T790M. The T790M mutation
develops in approximately 60 percent of patients treated with first- and
second-generation EGFR inhibitors. Rociletinib was granted Breakthrough
Therapy designation by the U.S.
About Rucaparib
Rucaparib is an oral, potent small molecule inhibitor of PARP1 and PARP2
being developed for the treatment of ovarian cancer, specifically in
patients with tumors with BRCA mutations and other DNA repair
deficiencies beyond BRCA, including those with high genomic loss of
heterozygosity (LOH) commonly referred to as “BRCA-like." Clovis is also
exploring rucaparib in other solid tumor types with significant BRCA and
BRCA-like populations, including prostate, breast and gastroesophageal
cancers. Rucaparib was granted Breakthrough Therapy designation by the
U.S.
About Lucitanib
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 (PDGFRα-β) and
fibroblast growth factor receptors 1 through 3 (FGFR1-3). Clovis, which
holds exclusive U.S. and Japanese rights, is collaborating with its
development partner Les Laboratoires Servier (Servier) on the global
clinical development of lucitanib outside of
To the extent that statements contained in this press release are not
descriptions of historical facts regarding
| CLOVIS ONCOLOGY, INC | |||||||||||||||||
| CONSOLIDATED FINANCIAL RESULTS | |||||||||||||||||
| (in thousands, except per share amounts) | |||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | ||||||||||||||
| Revenues: | |||||||||||||||||
| License and milestone revenue | $ | - | $ | - | $ | - | $ | 13,625 | |||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 75,995 | 50,149 | 269,251 | 137,705 | |||||||||||||
| General and administrative | 8,238 | 5,605 | 30,524 | 21,457 | |||||||||||||
| Acquired in-process research and development | - | - | 12,000 | 8,806 | |||||||||||||
| Impairment of intangible asset | 89,557 | - | 89,557 | 3,409 | |||||||||||||
| Change in fair value of contingent purchase consideration | (26,882 | ) | (1,864 | ) | (24,611 | ) | 707 | ||||||||||
| Total expenses | 146,908 | 53,890 | 376,721 | 172,084 | |||||||||||||
| Operating loss | (146,908 | ) | (53,890 | ) | (376,721 | ) | (158,459 | ) | |||||||||
| Other income (expense): | |||||||||||||||||
| Interest expense | (2,101 | ) | (2,093 | ) | (8,372 | ) | (2,604 | ) | |||||||||
| Foreign currency gains (losses) | 736 | 1,001 | 2,740 | 3,580 | |||||||||||||
| Other income (expense) | 164 | (106 | ) | 416 | (240 | ) | |||||||||||
| Other income (expense), net | (1,201 | ) | (1,198 | ) | (5,216 | ) | 736 | ||||||||||
| Loss before income taxes | (148,109 | ) | (55,088 | ) | (381,937 | ) | (157,723 | ) | |||||||||
| Income tax benefit (expense) | 28,568 | 181 | 29,076 | (2,308 | ) | ||||||||||||
| Net loss | $ | (119,541 | ) | $ | (54,907 | ) | $ | (352,861 | ) | $ | (160,031 | ) | |||||
| Basic and diluted net loss per common share | $ | (3.12 | ) | $ | (1.62 | ) | $ | (9.79 | ) | $ | (4.72 | ) | |||||
| Basic and diluted weighted average common shares outstanding | 38,321 | 33,941 | 36,026 | 33,889 | |||||||||||||
| RECONCILIATION OF GAAP TO NON-GAAP | ||||||||||||||||||
|
NET LOSS AND NET LOSS PER SHARE (in thousands, except per share amounts) |
||||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||||
| GAAP net loss | $ | (119,541 | ) | $ | (54,907 | ) | $ | (352,861 | ) | $ | (160,031 | ) | ||||||
| Adjustments: | ||||||||||||||||||
| Impairment of intangible asset (1) | 89,557 | - | 89,557 | - | ||||||||||||||
| Change in fair value of contingent purchase consideration (2) | (26,882 | ) | - | (26,882 | ) | - | ||||||||||||
| Income tax benefit (1) | (28,568 | ) | - | (28,568 | ) | - | ||||||||||||
| Non-GAAP net loss | $ | (85,434 | ) | $ | (54,907 | ) | $ | (318,754 | ) | $ | (160,031 | ) | ||||||
| GAAP net loss per common share | $ | (3.12 | ) | $ | (1.62 | ) | $ | (9.79 | ) | $ | (4.72 | ) | ||||||
| Non-GAAP net loss per common share | $ | (2.23 | ) | $ | (1.62 | ) | $ | (8.85 | ) | $ | (4.72 | ) | ||||||
|
The Company prepares its consolidated financial statements in accordance with U.S. GAAP. This press release also contains non-GAAP measurements of net loss and net loss per common share 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. |
|
| Explanation of adjustments: | |
|
(1) During the three months ended December 31, 2015, the Company recorded an $89.6 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 $28.6 million tax benefit associated with this charge. This adjustment removes the net of tax effect of this charge from our net loss. |
|
| (2) During the three months ended December 31, 2015, the Company recorded a $26.9 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 EOS acquisition. 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 | ||||||||
| (in thousands) | ||||||||
| December 31, | ||||||||
| 2015 | 2014 | |||||||
| Cash and cash equivalents | $ | 278,756 | $ | 482,677 | ||||
| Available-for-sale securities | 249,832 | - | ||||||
| Working capital | 464,125 | 443,400 | ||||||
| Total assets | 713,386 | 777,386 | ||||||
| Convertible senior notes | 279,885 | 278,680 | ||||||
| Common stock and additional paid-in capital | 1,130,016 | 785,123 | ||||||
| Total stockholders' equity | 300,650 | 331,630 | ||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20160225006572/en/
Source:
Clovis Oncology, Inc.
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
or
Anna
Sussman, 303-625-5022
asussman@clovisoncology.com