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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
For the fiscal year ended December 31, 2016.
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
For the transition period from to .
Commission file number: 001-35347
Clovis Oncology, Inc.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
5500 Flatiron Parkway, Suite 100
Boulder, Colorado
(Address of principal executive offices)
90-0475355
(I.R.S. Employer
Identification No.)
80301
(Zip Code)
(303) 625-5000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock par value $0.001 per share
Name of each exchange on which registered
The NASDAQ Global Select Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File
required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405) of this chapter) during the preceding 12 months (or for such
shorter period that the registrant was required to submit and post such files). Yes No
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to
the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment
to this Form 10-K.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.
See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Non-accelerated filer (Do not check if a smaller reporting company)
Accelerated filer
Smaller reporting company
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No
The aggregate market value of the registrant’s common stock, par value $0.001 per share, held by non-affiliates of the registrant on June 30, 2016, the
last business day of the registrant’s most recently completed second quarter, was $454,585,803 based on the closing price of the registrant’s common
stock on the NASDAQ Global Market on that date of $13.72 per share.
The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of February 16, 2017 was 44,626,493.
Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission pursuant to Regulation 14A in
connection with the registrant’s 2016 Annual Meeting of Stockholders, which is to be filed within 120 days after the end of the registrant’s fiscal year
ended December 31, 2016, are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent stated therein.
DOCUMENTS INCORPORATED BY REFERENCE
Table of Contents
TABLE OF CONTENTS
PART I
ITEM 1. BUSINESS
ITEM 1A. RISK FACTORS
ITEM 1B. UNRESOLVED STAFF COMMENTS
ITEM 2.
PROPERTIES
ITEM 3. LEGAL PROCEEDINGS
ITEM 4. MINE SAFETY DISCLOSURES
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS
AND ISSUER PURCHASES OF EQUITY SECURITIES
SELECTED FINANCIAL DATA
ITEM 6.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 8.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
FINANCIAL DISCLOSURE
ITEM 9A. CONTROLS AND PROCEDURES
ITEM 9B. OTHER INFORMATION
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
ITEM 11. EXECUTIVE COMPENSATION
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
SIGNATURES
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PART I
This Annual Report filed on Form 10-K and the information incorporated herein by reference includes statements
that are, or may be deemed, “forward-looking statements.” In some cases, these forward-looking statements can be
identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or, in each case, their
negative or other variations thereon or comparable terminology, although not all forward-looking statements contain
these words. They appear in a number of places throughout this Annual Report on Form 10-K and include statements
regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things,
the market acceptance and commercial viability of our approved product, the development of our sales and marketing
capabilities, the performance of our third party manufacturers, our ongoing and planned non-clinical studies and
clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for
our product candidates, including our ability to confirm the clinical benefit of our approved product through
confirmatory trials and other post-marketing requirements, the degree of clinical utility of our products, particularly in
specific patient populations, expectations regarding clinical trial data, expectations regarding sales of our products, our
results of operations, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate,
including our competition, and the trends that may affect the industry or us.
By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive
dynamics and industry change and depend on the economic circumstances that may or may not occur in the future or
may occur on longer or shorter timelines than anticipated. We caution you that forward-looking statements are not
guarantees of future performance and that our actual results of operations, financial condition and liquidity and the
development of the industry in which we operate may differ materially from the forward-looking statements contained
herein.
Any forward-looking statements that we make in this Annual Report on Form 10-K speak only as of the date of such
statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of
this Annual Report on Form 10-K or to reflect the occurrence of unanticipated events.
You should also read carefully the factors described in the “Risk Factors” section of this Annual Report on Form 10-
K to better understand the risks and uncertainties inherent in our business and underlying any forward-looking
statements. You are advised, however, to consult any further disclosures we make on related subjects in our Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K and our website.
Clovis Oncology®, the Clovis logo and Rubraca™ are trademarks of Clovis Oncology, Inc. in the United States and
in other selected countries. All other brand names or trademarks appearing in this report are the property of their
respective holders. Unless the context requires otherwise, references in this report to “Clovis,” the “Company,” “we,”
“us” and “our” refer to Clovis Oncology, Inc., together with its consolidated subsidiaries.
ITEM 1.
BUSINESS
Overview
We are a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer
agents in the United States, Europe and additional international markets. We target our development programs for the
treatment of specific subsets of cancer populations, and simultaneously develop, with partners, diagnostic tools intended
to direct a compound in development to the population that is most likely to benefit from its use.
Our commercial product Rubraca™ (rucaparib) is the first and only oral, small molecule poly ADP-ribose
polymerase, or PARP, inhibitor of PARP1, PARP2 and PARP3 approved in the United States by the Food and Drug
Administration, or FDA, as monotherapy for the treatment of patients with deleterious BRCA (human genes associated
with the repair of damaged DNA) mutation (germline and/or somatic) associated advanced ovarian cancer, who have
been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion
diagnostic for Rubraca™.
The Marketing Authorization Application, or MAA, submission with the European Medicines Agency, or EMA, for a
comparable ovarian cancer indication was accepted by the EMA during the fourth quarter of 2016. Additionally,
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rucaparib is being studied as a potential maintenance therapy for ovarian cancer patients in the ARIEL3 trial. Data from
ARIEL3 is anticipated in mid-2017. Pending positive data from ARIEL3, we intend to follow up with a supplemental
NDA for second-line maintenance therapy in women with ovarian cancer who have responded to platinum-based
therapy. Rucaparib is also being developed in patients with mutant BRCA tumors and other DNA repair deficiencies
beyond BRCA – commonly referred to as homologous recombination deficiencies, or HRD. Studies open for
enrollment or under consideration include prostate, breast, pancreatic, gastroesophageal, bladder and lung cancers. We
hold worldwide rights for rucaparib.
In addition, we have two other product candidates: lucitanib, an oral inhibitor of the tyrosine kinase activity of
vascular endothelial growth factor receptors (VEGFR) 1-3, platelet-derived growth factor receptors (PDGFR) alpha and
beta and fibroblast growth factor receptors (FGFR) 1-3, and rociletinib, an oral mutant-selective inhibitor of epidermal
growth factor receptor (“EGFR”). While we have stopped enrollment in ongoing trials for each of these candidates, we
continue to provide drug to patients whose clinicians recommend continuing therapy. We maintain certain development
and commercialization rights for lucitanib and global development and commercialization rights for rociletinib.
Clovis was founded in 2009. We have built our organization to support innovative oncology drug development for the
treatment of specific subsets of cancer populations. To implement our strategy, we have assembled an experienced team
with core competencies in global clinical and non-clinical development, regulatory operations and commercialization in
oncology, as well as conducting collaborative relationships with companies specializing in companion diagnostic
development.
Our Product
On December 19, 2016, we announced that the U.S. Food and Drug Administration, or FDA, approved Rubraca
(rucaparib) tablets as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or
somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for
therapy by an FDA-approved companion diagnostic for Rubraca. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in ARIEL3 and/or ARIEL4, our confirmatory trials. Our
commercial and medical affairs organizations in the United States are in place and are supporting the commercial launch
of Rubraca.
The Rubraca New Drug Application, or NDA, filing received priority review from the FDA and was reviewed and
approved under the FDA’s accelerated approval program. A priority review designation means the FDA’s goal is to take
action on an application within six months (rather than 10 months under a standard review) for a product intended to
treat a serious condition and that, if approved, would provide a significant improvement in safety or effectiveness. Under
the FDA’s accelerated approval program, the FDA may approve an application for a product intended to treat a serious
or life-threatening condition upon a determination that the product has an effect on a surrogate endpoint reasonably
likely to predict clinical benefit, or a clinical endpoint that can be measured earlier than irreversible morbidity or
mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit and
taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative
treatments. The NDA efficacy data set was based on results from subgroups of two multicenter, single-arm, open-label
clinical trials, Study 1 (Study 10, NCT01482715) and Study 2 (ARIEL2 Parts 1 and 2, NCT01891344), in women with
advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. Objective response
rate, or ORR, and duration of response, or DOR, were assessed by the investigator and independent radiology review, or
IRR, according to Response Evaluation Criteria in Solid Tumors, or RECIST, version 1.1.
The MAA submission with the EMA for a comparable ovarian cancer indication was accepted by the EMA during
the fourth quarter of 2016. We anticipate an opinion from the Committee for Medicinal Products for Human Use
(“CHMP”) in late 2017 and a favorable opinion could lead to a potential approval shortly thereafter. If approved in the
EU, we intend to commercialize rucaparib on our own and we are building our commercial infrastructure in Europe.
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Efficacy results
ORR and DOR in the 106 patients with BRCA-mutant ovarian cancer who received two or more chemotherapies who
were evaluable for efficacy in the pooled analysis of Study 1 and Study 2, were as follows:
Overall Response and Duration of Response in Patients with BRCA-mutant Ovarian Cancer Who Received Two
or More Chemotherapies in Study 1 and Study 2
ORR (95% CI)
Complete Response
Partial Response
Median DOR in months (95% CI)
Investigator-assessed
N=106
54% (44, 64)
9%
45%
9.2 (6.6, 11.6)
Response assessment by IRR was 42% (95% confidence interval, or CI: 32, 52), with a median DOR of 6.7 months
(95% CI: 5.5, 11.1). Investigator-assessed ORR was 66% (52/79; 95% CI: 54, 76) in platinum-sensitive patients, 25%
(5/20; 95% CI: 9, 49) in platinum-resistant patients, 0% (0/7; 95% CI: 0, 41) in platinum-refractory patients, 53%
(47/88; 95% CI: 43, 64) in patients with a germline BRCA mutation, 56% (10/18; 95% CI: 31, 79) in patients with a
somatic BRCA mutation, 68% (28/41; 95% CI: 52, 82) in patients who received two prior chemotherapies and 65%
(39/60; 95% CI: 52, 77) in patients who received two prior platinum-based chemotherapies. ORR was similar for
patients with a BRCA1 gene mutation or BRCA2 gene mutation. With respect to the target lesion component of
RECIST, the majority of patients experienced a decrease in the sum of the diameters of the target lesions.
Safety data
The overall safety evaluation of Rubraca 600 mg twice daily as monotherapy is based on data from 377 patients with
ovarian cancer treated in two open-label, single arm trials. The most common adverse reactions (≥ 20% of patients;
Grade 1-4) were nausea, asthenia/fatigue, vomiting, anemia, constipation, dysgeusia, decreased appetite, diarrhea,
abdominal pain, thrombocytopenia and dyspnea. The most common laboratory abnormalities (≥ 35% of patients; Grade
1-4) were increase in creatinine, increase in aspartate aminotransferase, or AST, levels, increase in alanine
aminotransferase levels, or ALT, decrease in hemoglobin, decrease in lymphocytes, increase in cholesterol, decrease in
platelets and decrease in absolute neutrophil count. The most common Grade 3-4 adverse reaction was anemia, and the
most common Grade 3-4 laboratory abnormality was a decrease in hemoglobin.
Myelodysplastic Syndrome/Acute Myeloid Leukemia, or MDS/AML, was reported in two of the 377 (0.5%) patients
with ovarian cancer treated with Rubraca. Both of these patients had received prior treatment with platinum and other
DNA damaging agents. In addition, AML was reported in two (<1%) patients with ovarian cancer enrolled in ARIEL3, a
blinded, randomized trial evaluating Rubraca versus placebo. One case of AML was fatal. Both patients had received
prior treatment with platinum and other DNA damaging agents.
Companion Diagnostic
Clovis partnered with Foundation Medicine, Inc. to co-develop a companion diagnostic test, the FDA approved
FoundationFocusTM CDx BRCA, to select patients for Rubraca treatment. FoundationFocus CDx BRCA is a next-generation
sequencing assay that assesses tumor BRCA mutations from tumor tissue samples from patients with ovarian cancer.
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Rucaparib Clinical Development
We are developing rucaparib for selected patient populations and collaborating with partners for companion
diagnostic development. The following table summarizes the ongoing studies:
The ARIEL (Assessment of Rucaparib in Ovarian Cancer Trial) program is a novel, integrated translational-clinical
program designed to accurately and prospectively identify ovarian cancer patients with tumor genotypes associated with
benefit from rucaparib therapy. Rucaparib is also being developed in patients with mutant BRCA tumors and other DNA
repair deficiencies beyond BRCA – commonly referred to HRD. Studies open for enrollment or under consideration
include prostate, breast, pancreatic, gastroesophageal, bladder and lung cancers.
The ARIEL3 pivotal study (NCT01968213) is a randomized, double-blind study comparing the effects of rucaparib
against placebo to evaluate whether rucaparib given as a maintenance therapy to platinum-sensitive patients can extend
the period of time for which the disease is controlled after a positive outcome with platinum-based chemotherapy.
Patients who have high-grade serous ovarian cancer and have had at least two prior lines of platinum based
chemotherapies are randomized to receive either placebo or rucaparib and the primary endpoint of the study is
progression free survival, or PFS. The primary efficacy analysis will evaluate, in a step-down process, BRCA-mutant
patients, all patients with a HRD signature (including BRCA and non-BRCA), followed by all patients. Target
enrollment in ARIEL3 was completed during the second quarter of 2016. Data from ARIEL3 are expected mid-2017.
Pending positive data from ARIEL3, we intend to follow up with a supplemental NDA for second-line maintenance
therapy in women with ovarian cancer who have responded to platinum-based therapy.
The ARIEL4 confirmatory study (NCT 02855944), which is open for enrollment, is a Phase 3 multicenter,
randomized study of rucaparib versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations (inclusive
of germline and/or somatic) who have failed two prior lines of therapy. The primary endpoint of the study is PFS.
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During the second half of 2016, we initiated the TRITON (Trial of Rucaparib in Prostate Indications) program in
prostate cancer, which includes two Clovis-sponsored potential registration studies which are currently open for
enrollment:
• The TRITON2 study, a Phase 2 single-arm study in men with metastatic castrate-resistant prostate cancer, or
mCRPC, enrolling patients with BRCA mutations and ataxia-telangiectasia mutations, or ATM, (both inclusive
of germline and/or somatic) or other deleterious mutations in other homologous recombination repair genes and
all patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of
androgen-receptor, or AR, targeted therapy in the castrate-resistant setting. The primary endpoints of the study
are radiologic ORR in patients with measurable disease and protein-specific antigen response rate in patients
who do not have measurable disease. TRITON2 initiated during the fourth quarter of 2016.
• The TRITON3 study, a Phase 3 comparative study in men with mCRPC enrolling BRCA mutant and ATM
(both inclusive of germline and/or somatic) patients who have progressed on AR-targeted therapy and who have
not yet received chemotherapy in the castrate-resistant setting. TRITON3 will compare rucaparib to physician’s
choice of AR-targeted therapy or chemotherapy in these patients. The planned primary endpoint of the study is
radiologic PFS. TRITON3 initiated during the first quarter of 2017.
In addition to the ARIEL and TRITON programs in ovarian and prostate, respectively, we are supporting several
clinical studies in ovarian, prostate and other indications:
• The Phase 2 investigator-initiated study, MITO-25, evaluating rucaparib and bevacizumab in combination as a
first-line maintenance therapy for advanced ovarian cancer expected to initiate during the first quarter of 2017.
• The Phase 1B combination study sponsored by Genentech, of the cancer immunotherapy Tecentriq
(atezolizumab; anti-PDL1) and rucaparib for the treatment of solid tumors and gynecological cancers, with a
focus on ovarian cancer, which is expected to have the first patient initiated during the second quarter of 2017.
The rationale for the combination is supported by non-clinical data that suggests greater activity in the
combination of rucaparib and a PDL-1 inhibitor compared with either agent alone.
• The investigator-initiated RUBY Phase 2 study in women with breast cancer whose tumors have a somatic
BRCA mutation or HRD signature other than a known germline BRCA mutation, which enrolled the first
patient in the third quarter of 2016.
• The investigator-initiated PLATFORM Phase 2 study in gastroesophageal cancer in the first-line maintenance
setting, which is expected to initiate during the first quarter of 2017.
• The investigator-initiated Phase 2 STRAT-STAMPEDE study in newly-diagnosed castrate-sensitive de novo
metastatic prostate cancer patients whose tumors have a tBRCA mutation or are HRD positive, which is
expected to initiate during the first half of 2017.
• The investigator-initiated RIO Phase 2 study in triple-negative or gBRCA breast cancer patients, which initiated
during the third quarter of 2015.
•
In February 2017, Clovis and Strata Oncology, Inc. (“Strata”) announced an agreement to accelerate patient
identification and enrollment for Clovis’ ongoing TRITON clinical trial program. The Strata Trial, sponsored
by Strata, is an observational study that provides next-generation sequencing at no cost to all advanced cancer
patients at clinical sites that have agreed to participate in the Strata Trial, and match advanced prostate cancer
patients with specified mutations to Clovis’ TRITON2 and TRITON3 clinical trials for rucaparib. Strata has
agreed not to provide similar matching services on behalf of any other Strata collaborator for any other mCRPC
clinical trials for patients having the same specified mutations.
DNA damage and cancer therapy
Cells in the human body are under constant attack from agents that can cause damage to DNA, including sunlight and
other forms of radiation, as well as DNA-binding chemicals that can cause changes in the composition of DNA. Cells
have evolved multiple mechanisms to enable such DNA repair, and these mechanisms are complementary to each other,
each driving repair of specific types of DNA damage. If a cell’s DNA damage repair system is overwhelmed, then the
cell will die undergoing a form of suicide termed apoptosis. A fundamental principle of cancer therapy is to damage cells
profoundly with radiation or DNA-binding drugs, such as alkylating agents or platinums, to induce apoptosis and,
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subsequently, cancer cell death. Multiple DNA repair mechanisms active in the cell may reduce the activity of these anti-
cancer therapies.
DNA repair
The PARP family comprises 17 structurally related proteins that have been identified on the basis of sequence
similarity. PARP1, PARP2, and PARP3 play a central role in DNA repair. They are rapidly recruited to the sites of DNA
damage and catalyze the recruitment of additional proteins that initiate the repair of damaged DNA. The breast cancer 1
(BRCA1) and breast cancer 2 (BRCA2) genes also have important roles in DNA repair pathways such as homologous
recombination. Mutations in BRCA1 and BRCA2 are associated with an increased risk of ovarian, breast, prostate, and
pancreatic cancers.
PARP inhibitors and synthetic lethality
Rucaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3.
PARP inhibitors have shown activity in BRCA1/2 mutant and homologous recombination (HR) repair deficient cancer
cell lines through a mechanism known as synthetic lethality in which the loss of two genes/pathways is required for cell
death. The inhibition/inactivation of repair pathways by administration of a PARP inhibitor in the context of an
underlying genetic defect such as a BRCA mutation results in tumor cell death through accumulation of unrepaired DNA
damage. In addition to catalytic inhibition of the enzymatic activity, PARP inhibitors may also function by “trapping”
PARP enzymes at damaged DNA. Trapped PARP-DNA complexes may act as “poisons” to interfere with replication
that would require BRCA dependent homologous recombination to be resolved.
Homologous recombination deficient tumors
Alterations in DNA repair genes other than BRCA1/2 have been observed in, and contribute to the hereditary risk of,
ovarian, breast, prostate and pancreatic cancers. PARP inhibitors have shown evidence of nonclinical and clinical
activity in tumors with alterations in non-BRCA HR genes. DNA repair deficiencies resulting from genetic and
epigenetic alterations can result in a “BRCA-like” phenotype that may also render tumor cells sensitive to PARP
inhibitors. One approach to identify patients with DNA repair deficiencies due to mechanisms other than a BRCA
mutation is to assess loss of heterozygosity (LOH), or the loss of one normal copy of a gene, which arises from error-
prone DNA repair pathways when HR is compromised. A next-generation sequencing (NGS) assay was developed in
collaboration with Foundation Medicine to use as a companion diagnostic to assess genomic LOH in tumor samples, and
this biomarker has the potential to expand the clinical utility of rucaparib in ovarian cancer and other indications.
Rociletinib - an Oral EGFR Mutant-Selective Inhibitor
Rociletinib is an oral mutant-selective inhibitor of epidermal growth factor receptor (“EGFR”). During the second
quarter of 2016, we received a Complete Response Letter (“CRL”) from the FDA for the rociletinib NDA, which was
submitted during the third quarter of 2015. The FDA issues a CRL to indicate that their review of an application is
complete and that the application is not ready for approval. In anticipation of receiving the CRL, we terminated
enrollment in all ongoing sponsored clinical studies, although we continue to provide drug to patients whose clinicians
recommend continuing rociletinib therapy. In addition, we withdrew our MAA for rociletinib on file with the EMA. We
are continuing analyses of rociletinib data to determine whether certain populations of patients may represent an
opportunity for a partner committed to investing in further clinical development. We hold global development and
commercialization rights for rociletinib.
Lucitanib – a VEGFR, PDGFR and FGFR Inhibitor
Lucitanib is an oral inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors (VEGFR)
1-3, platelet-derived growth factor receptors (PDGFR) alpha and beta and fibroblast growth factor receptors (FGFR) 1-3.
Lucitanib was previously evaluated in breast and lung cancers. Development in those indications has ceased and we
continue to provide drug to patients whose clinicians recommend continuing lucitanib therapy. Along with our
development partner, Servier, we are continuing to evaluate what, if any, further development of lucitanib will be
pursued. We hold development and commercialization rights in the U.S. and Japan and have sublicensed rights to
Europe and rest of world markets, excluding China, to Servier.
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Competition
The development and commercialization of new drugs is competitive, and we face competition from major
pharmaceutical and biotechnology companies worldwide. Our competitors may develop or market products or other
novel technologies that are more effective, safer or less costly than any that have been or will be commercialized by us,
or may obtain regulatory approval for their products more rapidly than we may obtain approval for ours.
The acquisition or licensing of pharmaceutical products is also very competitive, and a number of more established
companies, which have acknowledged strategies to license or acquire products, may have competitive advantages over
us, as may other emerging companies taking similar or different approaches to product acquisitions. Many of our
competitors will have substantially greater financial, technical and human resources than we have. Additional mergers
and acquisitions in the pharmaceutical industry may result in even more resources being concentrated in our competitors.
Competition may increase further as a result of advances made in the commercial applicability of technologies and
greater availability of capital for investment in these fields. Our success will be based in part on our ability to build and
actively manage a portfolio of drugs that addresses unmet medical needs and creates value in patient therapy.
Rucaparib Competition
Lynparza™/olaparib (AstraZeneca) was approved in December 2014 in the US as monotherapy in patients with
germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of
chemotherapy, and in the EU for use as monotherapy for the maintenance treatment of adult patients with platinum-
sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or
primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
There are a number of PARP inhibitors in clinical development including Tesaro’s niraparib, AbbVie’s veliparib and
ABT-767, Pfizer’s talazoparib. BeiGene’s BGB-290, and Checkpoint Therapeutics’ CK-102. While most PARP
inhibitor development focuses on ovarian cancer, breast cancer, and prostate cancer, additional efforts are aimed toward
bladder, lung, and pancreatic cancers as well.
Outside of the PARP class, Avastin®/bevacizumab is approved in the US for recurrent epithelial ovarian, fallopian
tube, or primary peritoneal cancer that is platinum-resistant in combination with paclitaxel, pegylated liposomal
doxorubicin, or topotecan, and was approved in December 2016 in the US for recurrent epithelial ovarian, fallopian tube,
or primary peritoneal cancer that is platinum-sensitive in combination with carboplatin and paclitaxel or in combination
with carboplatin and gemcitabine, followed by Avastin as a single agent. Other out of class agents approved for use in
advanced ovarian cancer include chemotherapeutic agents (e.g. platinum-based doublets, platinum monotherapy, non-
platinum chemotherapy, etc.), Doxil® (Janssen), and Hycamtin® (Novartis) and there are additional out-of-class agents
in clinical development that may pose a future competitive threat to rucaparib.
License Agreements
Pfizer Inc.
In June 2011, we entered into a license agreement with Pfizer Inc. to obtain the exclusive global rights to rucaparib.
The exclusive rights are exclusive even as to Pfizer and include the right to grant sublicenses. Pursuant to the terms of
the license agreement, we made a $7.0 million upfront payment to Pfizer. In April 2014, we initiated a pivotal
registration study for rucaparib, which resulted in a $0.4 million milestone payment to Pfizer as required by the license
agreement. In September 2016, we made a milestone payment of $0.5 million to Pfizer upon acceptance of the NDA for
rucaparib by the FDA. The MAA submission with the EMA for a comparable ovarian cancer indication was accepted by
the MAA during the fourth quarter of 2016, which resulted in a $0.5 million milestone payment to Pfizer as required by
the license agreement. These payments were recognized as acquired in-process research and development expense.
On August 30, 2016, we entered into a first amendment to the worldwide license agreement with Pfizer, which
amends the June 2011 existing worldwide license agreement to permit us to defer payment of the milestone payments
payable upon (i) FDA approval of an NDA for 1st Indication in US and (ii) EMA approval of an MAA for 1st Indication
in EU, to a date that is 18 months after the date of achievement of such milestones. In the event that we defer such
milestone payments, we have agreed to certain higher payments related to the achievement of such milestones.
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On December 19, 2016, the FDA approved Rubraca tablets as monotherapy for the treatment of patients with
deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with
two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.
The FDA approval resulted in a $0.75 million milestone payment to Pfizer as required by the license agreement. The
FDA approval also resulted in the obligation to pay a $20.0 million milestone payment, for which we have exercised the
option to defer payment by agreeing to pay $23.0 million within 18 months after the date of the FDA approval. These
payments were recognized as intangible assets and amortized over the estimated remaining useful life of rucaparib.
We are obligated under the license agreement to use commercially reasonable efforts to develop and commercialize
rucaparib and we are responsible for all remaining development and commercialization costs for rucaparib. We are
required to make regulatory milestone payments to Pfizer of up to an additional $69.75 million in aggregate if specified
clinical study objectives and regulatory filings, acceptances and approvals are achieved. In addition, we are obligated to
make sales milestone payments to Pfizer if specified annual sales targets for rucaparib are met, the majority of which
relate to annual sales targets of $500.0 million and above, which, in the aggregate, could amount to total milestone
payments of $170.0 million, and tiered royalty payments at a mid-teen percentage rate on our net sales, with standard
provisions for royalty offsets to the extent we need to obtain any rights from third parties to commercialize rucaparib.
The license agreement with Pfizer will remain in effect until the expiration of all of our royalty and sublicense
revenue obligations to Pfizer, determined on a product-by-product and country-by-country basis, unless we elect to
terminate the license agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure
such failure within specified time periods, Pfizer can terminate the agreement, resulting in a loss of our rights to
rucaparib and an obligation to assign or license to Pfizer any intellectual property rights or other rights we may have in
rucaparib, including our regulatory filings, regulatory approvals, patents and trademarks for rucaparib.
AstraZeneca UK Limited
In April 2012, we entered into a license agreement with AstraZeneca UK Limited to acquire exclusive rights
associated with rucaparib under a family of patents and patent applications that claim methods of treating patients with
PARP inhibitors in certain indications. The license enables the development and commercialization of rucaparib for the
uses claimed by these patents. Pursuant to the terms of the license agreement, we made an upfront payment of $0.25
million upon execution of the agreement. During the second quarter of 2016, we made a milestone payment of $0.3
million to AstraZeneca upon the NDA submission for rucaparib. These payments were recognized as acquired in-process
research and development expense. The FDA approval of rucaparib on December 19, 2016 resulted in a $0.35 million
milestone payment to AstraZeneca as required by the license agreement. This payment was recognized as intangible
assets and amortized over the estimated remaining useful life of rucaparib. AstraZeneca will also receive royalties on
any net sales of rucaparib.
Advenchen Laboratories LLC
In October 2008, Ethical Oncology Science, S.p.A. (“EOS”) (now known as Clovis Oncology Italy S.r.l.) entered into
an exclusive license agreement with Advenchen Laboratories LLC (“Advenchen”) to develop and commercialize
lucitanib on a global basis, excluding China. We are obligated to pay Advenchen tiered royalties at percentage rates in
the mid-single digits on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, after giving
effect to the first and second amendments to the license agreement, we are required to pay to Advenchen 25% of any
consideration, excluding royalties, we receive from sublicensees, in lieu of the milestone obligations set forth in the
agreement. We are obligated under the agreement to use commercially reasonable efforts to develop and commercialize
at least one product containing lucitanib, and we are also responsible for all remaining development and
commercialization costs for lucitanib.
The license agreement with Advenchen will remain in effect until the expiration of all of our royalty obligations to
Advenchen, determined on a product-by-product and country-by-country basis, unless we elect to terminate the
agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within
specified time periods, Advenchen can terminate the agreement, resulting in a loss of our rights to lucitanib.
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Les Laboratoires Servier
In September 2012, EOS entered into a collaboration and license agreement with Servier, whereby EOS sublicensed
to Servier exclusive rights to develop and commercialize lucitanib in all countries outside of the U.S., Japan and China.
In exchange for these rights, EOS received an upfront payment of €45.0 million. We are entitled to receive additional
payments on the achievement of specified development, regulatory and commercial milestones up to €100.0 million in
the aggregate, €10.0 million of which was received in the first quarter of 2014. In addition, we are entitled to receive
sales milestone payments if specified annual sales targets for lucitanib are met, each of which relates to annual sales
targets of €250.0 million and above, which, in the aggregate, could amount to a total of €250.0 million. We are also
entitled to receive royalties at percentage rates ranging from low-to-mid teens on sales of lucitanib by Servier.
We and Servier are developing lucitanib pursuant to a development plan agreed to between the parties. Servier is
responsible for all of the development costs for lucitanib up to €80.0 million. Cumulative global development costs in
excess of €80.0 million, if any, will be shared equally between us and Servier. During the second quarter of 2016, we
and Servier agreed to discontinue the development of lucitanib for breast cancer and lung cancer and are continuing to
evaluate what, if any, further development of lucitanib will be pursued. Based on current estimates, we expect to
complete the committed on-going development activities in 2017 and expect full reimbursement of our development
costs from Servier. Reimbursements are recorded as reduction to research and development expense on the Consolidated
Statement of Operations.
The collaboration and license agreement will remain in effect until the expiration of all of Servier’s royalty
obligations to us, determined on a product-by-product and country-by-country basis, unless Servier elects to terminate
the agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within
specified time periods, Servier can terminate the agreement, resulting in the granting of a perpetual license to Servier of
rights to lucitanib.
Celgene Corporation
In May 2010, we entered into an exclusive worldwide license agreement with Avila Therapeutics, Inc. (now Celgene
Avilomics Research Inc., part of Celgene Corporation (“Celgene”)) to discover, develop and commercialize a covalent
inhibitor of mutant forms of the EGFR gene product. Rociletinib was identified as the lead inhibitor candidate under the
license agreement. We are responsible for all non-clinical, clinical, regulatory and other activities necessary to develop
and commercialize rociletinib.
We made an upfront payment of $2.0 million upon execution of the license agreement, a $4.0 million milestone
payment in the first quarter of 2012 upon the acceptance by the FDA of our Investigational New Drug (“IND”)
application for rociletinib and a $5.0 million milestone payment in the first quarter of 2014 upon the initiation of the
Phase II study for rociletinib. In the third quarter of 2015, we made milestone payments totaling $12.0 million upon
acceptance of the NDA and MAA for rociletinib by the FDA and EMA, respectively. We recognized all payments prior
to commercial approval as acquired in-process research and development expense.
We are obligated to pay royalties at percentage rates ranging from mid-single digits to low teens on the volume of
annual net sales achieved. We are required to pay up to an additional aggregate of $98.0 million in development and
regulatory milestone payments if certain clinical study objectives and regulatory filings, acceptances and approvals are
achieved. In addition, we are required to pay up to an aggregate of $120.0 million in sales milestone payments if certain
annual sales targets are achieved.
We have full sublicensing rights under the license agreement, subject to our sharing equally with Celgene any upfront
payments from any sub-licensing arrangements relating to Japan, or Japan and any one or more of China, South Korea
and Taiwan, which we refer to herein as an Asian Partnership, and subject to our paying royalties on sales in Asia equal
to the greater of the royalty rates contained in our license agreement or 50% of the royalties we receive from our Asian
Partnership.
The license agreement will remain in effect until the expiration of all of our royalty and sublicense revenue
obligations to Celgene, determined on a product-by-product and country-by-country basis, unless we elect to terminate
the license agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure
within specified time periods, Celgene can terminate the agreement, resulting in a loss of our rights to rociletinib and an
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obligation to assign or license to Celgene any intellectual property rights or other rights we may have in rociletinib,
including our regulatory filings, regulatory approvals, patents and trademarks for rociletinib.
Government Regulation
Government authorities in the United States (including federal, state and local authorities) and in other countries,
extensively regulate, among other things, the manufacturing, research and clinical development, marketing, labeling and
packaging, storage, distribution, post-approval monitoring and reporting, advertising and promotion, pricing and export
and import of pharmaceutical products, such as those we are developing. The process of obtaining regulatory approvals
and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the
expenditure of substantial time and financial resources. Moreover, failure to comply with applicable regulatory
requirements may result in, among other things, warning letters, clinical holds, civil or criminal penalties, recall or
seizure of products, injunction, disbarment, partial or total suspension of production or withdrawal of the product from
the market. Any agency or judicial enforcement action could have a material adverse effect on us.
U.S. Government Regulation
In the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act (“FDCA”) and its
implementing regulations. Drugs are also subject to other federal, state and local statutes and regulations. The process
required by the FDA before product candidates may be marketed in the United States generally involves the following:
•
•
•
•
•
•
submission to the FDA of an IND which must become effective before human clinical trials may begin and
must be updated annually;
completion of extensive non-clinical laboratory tests and non-clinical animal studies, all performed in
accordance with the FDA’s Good Laboratory Practice regulations;
performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the
product candidate for each proposed indication;
submission to the FDA of an NDA after completion of the agreed clinical trial program;
a determination by the FDA within 60 days of its receipt of an NDA to file the NDA for review;
satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the active
pharmaceutical ingredient (“API”) and finished drug product are produced and tested to assess compliance with
Current Good Manufacturing Practices (“cGMP”) and/or sites involved in clinical studies to assess compliance
with Good Clinical Practices (“GCP”); and
• FDA review and approval of an NDA prior to any commercial marketing or sale of the drug in the United
States.
An IND is a request for authorization from the FDA to administer an investigational drug product to humans. The
central focus of an IND submission is on the general investigational plan and the protocol(s) for human studies. The IND
also includes results of animal studies or other human studies, as appropriate, as well as manufacturing information,
analytical data and any available clinical data or literature to support the use of the investigational new drug. An IND
must become effective before human clinical trials may begin. An IND will automatically become effective 30 days after
receipt by the FDA, unless before that time the FDA raises concerns or questions related to the proposed clinical trials.
In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding
concerns or questions before clinical trials can begin. Accordingly, submission of an IND may or may not result in the
FDA allowing clinical trials to commence.
Clinical trials involve the administration of the investigational drug to human subjects under the supervision of
qualified investigators in accordance with GCP, which include the requirement that all research subjects provide their
informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing,
among other things, the objectives of the study, the parameters to be used in monitoring safety and the efficacy criteria to
be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA
as part of the IND. Additionally, approval must also be obtained from each clinical trial site’s Institutional Review Board
(“IRB”) before the trials may be initiated, and the IRB must monitor the study until completed. There are also
requirements governing the reporting of ongoing clinical trials and clinical trial results to public registries.
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The clinical investigation of a drug is generally divided into three phases. Although the phases are usually conducted
sequentially, they may overlap or be combined. The three phases of an investigation are as follows:
• Phase I. Phase I includes the initial introduction of an investigational new drug into humans. Phase I clinical
trials are typically closely monitored and may be conducted in patients with the target disease or condition or in
healthy volunteers. These studies are designed to evaluate the safety, dosage tolerance, metabolism and
pharmacologic actions of the investigational drug in humans, the side effects associated with increasing doses,
and if possible, to gain early evidence on effectiveness. During Phase I clinical trials, sufficient information
about the investigational drug’s pharmacokinetics and pharmacological effects may be obtained to permit the
design of well-controlled and scientifically valid Phase 2 clinical trials. The total number of participants
included in Phase I clinical trials varies, but is generally in the range of 20 to 80.
• Phase II. Phase II includes controlled clinical trials conducted to preliminarily or further evaluate the
effectiveness of the investigational drug for a particular indication(s) in patients with the disease or condition
under study, to determine dosage tolerance and optimal dosage, and to identify possible adverse side effects and
safety risks associated with the drug. Phase II clinical trials are typically well-controlled, closely monitored, and
conducted in a limited patient population, usually involving no more than several hundred participants.
• Phase III. Phase III clinical trials are generally controlled clinical trials conducted in an expanded patient
population generally at geographically dispersed clinical trial sites. They are performed after preliminary
evidence suggesting effectiveness of the drug has been obtained and are intended to further evaluate dosage,
clinical effectiveness and safety, to establish the overall benefit-risk relationship of the investigational drug
product and to provide an adequate basis for product approval. Phase III clinical trials usually involve several
hundred to several thousand participants.
A pivotal study is a clinical study which adequately meets regulatory agency requirements for the evaluation of a
drug candidate’s efficacy and safety such that it can be used to justify the approval of the product. Generally, pivotal
studies are also Phase III studies but may be Phase II studies if the trial design provides a well-controlled and reliable
assessment of clinical benefit, particularly in situations where there is an unmet medical need.
The FDA, the IRB or the clinical trial sponsor may suspend or terminate a clinical trial at any time on various
grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Additionally,
some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor,
known as a data safety monitoring board or committee. This group provides authorization for whether or not a trial may
move forward at designated check points based on access to certain data from the study. We may also suspend or
terminate a clinical trial based on evolving business objectives and/or competitive climate.
Assuming successful completion of all required testing in accordance with all applicable regulatory requirements,
detailed investigational drug product information is submitted to the FDA in the form of an NDA requesting approval to
market the product for one or more indications.
The application includes all relevant data available from pertinent non-clinical and clinical trials, including negative
or ambiguous results, as well as positive findings, together with detailed information relating to the product’s chemistry,
manufacturing, controls and proposed labeling, among other things. Data can come from company-sponsored clinical
trials intended to test the safety and effectiveness of a use of a product, or from a number of alternative sources,
including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in
quality and quantity to establish the safety and effectiveness of the investigational drug product to the satisfaction of the
FDA.
Once the NDA submission has been accepted for filing, the FDA’s goal is to review applications within 10 months of
submission or, if the application relates to an unmet medical need in a serious or life-threatening indication, six months
from submission. The review process is often significantly extended by FDA requests for additional information or
clarification. The FDA may refer the application to an advisory committee for review, evaluation and recommendation
as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory
committee, but it typically follows such recommendations.
After the FDA evaluates the NDA and conducts inspections of clinical research facilities and/or manufacturing
facilities where the drug product and/or its API will be produced, it may issue an approval letter or a Complete Response
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Letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific
indications. A Complete Response Letter indicates that the review cycle of the application is complete, and the
application is not ready for approval. A Complete Response Letter may require additional clinical data and/or an
additional pivotal Phase III clinical trial(s), and/or other significant, expensive and time-consuming requirements related
to clinical trials, non-clinical studies or manufacturing. Even if such additional information is submitted, the FDA may
ultimately decide that the NDA does not satisfy the criteria for approval. The FDA could also approve the NDA with a
Risk Evaluation and Mitigation Strategies plan to mitigate risks, which could include medication guides, physician
communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other
risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling,
development of adequate controls and specifications or a commitment to conduct one or more post-market studies or
clinical trials. Such post-market testing may include Phase IV clinical trials and surveillance to further assess and
monitor the product’s safety and effectiveness after commercialization. Regulatory approval of oncology products often
requires that patients in clinical trials be followed for long periods to determine the overall survival benefit of the drug.
After regulatory approval of a drug product is obtained, we are required to comply with a number of post-approval
requirements. As a holder of an approved NDA, we would be required to report, among other things, certain adverse
reactions and production problems to the FDA, to provide updated safety and efficacy information and to comply with
requirements concerning advertising and promotional labeling for any of our products. Also, quality control and
manufacturing procedures must continue to conform to cGMP after approval to ensure and preserve the long term
stability of the drug product. The FDA periodically inspects manufacturing facilities to assess compliance with cGMP,
which imposes extensive procedural, substantive and record keeping requirements. In addition, changes to the
manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA
approval before being implemented. FDA regulations also require investigation and correction of any deviations from
cGMP and impose reporting and documentation requirements upon us and any third-party manufacturers that we may
decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and
quality control to maintain compliance with cGMP and other aspects of regulatory compliance.
We rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of
our product candidates. Future FDA and state inspections may identify compliance issues at our facilities or at the
facilities of our contract manufacturers that may disrupt production or distribution or require substantial resources to
correct. In addition, discovery of previously unknown problems with a product or the failure to comply with applicable
requirements may result in restrictions on a product, manufacturer or holder of an approved NDA, including withdrawal
or recall of the product from the market or other voluntary, FDA-initiated or judicial action that could delay or prohibit
further marketing. Newly discovered or developed safety or effectiveness data may require changes to a product’s
approved labeling, including the addition of new warnings and contraindications and also may require the
implementation of other risk management measures. Also, new government requirements, including those resulting from
new legislation, may be established or the FDA’s policies may change, which could delay or prevent regulatory approval
of our products under development.
Europe/Rest of World Government Regulation
In addition to regulations in the United States, we will be subject to a variety of regulations in other jurisdictions
governing, among other things, clinical trials and any commercial sales and distribution of our products.
Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory
authorities in foreign countries prior to the commencement of clinical trials or marketing of the product in those
countries. Certain countries outside of the United States have a similar process that requires the submission of a clinical
trial application much like the IND prior to the commencement of human clinical trials. In Europe, for example, a
clinical trial application, (“CTA”) must be submitted to each country’s national health authority and an independent
ethics committee, much like the FDA and IRB, respectively. Once the CTA is approved in accordance with a country’s
requirements, clinical trial development may proceed.
The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement
vary from country to country. In all cases, the clinical trials are conducted in accordance with GCP and the applicable
regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
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To obtain regulatory approval of an investigational drug under European Union regulatory systems, we must submit a
marketing authorization application. The application used to file the NDA in the United States is similar to that required
in Europe, with the exception of, among other things, country-specific document requirements.
For other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the
requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to
country. In all cases, again, the clinical trials are conducted in accordance with GCP and the applicable regulatory
requirements and the ethical principles that have their origin in the Declaration of Helsinki.
If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines,
suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and
criminal prosecution.
Available Special Regulatory Procedures
Formal Meetings
We are encouraged to engage and seek guidance from health authorities relating to the development and review of
investigational drugs, as well as marketing applications. In the United States, there are different types of official
meetings that may occur between us and the FDA. Each meeting type is subject to different procedures. Conclusions and
agreements from each of these meetings are captured in the official final meeting minutes issued by the FDA.
The EMA also provides the opportunity for dialogue with us. This is usually done in the form of Scientific Advice,
which is given by the Scientific Advice Working Party of CHMP. A fee is incurred with each Scientific Advice meeting.
Advice from either the FDA or EMA is typically provided based on questions concerning, for example, quality
(chemistry, manufacturing and controls testing), nonclinical testing and clinical studies and pharmacovigilance plans and
risk-management programs. Such advice is not legally binding on the sponsor. To obtain binding commitments from
health authorities in the United States and the European Union, SPA or Special Protocol Assessment procedures are
available. A SPA is an evaluation by the FDA of a protocol with the goal of reaching an agreement with the sponsor that
the protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval of the
product candidate with respect to effectiveness in the indication studied. The FDA’s agreement to a SPA is binding upon
the FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issue essential to
determining the safety or effectiveness of the product after clinical studies begin, or if the study sponsor fails to follow
the protocol that was agreed upon with the FDA. There is no guarantee that a study will ultimately be adequate to
support an approval even if the study is subject to a SPA.
Orphan Drug Designation
The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition that affects fewer
than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States, there is
no reasonable expectation that the cost of developing and making the drug for this type of disease or condition will be
recovered from sales in the United States. In the European Union, the EMA’s Committee for Orphan Medicinal Products
grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention or
treatment of a life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the
European Union Community. Additionally, designation is granted for products intended for the diagnosis, prevention or
treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is
unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in
developing the drug or biological product.
In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant
funding towards clinical trial costs, tax advantages and user-fee waivers. In addition, if a product receives the first FDA
approval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which
means the FDA may not approve any other application to market the same drug for the same indication for a period of
seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan
exclusivity.
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In the European Union, orphan drug designation also entitles a party to financial incentives such as reduction of fees
or fee waivers and 10 years of market exclusivity is granted following drug or biological product approval. This period
may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that
the product is sufficiently profitable not to justify maintenance of market exclusivity.
Orphan drug designation must be requested before submitting an application for marketing approval. Orphan drug
designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
Pediatric Development
In the United States, the FDCA provides for an additional six months of marketing exclusivity for a drug if reports are
filed of investigations studying the use of the drug product in a pediatric population in response to a written request from
the FDA. Separate from this potential exclusivity benefit, NDAs must contain data (or a proposal for post-marketing
activity) to assess the safety and effectiveness of an investigational drug product for the claimed indications in all
relevant pediatric populations in order to support dosing and administration for each pediatric subpopulation for which
the drug is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for
submission of some or all pediatric data until after approval of the product for use in adults or full or partial waivers if
certain criteria are met. Discussions about pediatric development plans can be discussed with the FDA at any time, but
usually occur any time between the end-of-Phase II meeting and submission of the NDA.
For the EMA, a Pediatric Investigation Plan, and/or a request for waiver or deferral, is required for submission prior
to submitting a marketing authorization application.
Authorization Procedures in the European Union
Medicines can be authorized in the European Union by using either the centralized authorization procedure or
national authorization procedures.
• Centralized procedure. The EMA implemented the centralized procedure for the approval of human medicines
to facilitate marketing authorizations that are valid throughout the European Union. This procedure results in a
single marketing authorization issued by the EMA that is valid across the European Union, as well as Iceland,
Liechtenstein and Norway. The centralized procedure is compulsory for human medicines that are: derived
from biotechnology processes, such as genetic engineering, contain a new active substance indicated for the
treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative disorders or autoimmune
diseases and other immune dysfunctions, and officially designated orphan medicines.
For medicines that do not fall within these categories, an applicant has the option of submitting an application
for a centralized marketing authorization to the EMA, as long as the medicine concerned is a significant
therapeutic, scientific or technical innovation, or if its authorization would be in the interest of public health.
• National authorization procedures. There are also two other possible routes to authorize medicinal products in
several countries, which are available for investigational drug products that fall outside the scope of the
centralized procedure:
Decentralized procedure. Using the decentralized procedure, an applicant may apply for simultaneous
authorization in more than one European Union country of medicinal products that have not yet been
authorized in any European Union country and that do not fall within the mandatory scope of the
centralized procedure.
Mutual recognition procedure. In the mutual recognition procedure, a medicine is first authorized in one
European Union Member State, in accordance with the national procedures of that country. Following
this, further marketing authorizations can be sought from other European Union countries in a procedure
whereby the countries concerned agree to recognize the validity of the original, national marketing
authorization.
Breakthrough Therapy Designation in the United States
The U.S. Congress created the Breakthrough Therapy designation program as a result of the passage of the Food and
Drug Administration Safety Act of 2012. FDA may grant Breakthrough Therapy status to a drug intended for the
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treatment of a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial
improvement over existing therapies on one or more clinically significant endpoints. The Breakthrough Therapy
designation, which may be requested by a sponsor when filing or amending an IND, is intended to facilitate and expedite
the development and FDA review of a product candidate. Specifically, the Breakthrough Therapy designation may
entitle the sponsor to more frequent meetings with the FDA during drug development, intensive guidance on clinical trial
design and expedited FDA review by a cross-disciplinary team comprised of senior managers. The designation does not
guarantee a faster development or review time as compared to other drugs, however, nor does it assure that the drug will
obtain ultimate marketing approval by the FDA. Once granted, the FDA may withdraw this designation at any time.
Expedited Review and Approval in the United States
The FDA has various programs, including Fast Track, priority review and accelerated approval, which are intended to
expedite or simplify the process for reviewing drugs and biologics, and/or provide for the approval of a drug or biologic
on the basis of a surrogate endpoint. Even if a drug qualifies for one or more of these programs, the FDA may later
decide that the drug no longer meets the conditions for qualification or that the time period for FDA review or approval
will be shortened. Generally, drugs that are eligible for these programs are those for serious or life-threatening
conditions, those with the potential to address unmet medical needs and those that offer meaningful benefits over
existing treatments. For example, based on results of the Phase III clinical trial(s) submitted in an NDA, upon the request
of an applicant, the FDA may grant the NDA a priority review designation, which sets the target date for FDA action on
the application at six months, rather than to the standard FDA review period of 10 months. Priority review is granted
where preliminary estimates indicate that a product, if approved, has the potential to provide a safe and effective therapy
where no satisfactory alternative therapy exists, or a significant improvement compared to marketed products is possible.
Priority review designation does not change the scientific/medical standard for approval or the quality of evidence
necessary to support approval.
Accelerated approval provides for an earlier approval for a new drug that is intended to treat a serious or life-
threatening disease or condition upon a determination that the product has an effect on a surrogate endpoint that is
reasonably likely to predict clinical benefit and is better than available therapy. A surrogate endpoint is a laboratory
measurement or physical sign used as an indirect or substitute measurement representing a clinically meaningful
outcome. The FDA will also take into account the severity, rarity or prevalence of the condition. As a condition of
approval for drugs granted accelerated approval, one or more post-marketing confirmatory studies are required to
confirm as predicted by the surrogate marker trial an effect on clinical benefit, which is defined as having a positive
effect on how a patient feels, functions or survives.
Accelerated Review in the European Union
Under the Centralized Procedure in the European Union, the maximum timeframe for the evaluation of a marketing
authorization application is 210 days (excluding clock stops, when additional written or oral information is to be
provided by the applicant in response to questions asked by the CHMP). Accelerated evaluation might be granted by the
CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest, defined by
three cumulative criteria: the seriousness of the disease (e.g. heavy disabling or life-threatening diseases) to be treated;
the absence or insufficiency of an appropriate alternative therapeutic approach; and anticipation of high therapeutic
benefit. In this circumstance, EMA ensures that the opinion of the CHMP is given within 150 days of submission of the
MAA, excluding clock stops.
Pharmaceutical Coverage, Pricing and Reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of any drug products for which we obtain
regulatory approval. In the United States and markets in other countries, sales of any products for which we receive
regulatory approval for commercial sale will depend in part on the availability of reimbursement from third-party payors.
Third-party payors include government health administrative authorities, managed care providers, private health insurers
and other organizations. The process for determining whether a payor will provide coverage for a drug product may be
separate from the process for setting the price or reimbursement rate that the payor will pay for the drug product. Third-
party payors may limit coverage to specific drug products on an approved list, or formulary, which might not include all
of the FDA-approved drugs for a particular indication. Third-party payors are increasingly challenging the price and
examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and
efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity
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and cost effectiveness of our products, in addition to the costs required to obtain FDA approvals. The development of a
product dossier and a Budget Impact Model may be helpful in assisting the payors in evaluating cost effectiveness. Our
product candidates may not be considered medically necessary or cost-effective. A payor’s decision to provide coverage
for a drug product does not imply that an adequate reimbursement rate will be established. Adequate third-party
reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on
our investment in product development.
There have been a number of federal and state proposals in recent years regarding the pricing of pharmaceutical
products, government control and other changes to the healthcare system of the United States. The U.S. government
enacted legislation providing a partial prescription drug benefit for Medicare beneficiaries. Government payment for
some of the costs of prescription drugs may increase demand for any products for which we receive marketing approval;
however, to obtain payments under this program, we would be required to sell products to Medicare recipients through
prescription drug plans operating pursuant to this legislation. These plans will likely negotiate discounted prices for our
products. Additionally, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education
Reconciliation Act (collectively, the “Affordable Care Act”) was enacted in 2010 with a goal of reducing the cost of
healthcare and substantially changing the way healthcare is financed by both government and private insurers. Among
other cost containment measures, the Affordable Care Act established:
• An annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and
biologic agents;
• A Medicare Part D coverage gap discount program, in which pharmaceutical manufacturers who wish to have
their drugs covered under Part D must offer discounts to eligible beneficiaries during their coverage gap period
(the “donut hole”); and
• A formula that increases the rebates a manufacturer must pay under the Medicaid Drug Rebate Program.
We expect that federal, state and local governments in the United States will continue to consider legislation to limit
the growth of healthcare costs, including the cost of prescription drugs. Future legislation could limit payments for
pharmaceuticals such as the drug candidates that we are developing.
Different pricing and reimbursement schemes exist in other countries. In the European Community, governments
influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national
health care systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive
and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To
obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that
compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states
allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure
on health care costs in general, particularly prescription drugs, has become very intense. As a result, increasingly high
barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-
priced markets exert a commercial pressure on pricing within a country.
The marketability of any products for which we receive regulatory approval for commercial sale may suffer if the
government and third-party payors fail to provide adequate coverage and reimbursement. In addition, emphasis on
reducing the rate of healthcare spending in the United States has increased, and we expect will continue to increase the
pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at any time.
Even if favorable coverage and reimbursement status is attained for one or more products for which we receive
regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. The
implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate
revenue, attain profitability or commercialize our products.
Advertising and Promotion
The FDA and other U.S. federal regulatory agencies closely regulate the marketing and promotion of drugs through,
among other things, the FDCA and the FDA’s implementing regulations and standards. The FDA’s review of marketing
and promotional activities encompasses, but is not limited to, direct-to-consumer advertising, healthcare provider-
directed advertising and promotion, sales representative communications to healthcare professionals, communications
regarding unapproved or “off-label” uses, industry-sponsored scientific and educational activities and promotional
activities involving the internet. A product cannot be commercially promoted before it is approved. After approval,
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product promotion can include only those claims relating to safety and effectiveness that are consistent with the labeling
approved by the FDA. FDA regulations impose stringent restrictions on manufacturers’ communications regarding off-
label uses. Failure to comply with applicable FDA requirements and restrictions regarding unapproved uses of a drug or
for other violations of its advertising and labeling laws and regulations, may result in adverse publicity and enforcement
action by the FDA, the Department of Justice or the Office of the Inspector General of the Department of Health and
Human Services, as well as state authorities. A range of penalties are possible that could have a significant commercial
consequences, including product seizures, injunctions, civil and/or criminal fines and agreements that materially restrict
the manner in which a company promotes or distributes its products or regulatory letters, which may require corrective
advertising or other corrective communications to healthcare professionals.
Other Healthcare Laws and Compliance Requirements
We are subject to various federal and state laws targeting fraud and abuse in the healthcare industry. For example, in
the United States, there are federal and state anti-kickback laws that prohibit the payment or receipt of kickbacks, bribes
or other remuneration intended to induce the purchase or recommendation of healthcare products and services or reward
past purchases or recommendations. Violations of these laws can lead to civil and criminal penalties, including fines,
imprisonment and exclusion from participation in federal healthcare programs.
The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or
paying remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing,
recommending, or arranging for a good or service, for which payment may be made under a federal healthcare program,
such as the Medicare and Medicaid programs. The reach of the Anti-Kickback Statute was broadened by the Affordable
Care Act, which, among other things, amended the intent requirement of the federal Anti-Kickback Statute and the
applicable criminal healthcare fraud statutes contained within 42 U.S.C. § 1320a-7b. Pursuant to the statutory
amendment, a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in
order to have committed a violation. In addition, the Affordable Care Act provides that the government may assert that a
claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or
fraudulent claim for purposes of the civil False Claims Act (discussed below) or the civil monetary penalties statute.
Many states have adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of
patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid programs.
The federal False Claims Act imposes liability on any person who, among other things, knowingly presents, or causes
to be presented, a false or fraudulent claim for payment by a federal program, including federal healthcare programs. The
“qui tam” provisions of the False Claims Act allow a private individual to bring civil actions on behalf of the federal
government alleging that the defendant has submitted a false claim to the federal government, and to share in any
monetary recovery. In addition, various states have enacted false claims laws analogous to the False Claims Act. Many
of these state laws apply where a claim is submitted to any third-party payor and not merely a federal healthcare
program. When an entity is determined to have violated the False Claims Act, it may be required to pay up to three times
the actual damages sustained by the government, plus civil penalties.
In addition to the laws described above, the Patient Protection and Affordable Care Act, as amended by the Health
Care Education Reconciliation Act, or the PPACA, also imposed new reporting requirements on drug manufacturers for
payments made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians
and their immediate family members. Failure to submit required information may result in civil monetary penalties of up
to an aggregate of $150,000 per year (or up to an aggregate of $1.0 million per year for “knowing failures”), for all
payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported
in an annual submission. Applicable drug manufacturers are required to collect data for each calendar year and submit
reports to CMS by March 31st of each subsequent calendar year. In addition, there are also an increasing number of state
laws that require manufacturers to make reports to states on pricing and marketing information. These laws may affect
our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us.
For those marketed products which are covered in the United States by the Medicaid programs, we have various
obligations, including government price reporting and rebate requirements, which generally require products be offered
at substantial rebates/discounts to Medicaid and certain purchasers (including “covered entities” purchasing under the
340B Drug Discount Program). We are also required to discount such products to authorized users of the Federal Supply
Schedule of the General Services Administration, under which additional laws and requirements apply. These programs
require submission of pricing data and calculation of discounts and rebates pursuant to complex statutory formulas, as
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well as the entry into government procurement contracts governed by the Federal Acquisition Regulations, and the
guidance governing such calculations is not always clear. Compliance with such requirements can require significant
investment in personnel, systems and resources, but failure to properly calculate our prices, or offer required discounts or
rebates could subject us to substantial penalties. One component of the rebate and discount calculations under the
Medicaid and 340B programs, respectively, is the “additional rebate”, a complex calculation which is based, in part, on
the rate at which a branded drug price increases over time more than the rate of inflation (based on the CPI-U). This
comparison is based on the baseline pricing data for the first full quarter of sales associated with a branded drug’s NDA,
and baseline data cannot generally be reset, even on transfer of the NDA to another manufacturer. This “additional
rebate” calculation can, in some cases where price increase have been relatively high versus the first quarter of sales of
the NDA, result in Medicaid rebates up to 100% of a drug’s “average manufacturer price” and 340B prices of one penny.
Subject to the control of Directive 89/105/EEC, pricing and reimbursement in the EU/EEA (European Economic Area)
is governed by national rules and policy and may vary from Member State to Member State.
Also, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created several new federal crimes,
including health care fraud and false statements relating to health care matters. The health care fraud statute prohibits
knowingly and willfully executing a scheme to defraud any health care benefit program, including private third-party
payors. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material
fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for
health care benefits, items or services. In addition, we may be subject to, or our marketing activities may be limited by,
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and its
implementing regulations, which established uniform standards for certain “covered entities” (healthcare providers,
health plans and healthcare clearinghouses) and their business associates governing the conduct of certain electronic
healthcare transactions and protecting the security and privacy of protected health information.
Regulation of Diagnostic Tests
In the United States, the FDCA and its implementing regulations, and other federal and state statutes and regulations
govern, among other things, medical device design and development, non-clinical and clinical testing, premarket
clearance or approval, registration and listing, manufacturing, labeling, storage, advertising and promotion, sales and
distribution, export and import, and post-market surveillance. Diagnostic tests are classified as medical devices under the
FDCA. Unless an exemption applies, diagnostic tests require marketing clearance or approval from the FDA prior to
commercial distribution. The two primary types of FDA marketing authorization applicable to a medical device are
premarket notification, also called 510(k) clearance, and premarket approval, or PMA approval. Because the diagnostic
tests being developed by our third-party collaborators are of substantial importance in preventing impairment of human
health, they are subject to the PMA approval process.
PMA applications must be supported by valid scientific evidence, which typically requires extensive data, including
technical, non-clinical, clinical and manufacturing data, to demonstrate to the FDA’s satisfaction the safety and
effectiveness of the device. For diagnostic tests, a PMA application typically includes data regarding analytical and
clinical validation studies. As part of its review of the PMA, the FDA will conduct a pre-approval inspection of the
manufacturing facility or facilities to ensure compliance with the Quality System Regulation, or QSR, which requires
manufacturers to follow design, testing, control, documentation and other quality assurance procedures. FDA review of
an initial PMA application is required by statute to take between six to ten months, although the process typically takes
longer, and may require several years to complete. If the FDA evaluations of both the PMA application and the
manufacturing facilities are favorable, the FDA will either issue an approval letter or an approvable letter, which usually
contains a number of conditions that must be met in order to secure the final approval of the PMA. If the FDA’s
evaluation of the PMA or manufacturing facilities is not favorable, the FDA will deny approval of the PMA or issue a
not approvable letter. A not approvable letter will outline the deficiencies in the application and, where practical, will
identify what is necessary to make the PMA approvable. The FDA may also determine that additional clinical trials are
necessary, in which case the PMA approval may be delayed for several months or years while the trials are conducted
and then the data submitted in an amendment to the PMA. Once granted, PMA approval may be withdrawn by the FDA
if compliance with post approval requirements, conditions of approval or other regulatory standards is not maintained or
problems are identified following initial marketing.
We and our third-party collaborators who are developing the companion diagnostics will work cooperatively to
generate the data required for submission with the PMA application, and will remain in close contact with the Center for
Devices and Radiological Health (“CDRH”) at the FDA to ensure that any changes in requirements are incorporated into
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the development plans. We anticipate that meetings with the FDA with regard to our drug product candidates, as well as
companion diagnostic product candidates, will include representatives from the Center for Drug Evaluation and
Research and CDRH to ensure that the NDA and PMA submissions are coordinated to enable FDA to conduct a parallel
review of both submissions. On July 14, 2011, the FDA issued its final guidance document addressing the development
and approval process for “In Vitro Companion Diagnostic Devices.” According to the guidance, for novel therapeutic
products such as our product candidates, the PMA for a companion diagnostic device should be developed and approved
or cleared contemporaneously with the therapeutic. We believe our programs for the development of our companion
diagnostics are consistent with this guidance.
In the EEA, in vitro medical devices are required to conform with the essential requirements of the E.U. Directive on
in vitro diagnostic medical devices (Directive No 98/79/EC, as amended). To demonstrate compliance with the essential
requirements, the manufacturer must undergo a conformity assessment procedure. The conformity assessment varies
according to the type of medical device and its classification. For low-risk devices, the conformity assessment can be
carried out internally, but for higher risk devices it requires the intervention of an accredited EEA Notified Body. If
successful, the conformity assessment concludes with the drawing up by the manufacturer of an EC Declaration of
Conformity entitling the manufacturer to affix the CE mark to its products and to sell them throughout the EEA. The
data generated for the U.S. registration will be sufficient to satisfy the regulatory requirements for the European Union
and other countries.
Patents and Proprietary Rights
The proprietary nature of, and protection for, our product candidates, processes and know-how are important to our
business. Our success depends in part on our ability to protect the proprietary nature of our product candidates,
technology, and know-how, to operate without infringing on the proprietary rights of others, and to prevent others from
infringing our proprietary rights. We seek patent protection in the United States and internationally for our product
candidates and other technology. Our policy is to patent or in-license the technology, inventions and improvements that
we consider important to the development of our business. We also rely on trade secrets, know-how and continuing
innovation to develop and maintain our competitive position. We cannot be sure that patents will be granted with respect
to any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we
be sure that any of our existing patents or any patents granted to us in the future will be commercially useful in
protecting our technology.
In June 2011, we obtained an exclusive, worldwide license from Pfizer to develop and commercialize rucaparib. U.S.
Patent 6,495,541, and its equivalent counterparts issued in dozens of countries, directed to the rucaparib composition of
matter, expire in 2020 and are potentially eligible for up to five years patent term extension in various jurisdictions. We
believe that patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984 (the
“Hatch-Waxman Act”) could be available to extend our patent exclusivity for rucaparib to the fourth quarter of 2023 in
the United States. In Europe, we believe that patent term extension under a supplementary protection certificate could be
available for an additional five years to at least 2025. In April 2012, we obtained an exclusive license from AstraZeneca
under a family of patents and patent applications which will permit the development and commercialization of rucaparib
for certain methods of treating patients with PARP inhibitors. Additionally, other patents and patent applications are
directed to methods of making, methods of using, dosing regimens, various salt and polymorphic forms and formulations
and have expiration dates ranging from 2020 through potentially 2035, including the camsylate salt/polymorph patent
family licensed from Pfizer, which expires in 2031 and a patent application directed to high dosage strength rucaparib
tablets that, if issued, will expire in 2035. We are aware of a number of challenges of salt and polymorph patents, and
while the ultimate results of patent challenges can be difficult to predict, we believe a number of factors, including a
constellation of unexpected properties, support the novelty and non-obviousness of our rucaparib camsylate
salt/polymorph composition of matter patent, would make a successful challenge of that patent more difficult.
We obtained rights to lucitanib by acquiring EOS in November 2013, along with its license agreements with
Advenchen and Servier. In October 2008, EOS entered into an exclusive license agreement with Advenchen to develop
and commercialize lucitanib on a global basis, excluding China. In September 2012, EOS entered into a collaboration
and license agreement with Servier whereby EOS sublicensed to Servier exclusive rights to develop and commercialize
lucitanib in all countries outside of the U.S., Japan and China. Composition of matter and method of use patent
protection for lucitanib and a group of structurally-related compounds is issued in the U.S., Europe and Japan and is
issued or pending in other jurisdictions. In the U.S., the composition of matter patent will expire in 2030, and in other
jurisdictions, it expires in 2028. We believe that patent term extension could be available to extend our composition of
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matter patent up to five years beyond the scheduled expiration under the Hatch-Waxman Act. Additionally, patents or
patent applications directed to methods of manufacturing lucitanib are issued or pending in the United States, Europe,
Japan, and China.
In May 2010, we acquired an exclusive, worldwide license to rociletinib from Celgene. U.S. Patent 8,975,927,
directed to rociletinib composition of matter, expires in 2032 and U.S. Patent 9,108,927, directed to rociletinib HBr salts
and polymorphs, expires in 2033. Other patent applications are pending that claim rociletinib generically that, if issued,
would have expiration dates in 2029. In January 2013, we acquired from Gatekeeper Pharmaceuticals, Inc. an exclusive
worldwide sub-license to a Dana Farber patent family having claims directed to wild-type sparing irreversible EGFR
inhibitors, such as rociletinib. We or our licensors have filed additional patent applications related to rociletinib methods
of use, metabolites, combinations, diagnostic methods and dosing regimens.
In addition, we intend to seek patent protection whenever available for any products or product candidates and related
technology we acquire in the future.
The patent positions of pharmaceutical firms like us are generally uncertain and involve complex legal, scientific and
factual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the patent
is issued. Consequently, we do not know whether any of the product candidates we acquire or license will gain patent
protection or, if any patents are issued, whether they will provide significant proprietary protection or will be challenged,
circumvented or invalidated. Because patent applications in the United States and certain other jurisdictions are
maintained in secrecy for 18 months, and since publication of discoveries in the scientific or patent literature often lags
behind actual discoveries, until that time we cannot be certain that we were the first to file any patent application related
to our product candidates. Moreover, we may have to participate in interference proceedings declared by the United
States Patent and Trademark Office (“U.S. PTO”) to determine priority of invention or in opposition or other third-party
proceedings in the U.S. or a foreign patent office, either of which could result in substantial cost to us, even if the
eventual outcome is favorable to us. There can be no assurance that the patents, if issued, would be held valid by a court
of competent jurisdiction. An adverse outcome in a third-party patent dispute could subject us to significant liabilities to
third parties, require disputed rights to be licensed from third parties or require us to cease using specific compounds or
technology.
The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained.
In most countries in which we file, the patent term is 20 years from the earliest date of filing a non-provisional patent
application. In the United States, a patent’s term may be lengthened by patent term adjustment, which compensates a
patentee for administrative delays by the U.S. PTO in granting a patent, or may be shortened if a patent is terminally
disclaimed over another patent.
The patent term of a patent that covers an FDA-approved drug may also be eligible for patent term extension, which
permits patent term restoration as compensation for the patent term lost during the FDA regulatory review process. The
Hatch-Waxman Act permits a patent term extension of up to five years beyond the expiration of the patent. The length of
the patent term extension is related to the length of time the drug is under regulatory review. Patent extension cannot
extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only one patent
applicable to an approved drug may be extended. Similar provisions are available in Europe and other non-
U.S. jurisdictions to extend the term of a patent that covers an approved drug. In the future, if and when our
pharmaceutical products receive FDA approval, we expect to apply for patent term extensions on patents covering those
products.
To protect our rights to any of our issued patents and proprietary information, we may need to litigate against
infringing third parties, or avail ourselves of the courts or participate in hearings to determine the scope and validity of
those patents or other proprietary rights. These types of proceedings are often costly and could be very time-consuming
to us, and we cannot assure you that the deciding authorities will rule in our favor. An unfavorable decision could allow
third parties to use our technology without being required to pay us licensing fees or may compel us to license needed
technologies to a third-party. Such a decision could even result in the invalidation or a limitation in the scope of our
patents or forfeiture of the rights associated with our patents or pending patent applications. To the extent prudent, we
intend to bring litigation against third parties that we believe are infringing one or more of our patents.
In addition, we have sought and intend to continue seeking orphan drug status whenever it is available. If a product
which has an orphan drug designation subsequently receives the first regulatory approval for the indication for which it
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has such designation, the product is entitled to orphan exclusivity, meaning that the applicable regulatory authority may
not approve any other applications to market the same drug for the same indication, except in certain very limited
circumstances, for a period of seven years in the United States and ten years in the European Union. Orphan drug
designation does not prevent competitors from developing or marketing different drugs for an indication.
We also rely on trade secret protection for our confidential and proprietary information. No assurance can be given
that others will not independently develop substantially equivalent proprietary information and techniques or otherwise
gain access to our trade secrets or disclose such technology, or that we can meaningfully protect our trade secrets.
However, we believe that the substantial costs and resources required to develop technological innovations will help us
to protect the competitive advantage of our products.
It is our policy to require our employees, consultants, outside scientific collaborators, sponsored researchers and other
advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with
us. These agreements provide that all confidential information developed or made known to the individual during the
course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in
specific circumstances. In the case of employees, the agreements provide that all inventions conceived by the individual
shall be our exclusive property. There can be no assurance, however, that these agreements will provide meaningful
protection or adequate remedies for our trade secrets in the event of unauthorized use or disclosure of such information.
Manufacturing
We currently contract with third parties for the manufacture of our product candidates for non-clinical studies and
clinical trials and intend to do so in the future. We currently have long-term agreements with third-party contract
manufacturing organizations (“CMOs”) for the production of the active ingredient and final product for rucaparib. We
do not own or operate manufacturing facilities for the production of clinical quantities of our product candidates. We
currently have no plans to build our own clinical or commercial scale manufacturing capabilities. To meet our projected
needs for commercial manufacturing, third parties with whom we currently work will need to increase their scale of
production or we will need to secure alternate suppliers. Although we rely on contract manufacturers, we have personnel
with extensive manufacturing experience to oversee the relationships with our contract manufacturers.
We have developed the process for manufacturing rucaparib’s active pharmaceutical ingredient (“API”) to a degree
sufficient to meet clinical demands and, as production capacity is increased as described below under “Lonza
Agreement,”, projected commercial requirements. Manufacturing of rucaparib API is being performed at a single CMO.
The rucaparib drug product formulation and manufacturing process to produce that formulation have been developed to
a degree sufficient to meet clinical demands and projected commercial requirements. A single third-party CMO capable
of both formulation development and drug product manufacturing is currently producing rucaparib drug product. Our
operating plan for the next 12 months includes a significant investment in inventory to meet the projected commercial
requirements for Rubraca. We believe the single third-party CMO is capable of manufacturing rucaparib’s API to a
degree sufficient to meet the projected market requirements.
To date, our third-party manufacturers have met our manufacturing requirements. We expect third-party
manufacturers to be capable of providing sufficient quantities of our product candidates to meet anticipated full scale
commercial demands.
Lonza Agreement
On October 3, 2016, we entered into an agreement with Lonza Ltd (“Lonza”) for the long-term manufacture and
supply of the API for rucaparib.
Under this agreement, Lonza will be a non-exclusive manufacturer of the rucaparib API during the 10 year term of
the agreement. Lonza will construct, in an existing Lonza facility, a production train that will be exclusively dedicated to
the manufacture of the rucaparib API. The dedicated production train will provide manufacturing capacity to meet our
currently anticipated needs for commercial supply of rucaparib API. We are obligated to make scheduled capital
program fee payments towards capital equipment and other costs associated with the construction of the dedicated
production train and, once the facility is operational, to pay a fixed facility fee each quarter for the duration of the term
of the agreement.
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Lonza will manufacture and store an advanced intermediate to be used in the subsequent production of the rucaparib
API. We will pay fixed fees on a per kilogram basis for quantities of the advanced intermediate and the rucaparib API
ordered by us, subject to certain adjustments. Until the dedicated facility is completed and operationally qualified, Lonza
will manufacture the rucaparib API in existing Lonza facilities at pricing established in the agreement.
Either party may terminate the agreement due to a material breach of the agreement by the other party, subject to
prior written notice and a cure period. We may terminate the agreement, subject to 90 days’ prior written notice, in the
event rucaparib is withdrawn from the market for certain reasons. In the event of such a termination by us, or termination
by Lonza due to material breach by us, we are obligated to compensate Lonza for any services rendered, or for which
costs have been incurred by Lonza in anticipation of services to be provided to us, and to pay to Lonza the remaining
amount of any capital program fees and quarterly fixed facility fees for the remainder of the term of the agreement. In
the event we terminate the agreement due to material breach by Lonza, Lonza is obligated to repay all or a portion of the
capital program fees previously paid by us.
The active pharmaceutical ingredient for lucitanib is currently being produced by a third-party supplier. To date, the
current production process has been sufficient to satisfy immediate clinical demands. We may undertake additional
development work to further optimize the active pharmaceutical ingredient manufacturing process. The finished drug
product for lucitanib is currently being manufactured at a CMO. The current product and process are sufficiently
developed to meet immediate clinical demands. Additional scale-up work and/or additional production capacity will be
necessary to support larger clinical development or commercialization requirements.
The active pharmaceutical ingredient for rociletinib is currently being manufactured by one CMO. The current drug
substance production process has already been sufficiently developed to satisfy immediate clinical demands. We have
engaged a single CMO capable of both formulation development and drug product manufacturing. The current drug
product production process has already been sufficiently developed to satisfy immediate clinical demands. Additional
scale-up work and/or additional production capacity may be necessary to support larger clinical development or
commercialization requirements.
Commercial Operations
We have established a commercial organization in the U.S., including sales, marketing, market access, and supply
chain management, to support the commercialization of Rubraca. We believe the U.S. oncology market for Rubraca in
its approved indication is addressable with a targeted sales and marketing organization, with capabilities that include the
management of key accounts such as managed care organizations, group-purchasing organizations, oncology group
networks and government accounts. We sell Rubraca through a limited distribution network consisting of select number
of specialty pharmacies and distributors. Healthcare providers order Rubraca through these suppliers. We intend to
continue promoting Rubraca ourselves in the U.S. for its current indication and any additional indications we may obtain
in the future. We retain the rights to Rubraca in the rest of the world. The MAA submission with the EMA for a
comparable ovarian cancer indication was completed and accepted during the fourth quarter of 2016. We may elect in
the future to utilize strategic partners, distributors or contract sales forces to assist in the commercialization of Rubraca.
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Customers
We are currently approved to sell Rubraca in the United States market. We distribute our product principally through
a limited number of specialty distributor and specialty pharmacy providers, collectively, our customers. Our customers
subsequently resell our products to patients and health care providers, at which time we recognize the associated
revenue.
Our customers, which distribute our product, consist of three specialty distributors and four specialty pharmacy
providers. Currently, we do not have a disproportionate concentration with any one of these customers and our sales
volume, once increased, is expected to be evenly distributed throughout. Furthermore, we do not believe the loss of one
of these customers would significantly impact the ability to distribute our product as we expect that sales volume would
be absorbed evenly by the remaining customers.
Employees
As of February 16, 2017, we employed 278 full-time employees. None of our employees is represented by labor
unions, and a very small number of international employees are covered by collective bargaining agreements. We
consider our relationship with our employees to be good.
Research and Development
We invested $251.1 million, $269.3 million and $137.7 million in research and development during the years ended
December 31, 2016, 2015 and 2014, respectively.
About Clovis
We were incorporated under the laws of the State of Delaware in April 2009 and completed our initial public offering
of our common stock in November 2011. Our common stock is listed on the NASDAQ Global Select Market under the
symbol “CLVS.” Our principal executive offices are located at 5500 Flatiron Parkway, Suite 100, Boulder, Colorado
80301, and our telephone number is (303) 625-5000. We maintain additional offices in San Francisco, California,
Cambridge, UK, and Milan, Italy. Our website address is www.clovisoncology.com. Our website and the information
contained on, or that can be accessed through, the website will not be deemed to be incorporated by reference in, and are
not considered part of, this report.
Available Information
As a public company, we file reports and proxy statements with the Securities and Exchange Commission (“SEC”).
These filings include our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and
proxy statements on Schedule 14A, as well as any amendments to those reports and proxy statements, and are available
free of charge through our website as soon as reasonably practicable after we file them with, or furnish them to, the SEC.
Once at www.clovisoncology.com, go to Investors & News/SEC Filings to locate copies of such reports. You may also
read and copy materials that we file with SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington,
DC 20549. You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-
SEC-0330. The SEC also maintains a website at www.sec.gov that contains reports, proxy statements and other
information regarding us and other issuers that file electronically with the SEC.
ITEM 1A. RISK FACTORS
Our business faces significant risks and uncertainties. Certain factors may have a material adverse effect on our
business prospects, financial condition and results of operations, and you should carefully consider them. Accordingly,
in evaluating our business, we encourage you to consider the following discussion of risk factors, in its entirety, in
addition to other information contained in or incorporated by reference into this Annual Report on Form 10-K and our
other public filings with the SEC. Other events that we do not currently anticipate or that we currently deem immaterial
may also affect our business, prospects, financial condition and results of operations.
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Risks Related to Our Financial Position and Capital Requirements
We have incurred significant losses since our inception and anticipate that we will continue to incur losses for the
foreseeable future. We have generated only modest historical revenues, which makes it difficult to assess our future
viability.
We are a biopharmaceutical company with a limited operating history. Biopharmaceutical product development is a
highly speculative undertaking and involves a substantial degree of risk. We have focused primarily on in-licensing and
developing our product candidates. We are not profitable and have incurred losses in each year since our inception in
April 2009. We have only a limited operating history upon which you can evaluate our business and prospects. There are
many risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the
biopharmaceutical area. Three of our product candidates, CO-101, CO-1686 (rociletinib) and CO-3810 (lucitanib),
encountered development and/or regulatory setbacks after initial promising data, leading us to discontinue enrollment in
ongoing clinical trials. We have received regulatory approval to market Rubraca in the U.S., but we do not yet know
whether it will achieve market acceptance and be commercially successful. We have generated only modest revenues
from product sales to date. We continue to incur significant research and development and other expenses related to our
ongoing operations. For the years ended December 31, 2016, 2015 and 2014, we had net losses of $349.1 million,
$352.9 million and $160.0 million, respectively. As of December 31, 2016, we had an accumulated deficit of $1,131.0
million. We expect to continue to incur losses for the foreseeable future. As such, we are subject to all of the risks
incident to the development of new biopharmaceutical products and related companion diagnostics, and we may
encounter unforeseen expenses, difficulties, complications, regulatory scrutiny, delays and other unknown factors that
may adversely affect our business. If any of our product candidates fail in clinical trials or do not gain regulatory
approval, or if Rubraca or any of our product candidates, if approved, fail to achieve market acceptance, we may never
become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in
subsequent periods. Our prior losses, combined with expected future losses, have had and will continue to have an
adverse effect on our stockholders’ equity and working capital.
We will require substantial additional funding which may not be available to us on acceptable terms, or at all. If we
fail to obtain additional financing, we may be unable to complete the development and commercialization of our
product candidates or continue our development programs.
Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend
substantial amounts to advance the clinical development of our product candidates and launch and commercialize any
product candidates for which we receive regulatory approval, including building our own commercial organizations to
address certain markets.
Based on current estimates, we believe that our existing cash, cash equivalents and available-for-sale securities will
allow us to fund our operating plan through at least the next 12 months. We do not have any material committed external
source of funds or other support for our development efforts.
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never
do in sufficient amounts, we expect to finance future cash needs through a combination of public or private equity
offerings, collaborations, strategic alliances and other similar licensing arrangements. We cannot be certain that
additional funding will be available on acceptable terms, or at all. Furthermore, it may be difficult for us to raise
additional funds while we are subject to uncertainty related to litigation described under “Part I, Item 3-Legal
Proceedings” in this report. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us,
we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of
our product candidates, or our plans for acquisition or in-license of new product candidates. We may also seek
collaborators for one or more of our current or future product candidates on terms that are less favorable than might
otherwise be available. Any of these events could significantly harm our business, financial condition and prospects.
Servicing our long-term debt requires a significant amount of cash, and we may not have sufficient cash flow from
our business to pay our substantial debt.
In September 2014, we completed a private placement of $287.5 million aggregate principal amount of 2.5%
convertible senior notes due 2021 (the “Notes”), resulting in net proceeds to the Company of $278.3 million after
deducting offering expenses. The Notes are governed by the terms of the indenture between the Company, as issuer, and
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The Bank of New York Mellon Trust Company, N.A., as trustee. Interest is payable on the Notes semi-annually, and the
Notes mature on September 15, 2021, unless redeemed, repurchased or converted prior to that date. In addition, if, as
defined by the terms of the indenture, a fundamental change occurs, holders of the Notes may require us to repurchase
for cash all or any portion of their Notes at a purchase price equal to 100% of the principal amount of the Notes to be
repurchased plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. As of
December 31, 2016, all $287.5 million principal amount of the Notes remained outstanding.
Our ability to make scheduled payments of interest and principal on the Notes, or to pay the repurchase price for the
Notes on a fundamental change, depends on our future performance, which is subject to economic, financial, competitive
and other factors beyond our control. We may not have sufficient cash in the future to service our debt. If we are unable
to generate such cash flow or secure additional sources of funding, we may be required to adopt one or more
alternatives, such as restructuring debt or obtaining additional equity capital on terms that may be onerous or highly
dilutive. Our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such
time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which
could result in a default on our debt obligations.
We and certain of our officers and directors have been named as defendants in several lawsuits that could result in
substantial costs and divert management’s attention.
We and certain of our officers were named as defendants in four separate purported class action lawsuits initiated in
2015, all of which have since been consolidated in the District of Colorado, that generally allege that we and certain of
our officers violated federal securities laws by making allegedly false and misleading statements regarding the progress
toward FDA approval and the potential for market success of rociletinib. Moreover, in January 2016, we and certain of
our officers, directors, investors and underwriters were named as defendants in a purported class action lawsuit that
alleges that the defendants violated the Securities Act because the offering documents for our July 2015 follow-on
offering contained allegedly false and misleading statements regarding the progress toward FDA approval and the
potential for market success of rociletinib. Additionally, in November 2016, we and certain of our officers, directors and
underwriters were named as defendants in an individual lawsuit that alleges that the defendants violated the Securities
Act because the offering documents for our July 2015 follow-on offering contained allegedly false and misleading
statements regarding the efficacy of rociletinib, its safety profile, and its prospects for market success. This action also
asserts Colorado state law claims and common law claims based on allegedly false and misleading statements regarding
rociletinib’s progress toward FDA approval.
We intend to engage in a vigorous defense of these lawsuits; however, we are unable to predict the outcome of these
matters at this time. If we are not successful in our defense of the class action litigation, we could be forced to make
significant payments to, or enter into other settlements with, our shareholders and their lawyers (and in certain
circumstances reimburse costs and expenses incurred by the underwriters), and such payments or settlement
arrangements could have a material adverse effect on our business, operating results and financial condition. For
example, we could incur substantial costs not covered by our directors’ and officers’ liability insurance, suffer a
significant adverse impact on our reputation and divert management’s attention and resources from other priorities, any
of which could have a material adverse effect on our business. In addition, any of these matters could require payments
that are not covered by, or exceed the limits of, our available directors’ and officers’ liability insurance, which could
have a material adverse effect on our operating results or financial condition.
Additional lawsuits with similar claims may be filed by other parties against us and our officers and directors. Even if
such claims are not successful, these lawsuits or other future similar actions, or other regulatory inquiries or
investigations, may result in substantial costs and have a significant adverse impact on our reputation and divert
management’s attention and resources, which could have a material adverse effect on our business, operating results or
financial condition.
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Risks Related to Our Business and Industry
We are highly dependent on the commercial success of Rubraca in the U.S.; Rubraca may not achieve market
acceptance and may not be commercially successful and we may not attain profitability and positive cash flow from
operations.
On December 19, 2016, the FDA granted approval for Rubraca as monotherapy for the treatment of patients with
deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian 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 commercially available. The degree of market acceptance and the commercial success of
Rubraca will depend on a number of factors, including:
the effectiveness of our sales and marketing strategy and operations;
•
• maintaining compliance with all regulatory requirements applicable to Rubraca and our commercial activities,
including the post-marketing requirements and post-marketing commitments required by the FDA to verify
Rubraca’s clinical benefit or safety by completing certain confirmatory trials, pharmacology studies and
additional diagnostic development;
•
•
•
•
•
the acceptance of Rubraca by patients and the medical community and the availability, perceived advantages
and relative cost, safety and efficacy of alternative and competing products and therapies;
the continued acceptable safety profile of Rubraca and the occurrence of any unexpected side effects, adverse
reactions or misuse, or any unfavorable publicity in these areas;
the ability of our third-party manufacturers to manufacture commercial supplies of Rubraca, to remain in good
standing with regulatory agencies, and to develop, validate and maintain commercially viable manufacturing
processes that are, to the extent required, compliant with current good manufacturing practice, or cGMP,
regulations;
the availability of coverage and adequate reimbursement from managed care plans, private health insurers and
other third party payors and the willingness and ability of patients to pay for Rubraca;
the development or commercialization of competing products or therapies;
• marketing and distribution support for Rubraca, including the degree to which the approved labeling supports
promotional initiatives for commercial success;
•
•
•
•
the actual market size for Rubraca, which may be different than expected;
our ability to enforce our intellectual property rights in and to Rubraca;
our ability to avoid third party patent interference or patent infringement claims; and
our ability to obtain regulatory approvals to commercialize Rubraca in markets outside of the U.S.
As many of these factors are beyond our control, we cannot assure you that we will ever be able to generate
meaningful revenue through the sale of Rubraca. In addition, we may experience significant fluctuations in sales of
Rubraca from period to period. We currently do not have any other product candidates in active development. Any
inability on our part to successfully commercialize Rubraca in the United States and any foreign territories where it may
be approved, or any significant delay in such approvals, could have a material adverse impact on our ability to execute
upon our business strategy and, ultimately, to generate sufficient revenues from Rubraca to reach or maintain
profitability or sustain our anticipated levels of operations.
Rubraca may cause undesirable side effects or have other properties that could limit its commercial potential.
If we or others identify previously unknown side effects or if known side effects are more frequent or severe than
in the past, then:
•
•
sales of Rubraca may decline;
regulatory approvals for Rubraca may be restricted or withdrawn;
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• we may decide to, or be required to, send product warning letters or field alerts to physicians, pharmacists and
hospitals;
•
•
•
additional nonclinical or clinical studies, changes in labeling or changes to manufacturing processes,
specifications and/or facilities may be required;
government investigations or lawsuits, including class action suits, may be brought against us; and
our reputation may suffer.
Any of the above occurrences would harm or prevent sales of Rubraca, increase our expenses and impair our
ability to successfully commercialize Rubraca. As Rubraca is commercially available, it may be used in a wider
population and in a less rigorously controlled environment than in clinical studies. As a result, regulatory authorities,
healthcare practitioners, third-party payors or patients may perceive or conclude that the use of Rubraca is associated
with previously unknown serious adverse effects, undermining our commercialization efforts.
If our sales, marketing and distribution capabilities for Rubraca or our product candidates for which we obtain
marketing approval are inadequate, we may be unable to generate revenue from sales of our products.
Prior to the launch of Rubraca, we had not commercialized any drug products as a company. To achieve commercial
success for Rubraca and any product candidate that may be approved by the FDA or comparable foreign regulatory
authorities, we must continue to expand our sales, marketing, managerial and other nontechnical capabilities or make
arrangements with third parties to perform these services. We will be competing with companies that currently have
extensive, well-funded, and more experienced sales and marketing operations. We may be unable to compete
successfully against these more established companies.
We have recently built a field organization and other capabilities for the sales, marketing and distribution of Rubraca
in the United States, and there are significant risks involved with building and managing a sales organization. Factors
that may inhibit our efforts to effectively commercialize Rubraca on our own include:
•
•
•
our inability to recruit, train, retain and incentivize adequate numbers of qualified and effective sales and
marketing personnel;
the inability of sales personnel to generate sufficient sales leads and to obtain access to physicians or persuade
adequate numbers of physicians to use or prescribe Rubraca;
our inability to effectively manage a geographically dispersed sales and marketing team.
If we are unable to maintain effective sales, marketing and distribution capabilities for Rubraca in the United
States or if we are unable to establish and maintain sales, marketing and distribution capabilities for Rubraca outside
of the United States, if approved, or for any other product candidate for which we obtain marketing approval,
whether independently or with third parties, we may not be able to generate product revenue or may not become
profitable. If the cost of establishing and maintaining a sales and marketing organization exceeds the cost-
effectiveness of doing so, we may not become profitable.
With respect to our product candidates, we may elect to collaborate with third parties that have direct sales forces
and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our
own sales force and distribution systems in certain territories. To the extent that we enter into licensing or co-
promotion arrangements for any of our product candidates, our product revenue may be lower than if we directly
marketed or sold our approved products. In addition, any revenue we receive as a result of such arrangements would
depend in whole or in part upon the efforts of such third parties, which may not be successful and are generally not
within our control. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able
to successfully commercialize our product candidates that receive regulatory approval. If we are not successful in
commercializing our product candidates, either on our own or through collaborations with one or more third parties,
our future product revenue will suffer and we may incur significant additional losses.
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We cannot give any assurance that that rucaparib will receive regulatory approval outside the United States or that
the rucaparib development program in other lines of therapies and indications will be successful or that our other
product candidates will receive regulatory approval.
To date, we have invested a significant portion of our efforts and financial resources in the acquisition and
development of our product candidates. Our business depends entirely on the successful development and
commercialization of our product candidates.
Each of our product candidates requires clinical development, management of clinical, non-clinical and
manufacturing activities, regulatory approval in multiple jurisdictions, obtaining manufacturing supply, building of a
commercial organization and significant marketing efforts in order to generate any revenues from product sales. We are
not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA
or comparable foreign regulatory authorities. To date, we have received regulatory approval from the FDA to market
Rubraca in the United States for certain limited indications. We may not receive similar regulatory approvals outside the
United States and we may never receive regulatory approval for any of our other product candidates. In addition, our
product development programs contemplate the development of companion diagnostics by third-party collaborators.
Companion diagnostics are subject to regulation as medical devices and must themselves be approved for marketing by
the FDA or certain other foreign regulatory agencies before our product candidates may be commercialized.
We cannot be certain that rucaparib will be successfully developed in other lines of therapy, tumor types or other
indications or that any of our product candidates will be successful in clinical trials or receive regulatory approval.
Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. Two of
our product candidates, CO-101 and rociletinib, encountered development and regulatory setbacks after initial promising
data, leading us to discontinue enrollment in ongoing clinical trials. Even if we successfully obtain regulatory approvals
to market one or more of our product candidates, our revenues will be dependent, in part, upon our diagnostic
collaborators’ ability to obtain regulatory approval of the companion diagnostics to be used with our product candidates,
as well as the size of the markets in the territories for which we gain regulatory approval and have commercial rights. If
the markets for patient subsets that we are targeting are not as significant as we estimate, we may not generate significant
revenues from sales of such products, if approved.
We plan to seek regulatory approval to commercialize our product candidates, and for other lines of therapies,
indications or tumor types for rucaparib, in the United States, the European Union and in additional foreign countries.
While the scope of regulatory approval is similar in other countries, obtaining separate regulatory approval in many
other countries requires compliance with numerous and varying regulatory requirements of such countries regarding
safety and efficacy and governing, among other things, clinical trials and commercial sales, pricing and distribution of
our product candidates, and we cannot predict success in these jurisdictions.
Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier
studies and trials may not be predictive of future trial results.
Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can
occur at any time during the clinical trial process. The results of non-clinical studies and early clinical trials of our
product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of
clinical trials may fail to show the desired safety and efficacy traits despite having progressed through non-clinical
studies and initial clinical trials. It is not uncommon for companies in the biopharmaceutical industry to suffer significant
setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results
in earlier trials. Indeed, based on the negative results of a pivotal study, we ceased further development of our previous
product candidate CO-101, and we decided to discontinue ongoing development of rociletinib in anticipation of the
issuance of a Complete Response Letter by the FDA. Additionally, our future clinical trial results may not be successful.
Although we have clinical trials ongoing, we may experience delays in our ongoing clinical trials, and we do not
know whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed
on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including delays related to:
•
obtaining regulatory approval to commence a trial;
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•
•
•
•
•
•
reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical
trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among
different CROs and trial sites;
obtaining institutional review board (“IRB”) approval at each site;
recruiting suitable patients to participate in a trial;
developing and validating companion diagnostics on a timely basis;
having patients complete a trial or return for post-treatment follow-up;
clinical sites deviating from trial protocol or dropping out of a trial;
adding new clinical trial sites; or
•
• manufacturing sufficient quantities of product candidate for use in clinical trials.
Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size
and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the
design of the clinical trial, competing clinical trials and clinicians’ and patients’ perceptions as to the potential
advantages of the drug being studied in relation to other available therapies, including any new drugs that may be
approved for the indications we are investigating. Furthermore, we rely on CROs and clinical trial sites to ensure the
proper and timely conduct of our clinical trials, and while we have agreements governing their committed activities, we
have limited influence over their actual performance.
We could encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which
such trials are being conducted, by the Data Safety Monitoring Board for such trial or by the FDA or other regulatory
authorities. Such authorities may impose a suspension or termination due to a number of factors, including failure to
conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical
trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold,
unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in
governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If we
experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial
prospects of our product candidates will be harmed, and our ability to generate product revenues from any of these
product candidates will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow
down our product candidate development and approval process and jeopardize our ability to commence product sales
and generate revenues. Any of these occurrences may harm our business, financial condition and prospects significantly.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may
also ultimately lead to the denial of regulatory approval of our product candidates.
The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and
inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for rucaparib in other
indications and lines of therapy or for our other product candidates, our business will be substantially harmed.
The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable, but typically
takes many years following the commencement of clinical trials and depends upon numerous factors, including the
substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of
clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and
may vary among jurisdictions. We have only obtained regulatory approval for Rubraca in the United States for a specific
indication, and it is possible that Rubraca may not obtain regulatory approval outside the United States or for broader
indications and lines of therapy or other tumor types or that any of our other existing product candidates or any product
candidates we may seek to develop in the future will ever obtain regulatory approval. Indeed, in anticipation of the
issuance of a Complete Response Letter by the FDA with respect to the rociletinib NDA, we decided to discontinue
ongoing development of rociletinib.
Our product candidates could fail to receive regulatory approval or approval may be delayed for many reasons,
including the following:
•
the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our
clinical trials;
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• we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities
that a product candidate is safe and effective for its proposed indication;
•
•
•
•
•
•
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable
foreign regulatory authorities for approval;
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from non-
clinical studies or clinical trials;
the data collected from clinical trials of our product candidates may not be sufficient to support the submission
of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere;
the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or
facilities of third-party manufacturers with which we contract for clinical and commercial supplies;
the FDA or comparable foreign regulatory authorities may fail to approve the companion diagnostics we
contemplate developing with partners; and
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly
change in a manner rendering our clinical data insufficient for approval.
This lengthy approval process, as well as the unpredictability of future clinical trial results, may result in our failing to
obtain regulatory approval to market our product candidates, which would significantly harm our business, results of
operations and prospects.
Even if we receive regulatory approval for our product candidates, we will be subject to ongoing obligations and
continued regulatory review, which may result in significant additional expense. Additionally, our product
candidates, if and when approved, could be subject to labeling and other restrictions and market withdrawal, and we
may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems
with our products.
Any regulatory approvals that we receive for our product candidates may also be subject to limitations on the
approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements
for potentially costly post-marketing testing and clinical trials and surveillance to monitor the safety and efficacy of the
product candidate. In addition, if the FDA or comparable foreign regulatory authority approves any of our product
candidates, the manufacturing processes, pricing, labeling, packaging, distribution, adverse event reporting, storage,
advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory
requirements. These requirements include submissions of safety and other post-marketing information and reports,
registration, as well as continued compliance with current good manufacturing practices and good clinical practices for
any clinical trials that we conduct post-approval. Later discovery of previously unknown problems with a product,
including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing
processes or failure to comply with regulatory requirements, may result in, among other things:
•
•
•
•
•
restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or
voluntary or mandatory product recalls;
fines, warning letters or holds on clinical trials;
refusal by the FDA and comparable foreign authorities to approve pending applications or supplements to
approved applications filed by us, or suspension or revocation of product license approvals;
product seizure or detention, or refusal to permit the import or export of products; and
injunctions or the imposition of civil or criminal penalties.
All of the foregoing limitations, obligations, and requirements also apply to Rubraca, for which we have received
regulatory approval in the United States for certain limited indications.
We may seek approval from U.S. and foreign regulatory authorities for one or more product candidates on a
conditional basis with full approval conditioned upon fulfilling the requirements of regulators. For example, we received
accelerated approval from the FDA for rucaparib and are seeking conditional marketing authorization from the E.U. for
rucaparib. Each of these approval pathways has certain conditions to approval, some of which may be post-approval,
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such as the conduct of a post-approval, or confirmatory, trial using due diligence. For example, continued approval of
Rubraca by the FDA may be contingent upon verification and description of clinical benefit in ARIEL3 and/or ARIEL4,
our confirmatory trials. If we are unable to fulfill the requirements of regulators that are conditions of a product’s
accelerated or conditional approval, if the confirmatory trial shows unfavorable results or increased or additional
undesirable side effects, or if regulators re-evaluate the data or risk-benefit profile of our product candidate, the
availability of accelerated or conditional approval may be withdrawn or our conditional approval may not result in full
approval or may be revoked or not renewed. Alternatively, we may be required to change a product candidate’s labeled
indications or even withdraw the product, if approved, from the market.
The FDA’s and comparable foreign authorities’ policies may change and additional government regulations may be
enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the
likelihood, nature or extent of government regulation that may arise from future legislation or administrative action,
either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the
adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any
marketing approval that we may have obtained, and we may not achieve or sustain profitability, which would adversely
affect our business. Any of the foregoing scenarios could materially harm the commercial prospects for our product
candidates.
Rubraca and our other product candidates may cause undesirable side effects or have other properties that could
delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant
negative consequences following marketing approval, if any.
Adverse events (“AEs”) attributable to our product candidates could cause us or regulatory authorities to interrupt,
delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the
FDA or other comparable foreign authorities. Clinical studies conducted to date have generated AEs related to our
product candidates, some of which have been serious. Patients treated with Rubraca have commonly experienced nausea,
vomiting, constipation, dysgeusia, anemia/decreased hemoglobin, decreased appetite, diarrhea, abdominal pain,
thrombocytopenia and fatigue/asthenia. In studies of lucitanib, hypertension, proteinuria and subclinical hypothyroidism
requiring supplementation are the most common AEs observed. The most notable AEs experienced by patients treated
with rociletinib include hyperglycemia and OTc prolongation. As is the case with all oncology drugs, it is possible that
there may be other potentially harmful characteristics associated with their use in future trials, including larger and
lengthier Phase III clinical trials. As we evaluate the use of our product candidates in combination with other active
agents, we may encounter safety issues as a result of the combined safety profiles of each agent, which could pose a
substantial challenge to that development strategy.
Results of our trials could reveal a high and unacceptable severity and prevalence of these or other side effects. In
such an event, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities
could order us to cease further development of or deny approval of our product candidates for any or all targeted
indications. The drug-related AEs could affect patient recruitment or the ability of enrolled patients to complete the trial
or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and
prospects significantly.
Additionally, if we or others later identify undesirable side effects caused by such products, a number of potentially
significant negative consequences could result, including:
•
•
regulatory authorities may withdraw approvals of such product;
regulatory authorities may require additional warnings on the label;
• we may be required to create a medication guide outlining the risks of such side effects for distribution to
patients;
• we could be sued and held liable for harm caused to patients; and
•
our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product
candidate, if approved, and could significantly harm our business, results of operations and prospects.
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Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics could harm our
drug development strategy.
As one of the key elements of our clinical development strategy, we seek to identify patient subsets within a disease
category who may derive selective and meaningful benefit from the product candidates we are developing. In
collaboration with partners, we plan to develop companion diagnostics to help us to more accurately identify patients
within a particular subset, both during our clinical trials and in connection with the commercialization of our product
candidates. Companion diagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities
as medical devices and require separate regulatory approval prior to commercialization. We do not develop companion
diagnostics internally and thus we are dependent on the sustained cooperation and effort of our third-party collaborators
in developing and obtaining approval for these companion diagnostics. We and our collaborators may encounter
difficulties in developing and obtaining approval for the companion diagnostics, including issues relating to
selectivity/specificity, analytical validation, reproducibility, or clinical validation. Any delay or failure by our
collaborators to develop or obtain regulatory approval of the companion diagnostics could delay or prevent approval of
our product candidates. In addition, our collaborators may encounter production difficulties that could constrain the
supply of the companion diagnostics, and both they and we may have difficulties gaining acceptance of the use of the
companion diagnostics in the clinical community. If such companion diagnostics fail to gain market acceptance, it would
have an adverse effect on our ability to derive revenues from sales of our products. In addition, the diagnostic company
with whom we contract may decide to discontinue selling or manufacturing the companion diagnostic that we anticipate
using in connection with development and commercialization of our product candidates or our relationship with such
diagnostic company may otherwise terminate. We may not be able to enter into arrangements with another diagnostic
company to obtain supplies of an alternative diagnostic test for use in connection with the development and
commercialization of our product candidates or do so on commercially reasonable terms, which could adversely affect
and/or delay the development or commercialization of our product candidates.
The failure to maintain our collaboration with Servier, or the failure of Servier to perform its obligations under the
collaboration, could negatively affect our business.
Pursuant to the terms of our collaboration and license agreement with Servier, Servier was granted exclusive rights to
develop and commercialize lucitanib in markets outside of the United States and Japan (excluding China). Consequently,
our ability to realize any revenues from lucitanib in the Servier territory depends on our success in maintaining our
collaboration with Servier and Servier’s ability to obtain regulatory approvals for, and to successfully commercialize,
lucitanib in its licensed territory. Although we collaborate with Servier to carry out a global development plan for
lucitanib, we have limited control over the amount and timing of resources that Servier will dedicate to these efforts.
Servier is responsible for all of the global development costs for lucitanib up to €80.0 million. Cumulative global
development costs in excess of €80.0 million, if any, will be shared equally between us and Servier. During the second
quarter of 2016, we and Servier agreed to discontinue the development of lucitanib for breast cancer and lung cancer and
are continuing to evaluate what, if any, further development of lucitanib will be pursued. Based on current estimates, we
expect to complete the committed on-going development activities in 2017 and expect full reimbursement of our
development costs from Servier. However, we have limited control over the costs Servier may incur with respect to its
development activities for the compound, and therefore our obligation to share additional costs could be triggered sooner
than planned.
We are subject to a number of other risks associated with our collaboration and license agreement with Servier,
including:
• Servier may not comply with applicable regulatory requirements with respect to developing or commercializing
lucitanib, which could adversely affect future development or sales of lucitanib in Servier’s licensed territory
and elsewhere;
•
If Servier does not agree to include within the global development plan new studies that we propose to conduct
for lucitanib, we may be responsible for all costs associated with carrying out such activities;
• We and Servier could disagree as to current or future development plans for lucitanib, and Servier may delay
clinical trials or stop a clinical trial for which it is the sponsor;
• There may be disputes between us and Servier, including disagreements regarding the collaboration and license
agreement, that may result in (1) the delay of or failure to achieve regulatory and commercial objectives that
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would result in milestone or royalty payments, (2) the delay or termination of any future development or
commercialization of lucitanib, and/or (3) costly litigation or arbitration that diverts our management’s attention
and resources;
• Business combinations or significant changes in Servier’s business strategy may adversely affect Servier’s
ability or willingness to perform its obligations under our collaboration and license agreement; and
• The royalties we are eligible to receive from Servier may be reduced or eliminated based upon Servier’s and our
ability to maintain or defend our intellectual property rights and the presence of generic competitors in Servier’s
licensed territory.
The collaboration and license agreement is subject to early termination, including through Servier’s right to terminate
the agreement without cause upon advance notice to us. If the agreement is terminated early, we may not be able to find
another collaborator for the further development and commercialization of lucitanib outside of the United States and
Japan on acceptable terms, or at all, and we could incur significant additional costs by pursuing continued development
and commercialization of lucitanib in those territories on our own.
We rely on third parties to conduct our non-clinical and clinical trials. If these third parties do not successfully carry
out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or
commercialize our product candidates and our business could be substantially harmed.
We have relied upon and plan to continue to rely upon third-party CROs to monitor and manage data for our ongoing
non-clinical and clinical programs. We rely on these parties for execution of our non-clinical and clinical trials, and
control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is
conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the
CROs does not relieve us of our regulatory responsibilities. We and our CROs are required to comply with GCP, which
are regulations and guidelines enforced by the FDA, the EEA and comparable foreign regulatory authorities for all of our
products in clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial
sponsors, principal investigators and trial sites. If we or any of our CROs fail to comply with applicable GCPs, the
clinical data generated in our clinical trials may be deemed unreliable and the FDA, the EMA or comparable foreign
regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that
any of our clinical trials comply with GCP regulations. In addition, our clinical trials must be conducted with product
produced under current GMP regulations. Our failure to comply with these regulations may require us to repeat clinical
trials, which would delay the regulatory approval process.
Our CROs have the right to terminate their agreements with us in the event of an uncured material breach. In
addition, some of our CROs have an ability to terminate their respective agreements with us if it can be reasonably
demonstrated that the safety of the subjects participating in our clinical trials warrants such termination, if we make a
general assignment for the benefit of our creditors or if we are liquidated.
If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with
alternative CROs or to do so on commercially reasonable terms. In addition, our CROs are not our employees, and
except for remedies available to us under our agreements with such CROs, we cannot control whether or not they devote
sufficient time and resources to our on-going clinical and non-clinical programs. If CROs do not successfully carry out
their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy
of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory
requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to
obtain regulatory approval for or successfully commercialize our product candidates. As a result, our results of
operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our
ability to generate revenues could be delayed.
Switching or adding additional CROs involves additional cost and requires management time and focus. In addition,
there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially
influence our ability to meet our desired clinical development timelines. Though we carefully manage our relationships
with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that
these delays or challenges will not have a material adverse effect on our business, financial condition and prospects.
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We rely completely on third parties to manufacture our clinical drug supplies and we intend to rely on third parties to
produce commercial supplies of any approved product candidate, and our commercialization of any of our product
candidates could be stopped, delayed or made less profitable if those third parties fail to obtain approval of the FDA
or comparable foreign regulatory authorities, fail to provide us with sufficient quantities of drug product or fail to do
so at acceptable quality levels or prices.
We do not currently have nor do we plan to acquire the infrastructure or capability internally to manufacture our
clinical drug supplies for use in the conduct of our clinical trials, and we lack the resources and the capability to
manufacture any of our product candidates on a clinical or commercial scale. We do not control the manufacturing
process of, and are completely dependent on, our contract manufacturing partners for compliance with the GMP
regulatory requirements for manufacture of both active drug substances and finished drug products. If our contract
manufacturers cannot successfully manufacture material that conforms to the strict regulatory requirements of the FDA
or others, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. In
addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality
assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these
facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need
to find alternative manufacturing facilities, which would significantly affect our ability to develop, obtain regulatory
approval for or market our product candidates, if approved.
We rely on our manufacturers to purchase from third-party suppliers the materials necessary to produce our product
candidates for our clinical trials. There are a limited number of suppliers of raw materials that we use to manufacture our
drugs and there may be a need to assess alternate suppliers to prevent a possible disruption of the manufacture of the
materials necessary to produce our product candidates for our clinical trials, and if approved, ultimately for commercial
sale. We do not have any control over the process or timing of the acquisition of these raw materials by our
manufacturers. Moreover, we currently do not have any agreements for the commercial production of these raw
materials. Any significant delay in the supply of a product candidate, or the raw material components thereof, for an
ongoing clinical trial due to the need to replace a third-party manufacturer could considerably delay completion of our
clinical trials, product testing and potential regulatory approval of our product candidates. If our manufacturers or we are
unable to purchase these raw materials after regulatory approval has been obtained for our product candidates, the
commercial launch of our product candidates would be delayed or there would be a shortage in supply, which would
impair our ability to generate revenues from the sale of our product candidates.
We are dependent on our third party manufacturers to conduct process development and scale-up work necessary to
support greater clinical development and commercialization requirements for our product candidates. Carrying out these
activities in a timely manner, and on commercially reasonable terms, is critical to the successful development and
commercialization of our product candidates. We expect that our third-party manufacturers are capable of providing
sufficient quantities of our product candidates to meet anticipated clinical and full-scale commercial demands, however
if third parties with whom we currently work are unable to meet our supply requirements, we will need to secure
alternate suppliers. While we believe that there are other contract manufacturers having the technical capabilities to
manufacture our product candidates, we cannot be certain that identifying and establishing relationships with such
sources would not result in significant delay or material additional costs.
We expect to continue to depend on third-party contract manufacturers for the foreseeable future. While we have
long-term agreements with Lonza for the manufacture of API for Rubraca and with the manufacturer of the finished drug
product, we have not entered into agreements with any alternate suppliers. We currently obtain our supplies of finished
drug product through individual purchase orders.
Our commercial success depends upon attaining significant market acceptance of our product candidates, if
approved, among physicians, patients, healthcare payors and major operators of cancer clinics.
Even if we obtain regulatory approval for our other product candidates, the product may not gain market acceptance
among physicians, health care payors, patients and the medical community, which are critical to commercial success.
Market acceptance of any product candidate for which we receive approval depends on a number of factors, including:
•
•
the efficacy and safety as demonstrated in clinical trials;
the timing of market introduction of such product candidate as well as competitive products;
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•
•
•
•
•
•
•
•
•
•
the clinical indications for which the drug is approved and the product label approved by regulatory authorities,
including any warnings that may be required on the label;
the approval, availability, market acceptance and reimbursement for the companion diagnostic;
acceptance by physicians, major operators of cancer clinics and patients of the drug as a safe and effective
treatment;
the potential and perceived advantages of such product candidate over alternative treatments, especially with
respect to patient subsets that we are targeting with such product candidate;
the safety of such product candidate seen in a broader patient group, including its use outside the approved
indications;
the cost, safety and efficacy of the product in relation to alternative treatments;
the availability of adequate reimbursement and pricing by third-party payors and government authorities;
relative convenience and ease of administration;
the prevalence and severity of adverse side effects; and
the effectiveness of our sales and marketing efforts.
If our product candidates are approved but fail to achieve an adequate level of acceptance by physicians, healthcare
payors and patients, we will not be able to generate significant revenues, and we may not become or remain profitable.
We face significant competition from other biotechnology and pharmaceutical companies, and our operating results
will suffer if we fail to compete effectively.
The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant
technological change. In addition, the competition in the oncology market is intense. We have competitors both in the
United States and internationally, including major multinational pharmaceutical companies, biotechnology companies
and universities and other research institutions.
In late 2014, Lynparza™ (olaparib) was approved in the U.S. as monotherapy in patients with germline BRCA
mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy and in the EU
for the maintenance treatment of BRCA mutated platinum-sensitive relapsed serous ovarian cancer. There are a number
of other PARP inhibitors in clinical development including Tesaro Inc.’s’s niraparib, AbbVie’s (veliparib) and ABT-
767, Pfizer’s talazoparib, BeiGene’s BGB-290, and Checkpoint Therapeutics’ CK-102.
There are currently no approved drugs that specifically inhibit each of VEGFR, PDGFR and FGFR, as does lucitanib;
however, there are currently a number of oral antiangiogenic drugs that target one or more of those markers and are
approved or in development for various solid tumors, including: nintedanib (Boehringer Ingelheim), lenvatinib (Eisai),
sunitinib (Pfizer), sorafenib (Bayer), pazopanib (Novartis), axitinib (Pfizer) and cabozantinib (Exelixis).
In November 2015, the FDA approved Tagrisso™ (osimertinib) for patients with metastatic EGFR T790M mutation-
positive NSCLC who have progressed on or after EGFR TKI therapy. This represents the first approved therapy for the
treatment of EGFR mutant NSCLC patients who test positive for the T790M mutation. In February 2016, the European
Commission granted conditional marketing approval to Tagrisso™ for the treatment of advanced NSCLC patients who
test positive for the T790M mutation. In addition, we are aware of a number of other products in development targeting
cancer-causing mutant forms of EGFR for the treatment of NSCLC patients. These products include Pfizer’s PF-
06747775, currently in Phase I/II trials, Astellas Pharma’s ASP8273, currently in Phase I/II trials, Novartis’ EGF816,
currently in Phase I/II trials, Hanmi Pharmaceutical’s and Boehringer Ingelheim’s BI-1482694 (HM61713), HM781-
36B (Poziotinib), currently in Phase I/II trials and Acea Bio (Hangzhou)’s avitinib and AC0010MA, currently in Phase
I/II trials. Bristol Myers Squibb’s Opdivo® and Merck’s Keytruda®, both approved for second-line NSCLC, may also
represent competition to rociletinib.
Many of our competitors have substantially greater financial, technical and other resources, such as larger research
and development staff and experienced marketing and manufacturing organizations. Additional mergers and acquisitions
in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our
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competitors. As a result, these companies may obtain regulatory approval more rapidly than we are able and may be
more effective in selling and marketing their products as well. Smaller or early-stage companies may also prove to be
significant competitors, particularly through collaborative arrangements with large, established companies. Competition
may increase further as a result of advances in the commercial applicability of technologies and greater availability of
capital for investment in these industries. Our competitors may succeed in developing, acquiring or licensing on an
exclusive basis drug products that are more effective or less costly than any drug candidate that we are currently
developing or that we may develop. If approved, our product candidates will face competition from commercially
available drugs, as well as drugs that are in the development pipelines of our competitors and later enter the market.
Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel
compounds or to in-license novel compounds that could make our product candidates less competitive. In addition, any
new product that competes with an approved product must demonstrate compelling advantages in efficacy, convenience,
tolerability and safety in order to overcome price competition and to be commercially successful. Accordingly, our
competitors may succeed in obtaining patent protection, receiving FDA, EMA or other regulatory approval or
discovering, developing and commercializing medicines before we do, which would have a material adverse effect on
our business.
Reimbursement may be limited or unavailable in certain market segments for our product candidates, which could
make it difficult for us to sell our products profitably.
There is significant uncertainty related to the third-party coverage and reimbursement of newly approved drugs. We
have received approval for Rubraca in the United States for certain limited indications. We intend to seek additional
approvals to market Rubraca and other product candidates in the United States, Europe and other selected foreign
jurisdictions. Market acceptance and sales of our product candidates in both domestic and international markets will
depend significantly on the availability of adequate coverage and reimbursement from third-party payors for any of our
product candidates and may be affected by existing and future healthcare reform measures. Government and other third-
party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of
reimbursement for new drugs and, as a result, they may not cover or provide adequate payment for our product
candidates. These payors may conclude that our product candidates are less safe, less effective or less cost-effective than
existing or later introduced products, and third-party payors may not approve our product candidates for coverage and
reimbursement or may cease providing coverage and reimbursement for these product candidates.
Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time
consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-
effectiveness data for the use of our products. We may not be able to provide data sufficient to gain acceptance with
respect to coverage and reimbursement. We cannot be sure that coverage or adequate reimbursement will be available
for any of our product candidates. Even if we obtain coverage for our product candidates, third-party payors may not
establish adequate reimbursement amounts, which may reduce the demand for, or the price of, our products. If
reimbursement of our future products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory
levels, we may be unable to achieve or sustain profitability.
In both the United States and certain foreign jurisdictions, there have been and we expect there will continue to be a
number of legislative and regulatory changes to the health care system that could affect our ability to sell our products
profitably. The U.S. government and other governments have shown significant interest in pursuing healthcare reform.
In particular, the Medicare Modernization Act of 2003 revised the payment methodology for many products under the
Medicare program in the United States. This has resulted in lower rates of reimbursement. In 2010, the Patient Protection
and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the
“Affordable Care Act”), was enacted. The Affordable Care Act substantially changed the way healthcare is financed by
both governmental and private insurers. Such government-adopted reform measures may adversely affect the pricing of
healthcare products and services in the United States or internationally and the amount of reimbursement available from
governmental agencies or other third-party payors.
There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels
directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict
the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies,
managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare may
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adversely affect the demand for any drug products for which we may obtain regulatory approval, as well as our ability to
set satisfactory prices for our products, to generate revenues, and to achieve and maintain profitability.
In some foreign countries, particularly in the European Union, the pricing of prescription pharmaceuticals is subject
to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable
time after the receipt of marketing approval for a product candidate. To obtain reimbursement or pricing approval in
some countries, we may be required to conduct additional clinical trials that compare the cost-effectiveness of our
product candidates to other available therapies. If reimbursement of our product candidates is unavailable or limited in
scope or amount in a particular country, or if pricing is set at unsatisfactory levels, we may be unable to achieve or
sustain profitability of our products in such country.
If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully
implement our business strategy. Further, we will need to grow our organization, and we may experience difficulties
in managing this growth, which could disrupt our operations.
Our industry has experienced a high rate of turnover of management personnel in recent years. Our ability to compete
in the highly competitive biotechnology and pharmaceuticals industries depends upon our ability to attract and retain
highly qualified managerial, scientific and medical personnel. We are highly dependent on our management, scientific
and medical personnel, especially Patrick J. Mahaffy, our President and Chief Executive Officer, Lindsey Rolfe, our
Executive Vice President of Clinical and Preclinical Development and Pharmacovigilance and Chief Medical Officer,
Dale Hooks, our Senior Vice President and Chief Commercial Officer and Gillian C. Ivers-Read, our Executive Vice
President, Technical Operations and Chief Regulatory Officer, whose services are critical to the successful
implementation of our product candidate acquisition, development and regulatory strategies.
Despite our efforts to retain valuable employees, members of our management, scientific, development and
commercial teams may terminate their employment with us on short notice. Pursuant to their employment arrangements,
each of our executive officers may voluntarily terminate their employment at any time by providing as little as thirty
days advance notice. Our employment arrangements with all of our employees provide for at-will employment, which
means that any of our employees could leave our employment at any time, with or, other than our executive officers,
without notice. For example, Andrew R. Allen, our former Executive Vice President of Clinical and Pre-Clinical
Development and Chief Medical Officer, resigned in July 2015, and Steven L. Hoerter, our former Executive Vice
President and Chief Commercial Officer, resigned in January 2016 and Erle T. Mast, our former Executive Vice
President and Chief Financial Officer, resigned in March 2016. The loss of the services of any of our executive officers
or other key employees and our inability to find suitable replacements could potentially harm our business, financial
condition and prospects. Our success also depends on our ability to continue to attract, retain and motivate highly skilled
junior, mid-level and senior managers as well as junior, mid-level and senior scientific and medical personnel.
As of February 16, 2017, we employed 278 full-time employees. As our development plans and strategies develop,
we expect to expand our employee base for managerial, operational, financial and other resources. Future growth will
impose significant added responsibilities on members of management, including the need to identify, recruit, maintain,
motivate and integrate additional employees. Also, our management may need to divert a disproportionate amount of its
attention away from our day-to-day activities and devote a substantial amount of time to managing these growth
activities. We may not be able to effectively manage the expansion of our operations which may result in weaknesses in
our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced
productivity among remaining employees. Our expected growth could require significant capital expenditures and may
divert financial resources from other projects. If our management is unable to effectively manage our expected growth,
our expenses may increase more than expected, our ability to generate revenues could be reduced and we may not be
able to implement our business strategy.
We may not be able to attract or retain qualified management and scientific personnel in the future due to the intense
competition for a limited number of qualified personnel among biopharmaceutical, biotechnology, pharmaceutical and
other businesses. Many of the other pharmaceutical companies that we compete against for qualified personnel have
greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also
may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may
be more appealing to high quality candidates than what we have to offer. In order to induce valuable employees to
continue their employment with us, we have provided stock options that vest over time. The value to employees of stock
options that vest over time is significantly affected by movements in our stock price that are beyond our control, and
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may at any time be insufficient to counteract more lucrative offers from other companies. If we are unable to continue to
attract and retain high quality personnel, the rate and success at which we can develop and commercialize product
candidates will be limited.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory
standards and requirements, which could have a material adverse effect on our business.
We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include
intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with
manufacturing standards we have established, comply with federal and state health-care fraud and abuse laws and
regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales,
marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to
prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a
wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other
business arrangements. Employee misconduct could also involve the improper use of information obtained in the course
of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We have adopted a Code
of Business Ethics and other compliance policies, but it is not always possible to identify and deter employee
misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown
or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming
from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are
not successful in defending ourselves or asserting our rights, those actions could have a significant effect on our business
and results of operations, including the imposition of significant fines or other sanctions.
Our relationships with healthcare professionals, investigators, consultants, customers (actual and potential) and
third-party payors are and will continue to be subject, directly or indirectly, to federal and state healthcare fraud and
abuse laws, false claims laws, transparency and disclosure (or “sunshine”) laws, government price reporting, and
health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws,
we could face substantial penalties.
Our operations may be directly, or indirectly through our customers, subject to various federal and state fraud and
abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act. These
laws may affect, among other things, our current activities with clinical study investigators and research subjects, as well
as proposed and future sales, marketing, disease awareness, and patient assistance programs. In addition, we may be
subject to patient privacy regulation by both the federal government and the states in which we conduct our business.
The laws that may affect our ability to operate include, but are not limited to:
•
•
•
•
the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully
soliciting, receiving, offering or paying remuneration, including any kickback, bribe, or certain rebate, directly
or indirectly, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or
recommendation of any good, facility, item or service for which payment will be made, in whole or in part,
under a federal healthcare program, such as the Medicare and Medicaid programs;
a person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or special intent
to violate the law in order to have committed a violation; in addition, the government may assert that a claim
including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or
fraudulent claim for purposes of the federal False Claims Act;
federal false claims and civil monetary penalty laws, including the False Claims Act, which impose criminal
and civil penalties, including through civil “qui tam” or “whistleblower” actions, against individuals or entities
from knowingly presenting, or causing to be presented, claims for payment or approval from federal programs,
such as Medicare and Medicaid, that are false or fraudulent, or knowingly making a false statement to
improperly avoid, decrease or conceal an obligation to pay money to the federal government;
the Health Insurance Portability and Accountability Act of 1996, or HIPAA which imposes criminal and civil
liability for, among other things, willfully executing, or attempting to execute, a scheme to defraud any
healthcare benefit program and making false statements relating to healthcare matters;
• HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its
implementing regulations, which also imposes certain requirements on certain covered healthcare providers,
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•
•
•
•
health plans, and healthcare clearinghouses, as well as their respective business associates that perform services
for them that involve the use, or disclosure of, individually identifiable health information, with respect to
safeguarding the privacy, security and transmission of individually identifiable health information;
the federal Physician Payment Sunshine Act, which requires certain manufacturers of drugs, devices, biologics
and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health
Insurance Program (with certain exceptions) to report annually to the Centers for Medicare and Medicaid
Services, or CMS, information related to payments or other transfers of value made to physicians (defined to
include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as
ownership and investment interests held by the physicians described above and their immediate family
members;
federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and
activities that potentially harm consumers;
federal government price reporting laws, which require drug manufacturers to calculate and report complex
pricing metrics to government agencies, including CMS, where such reported prices may be used in the
calculation of reimbursement and/or discounts on marketed products. Participation in these programs and
compliance with the applicable requirements may result in potentially significant discounts on products subject
to reimbursement under federal healthcare programs and increased infrastructure costs, and may potentially
limit a drug manufacturer’s ability to offer certain marketplace discounts; and
analogous state laws and regulations, such as state anti-kickback, false claims, consumer protection and unfair
competition laws which may apply to pharmaceutical business practices, including but not limited to, research,
distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or
services reimbursed by any third-party payer, including commercial insurers; state laws that require
pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and
the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that
may be made to healthcare providers and other potential referral sources; state laws that require drug
manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and
reporting of gifts, compensations and other remuneration and items of value provided to healthcare
professionals and entities; and state laws governing the privacy and security of health information in certain
circumstances, many of which differ from each other in significant ways and may not have the same effect, thus
complicating compliance efforts.
In addition, the research and development of our product candidates outside the United States, and any sales of our
products or product candidates once commercialized outside the United States will also likely subject us to foreign
equivalents of the healthcare laws mentioned above, among other foreign laws.
Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial
costs, including investments in infrastructure and additional resources. Because of the breadth of these laws and the
narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities,
including our consulting agreements and other relationships with physicians, could be subject to challenge under one or
more of such laws. Governmental and enforcement authorities may conclude that our business practices do not comply
with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws
and regulations. If our operations are found to be in violation of any of the laws described above or any other
governmental regulations that apply to us, we may be subject to, without limitation, civil, criminal, and administrative
penalties, damages, monetary fines, disgorgement, possible exclusion from participation in Medicare, Medicaid and
other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and
curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and
our results of operations.
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit
commercialization of our product candidates.
We face an inherent risk of product liability. For example, we may be sued if any product we develop allegedly
causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such
product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of
dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted
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under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may
incur substantial liabilities or be required to limit commercialization of our product candidates, if approved. Even
successful defense would require significant financial and management resources. Regardless of the merits or eventual
outcome, liability claims may result in:
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decreased demand for our product candidates or products that we may develop;
injury to our reputation;
• withdrawal of clinical trial participants;
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initiation of investigations by regulators;
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costs to defend the related litigation;
a diversion of management’s time and our resources;
substantial monetary awards to trial participants or patients;
increase in insurance premiums;
product recalls, withdrawals or labeling, marketing or promotional restrictions;
loss of revenues from product sales;
the inability to commercialize our product candidates; and
a decline in our stock price.
Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential
product liability claims could prevent or inhibit the commercialization of products we develop. We have a program of
product liability insurance covering our ongoing clinical trials; however, the amount of insurance we maintain may not
be adequate to cover all liabilities that we may incur. Although we maintain such insurance, any claim that may be
brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by
our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various
exclusions, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any
amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by
our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or suffer
security breaches.
We and our business partners maintain sensitive company data on our computer networks, including our intellectual
property and proprietary business information, as well as certain clinical trial information. Cybersecurity attacks are
becoming more commonplace and include, but are not limited to, malicious software, attempts to gain unauthorized
access to data and other electronic security breaches that could lead to disruptions in systems, misappropriation of
information and corruption of data. Despite the implementation of security measures, our internal computer systems and
those of our CROs and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized
access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced
any such material system failure, accident or security breach to date, if such an event were to occur and cause
interruptions in our operations, it could result in a material disruption of our development programs and business
operations. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in
delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the
extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or
inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development
of our product candidates could be delayed.
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Risks Related to Our Intellectual Property
If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not
adequate, we may not be able to compete effectively in our market.
We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the
intellectual property related to our technologies. Any disclosure to or misappropriation by third parties of our
confidential proprietary information could enable competitors to quickly duplicate or surpass our technological
achievements, thus eroding our competitive position in our market.
The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions
and can be uncertain. The patent applications that we own or license may fail to result in issued patents in the United
States or in other foreign countries. Even if the patents do successfully issue, third parties may challenge the validity,
enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable.
Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our
intellectual property or prevent others from designing around our claims. If the breadth or strength of protection
provided by the patent applications we hold or pursue with respect to our product candidates is threatened, it could
threaten our ability to commercialize our product candidates. Further, if we encounter delays in our clinical trials, the
period of time during which we could market our product candidates under patent protection would be reduced. Since
patent applications in the United States and most other countries are confidential for a period of time after filing, we
cannot be certain that we were the first to file any patent application related to our product candidates. Furthermore, an
interference proceeding can be provoked by a third-party or instituted by the United States Patent and Trademark Office
(“U.S. PTO”) to determine who was the first to invent any of the subject matter covered by the patent claims of our
applications.
In addition to the protection afforded by patents, we seek to rely on trade secret protection and confidentiality
agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce
and any other elements of our drug development processes that involve proprietary know-how, information or
technology that is not covered by patents. Although we require all of our employees to assign their inventions to us, and
all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how,
information or technology to enter into confidentiality agreements, we cannot be certain that our trade secrets and other
confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade
secrets or independently develop substantially equivalent information and techniques. Further, the laws of some foreign
countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a
result, we may encounter significant problems in protecting and defending our intellectual property both in the United
States and abroad. If we are unable to prevent material disclosure of the intellectual property related to our technologies
to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could
materially adversely affect our business, results of operations and financial condition.
Third-party claims of intellectual property infringement may prevent or delay our drug discovery and development
efforts.
Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third
parties. There is a substantial amount of litigation involving patent and other intellectual property rights in the
biotechnology and pharmaceutical industries, including interference, inter parties review and reexamination proceedings
before the U.S. PTO or oppositions and other comparable proceedings in foreign jurisdictions. Numerous United States
and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which
we are developing product candidates. As the biotechnology and pharmaceutical industries expand and more patents are
issued, the risk increases that our product candidates may give rise to claims of infringement of the patent rights of
others.
Third parties may assert that we are employing their proprietary technology without authorization. There are or may
be third-party patents with claims to materials, formulations, methods of manufacture or methods for treatment related to
the use or manufacture of our product candidates. Because patent applications can take many years to issue, there may be
currently pending patent applications, which may later result in issued patents that our product candidates may infringe.
In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these
patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of
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any of our product candidates, any molecules formed during the manufacturing process or any final product itself, the
holders of any such patents may be able to block our ability to commercialize such product candidate unless we obtain a
license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or
unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our
formulations, processes for manufacture or methods of use, including combination therapy or patient selection methods,
the holders of any such patent may be able to block our ability to develop and commercialize the applicable product
candidate unless we obtain a license, limit our uses, or until such patent expires or is finally determined to be held
invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all.
Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our
ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless
of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources
from our business. In the event of a successful claim of infringement against us, we may have to pay substantial
damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third
parties, limit our uses, pay royalties or redesign our infringing product candidates, which may be impossible or require
substantial time and monetary expenditure. We cannot predict whether any such license would be available at all or
whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may
need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates.
We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would
be unable to further develop and commercialize one or more of our product candidates, which could harm our business
significantly.
The patent protection and patent prosecution for some of our product candidates is dependent on third parties.
While we normally seek and gain the right to fully prosecute the patents relating to our product candidates, there may
be times when platform technology patents that relate to our product candidates are controlled by our licensors. This is
the case with our license to rociletinib, under which Celgene holds the right to prosecute and maintain the patents and
patent applications covering its core discovery technology, including molecular backbones, building blocks and classes
of compounds generated by that technology, aspects of which relate to rociletinib. While we have the right to jointly
prosecute and maintain the patent rights for the composition of matter for rociletinib, if Celgene or any of our future
licensing partners fail to appropriately prosecute and maintain patent protection for patents covering any of our product
candidates, our ability to develop and commercialize those product candidates may be adversely affected and we may
not be able to prevent competitors from making, using and selling competing products.
We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be
expensive, time consuming and unsuccessful.
Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we
may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an
infringement proceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable, or may
refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the
technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at
risk of being invalidated, held unenforceable or interpreted narrowly and could put our patent applications at risk of not
issuing.
Interference proceedings provoked by third parties or brought by the U.S. PTO may be necessary to determine the
priority of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome
could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our
business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Litigation
or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management
and other employees.
We may not be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidential
information, particularly in countries where the laws may not protect those rights as fully as in the United States.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation,
there is a risk that some of our confidential information could be compromised by disclosure during this type of
litigation. In addition, there could be public announcements of the results of hearings, motions or other interim
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proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a
substantial adverse effect on the price of our common stock.
We may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting and defending patents on all of our product candidates throughout the world would be
prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent
protection to develop their own products and further, may export otherwise infringing products to territories where we
have patent protection, but enforcement is not as strong as that in the United States. These products may compete with
our products in jurisdictions where we do not have any issued patents and our patent claims or other intellectual property
rights may not be effective or sufficient to prevent them from so competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in
foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the
enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals,
which could make it difficult for us to stop the infringement of our patents or marketing of competing products in
violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result
in substantial cost and divert our efforts and attention from other aspects of our business.
If we breach any of the agreements under which we license commercialization rights to our product candidates from
third parties, we could lose license rights that are important to our business.
We license the use, development and commercialization rights for all of our product candidates, and may enter into
similar licenses in the future. Under each of our existing license agreements we are subject to commercialization and
development, diligence obligations, milestone payment obligations, royalty payments and other obligations. If we fail to
comply with any of these obligations or otherwise breach our license agreements, including by failing to use
commercially reasonable efforts to develop or commercialize the product candidate, our licensing partners may have the
right to terminate the license in whole or in part. Generally, the loss of any one of our licenses or other licenses in the
future could materially harm our business, prospects, financial condition and results of operations.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property
rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage.
The following examples are illustrative:
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others may be able to make compounds that are similar to our product candidates but that are not covered by the
claims of the patents that we own or have exclusively licensed;
• we or our licensors or strategic partners might not have been the first to make the inventions covered by the
issued patent or pending patent application that we own or have exclusively licensed;
• we or our licensors or strategic partners might not have been the first to file patent applications covering certain
of our inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies
without infringing our intellectual property rights;
it is possible that our pending patent applications will not lead to issued patents;
issued patents that we own or have exclusively licensed may not provide us with any competitive advantages,
or may be held invalid or unenforceable, as a result of legal challenges by our competitors;
our competitors might conduct research and development activities in countries where we do not have patent
rights and then use the information learned from such activities to develop competitive products for sale in our
major commercial markets;
• we may not develop additional proprietary technologies that are patentable; and
•
the patents of others may have an adverse effect on our business.
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Should any of these events occur, they could significantly harm our business, results of operations and prospects.
Risks Related to Ownership of our Common Stock and Convertible Senior Notes
There may not be a viable public market for our common stock and as a result it may be difficult for you to sell your
shares of our common stock.
Our common stock had not been publicly traded prior to our initial public offering in November 2011. The trading
market for our common stock on the NASDAQ Global Select Market has been limited at times and an active trading
market for our shares may not be sustained. As a result of these and other factors, you may be unable to resell your
shares at a price that is attractive to you or at all. Further, an inactive market may also impair our ability to raise capital
by selling shares of our common stock and may impair our ability to enter into strategic partnerships or acquire
companies or products by using our shares of common stock as consideration.
The price of our stock has been, and may continue to be, volatile, and you could lose all or part of your investment.
The trading price of our common stock has been, and may continue to be, volatile and could be subject to wide
fluctuations in response to various factors, some of which are beyond our control. During the 12-month period ended
December 31, 2016, the price of our common stock on the NASDAQ Global Select Market ranged from $11.57 per
share to $46.97 per share. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this report,
these factors include:
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adverse results of regulatory actions or decisions;
our failure to successfully commercialize our product candidates, if approved;
actual or anticipated adverse results or delays in our clinical trials;
unanticipated serious safety concerns related to the use of any of our product candidates;
changes in laws or regulations applicable to our product candidates, including but not limited to clinical trial
requirements for approvals;
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability
to obtain patent protection for our product candidates;
our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;
inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable
prices;
our dependence on third parties, including CMOS and CROs, as well as our partners that provide us with
companion diagnostic products;
additions or departures of key scientific or management personnel;
failure to meet or exceed any financial guidance or expectations regarding development milestones that we may
provide to the public;
actual or anticipated variations in quarterly operating results;
failure to meet or exceed the estimates and projections of the investment community;
overall performance of the equity markets and other factors that may be unrelated to our operating performance
or the operating performance of our competitors, including changes in market valuations of similar companies;
conditions or trends in the biotechnology and biopharmaceutical industries;
introduction of new products offered by us or our competitors;
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us
or our competitors;
issuances of debt or equity securities;
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significant lawsuits, including patent or stockholder litigation;
sales of our common stock by us or our stockholders in the future;
trading volume of our common stock;
publication of research reports about us or our industry or positive or negative recommendations or withdrawal
of research coverage by securities analysts;
ineffectiveness of our internal controls;
general political and economic conditions;
effects of natural or man-made catastrophic events; and
other events or factors, many of which are beyond our control.
In addition, the stock market in general, and the NASDAQ Global Select Market and biotechnology companies in
particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to
the operating performance of these companies. Broad market and industry factors may negatively affect the market price
of our common stock, regardless of our actual operating performance. The realization of any of the above risks or any of
a broad range of other risks, including those described in these “Risk Factors,” could have a dramatic and material
adverse effect on the market price of our common stock.
Because our outstanding Notes are convertible into shares of our common stock, volatility or depressed prices of our
common stock could have a similar effect on the trading price of our Notes. In addition, the existence of the Notes may
encourage short selling in our common stock by market participants because the conversion of the Notes could depress
the price of our common stock.
The conversion of some or all of the Notes may dilute the ownership interest of existing stockholders. Holders of the
outstanding Notes will be able to convert them at any time prior to the close of business on the business day immediately
preceding September 15, 2021. Upon conversion, holders of the Notes will receive shares of common stock. Any sales in
the public market of shares of common stock issued upon conversion of such Notes could adversely affect the trading
price of our common stock. We cannot predict the size of future issuances or the effect, if any, that they may have on the
market price of our common stock. The issuance and sale of substantial amounts of common stock, or the perception that
such issuances and sales may occur, could adversely affect the market price of our common stock and impair our ability
to raise capital through the sale of additional equity or convertible debt securities.
Following periods of volatility in a company’s stock price, litigation has often been initiated against companies.
Following the decline in our stock price related to the rociletinib regulatory update in November 2015, a number of
lawsuits have been filed against us (see “Part I, Item 3-Legal Proceedings”). These proceedings and other similar
litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and resources,
which could materially and adversely affect our business and financial condition.
Certain members of management and their affiliates own a significant percentage of our stock and will be able to
exert significant influence over matters subject to stockholder approval.
Our executive officers, directors and their respective affiliates known to us beneficially owned approximately 14.8%
of our voting stock as of February 21, 2017. These stockholders may have the ability to significantly influence the
outcome of all matters submitted to our stockholders for approval. The interests of our executive officers, directors, and
their affiliates might not coincide with the interests of the other holders of our capital stock which may prevent or
discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as
one of our stockholders.
Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
Persons who were our stockholders prior to our initial public offering continue to hold a substantial number of shares
of our common stock. If such persons sell, or indicate an intention to sell, substantial amounts of our common stock in
the public market, the trading price of our common stock could decline.
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In addition, shares of common stock that are either subject to outstanding options or reserved for future issuance
under our equity incentive plans will become eligible for sale in the public market to the extent permitted by the
provisions of various vesting schedules and Rule 144 and Rule 701 under the Securities Act, and, in any event, we have
filed a registration statement permitting shares of common stock issued on exercise of options to be freely sold in the
public market. If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the
public market, the trading price of our common stock could decline.
Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our
equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could
cause our stock price to fall.
We expect that significant additional capital will be needed in the future to continue our planned operations. To raise
capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices
and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity
securities in more than one transaction, investors may be materially diluted by subsequent sales. Such sales may also
result in material dilution to our existing stockholders, and new investors could gain rights, preferences and privileges
senior to those of holders of our common stock.
Pursuant to our equity incentive plan(s), our compensation committee (or its designee) is authorized to grant equity-
based incentive awards to our employees, directors and consultants. As of December 31, 2016, the number of shares of
our common stock available for future grant under our 2011 Stock Incentive Plan (“2011 Plan”) is 2,006,352. The
number of shares of our common stock reserved for issuance under our 2011 Plan will be increased (i) from time to time
by the number of shares of our common stock forfeited upon the expiration, cancellation, forfeiture, cash settlement or
other termination of awards under our 2009 Equity Incentive Plan, and (ii) at the discretion of our board of directors, on
the date of each annual meeting of our stockholders, by up to the lesser of (x) a number of additional shares of our
common stock representing 4% of our then-outstanding shares of common stock on such date and (y) 2,758,621 shares
of our common stock. Future option and restricted stock unit, or RSU, grants and issuances of common stock under our
2011 Plan may have an adverse effect on the market price of our common stock. In addition, a substantial number of
shares of our common stock are reserved for issuance upon conversion of the Notes.
Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an
acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts
by our stockholders to replace or remove our current management.
Provisions in our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware
law, could make it more difficult for a third-party to acquire us or increase the cost of acquiring us, even if doing so
would benefit our stockholders or remove our current management. These provisions include:
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authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of
which may be issued without stockholder approval;
limiting the removal of directors by the stockholders;
creating a staggered board of directors;
prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a
meeting of our stockholders;
eliminating the ability of stockholders to call a special meeting of stockholders;
permitting our board of directors to accelerate the vesting of outstanding option grants upon certain transactions
that result in a change of control; and
establishing advance notice requirements for nominations for election to the board of directors or for proposing
matters that can be acted upon at stockholder meetings.
These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current
management by making it more difficult for stockholders to replace members of our board of directors, which is
responsible for appointing the members of our management. Because we are incorporated in Delaware, we are governed
by the provisions of Section 203 of the Delaware General Corporation Law, which may discourage, delay or prevent
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someone from acquiring us or merging with us whether or not it is desired by or beneficial to our stockholders. Under
Delaware law, a corporation may not, in general, engage in a business combination with any holder of 15% or more of
its capital stock unless the holder has held the stock for three years or, among other things, the board of directors has
approved the transaction. Any provision of our certificate of incorporation or bylaws or Delaware law that has the effect
of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for
their shares of our common stock, and could also affect the price that some investors are willing to pay for our common
stock. Additionally, certain provisions of our outstanding Notes could make it more difficult or more expensive for a
third party to acquire us. The repurchase price of the Notes must be paid in cash, and this obligation may have the effect
of discouraging, delaying or preventing an acquisition of the Company that would otherwise be beneficial to our security
holders.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our
business, our stock price and trading volume could decline.
The trading market for our common stock depends in part on the research and reports that securities or industry
analysts publish about us or our business. If one or more of the analysts who cover us downgrades our stock or publishes
inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these
analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease,
which might cause our stock price and trading volume to decline.
We may not be able to raise the funds necessary to repurchase the Notes upon a fundamental change, and our future
debt may contain limitations on our ability to repurchase the Notes.
If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the Notes, holders may
require us to repurchase for cash all or any portion of the Notes at a fundamental change repurchase price equal to 100%
of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the
fundamental change repurchase date. We may not have or be able to borrow the funds required to repurchase the Notes
on the fundamental change repurchase date. In addition, our ability to repurchase the Notes may otherwise be limited by
law, regulatory authority or agreements governing our future indebtedness. Our failure to repurchase the Notes at a time
when the repurchase is required by the indenture would constitute a default under the indenture. A default under the
indenture or the fundamental change itself could also lead to a default under agreements governing our future
indebtedness. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace
periods, we may not have sufficient funds to repay the indebtedness and repurchase the Notes when required.
We may incur substantially more debt or take other actions which would intensify the risks discussed above; and we
may not generate cash flow from operations in the future sufficient to satisfy our obligations under the Notes and any
future indebtedness we may incur.
We may incur substantial additional debt in the future, subject to the restrictions contained in any debt instruments
that we enter into in the future, some of which may be secured debt. We are not restricted under the terms of the
indenture governing the Notes from incurring additional debt, securing existing or future debt, recapitalizing our debt or
taking a number of other actions that are not limited by the terms of the indenture governing the Notes that could have
the effect of diminishing our ability to make payments on the Notes when due. Our ability to refinance the Notes or
future indebtedness will depend on the capital markets and our financial condition at such time. In addition, agreements
that govern any future indebtedness that we may incur may contain financial and other restrictive covenants that will
limit our ability to engage in activities that may be in our long-term best interests. Our failure to comply with those
covenants could result in an event of default that, if not cured or waived, could result in the acceleration of some or all of
our debt.
ITEM 1B. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 2.
PROPERTIES
Our principal offices are located at four leased facilities, a 29,177 square foot facility in Boulder, Colorado used
primarily for corporate functions, a 24,877 square foot facility in San Francisco, California used for clinical development
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operations and research laboratory space, a 4,411 square foot facility in Cambridge, United Kingdom used for our
European regulatory and clinical operations and a 416 square foot facility in Milan, Italy used for clinical operations.
These leases expire in January 2023, December 2021, May 2017 and March 2017, respectively. We believe that our
existing facilities are sufficient for our needs for the foreseeable future.
ITEM 3.
LEGAL PROCEEDINGS
On November 19, 2015, Steve Kimbro, a purported shareholder of Clovis, filed a purported class action complaint
(the “Kimbro Complaint”) against Clovis and certain of its officers in the United States District Court for the District of
Colorado. The Kimbro Complaint purports to be asserted on behalf of a class of persons who purchased Clovis stock
between October 31, 2013 and November 15, 2015. The Kimbro Complaint generally alleges that Clovis and certain of
its officers violated federal securities laws by making allegedly false and misleading statements regarding the progress
toward FDA approval and the potential for market success of rociletinib. The Kimbro Complaint seeks unspecified
damages.
Also on November 19, 2015, a second purported shareholder class action complaint was filed by Sonny P. Medina,
another purported Clovis shareholder, containing similar allegations to those set forth in the Kimbro Complaint, also in
the United States District Court for the District of Colorado (the “Medina Complaint”). The Medina Complaint purports
to be asserted on behalf of a class of persons who purchased Clovis stock between May 20, 2014 and November 13,
2015. On November 20, 2015, a third complaint was filed by John Moran in the United States District Court for the
Northern District of California (the “Moran Complaint”). The Moran Complaint contains similar allegations to those
asserted in the Kimbro and Medina Complaints and purports to be asserted on behalf of a plaintiff class who purchased
Clovis stock between October 31, 2013 and November 13, 2015.
On December 14, 2015, Ralph P. Rocco, a fourth purported shareholder of Clovis, filed a complaint in the United
States District Court for the District of Colorado (the “Rocco Complaint”). The Rocco Complaint contains similar
allegations to those set forth in the previous complaints and purports to be asserted on behalf of a plaintiff class who
purchased Clovis stock between October 31, 2013 and November 15, 2015.
On January 19, 2016, a number of motions were filed in both the District of Colorado and the Northern District of
California seeking to consolidate the shareholder class actions into one matter and for appointment of a lead plaintiff. All
lead plaintiff movants other than M.Arkin (1999) LTD and Arkin Communications LTD (the “Arkin Plaintiffs”)
subsequently filed notices of non-opposition to the Arkin Plaintiffs’ application.
On February 2, 2016, the Arkin Plaintiffs filed a motion to transfer the Moran Complaint to the District of Colorado
(the “Motion to Transfer”). Also on February 2, 2016, the defendants filed a statement in the Northern District of
California supporting the consolidation of all actions in a single court, the District of Colorado. On February 3, 2016, the
Northern District of California court denied without prejudice the lead plaintiff motions filed in that court pending a
decision on the Motion to Transfer.
On February 16, 2016, the defendants filed a memorandum in support of the Motion to Transfer, and plaintiff Moran
filed a notice of non-opposition to the Motion to Transfer. On February 17, 2016, the Northern District of California
court granted the Motion to Transfer.
On February 18, 2016, the Medina court issued an opinion and order addressing the various motions for consolidation
and appointment of lead plaintiff and lead counsel in the District of Colorado actions. By this ruling, the court
consolidated the Medina, Kimbro and Rocco actions into a single proceeding. The court also appointed the Arkin
Plaintiffs as the lead plaintiffs and Bernstein Litowitz Berger & Grossman as lead counsel for the putative class.
On April 1, 2016, the Arkin Plaintiffs and the defendants filed a stipulated motion to set the schedule for the filing of
a consolidated complaint in the Medina, Kimbro and Rocco actions (the “Consolidated Complaint”) and the responses
thereto, including the defendants’ motion to dismiss the Consolidated Complaint (the “Motion to Dismiss”), and to stay
discovery and related proceedings until the District of Colorado issues a decision on the Motion to Dismiss. The
stipulated motion was entered by the District of Colorado on April 4, 2016.
Subject to further agreed-upon extensions by the parties, the Arkin Plaintiffs filed a Consolidated Complaint on May
6, 2016. The Consolidated Complaint names as defendants the Company and certain of its current and former officers
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(the “Clovis Defendants”), certain underwriters (the “Underwriter Defendants”) for a Company follow-on offering
conducted in July 2015 (the “July 2015 Offering”) and certain Company venture capital investors (the “Venture Capital
Defendants”). The Consolidated Complaint alleges that defendants violated particular sections of the Securities
Exchange Act of 1934 (the “Exchange Act”) and the Securities Act of 1933 (the “Securities Act”). The purported
misrepresentations and omissions concern allegedly misleading statements about rociletinib. The consolidated action is
purportedly brought on behalf of investors who purchased the Company’s securities between May 31, 2014 and April 7,
2016 (with respect to the Exchange Act claims) and investors who purchased the Company’s securities pursuant or
traceable to the July 2015 Offering (with respect to the Securities Act claims). The Consolidated Complaint seeks
unspecified compensatory and recessionary damages.
On May 23, 2016, the Medina, Kimbro, Rocco, and Moran actions were consolidated for all purposes in a single
proceeding in the District of Colorado.
The Clovis Defendants, the Underwriter Defendants and the Venture Capital Defendants filed a Motion to Dismiss on
July 27, 2016, the Arkin Plaintiffs filed their opposition on September 23, 2016, and the defendants filed their replies on
October 14, 2016.
On February 9, 2017, Judge Raymond P. Moore of the District of Colorado issued an Opinion and Order granting in
part and denying in part the Clovis Defendants’ Motion to Dismiss. The Clovis Defendants’ Motion to Dismiss was
granted with prejudice with respect to named defendant Gillian Ivers-Read and granted with respect to certain statements
determined by the Court to be nonactionable statements of opinion or optimism. The Clovis Defendants’ Motion to
Dismiss was otherwise denied. Next, the Court granted in part and denied in part the Underwriter Defendants’ Motion to
Dismiss. The Underwriter Defendants’ Motion to Dismiss was granted without prejudice with respect to Plaintiffs’ claim
under Section 12(a) of the Securities Act and granted insofar as the Court determined that certain statements challenged
under Section 11 of the Securities Act are nonactionable statements of opinion or optimism. The Opinion and Order
provided that Plaintiffs shall have until February 23, 2017 to file an amended pleading directed solely as to their Section
12(a) claim against the Underwriter Defendants. The Underwriters Defendants’ Motion to dismiss was otherwise denied.
Finally, the court granted the Venture Capital Defendants’ Motion to Dismiss with prejudice.
The Clovis Defendants intend to vigorously defend against the allegations contained in the Kimbro, Medina, Moran
and Rocco Complaints, but there can be no assurance that the defense will be successful.
On January 22, 2016, the Electrical Workers Local #357 Pension and Health & Welfare Trusts, a purported
shareholder of Clovis, filed a purported class action complaint (the “Electrical Workers Complaint”) against Clovis and
certain of its officers, directors, investors and underwriters in the Superior Court of the State of California, County of
San Mateo. The Electrical Workers Complaint purports to be asserted on behalf of a class of persons who purchased
stock in Clovis’ July 8, 2015 follow-on offering. The Electrical Workers Complaint generally alleges that the defendants
violated the Securities Act because the offering documents for the July 8, 2015 follow-on offering contained allegedly
false and misleading statements regarding the progress toward FDA approval and the potential for market success of
rociletinib. The Electrical Workers Complaint seeks unspecified damages.
On February 25, 2016, the defendants removed the case to the United States District Court for the Northern District of
California and thereafter moved to transfer the case to the District of Colorado (“Motion to Transfer”). On March 2,
2016, the plaintiff filed a motion to remand the case to San Mateo County Superior Court (“Motion to Remand”).
Following briefing on the Motion to Transfer and the Motion to Remand, the Northern District of California held a
hearing on April 18, 2016 concerning the Motion to Remand, at the conclusion of which the court granted to the Motion
to Remand. On May 5, 2016, the Northern District of California issued a written decision and order granting the Motion
to Remand the case to the Superior Court, County of San Mateo and denying the Motion to Transfer as moot.
While the case was pending in the United States District Court for the Northern District of California, the parties
entered into a stipulation extending the defendants’ time to respond to the Electrical Workers Complaint for 30 days
following the filing of an amended complaint by plaintiff or the designation by plaintiff of the Electrical Workers
Complaint as the operative complaint. Following remand, Superior Court of the State of California, County of San
Mateo so-ordered the stipulation on June 22, 2016.
On June 30, 2016, the Electrical Workers Plaintiffs filed an amended Complaint (the “Amended Complaint”). The
Amended Complaint names as defendants the Company and certain of its current and former officers and directors,
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certain underwriters for the July 2015 Offering and certain Company venture capital investors. The Amended Complaint
purports to assert claims under the Securities Act based upon alleged misstatements in Clovis’ offering documents for
the July 2015 Offering. The Amended Complaint includes new allegations about the Company’s rociletinib disclosures.
The Amended Complaint seeks unspecified damages.
Pursuant to a briefing schedule ordered by the court on July 28, 2016, defendants filed a motion to stay the Electrical
Workers action pending resolution of the Medina, Kimbro, Moran, and Rocco actions in the District of Colorado
(“Motion to Stay”), and a demurrer to the Amended Complaint, on August 15, 2016; plaintiffs filed their oppositions on
August 31, 2016; and the defendants filed their reply briefs on September 15, 2016. On September 23, 2016, after
hearing oral argument, the San Mateo Superior Court granted defendants’ motion to stay proceedings pending resolution
of the related securities class action captioned Medina v. Clovis Oncology, Inc., et. al., No. 1:15-cv-2546 (the “Colorado
Action”). Per the order to stay proceedings, the San Mateo Superior Court will defer issuing a ruling on defendants’
pending demurrer, and the parties’ first status report as to the progress of the Colorado Action is due on March 23, 2017.
The Company intends to vigorously defend against the allegations contained in the Electrical Workers Amended
Complaint, but there can be no assurance that the defense will be successful.
On November 10, 2016, Antipodean Domestic Partners (“Antipodean”) filed a complaint (the “Antipodean
Complaint”) against Clovis and certain of its officers, directors and underwriters in New York Supreme Court, County of
New York. The Antipodean Complaint alleges that the defendants violated certain sections of the Securities Act by
making allegedly false statements to Antipodean and in the Offering Materials for the Secondary Offering relating to the
efficacy of rociletinib, its safety profile, and its prospects for market success. In addition to the Securities Act claims, the
Antipodean Complaint also asserts Colorado state law claims, and common law claims. Both the state law and common
law claims are based on the allegedly false and misleading statements regarding rociletinib’s progress toward FDA
approval. The Antipodean Complaint seeks compensatory, recessionary, and punitive damages.
On December 15, 2016, the Antipodean Plaintiffs filed an amended complaint (“the Amended Complaint”) asserting
substantially the same claims against the same defendants. The Amended Complaint purports to correct certain details in
the original Complaint.
On January 21, 2017, the parties entered into a stipulation extending the defendants’ time to respond to the
Antipodean Amended Complaint until March 29, 2017, subject to the terms and conditions stated therein. Pursuant to the
January 21, 2017 stipulation, the defendants filed a motion to stay the Antipodean action pending resolution of the
Medina, Kimbro, Moran, and Rocco actions in the District of Colorado (“Motion to Stay”) on January 31, 2017. The
Motion to Stay has a scheduled return date of March 24, 2017.
The Company intends to vigorously defend against the allegations contained in the Antipodean Amended Complaint,
but there can be no assurance that the defense will be successful.
We received a letter dated May 31, 2016 from an alleged owner of our common stock, which purports to set forth a
demand for inspection of certain of our books and records pursuant to 8 Del. C. § 220 (the “Macalinao Demand Letter”).
The Macalinao Demand Letter was purportedly made for the purposes of investigating alleged misconduct at the
Company relating to rociletinib. On June 24, 2016, we submitted a response to the Macalinao Demand Letter. We
believe that the allegations in the Macalinao Demand Letter are unfounded and that the Macalinao Demand Letter fails
to establish an entitlement to any of the requested documents, but there can be no assurance about the likelihood of an
adverse outcome. In January 2017, the Company produced certain books and records in response to the Macalinao
Demand Letter.
We received a letter dated December 15, 2016 from a second alleged owner of our common stock, which purports to
set forth a demand for inspection of the Company’s books and records pursuant to 8 Del. C. § 220 (the “McKenry
Demand Letter”). The McKenry Demand Letter was purportedly made for the purposes of investigating alleged
misconduct at the Company relating to rociletinib. In addition, citing unnamed sources, the McKenry Demand Letter
alleges that the Company engaged in patient eligibility, record management and verification, and informed consent
violations in connection with the TIGER-X study at multiple testing sites, and that the FDA is purportedly investigating
the Company’s conduct. On January 4, 2017, we submitted a response to the McKenry Demand Letter. The Company
believes that the allegations in the McKenry Demand Letter are unfounded and that the McKenry Demand Letter fails to
establish an entitlement to any of the requested documents, but there can be no assurance about the likelihood of an
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adverse outcome. In February 2017, the Company produced certain books and records in response to the McKenry
Demand Letter.
We have received requests for information from governmental agencies relating to our regulatory update
announcement in November 2015 that the FDA requested additional clinical data on the efficacy and safety of
rociletinib. We are cooperating with the inquiries.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS
AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information and Holders
Our common stock trades on the NASDAQ Global Select Market under the symbol “CLVS.” The following table sets
forth, for the periods indicated, the high and low sales prices for our common stock as reported on the NASDAQ Global
Select Market:
Balance, December 31, 2016
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
Balance, December 31, 2015
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
HIGH
LOW
$
$
$
$
$
$
$
$
34.75 $
20.90 $
40.29 $
46.97 $
83.46 $
102.28 $
116.75 $
109.18 $
16.78
11.57
13.43
25.50
54.88
68.40
65.00
24.50
On February 19, 2017, there were approximately 27 holders of record of our common stock. The holders of record
number does not include a substantially greater number of holders whose shares are held of record in nominee or street
name accounts through banks, brokers and/or other financial institutions.
Dividends
We have never declared or paid any cash dividends on our capital stock. We currently intend to retain all available
funds and any future earnings to support our operations and finance the growth and development of our business. We do
not intend to pay cash dividends on our common stock for the foreseeable future. Any future determination related to our
dividend policy will be made at the discretion of our board of directors and will depend upon, among other factors, our
results of operations, financial condition, capital requirements, contractual restrictions, business prospects and other
factors our board of directors may deem relevant.
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Securities Authorized for Issuance Under Equity Compensation Plans
Equity Compensation Plan Information
As of December 31, 2016
Weighted-
average
Number of
securities
remaining
available
for issuance
under equity
compensation
plans
(excluding
securities
reflected
in column (a))
Number of securities to exercise price
be issued upon exercise of outstanding
of outstanding options options and
and rights
rights
Plan Category
Equity compensation plans approved by security holders (1) (2)
Equity compensation plans not approved by security holders
Total
(a)
6,082,940 $
—
6,082,940 $
(b)
42.00
—
42.00
(c)
2,006,352
—
2,006,352
(1) As of December 31, 2016, 7,799,048 shares were authorized for issuance under our 2011 Stock Incentive Plan
(“2011 Plan”), which became effective upon closing of our initial public offering in November 2011, including
192,185 remaining shares available for future issuance under the 2009 Equity Incentive Plan (“2009 Plan”), which
were transferred to the 2011 Plan. The number of shares of our common stock reserved for issuance under the 2011
Plan will be increased (i) from time to time by the number of shares of our common stock forfeited upon the
expiration, cancellation, forfeiture, cash settlement or other termination of awards under the 2009 Plan and (ii) at the
discretion of our board of directors, on the date of each annual meeting of our stockholders, by up to the lesser of
(x) a number of additional shares of our common stock representing 4% of our then-outstanding shares of common
stock on such date and (y) 2,758,621 shares of our common stock.
(2) As of December 31, 2016, 265,723 shares were reserved for issuance under our 2011 Employee Stock Purchase
Plan (“ESPP”), which became effective upon closing of our initial public offering in November 2011. The number
of shares of our common stock reserved for issuance under the ESPP will be increased at the discretion of our board
of directors, on the date of each annual meeting of our stockholders, by up to the lesser of (x) a number of additional
shares of our common stock representing 1% of our then-outstanding shares of common stock on such date and
(y) 344,828 shares of our common stock.
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Performance Graph (1)
The following graph shows a comparison from December 31, 2011 through December 31, 2016 of the cumulative
total return on an assumed investment of $100 in cash in our common stock, the NASDAQ Composite Index and the
NASDAQ Biotechnology Index. Such returns are based on historical results and are not intended to suggest future
performance. Data for the NASDAQ Composite Index and the NASDAQ Biotechnology Index assume reinvestment of
dividends.
(1) This performance graph shall not be deemed “soliciting material” or to be “filed” with the SEC for purposes of
Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities under that
Section, and shall not be deemed incorporated by reference into any filing of Clovis Oncology, Inc. under the
Securities Act of 1933, as amended.
ITEM 6.
SELECTED FINANCIAL DATA
The following table sets forth certain of our selected historical financial data at the dates and for the periods indicated.
The selected historical statement of operations data presented below for the years ended December 31, 2016, 2015 and
2014 and the historical balance sheet data as of December 31, 2016 and 2015 have been derived from our audited
financial statements, which are included elsewhere in this Annual Report on Form 10-K. The historical statement of
operations data presented below for the years ended December 31, 2013 and 2012 and the historical balance sheet data
as of December 31, 2014, 2013 and 2012 have been derived from our audited financial statements that do not appear in
this report.
Our historical results are not necessarily indicative of results expected in any future period.
The selected historical financial data presented below should be read in conjunction with “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes
thereto, which are included elsewhere in this Annual Report on Form 10-K. The selected historical financial information
in this section is not intended to replace our financial statements and the related notes thereto.
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Statement of Operations Data:
Revenues:
Product revenue, net
License and milestone revenue
Total revenues
Operating expenses:
Cost of sales - product
Research and development
Selling, general and administrative
Acquired in-process research and development
Impairment of intangible asset
Change in fair value of contingent purchase
consideration
Total expenses
Operating loss
Other income (expense):
Interest expense
Foreign currency gains (losses)
Other income (expense)
Other income (expense), net
Loss before income taxes
Income tax benefit (expense)
Net loss
Basic and diluted net loss per common share
Basic and diluted weighted average common shares
outstanding
Balance Sheet Data:
Year Ended December 31,
2016
2015
2014
2013
2012
(in thousands, except per share amounts)
$
78 $
—
78
— $
—
—
— $
13,625
13,625
— $
—
—
—
—
—
70
251,129
40,731
1,300
104,517
—
269,251
30,524
12,000
89,557
—
137,705
21,457
8,806
3,409
—
66,545
16,567
250
—
—
58,894
10,638
4,250
—
(24,936)
372,811
(372,733)
(24,611)
376,721
(376,721)
707
172,084
(158,459)
405
83,767
(83,767)
—
73,782
(73,782)
(8,372)
2,740
416
(5,216)
(381,937)
29,076
(8,491)
(580)
633
(8,438)
(381,171)
32,034
—
(65)
(163)
(228)
(74,010)
27
$ (349,137) $ (352,861) $ (160,031) $ (84,532) $ (73,983)
(2.97)
$
(2,604)
3,580
(240)
736
(157,723)
(2,308)
—
(535)
(178)
(713)
(84,480)
(52)
(9.07) $
(4.72) $
(9.79) $
(2.95) $
38,478
36,026
33,889
28,672
24,915
2016
2015
2014
2013
2012
As of December 31,
(in thousands)
Cash, cash equivalents and available-for-sale
securities
Working capital
Total assets
Convertible senior notes
Common stock and additional paid-in capital
Total stockholders’ (deficit) equity
$ 266,183 $
213,813
364,557
281,126
528,588 $ 482,677 $ 323,228 $ 144,097
132,712
464,125 443,400
145,994
713,386 786,206
—
279,885 278,680
317,925
1,174,989 1,130,016 785,123
133,496
300,650 331,630
307,644
649,635
—
762,204
497,886
(3,634)
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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together
with our financial statements and related notes appearing at the end of this Annual Report on Form 10-K. Some of the
information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K,
including information with respect to our plans and strategy for our business and related financing, includes forward-
looking statements that involve risks and uncertainties. You should read the “Risk Factors” section of this report for a
discussion of important factors that could cause actual results to differ materially from the results described in or
implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We are a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer
agents in the United States, Europe and additional international markets. We target our development programs for the
treatment of specific subsets of cancer populations, and simultaneously develop, with partners, diagnostic tools intended
to direct a compound in development to the population that is most likely to benefit from its use.
Our commercial product Rubraca (rucaparib) is the first and only oral, small molecule poly ADP-ribose polymerase,
or PARP, inhibitor of PARP1, PARP2 and PARP3 approved in the United States by the FDA as monotherapy for the
treatment of patients with deleterious BRCA (human genes associated with the repair of damaged DNA) mutation
(germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies,
and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.
The MAA submission with the EMA for a comparable ovarian cancer indication was accepted by the EMA during
the fourth quarter of 2016. Additionally, rucaparib is being studied as a potential maintenance therapy for ovarian cancer
patients in the ARIEL3 trial. Data from ARIEL3 is anticipated in mid-2017. Pending positive data from ARIEL3, we
intend to follow up with a supplemental NDA for second-line maintenance therapy in women with ovarian cancer who
have responded to platinum-based therapy. Rucaparib is also being developed in patients with mutant BRCA tumors
and other DNA repair deficiencies beyond BRCA – commonly referred to as homologous recombination deficiencies.
Studies open for enrollment or under consideration include prostate, breast, pancreatic, gastroesophageal, bladder and
lung cancers. We hold worldwide rights for rucaparib.
In addition, we have two other product candidates: lucitanib, an oral inhibitor of the tyrosine kinase activity of
vascular endothelial growth factor receptors (VEGFR) 1-3, platelet-derived growth factor receptors (PDGFR) alpha and
beta and fibroblast growth factor receptors (FGFR) 1-3, and rociletinib, an oral mutant-selective inhibitor of EGFR.
Clinical development for each of these candidates has ceased and we continue to provide drug to patients whose
clinicians recommend continuing therapy. We maintain certain development and commercialization rights for lucitanib
and global development and commercialization rights for rociletinib.
We commenced operations in April 2009. To date, we have devoted substantially all of our resources to identifying
and in-licensing product candidates, performing development activities with respect to those product candidates and the
general and administrative support of these operations. Through December 31, 2016, we have generated $13.6 million in
license and milestone revenue related to our collaboration and license agreement with Servier and have generated $0.1
million product revenue related to sales of Rubraca, which we began to commercialize on December 19, 2016. We have
principally funded our operations using the net proceeds from the sale of convertible preferred stock, the issuance of
convertible promissory notes, public offerings of our common stock and our convertible senior notes offering.
We have never been profitable and, as of December 31, 2016, we had an accumulated deficit of $1,131.0 million. We
incurred net losses of $349.1 million, $352.9 million and $160.0 million for the years ended December 31, 2016, 2015
and 2014, respectively, and had cash, cash equivalents and available-for-sale securities totaling $266.2 million at
December 31, 2016.
We expect to incur significant losses for the foreseeable future, as we incur costs related to commercial activities
associated with Rubraca. In January 2017, we sold 5,750,000 shares of our common stock in a public offering at $41.00
per share. The net proceeds from the offering were $221.2 million, after deducting underwriting discounts and
commissions and offering expenses. We intend to use the net proceeds of the offering for general corporate purposes,
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including commercial planning and sales and marketing expenses associated with the launch of Rubraca in the United
States and, if approved by the EMA, in Europe, funding of our development programs, selling, general and
administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.
Based on our current estimates, we believe that our cash, cash equivalents and available-for-sale securities will allow us
to fund activities through at least the next 12 months. Until we can generate a sufficient amount of revenue from
Rubraca, we expect to finance our operations in part through additional public or private equity or debt offerings and
may seek additional capital through arrangements with strategic partners or from other sources. Adequate additional
financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would
have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to
generate significant revenues to achieve profitability, and we may never do so.
Product License Agreements
Rucaparib
In June 2011, we entered into a license agreement with Pfizer Inc. to acquire exclusive global development and
commercialization rights to rucaparib. The exclusive rights are exclusive even as to Pfizer and include the right to grant
sublicenses. Pursuant to the terms of the license agreement, we made a $7.0 million upfront payment to Pfizer. In April
2014, we initiated a pivotal registration study for rucaparib, which resulted in a $0.4 million milestone payment to Pfizer
as required by the license agreement. In September 2016, we made a milestone payment of $0.5 million to Pfizer upon
acceptance of the NDA for rucaparib by the FDA. The MAA submission with the EMA for a comparable ovarian cancer
indication was completed and accepted by the MAA during the fourth quarter of 2016, which resulted in a $0.5 million
milestone payment to Pfizer as required by the license agreement. These payments were recognized as acquired in-
process research and development expense.
On August 30, 2016, we entered into a first amendment to the worldwide license agreement with Pfizer, which
amends the June 2011 existing worldwide license agreement to permit us to defer payment of the milestone payments
payable upon (i) FDA approval of an NDA for 1st Indication in US and (ii) EMA approval of an MAA for 1st Indication
in EU, to a date that is 18 months after the date of achievement of such milestones. In the event that we defer such
milestone payments, we have agreed to certain higher payments related to the achievement of such milestones.
On December 19, 2016, the FDA approved Rubraca tablets as monotherapy for the treatment of patients with
deleterious BRCA mutation (germline and/or somatic) associated with advanced ovarian cancer, who have been treated
with two or more chemotherapies, and selected for therapy based on FDA-approved companion diagnostic for Rubraca.
The FDA approval resulted in a $0.75 million milestone payment to Pfizer as required by the license agreement. The
FDA approval also resulted in the obligation to pay a $20.0 million milestone payment, for which we have exercised the
option to defer payment by agreeing to pay $23.0 million within 18 months after the date of the FDA approval. These
payments were recognized as intangible assets and amortized over the estimated remaining useful life of rucaparib.
We are obligated under the license agreement to use commercially reasonable efforts to develop and commercialize
rucaparib and we are responsible for all remaining development and commercialization costs for rucaparib. We are
required to make regulatory milestone payments to Pfizer of up to an additional $69.75 million in aggregate if specified
clinical study objectives and regulatory filings, acceptances and approvals are achieved. In addition, we are obligated to
make sales milestone payments to Pfizer if specified annual sales targets for rucaparib are met, the majority of which
relate to annual sales targets of $500.0 million and above, which, in the aggregate, could amount to total milestone
payments of $170.0 million, and tiered royalty payments at a mid-teen percentage rate on our net sales, with standard
provisions for royalty offsets to the extent we need to obtain any rights from third parties to commercialize rucaparib.
The license agreement with Pfizer will remain in effect until the expiration of all of our royalty and sublicense
revenue obligations to Pfizer, determined on a product-by-product and country-by-country basis, unless we elect to
terminate the license agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure
such failure within specified time periods, Pfizer can terminate the agreement, resulting in a loss of our rights to
rucaparib and an obligation to assign or license to Pfizer any intellectual property rights or other rights we may have in
rucaparib, including our regulatory filings, regulatory approvals, patents and trademarks for rucaparib.
In April 2012, we entered into a license agreement with AstraZeneca UK Limited to acquire exclusive rights
associated with rucaparib under a family of patents and patent applications that claim methods of treating patients with
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PARP inhibitors in certain indications. The license enables the development and commercialization of rucaparib for the
uses claimed by these patents. Pursuant to the terms of the license agreement, we made an upfront payment of $0.25
million upon execution of the agreement. During the second quarter of 2016, we made a milestone payment of $0.3
million to AstraZeneca upon the NDA submission for rucaparib. These payments were recognized as acquired in-process
research and development expense. The FDA approval of rucaparib on December 19, 2016 resulted in a $0.35 million
milestone payment to AstraZeneca as required by the license agreement. This payment was recognized as intangible
assets and amortized over the estimated remaining useful life of rucaparib. AstraZeneca will also receive royalties on
any net sales of rucaparib.
Lucitanib
In October 2008, EOS (now known as Clovis Oncology Italy S.r.l.) entered into an exclusive license agreement with
Advenchen to develop and commercialize lucitanib on a global basis, excluding China. We are obligated to pay
Advenchen tiered royalties at percentage rates in the mid-single digits on net sales of lucitanib, based on the volume of
annual net sales achieved. In addition, after giving effect to the first and second amendments to the license agreement,
we are required to pay to Advenchen 25% of any consideration, excluding royalties, we receive from sublicensees, in
lieu of the milestone obligations set forth in the agreement. We are obligated under the agreement to use commercially
reasonable efforts to develop and commercialize at least one product containing lucitanib, and we are also responsible
for all remaining development and commercialization costs for lucitanib. In the first quarter of 2014, we recognized
acquired in-process research and development expense of $3.4 million, which represents 25% of the sublicense
agreement consideration of $13.6 million received from Servier upon the end of opposition and appeal of the lucitanib
patent by the European Patent Office.
The license agreement with Advenchen will remain in effect until the expiration of all of our royalty obligations to
Advenchen, determined on a product-by-product and country-by-country basis, unless we elect to terminate the
agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within
specified time periods, Advenchen can terminate the agreement, resulting in a loss of our rights to lucitanib.
In September 2012, EOS entered into a collaboration and license agreement with Servier whereby EOS sublicensed to
Servier exclusive rights to develop and commercialize lucitanib in all countries outside of the U.S., Japan and China. In
exchange for these rights, EOS received an upfront payment of €45.0 million. We are entitled to receive additional
payments upon achievement of specified development, regulatory and commercial milestones up to €100.0 million in the
aggregate, €10.0 million of which was received in the first quarter of 2014. In addition, we are entitled to receive sales
milestone payments if specified annual sales targets for lucitanib are met, which, in the aggregate, could total
€250.0 million. We are also entitled to receive royalties on sales of lucitanib by Servier.
We and Servier are developing lucitanib pursuant to a development plan agreed to between the parties. Servier is
responsible for all of the global development costs for lucitanib up to €80.0 million. Cumulative global development
costs in excess of €80.0 million, if any, will be shared equally between us and Servier. During the second quarter of
2016, we and Servier agreed to discontinue the development of lucitanib for breast cancer and lung cancer and are
continuing to evaluate what, if any, further development of lucitanib will be pursued. Based on current estimates, we
expect to complete the committed on-going development activities in 2017 and expect full reimbursement of our
development costs from Servier. Reimbursements are recorded as a reduction to research and development expense on
the Consolidated Statements of Operations.
Rociletinib
In May 2010, we entered into an exclusive worldwide license agreement with Celgene to discover, develop and
commercialize a covalent inhibitor of mutant forms of the EGFR gene product. Rociletinib was identified as the lead
inhibitor candidate under the license agreement. We are responsible for all non-clinical, clinical, regulatory and other
activities necessary to develop and commercialize rociletinib.
We made an upfront payment of $2.0 million upon execution of the license agreement, a $4.0 million milestone
payment in the first quarter of 2012 upon the acceptance by the FDA of our IND application for rociletinib and a $5.0
million milestone payment in the first quarter of 2014 upon the initiation of the Phase II study for rociletinib. In the third
quarter of 2015, we made milestone payments totaling $12.0 million upon acceptance of the NDA and MAA for
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rociletinib by the FDA and EMA, respectively. We recognized all payments prior to commercial approval as acquired in-
process research and development expense.
During the second quarter of 2016, we received a CRL from the FDA for the rociletinib NDA. The FDA issues a
CRL to indicate that their review of an application is complete and that the application is not ready for approval. In
anticipation of receiving the CRL, we terminated enrollment in all ongoing sponsored clinical studies, although we
continue to provide drug to patients whose clinicians recommend continuing rociletinib therapy. In addition, we
withdrew our MAA for rociletinib on file with the EMA. We are continuing analyses of rociletinib data to determine
whether certain populations of patients may represent an opportunity for a partner committed to investing in further
clinical development.
We are obligated to pay royalties at percentage rates ranging from mid-single digits to low-teens based on the volume
of annual net sales achieved. We are required to pay up to an additional aggregate of $98.0 million in development and
regulatory milestone payments if certain clinical study objectives and regulatory filings, acceptances and approvals are
achieved. In addition, we are required to pay up to an aggregate of $120.0 million in sales milestone payments if certain
annual sales targets are achieved.
Financial Operations Overview
Revenue
To date, we have generated $13.6 million in license and milestone revenue related to our collaboration and license
agreement with Servier. During December 2016, we recorded $0.1 million revenue related to sales of Rubraca, which we
began to commercialize on December 19, 2016. For further discussion of our revenue recognition policy, see “Critical
Accounting Policies and Significant Judgments and Estimates” below. Our ability to generate revenue and become
profitable depends upon our ability to successfully commercialize products. Any inability on our part to successfully
commercialize Rubraca in the United States and any foreign territories where it may be approved, or any significant
delay in such approvals, could have a material adverse impact on our ability to execute upon our business strategy and,
ultimately, to generate sufficient revenues from Rubraca to reach or maintain profitability or sustain our anticipated
levels of operations.
Research and Development Expenses
Research and development expenses consist of costs incurred for the development of our product candidates and
companion diagnostics, which include:
•
•
•
license fees and milestone payments related to the acquisition of in-licensed products, which are reported on our
Consolidated Statements of Operations as acquired in-process research and development;
employee-related expenses, including salaries, benefits, travel and share-based compensation expense;
expenses incurred under agreements with contract research organizations (“CROs”) and investigative sites that
conduct our clinical trials;
the cost of acquiring, developing and manufacturing clinical trial materials;
costs associated with non-clinical activities and regulatory operations;
•
•
• market research, disease education and other commercial product planning activities, including the hiring of a
U.S. sales and marketing and medical affairs organization in preparation for commercial launch of rucaparib;
and
activities associated with the development of companion diagnostics for our product candidates.
•
Research and development costs are expensed as incurred. License fees and milestone payments related to in-licensed
products and technology are expensed if it is determined that they have no alternative future use. Costs for certain
development activities, such as clinical trials and manufacturing of clinical supply, are recognized based on an
evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations
or information provided to us by our vendors. As a result of the FDA approval of Rubraca and the discontinuation of
enrollment in rociletinib, our research and development expenses will decrease for 2017 as we continue to
commercialize Rubraca and commercialization related expenses are classified as selling, general and administrative
expenses and not research and development costs.
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The following table identifies research and development and acquired in-process research and development costs on a
program-specific basis for our products under development. Personnel-related costs, depreciation and share-based
compensation are not allocated to specific programs, as they are deployed across multiple projects under development
and, as such, are separately classified as personnel and other expenses in the table below.
2016
Year Ended December 31,
2015
(in thousands)
2014
Rucaparib Expenses
Research and development
Acquired in-process R&D
Rucaparib Total
Lucitanib Expenses
Research and development (a)
Acquired in-process R&D
Lucitanib Total
Rociletinib Expenses
Research and development
Acquired in-process R&D
Rociletinib Total
Personnel and other expenses
Total
$ 101,598 $ 58,922 $ 35,010
400
35,410
1,300
102,898
—
58,922
(1,337)
—
(1,337)
1,923
—
1,923
(491)
3,406
2,915
69,920
122,912
43,768
5,000
12,000
—
74,920
134,912
43,768
107,100
33,266
85,494
$ 252,429 $ 281,251 $ 146,511
(a) This amount reflects actual costs incurred less amounts due from Servier for reimbursable development expenses
pursuant to the collaboration and license agreement described in Note 11, License Agreements, to our audited
consolidated financial statements included in this Annual Report on Form 10-K.
Research and development expenses increased significantly from 2014 through 2015 due to the expansion of our
clinical development activities for rociletinib and rucaparib. In addition, during 2015, we increased commercial product
planning activities in anticipation of the potential regulatory approval and commercial launch in the U.S. of rociletinib.
These activities included the hiring of our U.S. sales and marketing and medical affairs organizations. For 2016, research
and development expenses decreased compared to 2015 primarily due to decreased development activities for the
rociletinib program, partially offset by higher expenses related to the rucaparib program.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist principally of salaries and related costs for personnel in
executive, finance, legal, investor relations, human resources and information technology functions. Other general and
administrative expenses include facilities expenses, communication expenses, information technology costs, corporate
insurance and professional fees for legal, consulting and accounting services. With the FDA approval of Rubraca on
December 19, 2016, all sales and marketing expenses associated with Rubraca are included in selling, general and
administrative expenses.
Effective May 9, 2016, at Mr. Mahaffy’s request, the Compensation Committee of the Board of Directors approved
his waiver of any annual base salary in excess of $1.00, plus the cost of the employee portion of any premiums to be paid
pursuant to any health and welfare benefit plans maintained by us and any tax withholdings related to health and welfare
benefits. Such waiver continued in effect until the earliest to occur of (i) the Company entering into a definitive
agreement with respect to a transaction that if consummated would constitute a Change in Control (as defined in his
Employment Agreement) or the public announcement of a proposal or transaction that if consummated would constitute
a Change of Control, (ii) approval by the FDA to commercially distribute, sell or market rucaparib, and (iii) termination
of his employment by the Company without Just Cause or by Mr. Mahaffy for Good Reason (each as defined in his
Employment Agreement). On December 19, 2016, the FDA approved Rubraca resulting in the discontinuation of Mr.
Mahaffy’s waiver.
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Acquired In-Process Research and Development Expenses
Acquired in-process research and development expenses consist of upfront payments to acquire a new drug
compound, as well as subsequent milestone payments. Acquired in-process research and development payments are
immediately expensed provided that the drug has not achieved regulatory approval for marketing and, absent obtaining
such approval, has no alternative future use. Once regulatory approval is received, payments to acquire rights, and the
related milestone payments, are capitalized and the amortization of such assets recorded to product cost of sales.
Impairment of Intangible Asset
In connection with the acquisition of EOS in November 2013, we recorded intangible assets to reflect the fair value of
acquired in-process research and development (“IPR&D”) as of the acquisition date. The fair value was established
based upon discounted cash flow models using assumptions related to the timing of development, probability of
development and regulatory success, sales and commercialization factors and estimated product life. During the second
quarter of 2016, we recorded a $104.5 million impairment charge due to our and our development partner’s decision to
discontinue the development of lucitanib for breast cancer. At December 31, 2016, the IPR&D intangible asset recorded
on the Consolidated Balance Sheets was zero. Previously, the Company recorded an $89.6 million impairment charge to
the IPR&D intangible assets during the fourth quarter of 2015.
Change in Fair Value of Contingent Purchase Consideration
In connection with the acquisition of EOS in November 2013, we also recorded a purchase consideration liability
equal to the estimated fair value of future payments that are contingent upon the achievement of various regulatory and
sales milestones. Subsequent to the acquisition date, we re-measure contingent consideration arrangements at fair value
each reporting period and record changes in fair value to change in fair value of contingent purchase consideration and
foreign currency gains (losses) for changes in the foreign currency translation rate on the Consolidated Statements of
Operations. Changes in fair value are primarily attributed to new information about the likelihood of achieving such
milestones and the passage of time. In the absence of new information, changes to fair value reflect only the passage of
time as we progress towards the achievement of future milestones. During the second quarter of 2016, we recorded a
$25.5 million reduction in the fair value of the contingent purchase consideration liability due to our and our
development partner’s decision to discontinue the development of lucitanib for breast cancer. At December 31, 2016, the
contingent purchase consideration liability recorded on the Consolidated Balance Sheets remained at zero due to the
uncertainty of achieving any of the lucitanib regulatory milestones, and therefore the remote likelihood of future
milestone payout amounts to the former EOS shareholders.
Other Income and Expense
Other income and expense is primarily comprised of foreign currency gains and losses resulting from transactions
with CROs, investigational sites and contract manufacturers where payments are made in currencies other than the U.S.
dollar. In addition, a significant portion of the contingent purchase consideration liability will be settled in Euro-
denominated payments if certain future milestones are achieved and is subject to fluctuations in foreign currency rates.
Other expense also includes interest expense recognized related to our convertible senior notes.
Critical Accounting Policies and Significant Judgments and Estimates
Our discussion and analysis of our financial condition and results of operations are based on our financial statements,
which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these
financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities,
expenses and revenue and related disclosures. On an ongoing basis, we evaluate our estimates and judgments, including
those related to contingent purchase consideration, the allocation of purchase consideration, intangible asset impairment,
clinical trial accruals and share-based compensation. We base our estimates on historical experience, known trends and
events and various other factors that are believed to be reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates under different assumptions or conditions.
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Our significant accounting policies are described in more detail in the notes to our consolidated financial statements
appearing elsewhere in this Annual Report on Form 10-K. We believe the following accounting policies to be most
critical to the judgments and estimates used in the preparation of our financial statements.
Accrued Research and Development Expenses
As part of the process of preparing our financial statements, we are required to estimate our accrued expenses. This
process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services
that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for
the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service
providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make
estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and
circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers
and make adjustments if necessary. Examples of estimated accrued research and development expenses include:
•
•
•
•
•
fees paid to CROs in connection with clinical studies;
fees paid to investigative sites in connection with clinical studies;
fees paid to vendors in connection with non-clinical development activities;
fees paid to vendors associated with the development of companion diagnostics; and
fees paid to vendors related to product manufacturing, development and distribution of clinical supplies.
We base our expenses related to clinical studies on our estimates of the services received and efforts expended
pursuant to contracts with multiple CROs that conduct and manage clinical studies on our behalf. The financial terms of
these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows.
There may be instances in which payments made to our vendors will exceed the level of services provided and result in a
prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful
enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we estimate the time
period over which services will be performed, enrollment of patients, number of sites activated and the level of effort to
be expended in each period. If the actual timing of the performance of services or the level of effort varies from our
estimate, we adjust the accrual or prepaid accordingly. Although we do not expect our estimates to be materially
different from amounts actually incurred, our understanding of the status and timing of services performed relative to the
actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too
low in any particular period. Based on the amount of accrued research and development expenses as of December 31,
2016, if our estimates of our net accrued liabilities are too high or too low by 5%, this could increase or decrease our
research and development expenses by approximately $1.8 million.
Share-Based Compensation
Determining the amount of share-based compensation to be recorded requires us to develop estimates of the fair value
of stock options as of their grant date. Compensation expense is recognized over the vesting period of the award.
Calculating the fair value of share-based awards requires that we make highly subjective assumptions. We use the Black-
Scholes option pricing model to value our stock option awards. Use of this valuation methodology requires that we make
assumptions as to the expected dividend yield, price volatility of our common stock, the risk-free interest rate for a
period that approximates the expected term of our stock options and the expected term of our stock options. We utilize a
dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash
dividends.
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The fair value of stock options for the years ended December 31, 2016, 2015 and 2014 was estimated at the grant date
using the following weighted average assumptions for the respective periods:
Dividend yield
Volatility (a)
Risk-free interest rate (b)
Expected term (years) (c)
Year Ended December 31,
2014
2016
—
—
70 %
1.77 % 1.77 % 1.92 %
6.1
5.8
2015
—
72 %
93 %
6.2
(a) Volatility: The expected volatility was estimated using our historical data.
(b) Risk-free interest rate: The rate is based on the yield on the grant date of a zero-coupon U.S. Treasury bond whose
maturity period approximates the option’s expected term.
(c) Expected term: The expected term of the award was estimated using our historical data.
We recognized share-based compensation expense of approximately $39.8 million, $40.4 million and $21.5 million
for the years ended December 31, 2016, 2015 and 2014, respectively. As of December 31, 2016, we had $86.8 million in
total unrecognized share-based compensation expense, net of related forfeiture estimates, which is expected to be
recognized over a weighted-average remaining vesting period of 3.1 years. We expect our share-based compensation to
continue to grow in future periods due to the potential increases in the value of our common stock and headcount.
We are required to estimate the level of forfeitures expected to occur and record compensation expense only for those
awards that we ultimately expect will vest.
Valuation of Contingent Consideration Resulting from a Business Combination
Contingent consideration resulting from a business combination is reported at its fair value on the acquisition date.
Each subsequent reporting period, the contingent consideration obligations are revalued and changes in fair value are
recorded to change in fair value of contingent purchase consideration and foreign currency gains (losses) for changes in
the foreign currency translation rate on the Consolidated Statements of Operations.
Changes to contingent consideration obligations can result from adjustments to discount rates and time periods,
updates in the assumed achievement or timing of any development milestone or changes in the probability of certain
clinical events and regulatory approvals. The assumptions related to determining the value of contingent consideration
require significant judgment and changes to the assumptions may have a material impact on the amount of expense
recorded in any given period. The acquisition of EOS resulted in the recognition of a contingent consideration liability,
based on assumptions related to potential future payout amounts, estimated discount rate, probability of success for each
milestone achievement and the estimated timing of the milestone payments to the former EOS shareholders.
During the second quarter 2016, we recorded $25.5 million reduction in fair value of the contingent purchase
consideration due to our and our development partner’s decision to discontinue the development of lucitanib for breast
cancer. At December 31, 2016, the contingent purchase consideration liability recorded on the Consolidated Balance
Sheets remained at zero due to the uncertainty of achieving any of the lucitanib regulatory milestones, and therefore the
remote likelihood of future milestone payout amounts to the former EOS shareholders.
Intangible Assets
Definite-lived intangible assets related to capitalized milestones under license agreements are amortized on a straight-
line basis over their remaining useful lives, which are estimated to be the remaining patent life. If our estimate of the
product’s useful life is shorter than the remaining patent life, then a shorter period is used. Amortization expense is
recorded as a component of cost of sales in the Consolidated Statements of Operations.
IPR&D assets were established as part of the acquisition of EOS in November 2013 and have not been amortized, but
have been assessed for impairment.
Intangible assets are evaluated for impairment at least annually in the fourth quarter or more frequently if impairment
indicators exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the decision to
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discontinue the development of a drug, the receipt of additional clinical or nonclinical data regarding our drug candidate or a
potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information
regarding potential sales for the drug. In connection with any impairment assessment, the fair value of the intangible assets
as of the date of assessment is compared to the carrying value of the intangible asset. Impairment losses are recognized if
the carrying value of an intangible asset is both not recoverable and exceeds its fair value. During the second quarter of
2016, we recorded a $104.5 million impairment charge to the IPR&D intangible assets due to our and our development
partner’s decision to discontinue the development of lucitanib for breast cancer, thereby reducing the remaining carrying
value to zero.
Revenue Recognition
We are currently approved to sell Rubraca in the United States markets. We distribute our product principally
through a limited number of specialty distributor and specialty pharmacy providers, collectively, our customers. Our
customers subsequently resell our products to patients and health care providers. Separately, we have arrangements with
certain payors and other third parties that provide for government-mandated and privately-negotiated rebates,
chargebacks and discounts.
Revenues from product sales are recognized when persuasive evidence of an arrangement exists, delivery has
occurred and title of the product and associated risk of loss has passed to the customer, the price is fixed or determinable,
collection from the customer has been reasonably assured and all performance obligations have been met and returns and
allowances can be reasonably estimated. Product sales are recorded net of estimated rebates, chargebacks, discounts and
other deductions as well as estimated product returns. Estimating rebates, chargebacks, discounts, product returns and
other deductions requires significant judgments about future events and uncertainties, and requires us to rely heavily on
assumptions, as well as historical experience. We only recognize revenue on product sales once the product is resold to
the patient or healthcare provider by the specialty distributor or specialty pharmacy provider, therefore reducing the
significance of estimates made for product returns.
For the year ended December 31, 2016, we recognized $0.1 million of product revenue. Based on our policy to
expense costs associated with the manufacture of our products prior to regulatory approval, certain of the costs of
Rubraca units recognized as revenue during the year ended December 31, 2016 were expensed prior to the December 19,
2016 FDA approval, and therefore are not included in cost of sales during the current period. We expect cost of sales to
increase in relation to product revenues as we deplete these inventories. We expect to use the remaining pre-
commercialization inventory for product sales through the third quarter of 2017.
Revenue is recognized from milestone payments when the following criteria have been met: (1) persuasive evidence
of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the price is fixed or determinable;
and (4) collectability is reasonably assured. We exercise judgment in determining that collectability is reasonably
assured or that services have been delivered in accordance with the arrangement. We assess whether the fee is fixed or
determinable based on the payment terms associated with the transaction and whether the sales price is subject to refund
or adjustment. We assess collectability based primarily on the customer’s payment history and creditworthiness of the
customer. Payments that are contingent upon the achievement of a milestone will be recognized in the period in which
the milestone is achieved.
Results of Operations
Comparison of Years Ended December 31, 2016, 2015 and 2014:
License and Milestone Revenue. License and milestone revenue for the year ended December 31, 2014 was due to
the recognition of $13.6 million of milestone revenue from Servier upon the end of opposition and appeal of the
lucitanib patent by the European Patent Office in the first quarter of 2014. We did not recognize any license and
milestone revenue in 2016 and 2015.
Product Revenue, Net. Product revenue for the year ended December 31, 2016 was due to the recognition of $0.1
million of product revenue from the sale of Rubraca, which was approved for sale in the United States markets on
December 19, 2016.
Cost of Sales - Product. Cost of sales for the year ended December 31, 2016 consists of costs associated with the sale
of Rubraca, mainly freight, royalties and amortization of capitalized acquired intangible license right and milestone
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payments related to Rubraca. Based on our policy to expense costs associated with the manufacture of our products prior
to regulatory approval, certain of the costs of Rubraca units recognized as revenue during the year ended December 31,
2016 were expensed prior to the December 19, 2016 FDA approval, and therefore are not included in costs of sales
during the current period. We expect cost of sales to increase in relation to product revenues as we deplete these
inventories and amortize the capitalized acquired intangible license rights and milestone payments related to Rubraca.
We expect to use the remaining pre-commercialization inventory for product sales through the third quarter of 2017.
Research and Development Expenses. Research and development expenses for the years ended December 31, 2016,
2015 and 2014 were as follows:
Research and development expenses
Increase (decrease) from prior year
% Change from prior year
2016
Year Ended December 31,
2015
(in thousands)
$ 269,251
$ 131,546
2014
$ 137,705
n/a
n/a
(6.7)%
95.5 %
$ 251,129
$ (18,122)
The decrease in research and development expenses for the year ended December 31, 2016 compared to 2015 was
primarily due to decreased development activities for the rociletinib program partially offset by higher expenses related
to the rucaparib program.
Clinical trial costs for rucaparib were $14.0 million higher in 2016 than the prior year primarily due to higher
enrollment in the ARIEL2 and ARIEL3 studies in ovarian cancer. Market research, disease education and other
commercial product planning activities were $16.6 million higher than the prior year due to the preparation for the
potential regulatory approval and commercial launch of rucaparib. Clinical supply and related manufacturing
development costs were $9.2 million higher than the prior year, as we increased production to support the expanded
clinical studies. In addition, diagnostic development costs for rucaparib were $0.9 million higher than the prior year due
to the advancement of our collaboration with Foundation Medicine, Inc. to develop a novel companion diagnostic test to
identify patients most likely to respond to rucaparib.
Salaries, share-based compensation expense and other personnel-related costs were $24.0 million higher in 2016
driven by increased headcount to support our expanded development and commercial planning activities. During the
third quarter of 2015, we completed the hiring of our U.S. sales and marketing and medical affairs organization in
preparation for the potential regulatory approval and commercial launch of rociletinib.
Clinical trial costs for rociletinib were $41.0 million lower in 2016 than the prior year primarily due to the completion
of patient enrollment in the TIGER-1, TIGER-2 and TIGER-X studies in non-small cell lung cancer. This decrease was
partially offset by higher clinical trial costs for the TIGER-3 study, which began enrolling patients during the second
quarter of 2015. Market research, disease education and other commercial planning activities were $19.7 million lower
than the prior year. We incurred higher costs during 2015 due to the preparation for the potential regulatory approval and
commercial launch of rociletinib. In addition, clinical supply and related manufacturing development costs were $17.2
million lower than the prior year driven by timing of production to support our clinical studies.
The increase in research and development expenses for the year ended December 31, 2015 compared to 2014 was
primarily due to increased development activities for the rociletinib and rucaparib programs.
Clinical trial costs for rucaparib were $10.3 million higher in 2015 than the prior year primarily due to higher
enrollment in the ARIEL2 and ARIEL3 studies in ovarian cancer, as well as the expansion of Study 010 in 2015.
Development costs for rucaparib were $5.9 million higher than 2014 due to the advancement of our collaboration with
Foundation Medicine, Inc. to develop a novel companion diagnostic test to identify patients most likely to respond to
rucaparib.
Salaries, share-based compensation expense and other personnel-related costs were $49.4 million higher in 2015,
including a $15.8 million increase in share-based compensation expense, driven by increased headcount to support our
expanded development and commercial planning activities. During 2015, we completed the hiring of our U.S. sales and
marketing and medical affairs organizations in preparation for the potential commercial launch of rociletinib.
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Costs associated with non-clinical and clinical development activities for rociletinib were $35.6 million higher in
2015 than 2014 driven by increased patient enrollment in the TIGER program of studies in NSCLC. In addition, market
research, disease education and other commercial product planning activities for rociletinib were $18.2 million higher in
2015 due to the preparation for the potential commercial launch of rociletinib.
Clinical supply and related manufacturing development costs for both programs were $3.2 million higher than 2014,
as we increased production to support the expanded clinical studies.
Selling, General and Administrative Expenses. General and administrative expenses for the years ended
December 31, 2016, 2015 and 2014 were as follows:
Selling, general and administrative expenses
Increase from prior year
% Change from prior year
2016
Year Ended December 31,
2015
(in thousands)
$ 30,524
$ 9,067
2014
$ 40,731
$ 10,207
33.4 %
42.3 %
$ 21,457
n/a
n/a
The increase in selling, general and administrative expenses for the year ended December 31, 2016 over 2015 was
primarily due to $3.1 million of selling expenses related to the commercialization of Rubraca, $5.3 million higher legal
expense and, to a lesser extent, higher personnel costs. Pre-commercialization activities for Rubraca were included in
research and development expenses.
The increase in selling, general and administrative expenses for the year ended December 31, 2015 over 2014 was
primarily due to $3.0 million higher share-based compensation expense, $1.4 million higher facilities expense, $1.2
million higher personnel costs, $1.1 million higher legal expense and $1.0 million higher consulting fees.
Acquired In-Process Research and Development Expenses. Acquired in-process research and development expenses
for the years ended December 31, 2016, 2015 and 2014 were as follows:
Acquired in-process research and development
Increase (decrease) from prior year
% Change from prior year
2016
Year Ended December 31,
2015
(in thousands)
$ 12,000
$ 3,194
$ 1,300
$ (10,700)
(89.2)%
36.3 %
$ 8,806
n/a
n/a
2014
Acquired in-process research and development expenses decreased for the year ended December 31, 2016 compared
to 2015. During the third quarter of 2015, we made milestone payments totaling $12.0 million to Celgene upon
acceptance of the NDA and MAA for rociletinib by the FDA and EMA, respectively. During the second quarter of 2016,
we made a milestone payment of $0.3 million to AstraZeneca upon the NDA submission for rucaparib. During 2016, we
made milestone payments totaling $1.0 million to Pfizer upon acceptance of the NDA and MAA for rucaparib by the
FDA and EMA, respectively.
The increase in acquired in-process research and development expenses for the year ended December 31, 2015
compared to 2014 was due to higher payments made to partners related to in-licensing agreements. During the third
quarter of 2015, we made milestone payments totaling $12.0 million to Celgene upon acceptance of the NDA and MAA
for rociletinib by the FDA and EMA, respectively. During the first quarter of 2014, we made a $5.0 million milestone
payment to Celgene upon initiation of the Phase II study for rociletinib, and we recorded a $3.4 million charge for a
milestone payment to Advenchen, representing 25% of the sublicense agreement consideration of $13.6 million received
from Servier upon the end of opposition and appeal of the lucitanib patent by the European Patent Office. During the
second quarter of 2014, we also made a $0.4 million milestone payment to Pfizer upon initiation of a pivotal registration
study for rucaparib.
Impairment of Intangible Asset. During the second quarter of 2016, we recorded a $104.5 million impairment charge
to the IPR&D intangible asset relating to our lucitanib product candidate which reduced the carrying value of the
intangible assets related to the product to zero. This reduction in the estimated fair value of lucitanib was the result of
our and our development partner’s decision to discontinue the development of lucitanib for breast cancer. During the
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fourth quarter of 2015, we recorded an $89.6 million impairment charge to the IPR&D intangible asset relating to our
lucitanib product candidate. This reduction in the estimated fair value of lucitanib was the result of our and our
development partner’s decision to terminate the development of lucitanib for lung cancer, as well as updates to the
probability-weighted discounted cash flow assumptions for the breast cancer indication. During the first quarter of 2014,
we recorded a $3.4 million reduction to the intangible asset’s expected future cash flows resulting from the receipt of a
lucitanib milestone payment from Servier.
Change in Fair Value of Contingent Purchase Consideration. Change in fair value of contingent purchase
consideration was a decrease of $24.9 million for the year ended December 31, 2016 compared to a decrease of $24.6
million for the year ended December 31, 2015 and an increase of $0.7 million for the year ended December 31, 2014.
During the second quarter of 2016, we recorded a $25.5 million reduction in the fair value of the contingent purchase
consideration liability due to our and our development partner’s decision to discontinue the development of lucitanib for
breast cancer. During the fourth quarter of 2015, we recorded a $26.9 million reduction in the fair value of the contingent
purchase consideration liability due to a change in the estimated probability-weighted future milestone payments, as well
as the timing of such payments, for the lucitanib program.
Other Income (Expense), Net. Other income (expense), net for the years ended December 31, 2016, 2015 and 2014
was as follows:
Other income (expense), net
Favorable (unfavorable) change from prior year
Favorable (unfavorable) % Change from prior year
2016
Year Ended December 31,
2015
(in thousands)
$ (5,216)
$ (5,952)
$
2014
$ (8,438)
$ (3,222)
(61.8)% (808.7) %
736
n/a
n/a
Other expense increased for the year ended December 31, 2016 compared to 2015. During 2016, we recognized $0.6
million of foreign currency losses compared with $2.7 million of gains in 2015. The change in the foreign currency gains
and losses was driven by fluctuations in the foreign currency rate utilized to translate our Euro-denominated contingent
purchase consideration liability into U.S. dollars.
Other expense increased for the year ended December 31, 2015 compared to 2014 primarily due to higher interest
expense related to our convertible senior notes issued in September 2014.
Income Tax Benefit (Expense). For the year ended December 31, 2016, we recognized a $28.4 million deferred tax
benefit associated with the impairment of the IPR&D intangible assets recorded in the second quarter of 2016. In
addition, during the first quarter 2016, we recognized a $3.6 million deferred tax benefit due to a reduction in the enacted
corporate tax rate of a foreign jurisdiction in which we operate.
For the year ended December 31, 2015, we recognized a $29.1 million deferred tax benefit primarily associated with
the impairment of the IPR&D intangible assets recorded in the fourth quarter of 2015.
For the year ended 2014, we recognized income tax expense primarily due to recording foreign tax provisions during
the first quarter of 2014 related to milestone revenue recognized under the Servier license agreement, partially offset by
a deferred tax benefit recognized upon the reduction of the carrying value of the IPR&D intangible assets in the first
quarter of 2014.
Liquidity and Capital Resources
To date, we have funded our operations through the public offering of our common stock and the private placement
of convertible debt securities and preferred stock. In January 2017, we sold 5,750,000 shares of our common stock in a
public offering at $41.00 per share. The net proceeds from the offering were $221.2 million, after deducting
underwriting discounts and commissions and offering expenses. As of December 31, 2016, we had cash, cash
equivalents and available-for-sale securities totaling $266.2 million.
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The following table sets forth the primary sources and uses of cash for each of the periods set forth below:
Net cash used in operating activities
Net cash provided by (used in) investing activities
Net cash provided by financing activities
Effect of exchange rate changes on cash and cash
equivalents
Net (decrease) increase in cash and cash equivalents
Operating Activities
2016
Year Ended December 31,
2015
(in thousands)
$ (266,680) $ (253,066) $ (117,051)
(2,286)
(254,578)
199,299
279,476
304,480
5,176
2014
(365)
(690)
$ (62,570) $ (203,921) $ 159,449
(757)
Net cash used in operating activities for all periods resulted primarily from our net losses adjusted for non-cash
charges and changes in components of working capital. Net cash used in operating activities increased $13.6 million for
the year ended December 31, 2016 compared to 2015 driven by an increase in payments for other accrued expenses
related to the rociletinib program of non-clinical and clinical development studies, for which enrollment was completed
in 2016.
Net cash used in operating activities increased $136.0 million for the year ended December 31, 2015 compared to
2014 driven by higher rociletinib and rucaparib research and development costs associated with the expansion of the
clinical trials, as well as the preparation for the potential commercial launch of rociletinib, and higher salaries, benefits
and personnel-related costs resulting from increased headcount to support the expanded development activities and
commercial planning for our product candidates. During the third quarter of 2015, we made milestone payments totaling
$12.0 million to Celgene upon acceptance of the NDA and MAA for rociletinib by the FDA and EMA, respectively.
During the year ended December 31, 2015, we also paid $7.3 million in interest related to the convertible senior notes.
The net loss for the year ended December 31, 2014 was partially offset by a $13.6 million milestone revenue payment
received from Servier.
Investing Activities
Net cash provided by investing activities for the year ended December 31, 2016 includes $200.0 million in sales of
available-for-sale securities compared to net purchases of $251.5 million in 2015.
Net cash used in investing activities increased $252.3 million for the year ended December 31, 2015 compared to
2014 primarily due to net purchases of available-for-sale securities.
Financing Activities
Net cash provided by financing activities for the year ended December 31, 2016 is due to $5.2 million received from
employee stock option exercises and stock purchases under the employee stock purchase plan.
Net cash provided by financing activities for the year ended December 31, 2015 includes $298.5 million in net
proceeds received from our common stock offering in July 2015 and $6.0 million received from employee stock option
exercises and stock purchases under the employee stock purchase plan.
Net cash provided by financing activities for the year ended December 31, 2014 includes $278.3 million in net
proceeds received from our convertible senior notes offering in September 2014 and $1.2 million received from
employee stock option exercises and stock purchases under the employee stock purchase plan.
Operating Capital Requirements
On December 19, 2016, the FDA approved Rubraca tablets as monotherapy for the treatment of patients with
deleterious BRCA mutation (germline and/or somatic) associated with advanced ovarian cancer, who have been treated
with two or more chemotherapies, and selected for therapy based on FDA-approved companion diagnostic for Rubraca.
We expect to incur significant losses for the foreseeable future, as we commercialize Rubraca and expand our selling,
general and administrative functions to support the growth in our commercial organization. Additionally, our operating
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plan for the next 12 months includes a significant investment in inventory to meet the projected commercial
requirements for Rubraca. We receive the active pharmaceutical ingredient in Rubraca from one supplier and we
experience long lead times associated with its production. Accordingly, we expect to experience a decrease in our
liquidity at the beginning of a production cycle and an increase as the inventory produced is sold through.
As of December 31, 2016, we had cash, cash equivalents and available-for-sale securities totaling $266.2 million and
total current liabilities of $65.6 million. In January 2017, we sold 5,750,000 shares of our common stock in a public
offering at $41.00 per share. The net proceeds from the offering were $221.2 million, after deducting underwriting
discounts and commissions and offering expenses. We intend to use the net proceeds of the offering for general
corporate purposes, including commercial planning and sales and marketing expenses associated with the launch of
Rubraca in the United States and, if approved by the EMA in Europe, funding of its development programs, selling,
general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working
capital. Based on current estimates, we believe that our existing cash, cash equivalents and available-for-sale securities
will allow us to fund our operating plan through at least the next 12 months.
Because of the numerous risks and uncertainties associated with research, development and commercialization of
pharmaceutical products, we are unable to estimate the exact amounts of our working capital requirements. Our future
funding requirements will depend on many factors, including but not limited to:
•
•
•
•
•
•
•
•
the number and characteristics of the product candidates, companion diagnostics and indications we pursue;
the achievement of various development, regulatory and commercial milestones resulting in required payments
to partners pursuant to the terms of our license agreements;
the scope, progress, results and costs of researching and developing our product candidates and related
companion diagnostics and conducting clinical and non-clinical trials;
the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates and
companion diagnostics;
the cost of commercialization activities, including marketing and distribution costs;
the cost of manufacturing any of our product candidates we successfully commercialize;
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims,
including litigation costs and outcome of such litigation; and
the timing, receipt and amount of sales, if any, of our product candidates.
Contractual Obligations and Commitments
The following table summarizes our contractual obligations at December 31, 2016 (in thousands):
Less than 1
Year
1 to 3 Years 3 to 5 Years
More Than 5
Years
Total
Convertible senior notes
Interest on convertible senior notes
Operating lease commitments
Milestone payments (a)
Purchase and other commitments (b)
Total
$
— $
— $ 287,500 $
— $ 287,500
33,841
—
12,279
7,187
9,880
600
3,838
1,822
23,000
—
—
—
49,177
171,350
47,086
23,543
$ 58,186 $ 92,539 $ 327,160 $ 47,686 $ 525,571
14,375
3,620
23,000
51,544
(a) Amount relates to a $20 million milestone payment, which we have exercised the option to defer payment by
agreeing to pay $23 million within 18 months after the date of the FDA approval of Rubraca on December 19, 2016.
(b) On October 3, 2016, we entered into a Manufacturing and Services Agreement (the “Agreement”) with a non-
exclusive third-party supplier for the production of the active ingredient for rucaparib. Under the terms of the
Agreement, we will provide the third-party supplier a rolling forecast for the supply of the active ingredient in
rucaparib that will be updated by us on a quarterly basis. We are obligated to order material sufficient to satisfy an
initial quantity specified in any forecast. In addition, the third-party supplier will construct, in its existing facility, a
production train that will be exclusively dedicated to the manufacture of the rucaparib active ingredient. We are
obligated to make scheduled capital program fee payments toward capital equipment and other costs associated with
the construction of the dedicated production train. Further, once the facility is operational, we are obligated to pay a
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fixed facility fee each quarter for the duration of the Agreement, which expires on December 31, 2025, unless
extended by mutual consent of the parties.
Royalty and License Fee Commitments
We have certain obligations under licensing agreements with third parties contingent upon achieving various
development, regulatory and commercial milestones. On August 30, 2016, we entered into a first amendment to the
worldwide license agreement with Pfizer, which amends the June 2011 existing worldwide license agreement to permit
us to defer payment of the milestone payments payable upon (i) FDA approval of an NDA for 1st Indication in US and
(ii) EMA approval of an MAA for 1st Indication in EU, to a date that is 18 months after the date of achievement of such
milestones. In the event that we defer such milestone payments, we have agreed to certain higher payments related to the
achievement of such milestones.
On December 19, 2016, the FDA approved Rubraca tablets as monotherapy for the treatment of patients with
deleterious BRCA mutation (germline and/or somatic) associated with advanced ovarian cancer, who have been treated
with two or more chemotherapies, and selected for therapy based on FDA-approved companion diagnostic for Rubraca.
The FDA approval resulted in a $0.75 million milestone payment to Pfizer as required by the license agreement. The
FDA approval also resulted in the obligation to pay a $20.0 million milestone payment, in which we have exercised the
option to defer payment by agreeing to pay $23.0 million within 18 months after the date of the FDA approval. These
payments were recognized as intangible assets and will be amortized over the estimated remaining useful life of
rucaparib.
Pursuant to our license agreements for the development of rucaparib, we are required to make regulatory milestone
payments up to an additional $69.75 million in aggregate if specified clinical study objectives and regulatory filings,
acceptances and approvals are achieved. In addition, we are obligated to make sales milestone payments if specified
annual sales targets for rucaparib are met, the majority of which relate to annual sales targets of $500.0 million and
above, which, in aggregate, could amount to total milestone payments of $170.0 million, and tiered royalty payments at
a mid-teen percentage rate on our net sales, with standard provisions for royalty offsets to the extent we need to obtain
any rights from third parties to commercialize rucaparib.
We are obligated to pay additional consideration to the former EOS shareholders if certain future regulatory and
lucitanib-related sales milestones are achieved. The estimated fair value of these payments was recorded as contingent
purchase consideration on our Consolidated Balance Sheets. The potential contingent milestone payments range from a
zero payment, which assumes lucitanib fails to achieve any of the regulatory milestones, to $186.0 million ($65.0 million
and €115.0 million) if all regulatory and sales milestones are met, utilizing the translation rate at December 31, 2016.
The estimated fair value of the liability was zero at December 31, 2016 due to the uncertainty of achieving any of the
lucitanib regulatory milestones, and therefore the remote likelihood of future milestone payout amounts to the former
EOS shareholders. We are also obligated to pay to Advenchen 25% of any consideration, excluding royalties, received
pursuant to any sublicense agreements for lucitanib, including the agreement with Servier.
Pursuant to our license agreement for the development and commercialization of rociletinib, we may be required to
pay up to an additional aggregate of $98.0 million in regulatory milestone payments if certain clinical study objectives
and regulatory filings, acceptance and approvals are achieved. Further, we may be required to pay up to an aggregate of
$120.0 million in sales milestone payments if certain annual sales targets are met for rociletinib.
Finally, pursuant to terms of each of our product license agreements, we will pay royalties to our licensors on sales, if
any, of the respective products.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as
defined under the rules promulgated by the U.S. Securities and Exchange Commission.
Tax Loss Carryforwards
As of December 31, 2016, we have net operating loss (“NOL”) carryforwards of approximately $711.8 million to
offset future federal income taxes. We also have research and development and orphan drug tax credit carryforwards of
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$240.7 million to offset future federal income taxes. The federal net operating loss carryforwards and research and
development and orphan drug tax credit carryforwards expire at various times through 2036.
We believe that a change in ownership as defined under Section 382 of the U.S. Internal Revenue Code occurred as a
result of our public offering of common stock completed in April 2012. Future utilization of the federal net operating
losses and tax credit carryforwards accumulated from inception to the change in ownership date will be subject to annual
limitations to offset future taxable income. At this time, we do not believe this limitation will prevent the utilization of
the federal NOL or credit carryforward prior to expiration. It is possible that a change in ownership will occur in the
future, which will limit the NOL amounts generated since the last estimated change in ownership. At December 31,
2016, we recorded a 100% valuation allowance against our net deferred tax assets in the U.S. of approximately $588.8
million and a $3.6 million valuation allowance against tax assets in foreign jurisdictions, as we believe it is more likely
than not that the tax benefits will not be fully realized. In the future, if we determine that a portion or all of the tax
benefits associated with our tax carryforwards will be realized, net income would increase in the period of determination.
Recently Adopted Accounting Standards
In August 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-15, “Disclosure of
Uncertainties About an Entity’s Ability to Continue as a Going Concern,” which requires management to evaluate
whether there are conditions or events that raise substantial doubt about an entity’s ability to continue as a going concern
and to provide disclosures when certain criteria are met. The guidance is effective for annual periods beginning in 2016
and interim reporting periods starting in the first quarter of 2017. Early application is permitted. We adopted this
standard effective December 31, 2016. Adoption of the standard resulted in no change to our disclosures.
Recently Issued Accounting Standards
In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers” and has subsequently
issued several supplemental and/or clarifying ASUs (collectively, “ASC 606”). ASC 606 prescribes a single common
revenue standard that replaces most existing U.S. GAAP revenue recognition guidance. ASC 606 is intended to provide
a more consistent interpretation and application of the principles outlined in the standard across filers in multiple
industries and within the same industries compared to current practices, which should improve comparability. Adoption
of ASC 606 is required for annual and interim periods beginning after December 15, 2017. Upon adoption, we must
elect to adopt either retrospectively to each prior reporting period presented or use the cumulative effect transition
method with the cumulative effect of initial adoption recognized at the date of initial application. We began recognizing
revenue from product sales for the first time after the FDA approval of Rubraca on December 19, 2016 and have adopted
a revenue recognition policy accordingly. We have not determined what adoption transition method we will use. We are
currently assessing the impact that the future adoption of ASC 606 may have on our consolidated financial statements
and related disclosures by analyzing our current accounting policies and practices to identify potential differences in
applying the guidance of ASC 606.
In July 2015, the FASB issued ASU No. 2015-11, which amends existing guidance for measurement of
inventory. Current inventory guidance requires an entity to measure inventory at the lower of cost or market. Market
could be replacement cost, net realizable value, or net realizable value less an approximately normal profit margin. An
entity should measure all inventory to which the amendments apply at the lower of cost and net realizable value. Net
realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of
completion, disposal, and transportation. The amendments are effective for fiscal years beginning after December 15,
2016, and interim periods within fiscal years beginning after December 15, 2017. The amendments should be applied
prospectively with earlier application permitted as of the beginning of an interim or annual reporting period. We do not
expect the adoption of this guidance to have a material impact on our consolidated financial statements.
In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” which requires lessees to recognize
assets and liabilities for the rights and obligations created by most leases on their balance sheet. The guidance is
effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early
application is permitted. ASU 2016-02 requires modified retrospective adoption for all leases existing at, or entered into
after, the date of initial application, with an option to use certain transition relief. We are currently evaluating the impact
the standard may have on our consolidated financial statements and related disclosures.
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In March 2016, the FASB issued ASU No. 2016-09, “Compensation – Stock Compensation (Topic 718):
Improvements to Employee Share-Based Payment Accounting”, to simplify financial reporting of the income tax
impacts of share-based compensation arrangements. ASU No. 2016-09 is effective for us for annual and interim periods
beginning after January 1, 2017. The classification guidance under ASU No. 2016-09 requires the recognition of excess
tax benefits from share-based compensation arrangements as a discrete item within income tax benefit rather than
additional paid-in capital and the classification guidance requiring presentation of excess tax benefits from share-based
compensation arrangements as an operating activity on the statement of cash flows, rather than as an operating activity.
The adoption of ASU No 2016-09 is expected to have no immediate impact on our financial statements and related
disclosures because we do not currently recognize a tax benefit related to share-based compensation expense as we
maintain net operating loss carryforwards and have established a valuation allowance against the entire net deferred tax
asset as of December 31, 2016. Further, we have elected to continue to estimate the number of stock-based awards
expected to vest, as permitted by ASU 2016-09, rather than electing to account for forfeitures as the occur.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to market risk related to changes in interest rates. As of December 31, 2016, we had cash, cash
equivalents and available-for-sale securities of $266.2 million, consisting of bank demand deposits, money market funds
and U.S. treasury securities. The primary objectives of our investment policy are to preserve principal and maintain
proper liquidity to meet operating needs. Our investment policy specifies credit quality standards for our investments and
limits the amount of credit exposure to any single issue, issuer or type of investment. Our primary exposure to market
risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly
because our investments are in short-term securities. Our available-for-sale securities are subject to interest rate risk and
will decline in value if market interest rates increase. Due to the short-term duration of our investment portfolio and the
low risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material
effect on the fair value of our portfolio.
We contract with contract research organizations, investigational sites and contract manufacturers globally where
payments are made in currencies other than the U.S. dollar. In addition, on October 3, 2016, we entered into a
Manufacturing and Services Agreement with a Swiss company for the production and supply of the active ingredient for
rucaparib. Under the terms of this agreement, payments for the supply of the active ingredient in rucaparib as well as
scheduled capital program fee payment toward capital equipment and other costs associated with the construction of a
dedicated production train will be made in Swiss francs. Once the production facility is operational, we are obligated to
pay a fixed facility fee each quarter for the duration of the agreement, which expires on December 31, 2025.
As of December 31, 2016, $171.4 million of purchase commitments exist under the Swiss Manufacturing and
Services Agreement and we are required to remit amounts due in Swiss francs. Due to other variables that may exist, it is
difficult to quantify the impact of a particular change in exchange rates. However, we estimate that if the value of the US
dollar was to strengthen by 10% compared to the value of Swiss franc as of December 31, 2016, it would decrease the
total US dollar purchase commitment under the Swiss Manufacturing and Services Agreement by approximately $16.0
million. Similarly, a 10% weakening of the US dollar compared to the Swiss franc would increase the total US dollar
purchase commitment by approximately $19.0 million.
While we periodically hold foreign currencies, primarily Euro and Pound Sterling, we do not use other financial
instruments to hedge our foreign exchange risk. Transactions denominated in currencies other than the functional
currency are recorded based on exchange rates at the time such transactions arise. As of December 31, 2016 and 2015,
approximately 1% and 3%, respectively, of our total liabilities were denominated in currencies other than the functional
currency.
ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements required by this Item are included in Item 15 of this report and are presented beginning on
page F-1.
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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures
Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports
we file or submit under the Securities Exchange Act of 1934, as amended (“Exchange Act”) is recorded, processed,
summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and
forms, and that such information is accumulated and communicated to our management, including the Chief Executive
Officer and the Principal Financial and Accounting Officer, to allow timely decisions regarding required disclosures.
Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of
achieving the desired control objective.
As of December 31, 2016, our management, with the participation of our Chief Executive Officer and Principal
Financial and Accounting Officer, performed an evaluation of the effectiveness of the design and operation of our
disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Based on this
evaluation, our Chief Executive Officer and Principal Financial and Accounting Officer concluded that, as of
December 31, 2016, the design and operation of our disclosure controls and procedures were effective at the reasonable
assurance level.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining effective internal control over financial reporting
and for the assessment of the effectiveness of internal control over financial reporting. Internal control over financial
reporting is a process designed by, or under the supervision of, a company’s principal executive officer and principal
financial officer and effected by our board of directors, management and other personnel, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with generally accepted accounting principles. Our internal control over financial reporting includes those
policies and procedures that:
•
•
•
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and
dispositions of our assets;
provide reasonable assurance that transactions are recorded as necessary to permit preparation of the
consolidated financial statements in accordance with generally accepted accounting principles, and that our
receipts and expenditures are being made only in accordance with authorizations of our management and
directors; and
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or
disposition of our assets that could have a material effect on the consolidated financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions or the degree of compliance with the policies or procedures may deteriorate.
As of December 31, 2016, our management, with the participation of our Chief Executive Officer and Principal
Financial and Accounting Officer, assessed the effectiveness of our internal control over financial reporting as defined in
Rules 13a-15(f) or 15d-15(f) of the Exchange Act. In making its assessment, management used the criteria established in
Internal Control—Integrated Framework (2013 framework) issued by the Committee of Sponsoring Organizations of
the Treadway Commission. Based on its assessment, our management determined that, as of December 31, 2016, we
maintained effective internal control over financial reporting based on those criteria.
In addition, the effectiveness of our internal control over financial reporting as of December 31, 2016 has been
audited by Ernst & Young, LLP, an independent registered public accounting firm.
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Changes in Internal Control Over Financial Reporting
There were no changes in our internal controls over financial reporting during the quarter ended December 31, 2016
that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
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Report of Independent Registered Public Accounting Firm
The Stockholders and Board of Directors of Clovis Oncology, Inc.
We have audited Clovis Oncology, Inc.’s internal control over financial reporting as of December 31, 2016, based on
criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission (2013 framework) (the COSO criteria). Clovis Oncology, Inc.’s management is responsible
for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal
control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial
Reporting. Our responsibility is to express an opinion on the company’s internal control over financial reporting based
on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United
States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining
an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing
and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such
other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis
for our opinion.
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles. A company’s internal control over financial reporting includes those policies
and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of
management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may
deteriorate.
In our opinion, Clovis Oncology, Inc. maintained, in all material respects, effective internal control over financial
reporting as of December 31, 2016, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States), the consolidated balance sheets of Clovis Oncology, Inc., as of December 31, 2016 and 2015, and the related
consolidated statements of operations, comprehensive loss, stockholders' (deficit) equity, and cash flows for each of the
three years in the period ended December 31, 2016 and our report dated February 23, 2017 expressed an unqualified
opinion thereon.
/s/ Ernst & Young LLP
Denver, Colorado
February 23, 2017
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ITEM 9B. OTHER INFORMATION
None.
PART III
Certain information required by Part III is omitted from this Annual Report on Form 10-K and is incorporated herein
by reference from our definitive proxy statement relating to our 2017 annual meeting of stockholders, pursuant to
Regulation 14A of the Securities Exchange Act of 1934, as amended, also referred to in this Form 10-K as our 2017
Proxy Statement, which we expect to file with the SEC no later than April 30, 2017.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Information regarding our directors, including the audit committee and audit committee financial experts, and
executive officers and compliance with Section 16(a) of the Exchange Act will be included in our 2017 Proxy Statement
and is incorporated herein by reference.
We have adopted a Code of Business Ethics for all of our directors, officers and employees as required by NASDAQ
governance rules and as defined by applicable SEC rules. Stockholders may locate a copy of our Code of Business
Ethics on our website at www.clovisoncology.com or request a copy without charge from:
Clovis Oncology, Inc.
Attention: Investor Relations
5500 Flatiron Parkway, Suite 100
Boulder, CO 80301
We will post to our website any amendments to the Code of Business Ethics and any waivers that are required to be
disclosed by the rules of either the SEC or NASDAQ.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item regarding executive compensation will be included in our 2017 Proxy
Statement and is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
The information required by this item regarding security ownership of certain beneficial owners and management will
be included in the 2017 Proxy Statement and is incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
The information required by this item regarding certain relationships and related transactions and director
independence will be included in the 2017 Proxy Statement and is incorporated herein by reference.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this item regarding principal accounting fees and services will be included in the 2017
Proxy Statement and is incorporated herein by reference.
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PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following documents are being filed as part of this report:
(1) Financial Statements.
Reference is made to the Index to Financial Statements of Clovis Oncology, Inc. appearing on page F-1 of this
report.
(2) Financial Statement Schedules.
All financial statement schedules have been omitted because they are not applicable or not required or because the
information is included elsewhere in the Financial Statements or the Notes thereto.
(3) Exhibits.
Reference is made to the Index to Exhibits filed as a part of this Annual Report on Form 10-K.
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Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
Date: February 23, 2017
CLOVIS ONCOLOGY, INC.
By: /S/ PATRICK J. MAHAFFY
Patrick J. Mahaffy
President and Chief Executive Officer; Director
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed by the
following persons on behalf of the registrant and in the capacities and on the dates indicated:
Name
Title
Date
/S/ PATRICK J. MAHAFFY
Patrick J. Mahaffy
President and Chief Executive Officer; Director
(Principal Executive Officer)
February 23, 2017
/S/ DANIEL W. MUEHL
Daniel W. Muehl
/S/ BRIAN G. ATWOOD
Brian G. Atwood
/S/ M. JAMES BARRETT
M. James Barrett
/S/ JAMES C. BLAIR
James C. Blair
/S/ KEITH FLAHERTY
Keith Flaherty
/S/ GINGER L. GRAHAM
Ginger L. Graham
/S/ PAUL KLINGENSTEIN
Paul Klingenstein
/S/ EDWARD J. MCKINLEY
Edward J. McKinley
/S/ THORLEF SPICKSCHEN
Thorlef Spickschen
Senior Vice President of Finance
February 23, 2017
(Principal Financial Officer and Principal
Accounting Officer)
February 23, 2017
February 23, 2017
February 23, 2017
February 23, 2017
February 23, 2017
February 23, 2017
February 23, 2017
February 23, 2017
Director
Director
Director
Director
Director
Director
Director
Director
79
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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Statements of Operations
Consolidated Statements of Comprehensive Loss
Consolidated Balance Sheets
Consolidated Statements of Stockholders’ (Deficit) Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
F-2
F-3
F-4
F-5
F-6
F-7
F-8
F-1
Table of Contents
Report of Independent Registered Public Accounting Firm
The Stockholders and Board of Directors of Clovis Oncology, Inc.
We have audited the accompanying consolidated balance sheets of Clovis Oncology, Inc. as of December 31, 2016 and
2015, and the related consolidated statements of operations, comprehensive loss, stockholders' (deficit) equity, and cash
flows for each of the three years in the period ended December 31, 2016. These financial statements are the
responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements
based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United
States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the
financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used
and significant estimates made by management, as well as evaluating the overall financial statement presentation. We
believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated
financial position of Clovis Oncology, Inc. at December 31, 2016 and 2015, and the consolidated results of its operations
and its cash flows for each of the three years in the period ended December 31, 2016, in conformity with U.S. generally
accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States), Clovis Oncology, Inc.’s internal control over financial reporting as of December 31, 2016, based on criteria
established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (2013 framework) and our report dated February 23, 2017 expressed an unqualified opinion
thereon.
/s/ Ernst & Young LLP
Denver, Colorado
February 23, 2017
F-2
Table of Contents
CLOVIS ONCOLOGY, INC.
Consolidated Statements of Operations
For the Year ended December 31,
2015
(in thousands, except per share amounts)
2016
2014
Revenues:
Product revenue, net
License and milestone revenue
Total revenues
Operating expenses:
Cost of sales - product
Research and development
Selling, general and administrative
Acquired in-process research and development
Impairment of intangible asset
Change in fair value of contingent purchase consideration
Total expenses
Operating loss
Other income (expense):
Interest expense
Foreign currency gains (losses)
Other income (expense)
Other income (expense), net
Loss before income taxes
Income tax benefit (expense)
Net loss
Basic and diluted net loss per common share
Basic and diluted weighted average common shares outstanding
$
78 $
—
78
— $
—
—
—
13,625
13,625
70
—
40,731
1,300
104,517
—
251,129 269,251 137,705
21,457
8,806
3,409
707
372,811 376,721 172,084
(372,733) (376,721) (158,459)
30,524
12,000
89,557
(24,936) (24,611)
(8,491)
(580)
633
(8,438)
(8,372)
2,740
416
(5,216)
(2,604)
3,580
(240)
736
(381,171) (381,937) (157,723)
(2,308)
$ (349,137) $ (352,861) $ (160,031)
(4.72)
$
33,889
(9.79) $
36,026
(9.07) $
38,478
29,076
32,034
See accompanying Notes to Consolidated Financial Statements.
F-3
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CLOVIS ONCOLOGY, INC.
Consolidated Statements of Comprehensive Loss
Net loss
Other comprehensive loss
Foreign currency translation adjustments, net of tax
Net unrealized gain (loss) on available-for-sale securities, net of tax
Other comprehensive loss
Comprehensive loss
2016
For the Year ended December 31,
2015
(in thousands)
$ (349,137) $ (352,861) $ (160,031)
2014
(357)
237
(120)
(29,144)
—
(29,144)
$ (349,257) $ (375,873) $ (189,175)
(22,629)
(383)
(23,012)
See accompanying Notes to Consolidated Financial Statements.
F-4
Table of Contents
CLOVIS ONCOLOGY, INC.
Consolidated Balance Sheets
ASSETS
Current assets:
Cash and cash equivalents
Accounts receivable
Available-for-sale securities
Prepaid research and development expenses
Other current assets
Total current assets
Property and equipment, net
Intangible assets, net
Goodwill
Other assets
Total assets
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY
Current liabilities:
Accounts payable
Accrued research and development expenses
Other accrued expenses
Total current liabilities
Contingent purchase consideration
Deferred income taxes, net
Milestone liability
Convertible senior notes
Deferred rent, long-term
Total liabilities
December 31,
2016
2015
(in thousands, except for share amounts)
$
$
$
216,186 $
121
49,997
6,427
6,679
279,410
4,440
21,047
57,192
2,468
364,557 $
10,912 $
35,198
19,487
65,597
—
—
20,062
281,126
1,406
368,191
278,756
—
249,832
3,377
7,736
539,701
4,946
101,500
59,327
7,912
713,386
11,260
53,011
11,305
75,576
24,661
31,133
—
279,885
1,481
412,736
Commitments and contingencies (Note 10)
Stockholders' equity:
Preferred stock, par value $0.001 per share; 10,000,000 shares authorized, no
shares issued and outstanding at December 31, 2016 and December 31, 2015
Common stock, $0.001 par value per share, 100,000,000 shares authorized at
December 31, 2016 and December 31, 2015; 38,724,090 and 38,359,454 shares
issued and outstanding at December 31, 2016 and December 31, 2015 respectively
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total stockholders' (deficit) equity
Total liabilities and stockholders' (deficit) equity
$
—
—
39
1,174,950
(47,580)
(1,131,043)
(3,634)
364,557 $
38
1,129,978
(47,460)
(781,906)
300,650
713,386
See accompanying Notes to Consolidated Financial Statements.
F-5
Table of Contents
CLOVIS ONCOLOGY, INC.
Consolidated Statements of Stockholders’ (Deficit) Equity
Common Stock
Shares
Amount
Additional
Paid-In
Capital
Accumulated
Other
Comprehensive Accumulated
Income (Loss)
Deficit
Total
Balance at January 1,2014
Issuance of common stock under
employee stock purchase plan
Exercise of stock options
Share-based compensation expense
Foreign currency translation adjustments
Net loss
Balance at December 31, 2014
Issuance of common stock, net of
issuance costs of $17,741
Issuance of common stock under
employee stock purchase plan
Exercise of stock options
Share-based compensation expense
Net unrealized loss on available-for-sale
securities
Foreign currency translation adjustments
Net loss
Balance at December 31, 2015
Issuance of common stock under
employee stock purchase plan
Exercise of stock options
Issuance of common stock from vesting
of restricted stock units, net of shares
withheld for taxes
Share-based compensation expense
Net unrealized gain on available-for-sale
securities
Foreign currency translation adjustments
Net loss
Balance at December 31, 2016
32,021
295,759
—
—
—
—
38,359,454
110,508
247,431
6,697
—
—
—
—
33,897,321 $
13,633
66,233
—
—
—
33,977,187
(in thousands, except for share amounts)
34 $
762,170 $
4,696 $
(269,014) $
497,886
—
—
—
—
—
34
481
921
21,517
—
—
785,089
—
—
—
(29,144)
—
(24,448)
—
—
—
—
(160,031)
(429,045)
481
921
21,517
(29,144)
(160,031)
331,630
4,054,487
4
298,505
—
298,509
493
5,534
40,357
—
—
—
—
—
—
—
—
—
—
1,129,978
(383)
(22,629)
—
(47,460)
—
—
(352,861)
(781,906)
1,965
3,268
(57)
39,796
—
—
—
—
—
—
—
—
—
—
—
—
—
—
38
—
1
—
—
493
5,534
40,357
(383)
(22,629)
(352,861)
300,650
1,965
3,269
(57)
39,796
237
(357)
(349,137)
(3,634)
—
—
—
39 $ 1,174,950 $
—
—
—
237
(357)
—
—
—
(349,137)
(47,580) $ (1,131,043) $
38,724,090 $
See accompanying Notes to Consolidated Financial Statements.
F-6
Table of Contents
CLOVIS ONCOLOGY, INC.
Consolidated Statements of Cash Flows
2016
Year ended December 31,
2015
(in thousands)
2014
Operating activities
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
$ (349,137) $ (352,861) $ (160,031)
Share-based compensation expense
Depreciation and amortization
Amortization of premiums and discounts on available-for-sale securities
Amortization of debt issuance costs
Impairment of intangible asset
Change in fair value of contingent purchase consideration
Loss on disposal of equipment
Deferred income taxes
39,796
1,141
211
1,242
104,517
(24,661)
105
(31,771)
40,357
761
1,400
1,205
89,557
(27,792)
39
(28,874)
21,517
444
—
368
3,409
(3,301)
67
761
Changes in operating assets and liabilities:
Accounts receivable
Prepaid and accrued research and development expenses
Other operating assets
Accounts payable
Other accrued expenses
Net cash used in operating activities
Investing activities
Purchases of property and equipment
Proceeds from sale of property and equipment
Purchases of available-for-sale securities
Sales of available-for-sale securities
Net cash provided by (used in) investing activities
Financing activities
(121)
(15,364)
1,039
(1,544)
7,867
(266,680)
—
14,122
(4,380)
8,105
5,295
(253,066)
—
18,112
(910)
(1,369)
3,882
(117,051)
(766)
65
—
200,000
199,299
(3,035)
—
(392,540)
140,997
(254,578)
(2,286)
—
—
—
(2,286)
Proceeds from the sale of common stock, net of issuance costs
Proceeds from the issuance of convertible senior notes, net of issuance costs
Proceeds from the exercise of stock options and employee stock purchases
Net cash provided by financing activities
Effect of exchange rate changes on cash and cash equivalents
(Decrease) increase in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
Supplemental disclosure of cash flow information:
Cash paid for interest
Non-cash investing and financing activities:
—
298,509
—
278,313
—
—
1,163
5,971
5,176
279,476
304,480
5,176
(690)
(757)
(365)
159,449
(203,921)
(62,570)
278,756
323,228
482,677
$ 216,186 $ 278,756 $ 482,677
$
7,188 $
7,307 $
—
Acquired in-process research and development - milestone not paid as of
period end
$
21,100 $
— $
—
See accompanying Notes to Consolidated Financial Statements.
F-7
Table of Contents
1. Nature of Business
CLOVIS ONCOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
We are a biopharmaceutical company focused on acquiring, developing and commercializing cancer treatments in the
United States, Europe and other international markets. We have and intend to continue to license or acquire rights to
oncology compounds in all stages of clinical development. In exchange for the right to develop and commercialize these
compounds, we generally expect to provide the licensor with a combination of upfront payments, milestone payments
and royalties on future sales. In addition, we generally expect to assume the responsibility for future drug development
and commercialization costs. We currently operate in one segment. Since inception, our operations have consisted
primarily of developing in-licensed compounds, evaluating new product acquisition candidates and general corporate
activities.
During the second quarter of 2016, we completed the submission of our NDA with the FDA for potential accelerated
approval of rucaparib in the U.S. The FDA granted the rucaparib NDA priority review status with a Prescription Drug
User Fee Act action date of February 23, 2017. On December 19, 2016, the FDA approved Rubraca (rucaparib) tablets
as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated with
advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on
FDA-approved companion diagnostic for Rubraca. We submitted our first E.U. regulatory application in the fourth
quarter of 2016, which was accepted during the fourth quarter of 2016.
Liquidity
We have incurred significant net losses since inception and have relied on our ability to fund our operations through
debt and equity financings. We expect operating losses and negative cash flows to continue for the foreseeable future. As
we continue to incur losses, transition to profitability is dependent upon achieving a level of revenue from Rubraca
adequate to support our cost structure. We may never achieve profitability, and unless and until it does, we will continue
to need to raise additional cash.
In January 2017, we sold 5,750,000 shares of our common stock in a public offering at $41.00 per share. The net
proceeds from the offering were $221.2 million, after deducting underwriting discounts and commissions and offering
expenses. We intend to use the net proceeds of the offering for general corporate purposes, including commercial
planning and sales and marketing expenses associated with the launch of Rubraca in the United States and, if approved
by the EMA in Europe, funding of its development programs, selling, general and administrative expenses, acquisition
or licensing of additional product candidates or businesses and working capital. Based on our current estimates, we
believe that our cash, cash equivalents and available-for-sale securities will allow us to fund activities through the next
12 months, although there can be no assurance that this can, in fact, be accomplished.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting
principles (“U.S. GAAP”). The consolidated financial statements include our accounts and our wholly-owned
subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation.
Reclassifications
Certain reclassifications have been made to prior year amounts to conform to the current year presentation. These
reclassifications had no effect on our previously reported results of operations, financial position or cash flows.
F-8
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Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and
assumptions that affect the reported amounts of assets, liabilities, expenses and revenue and related disclosures. On an
ongoing basis, we evaluate our estimates, including estimates related to revenue, contingent purchase consideration,
intangible asset impairment, clinical trial accruals and share-based compensation expense. We base our estimates on
historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the
circumstances. Actual results may differ from those estimates or assumptions.
Revenue Recognition
We are currently approved to sell Rubraca in the United States market. We distribute our product principally through
a limited number of specialty distributor and specialty pharmacy providers, collectively, our customers. Our customers
subsequently resell our products to patients and health care providers. Separately, we have arrangements with certain
payors and other third-parties that provide for government-mandated and privately-negotiated rebates, chargebacks and
discounts.
Revenues from product sales are recognized when persuasive evidence of an arrangement exists, delivery has
occurred and title of the product and associated risk of loss has passed to the customer, the price is fixed or determinable,
collection from the customer has been reasonably assured and all performance obligations have been met and returns and
allowances can be reasonably estimated. Product sales are recorded net of estimated rebates, chargebacks, discounts and
other deductions as well as estimated product returns. Estimating rebates, chargebacks, discounts, product returns and
other deductions requires significant judgments about future events and uncertainties, and requires us to rely heavily on
assumptions, as well as historical experience. We only recognize revenue on product sales once the product is resold to
the patient or healthcare provider by the specialty distributor or specialty pharmacy provider, therefore reducing the
significance of estimates made for product returns.
For the year ended December 31, 2016, we recognized $0.1 million of product revenue. Based on our policy to
expense costs associated with the manufacture of our products prior to regulatory approval, manufacturing of Rubraca
units recognized as revenue during the year ended December 31, 2016 were expensed prior to the December 19, 2016
U.S. Food and Drug Administration (“FDA”) approval, and therefore are not included in cost of sales during the current
period. We expect cost of sales to increase in relation to product revenues as we deplete these inventories.
Revenue is recognized from license milestone payments when persuasive evidence of an arrangement exists, delivery
has occurred or services have been rendered, the price is fixed or determinable and, collectability is reasonably assured.
We exercise judgment in determining that collectability is reasonably assured or that services have been delivered in
accordance with the arrangement. We assess whether the fee is fixed or determinable based on the payment terms
associated with the transaction and whether the sales price is subject to refund or adjustment. We assess collectability
based primarily on the customer's payment history and creditworthiness of the customer. Payments that are contingent
upon the achievement of a substantive milestone will be recognized in the period in which the milestone is achieved.
Fair Value of Financial Instruments
Cash, cash equivalents, available-for-sale securities and contingent purchase consideration are carried at fair value.
Financial instruments, including other current assets and accounts payable, are carried at cost, which approximates fair
value given their short-term nature (see Note 4, Fair Value Measurements).
Cash, Cash Equivalents and Available-for-Sale Securities
We consider all highly liquid investments with original maturities at the date of purchase of three months or less to be
cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily
in certificate of deposits, commercial paper and U.S. government and U.S. government agency obligations.
Marketable securities are considered to be available-for-sale securities and consist of U.S. treasury securities.
Available-for-sale securities are reported at fair value on the Consolidated Balance Sheets and unrealized gains and
losses are included in accumulated other comprehensive loss on the Consolidated Balance Sheets. Realized gains and
losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense)
F-9
Table of Contents
on the Consolidated Statements of Operations. The cost of investments for purposes of computing realized and
unrealized gains and losses is based on the specific identification method. Investments with maturities beyond one year
are classified as short-term based on our intent to fund current operations with these securities or to make them available
for current operations.
A decline in the market value of a security below its cost that is deemed to be other than temporary is charged to
earnings and results in the establishment of a new cost basis for the security. Factors evaluated to determine if an
investment is other-than-temporarily impaired include significant deterioration in earnings performance, credit rating,
asset quality or business prospects of the issuer; adverse changes in the general market conditions in which the issuer
operates; and our intent and ability to hold the security until an anticipated recovery in value occurs.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated
using the straight-line method over the estimated useful lives of the assets. Equipment purchased for use in
manufacturing and clinical trials is evaluated to determine whether the equipment is solely beneficial for a drug
candidate in the development stage or whether it has an alternative use. Equipment with an alternative use is capitalized.
Leasehold improvements are amortized over the economic life of the asset or the lease term, whichever is shorter.
Maintenance and repairs are expensed as incurred. The estimated useful lives of our capitalized assets are as follows:
Computer hardware and software
Leasehold improvements
Laboratory, manufacturing and office equipment
Furniture and fixtures
Long-Lived Assets
Estimated
Useful Life
3 to 5 years
6 years
5 to 7 years
10 years
We review long-lived assets for impairment when events or changes in circumstances indicate that the carrying value
of the assets may not be recoverable. Recoverability is measured by comparison of the assets’ book value to future net
undiscounted cash flows that the assets are expected to generate. If the carrying value of the assets exceed their future
net undiscounted cash flows, an impairment charge is recognized for the amount by which the carrying value of the
assets exceeds the fair value of the assets.
Intangible Assets, Net
Definite-lived intangible assets related to capitalized milestones under license agreements are amortized on a straight-
line basis over their remaining useful lives, which are estimated to be the remaining patent life. If our estimate of the
product’s useful life is shorter than the remaining patent life, then a shorter period is used. Amortization expense is
recorded as a component of cost of sales on the Consolidated Statements of Operations.
Intangible acquired in-process research and development (“IPR&D”) assets were established as part of the acquisition
of Ethical Oncology Science, S.p.A. (“EOS”) in November 2013 and were not amortized.
Intangible assets are evaluated for impairment at least annually in the fourth quarter or more frequently if impairment
indicators exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the decision to
discontinue the development of a drug, the receipt of additional clinical or nonclinical data regarding our drug candidate or a
potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information
regarding potential sales for the drug. In connection with any impairment assessment, the fair value of the intangible assets
as of the date of assessment is compared to the carrying value of the intangible asset. Impairment losses are recognized if
the carrying value of an intangible asset is both not recoverable and exceeds its fair value. During the second quarter of
2016, we recorded a $104.5 million impairment charge to the IPR&D intangible assets, reducing the remaining carrying
value to zero (see Note 6, Intangible Assets and Goodwill). Previously, the Company recorded an $89.6 million
impairment charge to the IPR&D intangible assets during the fourth quarter of 2015.
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Goodwill
Goodwill represents the excess of the purchase price over the fair value of net assets acquired in a business
combination accounted for under the acquisition method of accounting and is not amortized, but is subject to impairment
testing at least annually in the fourth quarter or when a triggering event is identified that could indicate a potential
impairment. We are organized as a single reporting unit and perform impairment testing by comparing the carrying value
of the reporting unit to the fair value of the Company. Goodwill was recorded as a result of the EOS acquisition.
Other Current Assets
Other current assets are comprised of the following (in thousands):
Receivable from partners
Prepaid insurance
Receivable from landlord
Prepaid expenses - other
Receivable - other
Other
Total
Other Accrued Expenses
Other accrued expenses are comprised of the following (in thousands):
Accrued personnel costs
Accrued interest payable
Accrued expenses - other
Total
December 31,
2016
2015
$ 2,882 $ 3,241
1,231
1,153
1,023
889
199
$ 6,679 $ 7,736
1,234
—
2,109
364
90
December 31,
2016
2015
$ 15,850 $ 8,250
2,096
959
$ 19,487 $ 11,305 `
2,096
1,541
Valuation of Contingent Consideration Resulting from a Business Combination
Subsequent to the acquisition date, we re-measure contingent consideration arrangements at fair value each reporting
period and record changes in fair value to change in fair value of contingent purchase consideration and foreign currency
gains (losses) for changes in the foreign currency translation rate on the Consolidated Statements of Operations. Changes
in fair value are primarily attributed to new information about the IPR&D assets, including changes in timeline and
likelihood of success, and the passage of time. In the absence of new information, changes in fair value reflect only the
passage of time. During the fourth quarter of 2015, we recorded a $26.9 million reduction in the fair value of the
contingent purchase consideration liability due to a change in the estimated probability-weighted future discounted
milestone payments, as well as the timing of such payments, for the lucitanib program. Then, during the second quarter
of 2016, we recorded a $25.5 million reduction in the fair value of the contingent purchase consideration liability due to
our and our development partner’s decision to discontinue the development of lucitanib for breast cancer. At December
31, 2016, the contingent purchase consideration liability recorded on the Consolidated Balance Sheets remained at zero
due to the uncertainty of achieving any of the lucitanib regulatory milestones, and therefore the remote likelihood of
future milestone payouts.
Research and Development Expense
Research and development costs are charged to expense as incurred and include, but are not limited to, salary and
benefits, share-based compensation, clinical trial activities, drug development and manufacturing, companion diagnostic
development and third-party service fees, including contract research organizations and investigative sites. During 2015,
we completed the hiring of our U.S. sales and marketing and medical affairs organizations in preparation for the
potential commercial launch of Rubraca. These costs were also included in research and development expense before the
FDA approval of Rubraca.
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Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress
to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to
us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual
arrangements, which may differ from the pattern of costs incurred and are reflected on the Consolidated Balance Sheets
as prepaid or accrued research and development expenses.
Acquired In-Process Research and Development Expense
We have acquired and expect to continue to acquire the rights to develop and commercialize new drug candidates.
The upfront payments to acquire a new drug compound, as well as subsequent milestone payments, are immediately
expensed as acquired in-process research and development provided that the drug has not achieved regulatory approval
for marketing and, absent obtaining such approval, has no alternative future use. Once regulatory approval is received,
payments to acquire rights, and the related milestone payments, are capitalized and the amortization of such assets
recorded to product cost of sales.
Share-Based Compensation Expense
Share-based compensation is recognized as expense for all share-based awards made to employees and directors and
is based on estimated fair values. We determine equity-based compensation at the grant date using the Black-Scholes
option pricing model. The value of the award that is ultimately expected to vest is recognized as expense on a straight-
line basis over the requisite service period. Any changes to the estimated forfeiture rates are accounted for prospectively.
Inventory
Inventories are stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. Prior
to the regulatory approval of Rubraca, we incurred expenses for the manufacture of drug that could potentially be
available to support the commercial launch of Rubraca. Until the first reporting period when regulatory approval has
been received, we record all such costs as research and development expense. We periodically analyze our inventory
levels, and write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated
realizable value and/or inventory in excess of expected sales requirements as cost of product revenues. Expired inventory
would be disposed of and the related costs would be written off as cost of product revenues.
The active pharmaceutical ingredient in Rubraca is currently produced by a single supplier.
Concentration of Credit Risk
Financial instruments that potentially subject us to concentrations of credit risk are primarily cash, cash equivalents
and available-for-sale securities. We maintain our cash and cash equivalent balances in the form of money market
accounts with financial institutions that we believe are creditworthy. Available-for-sale securities are invested in
accordance with our investment policy. The investment policy includes guidelines on the quality of the institutions and
financial instruments and defines allowable investments that we believe minimizes the exposure to concentration of
credit risk. We have no financial instruments with off-balance sheet risk of accounting loss.
Foreign Currency
The assets and liabilities of our foreign operations are translated into U.S. dollars at current exchange rates and the
results of operations are translated at the average exchange rates for the reported periods. The resulting translation
adjustments are included in accumulated other comprehensive loss on the Consolidated Balance Sheets. Transactions
denominated in currencies other than the functional currency are recorded based on exchange rates at the time such
transactions arise. Transaction gains and losses are recorded to foreign currency gains (losses) on the Consolidated
Statements of Operations. As of December 31, 2016 and 2015, approximately 1% and 3%, respectively, of our total
liabilities were denominated in currencies other than the functional currency.
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Income Taxes
We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized
for the future tax consequences attributable to differences between the financial statement carrying amounts of existing
assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences
are expected to affect taxable income. Tax benefits are recognized when it is more likely than not that a tax position will
be sustained during an audit. Deferred tax assets are reduced by a valuation allowance if current evidence indicates that
it is considered more likely than not that these benefits will not be realized.
Recently Adopted Accounting Standards
In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
No. 2014-15, “Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern,” which requires
management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s ability to
continue as a going concern and to provide disclosures when certain criteria are met. The guidance is effective for annual
periods beginning in 2016 and interim reporting periods starting in the first quarter of 2017. Early application is
permitted. We adopted this standard effective December 31, 2016. Adoption of the standard resulted in no material
change to our disclosures.
Recently Issued Accounting Standards
In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers” and has subsequently
issued several supplemental and/or clarifying ASUs (collectively, “ASC 606”). ASC 606 prescribes a single common
revenue standard that replaces most existing U.S. GAAP revenue recognition guidance. ASC 606 is intended to provide
a more consistent interpretation and application of the principles outlined in the standard across filers in multiple
industries and within the same industries compared to current practices, which should improve comparability. Adoption
of ASC 606 is required for annual and interim periods beginning after December 15, 2017. Upon adoption, we must
elect to adopt either retrospectively to each prior reporting period presented or use the cumulative effect transition
method with the cumulative effect of initial adoption recognized at the date of initial application. We began recognizing
revenue from product sales for the first time after the FDA approval of Rubraca on December 16, 2016 and have adopted
a revenue recognition policy accordingly. We have not determined what adoption transition method we will use upon the
adoption of ASC 606. We are currently assessing the impact that the future adoption of ASC 606 may have on our
consolidated financial statements and related disclosures by analyzing our current accounting policies and practices to
identify potential differences in applying the guidance of ASC 606.
In July 2015, the FASB issued ASU No. 2015-11, which amends existing guidance for measurement of
inventory. Current inventory guidance requires an entity to measure inventory at the lower of cost or market. Market
could be replacement cost, net realizable value, or net realizable value less an approximately normal profit margin. An
entity should measure all inventory to which the amendments apply at the lower of cost and net realizable value. Net
realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of
completion, disposal, and transportation. The amendments are effective for fiscal years beginning after December 15,
2016, and interim periods within fiscal years beginning after December 15, 2017. The amendments should be applied
prospectively with earlier application permitted as of the beginning of an interim or annual reporting period. We do not
expect the adoption of this guidance to have a material impact on our consolidated financial statements.
In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” which requires lessees to recognize
assets and liabilities for the rights and obligations created by most leases on their balance sheet. The guidance is
effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early
application is permitted. ASU 2016-02 requires modified retrospective adoption for all leases existing at, or entered into
after, the date of initial application, with an option to use certain transition relief. We are currently evaluating the impact
the standard may have on our consolidated financial statements and related disclosures.
In March 2016, the FASB issued ASU No. 2016-09, “Compensation – Stock Compensation (Topic 718):
Improvements to Employee Share-Based Payment Accounting”, to simplify financial reporting of the income tax
impacts of share-based compensation arrangements. ASU No. 2016-09 is effective for us for annual and interim periods
beginning after January 1, 2017. The classification guidance under ASU No. 2016-09 requires the recognition of excess
tax benefits from share-based compensation arrangements as a discrete item within income tax benefit rather than
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additional paid-in capital and the classification guidance requiring presentation of excess tax benefits from share-based
compensation arrangements as an operating activity on the statement of cash flows, rather than as an financing activity.
The adoption of ASU No 2016-09 is expected to have no immediate impact on our financial statements and related
disclosures because we do not currently recognize a tax benefit related to share-based compensation expense as we
maintain net operating loss carryforwards and have established a valuation allowance against the entire net deferred tax
asset as of December 31, 2016. Further, we have elected to continue to estimate the number of stock-based awards
expected to vest, as permitted by ASU 2016-09, rather than electing to account for forfeitures as they occur.
3. Property and Equipment
Property and equipment consisted of the following (in thousands):
December 31,
2016
2015
Laboratory, manufacturing and office equipment
Leasehold improvements
Furniture and fixtures
Computer hardware and software
Total property and equipment
Less: accumulated depreciation
Total property and equipment, net
2,276
1,411
855
7,097
$ 2,555 $ 2,556
1,861
1,487
833
6,737
(1,791)
$ 4,440 $ 4,946
(2,657)
Depreciation expense related to property and equipment was approximately $1.1 million, $0.8 million and $0.4
million for the years ended December 31, 2016, 2015 and 2014, respectively.
4. Fair Value Measurements
Fair value is defined as the exchange price that would be received to sell an asset or paid to transfer a liability (at exit
price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market
participants on the measurement date. The three levels of inputs that may be used to measure fair value include:
Level 1: Quoted prices in active markets for identical assets or liabilities. Our Level 1 assets consist of money market
investments. We do not have Level 1 liabilities.
Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active
markets or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities. Our Level 2 assets consist of U.S. treasury securities.
We do not have Level 2 liabilities.
Level 3: Unobservable inputs that are supported by little or no market activity. We do not have Level 3 assets. The
contingent purchase consideration related to the undeveloped lucitanib product rights acquired with the
purchase of EOS in November 2013 is a Level 3 liability. The fair value of this liability is based on
unobservable inputs and includes valuations for which there is little, if any, market activity. During the
second quarter of 2016, we recorded a $25.5 million reduction in the fair value of the contingent purchase
consideration liability due to our and our development partner’s decision to discontinue the development of
lucitanib for breast cancer, reducing the remaining fair value to zero. The fair value and carrying value
remained at zero as of December 31, 2016.
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The following table identifies our assets and liabilities that were measured at fair value on a recurring basis (in
thousands):
Balance
Level 1
Level 2
Level 3
December 31, 2016
Assets:
Money market
U.S. treasury securities
Total assets at fair value
Liabilities:
Contingent purchase consideration
Total liabilities at fair value
December 31, 2015
Assets:
Money market
U.S. treasury securities
Total assets at fair value
Liabilities:
Contingent purchase consideration
Total liabilities at fair value
$ 202,361 $ 202,361 $
— $
49,997
—
49,997
$ 252,358 $ 202,361 $ 49,997 $
$
$
— $
— $
— $
— $
— $
— $
$ 251,037 $ 251,037 $
249,832
$ 500,869 $ 251,037 $ 249,832 $
249,832
— $
—
—
—
—
—
—
—
—
—
$ 24,661 $
$ 24,661 $
— $
— $
— $ 24,661
— $ 24,661
There were no liabilities that were measured at fair value on a recurring basis as of December 31, 2016. There were
no transfers between the Level 1 and Level 2 categories or into or out of the Level 3 category during the year ended
December 31, 2016.
The following table rolls forward the fair value of Level 3 instruments (significant unobservable inputs) (in
thousands):
Liabilities:
Balance at beginning of period
Change in fair value
Change in foreign currency gains and losses
Balance at end of period
For the Year Ended
December 31,
2016
$
$
24,661
(24,936)
275
—
The change in the fair value of Level 3 instruments is included in change in fair value of contingent purchase
consideration and foreign currency gains (losses) for changes in the foreign currency translation rate on the Consolidated
Statements of Operations.
Financial instruments not recorded at fair value include our convertible senior notes. At December 31, 2016, the
carrying amount of the convertible senior notes was $281.1 million, which represents the aggregate principal amount net
of remaining debt issuance costs, and the fair value was $297.6 million. The fair value was determined using Level 2
inputs based on the indicative pricing published by certain investment banks or trading levels of the convertible senior
notes, which are not listed on any securities exchange or quoted on an inter-dealer automated quotation system. See Note
7, Convertible Senior Notes for discussion of the convertible senior notes. The carrying amounts of accounts payable and
accrued expenses approximate their fair value due to their short-term maturities.
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5. Available-for-Sale Securities
As of December 31, 2016, available-for-sale securities consisted of the following (in thousands):
U.S. treasury securities
$
Gross
Unrealized Unrealized
Gross
Aggregate
Amortized
Cost
50,004 $
Gains
Losses
— $
(7) $
Fair
Value
49,997
As of December 31, 2016, the fair value and gross unrealized losses of available-for-sale securities that have been in a
continuous unrealized loss position for less than 12 months were as follows (in thousands):
U.S. treasury securities
$
Aggregate
Gross
Unrealized
Fair
Value
49,997 $
Losses
(7)
Our investments have been in an unrealized loss position for one month. Based upon our evaluation of all relevant
factors, we believe that the decline in fair value of securities held at December 31, 2016 below cost is temporary, and we
intend to retain our investment in these securities for a sufficient period of time to allow for recovery of the fair value.
As of December 31, 2016, the amortized cost and fair value of available-for-sale securities by contractual maturity
were (in thousands):
Due in one year or less
Due in one year to two years
Total
6. Intangible Assets and Goodwill
Amortized
Cost
50,004 $
—
50,004 $
$
$
Fair
Value
49,997
—
49,997
At December 31, 2016, intangible assets related to capitalized milestones under license agreements consisted of the
following (in thousands):
Intangible asset - milestones
Accumulated amortization
Total intangible asset, net
$
December 31,
2016
21,100
(53)
21,047
$
The estimated useful lives of these intangibles assets extended through 2031. There were no intangible assets related
to capitalized milestones under license agreement as of December 31, 2015.
We recorded an amortization expense of $0.053 million related to capitalized milestone payments during the year
ended December 31, 2016. There was no amortization expense during the year ended December 31, 2015. Estimated
future amortization expense for intangible assets as of December 31, 2016 is as follows (in thousands):
2017
2018
2019
2020
2021
Thereafter
$ 1,486
1,486
1,486
1,486
1,486
13,617
$ 21,047
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IPR&D assets and goodwill were established as part of the purchase accounting of EOS in November 2013, and
consisted of the following (in thousands):
IPR&D assets:
Balance at beginning of period
Impairment of intangible asset (a)
Change in foreign currency gains and losses
Balance at end of period
Goodwill:
Balance at beginning of period
Change in foreign currency gains and losses
Balance at end of period
December 31,
2016
2015
101,500 $
(104,517)
3,017
— $
212,900
(89,557)
(21,843)
101,500
59,327 $
(2,135)
57,192 $
66,055
(6,728)
59,327
$
$
$
$
(a) During the second quarter of 2016, we recorded a $104.5 million impairment charge due to our and our
development partner’s decision to discontinue the development of lucitanib for breast cancer. At December 31,
2016, the IPR&D intangible asset recorded on the Consolidated Balance Sheets was zero.
During the fourth quarter of 2015, we recorded an $89.6 million impairment charge due to our and our development
partner’s decision to terminate the development of lucitanib for lung cancer, as well as updates to the probability-
weighted discounted cash flow assumptions for the breast cancer indication.
These reductions were included in impairment of intangible asset on the Consolidated Statements of Operations.
As of December 31, 2016, no impairment to the carrying value of the goodwill was identified.
7. Convertible Senior Notes
On September 9, 2014, we completed a private placement of $287.5 million aggregate principal amount of 2.5%
convertible senior notes due 2021 (the “Notes”) resulting in net proceeds of $278.3 million after deducting offering
expenses. In accordance with the accounting guidance, the conversion feature did not meet the criteria for bifurcation,
and the entire principal amount was recorded as a long-term liability on the Consolidated Balance Sheets.
The Notes are governed by the terms of the indenture between the Company, as issuer, and The Bank of New York
Mellon Trust Company, N.A., as trustee. The Notes are senior unsecured obligations and bear interest at a rate of
2.5% per year, payable semi-annually in arrears on March 15 and September 15 of each year. The Notes will mature on
September 15, 2021, unless earlier converted, redeemed or repurchased.
Holders may convert all or any portion of the Notes at any time prior to the close of business on the business day
immediately preceding the maturity date. Upon conversion, the holders will receive shares of our common stock at an
initial conversion rate of 16.1616 shares per $1,000 in principal amount of Notes, equivalent to a conversion price of
approximately $61.88 per share. The conversion rate is subject to adjustment upon the occurrence of certain events
described in the indenture, but will not be adjusted for any accrued and unpaid interest. In addition, following certain
corporate events that occur prior to the maturity date or upon our issuance of a notice of redemption, we will increase the
conversion rate for holders who elect to convert the Notes in connection with such a corporate event or during the related
redemption period in certain circumstances.
On or after September 15, 2018, we may redeem the Notes, at our option, in whole or in part, if the last reported sale
price of our common stock has been at least 150% of the conversion price then in effect for at least 20 trading days
(whether or not consecutive) during any 30 consecutive trading day period ending not more than two trading days
preceding the date on which we provide written notice of redemption at a redemption price equal to 100% of the
principal amount of the Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date.
No sinking fund is provided for the Notes.
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If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the Notes, holders may
require us to repurchase for cash all or any portion of the Notes at a fundamental change repurchase price equal to 100%
of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the
fundamental change repurchase date.
The Notes rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of
payment to the Notes; equal in right of payment to all of our liabilities that are not so subordinated; effectively junior in
right of payment to any secured indebtedness to the extent of the value of the assets securing such indebtedness; and
structurally junior to all indebtedness and other liabilities (including trade payables) of our subsidiaries.
In connection with the issuance of the Notes, we incurred $9.2 million of debt issuance costs. The debt issuance costs
are amortized as interest expense over the expected life of the Notes using the effective interest method. We determined
the expected life of the debt was equal to the seven-year term of the Notes. As of December 31, 2016 and 2015, the
balance of unamortized debt issuance costs was $6.4 million and $7.6 million, respectively, and is recorded as a
reduction to the convertible senior notes at the Consolidated Balance Sheets.
The following table sets forth total interest expense recognized related to the Notes during the years ended
December 31, 2016 and 2015 (in thousands):
Contractual interest expense
Accretion of interest on milestone liability
Amortization of debt issuance costs
Total interest expense
8. Stockholders’ Equity
Common Stock
Year ended December 31,
2016
2015
$ 7,187 $ 7,167
—
1,205
$ 8,491 $ 8,372
62
1,242
In July 2015, we sold 4,054,487 shares of our common stock in a public offering at $78.00 per share. The net
proceeds from the offering were $298.5 million, after deducting underwriting discounts and commissions and offering
expenses.
In January 2017, we sold 5,750,000 shares of our common stock in a public offering at $41.00 per share. The net
proceeds from the offering were $221.2 million, after deducting underwriting discounts and commissions and offering
expenses.
The holders of common stock are entitled to one vote per share on all matters to be voted upon by our stockholders.
Subject to the preferences that may be applicable to any outstanding shares of preferred stock, the holders of common
stock are entitled to receive ratably such dividends, if any, as may be declared by our Board of Directors.
Accumulated Other Comprehensive Loss
Accumulated other comprehensive loss consists of changes in foreign currency translation adjustments, which
includes changes in a subsidiary’s functional currency, and unrealized gains and losses on available-for-sale securities.
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The accumulated balances related to each component of other comprehensive income (loss) are summarized as
follows (in thousands):
Balance December 31, 2014
Other comprehensive income (loss)
Total before tax
Tax effect
Balance December 31, 2015
Other comprehensive income (loss)
Total before tax
Tax effect
Balance December 31, 2016
Foreign
Currency
Translation
Adjustments
$ (24,448) $
(22,629)
(47,077)
—
(47,077)
(1,693)
(48,770)
1,336
$ (47,434) $
Unrealized
(Losses) Gains
Total
Accumulated
Other
Comprehensive
— $
(383)
(383)
—
(383)
224
(159)
13
(146) $
Loss
(24,448)
(23,012)
(47,460)
—
(47,460)
(1,469)
(48,929)
1,349
(47,580)
The other comprehensive income (loss) related to foreign currency translation adjustments for the years ended
December 31, 2016 and 2015 was primarily due to the currency translation of the IPR&D intangible assets, goodwill and
deferred income taxes (see Note 6, Intangible Assets and Goodwill). There were no reclassifications out of accumulated
other comprehensive loss in the both years ended December 31, 2016 and 2015.
9. Share-Based Compensation
Stock Options
In August 2011, our Board of Directors approved the 2011 Stock Incentive Plan (the “2011 Plan”), which became
effective upon the closing of our initial public offering in November 2011. The 2011 Plan provides for the granting of
incentive and nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance
awards and other share-based awards to our employees, directors and consultants. Common shares authorized for
issuance under the 2011 Plan were 7,799,048 at December 31, 2016, which represents the initial reserve of 1,250,000
shares of common stock plus 192,185 shares of common stock remaining for future grant from the 2009 Equity Incentive
Plan (the “2009 Plan”), which was terminated upon the closing of our initial public offering in November 2011, and
6,356,863 new shares authorized by the Board of Directors at the annual meetings of stockholders. Future forfeitures and
cancellations of options previously granted under the 2009 Plan were transferred to and also available for grant under the
2011 Plan. Stock options granted vest ratably over either a one-year period or three-year period for Board of Director
grants. Employee stock options generally vest over a four-year period with 25% of the options cliff-vesting after year
one and the remaining options vesting ratably over each subsequent month. All stock options expire 10 years from the
date of grant.
Share-based compensation expense for the years ended December 31, 2016, 2015 and 2014, respectively, was
recognized in the accompanying Consolidated Statements of Operations as follows (in thousands):
Research and development
Selling, general and administrative
Total share-based compensation expense
2016
Year ended December 31,
2015
$ 27,558 $ 27,321 $ 11,474
12,238
10,043
13,036
$ 39,796 $ 40,357 $ 21,517
2014
We did not recognize a tax benefit related to share-based compensation expense during the years ended December 31,
2016, 2015 and 2014, respectively, as we maintain net operating loss carryforwards and has established a valuation
allowance against the entire net deferred tax asset as of December 31, 2016.
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The following table summarizes the activity relating to our options to purchase common stock:
Weighted
Average
Weighted
Average Remaining
Exercise Contractual
Term (Years)
Price
Aggregate
Intrinsic
Value
(Thousands)
Number of
Options
Outstanding at December 31, 2015
Granted
Exercised
Forfeited
Outstanding at December 31, 2016 (a)
Vested and expected to vest at December 31, 2016
Vested and exercisable at December 31, 2016
5,360,257 $ 51.53
22.57
1,955,637
13.21
(247,431)
55.07
(1,547,981)
5,520,482 $ 42.00
5,176,887 $ 42.29
2,836,714 $ 43.54
7.5 $ 78,532
7.4 $ 73,170
6.1 $ 39,580
(a) Includes 33,750 performance-based stock options granted to our executives in the first quarter of 2015, which vested
on approval by the FDA in December 19, 2016 to commercially distribute, sell or market Rubraca. Related stock
compensation expense was recognized on that date.
The aggregate intrinsic value in the table above represents the pretax intrinsic value, based on our closing stock price
of $44.42 as of December 31, 2016, which would have been received by the option holders had all option holders with
in-the-money options exercised their options as of that date.
The following table summarizes information about our stock options as of and for the years ended December 31,
2016, 2015 and 2014:
Year ended December 31,
2015
2014
2016
Weighted-average grant date fair value per share
Intrinsic value of options exercised
Cash received from stock option exercises
16.62 $
$
38.47
$ 3,118,097 $ 19,976,769 $ 2,906,304
$ 3,267,721 $ 5,478,211 $ 682,678
52.70 $
The fair value of each share-based award is estimated on the grant date using the Black-Scholes option pricing model
based upon the weighted-average assumptions provided in the following table:
Dividend yield
Volatility (a)
Risk-free interest rate (b)
Expected term (years) (c)
Year ended December 31,
2016 2015 2014
—
70 %
1.77 % 1.77 % 1.92 %
6.1
—
72 %
—
93 %
5.8
6.2
(a) Volatility: The expected volatility was estimated using our historical data.
(b) Risk-free interest rate: The rate is based on the yield on the grant date of a zero-coupon U.S. Treasury bond whose
maturity period approximates the option’s expected term.
(c) Expected term: The expected term of the award was estimated using our historical data.
The total fair value of stock options vested during the years ended December 31, 2016, 2015 and 2014 was $40.8
million, $36.5 million and $13.0 million, respectively.
Restricted Stock
During 2016, we issued restricted stock units (“RSUs”) to certain employees under the 2011 Stock Incentive Plan.
The RSUs ratably cliff vest after year one with the remaining RSUs vesting ratably each subsequent quarter over either
the two-year or four-year vesting period of the grant. Vested RSUs are payable in shares of our common stock at the end
of the vesting period. RSUs are measured based on the fair value of the underlying stock on the grant date. Shares issued
on the vesting dates are net of the minimum statutory tax to be paid by us on behalf of our employees. As a result, the
actual number of shares issued will be lower than the actual number of RSUs vested.
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The following table summarizes the activity related to our unvested RSUs:
Number of
Units
Unvested at December 31, 2015
Granted
Vested (a)
Forfeited
Unvested as of December 31, 2016
Expected to vest after December 31, 2016
Weighted
Average
Grant Date
Fair Value
—
24.29
19.37
19.56
24.70
24.50
— $
610,805
(10,375)
(37,972)
562,458 $
472,242 $
(a) During 2016, we accelerated vesting of RSUs for certain employees.
Common Stock Reserved for Issuance
As of December 31, 2016, we reserved shares of common stock for future issuance as follows:
2009 Equity Incentive Plan
2011 Stock Incentive Plan
2011 Employee Stock Purchase Plan
Total
Employee Stock Purchase Plan
Common Stock
Outstanding
Available for
Grant
or Future
Issuance
361,018
—
5,721,922 1,740,629
265,723
6,082,940 2,006,352
—
Total Shares of
Common Stock
Reserved
361,018
7,462,551
265,723
8,089,292
In August 2011, our Board of Directors approved the Clovis Oncology, Inc. 2011 Employee Stock Purchase Plan (the
“Purchase Plan”). Each year, on the date of our annual meeting of stockholders and at the discretion of our board of
directors, the amount of shares reserved for issuance under the Purchase Plan may be increased by up to the lesser of
(1) a number of additional shares of our common stock representing 1% of our then-outstanding shares of common
stock, (2) 344,828 shares of our common stock and (3) a lesser number of shares as approved by the Board. The
Purchase Plan provides for consecutive six-month offering periods, during which participating employees may elect to
have up to 10% of their compensation withheld and applied to the purchase of common stock at the end of each offering
period. The purchase price of the common stock is 85% of the lower of the fair value of a share of common stock on the
first trading date of each offering period or the fair value of a share of common stock on the last trading day of the
offering period. The Purchase Plan will terminate on August 24, 2021, the tenth anniversary of the date of initial
adoption of the Purchase Plan. We sold 110,508 and 32,021 shares to employees in 2016 and 2015, respectively. There
were 265,723 shares available for sale under the Purchase Plan as of December 31, 2016. The weighted-average
estimated grant date fair value of purchase awards under the Purchase Plan during the years ended December 31, 2016
and 2015 was $11.70 and $26.80 per share, respectively. The total share-based compensation expense recorded as a
result of the Purchase Plan was approximately $0.8 million, $0.9 million and $0.2 million during the years ended
December 31, 2016, 2015 and 2014, respectively.
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The fair value of purchase awards granted to our employees during the years ended December 31, 2016, 2015 and
2014, respectively, was estimated using the Black-Scholes option pricing model based upon the weighted-average
assumptions provided in the following table:
Dividend yield
Volatility (a)
Risk-free interest rate (b)
Expected term (years) (c)
Year ended December 31,
2016 2015 2014
—
71 %
0.40 % 0.11 % 0.07 %
0.5
—
71 %
—
92 %
0.5
0.5
(a) Volatility: The expected volatility was estimated using our historical data.
(b) Risk-free interest rate: The rate is based on the U.S. Treasury yield in effect at the time of grant with terms similar
to the contractual term of the purchase right.
(c) Expected term: The expected life of the award represents the six-month offering period for the Purchase Plan.
Unrecognized share-based compensation expense related to non-vested options and RSUs, adjusted for expected
forfeitures, was $86.8 million as of December 31, 2016. The unrecognized share-based compensation expense is
expected to be recognized over the weighted-average remaining vesting period of 3.1 years.
10. Commitments and Contingencies
We lease office space in Boulder, Colorado, San Francisco, California, Cambridge, UK and Milan, Italy under non-
cancelable operating lease agreements that expire through 2023.
The lease agreements contain periodic rent increases that result in the recording deferred rent over the terms of certain
leases. In June 2015, we entered into a seven-year lease agreement for new office space in Boulder, Colorado. Pursuant
to the terms of the lease, the landlord reimbursed us for $1.1 million of leasehold improvement expenditures (the
“Tenant Improvement Allowance”). In December 2015, upon completion of construction, we recorded the Tenant
Improvement Allowance as deferred rent, which is being amortized as a reduction to rental expense over the lease term.
Rental expense under these leases was $2.2 million, $2.4 million and $1.4 million for the years ended December 31,
2016, 2015 and 2014, respectively.
Future minimum rental commitments, by fiscal year and in the aggregate, for our operating leases are provided below
(in thousands):
2017
2018
2019
2020
2021
Thereafter
Total future minimum lease payments
Manufacture and Services Agreement Commitments
December 31,
2016
$
$
1,822
1,783
1,837
1,891
1,947
600
9,880
On October 3, 2016, we entered into a Manufacturing and Services Agreement (the “Agreement”) with a non-
exclusive third-party supplier for the production of the active ingredient for rucaparib. Under the terms of the
Agreement, we will provide the third-party supplier a rolling forecast for the supply of the active ingredient in rucaparib
that will be updated by us on a quarterly basis. We are obligated to order material sufficient to satisfy an initial quantity
specified any forecast. In addition, the third-party supplier will construct, in its existing facility, a production train that
will be exclusively dedicated to the manufacture of the rucaparib active ingredient. We are obligated to make scheduled
capital program fee payments toward capital equipment and other costs associated with the construction of the dedicated
production train. Further, once the facility is operational, we are obligated to pay a fixed facility fee each quarter for the
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duration of the Agreement, which expires on December 31, 2025, unless extended by mutual consent of the parties. As
of December 31, 2016, $171.4 million of purchase commitments exist under the Agreement.
We have an existing agreement with the same third-party supplier, dated February 8, 2013, as amended, under which
the third-party supplier supplied the active ingredient for rucaparib for clinical development. During the years ended
December 31, 2016, 2015 and 2014, $9.7 million, $6.0 million and $3.3 million, respectively, of purchases were
performed under this agreement.
Legal Proceedings
We and certain of our officers were named as defendants in several lawsuits, as described below. We cannot
reasonably predict the outcome of these legal proceedings, nor can we estimate the amount of loss or range of loss, if
any, that may result. An adverse outcome in these proceedings could have a material adverse effect on our results of
operations, cash flows or financial condition.
On November 19, 2015, Steve Kimbro, a purported shareholder of Clovis, filed a purported class action complaint
(the “Kimbro Complaint”) against Clovis and certain of its officers in the United States District Court for the District of
Colorado. The Kimbro Complaint purports to be asserted on behalf of a class of persons who purchased Clovis stock
between October 31, 2013 and November 15, 2015. The Kimbro Complaint generally alleges that Clovis and certain of
its officers violated federal securities laws by making allegedly false and misleading statements regarding the progress
toward FDA approval and the potential for market success of rociletinib. The Kimbro Complaint seeks unspecified
damages.
Also on November 19, 2015, a second purported shareholder class action complaint was filed by Sonny P. Medina,
another purported Clovis shareholder, containing similar allegations to those set forth in the Kimbro Complaint, also in
the United States District Court for the District of Colorado (the “Medina Complaint”). The Medina Complaint purports
to be asserted on behalf of a class of persons who purchased Clovis stock between May 20, 2014 and November 13,
2015. On November 20, 2015, a third complaint was filed by John Moran in the United States District Court for the
Northern District of California (the “Moran Complaint”). The Moran Complaint contains similar allegations to those
asserted in the Kimbro and Medina Complaints and purports to be asserted on behalf of a plaintiff class who purchased
Clovis stock between October 31, 2013 and November 13, 2015.
On December 14, 2015, Ralph P. Rocco, a fourth purported shareholder of Clovis, filed a complaint in the United
States District Court for the District of Colorado (the “Rocco Complaint”). The Rocco Complaint contains similar
allegations to those set forth in the previous complaints and purports to be asserted on behalf of a plaintiff class who
purchased Clovis stock between October 31, 2013 and November 15, 2015.
On January 19, 2016, a number of motions were filed in both the District of Colorado and the Northern District of
California seeking to consolidate the shareholder class actions into one matter and for appointment of a lead plaintiff. All
lead plaintiff movants other than M. Arkin (1999) LTD and Arkin Communications LTD (the “Arkin Plaintiffs”)
subsequently filed notices of non-opposition to the Arkin Plaintiffs’ application.
On February 2, 2016, the Arkin Plaintiffs filed a motion to transfer the Moran Complaint to the District of Colorado
(the “Motion to Transfer”). Also on February 2, 2016, the defendants filed a statement in the Northern District of
California supporting the consolidation of all actions in a single court, the District of Colorado. On February 3, 2016, the
Northern District of California court denied without prejudice the lead plaintiff motions filed in that court pending a
decision on the Motion to Transfer.
On February 16, 2016, the defendants filed a memorandum in support of the Motion to Transfer, and plaintiff Moran
filed a notice of non-opposition to the Motion to Transfer. On February 17, 2016, the Northern District of California
court granted the Motion to Transfer.
On February 18, 2016, the Medina court issued an opinion and order addressing the various motions for consolidation
and appointment of lead plaintiff and lead counsel in the District of Colorado actions. By this ruling, the court
consolidated the Medina, Kimbro and Rocco actions into a single proceeding. The court also appointed the Arkin
Plaintiffs as the lead plaintiffs and Bernstein Litowitz Berger & Grossman as lead counsel for the putative class.
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On April 1, 2016, the Arkin Plaintiffs and the defendants filed a stipulated motion to set the schedule for the filing of
a consolidated complaint in the Medina, Kimbro and Rocco actions (the “Consolidated Complaint”) and the responses
thereto, including the defendants’ motion to dismiss the Consolidated Complaint (the “Motion to Dismiss”), and to stay
discovery and related proceedings until the District of Colorado issues a decision on the Motion to Dismiss. The
stipulated motion was entered by the District of Colorado on April 4, 2016.
Subject to further agreed-upon extensions by the parties, the Arkin Plaintiffs filed a Consolidated Complaint on May
6, 2016. The Consolidated Complaint names as defendants the Company and certain of its current and former officers
(the “Clovis Defendants”), certain underwriters (the “Underwriter Defendants”) for a Company follow-on offering
conducted in July 2015 (the “July 2015 Offering”) and certain Company venture capital investors (the “Venture Capital
Defendants”). The Consolidated Complaint alleges that defendants violated particular sections of the Securities
Exchange Act of 1934 (the “Exchange Act”) and the Securities Act of 1933 (the “Securities Act”). The purported
misrepresentations and omissions concern allegedly misleading statements about rociletinib. The consolidated action is
purportedly brought on behalf of investors who purchased the Company’s securities between May 31, 2014 and April 7,
2016 (with respect to the Exchange Act claims) and investors who purchased the Company’s securities pursuant or
traceable to the July 2015 Offering (with respect to the Securities Act claims). The Consolidated Complaint seeks
unspecified compensatory and recessionary damages.
On May 23, 2016, the Medina, Kimbro, Rocco, and Moran actions were consolidated for all purposes in a single
proceeding in the District of Colorado.
The Clovis Defendants, the Underwriter Defendants and the Venture Capital Defendants filed a Motion to Dismiss on
July 27, 2016, the Arkin Plaintiffs filed their opposition on September 23, 2016, and the defendants filed their replies on
October 14, 2016.
On February 9, 2017, Judge Raymond P. Moore of the District of Colorado issued an Opinion and Order granting in
part and denying in part the Clovis Defendants’ Motion to Dismiss. The Clovis Defendants’ Motion to Dismiss was
granted with prejudice with respect to named defendant Gillian Ivers-Read and granted with respect to certain statements
determined by the Court to be nonactionable statements of opinion or optimism. The Clovis Defendants’ Motion to
Dismiss was otherwise denied. Next, the Court granted in part and denied in part the Underwriter Defendants’ Motion to
Dismiss. The Underwriter Defendants’ Motion to Dismiss was granted without prejudice with respect to Plaintiffs’ claim
under Section 12(a) of the Securities Act and granted insofar as the Court determined that certain statements challenged
under Section 11 of the Securities Act are nonactionable statements of opinion or optimism. The Opinion and Order
provided that Plaintiffs shall have until February 23, 2017 to file an amended pleading directed solely as to their Section
12(a) claim against the Underwriter Defendants. The Underwriters Defendants’ Motion to dismiss was otherwise denied.
Finally, the court granted the Venture Capital Defendants’ Motion to Dismiss with prejudice.
The Clovis Defendants intend to vigorously defend against the allegations contained in the Kimbro, Medina, Moran
and Rocco Complaints, but there can be no assurance that the defense will be successful.
On January 22, 2016, the Electrical Workers Local #357 Pension and Health & Welfare Trusts, a purported
shareholder of Clovis, filed a purported class action complaint (the “Electrical Workers Complaint”) against Clovis and
certain of its officers, directors, investors and underwriters in the Superior Court of the State of California, County of
San Mateo. The Electrical Workers Complaint purports to be asserted on behalf of a class of persons who purchased
stock in Clovis’ July 8, 2015 follow-on offering. The Electrical Workers Complaint generally alleges that the defendants
violated the Securities Act because the offering documents for the July 8, 2015 follow-on offering contained allegedly
false and misleading statements regarding the progress toward FDA approval and the potential for market success of
rociletinib. The Electrical Workers Complaint seeks unspecified damages.
On February 25, 2016, the defendants removed the case to the United States District Court for the Northern District of
California and thereafter moved to transfer the case to the District of Colorado (“Motion to Transfer”). On March 2,
2016, the plaintiff filed a motion to remand the case to San Mateo County Superior Court (“Motion to Remand”).
Following briefing on the Motion to Transfer and the Motion to Remand, the Northern District of California held a
hearing on April 18, 2016 concerning the Motion to Remand, at the conclusion of which the court granted to the Motion
to Remand. On May 5, 2016, the Northern District of California issued a written decision and order granting the Motion
to Remand the case to the Superior Court, County of San Mateo and denying the Motion to Transfer as moot.
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While the case was pending in the United States District Court for the Northern District of California, the parties
entered into a stipulation extending the defendants’ time to respond to the Electrical Workers Complaint for 30 days
following the filing of an amended complaint by plaintiff or the designation by plaintiff of the Electrical Workers
Complaint as the operative complaint. Following remand, Superior Court of the State of California, County of San
Mateo so-ordered the stipulation on June 22, 2016.
On June 30, 2016, the Electrical Workers Plaintiffs filed an amended Complaint (the “Amended Complaint”). The
Amended Complaint names as defendants the Company and certain of its current and former officers and directors,
certain underwriters for the July 2015 Offering and certain Company venture capital investors. The Amended Complaint
purports to assert claims under the Securities Act based upon alleged misstatements in Clovis’ offering documents for
the July 2015 Offering. The Amended Complaint includes new allegations about the Company’s rociletinib
disclosures. The Amended Complaint seeks unspecified damages.
Pursuant to a briefing schedule ordered by the court on July 28, 2016, defendants filed a motion to stay the Electrical
Workers action pending resolution of the Medina, Kimbro, Moran, and Rocco actions in the District of Colorado
(“Motion to Stay”), and a demurrer to the Amended Complaint, on August 15, 2016; plaintiffs filed their oppositions on
August 31, 2016; and the defendants filed their reply briefs on September 15, 2016. On September 23, 2016, after
hearing oral argument, the San Mateo Superior Court granted defendants’ motion to stay proceedings pending resolution
of the related securities class action captioned Medina v. Clovis Oncology, Inc., et. al., No. 1:15-cv-2546 (the “Colorado
Action”). Per the order to stay proceedings, the San Mateo Superior Court will defer issuing a ruling on defendants’
pending demurrer, and the parties’ first status report as to the progress of the Colorado Action is due on March 23, 2017.
The Company intends to vigorously defend against the allegations contained in the Electrical Workers Amended
Complaint, but there can be no assurance that the defense will be successful.
On November 10, 2016, Antipodean Domestic Partners (“Antipodean”) filed a complaint (the “Antipodean
Complaint”) against Clovis and certain of its officers, directors and underwriters in New York Supreme Court, County of
New York. The Antipodean Complaint alleges that the defendants violated certain sections of the Securities Act by
making allegedly false statements to Antipodean and in the Offering Materials for the Secondary Offering relating to the
efficacy of rociletinib, its safety profile, and its prospects for market success. In addition to the Securities Act claims, the
Antipodean Complaint also asserts Colorado state law claims, and common law claims. Both the state law and common
law claims are based on the allegedly false and misleading statements regarding rociletinib’s progress toward FDA
approval. The Antipodean Complaint seeks compensatory, recessionary, and punitive damages.
On December 15, 2016, the Antipodean Plaintiffs filed an amended complaint (“the Amended Complaint”) asserting
substantially the same claims against the same defendants. The Amended Complaint purports to correct certain details in
the original Complaint.
On January 21, 2017, the parties entered into a stipulation extending the defendants’ time to respond to the
Antipodean Amended Complaint until March 29, 2017, subject to the terms and conditions stated therein. Pursuant to the
January 21, 2017 stipulation, the defendants filed a motion to stay the Antipodean action pending resolution of the
Medina, Kimbro, Moran, and Rocco actions in the District of Colorado (“Motion to Stay”) on January 31, 2017. The
Motion to Stay has a scheduled return date of March 24, 2017.
The Company intends to vigorously defend against the allegations contained in the Antipodean Amended Complaint,
but there can be no assurance that the defense will be successful.
We received a letter dated May 31, 2016 from an alleged owner of our common stock, which purports to set forth a
demand for inspection of certain of our books and records pursuant to 8 Del. C. § 220 (the “Macalinao Demand Letter”).
The Macalinao Demand Letter was purportedly made for the purposes of investigating alleged misconduct at the
Company relating to rociletinib. On June 24, 2016, we submitted a response to the Macalinao Demand Letter. We
believe that the allegations in the Macalinao Demand Letter are unfounded and that the Macalinao Demand Letter fails
to establish an entitlement to any of the requested documents, but there can be no assurance about the likelihood of an
adverse outcome. In January 2017, the Company produced certain books and records in response to the Macalinao
Demand Letter.
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We received a letter dated December 15, 2016 from a second alleged owner of our common stock, which purports to
set forth a demand for inspection of the Company’s books and records pursuant to 8 Del. C. § 220 (the “McKenry
Demand Letter”). The McKenry Demand Letter was purportedly made for the purposes of investigating alleged
misconduct at the Company relating to rociletinib. In addition, citing unnamed sources, the McKenry Demand Letter
alleges that the Company engaged in patient eligibility, record management and verification, and informed consent
violations in connection with the TIGER-X study at multiple testing sites, and that the FDA is purportedly investigating
the Company’s conduct. On January 4, 2017, we submitted a response to the McKenry Demand Letter. The Company
believes that the allegations in the McKenry Demand Letter are unfounded and that the McKenry Demand Letter fails to
establish an entitlement to any of the requested documents, but there can be no assurance about the likelihood of an
adverse outcome. In February 2017, the Company produced certain books and records in response to the McKenry
Demand Letter.
We have received requests for information from governmental agencies relating to our regulatory update
announcement in November 2015 that the FDA requested additional clinical data on the efficacy and safety of
rociletinib. We are cooperating with the inquiries.
11. License Agreements
Rucaparib
In June 2011, we entered into a worldwide license agreement with Pfizer Inc. to obtain exclusive global rights to
develop and commercialize rucaparib. The exclusive rights are exclusive even as to Pfizer and include the right to grant
sublicenses. Pursuant to the terms of the license agreement, we made a $7.0 million upfront payment to Pfizer. In April
2014, we initiated a pivotal registration study for rucaparib, which resulted in a $0.4 million milestone payment to Pfizer
as required by the license agreement. In September 2016, we made milestone payment of $0.5 million to Pfizer upon
acceptance of the NDA for rucaparib by the FDA. The MAA submission with the EMA for a comparable ovarian cancer
indication was accepted by the MAA during the fourth quarter of 2016, which resulted in a $0.5 million milestone
payment to Pfizer as required by the license agreement. These payments were recognized as acquired in-process research
and development expense.
On August 30, 2016, we entered into a first amendment to the worldwide license agreement with Pfizer, which
amends the June 2011 existing worldwide license agreement to permit us to defer payment of the milestone payments
payable upon (i) FDA approval of an NDA for 1st Indication in US and (ii) EMA approval of an MAA for 1st Indication
in EU, to a date that is 18 months after the date of achievement of such milestones. In the event that we defer such
milestone payments, we have agreed to certain higher payments related to the achievement of such milestones.
On December 19, 2016, the FDA approved Rubraca tablets as monotherapy for the treatment of patients with
deleterious BRCA mutation (germline and/or somatic) associated with advanced ovarian cancer, who have been treated
with two or more chemotherapies, and selected for therapy based on FDA-approved companion diagnostic for Rubraca.
The FDA approval resulted in a $0.75 million milestone payment to Pfizer as required by the license agreement. The
FDA approval also resulted in the obligation to pay a $20.0 million milestone payment, for which we have exercised the
option to defer payment by agreeing to pay $23.0 million within 18 months after the date of the FDA approval. These
payments were recognized as intangible assets and amortized over the estimated remaining useful life of rucaparib.
We are obligated under the license agreement to use commercially reasonable efforts to develop and commercialize
rucaparib and we are responsible for all remaining development and commercialization costs for rucaparib. We are
required to make regulatory milestone payments to Pfizer of up to an additional $69.75 million in aggregate if specified
clinical study objectives and regulatory filings, acceptances and approvals are achieved. In addition, we are obligated to
make sales milestone payments to Pfizer if specified annual sales targets for rucaparib are met, the majority of which
relate to annual sales targets of $500.0 million and above, which, in the aggregate, could amount to total milestone
payments of $170.0 million, and tiered royalty payments at a mid-teen percentage rate on our net sales, with standard
provisions for royalty offsets to the extent we need to obtain any rights from third parties to commercialize rucaparib.
The license agreement with Pfizer will remain in effect until the expiration of all of our royalty and sublicense
revenue obligations to Pfizer, determined on a product-by-product and country-by-country basis, unless we elect to
terminate the license agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure
such failure within specified time periods, Pfizer can terminate the agreement, resulting in a loss of our rights to
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rucaparib and an obligation to assign or license to Pfizer any intellectual property rights or other rights we may have in
rucaparib, including our regulatory filings, regulatory approvals, patents and trademarks for rucaparib.
In April 2012, we entered into a license agreement with AstraZeneca UK Limited to acquire exclusive rights
associated with rucaparib under a family of patents and patent applications that claim methods of treating patients with
PARP inhibitors in certain indications. The license enables the development and commercialization of rucaparib for the
uses claimed by these patents. Pursuant to the terms of the license agreement, we made an upfront payment of $0.25
million upon execution of the agreement. During the second quarter of 2016, we made a milestone payment of $0.3
million to AstraZeneca upon the NDA submission for rucaparib. These payments were recognized as acquired in-process
research and development expense. The FDA approval of rucaparib on December 19, 2016 resulted in a $0.35 million
milestone payment to AstraZeneca as required by the license agreement. This payment was recognized in intangible
assets and amortized over the estimated remaining useful life of rucaparib. AstraZeneca will also receive royalties on
any net sales of rucaparib.
Lucitanib
In connection with our acquisition of EOS in November 2013, we gained rights to develop and commercialize
lucitanib, an oral, selective tyrosine kinase inhibitor. As further described below, EOS licensed the worldwide rights,
excluding China, to develop and commercialize lucitanib from Advenchen Laboratories LLC (“Advenchen”).
Subsequently, rights to develop and commercialize lucitanib in markets outside the U.S. and Japan were sublicensed by
EOS to Servier in exchange for upfront milestone fees, royalties on sales of lucitanib in the sublicensed territories and
research and development funding commitments.
In October 2008, EOS entered into an exclusive license agreement with Advenchen to develop and commercialize
lucitanib on a global basis, excluding China. We are obligated to pay Advenchen tiered royalties at percentage rates in
the mid-single digits on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, we are
obligated to pay to Advenchen 25% of any consideration, excluding royalties, received pursuant to any sublicense
agreements for lucitanib, including the agreement with Servier. We are obligated under the agreement to use
commercially reasonable efforts to develop and commercialize at least one product candidate containing lucitanib, and
we are also responsible for all remaining development and commercialization costs for lucitanib.
In the first quarter of 2014, we recognized acquired in-process research and development expense of $3.4 million,
which represents 25% of the sublicense agreement consideration of $13.6 million received from Servier upon the end of
opposition and appeal of the lucitanib patent by the European Patent Office.
In September 2012, EOS entered into a collaboration and license agreement with Servier whereby EOS sublicensed to
Servier exclusive rights to develop and commercialize lucitanib in all countries outside of the U.S., Japan and China. In
exchange for these rights, EOS received an upfront payment of €45.0 million. We are entitled to receive additional
payments upon achievement of specified development, regulatory and commercial milestones up to €100.0 million in the
aggregate, €10.0 million of which was received in the first quarter of 2014. In addition, we are entitled to receive sales
milestone payments if specified annual sales targets for lucitanib are met, which, in the aggregate, could total
€250.0 million. We are also entitled to receive royalties at percentage rates ranging from low to mid-teens on sales of
lucitanib by Servier.
The development, regulatory and commercial milestones represent non-refundable amounts that would be paid by
Servier to us if certain milestones are achieved in the future. These milestones, if achieved, are substantive as they relate
solely to past performance, are commensurate with estimated enhancement of value associated with the achievement of
each milestone as a result of our performance, which are reasonable relative to the other deliverables and terms of the
arrangement, and are unrelated to the delivery of any further elements under the arrangement.
We and Servier are developing lucitanib pursuant to a development plan agreed to between the parties. Servier is
responsible for all of the global development costs for lucitanib up to €80.0 million. Cumulative global development
costs in excess of €80.0 million, if any, will be shared equally between us and Servier. During the second quarter of
2016, we and Servier agreed to discontinue the development of lucitanib for breast cancer and lung cancer and are
continuing to evaluate what, if any, further development of lucitanib will be pursued. Based on current estimates, we
expect to complete the committed on-going development activities in 2017 and expect full reimbursement of our
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development costs from Servier. Reimbursements are recorded as a reduction to research and development expense on
the Consolidated Statements of Operations.
We recorded a $1.3 million and $3.2 million receivable at December 31, 2016 and 2015, respectively, for the
reimbursable development costs incurred under the global development plan, which is included in other current assets on
the Consolidated Balance Sheets. During the years ending December 31, 2016, 2015 and 2014, we incurred $7.7 million,
$13.7 million and $9.5 million, respectively, in research and development costs and recorded reductions in research and
development expense of $9.0 million, $11.8 million and $10.0 million, respectively, for reimbursable development costs
due from Servier.
Rociletinib
In May 2010, we entered into an exclusive worldwide license agreement with Celgene to discover, develop and
commercialize a covalent inhibitor of mutant forms of the epidermal growth factor receptor (“EGFR”) gene product.
Rociletinib was identified as the lead inhibitor candidate under the license agreement. We are responsible for all non-
clinical, clinical, regulatory and other activities necessary to develop and commercialize rociletinib.
We made an upfront payment of $2.0 million upon execution of the license agreement, a $4.0 million milestone
payment in the first quarter of 2012 upon the acceptance by the FDA of our Investigational New Drug application for
rociletinib and a $5.0 million milestone payment in the first quarter of 2014 upon initiation of the Phase II study for
rociletinib. In the third quarter of 2015, we made milestone payments totaling $12.0 million upon acceptance of the
NDA and MAA for rociletinib by the FDA and EMA, respectively. We recognized all payments prior to commercial
approval as acquired in-process research and development expense.
We are obligated to pay royalties at percentage rates ranging from mid-single digits to low teens based on the volume
of annual net sales achieved. We are required to pay up to an additional aggregate of $98.0 million in development and
regulatory milestone payments if certain clinical study objectives and regulatory filings, acceptances and approvals are
achieved. In addition, we are required to pay up to an aggregate of $120.0 million in sales milestone payments if certain
annual sales targets are achieved, the majority of which relate to annual sales targets of $500.0 million and above.
12. Net Loss Per Common Share
Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares
outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average
number of common share equivalents outstanding using the treasury-stock method for the stock options and the if-
converted method for the Notes. As a result of our net losses for the periods presented, all potentially dilutive common
share equivalents were considered anti-dilutive and were excluded from the computation of diluted net loss per share.
The shares outstanding at the end of the respective periods presented in the table below were excluded from the
calculation of diluted net loss per share due to their anti-dilutive effect (in thousands):
Year ended December 31,
2014
2015
2016
3,398
4,646
8,044
2,031
4,646
6,677
2,973
4,646
7,619
Common shares under option
Convertible senior notes
Total potential dilutive shares
F-28
Table of Contents
13. Income Taxes
The geographical components of income (loss) before income taxes consisted of the following (in thousands):
Domestic
Foreign
Total loss before income taxes
2016
Year ended December 31,
2015
$ (277,776) $ (290,342) $ (165,220)
(103,395)
7,497
$ (381,171) $ (381,937) $ (157,723)
(91,595)
2014
The income tax provision consists of the following current and deferred foreign tax expenses (in thousands). No
significant U.S. tax expense was recognized in the periods presented.
Foreign:
Current expense
Deferred (benefit) expense
Total income tax (benefit) expense
Year ended December 31,
2015
2016
2014
$
$
64 $
— $
(32,098) (29,076)
(32,034) $ (29,076) $
1,547
761
2,308
A reconciliation of the U.S. statutory income tax rate to our effective tax rate is as follows:
Year ended December 31,
Federal income tax benefit at statutory rate
State income tax benefit, net of federal benefit
Tax credits
Change in tax status of foreign subsidiary
Limitation on future foreign tax credits
Change in uncertain tax positions
Other
Change in valuation allowance
Effective income tax rate
2015
2016
2014
(34.0)% (34.0)% (34.0)%
(3.0)
(13.6)
—
(5.0)
—
0.4
47.6
(3.6)
(10.8)
—
(5.9)
4.2
2.3
39.4
(8.4)% (7.6)%
(3.5)
(20.5)
(13.5)
—
—
1.0
72.0
1.5 %
The components of our deferred tax assets and liabilities are as follows (in thousands):
Deferred tax assets:
Net operating loss carryforward
Tax credit carryforwards
Intangible assets
Deductible foreign taxes
Share-based compensation expense
Foreign currency translation
Product acquisition costs
Accrued liabilities and other
Total deferred tax assets
Valuation allowance
Deferred tax assets, net of valuation allowance
Deferred tax liabilities:
Intangible assets
Contingent purchase consideration
Prepaid expenses and other
Total deferred tax liabilities
Net deferred tax liability
F-29
December 31,
2016
2015
$ 275,898 $ 189,663
179,865
217,948
26,766
42,745
10,836
—
23,844
31,390
17,471
10,510
10,470
9,764
4,147
5,384
463,062
593,639
(449,080)
(592,423)
13,982
1,216
—
—
(1,216)
(1,216)
(31,871)
(11,142)
(2,102)
(45,115)
— $ (31,133)
$
Table of Contents
The realization of deferred tax assets is dependent upon a number of factors including future earnings, the timing and
amount of which is uncertain. A valuation allowance was established for the net deferred tax asset balance due to
management’s belief that the realization of these assets is not likely to occur in the foreseeable future. We recorded an
increase to the valuation allowance of $143.3 million and $190.1 million during the years ended December 31, 2016 and
2015, respectively, primarily due to an increase in net operating loss and tax credit carryforwards.
In addition, the Company recognizes tax benefits if it is more likely than not to be sustained under audit by the
relevant taxing authority based on technical merits. An uncertain tax position will not be recognized if it has less than a
50% likelihood of being sustained during audit. If the threshold is met, the tax benefit is measured and recognized at the
largest amount above the greater than 50% likelihood threshold at time of settlement. The balance of unrecognized tax
benefits at December 31, 2016 of $24.1 million, if recognized, would not impact the Company’s effective tax rate as
long as they remain subject to a full valuation allowance. The following table summarizes the gross amounts of
unrecognized tax benefits (in thousands):
Balance at beginning of year
Additions related to prior periods tax positions
Additions related to current period tax positions
Settlements with tax authorities
Expiration of statute of limitations
Balance at end of year
Year ended
December 31,
2016
$
$
—
17,844
6,231
—
—
24,075
There were no unrecognized tax benefits due to uncertain tax positions in 2015.
As of December 31, 2016, we had approximately $711.8 million, $1.0 billion and $1.9 million of U.S. federal, state
and foreign net operating loss carryforwards, respectively. The U.S. net operating losses will expire from 2029 to 2036 if
not utilized. Included in the U.S. net operating loss was approximately $18.2 million of stock compensation expense, the
benefit of which, if realized, will be an increase to additional paid-in-capital and a reduction to taxes payable. In
addition, we have research and development and orphan drug tax credit carryforwards of $240.7 million that will expire
from 2029 through 2036 if not utilized.
We believe that a change in ownership as defined under Section 382 of the U.S. Internal Revenue Code occurred as a
result of our public offering of common stock completed in April 2012. Future utilization of the federal net operating
losses (“NOL”) and tax credit carryforwards accumulated from inception to the change in ownership date will be subject
to annual limitations to offset future taxable income. At this time, we do not believe this limitation will prevent the
utilization of the federal NOL or credit carryforward prior to expiration. It is possible that a change in ownership will
occur in the future, which will limit the NOL amounts generated since the last estimated change. Our federal and state
income taxes for the period from inception to December 31, 2016 remain open to an audit. Our foreign subsidiaries are
also subject to tax audits by tax authorities in the jurisdictions where they operate for the periods from December 31,
2010 to December 31, 2016.
In December 2014, we converted a non-U.S. entity into a U.S. entity for U.S. income tax purposes. As a result of this
election, the subsidiary was treated as a flow through entity for U.S. federal tax purposes. The election generated
deferred tax assets, calculated as the difference between the subsidiary’s tax basis and the underlying financial statement
basis of the assets.
We may be assessed interest and penalties related to the settlement of tax positions and such amounts will be
recognized within income tax expense when assessed. To date, no interest and penalties have been recognized by us.
F-30
Table of Contents
14. Employee Benefit Plans
We maintain a retirement plan, which is qualified under section 401(k) of the Internal Revenue Code for our
U.S. employees. The plan allows eligible employees to defer, at the employee’s discretion, pretax compensation up to
the IRS annual limits. We matched contributions up to 4% of the eligible employee’s compensation or the maximum
amount permitted by law. Total expense for contributions made to U.S. employees was approximately $1.6 million, $0.8
million and $0.4 million for the years ended December 31, 2016, 2015 and 2014, respectively. Our international
employees participate in retirement plans or postretirement life insurance plans governed by the local laws in effect for
the country in which they reside. We made contributions to the retirement plans or postretirement life insurance plans of
international employees of approximately $0.2 million, $0.2 million and $0.1 million for the years ended December 31,
2016, 2015 and 2014, respectively.
15. Quarterly Information (Unaudited)
The results of operations on a quarterly basis for the years ended December 31, 2016 and 2015 were as follows (in
thousands):
March 31, June 30, September 30, December 31, March 31, June 30, September 30, December 31,
2016
2016 (1)
2016
2016
2015
2015
2015
2015 (1)
`
$
Revenues:
Product revenue, net
License and milestone
revenue
Total revenue
Expenses:
— $
— $
— $
78 $
— $
— $
— $
—
—
—
—
—
—
—
78
—
—
—
—
—
—
—
—
—
Cost of sales - product
Research and development
Selling, general and
administrative
Acquired in-process
research and development
Impairment of intangible
asset
Change in fair value of
contingent purchase
consideration
Total expenses
—
74,608
—
67,729
—
54,338
70
54,454
—
—
56,750 60,368
—
76,138
—
75,995
9,827
9,552
9,162
12,190
6,751
7,204
8,331
8,238
—
300
500
500
—
—
12,000
—
— 104,517
—
—
—
—
—
89,557
516
(25,452)
84,951 156,646
(84,951) (156,646)
—
64,000
(64,000)
724
764
—
67,214
64,225 68,336
(67,136) (64,225) (68,336)
783
97,252
(97,252)
(26,882)
146,908
(146,908)
Operating loss
Other income (expense):
Interest expense
Foreign currency gains (losses)
Other income (expense)
Other income (expense), net
Loss before income taxes
Income tax (expense) benefit
Net loss
Basic and diluted net loss per
common share
Basic and diluted weighted
average common shares
outstanding
(2,104)
(551)
25
(2,630)
(2,106)
183
196
(1,727)
(87,581) (158,373)
29,059
$ (83,400) $ (129,314) $
4,181
(2,108)
(66)
252
(1,922)
(65,922)
227
(65,695) $
(2,075)
3,247
11
1,183
(2,173)
(146)
160
(2,159)
(2,097)
(1,142)
62
(3,177)
(69,295) (63,042) (71,513)
(18)
(70,728) $ (63,144) $ (71,531) $
(1,433)
(102)
(2,099)
(101)
179
(2,021)
(99,273)
628
(98,645) $
(2,101)
736
164
(1,201)
(148,109)
28,568
(119,541)
$
(2.17) $
(3.37) $
(1.70) $
(1.83) $
(1.86) $
(2.10) $
(2.62) $
(3.12)
38,360
38,389
38,538
38,624
34,011 34,088
37,613
38,321
(1) In the second quarter of 2016, we recorded a $104.5 million impairment charge to the IPR&D intangible asset
related to our lucitanib product candidate. In the fourth quarter of 2015, we recorded a $89.6 million intangible
impairment charge which was also related to our lucitanib product candidate.
F-31
Table of Contents
INDEX TO EXHIBITS
Exhibit
Number
Exhibit Description
3.1(5)
Amended and Restated Certificate of Incorporation of Clovis Oncology, Inc.
3.2(5)
Amended and Restated Bylaws of Clovis Oncology, Inc.
4.1(3)
Form of Common Stock Certificate of Clovis Oncology, Inc.
4.2(8)
Indenture, dated as of September 9, 2014, by and between the Company and The Bank of New York
Mellon Trust Company, N.A.
10.1*(4)
Amended and Restated Strategic License Agreement, dated as of June 16, 2011, by and between Clovis
Oncology, Inc. and Avila Therapeutics, Inc.
10.2*(4)
License Agreement, dated as of June 2, 2011, by and between Clovis Oncology, Inc. and Pfizer Inc.
10.3+(1)
Clovis Oncology, Inc. 2009 Equity Incentive Plan.
10.4+(4)
Clovis Oncology, Inc. 2011 Stock Incentive Plan.
10.5+(1)
Form of Clovis Oncology, Inc. 2009 Equity Incentive Plan Stock Option Agreement.
10.6+(4)
Form of Clovis Oncology, Inc. 2011 Stock Incentive Plan Stock Option Agreement.
10.7+(3)
Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Patrick J.
Mahaffy.
10.8+(3)
Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Erle T. Mast.
10.9+(3)
Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Gillian C. Ivers-
Read.
10.10+(1)
Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Paul
Klingenstein.
10.11+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and James C. Blair.
10.12+(1)
Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Edward J.
McKinley.
10.13+(1)
Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Thorlef
Spickschen.
10.14+(1)
Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and M. James
Barrett.
10.15+(1)
Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Brian G.
Atwood.
10.16+(1)
Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Patrick J.
Mahaffy.
10.17+(1) Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Erle T. Mast.
E-1
Table of Contents
Exhibit
Number
10.18+(1)
Exhibit Description
Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Gillian C. Ivers-
Read.
10.19+(1)
Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Andrew R.
Allen.
10.20+(4) Clovis Oncology, Inc. 2011 Employee Stock Purchase Plan.
10.21+(4) Clovis Oncology, Inc. 2011 Cash Bonus Plan.
10.22+(6)
Employment Agreement, dated as of March 22, 2012, by and between Clovis Oncology, Inc. and Steven L.
Hoerter.
10.23+(6)
Indemnification Agreement, dated as of March 22, 2012, by and between Clovis Oncology, Inc. and Steven
L. Hoerter.
10.24+(2)
Indemnification Agreement, dated as of June 13, 2013, between Clovis Oncology, Inc. and Ginger L.
Graham.
10.25+(2) Indemnification Agreement, dated as of June 13, 2013, between Clovis Oncology, Inc. and Keith Flaherty.
10.26(7)
Stock Purchase Agreement, dated as of November 19, 2013, by and among the Company, EOS, the Sellers
listed on Exhibit A thereto and Sofinnova Capital V FCPR, acting in its capacity as the Sellers’
Representative.
10.27*(7)
Development and Commercialization Agreement, dated as of October 24, 2008, by and between
Advenchen Laboratories LLC and Ethical Oncology Science S.p.A., as amended by the First Amendment,
dated as of April 13, 2010 and the Second Amendment, dated as of July 30, 2012.
10.28*(7)
Collaboration and License Agreement, dated as of September 28, 2012, by and between Ethical Oncology
Science S.p.A. and Les Laboratoires Servier and Institut de Recherches Internationales Servier.
10.29+(12)
Indemnification Agreement, dated as of January 29, 2016, by and between Clovis Oncology, Inc. and
Lindsey Rolfe.
10.30+(12)
Employment Agreement, dated as of February 25, 2016, by and between Clovis Oncology, Inc. and
Lindsey Rolfe.
10.31+(12)
Indemnification Agreement, dated as of January 26, 2016, by and between Clovis Oncology, Inc. and Dale
Hooks.
10.32+(12)
Employment Agreement, dated as of January 26, 2016, by and between Clovis Oncology, Inc. and Dale
Hooks.
10.33+(9)
Indemnification Agreement, dated as of February 17, 2016, by and between Clovis Oncology, Inc. and
Daniel W. Muehl.
10.34+(10)
Offer Letter, dated as of May 27, 2015, by and between Clovis Oncology, Inc. and Daniel W. Muehl.
10.35+(10)
Salary Waiver Letter, dated as of May 9, 2016, by and between Clovis Oncology, Inc. and Patrick J.
Mahaffy.
10.36*(11)
First Amendment to License Agreement, by and between Clovis Oncology, Inc. and Pfizer Inc., dated as of
August 30, 2016.
10.37+
Form of Clovis Oncology, Inc. 2011 Stock Incentive Plan RSU Agreement.
E-2
Table of Contents
Exhibit
Number
10.38*
Manufacturing Services Agreement, by and between Clovis Oncology, Inc. and Lonza Ltd, dated as of
October 3, 2016.
Exhibit Description
21.1(12)
List of Subsidiaries of Clovis Oncology, Inc.
23.1
Consent of Independent Registered Public Accounting Firm
31.1
31.2
32.1
32.2
Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange
Act of 1934, as amended.
Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange
Act of 1934, as amended.
Certification of principal executive officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002.
Certification of principal financial officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002.
101.INS
XBRL Instance Document
101.SCH
XBRL Taxonomy Extension Schema Document
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB XBRL Taxonomy Extension Label Linkbase Document
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document
(1) Filed as an exhibit with the Registrant’s Registration Statement on Form S-1 (File No. 333-175080) on June 23,
2011.
(2) Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on June 14, 2013.
(3) Filed as an exhibit with Amendment No. 2 to the Registrant’s Registration Statement on Form S-1 (File No. 333-
175080) on August 31, 2011.
(4) Filed as an exhibit with Amendment No. 3 to the Registrant’s Registration Statement on Form S-1 (File No. 333-
175080) on October 31, 2011.
(5) Filed as an exhibit with the Registrant’s Annual Report on Form 10-K on March 15, 2012.
(6) Filed as an exhibit with the Registrant’s Registration Statement on Form S-1 (File No. 333-180293) on March 23,
2012.
(7) Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on November 19, 2013.
(8) Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on September 9, 2014.
(9) Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on April 1, 2016.
(10) Filed as an exhibit with the Registrant’s Quarterly Report on Form 10-Q on May 9, 2016.
(11) Filed as an exhibit with the Registrant’s Quarterly Report on Form 10-Q on November 4, 2016.
(12) Filed as an exhibit with the Registrant’s Annual Report on Form 10-K on February 29, 2016
+ Indicates management contract or compensatory plan.
* Confidential treatment has been sought or granted with respect to portions of this exhibit, which portions have been
omitted and filed separately with the Securities and Exchange Commission.
E-3