Clovis Oncology
Annual Report 2017

Plain-text annual report

Table of Contents UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549FORM 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, 2017. ☐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: 001-35347Clovis Oncology, Inc.(Exact name of Registrant as specified in its charter) Delaware 90-0475355(State or other jurisdiction ofincorporation or organization) (I.R.S. EmployerIdentification No.) 5500 Flatiron Parkway, Suite 100Boulder, Colorado 80301(Address of principal executive offices) (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 Name of each exchange on which registeredCommon Stock par value $0.001 per share 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 duringthe 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 thepast 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 besubmitted 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 theregistrant 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 ofregistrant’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, smaller reporting company, or an emerginggrowth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company, and “emerging growth company” in Rule 12b-2 ofthe Exchange Act. Large accelerated filer☒Accelerated filer☐ Non-accelerated filer☐ (Do not check if a smaller reporting company)Smaller reporting company☐Emerging growth company☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ 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, 2017, the lastbusiness day of the registrant’s most recently completed second quarter, was $4,220,084,525 based on the closing price of the registrant’s common stock on theNASDAQ Global Market on that date of $93.63 per share. The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of February 21, 2018 was 50,573,183. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement to be filed with the Securities and ExchangeCommission pursuant to Regulation 14A in connection with the registrant’s 2017 Annual Meeting of Stockholders, which is to be filed within 120 days after theend of the registrant’s fiscal year ended December 31, 2017, are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent statedtherein. Table of ContentsTABLE OF CONTENTS PagePART I ITEM 1. BUSINESS3ITEM 1A. RISK FACTORS29ITEM 1B. UNRESOLVED STAFF COMMENTS53ITEM 2. PROPERTIES53ITEM 3. LEGAL PROCEEDINGS53ITEM 4. MINE SAFETY DISCLOSURES55PART II ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS ANDISSUER PURCHASES OF EQUITY SECURITIES56ITEM 6. SELECTED FINANCIAL DATA58ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OFOPERATIONS60ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK74ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA75ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIALDISCLOSURE75ITEM 9A. CONTROLS AND PROCEDURES75ITEM 9B. OTHER INFORMATION78PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE78ITEM 11. EXECUTIVE COMPENSATION78ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATEDSTOCKHOLDER MATTERS78ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE78ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES78PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES79 SIGNATURES83 2 Table of Contents PART I This Annual Report filed on Form 10-K and the information incorporated herein by reference includes statements thatare, or may be deemed, “forward-looking statements.” In some cases, these forward-looking statements can be identified bythe 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 variationsthereon or comparable terminology, although not all forward-looking statements contain these words. They appear in anumber 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 andcommercial viability of our approved product, the development of our sales and marketing capabilities, the performance ofour third party manufacturers, our ongoing and planned non-clinical studies and clinical trials, the timing of and ourability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, including ourability to confirm the clinical benefit of our approved product through confirmatory trials and other post-marketingrequirements, the degree of clinical utility of our products, particularly in specific patient populations, expectationsregarding 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 thatmay affect the industry or us. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitivedynamics and industry change and depend on the economic circumstances that may or may not occur in the future or mayoccur on longer or shorter timelines than anticipated. We caution you that forward-looking statements are not guaranteesof future performance and that our actual results of operations, financial condition and liquidity and the development ofthe 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 suchstatement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of thisAnnual Report on Form 10-K or to reflect the occurrence of unanticipated events. For all forward-looking statements, weclaim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation ReformAct of 1995. You should also read carefully the factors described in the “Risk Factors” section of this Annual Report on Form 10-K tobetter understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. Youare 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 inother selected countries. All other brand names or trademarks appearing in this report are the property of their respectiveholders. 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-canceragents in the United States, Europe and additional international markets. We target our development programs for thetreatment of specific subsets of cancer populations, and simultaneously develop, with partners, diagnostic tools intended todirect a compound in development to the population that is most likely to benefit from its use. Our marketed product Rubraca® (rucaparib) is approved on an accelerated basis in the United States by the Food andDrug Administration (“FDA”) as monotherapy for the treatment of patients with deleterious BRCA (human genes associatedwith the repair of damaged DNA) mutation (germline and/or somatic) associated advanced ovarian cancer who have beentreated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic forRubraca. Continued approval for this indication may be contingent upon verification and description of clinical benefit inconfirmatory trials. We launched Rubraca in the United States in December 2016 for this indication.3 ®Table of Contents The FDA is currently reviewing on a priority review timeline our supplemental New Drug Application (“sNDA”) forRubraca as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritonealcancer who are in a complete or partial response to platinum-based chemotherapy. Our Marketing Authorization Application (“MAA”) submitted to the European Union’s European Medicines Agency(“EMA”) for an ovarian cancer treatment indication for Rubraca is currently under review by the EMA’s Committee forMedicinal Products for Human Use (“CHMP”). Following a Scientific Advisory Group - Oncology meeting and an oralexplanation by us before the CHMP in February 2018, the CHMP has communicated a positive trend vote for the MAA andtheir intention to hold a final vote on the treatment indication at their March 2018 meeting. Beyond our labeled indication, we have a robust Rubraca clinical development program underway in a variety of solidtumor types, also including prostate and bladder cancers, and in July 2017, we entered into a broad clinical collaborationwith Bristol-Myers Squibb Company to evaluate the combination of their immunotherapy Opdivo® (nivolumab) withRubraca in several tumor types. We hold worldwide rights for Rubraca. In addition, we have two other product candidates: lucitanib, an oral inhibitor of the tyrosine kinase activity of vascularendothelial growth factor receptors (“VEGFR”) 1-3, platelet-derived growth factor receptors (“PDGFR”) alpha and beta andfibroblast growth factor receptors (“FGFR”) 1-3, and rociletinib, an oral mutant-selective inhibitor of epidermal growth factorreceptor (“EGFR”). While we have stopped enrollment in ongoing trials for each of these candidates, we continue to providedrug to patients whose clinicians recommend continuing therapy. We maintain certain development and commercializationrights 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 thetreatment of specific subsets of cancer populations. To implement our strategy, we have assembled an experienced team withcore competencies in global clinical and non-clinical development, regulatory operations and commercialization inoncology, as well as conducting collaborative relationships with companies specializing in companion diagnosticdevelopment. Rubraca – a PARP Inhibitor Overview Rubraca (rucaparib) is an oral, small molecule poly ADP-ribose polymerase (“PARP”) inhibitor of PARP1, PARP2 andPARP3. We in-licensed Rubraca from Pfizer Inc. in June 2011. In the United States, Rubraca is approved by the FDA for thetreatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer whohave been treated with two or more chemotherapies, and selected for therapy by an FDA-approved companion diagnostic forRubraca. The indication is approved under the FDA’s accelerated approval program based on objective response rate andduration of response, and is based on results from two multicenter, single-arm, open-label clinical trials. Continued approvalfor this indication may be contingent upon verification and description of clinical benefit in ARIEL3 and/or ARIEL4, ourconfirmatory trials. Foundation Medicine, Inc. has developed two companion diagnostics that are FDA-approved andcommercially available for selection of patients for treatment with Rubraca in this indication: FoundationFocus™CDxBRCA and FoundationOne CDx™. In October 2017 we submitted a sNDA for Rubraca for the maintenance treatment of adult patients with recurrentepithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-basedchemotherapy. In December 2017, the FDA accepted our sNDA for Rubraca and granted priority review status to theapplication with a Prescription Drug User Free Act (“PDUFA”) goal date of April 6, 2018. If approved, we expect thatdiagnostic testing would not be required for patients to be prescribed Rubraca in this maintenance treatment indication. Wehave approximately 150 field-based personnel in the United States, and these commercial and medical affairs organizationsalready in place will support the commercial launch of Rubraca, if approved in this expanded maintenance treatmentindication. The second-line maintenance treatment paradigm in ovarian cancer is being rapidly adopted in the U.S. following theapproval of two other PARP inhibitors in this setting during 2017. If Rubraca is approved in this setting, with no requirementfor diagnostic testing as supported by the ARIEL3 data, it would be possible to address a patient population4 Table of Contentsapproximately four times larger than our initial niche treatment indication, which is limited to women with ovarian cancer inthe third-line setting with a BRCA mutation. BRCA mutations are believed to occur in approximately 25 percent of womenwith ovarian cancer. Our MAA submitted to the EMA for an ovarian cancer treatment indication is currently under review. Followinga Scientific Advisory Group - Oncology meeting and an oral explanation before the CHMP in February 2018, the CHMPcommunicated to us that they held a trend vote for the MAA and the result was positive. The CHMP also communicated to ustheir intention to hold a final vote on the treatment indication at their March 2018 meeting. The CHMP’s trend vote is notbinding on the CHMP with respect to the final vote. The indication currently under consideration by the CHMP focuses on asubset of platinum-sensitive ovarian cancer where there is particular unmet need. If Rubraca receives a favorable opinionfrom the CHMP in March, a potential approval from the European Commission is expected during the second quarter of2018. In the event of such an approval for the treatment indication, we intend to submit a variation to the marketingauthorization (“MA”) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, orprimary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, for which we anticipatea CHMP opinion may come during the fourth quarter of 2018. The EMA’s Committee for Orphan Medicinal Products(“COMP”) will meet in March 2018 to review and issue a final opinion on our application to maintain the orphan drugdesignation for Rubraca submitted as part of the MAA review process. While Rubraca currently has orphan drug designationin the EU, there is no assurance that COMP will maintain such designation post-approval. In the event of a negative opinionfor the treatment indication, we expect to file a new MAA for the maintenance treatment indication during the second quarterof 2018. If approved in the EU, we intend to commercialize Rubraca on our own and we are building our commercial andmedical affairs infrastructure in Europe. The leadership of those teams is in place, and we intend to hire field sales personnelas pricing and reimbursement decisions are made and approvals are received. The Role of PARP Inhibition in Cancer Therapy Cells in the human body are under constant attack from agents that can cause damage to DNA, including sunlight andother forms of radiation, as well as DNA-binding chemicals that can cause changes in the composition of DNA. Cells haveevolved multiple mechanisms to enable such DNA repair, and these mechanisms are complementary to each other, eachdriving repair of specific types of DNA damage. If a cell’s DNA damage repair system is overwhelmed, then the cell will dieundergoing a form of suicide termed apoptosis. A fundamental principle of cancer therapy is to damage cells profoundly withradiation or DNA-binding drugs, such as alkylating agents or platinums, to induce apoptosis and, subsequently, cancer celldeath. Multiple DNA repair mechanisms active in the cell may reduce the activity of these anti-cancer therapies. 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 andcatalyze the recruitment of additional proteins that initiate the repair of damaged DNA. The breast cancer 1 (BRCA1) andbreast cancer 2 (BRCA2) genes also have important roles in DNA repair pathways such as homologous recombination.According to the National Cancer Institute, BRCA1 and BRCA2 mutations are associated with an increased risk of ovarian,breast, prostate, and pancreatic cancers. Rubraca is an inhibitor of PARP enzymes, including PARP1, PARP2, and PARP3. PARP inhibitors have shown activity inBRCA1/2 mutant and homologous recombination (“HR”) repair deficient cancer cell lines through a mechanism known assynthetic lethality in which the loss of two genes/pathways is required for cell death. The inhibition/inactivation of repairpathways by administration of a PARP inhibitor in the context of an underlying genetic defect such as a BRCA mutationresults in tumor cell death through accumulation of unrepaired DNA damage. 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 intumors with alterations in non-BRCA HR genes. DNA repair deficiencies resulting from genetic and epigenetic alterationscan result in a “BRCA-like” phenotype that may also render tumor cells sensitive to PARP inhibitors. One approach toidentify patients with DNA repair deficiencies due to mechanisms other than a mutation in BRCA or other non-BRCA HRgenes is to assess loss of heterozygosity (“LOH”), or the loss of one normal copy of a gene, which arises from error-proneDNA repair pathways when HR is compromised. 5 Table of ContentsOn the basis of these scientific observations, we initially developed Rubraca in ovarian cancer patients with tumorshaving BRCA mutations or other homologous recombination deficiencies (“HRD”). These molecular markers also may beused to select patients with other tumors for treatment with Rubraca. Thus, in addition to ovarian trials, studies open forenrollment or under consideration to further evaluate Rubraca, either alone or in combination with other agents, includeprostate, breast, pancreatic, bladder, gastroesophageal and lung cancers. Rubraca Clinical Development We are developing Rubraca for selected patient populations and collaborating with partners for companion diagnosticdevelopment. We have focused our development strategy for Rubraca on indications where we believe patient populationsexhibit higher frequencies of mutant BRCA tumors or HRD, where PARP inhibitors have demonstrated clinical or pre-clinical activity in tumors. In certain of these trials, we or our partners will have access to interim data on a periodic orcontinuing basis that will not be made available publicly on the same timeframe as such data becomes available to us, or atall. The following table summarizes the ongoing Clovis- or partner-sponsored studies: Ovarian cancer According to the American Cancer Society, an estimated more than 22,000 women were diagnosed with ovarian cancer inthe United States in 2017, and according to GLOBOCAN in 2012, an estimated more than 65,000 women in Europe arediagnosed each year with ovarian cancer, and ovarian cancer is among those cancers with the highest rate of deaths.Approximately 80% to 85% of ovarian cancer cases are not diagnosed, and therefore remain untreated, until the disease hasspread to other parts of the body, or metastasized. Most women with ovarian cancer will relapse after surgery and/orchemotherapy. BRCA mutations, either germline or somatic, are believed to occur in approximately 25 percent of womenwith ovarian cancer according to an article published in Clinical Cancer Research in 2014. The ARIEL (Assessment of Rucaparib In Ovarian CancEr TriaL) program is a novel, integrated translational-clinicalprogram designed to accurately and prospectively identify ovarian cancer patients with tumor genotypes associated withbenefit from Rubraca therapy. ARIEL2 (NCT01891344) is a two-part single-arm open label study designed to identify pre-specified tumor characteristicsthat predict sensitivity to Rubraca using DNA sequencing to evaluate each patient’s tumor. Part 1 enrolled 204 platinum-sensitive patients and updated results were presented in June 2016. Part 2 enrolled 286 patients with advanced ovariancancer who have received at least three prior chemotherapy regimens and includes platinum-sensitive, -resistant and -refractory patients. ARIEL2 is evaluating clinical response in patients classified into molecularly-defined subgroups,including germline BRCA-mutant, somatic BRCA-mutant and HRD by a prospectively defined genomic signature. The efficacy of Rubraca in the ovarian cancer treatment setting was assessed in 106 patients from ARIEL2 and Study 10(NCT01482715, a multicenter, single-arm, open-label clinical trial of Rubraca), in patients with advanced BRCA-6 Table of Contentsmutant ovarian cancer who had progressed after two or more prior chemotherapies. Median age was 59 years and mediannumber of prior chemotherapy regimens was three. All 106 patients received the starting dose of Rubraca 600 mg twice daily.The major efficacy outcome measure of both trials was objective response rate (ORR) and duration of response (DOR) asassessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. All responseswere confirmed. ORR assessed by investigator was 54% (95% Confidence Interval, or CI: 44, 64), with a median DOR of 9.2months (95% CI: 6.6, 11.6). ORR by independent radiology review was 42% (95%: 32, 52), with a median DOR of 6.7months (95% CI: 5.5, 11.1). The overall safety evaluation of Rubraca in the advanced ovarian cancer treatment setting is based on data from 377patients with ovarian cancer from ARIEL2 and Study 10. 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 increatinine, increase in aspartate aminotransferase (“AST”) levels, increase in alanine aminotransferase (“ALT”) levels,decrease in hemoglobin, decrease in lymphocytes, increase in cholesterol, decrease in platelets and decrease in absoluteneutrophil count. Elevations in ALT/AST concentrations were generally self-limiting and not associated with other signs ofliver toxicity. Rubraca requires monitoring of complete blood counts at baseline, and monthly thereafter. The most commonGrade 3-4 adverse reaction was anemia, and the most common Grade 3-4 laboratory abnormality was a decrease inhemoglobin. 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 andother DNA damaging agents. In addition, AML was reported in two (<1%) patients with ovarian cancer enrolled in ARIEL3.One case of AML was fatal. Both patients had received prior treatment with platinum and other DNA damaging agents. The data from the two studies formed the basis of our submission of a New Drug Application (“NDA”) in the United Statesto the FDA in late June 2016. The application was granted priority review and approved under FDA’s accelerated approvalprogram on December 19, 2016 as monotherapy for the treatment of patients with deleterious BRCA mutation (germlineand/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selectedfor therapy based on an FDA-approved companion diagnostic for Rubraca. Continued approval for this indication may becontingent upon verification and description of clinical benefit in ARIEL3 and/or ARIEL4, our confirmatory trials. The efficacy of Rubraca in the ovarian cancer maintenance treatment setting was investigated in ARIEL3(NCT01968213), a double-blind, multicenter clinical trial in which 564 patients with recurrent epithelial ovarian, fallopiantube, or primary peritoneal cancer who were in response to platinum-based chemotherapy were randomized (2:1) to receiveRubraca tablets 600 mg orally twice daily (n=375) or placebo (n=189). Treatment was continued until disease progression orunacceptable toxicity. All patients had achieved a response (complete or partial) to their most recent platinum-basedchemotherapy. Randomization was stratified by best response to last platinum (complete or partial), time to progressionfollowing the penultimate platinum therapy (6 to < 12 months and ≥ 12 months), and tumor biomarker status. The majorefficacy outcome was investigator-assessed progression-free survival (“PFS”) evaluated according to RECISTv1.1. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1)tumor BRCA mutant (tBRCAmut) patients, inclusive of germline and somatic BRCA mutations (n=196); 2) HRD patients,including tBRCAmut patients and BRCA wild-type with high LOH (n=354), and, finally, 3) the intent-to-treat population, orall patients treated in ARIEL3 (n=564). ARIEL3 demonstrated a statistically significant improvement in PFS for patientsrandomized to Rubraca as compared with placebo in all patients, and in the HRD and tBRCAmut subgroups. Median PFS inthe tBRCAmut patients was 16.6 months (95% CI: 13.4–22.9) in the Rubraca group (n=130) versus 5.4 months (95% CI: 3.4–6.7) in the placebo group (n=66) (Hazard Ratio, or HR: 0.23 [95% CI: 0.16–0.34]; p<0.0001). Median PFS in the HRDpatients was 13.6 months (95% CI: 10.9–16.2) in the Rubraca group (n=236) versus 5.4 months (95% CI: 5.1–5.6) in theplacebo group (n=118) (HR: 0.32 [95% CI: 0.24–0.42]; p<0·0001). Median PFS in the intent-to-treat population was 10.8months (95% CI: 8.3–11.4) in the Rubraca group (n=375) versus 5.4 months (95% CI: 5.3–5.5) in the placebo group (n=189)(HR: 0.36 [95% CI: 0.30–0.45]; p<0·0001). Results from a blinded independent radiology review (“BICR”) were consistent. In a pre-specified analysis of the keystand-alone secondary endpoint of progression-free survival assessed by BICR, PFS was also improved in the Rubraca groupcompared with placebo in all three populations. Median PFS in the tBRCAmut patients was 26.8 months (95% CI: 19.2 tonot reached) in the Rubraca group versus 5.4 months (95% CI: 4.9–8.1) in the placebo group (HR: 0.20 [95%7 Table of ContentsCI: 0.13–0.32]; p<0.0001). Median PFS in the HRD patients was 22.9 months (95% CI: 16.2 to not reported) in the Rubracagroup versus 5.5 months (95% CI: 5.1–7.4) in the placebo group (HR: 0.34 [95% CI: 0.24–0.47]; p<0.0001). Median PFS inthe intent-to-treat population was 13.7 months (95% CI: 11.0–19.1) versus 5.4 months (95% CI: 5.1–5.5) in the placebogroup (HR: 0.35 [0.28–0.45]; p<0.0001). Enrollment in ARIEL3 included one-third of patients who had achieved a complete response to their prior platinum-basedtherapy, and two-thirds of patients who had achieved a partial response to their prior platinum-based therapy. Of those with apartial response, 37% had measurable disease at the time of enrollment and were therefore evaluable for response. Theconfirmed overall response rate by investigator-assessed RECISTv1.1 in the tBRCAmut group treated with Rubraca was37.5% (15/40), of these, 17.5% (7/40) were complete responses. This compared with 9% (2/23) in the placebo group(p=0.0055). No complete responses were seen in the tBRCAmut placebo group. RECIST responses were also observed inBRCA wild-type HRD-positive and BRCA wild-type HRD-negative subgroups. RECIST responses were not assessed byindependent blinded review. Safety data from ARIEL3 demonstrated consistency with prior Rubraca studies. Treatment emergent adverse events(“TEAEs”) in the ARIEL3 Rubraca group were generally managed with dose modifications and not associated with increasedmortality or morbidity compared with the placebo group. The most common (occurring in ≥5% of patients) TEAEs of grade≥3 reported in patients treated with Rubraca in the ARIEL3 study were anemia/decreased hemoglobin (21%), increase inALT/AST (10%), neutropenia (7%), asthenia/fatigue (7%) and thrombocytopenia (5%). The discontinuation rate for TEAEs(excluding disease progression) was 15% for Rubraca-treated patients and 2% for the placebo arm. In ARIEL3, the rate oftreatment-emergent myelodysplastic syndrome (“MDS”)/acute myeloid leukemia (“AML”) in the Rubraca arm was <1%(3/372), and no patients on the placebo arm experienced treatment-emergent MDS/AML. In approximately 1,100 patientstreated with Rubraca, MDS/AML occurred in 10 patients (0.9%), including those in long term follow-up. Of these, 5 occurredduring treatment or during the 28 day safety follow-up (0.5%). The duration of Rubraca treatment prior to the diagnosis ofMDS/AML ranged from 1 month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNAdamaging agents. At the time of the analysis of PFS, overall survival (OS) data were not mature (with 22% of events). The comprehensivedataset for ARIEL3 was presented at the 2017 European Society of Medical Oncology (“ESMO”) Congress in earlySeptember 2017 and subsequently published in The Lancet. Based on the ARIEL3 dataset, in October 2017 we submitted a supplemental NDA for Rubraca as maintenance treatmentin adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete orpartial response to platinum-based chemotherapy. The application was granted priority review status by the FDA and has aPDUFA date of April 6, 2018. The ARIEL4 confirmatory study (NCT 02855944), which is open for enrollment, is a Phase 3 multicenter, randomizedstudy of Rubraca versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations (inclusive of germlineand/or somatic) who have failed two prior lines of therapy. The primary endpoint of the study is PFS. The Phase 1 RUCA-J study, sponsored by us, recently initiated with the first patient dosed with Rubraca in Japan. ThePhase 1 study seeks to identify the recommended dose of rucaparib in Japanese patients. Prostate cancer The American Cancer Society estimates that more than 164,000 men in the United States will be diagnosed with prostatecancer in 2018, and the GLOBOCAN Cancer Fact Sheets estimated that approximately 345,000 men in Europe werediagnosed with prostate cancer in 2012. Castrate-resistant prostate cancer has a high likelihood of developing metastases.Metastatic castrate-resistant prostate cancer, or mCRPC, is an incurable disease, usually associated with poor prognosis.According to the American Cancer Society, the five-year survival rate for mCRPC is approximately 29%. Germline orsomatic mutations in BRCA, ATM and other DNA repair genes are believed to be present at frequencies of 20 percent orhigher in mCRPC, according to an article published in JCO Precision Oncology in 2017. These molecular markers may beused to select patients for treatment with a PARP inhibitor. Additionally, preclinical studies of rucaparib have demonstratedactivity in prostate cell cancer lines deficient in BRCA or ATM.8 Table of Contents The TRITON (Trial of Rucaparib in Prostate Indications) program in prostate cancer initiated in the second half of 2016,and currently includes two Clovis-sponsored potential registration studies currently open for enrollment:·The TRITON2 study (NCT02952534), a Phase 2 single-arm study of Rubraca in men with mCRPC enrolling patientswith BRCA mutations and ataxia-telangiectasia mutations, or ATM, (both inclusive of germline and/or somatic) orother deleterious mutations in other homologous recombination repair genes. All patients will have progressed afterreceiving one line of taxane-based chemotherapy and one or two lines of androgen receptor (“AR”) targeted therapyin the castrate-resistant setting. The primary endpoints of the study are radiologic ORR in patients with measurabledisease and protein-specific antigen (“PSA”) response rate in patients who do not have measurable disease.TRITON2 initiated during the fourth quarter of 2016, and interim data are expected at a medical meeting during thesecond half of 2018. The estimated primary completion date for TRITON2 is the second half of 2019. Pendingpositive data, TRITON2 could potentially serve as the basis for an accelerated approval in the U.S.·The TRITON3 study (NCT02975934), a Phase 3 comparative study in men with mCRPC enrolling BRCA mutantand ATM (both inclusive of germline and/or somatic) patients who have progressed on AR-targeted therapy andwho have not yet received chemotherapy in the castrate-resistant setting. TRITON3 will compare Rubraca tophysician’s choice of AR-targeted therapy or chemotherapy in these patients. The planned primary endpoint of thestudy is radiologic PFS. TRITON3 initiated during the first quarter of 2017, and this earlier-line comparative studycould potentially serve as a confirmatory study in the advanced prostate setting. Bladder cancer According to GLOBOCAN Cancer Fact Sheets, bladder cancer was one of the top six most common cancers in the UnitedStates as of 2012, with an estimated 79,000 new cases of bladder cancer diagnosed in the United States in 2017, according tothe National Cancer Institute. Approximately 20% to 30% of newly diagnosed bladder cancer patients have disease that hasinvaded the muscle, according to the National Cancer Institute. Muscle-invasive bladder cancer is a disease with poorprognosis. Overall survival of these patients after initial cisplatin-containing chemotherapy is 13-15 months, with mostpatients experiencing relapse of disease in 9 months, according to an article published in the European Journal of Cancer in2006. After the first one or two lines of anti-cancer treatments, options for these patients are limited, with platinum therapy asthe current standard of care. Based an analysis of The Cancer Genome Atlas (“TCGA”), bladder cancer data set, we believeapproximately 60% of bladder cancer tumors have alterations in homologous recombination repair genes or other genomicfeatures associated with HRD. We initiated a potential registration study in bladder cancer during the first quarter of 2018, called ATLAS (A Study ofRucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma). ATLAS (NCT03397394) is a phase 2single-arm study enrolling patients with relapsed metastatic urothelial carcinoma following one or two prior standard of careregimens, with measurable disease, and no prior PARP treatment. The planned primary endpoint is overall response rate, andthe study will enroll all comers, with no selection based on HRD status. Pending positive data, we believe this trial designcould support a sNDA in an all comers population, without regard to biomarker status. Combination trialsIn July 2017, we and Bristol-Myers Squibb Company (“BMS”) announced a broad clinical collaboration evaluating thecombination of Rubraca with BMS’s immunotherapy Opdivo® (nivolumab) in multiple tumor types. Three trials areunderway or expected to initiate in the first half of 2018:·The ATHENA study, a phase 3 study in advanced ovarian cancer, sponsored by Clovis;·A phase 3 study in advanced triple-negative breast cancer (TNBC), sponsored by BMS; and·A phase 2 study in mCRPC sponsored by BMS.We believe that a preclinical rationale supports the conduct of clinical trials of the combination of our PARP inhibitorRubraca with immune checkpoint inhibitors such as the PD-1 inhibitor Opdivo. BRCA1 and BRCA2 and other HRDmutations are associated with increased tumor mutational burden, which may create additional tumor-specific antigens or“neoepitopes.” Increased tumor mutation burden has been shown to correlate with increased benefit from immune checkpointblockade. In addition, cell death that is induced by a PARP inhibitor is considered immunogenic, and stimulates a “STING-like” pathway due to fragmented DNA release into cytosol. In mice studies, rucaparib and an anti-9 Table of ContentsPD-1 antibody demonstrated anti-tumor activity in BRCA1 mutant ovarian tumors. The combination of rucaparib and eitheran anti-PD-L1 or anti-CTLA-4 antibody were equally compelling in preclinical studies.ATHENA is a four-arm first-line maintenance treatment study to evaluate Rubraca and Opdivo, Rubraca, Opdivo andplacebo in an estimated 1,000 newly diagnosed patients with stage III/IV high-grade ovarian, fallopian tube, or primaryperitoneal cancer who have completed platinum-based chemotherapy. The primary objectives are to determine if thecombination of Rubraca and Opdivo meaningfully extends PFS versus Rubraca monotherapy, or versus placebo, and todetermine if Rubraca extends PFS versus placebo. The analysis of the study results will evaluate, in a step-down manner, thetBRCA/HRD and intent-to-treat subpopulations. We are the sponsor, and will also conduct and fund the ATHENA study,which is expected to initiate in the first half of 2018.The combination study of Rubraca and Opdivo in patients with advanced TNBC will be sponsored and conducted byBMS, with study costs to be shared by Clovis and BMS. The study is expected to initiate in the first half of 2018.The mCRPC study is a three-arm study evaluating Opdivo + Rubraca, Opdivo + docetaxel + prednisone, and Opdivo +enzalutamide, with the objective of determining how the combination affects objective response rate and PSA response. Thestudy will enroll patients with biomarker negative or positive disease, and tumor tissue samples will be used to determinebiomarker status. BMS is sponsoring, conducting and funding the 300 patient study in mCRPC, which initiated in the fourthquarter of 2017.In addition, a Phase 1b study (WO39409; NCT NCT03101280) sponsored by Hoffman-La Roche (Genentech) is underwayevaluating the combination of cancer immunotherapy Tecentriq® (atezolizumab; anti-PDL1) and Rubraca for the treatmentof advanced gynecological cancers and TNBC in patients with a tumor BRCA or HRD mutation. This study began enrollingpatients in the first half of 2017. Companion DiagnosticsWe partnered with Foundation Medicine, Inc. to co-develop a companion diagnostic test, the FDA approvedFoundationFocus™ CDx BRCA, to select patients for treatment with Rubraca in the ovarian cancer treatment indication.FoundationFocus CDx BRCA is a next-generation sequencing (“NGS”) assay that assesses tumor BRCA mutations fromtumor tissue samples from patients with ovarian cancer.On November 30, 2017, Foundation announced FDA approval of its comprehensive companion diagnostic test for solidtumors, FoundationOne™ CDx, a NGS based in vitro diagnostic device for detection of substitutions, insertion and deletionalterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signaturesincluding microsatellite instability and tumor mutational burden. Among the genes assessed by the test are BRCA1/2, andFoundationOne™ CDx is approved as a companion diagnostic to select patients for treatment with Rubraca in the advancedovarian cancer treatment indication.As part of our collaboration with Foundation, we also developed an NGS test to use as a diagnostic to assess genomic LOHin tumor samples, and this biomarker has the potential to expand the clinical utility of Rubraca in ovarian cancer and otherindications. This test, FoundationFocus™ CDx BRCA HRD test, was used to assess HRD status in patient tumor samples inthe ARIEL3 study.We also have a companion diagnostic collaboration with Myriad Genetics, Inc. (“Myriad”) to support a post-marketingregulatory commitment related to Rubraca’s initial approval in the ovarian cancer treatment setting. Myriad will submit asupplementary premarket approval (“sPMA”) application under its existing PMA for BRACAnalysis CDx to includeRubraca. BRACAnalysis CDx is Myriad’s blood-based assay for the qualitative detection and classification of germlinemutations in BRCA1/2 genes.10 Table of Contents 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. Lucitanibwas previously evaluated in breast and lung cancers. Development in those indications has ceased and we continue toprovide drug to patients whose clinicians recommend continuing lucitanib therapy. We are continuing to evaluate what, ifany, further development of lucitanib will be pursued. We hold development and commercialization rights in the U.S. andJapan and have sublicensed rights to Europe and rest of world markets, excluding China, to Servier. Rociletinib - an Oral EGFR Mutant-Selective Inhibitor Rociletinib is an oral mutant-selective inhibitor of epidermal growth factor receptor (“EGFR”). We terminated enrollmentin all sponsored clinical studies, although we continue to provide drug to patients whose clinicians recommend continuingrociletinib therapy. We are continuing analyses of rociletinib data to determine whether certain populations of patients mayrepresent an opportunity for a partner committed to investing in further clinical development. We hold global developmentand commercialization rights for rociletinib. Competition The development and commercialization of new drugs is competitive, and we face competition from major pharmaceuticaland biotechnology companies worldwide. Our competitors may develop or market products or other novel technologies thatare more effective, safer or less costly than any that have been or will be commercialized by us, or may obtain regulatoryapproval 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 establishedcompanies, which have acknowledged strategies to license or acquire products, may have competitive advantages over us, asmay other emerging companies taking similar or different approaches to product acquisitions. Many of our competitors havesubstantially greater financial, technical and human resources than we have. Additional mergers and acquisitions in thepharmaceutical industry may result in even more resources being concentrated in our competitors. Competition may increasefurther as a result of advances made in the commercial applicability of technologies and greater availability of capital forinvestment in these fields. Our success will be based in part on our ability to build and actively manage a portfolio of drugsthat addresses unmet medical needs and creates value in patient therapy. Rubraca Competition Lynparza®/olaparib (AstraZeneca) was the first PARP inhibitor to market and has been approved in the US in thefollowing indications:·as monotherapy for the treatment of adult patients who have deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy;·as monotherapy for the maintenance treatment of adult patients with recurrent epithelial, fallopian tube or primaryperitoneal cancer, who are in a complete or partial response to platinum-based chemotherapy; and·as monotherapy in patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor 2(HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant,or metastatic setting. Lynparza is approved 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 primaryperitoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. In February2018, the CHMP adopted a positive opinion recommending this label be changed and expanded to remove the limitation ofuse in BRCA-mutated patients. Lynparza has indications for ovarian cancer across 57 countries (as of year-end 2017). 11 Table of ContentsIn July 2017, AstraZeneca and Merck & Co., Inc. announced a global strategic oncology collaboration to co-develop andco-commercialise Lynparza for multiple cancer types. Lynparza is being investigated, alone and in combination with otheragents, in multiple indications across several tumor types, including breast, prostate, and pancreatic cancers. Zejula®/niraparib (Tesaro) was approved in March 2017 in the United States as monotherapy for the maintenancetreatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in acomplete or partial response to platinum-based chemotherapy. Zejula was approved in November 2017 in the EU for thesame indication. Additional clinical investigations of Zejula in ovarian, breast and lung cancers are ongoing or planned.Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancerworldwide, except in Japan. There are a number of PARP inhibitors in clinical development including AbbVie’s veliparib and ABT-767, Pfizer’stalazoparib, BeiGene’s BGB-290, and Checkpoint Therapeutics’ CK-102. While most PARP inhibitor development focuseson ovarian, breast and prostate cancers, additional efforts are aimed toward bladder, lung, and pancreatic cancers as well. In addition, combination approaches that include PARP inhibitors, including Lynparza or Zejula, with other anticanceragents are in various phases of clinical development across a variety of oncology indications. These combination therapiesmay result in future competitive pressure on Rubraca, and multiple data readouts for such studies are anticipated throughout2018 and beyond. Outside of the PARP class, Avastin®/bevacizumab is approved in the US for recurrent epithelial ovarian, fallopian tube, orprimary peritoneal cancer that is platinum-resistant in combination with paclitaxel, pegylated liposomal doxorubicin, ortopotecan, and was approved in December 2016 in the US for recurrent epithelial ovarian, fallopian tube, or primaryperitoneal cancer that is platinum-sensitive in combination with carboplatin and paclitaxel or in combination withcarboplatin and gemcitabine, followed by Avastin as a single agent. Other out of class agents approved for use in advancedovarian cancer include chemotherapeutic agents (e.g. platinum-based doublets, platinum monotherapy, non-platinumchemotherapy, etc.), Doxil® (Janssen), and Hycamtin® (Novartis). There are additional out-of-class agents in clinicaldevelopment that may pose a future competitive threat to Rubraca. License Agreements Pfizer Inc. In June 2011, we entered into a license agreement with Pfizer Inc. (“Pfizer”) to obtain the exclusive global rights todevelop and commercialize Rubraca. The exclusive rights are exclusive even as to Pfizer and include the right to grantsublicenses. Pursuant to the terms of the license agreement, we made a $7.0 million upfront payment to Pfizer and arerequired to make additional payments to Pfizer for the achievement of certain development and regulatory and salesmilestones and royalties on sales as required by the license agreement. Prior to the FDA approval of Rubraca, we mademilestones payments of $1.4 million, which 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 theJune 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) European Commission approval of an MAA for 1st Indication inEU, to a date that is 18 months after the date of achievement of such milestones. In the event that we defer such milestonepayments, we have agreed to pay an additional $3.0 million related to the achievement of each such milestone. On December 19, 2016, the FDA approved Rubraca as monotherapy for the treatment of patients with deleterious BRCAmutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or morechemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. The FDA approvalresulted in a $0.75 million milestone payment to Pfizer as required by the license agreement, which was made in the firstquarter of 2017. The FDA approval also resulted in the obligation to pay a $20.0 million milestone payment, for which wehave exercised the option to defer payment by agreeing to pay $23.0 million within 18 months after the date of the FDAapproval. These payments were recognized as intangible assets and amortized over the estimated remaining useful life ofRubraca. 12 Table of ContentsWe are obligated under the license agreement to use commercially reasonable efforts to develop and commercializeRubraca and we are responsible for all ongoing development and commercialization costs for Rubraca. We are required tomake regulatory milestone payments to Pfizer of up to an additional $69.75 million in aggregate if specified clinical studyobjectives and regulatory filings, acceptances and approvals are achieved. In addition, we are obligated to make salesmilestone payments to Pfizer if specified annual sales targets for Rubraca are met, which relate to annual sales targets of$250.0 million and above, which, in the aggregate, could amount to total milestone payments of $170.0 million, and tieredroyalty payments at a mid-teen percentage rate on our net sales, with standard provisions for royalty offsets to the extent weneed to obtain any rights from third parties to commercialize Rubraca. The license agreement with Pfizer will remain in effect until the expiration of all of our royalty and sublicense revenueobligations to Pfizer, determined on a product-by-product and country-by-country basis, unless we elect to terminate thelicense agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure withinspecified time periods, Pfizer can terminate the agreement, resulting in a loss of our rights to Rubraca and an obligation toassign or license to Pfizer any intellectual property rights or other rights we may have in Rubraca, including our regulatoryfilings, regulatory approvals, patents and trademarks for Rubraca. AstraZeneca UK Limited In April 2012, we entered into a license agreement with AstraZeneca UK Limited (“AstraZeneca”) to acquire exclusiverights associated with Rubraca under a family of patents and patent applications that claim methods of treating patients withPARP inhibitors in certain indications. The license enables the development and commercialization of Rubraca for the usesclaimed by these patents. Pursuant to the terms of the license agreement, we made an upfront payment of $0.25 million uponexecution of the agreement. During the second quarter of 2016, we made a milestone payment of $0.3 million to AstraZenecaupon the NDA submission for Rubraca. These payments were recognized as acquired in-process research and developmentexpense. The FDA approval of Rubraca on December 19, 2016 resulted in a final $0.35 million milestone payment toAstraZeneca as required by the license agreement. This payment was recognized as intangible assets and amortized over theestimated remaining useful life of Rubraca. AstraZeneca also receives royalties on net sales of Rubraca. Advenchen Laboratories LLC In October 2008, Ethical Oncology Science, S.p.A. (“EOS”) (now known as Clovis Oncology Italy S.r.l.) entered into anexclusive license agreement with Advenchen Laboratories LLC (“Advenchen”) to develop and commercialize lucitanib on aglobal basis, excluding China. We are obligated to pay Advenchen tiered royalties at percentage rates in the mid-singledigits on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, after giving effect to the firstand second amendments to the license agreement, we are required to pay to Advenchen 25% of any consideration, excludingroyalties, we receive from sublicensees, in lieu of the milestone obligations set forth in the agreement. We are obligatedunder the agreement to use commercially reasonable efforts to develop and commercialize at least one product containinglucitanib, 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 toAdvenchen, determined on a product-by-product and country-by-country basis, unless we elect to terminate the agreementearlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within specified timeperiods, Advenchen can terminate the agreement, resulting in a loss of our rights to lucitanib. Les Laboratoires Servier In September 2012, EOS entered into a collaboration and license agreement with Les Laboratoires Servier and Institut deRecherches Internationales Servier (collectively, “Servier”), whereby EOS sublicensed to Servier exclusive rights to developand commercialize lucitanib in all countries outside of the U.S., Japan and China. In exchange for these rights, EOS receivedan upfront payment of €45.0 million. We are entitled to receive additional payments on the achievement of specifieddevelopment, regulatory and commercial milestones up to €100.0 million in the aggregate, €10.0 million of which wasreceived in the first quarter of 2014. In addition, we are entitled to receive sales milestone payments if specified annual salestargets for lucitanib are met, each of which relates to annual sales targets of €250.0 million and above, which, in theaggregate, could amount to a total of €250.0 million. We are also entitled to receive royalties at percentage rates rangingfrom low-to-mid teens on sales of lucitanib by Servier.13 Table of Contents We and Servier are developing lucitanib pursuant to a development plan agreed to between the parties. Servier isresponsible for all of the development costs for lucitanib up to €80.0 million. Cumulative global development costs inexcess of €80.0 million, if any, will be shared equally between us and Servier. During the second quarter of 2016, we andServier agreed to discontinue the development of lucitanib for breast cancer. During 2017, we completed the committed on-going development activities and received full reimbursement of our development costs from Servier. Reimbursements arerecorded 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 tous, determined on a product-by-product and country-by-country basis, unless Servier elects to terminate the agreementearlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within specified timeperiods, Servier can terminate the agreement, resulting in the granting of a perpetual license to Servier of rights to lucitanib. Celgene CorporationIn May 2010, we entered into an exclusive worldwide license agreement with Avila Therapeutics, Inc. (now CelgeneAvilomics Research Inc., part of Celgene Corporation (“Celgene”)) to discover, develop and commercialize a covalentinhibitor of mutant forms of the EGFR gene product. Rociletinib was identified as the lead inhibitor candidate under thelicense agreement. We are responsible for all non-clinical, clinical, regulatory and other activities necessary to develop andcommercialize rociletinib. We made an upfront payment of $2.0 million upon execution of the license agreement, a $4.0 million milestone paymentin the first quarter of 2012 upon the acceptance by the FDA of our Investigational New Drug (“IND”) application forrociletinib and a $5.0 million milestone payment in the first quarter of 2014 upon the initiation of the Phase II study forrociletinib. In the third quarter of 2015, we made milestone payments totaling $12.0 million upon acceptance of the NDAand MAA for rociletinib by the FDA and EMA, respectively. We recognized all payments prior to commercial approval asacquired 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 annualnet sales achieved. We are required to pay up to an additional aggregate of $98.0 million in development and regulatorymilestone payments if certain clinical study objectives and regulatory filings, acceptances and approvals are achieved. Inaddition, we are required to pay up to an aggregate of $120.0 million in sales milestone payments if certain annual salestargets are achieved. We have full sublicensing rights under the license agreement, subject to our sharing equally with Celgene any upfrontpayments from any sub-licensing arrangements relating to Japan, or Japan and any one or more of China, South Korea andTaiwan, which we refer to herein as an Asian Partnership, and subject to our paying royalties on sales in Asia equal to thegreater 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 toCelgene, determined on a product-by-product and country-by-country basis, unless we elect to terminate the licenseagreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within specifiedtime periods, Celgene can terminate the agreement, resulting in a loss of our rights to rociletinib and an obligation to assignor license to Celgene any intellectual property rights or other rights we may have in rociletinib, including our regulatoryfilings, 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 andpackaging, storage, distribution, post-approval monitoring and reporting, advertising and promotion, pricing and export andimport of pharmaceutical products. The process of obtaining regulatory approvals and the subsequent compliance withappropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financialresources. Moreover, failure to comply with applicable regulatory requirements may result in, among other14 Table of Contentsthings, warning letters, clinical holds, civil or criminal penalties, recall or seizure of products, injunction, disbarment, partialor total suspension of production or withdrawal of the product from the market. U.S. Government Regulation In the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act (“FDCA”) and itsimplementing regulations. Drugs are also subject to other federal, state and local statutes and regulations. The processrequired by the FDA before product candidates may be marketed in the United States generally involves the following:·completion of extensive non-clinical laboratory tests and non-clinical animal studies, all performed in accordancewith the FDA’s Good Laboratory Practice regulations;·submission to the FDA of an IND which must become effective before human clinical trials may begin and must beupdated at least annually;·performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the productcandidate for each proposed indication;·submission to the FDA of a marketing authorization application in the form of an NDA for the initial commercialsale of a product, or of a sNDA, for approval of a new indication if the product is already approved for anotherindication;·satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the activepharmaceutical ingredient (“API”) and finished drug product are produced and tested to assess compliance withCurrent Good Manufacturing Practices (“cGMP”) and/or sites involved in clinical studies to assess compliance withGood Clinical Practices (“GCP”);·if FDA convenes an advisory committee, satisfactory completion of the advisory committee review; and·FDA review and approval of the marketing authorization application and product prescribing information prior toany commercial marketing or sale of the drug for the intended use. An IND is a request for authorization from the FDA to administer a product candidate to humans. The central focus of anIND submission is on the general investigational plan and the protocol(s) for human studies. The IND also includes results ofanimal studies or other human studies, as appropriate, as well as manufacturing information, analytical data and anyavailable clinical data or literature to support the use of the product candidate. An IND must become effective before humanclinical trials may begin. An IND will automatically become effective 30 days after receipt by the FDA, unless before thattime the FDA raises concerns or questions related to the proposed clinical trials, including concerns that human researchsubjects will be exposed to unreasonable health risks. In such a case, the IND may be placed on clinical hold requiring delayof a proposed clinical investigation, and the IND sponsor and the FDA must resolve any outstanding concerns or questionsbefore clinical trials can begin. Accordingly, submission of an IND may or may not result in the FDA allowing clinical trialsto commence. Clinical trials involve the administration of the drug candidate to human subjects under the supervision of qualifiedinvestigators in accordance with GCP, which include the requirement that all research subjects provide their informedconsent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among otherthings, the objectives of the study, the parameters to be used in monitoring safety and the efficacy criteria to be evaluated. Aprotocol 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 an Institutional Review Board (“IRB”) for each medical center proposingto conduct the clinical trial before the trials may be initiated, and the IRB must monitor the study until completed. Clinicaltrials are subject to central registration and results reporting requirements, such as on www.clinicaltrials.gov. The clinical investigation of a drug is generally divided into three phases. Although the phases are usually conductedsequentially, they may overlap or be combined. The three phases of an investigation are as follows:·Phase 1. Phase 1 includes the initial introduction of the product candidate into humans. Phase 1 clinical trials aretypically closely monitored and may be conducted in patients with the target disease or condition or in healthyvolunteers. These studies are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologicactions of product candidate in humans, the side effects associated with increasing doses, and if possible, to gainearly evidence on effectiveness. During Phase 1 clinical trials, sufficient information about the15 Table of Contentsproduct candidate’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 1clinical trials varies, but is generally in the range of 20 to 80.·Phase 2. Phase 2 includes controlled clinical trials conducted to preliminarily or further evaluate the effectiveness ofthe product candidate for a particular indication(s) in patients with the disease or condition under study, todetermine dosage tolerance and optimal dosage, and to identify possible adverse side effects and safety risksassociated with the drug. Phase 2 clinical trials are typically well-controlled, closely monitored, and conducted in alimited patient population, usually involving no more than several hundred participants.·Phase 3. Phase 3 clinical trials are generally controlled clinical trials conducted in an expanded patient populationgenerally at geographically dispersed clinical trial sites. They are performed after preliminary evidence suggestingeffectiveness of the drug has been obtained and are intended to further evaluate dosage, clinical effectiveness andsafety, to establish the overall benefit-risk relationship of the investigational drug product and to provide anadequate basis for product approval. Phase 3 clinical trials usually involve several hundred to several thousandparticipants. A pivotal study is a clinical study which adequately meets regulatory agency requirements for the evaluation of a drugcandidate’s efficacy and safety such that it can be used to justify the approval of the product. Generally, pivotal studies arealso Phase 3 studies but may be Phase 2 studies if the trial design provides a well-controlled and reliable assessment ofclinical benefit, particularly in situations where there is an unmet medical need. The FDA, an 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 clinicaltrials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as anIndependent Data Monitoring Committee (“IDMC”). The IDMC receives special access to un-blinded data during theclinical trial and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or othergrounds, such as no demonstration of efficacy. We may also suspend or terminate a clinical trial based on evolving businessobjectives and/or competitive climate. Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, detailedproduct development information is submitted to the FDA in the form of an NDA or sNDA requesting approval to market theproduct for one or more indications. The application includes all relevant data available from pertinent non-clinical and clinical trials, including negative orambiguous 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 trialsintended to test the safety and effectiveness of a use of a product, or from a number of alternative sources, including studiesinitiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity toestablish the safety and effectiveness of the product candidate to the satisfaction of the FDA. Once the marketing application submission has been accepted for filing, the FDA’s goal is to review applications within10 months of acceptance for filing or, if the application relates to treatment of a serious or life-threatening condition and isgranted fast track priority review designation, six months from acceptance for filing. The review process is often significantlyextended by FDA requests for additional information or clarification. The FDA may refer the application to an advisorycommittee for review, evaluation and recommendation as to whether the application should be approved. The FDA is notbound by the recommendation of an advisory committee, but it typically follows such recommendations. After the FDA evaluates the NDA or sNDA and conducts inspections of clinical research facilities and/or manufacturingfacilities where the drug product and/or its API will be produced, it may issue an approval letter or a Complete ResponseLetter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specificindications. A Complete Response Letter indicates that the review cycle of the application is complete, and the application isnot ready for approval. A Complete Response Letter may require additional clinical data and/or an additional pivotal Phase 3clinical trial(s), and/or other significant, expensive and time-consuming requirements related to clinical trials, non-clinicalstudies or manufacturing. Even if such additional information is submitted, the FDA may ultimately decide that theapplication does not satisfy the criteria for approval. The FDA could also approve the NDA with a Risk Evaluation andMitigation Strategies plan to mitigate risks, which could include16 Table of Contentsmedication 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, changesto 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 furtherassess and monitor the product’s safety and effectiveness after commercialization. Regulatory approval of oncology productsoften requires that patients in clinical trials be followed for long periods to determine the overall survival benefit of the drug. Products manufactured or distributed pursuant to FDA approvals are subject to continuing regulation by the FDA,including recordkeeping requirements and reporting of adverse experiences with the drug. Adverse event experience with theproduct must be reported to the FDA in a timely fashion and pharmacovigilance programs to proactively look for theseadverse events are mandated by the FDA. Newly discovered or developed safety or effectiveness data may require changes toa product’s approved labeling, including the addition of new warnings and contraindications and also may require theimplementation of other risk management measures. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain stateagencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance withGMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.Following such inspections, the FDA may issue notices on Form FDA 483 and Warning Letters that could cause us to modifycertain activities. A Form FDA 483 notice, if issued at the conclusion of an FDA inspection, can list conditions the FDAinvestigators believe may have violated cGMP or other FDA regulations or guidance. Failure to adequately and promptlycorrect the observations(s) can result in further regulatory enforcement action. In addition to Form FDA 483 notices andWarning Letters, failure to comply with the statutory and regulatory requirements can subject a manufacturer to possiblelegal or regulatory action, such as suspension of manufacturing, seizure of product, injunctive action or possible civilpenalties. In addition, changes to the manufacturing process are strictly regulated, and, depending on the significance of thechange, may require prior FDA approval before being implemented. FDA regulations also require investigation andcorrection of any deviations from cGMP and impose reporting and documentation requirements upon us and any third-partymanufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in thearea of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance. Government Regulation Outside of the United States In addition to regulations in the United States, we are subject to a variety of regulations in other jurisdictions governing,among other things, clinical trials and any commercial sales and distribution of our products. The approval process andrequirements governing the conduct of clinical trials, product licensing, pricing, and reimbursement vary greatly fromcountry to country, and the time may be longer or shorter than that required for FDA approval. Regardless of whether we hold FDA approval for a product, we must obtain the requisite approvals from regulatoryauthorities 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 trialapplication much like the IND prior to the commencement of human clinical trials. In Europe, for example, a clinical trialapplication, (“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, clinicaltrial development may proceed. Medicines can be authorized in the European Union by using either the centralized authorization procedure or nationalauthorization procedures. Under the centralized procedure, marketing authorization applications are submitted to the EMAwhose CHMP reviews the application and issues an opinion on it. The opinion is considered by the European Commission(“EC”) which is responsible for deciding applications. If the application is approved, the EC grants a single marketingauthorization that is valid for all European Union member states as well as Iceland, Liechtenstein and Norway. Thecentralized procedure is compulsory for human medicines that contain a new active substance indicated for the treatment ofcertain diseases, including cancer. The national authorization procedures, the decentralized and mutual recognition procedures, are available for products forwhich the centralized procedure is not compulsory. Using the decentralized procedure, an applicant may apply forsimultaneous authorization in more than one European Union country of medicinal products that have not yet17 Table of Contentsbeen authorized in any European Union country and that do not fall within the mandatory scope of the centralizedprocedure. Under the mutual recognition procedure, a medicine is first authorized in one European Union Member State, inaccordance with the national procedures of that country. Following this, further marketing authorizations can be sought fromother European Union countries in a procedure whereby the countries concerned agree to recognize the validity of theoriginal, national marketing authorization Available Special Regulatory Procedures Formal Meetings We are encouraged to engage and seek guidance from health authorities relating to the development and review ofinvestigational drugs, as well as marketing applications. In the United States, there are different types of official meetingsthat may occur between us and the FDA. Each meeting type is subject to different procedures. Conclusions and agreementsfrom 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, whichis 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 the FDA inthe United States, Special Protocol Assessment (“SPA”) procedures are available. A SPA is an evaluation by the FDA of aprotocol with the goal of reaching an agreement with the sponsor that the protocol design, clinical endpoints and statisticalanalyses are acceptable to support regulatory approval of the product candidate with respect to effectiveness in theindication studied. The FDA’s agreement to a SPA is binding upon the FDA except in limited circumstances, such as if theFDA identifies a substantial scientific issue essential to determining the safety or effectiveness of the product after clinicalstudies begin, or if the study sponsor fails to follow the protocol that was agreed upon with the FDA. There is no guaranteethat 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 than200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States and there is noreasonable expectation that the cost of developing and making the drug for this type of disease or condition will berecovered from sales in the United States. In the European Union, the EMA’s Committee for Orphan Medicinal Productsgrants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention ortreatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in theEuropean Union Community. Additionally, designation is granted for products intended for the diagnosis, prevention ortreatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it isunlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developingthe drug or biological product. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grantfunding towards clinical trial costs, tax advantages and user-fee waivers. In addition, if a product receives the first FDAapproval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, whichmeans the FDA may not approve any other application to market the same drug for the same indication for a period of sevenyears, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity. In the European Union, orphan drug designation also entitles a party to financial incentives such as reduction of fees orfee waivers and 10 years of market exclusivity is granted following drug or biological product approval. This period may bereduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product issufficiently profitable not to justify maintenance of market exclusivity. Orphan drug designation must be requested before submitting an application for marketing approval. Orphan drugdesignation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.18 Table of Contents Pediatric Development In the United States, the FDCA provides for an additional six months of marketing exclusivity for a drug if reports are filedof 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 assessthe safety and effectiveness of an investigational drug product for the claimed indications in all relevant pediatricpopulations in order to support dosing and administration for each pediatric subpopulation for which the drug is safe andeffective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or allpediatric 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 timebetween 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 tosubmitting a marketing authorization application. 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 DrugAdministration Safety and Innovation Act of 2012. FDA may grant Breakthrough Therapy status to a drug intended for thetreatment of a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantialimprovement over existing therapies on one or more clinically significant endpoints. The Breakthrough Therapydesignation, which may be requested by a sponsor when filing or amending an IND, is intended to facilitate and expedite thedevelopment and FDA review of a product candidate. Specifically, the Breakthrough Therapy designation may entitle thesponsor to more frequent meetings with the FDA during drug development, intensive guidance on clinical trial design andexpedited FDA review by a cross-disciplinary team comprised of senior managers. The designation does not guarantee afaster development or review time as compared to other drugs, however, nor does it assure that the drug will obtain ultimatemarketing 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 toexpedite or simplify the process for reviewing drugs and biologics, and/or provide for the approval of a drug or biologic onthe basis of a surrogate endpoint. Even if a drug qualifies for one or more of these programs, the FDA may later decide thatthe drug no longer meets the conditions for qualification or that the time period for FDA review or approval will beshortened. Generally, drugs that are eligible for these programs are those for serious or life-threatening conditions, those withthe potential to address unmet medical needs and those that offer meaningful benefits over existing treatments. For example,based on results of the Phase 3 clinical trial(s) submitted in an NDA, upon the request of an applicant, the FDA may grant theNDA a priority review designation, which sets the target date for FDA action on the application at six months from the 60-day filing date, if the drug is anew molecular entity, rather than to the standard FDA review period of 10 months. Priorityreview is granted where preliminary estimates indicate that a product, if approved, has the potential to provide a safe andeffective therapy where no satisfactory alternative therapy exists, or a significant improvement compared to marketedproducts is possible. Priority review designation does not change the scientific/medical standard for approval or the qualityof 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-threateningdisease or condition upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely topredict clinical benefit and is better than available therapy. A surrogate endpoint is a laboratory measurement or physicalsign used as an indirect or substitute measurement representing a clinically meaningful outcome. The FDA will also take intoaccount 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 effecton clinical benefit, which is defined as having a positive effect on how a patient feels, functions or survives. 19 Table of ContentsAccelerated Review in the European Union Under the Centralized Procedure in the European Union, the maximum timeframe for the evaluation of a marketingauthorization application is 210 days (excluding clock stops, when additional written or oral information is to be providedby the applicant in response to questions asked by the CHMP). Accelerated evaluation might be granted by the CHMP inexceptional cases, when a medicinal product is expected to be of a major public health interest, defined by three cumulativecriteria: the seriousness of the disease (e.g. heavy disabling or life-threatening diseases) to be treated; the absence orinsufficiency of an appropriate alternative therapeutic approach; and anticipation of high therapeutic benefit. In thiscircumstance, EMA ensures that the opinion of the CHMP is given within 150 days of submission of the MAA, excludingclock stops. Pharmaceutical Coverage, Pricing and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of any drug products for which we obtainregulatory approval. In the United States and markets in other countries, sales of any products for which we receiveregulatory approval for commercial sale 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 otherorganizations. The process for determining whether a payor will provide coverage for a drug product may be separate fromthe process for setting the price or reimbursement rate that the payor will pay for the drug product. Third-party payors maylimit coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA-approveddrugs for a particular indication. Third-party payors are increasingly challenging the price and examining the medicalnecessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. We may need toconduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost effectiveness of ourproducts, in addition to the costs required to obtain FDA approvals. The development of a product dossier and a BudgetImpact Model may be helpful in assisting the payors in evaluating cost effectiveness. Our approved products may not beconsidered medically necessary or cost-effective. A payor’s decision to provide coverage for a drug product does not implythat an adequate reimbursement rate will be established. Adequate third-party reimbursement may not be available to enableus 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 legislationproviding a partial prescription drug benefit for Medicare beneficiaries. Government payment for some of the costs ofprescription drugs may increase demand for any products for which we receive marketing approval; however, to obtainpayments under this program, we are required to sell products to Medicare recipients through prescription drug plansoperating pursuant to this legislation. These plans will likely negotiate discounted prices for our products. Additionally, thePatient 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 theway healthcare is financed by both government and private insurers. Among other cost containment measures, the AffordableCare Act established:·An annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs andbiologic agents;·A Medicare Part D coverage gap discount program, in which pharmaceutical manufacturers who wish to have theirdrugs 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. Since its enactment, there have been judicial and Congressional challenges to certain aspects of the Affordable Care Act.We expect that the current presidential administration and U.S. Congress will likely continue to seek to modify, repeal, orotherwise invalidate all, or certain provisions of, the Affordable Care Act. Most recently, the Tax Cuts and Jobs Act wasenacted, which, among other things, removes penalties for not complying with Affordable Care Act’s individual mandate tocarry health insurance. There is still uncertainty with respect to the impact President Trump’s administration and the U.S.Congress may have, if any, and any changes will likely take time to unfold, and could have an impact on coverage andreimbursement for healthcare items and services covered by plans that were authorized by the Affordable Care Act. 20 Table of ContentsIn addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. Thesechanges include aggregate reductions to Medicare payments to providers of 2% per fiscal year, which went into effect onApril 1, 2013 and, due to subsequent legislative amendments to the statute, will stay in effect through 2025 unless additionalCongressional action is taken. Additionally, in January 2013, the American Taxpayer Relief Act of 2012 was signed into law,which, among other things, further reduced Medicare payments to several types of providers and increased the statute oflimitations period for the government to recover overpayments to providers from three to five years. Recently there has beenheightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which hasresulted in several Congressional inquiries and proposed bills designed to, among other things, reform government programreimbursement methodologies. Individual states in the United States have also become increasingly active in implementingregulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints,discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases,designed to encourage importation from other countries and bulk purchasing. We expect that federal, state and localgovernments in the United States will continue to consider legislation to limit the growth of healthcare costs, including thecost of prescription drugs. Future legislation could limit payments for pharmaceuticals such as our products. Moreover, payment methodologies, including payment for companion diagnostics, have been subject to changes due tohealthcare legislation and regulatory initiatives. For example, CMS began bundling the Medicare payments for certainlaboratory tests ordered while a patient received services in a hospital outpatient setting. Additionally, on April 1, 2014, theProtecting Access to Medicare Act of 2014, or PAMA, was signed into law, which, among other things, significantly altersthe current payment methodology under the Clinical Laboratory Fee Schedule. Beginning on January 1, 2018, the Medicarepayment rate for each clinical diagnostic lab test, with some exceptions, is equal to the weighted median private payerpayment for the test, as calculated using data collected by applicable laboratories during the data collection period andreported to CMS during a specified data reporting period. Also under PAMA, CMS is required to adopt temporary billingcodes to identify new clinical diagnostic laboratory tests and advanced diagnostic laboratory tests that do not already haveunique diagnostic codes, and that have been cleared or approved by the FDA. Different pricing and reimbursement schemes exist in other countries. In the European Community, governmentsinfluence the price of pharmaceutical products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive andnegative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtainreimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare thecost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companies tofix their own prices for medicines, but monitor and control company profits. The downward pressure on health care costs ingeneral, particularly prescription drugs, has become very intense. As a result, increasingly high barriers are being erected tothe entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert a commercialpressure on pricing within a country. The marketability of any products for which we receive regulatory approval for commercial sale may suffer if thegovernment and third-party payors fail to provide adequate coverage and reimbursement. In addition, emphasis on reducingthe rate of healthcare spending in the United States has increased, and we expect will continue to increase the pressure onpharmaceutical pricing. There has been particular and increasing legislative interest in the United States with respect to drugpricing practices, particularly with respect to drugs that have been subject to relatively large price increases over relativelyshort time periods. Certain independent charitable foundations operate programs that provide grants to defray medicalexpenses (including cost-sharing obligations for drug treatments and health insurance premiums) for patients who meetcertain financial need criteria and suffer from specific chronic illnesses or rare disorders. There has been recent enforcementinterest regarding donations by pharmaceutical manufacturers to such foundations on the bases that such donations wereused in part to guide patients to those donors’ products or that the donors obtained data on how the donations were used,including how often donations correlate to the frequency of referrals to donors’ products. There have been several U.S.Congressional inquiries and proposed bills designed to, among other things, bring more transparency to drug pricing, reviewthe relationship between pricing and manufacturer patient programs, and reform government program reimbursementmethodologies for drugs. Coverage policies and third-party reimbursement rates may change at any time. Even if favorablecoverage and reimbursement status is attained for one or more products for which we receive regulatory approval, lessfavorable coverage policies and reimbursement rates may be implemented in the future. The implementation of costcontainment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability orcommercialize our products.21 Table of Contents 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 andpromotional activities encompasses, but is not limited to, direct-to-consumer advertising, healthcare provider-directedadvertising and promotion, sales representative communications to healthcare professionals, communications regardingunapproved or “off-label” uses, industry-sponsored scientific and educational activities and promotional activities involvingthe internet. A product cannot be commercially promoted before it is approved. After approval, product promotion caninclude only those claims relating to safety and effectiveness that are consistent with the labeling approved by the FDA. FDAregulations impose stringent restrictions on manufacturers’ communications regarding off-label uses. Failure to comply withapplicable FDA requirements and restrictions regarding unapproved uses of a drug or for other violations of its advertisingand labeling laws and regulations, may result in adverse publicity and enforcement action by the FDA, the Department ofJustice or the Office of the Inspector General of the Department of Health and Human Services, as well as state authorities. Arange of penalties are possible that could have 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 itsproducts or regulatory letters, which may require corrective advertising or other corrective communications to healthcareprofessionals. Other Healthcare Laws and Compliance Requirements We are subject to various laws targeting fraud and abuse in the healthcare industry, including anti-kickback laws and falseclaims laws. For example, in the United States, there are federal and state anti-kickback laws that prohibit the payment orreceipt of kickbacks, bribes or other remuneration intended to induce the purchase or recommendation of healthcare productsand 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 payingremuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, recommending, orarranging for a good or service, for which payment may be made under a federal healthcare program, such as the Medicareand Medicaid programs. The reach of the Anti-Kickback Statute was broadened by the Affordable Care Act, which, amongother things, amended the intent requirement of the federal Anti-Kickback Statute and the applicable criminal healthcarefraud statutes contained within 42 U.S.C. § 1320a-7b. Pursuant to the statutory amendment, a person or entity no longerneeds to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation. Inaddition, the Affordable Care Act provides that the government may assert that a claim including items or services resultingfrom a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil FalseClaims Act (discussed below) or the civil monetary penalties statute. Many states have adopted laws similar to the federalAnti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by anysource, 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 tobe presented, a false or fraudulent claim for payment by a federal program, including federal healthcare programs. The “quitam” provisions of the False Claims Act allow a private individual to bring civil actions on behalf of the federal governmentalleging that the defendant has submitted a false claim to the federal government, and to share in any monetary recovery. Inaddition, various states have enacted false claims laws analogous to the False Claims Act. Many of these state laws applywhere a claim is submitted to any third-party payor and not merely a federal healthcare program. When an entity isdetermined to have violated the False Claims Act, it may be required to pay up to three times the actual damages sustainedby the government, plus civil penalties. In addition, a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration, including waivers ofco-payments and deductible amounts (or any part thereof), that the person knows or should know is likely to influence thebeneficiary’s selection of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or servicesmay be liable for civil monetary penalties of up to $15,270 for each wrongful act. Moreover, in certain cases, providers whoroutinely waive copayments and deductibles for Medicare and Medicaid beneficiaries can also be held liable under the Anti-kickback Statute and civil False Claims Act, which can impose additional penalties associated with the wrongful act. One ofthe statutory exceptions to the prohibition is non-routine, unadvertised waivers of copayments or deductible amounts basedon individualized determinations of financial need or exhaustion of reasonable22 Table of Contentscollection efforts. The Office of Inspector General of the Department of Health and Human Services emphasizes, however,that this exception should only be used occasionally to address special financial needs of a particular patient. Although thisprohibition applies only to federal healthcare program beneficiaries, the routine waivers of copayments and deductiblesoffered to patients covered by commercial payers may implicate applicable state laws related to, among other things,unlawful schemes to defraud, excessive fees for services, tortious interference with patient contracts and statutory or commonlaw fraud. To the extent our patient assistance programs are found to be inconsistent with applicable laws, we may berequired to restructure or discontinue such programs, or be subject to other significant penalties. In addition to the laws described above, the Affordable Care Act also imposed new reporting requirements on drugmanufacturers for payments made to physicians and teaching hospitals, as well as ownership and investment interests held byphysicians and their immediate family members. Failure to submit required information may result in civil monetarypenalties of up to an aggregate of $165,786 per year (or up to an aggregate of $1.105 million per year for “knowingfailures”), for all payments, transfers of value or ownership or investment interests that are not timely, accurately andcompletely reported in an annual submission. Applicable drug manufacturers are required to collect data for each calendaryear and submit reports to CMS by March 31st of each subsequent calendar year. In addition, there are also an increasingnumber of state laws that require manufacturers to make reports to states on pricing and marketing information. These lawsmay 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 variousobligations, including government price reporting and rebate requirements, which generally require products be offered atsubstantial rebates/discounts to Medicaid and certain purchasers (including “covered entities” purchasing under the 340BDrug Discount Program). We are also required to discount such products to authorized users of the Federal Supply Scheduleof the General Services Administration, under which additional laws and requirements apply. These programs requiresubmission of pricing data and calculation of discounts and rebates pursuant to complex statutory formulas, as well as theentry into government procurement contracts governed by the Federal Acquisition Regulations, and the guidance governingsuch 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 tosubstantial 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 drugprice increases over time more than the rate of inflation (based on the CPI-U). This comparison is based on the baselinepricing data for the first full quarter of sales associated with a branded drug’s NDA, and baseline data cannot generally bereset, even on transfer of the NDA to another manufacturer. This “additional rebate” calculation can, in some cases whereprice increase have been relatively high versus the first quarter of sales of the NDA, result in Medicaid rebates up to 100% ofa drug’s “average manufacturer price” and 340B prices of one penny. Subject to the control of Directive 89/105/EEC, pricingand reimbursement in the EU/EEA (European Economic Area) is governed by national rules and policy and may vary fromMember 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. Most healthcare providers who are expectedto prescribe our products and from whom we obtain patient health information are subject to privacy and securityrequirements under HIPAA. Although we are not directly subject to HIPAA, we could be subject to criminal penalties if weknowingly obtain individually identifiable health information from a HIPAA-covered entity in a manner that is notauthorized or permitted by HIPAA. Similar to the federal Anti-Kickback Statute, a person or entity does not need to haveactual knowledge of the statute or specific intent to violate it in order to have committed a violation. Other countries alsohave, or are developing, laws governing the collection, use and transmission of personal information. For example, the EUData Privacy Directive (95/46/EC), which will be replaced on May 28, 2018 by the more restrictive General Data ProtectionRegulation (Regulation (EU) 2016/679) and the Swiss Federal Act on Data Protection, regulate the processing of personaldata within the European Union and between countries in the European Union and countries outside of the European Union,including the U.S. Failure to provide adequate privacy protections and maintain compliance with the new EU-U.S. PrivacyShield framework, which will replace the previous safe harbor mechanisms, could jeopardize business transactions acrossborders and result in significant penalties, These laws could create liability for us or increase our cost of doing business. 23 Table of ContentsRegulation of Diagnostic Tests In the United States, the FDCA and its implementing regulations, and other federal and state statutes and regulationsgovern, among other things, medical device design and development, non-clinical and clinical testing, premarket clearanceor 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. Unlessan exemption applies, diagnostic tests require marketing clearance or approval from the FDA prior to commercialdistribution. The two primary types of FDA marketing authorization applicable to a medical device are premarketnotification, also called 510(k) clearance, and premarket approval, or PMA approval. Because the diagnostic tests beingdeveloped by our third-party collaborators are of substantial importance in preventing impairment of human health, they aresubject to the PMA approval process. PMA applications must be supported by valid scientific evidence, which typically requires extensive data, includingtechnical, non-clinical, clinical and manufacturing data, to demonstrate to the FDA’s satisfaction the safety and effectivenessof the device. For diagnostic tests, a PMA application typically includes data regarding analytical and clinical validationstudies. As part of its review of the PMA, the FDA will conduct a pre-approval inspection of the manufacturing facility orfacilities 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 requiredby statute to take between six to ten months, although the process typically takes longer, and may require several years tocomplete. If the FDA evaluations of both the PMA application and the manufacturing facilities are favorable, the FDA willeither issue an approval letter or an approvable letter, which usually contains a number of conditions that must be met inorder 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 deficienciesin the application and, where practical, will identify what is necessary to make the PMA approvable. The FDA may alsodetermine that additional clinical trials are necessary, in which case the PMA approval may be delayed for several months oryears while the trials are conducted and then the data submitted in an amendment to the PMA. Once granted, PMA approvalmay be withdrawn by the FDA if compliance with post approval requirements, conditions of approval or other regulatorystandards is not maintained or problems are identified following initial marketing. We and our third-party collaborators who are developing companion diagnostics work cooperatively to generate the datarequired for submission with a PMA application, and remain in close contact with the Center for Devices and RadiologicalHealth (“CDRH”) at the FDA to ensure that any changes in requirements are incorporated into the development plans.Meetings with the FDA with regard to our drug product candidates, as well as companion diagnostic product candidates,typically include representatives from the Center for Drug Evaluation and Research and CDRH when appropriate to ensurethat the NDA and PMA submissions are coordinated to enable FDA to conduct a parallel review of both submissions. TheFDA has issued guidance documents addressing the development and approval process for “In Vitro Companion DiagnosticDevices.” According to these guidance documents, for novel therapeutic products such as our product candidates, the PMAfor a companion diagnostic device should generally be developed and approved or cleared contemporaneously with thetherapeutic. In the EEA, in vitro medical devices are required to conform to the essential requirements of the E.U. Directive on in vitrodiagnostic medical devices (Directive No 98/79/EC, as amended). To demonstrate compliance with the essentialrequirements, the manufacturer must undergo a conformity assessment procedure. The conformity assessment variesaccording to the type of medical device and its classification. For low-risk devices, the conformity assessment can be carriedout internally, but for higher risk devices it requires the intervention of an accredited EEA Notified Body. If successful, theconformity assessment concludes with the drawing up by the manufacturer of an EC Declaration of Conformity entitling themanufacturer 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 ourbusiness. 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 ourproprietary rights. We seek patent protection in the United States and internationally for our product24 Table of Contentscandidates and other technology. Our policy is to patent or in-license the technology, inventions and improvements that weconsider important to the development of our business. We also rely on trade secrets, know-how and continuing innovationto develop and maintain our competitive position. We cannot be sure that patents will be granted with respect to any of ourpending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any ofour 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 ofmatter, expire in 2020 and are potentially eligible for up to five years patent term extension in various jurisdictions. Webelieve 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 UnitedStates. In Europe, we believe that patent term extension under a supplementary protection certificate could be available foran additional five years to at least 2025. In April 2012, we obtained an exclusive license from AstraZeneca under a family ofpatents and patent applications which will permit the development and commercialization of rucaparib for certain methodsof treating patients with PARP inhibitors. Additionally, other patents and patent applications are directed to methods ofmaking, methods of using, dosing regimens, various salt and polymorphic forms and formulations and have expiration datesranging 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 expirein 2035. As of February 27, 2018, the rucaparib camsylate salt patent was issued in 47 countries to date (including US andEurope), with applications pending in 9 countries, and the rucaparib composition of matter patent was issued in 48 countries.We are aware of a number of challenges of salt and polymorph patents. Two oppositions were filed in the granted Europeancounterpart of the rucaparib camsylate salt/polymorph patent on June 20, 2017. European oppositions are commonly filedagainst patents related to pharmaceutical products. The grounds of opposition related to Rubraca were lack of novelty andlack of inventive step. The novelty and inventive step challenges are based on prior art references (or closely relateddisclosures) that were previously raised by the European patent examiner during prosecution of the application. The claimsof the granted patent were found to be patentable over this prior art. While the ultimate results of patent challenges can bedifficult to predict, we believe a number of factors, including a constellation of unexpected properties, support the noveltyand non-obviousness of our rucaparib camsylate salt/polymorph composition of matter patent. Based on these facts, webelieve, a successful challenge of that patent would be difficult. We obtained rights to lucitanib by acquiring EOS in November 2013, along with its license agreements with Advenchenand Servier. In October 2008, EOS entered into an exclusive license agreement with Advenchen to develop andcommercialize lucitanib on a global basis, excluding China. In September 2012, EOS entered into a collaboration andlicense agreement with Servier whereby EOS sublicensed to Servier exclusive rights to develop and commercialize lucitanibin all countries outside of the U.S., Japan and China. Composition of matter and method of use patent protection for lucitaniband a group of structurally-related compounds is issued in the U.S., Europe and Japan and is issued or pending in otherjurisdictions. 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 matter patent up to five years beyondthe scheduled expiration under the Hatch-Waxman Act. Additionally, patents or patent applications directed to methods ofmanufacturing 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 torociletinib composition of matter, expires in 2032 and U.S. Patent 9,108,927, directed to rociletinib HBr salts andpolymorphs, expires in 2033. Other patent applications are pending that claim rociletinib generically that, if issued, wouldhave expiration dates in 2029. In January 2013, we acquired from Gatekeeper Pharmaceuticals, Inc. an exclusive worldwidesub-license to a Dana Farber patent family having claims directed to wild-type sparing irreversible EGFR inhibitors, such asrociletinib. 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 relatedtechnology we acquire in the future. The patent positions of pharmaceutical firms like us are generally uncertain and involve complex legal, scientific andfactual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the patent25 Table of Contentsis issued. Consequently, we do not know whether any of the product candidates we acquire or license will gain patentprotection 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 maintainedin secrecy for 18 months, and since publication of discoveries in the scientific or patent literature often lags behind actualdiscoveries, until that time we cannot be certain that we were the first to file any patent application related to our productcandidates. Moreover, we may have to participate in interference proceedings declared by the United States Patent andTrademark 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 tous. There can be no assurance that the patents, if issued, would be held valid by a court of competent jurisdiction. An adverseoutcome in a third-party patent dispute could subject us to significant liabilities to third parties, require disputed rights to belicensed 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. Inmost countries in which we file, the patent term is 20 years from the earliest date of filing a non-provisional patentapplication. In the United States, a patent’s term may be lengthened by patent term adjustment, which compensates apatentee for administrative delays by the U.S. PTO in granting a patent, or may be shortened if a patent is terminallydisclaimed over another patent. The patent term of a patent that covers an FDA-approved drug may also be eligible for patent term extension, whichpermits patent term restoration as compensation for the patent term lost during the FDA regulatory review process. TheHatch-Waxman Act permits a patent term extension of up to five years beyond the expiration of the patent. The length of thepatent term extension is related to the length of time the drug is under regulatory review. Patent extension cannot extend theremaining term of a patent beyond a total of 14 years from the date of product approval and only one patent applicable to anapproved drug may be extended. Similar provisions are available in Europe and other non-U.S. jurisdictions to extend theterm 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 infringingthird parties, or avail ourselves of the courts or participate in hearings to determine the scope and validity of those patents orother proprietary rights. These types of proceedings are often costly and could be very time-consuming to us, and we cannotassure you that the deciding authorities will rule in our favor. An unfavorable decision could allow third parties to use ourtechnology 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 rightsassociated with our patents or pending patent applications. To the extent prudent, we intend to bring litigation against thirdparties 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 whichhas an orphan drug designation subsequently receives the first regulatory approval for the indication for which it has suchdesignation, the product is entitled to orphan exclusivity, meaning that the applicable regulatory authority may not approveany other applications to market the same drug for the same indication, except in certain very limited circumstances, for aperiod of seven years in the United States and ten years in the European Union. Orphan drug designation does not preventcompetitors 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 thatothers will not independently develop substantially equivalent proprietary information and techniques or otherwise gainaccess to our trade secrets or disclose such technology, or that we can meaningfully protect our trade secrets. However, webelieve that the substantial costs and resources required to develop technological innovations will help us to protect thecompetitive advantage of our products. It is our policy to require our employees, consultants, outside scientific collaborators, sponsored researchers and otheradvisors 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 ofthe individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specificcircumstances. In the case of employees, the agreements provide that all inventions conceived by the individual26 Table of Contentsshall be our exclusive property. There can be no assurance, however, that these agreements will provide meaningfulprotection 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 clinicaltrials and intend to do so in the future. We currently have long-term agreements with third-party contract manufacturingorganizations (“CMOs”) for the production of the active ingredient and final product for Rubraca. We do not own or operatemanufacturing facilities for the production of clinical quantities of our product candidates. We currently have no plans tobuild our own clinical or commercial scale manufacturing capabilities. To meet our projected needs for commercialmanufacturing, we are working with our current third party suppliers to increase their scale of production and we are in theprocess of evaluating additional second source suppliers. Although we rely on contract manufacturers, we have personnelwith extensive manufacturing experience to oversee the relationships with our contract manufacturers. We have developed the process for manufacturing Rubraca’s active pharmaceutical ingredient (“API”) to a degreesufficient to meet clinical demands and, as production capacity is increased as described below under “Lonza Agreement,”projected commercial requirements. Manufacturing of Rubraca API is being performed at a single CMO. The Rubraca drugproduct formulation and manufacturing process to produce that formulation have been developed to a degree sufficient tomeet clinical demands and projected commercial requirements. A single third-party CMO capable of both formulationdevelopment and drug product manufacturing is currently producing Rubraca drug product. Our operating plan for the next12 months includes a significant investment in inventory to meet the projected commercial requirements for Rubraca. To date, our third-party manufacturers have met our manufacturing requirements. We expect third-party manufacturers tobe 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 ofthe API for rucaparib. Under this agreement, Lonza will be a non-exclusive manufacturer of the rucaparib API during the 10 year term of theagreement. Lonza will construct, in an existing Lonza facility, a production train that will be exclusively dedicated to themanufacture of the rucaparib API. The dedicated production train will provide manufacturing capacity to meet our currentlyanticipated needs for commercial supply of rucaparib API. We are obligated to make scheduled capital program fee paymentstowards capital equipment and other costs associated with the construction of the dedicated production train and, once thefacility is operational, to pay a fixed facility fee each quarter for the duration of the term of the agreement. The dedicatedproduction train is estimated to be completed during the fourth quarter of 2018 at which time Lonza will begin producingAPI under this agreement. 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 byus, subject to certain adjustments. Until the dedicated facility is completed and operationally qualified, Lonza willmanufacture 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 priorwritten notice and a cure period. We may terminate the agreement, subject to 90 days’ prior written notice, in the eventrucaparib is withdrawn from the market for certain reasons. In the event of such a termination by us, or termination by Lonzadue to material breach by us, we are obligated to compensate Lonza for any services rendered, or for which costs have beenincurred by Lonza in anticipation of services to be provided to us, and to pay to Lonza the remaining amount of any capitalprogram fees and quarterly fixed facility fees for the remainder of the term of the agreement. In the event we terminate theagreement due to material breach by Lonza, Lonza is obligated to repay all or a portion of the capital program feespreviously paid by us. 27 Table of ContentsThe active pharmaceutical ingredient for lucitanib is currently being produced by a third-party supplier. To date, thecurrent production process has been sufficient to satisfy immediate clinical demands. We may undertake additionaldevelopment work to further optimize the active pharmaceutical ingredient manufacturing process. The finished drugproduct for lucitanib is currently being manufactured at a CMO. The current product and process are sufficiently developedto meet immediate clinical demands. Additional scale-up work and/or additional production capacity will be necessary tosupport larger clinical development or commercialization requirements. The active pharmaceutical ingredient for rociletinib is currently being manufactured by one CMO. The current drugsubstance production process has already been sufficiently developed to satisfy immediate clinical demands. We haveengaged a single CMO capable of both formulation development and drug product manufacturing. The current drug productproduction process has already been sufficiently developed to satisfy immediate clinical demands. Additional scale-up workand/or additional production capacity may be necessary to support larger clinical development or commercializationrequirements. Commercial Operations Our commercial organization in the U.S. is in place and supporting the commercial sale of Rubraca. We believe the U.S.oncology market for Rubraca in both of its approved indications is addressable with a targeted sales and marketingorganization, 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 limiteddistribution network consisting of select number of specialty pharmacies and distributors. Healthcare providers prescribeRubraca to patients and the specialty pharmacies and distributors dispense Rubraca directly to patients. We intend tocontinue promoting Rubraca ourselves in the U.S. for its current indications and any additional indications we may obtain inthe future. We retain the rights to Rubraca in the rest of the world. The MAA submission with the EMA for an ovarian cancertreatment indication is currently under review. If approved in the EU, we intend to commercialize rucaparib on our own andwe are building our commercial and medical affairs infrastructure in Europe. The leadership of those teams is in place, and wewill hire field sales personnel as pricing and reimbursement decisions are made and approvals are received. Customers We are currently approved to sell Rubraca in the U.S. market. We distribute our product principally through a limitednumber of specialty distributor and specialty pharmacy providers, collectively, our customers. Our customers subsequentlysell 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.Furthermore, we do not believe the loss of one of these customers would significantly impact the ability to distribute ourproduct as we expect that sales volume would be absorbed evenly by the remaining customers. Employees As of February 16, 2018, we employed 360 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 ourrelationship with our employees to be good. As part of the Compensation Committee’s annual review of overall employee compensation, effective March 1, 2018, inorder to align their base salary compensation with the 50th percentile of similarly situated employees at the Company’s peergroup companies, the Compensation Committee approved for Mr. Mahaffy a base salary increase of 7.1% to $696,300, forMr. Muehl a base salary increase of 15.7% to $433,800, for Ms. Ivers-Read a base salary increase of 3.0% to $450,246, for Dr.Rolfe a base salary increase of 4.1% to $489,300 and for Mr. Hooks a base salary increase of 5.3% to $421,300. Also, theCompensation Committee approved new bonus targets (as a percentage of their new annual base salaries) for each of theseexecutive officers as follows: for Mr. Mahaffy, 70%; for Ms. Ivers-Read and Dr. Rolfe, 50%; and for Messrs. Muehl andHooks, 45%. In addition, as part of the annual grants of equity awards to employees of the Company, the CompensationCommittee approved the following equity awards to such executive officers to be made on March 1, 2018: Mr. Mahaffy,options to purchase 120,000 shares of the Company’s common stock; Mr. Muehl, options to purchase 9,000 shares of theCompany’s common stock and 9,000 restricted stock units (“RSUs”); Ms. Ivers-Read, options to purchase 11,000 shares ofthe Company’s common stock and 11,000 restricted28 Table of Contentsstock units; Dr. Rolfe, options to purchase 11,000 shares of the Company’s common stock and 11,000 restricted stock units;and Mr. Hooks, options to purchase 9,000 shares of the Company’s common stock and 9,000 restricted stock units. Research and Development We invested $142.5 million, $251.1 million and $269.3 million in research and development during the years endedDecember 31, 2017, 2016 and 2015, respectively. About Clovis We were incorporated under the laws of the State of Delaware in April 2009 and completed our initial public offering ofour 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 ourtelephone number is (303) 625-5000. We maintain additional offices in San Francisco, California, Cambridge, UK, andMilan, Italy. Our website address is www.clovisoncology.com. Our website and the information contained on, or that can beaccessed through, the website will not be deemed to be incorporated by reference in, and are not considered part of, thisreport. Available Information As a public company, we file reports and proxy statements with the Securities and Exchange Commission (“SEC”). Thesefilings include our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and proxystatements on Schedule 14A, as well as any amendments to those reports and proxy statements, and are available free ofcharge through our website as soon as reasonably practicable after we file them with, or furnish them to, the SEC. Once atwww.clovisoncology.com, go to Investors & News/SEC Filings to locate copies of such reports. You may also read and copymaterials that we file with SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. You mayobtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC alsomaintains a website at www.sec.gov that contains reports, proxy statements and other information regarding us and otherissuers 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 businessprospects, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluatingour business, we encourage you to consider the following discussion of risk factors, in its entirety, in addition to otherinformation contained in or incorporated by reference into this Annual Report on Form 10-K and our other public filingswith the SEC. Other events that we do not currently anticipate or that we currently deem immaterial may also affect ourbusiness, prospects, financial condition and results of operations. 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 theforeseeable future. We have generated only modest historical revenues, which makes it difficult to assess our futureviability. We are a biopharmaceutical company with a limited operating history. Biopharmaceutical product development is ahighly speculative undertaking and involves a substantial degree of risk. We have focused primarily on in-licensing anddeveloping our product candidates. We are not profitable and have incurred losses in each year since our inception in April2009. We have only a limited operating history upon which you can evaluate our business and prospects. There are manyrisks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in thebiopharmaceutical 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 inthen-ongoing clinical trials. We have received regulatory approval to market Rubraca in the U.S., but we do not yet knowwhether it will be approved in other jurisdictions or whether it will achieve market acceptance and be commerciallysuccessful. We have generated only modest revenues from product sales to date. We continue to incur29 Table of Contentssignificant research and development and other expenses related to our ongoing operations. For the years ended December31, 2017, 2016 and 2015, we had net losses of $346.4 million, $349.1 million and $352.9 million, respectively. As ofDecember 31, 2017, we had an accumulated deficit of $1,447.4 million. We expect to continue to incur losses for theforeseeable future. As such, we are subject to all of the risks incident to the development of new biopharmaceutical productsand related companion diagnostics, and we may encounter unforeseen expenses, difficulties, complications, regulatoryscrutiny, delays and other unknown factors that may adversely affect our business. If any of our product candidates fail inclinical trials or do not gain regulatory approval, or if Rubraca or any of our product candidates, if approved, fail to achievemarket acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able tosustain profitability in subsequent periods. Our prior losses, combined with expected future losses, have had and willcontinue 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 toobtain additional financing, we may be unable to complete the development and commercialization of our productcandidates or continue our development programs. Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend substantialamounts to advance the clinical development of our product candidates and launch and commercialize any productcandidates for which we receive regulatory approval, including building our own commercial organizations to addresscertain markets. Based on current estimates, we believe that our existing cash, cash equivalents and available-for-sale securities will allowus to fund our operating plan through at least the next 12 months. We do not have any material committed external source offunds 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 insufficient 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 willbe available on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts or on termsacceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of oneor more of our product candidates, or our plans for acquisition or in-license of new product candidates. We may also seekcollaborators for one or more of our current or future product candidates on terms that are less favorable than might otherwisebe 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 ourbusiness to pay our substantial debt. In September 2014, we completed a private placement of $287.5 million aggregate principal amount of 2.5% convertiblesenior notes due 2021 (the “Notes”), resulting in net proceeds to the Company of $278.3 million after deducting offeringexpenses. The Notes are governed by the terms of the indenture between the Company, as issuer, and The Bank of New YorkMellon Trust Company, N.A., as trustee. Interest is payable on the Notes semi-annually, and the Notes mature onSeptember 15, 2021, unless redeemed, repurchased or converted prior to that date. In addition, if, as defined by the terms ofthe indenture, a fundamental change occurs, holders of the Notes may require us to repurchase for cash all or any portion oftheir Notes at a purchase price equal to 100% of the principal amount of the Notes to be repurchased plus accrued and unpaidinterest, if any, to, but excluding, the fundamental change repurchase date. As of December 31, 2017, all $287.5 millionprincipal 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 Noteson a fundamental change, depends on our future performance, which is subject to economic, financial, competitive and otherfactors beyond our control. We may not have sufficient cash in the future to service our debt. If we are unable to generatesuch cash flow or secure additional sources of funding, we may be required to adopt one or more alternatives, such asrestructuring debt or obtaining additional equity capital on terms that may be onerous or highly dilutive. Our ability torefinance our indebtedness will depend on the capital markets and our financial condition at such time. We may not be ableto engage in any of these activities or engage in these activities on desirable terms, which could result in a default on ourdebt obligations. 30 Table of ContentsWe and certain of our officers and directors have been named as defendants in several lawsuits that could result insubstantial costs and divert management’s attention. We and certain of our officers have been named as defendants in a number of lawsuits that generally allege that we andcertain of our officers violated federal securities laws by making allegedly false and misleading statements regarding theprogress toward FDA approval and the potential for market success of rociletinib. Some of these lawsuits have been settledwhile others remain outstanding and others may still be brought. See “Part I, Item 3-Legal Proceedings” in this report. We intend to engage in a vigorous defense of these lawsuits; however, we are unable to predict the outcome of thesematters at this time. If we are not successful in our defense of these litigation matters, we could be forced to make significantpayments to, or enter into other settlements with, our security holders and their lawyers (and in certain circumstancesreimburse costs and expenses incurred by the underwriters), and such payments or settlement arrangements could have amaterial adverse effect on our business, operating results and financial condition. For example, we could suffer a significantadverse impact on our reputation and divert management’s attention and resources from other priorities, any of which couldhave a material adverse effect on our business. In addition, any of these matters could require payments that are not coveredby, or exceed the limits of, our available directors’ and officers’ liability insurance, which could have a material adverseeffect on our operating results or financial condition. We will not receive any further contributions from our insurancecarriers for any amounts (including damages, settlement costs or legal fees) relating to the Company’s regulatory updateannouncement in November 2015 that the FDA requested additional clinical data on the efficacy and safety of rociletinib. Additional lawsuits with similar claims may be filed by other parties against us and our officers and directors. Even if suchclaims are not successful, these lawsuits or other future similar actions, or other regulatory inquiries or investigations, mayresult in substantial costs and have a significant adverse impact on our reputation and divert management’s attention andresources, which could have a material adverse effect on our business, operating results or financial condition. The recently passed comprehensive tax reform bill could adversely affect our business and financial condition. On December 22, 2017, President Trump signed into law new legislation that significantly revises the Internal RevenueCode of 1986, as amended. The newly enacted federal income tax law, among other things, contains significant changes tocorporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%,limitation of the tax deduction for interest expense to 30% of adjusted earnings (except for certain small businesses),limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operatingloss carrybacks, one time taxation of offshore earnings at reduced rates regardless of whether they are repatriated, eliminationof U.S. tax on foreign earnings (subject to certain important exceptions), immediate deductions for certain new investmentsinstead of deductions for depreciation expense over time, and modifying or repealing many business deductions and credits(including reducing the business tax credit for certain clinical testing expenses incurred in the testing of certain drugs for rarediseases or conditions generally referred to as “orphan drugs”). Notwithstanding the reduction in the corporate income taxrate, the overall impact of the new federal tax law is uncertain, and our business and financial condition could be adverselyaffected. In addition, it is uncertain if and to what extent various states will conform to the newly enacted federal tax law. Theimpact of this tax reform on holders of our common stock is also uncertain and could be adverse. Investors should consultwith their legal and tax advisors with respect to this legislation and the potential tax consequences of investing in or holdingour common stock. 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 acceptanceand 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 withdeleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with twoor more chemotherapies, and selected for therapy based on an FDA approved companion diagnostic for Rubraca. Our MAAsubmitted to the EMA for an ovarian cancer treatment indication is currently under review by the CHMP, and in February2018, the CHMP communicated to us their intention to hold a final vote on the treatment indication at their31 Table of ContentsMarch 2018 meeting. Rubraca is commercially available in the U.S. The degree of market acceptance and the commercialsuccess 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 and, if approvedin Europe, the EMA, 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 andrelative 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, adversereactions 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 goodstanding with regulatory agencies, and to develop, validate and maintain commercially viable manufacturingprocesses that are, to the extent required, compliant with current good manufacturing practice (“cGMP”) regulations;·the availability of coverage and adequate reimbursement from managed care plans, private health insurers and otherthird 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 supportspromotional 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 meaningfulrevenue through the sale of Rubraca. In addition, we may experience significant fluctuations in sales of Rubraca from periodto period. We currently do not have any other product candidates in active development though we are exploring rucaparibin other indications. Any inability on our part to successfully commercialize Rubraca in the United States and any foreignterritories where it may be approved, or any significant delay in such approvals, could have a material adverse impact on ourability to execute upon our business strategy and, ultimately, to generate sufficient revenues from Rubraca to reach ormaintain 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 thepast, then:·sales of Rubraca may decline;·regulatory approvals for Rubraca may be restricted or withdrawn;·we may decide to, or be required to, send product warning letters or field alerts to physicians, pharmacists andhospitals;·additional nonclinical or clinical studies, changes in labeling or changes to manufacturing processes, specificationsand/or facilities may be required;·government investigations or lawsuits, including class action suits, may be brought against us; and·our reputation may suffer. 32 Table of ContentsAny of the above occurrences would harm or prevent sales of Rubraca, increase our expenses and impair our ability tosuccessfully commercialize Rubraca. As Rubraca is commercially available, it may be used in a wider population and in aless 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 unknownserious adverse effects, undermining our commercialization efforts. If our sales, marketing and distribution capabilities for Rubraca or our product candidates for which we obtainmarketing 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 commercialsuccess for Rubraca and any product candidate that may be approved by the FDA or comparable foreign regulatoryauthorities, we must continue to expand our sales, marketing, managerial and other nontechnical capabilities or makearrangements with third parties to perform these services. We will be competing with companies that currently haveextensive, well-funded, and more experienced sales and marketing operations. We may be unable to compete successfullyagainst these more established companies. We have recently built a field organization and other capabilities for the sales, marketing and distribution of Rubraca inthe United States and have hired the commercial infrastructure in the European Union, and there are significant risksinvolved with building and managing a sales organization. Factors that may inhibit our efforts to effectively commercializeRubraca on our own include:·our inability to recruit, train, retain and incentivize adequate numbers of qualified and effective sales and marketingpersonnel;·the inability of sales personnel to generate sufficient sales leads and to obtain access to physicians or persuadeadequate 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 or if we are unable toestablish and maintain sales, marketing and distribution capabilities for Rubraca outside of the United States, if approved, orfor any other product candidate for which we obtain marketing approval, whether independently or with third parties, we maynot be able to generate product revenue or may not become profitable. If the cost of establishing and maintaining a sales andmarketing 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 andestablished distribution systems, either to augment our own sales force and distribution systems or in lieu of our own salesforce and distribution systems in certain territories. To the extent that we enter into licensing or co-promotion arrangementsfor any of our product candidates, our product revenue may be lower than if we directly marketed or sold our approvedproducts. In addition, any revenue we receive as a result of such arrangements would depend in whole or in part upon theefforts of such third parties, which may not be successful and are generally not within our control. If we are unable to enterinto such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our productcandidates that receive regulatory approval. If we are not successful in commercializing our product candidates, either on ourown or through collaborations with one or more third parties, our future product revenue will suffer and we may incursignificant additional losses. We cannot give any assurance that rucaparib will receive regulatory approval outside the United States or that therucaparib development program in other lines of therapies and indications will be successful or that our other productcandidates will receive regulatory approval. To date, we have invested a significant portion of our efforts and financial resources in the acquisition and developmentof our product candidates. Our business depends entirely on the successful development and commercialization of ourproduct candidates. Each of our product candidates requires clinical development, management of clinical, non-clinical and manufacturingactivities, regulatory approval in multiple jurisdictions, obtaining manufacturing supply, building of a commercialorganization and significant marketing efforts in order to generate any revenues from product sales. We are not permitted tomarket or promote any of our product candidates before we receive regulatory approval from the FDA33 Table of Contentsor comparable foreign regulatory authorities. To date, we have received regulatory approval from the FDA to market Rubracain the United States for a certain limited indication. We may not receive similar regulatory approvals outside the UnitedStates and we may never receive regulatory approval for any of our other product candidates. In addition, our productdevelopment programs contemplate the development of companion diagnostics by third-party collaborators. Companiondiagnostics are subject to regulation as medical devices and must themselves be approved for marketing by the FDA orcertain 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 otherindications 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. Three of our productcandidates, CO-101, rociletinib and lucitanib 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 marketone or more of our product candidates, our revenues will be dependent, in part, upon our diagnostic collaborators’ ability toobtain regulatory approval of the companion diagnostics to be used with our product candidates, as well as the size of themarkets in the territories for which we gain regulatory approval and have commercial rights. If the markets for patient subsetsthat we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of suchproducts, if approved. We plan to seek regulatory approval to commercialize our product candidates, and for other lines of therapies, indicationsor tumor types for rucaparib, in the United States, the European Union and in additional foreign countries. While the scope ofregulatory approval is similar in other countries, obtaining separate regulatory approval in many other countries requirescompliance with numerous and varying regulatory requirements of such countries regarding safety and efficacy andgoverning, among other things, clinical trials and commercial sales, pricing and distribution of our product candidates, andwe cannot predict success in these jurisdictions. Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlierstudies 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 canoccur at any time during the clinical trial process. The results of non-clinical studies and early clinical trials of our productcandidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trialsmay fail to show the desired safety and efficacy traits despite having progressed through non-clinical studies and initialclinical trials. It is not uncommon for companies in the biopharmaceutical industry to suffer significant setbacks in advancedclinical 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 as a result of the issuance of a Complete Response Letterby 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 knowwhether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed onschedule, if at all. Clinical trials can be delayed for a variety of reasons, including delays related to:·obtaining regulatory approval to commence a trial;·reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trialsites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROsand 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.34 Table of Contents Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size andnature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design ofthe clinical trial, competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the drugbeing studied in relation to other available therapies, including any new drugs that may be approved for the indications weare investigating. Furthermore, we rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinicaltrials, and while we have agreements governing their committed activities, we have limited influence over their actualperformance. We could encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in whichsuch trials are being conducted, by the Data Safety Monitoring Board for such trial or by the FDA or other regulatoryauthorities. Such authorities may impose a suspension or termination due to a number of factors, including failure to conductthe clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trialoperations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseensafety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulationsor administrative actions or lack of adequate funding to continue the clinical trial. If we experience delays in the completionof, or termination of, any clinical trial of our product candidates, the commercial prospects of our product candidates will beharmed, and our ability to generate product revenues from any of these product candidates will be delayed. In addition, anydelays in completing our clinical trials will increase our costs, slow down our product candidate development and approvalprocess and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm ourbusiness, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in thecommencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our productcandidates. The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming andinherently unpredictable, and if we are ultimately unable to obtain regulatory approval for rucaparib in other indicationsand 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 takesmany years following the commencement of clinical trials and depends upon numerous factors, including the substantialdiscretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical datanecessary to gain approval may change during the course of a product candidate’s clinical development and may vary amongjurisdictions. We have obtained regulatory approval for Rubraca in the United States for a specific indication, and it ispossible that Rubraca may not obtain regulatory approval outside the United States or for broader indications and lines oftherapy or other tumor types or that any of our other existing product candidates or any product candidates we may seek todevelop in the future will ever obtain regulatory approval. Indeed, with the issuance of a Complete Response Letter by theFDA 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, includingthe following:·the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinicaltrials;·we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that aproduct 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 comparableforeign regulatory authorities for approval;·the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from non-clinicalstudies or clinical trials;·the data collected from clinical trials of our product candidates may not be sufficient to support the submission of anNDA 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 ofthird-party manufacturers with which we contract for clinical and commercial supplies;35 Table of Contents·the FDA or comparable foreign regulatory authorities may fail to approve the companion diagnostics wecontemplate developing with partners; and·the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantlychange 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 toobtain regulatory approval to market our product candidates, which would significantly harm our business, results ofoperations and prospects. Even if we receive regulatory approval for our product candidates, we will be subject to ongoing obligations andcontinued regulatory review, which may result in significant additional expense. Additionally, our product candidates, ifand when approved, could be subject to labeling and other restrictions and market withdrawal, and we may be subject topenalties 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 approvedindicated uses for which the product may be marketed or to the conditions of approval, or contain requirements forpotentially costly post-marketing testing and clinical trials and surveillance to monitor the safety and efficacy of the productcandidate. In addition, if the FDA or comparable foreign regulatory authority approves any of our product candidates, themanufacturing processes, pricing, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotionand recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirementsinclude submissions of safety and other post-marketing information and reports, registration, as well as continuedcompliance with current good manufacturing practices and good clinical practices for any clinical trials that we conductpost-approval. Later discovery of previously unknown problems with a product, including adverse events of unanticipatedseverity or frequency, or with our third-party manufacturers or manufacturing processes or failure to comply with regulatoryrequirements, may result in, among other things:·restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market orvoluntary 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 approvedapplications 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 receivedregulatory 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 conditionalbasis with full approval conditioned upon fulfilling the requirements of regulators. For example, we received acceleratedapproval from the FDA for the initial indication for Rubraca and are seeking conditional marketing authorization from theE.U. for rucaparib. Each of these approval pathways has certain conditions to approval, some of which may be post-approval,such as the conduct of a post-approval, or confirmatory, trial using due diligence. For example, continued approval ofRubraca by the FDA may be contingent upon verification and description of clinical benefit in ARIEL3 and/or ARIEL4, ourconfirmatory trials. If we are unable to fulfill the requirements of regulators that are conditions of a product’s accelerated orconditional approval, if the confirmatory trial shows unfavorable results or increased or additional undesirable side effects, orif regulators re-evaluate the data or risk-benefit profile of our product candidate, the availability of accelerated or conditionalapproval 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, ifapproved, from the market. The FDA’s and comparable foreign authorities’ policies may change and additional government regulations may beenacted 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 UnitedStates or abroad. If we are slow or unable to adapt to changes in existing requirements or the36 Table of Contentsadoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketingapproval that we may have obtained, and we may not achieve or sustain profitability, which would adversely affect ourbusiness. 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 orprevent their regulatory approval, limit the commercial profile of an approved label or result in significant negativeconsequences following marketing approval, if any. Adverse events (“AEs”) attributable to our product candidates could cause us or regulatory authorities to interrupt, delayor halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA orother comparable foreign authorities. Clinical studies conducted to date have generated AEs related to our productcandidates, 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 andfatigue/asthenia. In studies of lucitanib, hypertension, proteinuria and subclinical hypothyroidism requiringsupplementation are the most common AEs observed. The most notable AEs experienced by patients treated with rociletinibinclude hyperglycemia and OTc prolongation. As is the case with all oncology drugs, it is possible that there may be otherpotentially harmful characteristics associated with their use in future trials, including larger and lengthier Phase III clinicaltrials. As we evaluate the use of our product candidates in combination with other active agents, we may encounter safetyissues as a result of the combined safety profiles of each agent, which could pose a substantial challenge to that developmentstrategy. Results of our trials could reveal a high and unacceptable severity and prevalence of these or other side effects. In such anevent, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order us tocease further development of or deny approval of our product candidates for any or all targeted indications. The drug-relatedAEs could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential productliability 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 potentiallysignificant 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 productcandidate, if approved, and could significantly harm our business, results of operations and prospects. Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics could harm our drugdevelopment strategy. As one of the key elements of our clinical development strategy, we seek to identify patient subsets within a diseasecategory who may derive selective and meaningful benefit from the product candidates we are developing. In collaborationwith partners, we plan to develop companion diagnostics to help us to more accurately identify patients within a particularsubset, both during our clinical trials and in connection with the commercialization of our product candidates. Companiondiagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities as medical devices andrequire separate regulatory approval prior to commercialization. We do not develop companion diagnostics internally andthus we are dependent on the sustained cooperation and effort of our third-party collaborators in developing and obtainingapproval for these companion diagnostics. We and our collaborators may encounter difficulties in developing and obtainingapproval for the companion diagnostics, including issues relating to selectivity/specificity, analytical validation,reproducibility, or clinical validation. Any delay or failure by our37 Table of Contentscollaborators to develop or obtain regulatory approval of the companion diagnostics could delay or prevent approval of ourproduct candidates. In addition, our collaborators may encounter production difficulties that could constrain the supply ofthe companion diagnostics, and both they and we may have difficulties gaining acceptance of the use of the companiondiagnostics in the clinical community. If such companion diagnostics fail to gain market acceptance, it would have anadverse effect on our ability to derive revenues from sales of our products. In addition, the diagnostic company with whomwe contract may decide to discontinue selling or manufacturing the companion diagnostic that we anticipate using inconnection with development and commercialization of our product candidates or our relationship with such diagnosticcompany may otherwise terminate. We may not be able to enter into arrangements with another diagnostic company toobtain supplies of an alternative diagnostic test for use in connection with the development and commercialization of ourproduct candidates or do so on commercially reasonable terms, which could adversely affect and/or delay the development orcommercialization of our product candidates. We rely on third parties to conduct our non-clinical and clinical trials. If these third parties do not successfully carry outtheir contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercializeour 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 ongoingnon-clinical and clinical programs. We rely on these parties for execution of our non-clinical and clinical trials, and controlonly certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted inaccordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the CROs does notrelieve us of our regulatory responsibilities. We and our CROs are required to comply with GCP, which are regulations andguidelines enforced by the FDA, the EEA and comparable foreign regulatory authorities for all of our products in clinicaldevelopment. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principalinvestigators and trial sites. If we or any of our CROs fail to comply with applicable GCPs, the clinical data generated in ourclinical trials may be deemed unreliable and the FDA, the EMA or comparable foreign regulatory authorities may require usto perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspectionby a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCPregulations. In addition, our clinical trials must be conducted with product produced under current GMP regulations. Ourfailure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approvalprocess. 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 thatthe safety of the subjects participating in our clinical trials warrants such termination, if we make a general assignment for thebenefit 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 withalternative CROs or to do so on commercially reasonable terms. In addition, our CROs are not our employees, and except forremedies available to us under our agreements with such CROs, we cannot control whether or not they devote sufficient timeand resources to our on-going clinical and non-clinical programs. If CROs do not successfully carry out their contractualduties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical datathey 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 orsuccessfully commercialize our product candidates. As a result, our results of operations and the commercial prospects for ourproduct 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, thereis a natural transition period when a new CRO commences work. As a result, delays occur, which can materially influence ourability 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 orchallenges will not have a material adverse effect on our business, financial condition and prospects. 38 Table of ContentsWe rely completely on third parties to manufacture our clinical drug supplies and we intend to rely on third parties toproduce commercial supplies of any approved product candidate, and our commercialization of any of our productcandidates could be stopped, delayed or made less profitable if those third parties fail to obtain approval of the FDA orcomparable foreign regulatory authorities, fail to provide us with sufficient quantities of drug product or fail to do so atacceptable quality levels or prices. We do not currently have nor do we plan to acquire the infrastructure or capability internally to manufacture our clinicaldrug supplies for use in the conduct of our clinical trials, and we lack the resources and the capability to manufacture any ofour product candidates on a clinical or commercial scale. We do not control the manufacturing process of, and are completelydependent on, our contract manufacturing partners for compliance with the GMP regulatory requirements for manufacture ofboth active drug substances and finished drug products. If our contract manufacturers cannot successfully manufacturematerial that conforms to the strict regulatory requirements of the FDA or others, they will not be able to secure and/ormaintain regulatory approval for their manufacturing facilities. In addition, we have no control over the ability of ourcontract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or acomparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or ifit withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which wouldsignificantly 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 productcandidates for our clinical trials. There are a limited number of suppliers of raw materials that we use to manufacture ourdrugs and there may be a need to assess alternate suppliers to prevent a possible disruption of the manufacture of thematerials 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 significantdelay in the supply of a product candidate, or the raw material components thereof, for an ongoing clinical trial due to theneed to replace a third-party manufacturer could considerably delay completion of our clinical trials, product testing andpotential regulatory approval of our product candidates. If our manufacturers or we are unable to purchase these raw materialsafter regulatory approval has been obtained for our product candidates, the commercial launch of our product candidateswould be delayed or there would be a shortage in supply, which would impair our ability to generate revenues from the saleof our product candidates. We are dependent on our third party manufacturers to conduct process development and scale-up work necessary tosupport greater clinical development and commercialization requirements for our product candidates. Carrying out theseactivities in a timely manner, and on commercially reasonable terms, is critical to the successful development andcommercialization of our product candidates. We expect that our third-party manufacturers are capable of providingsufficient quantities of our product candidates to meet anticipated clinical and full-scale commercial demands, however ifthird parties with whom we currently work are unable to meet our supply requirements, we will need to secure alternatesuppliers. While we believe that there are other contract manufacturers having the technical capabilities to manufacture ourproduct candidates, we cannot be certain that identifying and establishing relationships with such sources would not result insignificant 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 productthrough 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 acceptanceamong physicians, health care payors, patients and the medical community, which are critical to commercial success. Marketacceptance 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;39 Table of Contents·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 withrespect 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 approvedindications;·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, healthcarepayors 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 willsuffer if we fail to compete effectively. The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significanttechnological change. In addition, the competition in the oncology market is intense. We have competitors both in theUnited States and internationally, including major multinational pharmaceutical companies, biotechnology companies anduniversities and other research institutions. Lynparza™ (olaparib) is approved in the U.S. as monotherapy in patients with germline BRCA mutated advanced ovariancancer who have been treated with three or more prior lines of chemotherapy, as monotherapy for the maintenance treatmentof adult patients with recurrent epithelial, fallopian tube or primary peritoneal cancer, who are in a complete or partialresponse to platinum-based chemotherapy and as monotherapy in patients with deleterious or suspected deleteriousgBRCAm, human epidermal growth factor 2 (HER2)-negative metastatic breast cancer who have been treated withchemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Lynparza is also approved in the EU for the maintenancetreatment of BRCA mutated platinum-sensitive relapsed serous ovarian cancer. In February 2018, the CHMP adopted apositive opinion recommending this label be changed and expanded to remove the limitation of use in BRCA-mutatedpatients. Lynparza has indications for ovarian cancer across 57 countries (as of year-end 2017). In July 2017, AstraZenecaand Merck & Co., Inc. announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparzafor multiple cancer types. Lynparza is being investigated, alone and in combination with other agents, in multipleindications across several tumor types, including breast, prostate, and pancreatic cancers. Zejula®/niraparib (Tesaro) was approved in March 2017 in the United States as monotherapy for the maintenancetreatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in acomplete or partial response to platinum-based chemotherapy. Zejula was approved in November 2017 in the EU for thesame indication. Additional clinical investigations of Zejula in ovarian, breast and lung cancers are ongoing or planned.Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancerworldwide, except in Japan. There are a number of PARP inhibitors in clinical development including AbbVie’s veliparib and ABT-767, Pfizer’stalazoparib, BeiGene’s BGB-290, and Checkpoint Therapeutics’ CK-102. While most PARP inhibitor development focuseson ovarian, breast and prostate cancers, additional efforts are aimed toward bladder, lung, and pancreatic cancers as well. 40 Table of ContentsIn addition, combination approaches that include PARP inhibitors, including Lynparza or Zejula, with other anticanceragents are in various phases of clinical development across a variety of oncology indications. These combination therapiesmay result in future competitive pressure on Rubraca, and multiple data readouts for such studies are anticipated throughout2018 and beyond. Many of our competitors have substantially greater financial, technical and other resources, such as larger research anddevelopment staff and experienced marketing and manufacturing organizations. Additional mergers and acquisitions in thebiotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. As aresult, these companies may obtain regulatory approval more rapidly than we are able and may be more effective in sellingand 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 aresult of advances in the commercial applicability of technologies and greater availability of capital for investment in theseindustries. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis drug products that aremore 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 developmentpipelines of our competitors and later enter the market. Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel compoundsor to in-license novel compounds that could make our product candidates less competitive. In addition, any new product thatcompetes with an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability andsafety in order to overcome price competition and to be commercially successful. Accordingly, our competitors may succeedin obtaining patent protection, receiving FDA, European Commission 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 itdifficult for us to sell our products profitably. There is significant uncertainty related to the third-party coverage and reimbursement of newly approved drugs. We havereceived approval for Rubraca in the United States for a limited indication. We intend to seek additional approvals to marketRubraca and other product candidates in the United States, Europe and other selected foreign jurisdictions. Marketacceptance and sales of our product candidates in both domestic and international markets will depend significantly on theavailability of adequate coverage and reimbursement from third-party payors for any of our product candidates and may beaffected by existing and future healthcare reform measures. Government and other third-party payors are increasinglyattempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new drugs and, as aresult, they may not cover or provide adequate payment for our product candidates. These payors may conclude that ourproduct candidates are less safe, less effective or less cost-effective than existing or later introduced products, and third-partypayors may not approve our product candidates for coverage and reimbursement or may cease providing coverage andreimbursement for these product candidates. Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a timeconsuming 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 respectto coverage and reimbursement. We cannot be sure that coverage or adequate reimbursement will be available for any of ourproduct candidates. Even if we obtain coverage for our product candidates, third-party payors may not establish adequatereimbursement amounts, which may reduce the demand for, or the price of, our products. If reimbursement of our futureproducts is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable toachieve or sustain profitability. In both the United States and certain foreign jurisdictions, there have been and we expect there will continue to be anumber of legislative and regulatory changes to the health care system that could affect our ability to sell our productsprofitably. The U.S. government and other governments have shown significant interest in pursuing healthcare reform. Inparticular, the Medicare Modernization Act of 2003 revised the payment methodology for many products under theMedicare program in the United States. This has resulted in lower rates of reimbursement. In 2010, the Patient Protection andAffordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Affordable CareAct”), was enacted. The Affordable Care Act substantially changed the way healthcare is financed by both governmental andprivate insurers. Such government-adopted reform measures may adversely affect the pricing of41 Table of Contentshealthcare products and services in the United States or internationally and the amount of reimbursement available fromgovernmental agencies or other third-party payors. Moreover, payment methodologies, including payment for companion diagnostics, may be subject to changes inhealthcare legislation and regulatory initiatives. For example, the CMS has begun bundling the Medicare payments forcertain laboratory tests ordered while a patient received services in a hospital outpatient setting and, in 2018, the CMS beganpaying for clinical laboratory services based on a weighted average of reported prices that private payors, MedicareAdvantage plans, and Medicaid Managed Care plans pay for laboratory services. There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levelsdirected at broadening the availability of healthcare and containing or lowering the cost of healthcare. Recently there hasalso been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products,which has resulted in several Congressional inquiries and proposed bills designed to, among other things, reform governmentprogram reimbursement methodologies. Individual states in the United States have also become increasingly active inimplementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursementconstraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, insome cases, designed to encourage importation from other countries and bulk purchasing. We cannot predict the initiativesthat may be adopted in the future. The continuing efforts of the government, insurance companies, managed careorganizations and other payors of healthcare services to contain or reduce costs of healthcare may adversely affect thedemand for any drug products for which we may obtain regulatory approval, as well as our ability to set satisfactory prices forour 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 togovernmental control. In these countries, pricing negotiations with governmental authorities can take considerable time afterthe receipt of marketing approval for a product candidate. To obtain reimbursement or pricing approval in some countries, wemay be required to conduct additional clinical trials that compare the cost-effectiveness of our product candidates to otheravailable therapies. If reimbursement of our product candidates is unavailable or limited in scope or amount in a particularcountry, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability of our products insuch country. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfullyimplement our business strategy. Further, we will need to grow our organization, and we may experience difficulties inmanaging 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 inthe highly competitive biotechnology and pharmaceuticals industries depends upon our ability to attract and retain highlyqualified managerial, scientific and medical personnel. We are highly dependent on our management, scientific and medicalpersonnel, especially Patrick J. Mahaffy, our President and Chief Executive Officer, Lindsey Rolfe, our Executive VicePresident of Clinical and Preclinical Development and Pharmacovigilance and Chief Medical Officer, Dale Hooks, our SeniorVice President and Chief Commercial Officer and Gillian C. Ivers-Read, our Executive Vice President, Technical Operationsand Chief Regulatory Officer, whose services are critical to the successful implementation of our product candidateacquisition, development and regulatory strategies. Despite our efforts to retain valuable employees, members of our management, scientific, development and commercialteams may terminate their employment with us on short notice. Pursuant to their employment arrangements, each of ourexecutive officers may voluntarily terminate their employment at any time by providing as little as thirty days advancenotice. Our employment arrangements with all of our employees provide for at-will employment, which means that any of ouremployees 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 inJanuary 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 suitablereplacements could potentially harm our business, financial condition and prospects. Our success also depends on our abilityto continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well as junior, mid-leveland senior scientific and medical personnel. 42 Table of ContentsAs of February 16, 2018, we employed 360 full-time employees. As our development plans and strategies develop, weexpect to expand our employee base for managerial, operational, financial and other resources. Future growth will imposesignificant added responsibilities on members of management, including the need to identify, recruit, maintain, motivate andintegrate additional employees. Also, our management may need to divert a disproportionate amount of its attention awayfrom our day-to-day activities and devote a substantial amount of time to managing these growth activities. We may not beable to effectively manage the expansion of our operations which may result in weaknesses in our infrastructure, give rise tooperational mistakes, loss of business opportunities, loss of employees and reduced productivity among remainingemployees. Our expected growth could require significant capital expenditures and may divert financial resources from otherprojects. If our management is unable to effectively manage our expected growth, our expenses may increase more thanexpected, 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 intensecompetition for a limited number of qualified personnel among biopharmaceutical, biotechnology, pharmaceutical and otherbusinesses. Many of the other pharmaceutical companies that we compete against for qualified personnel have greaterfinancial and other resources, different risk profiles and a longer history in the industry than we do. They also may providemore diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealingto high quality candidates than what we have to offer. In order to induce valuable employees to continue their employmentwith us, we have provided stock options that vest over time. The value to employees of stock options that vest over time issignificantly affected by movements in our stock price that are beyond our control, and may at any time be insufficient tocounteract more lucrative offers from other companies. If we are unable to continue to attract and retain high qualitypersonnel, 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 standardsand 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 intentionalfailures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards wehave established, comply with federal and state health-care fraud and abuse laws and regulations, report financial informationor data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in thehealthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and otherabusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing andpromotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct couldalso involve the improper use of information obtained in the course of clinical trials, which could result in regulatorysanctions and serious harm to our reputation. We have adopted a Code of Business Ethics and other compliance policies, butit is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent thisactivity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmentalinvestigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If anysuch actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actionscould have a significant effect on our business and results of operations, including the imposition of significant fines or othersanctions. 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 abuselaws, false claims laws, transparency and disclosure (or “sunshine”) laws, government price reporting, and healthinformation privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we couldface substantial penalties. Our operations may be directly, or indirectly through our customers, subject to various federal and state fraud and abuselaws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act. These laws mayaffect, among other things, our current activities with clinical study investigators and research subjects, as well as proposedand future sales, marketing, disease awareness, and patient assistance programs. In addition, we may be subject to patientprivacy regulation by both the federal government and the states in which we conduct our business. The laws that may affectour ability to operate include, but are not limited to:·the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfullysoliciting, receiving, offering or paying remuneration, including any kickback, bribe, or certain rebate, directly43 Table of Contentsor indirectly, to induce, or in return for, either the referral of an individual, or the purchase, lease, order orrecommendation of any good, facility, item or service for which payment will be made, in whole or in part, under afederal healthcare program, such as the Medicare and Medicaid programs. A person or entity does not need to haveactual knowledge of the federal Anti-Kickback Statute or special intent to violate the law in order to havecommitted a violation; in addition, the government may assert that a claim including items or services resultingfrom a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of thefederal False Claims Act; ·federal false claims laws, including the False Claims Act, which impose criminal and civil penalties, includingthrough civil “qui tam” or “whistleblower” actions, against individuals or entities from knowingly presenting, orcausing to be presented, claims for payment or approval from federal programs, such as Medicare and Medicaid, thatare false or fraudulent, or knowingly making a false statement to improperly avoid, decrease or conceal anobligation to pay money to the federal government;·the Health Insurance Portability and Accountability Act of 1996, or HIPAA which imposes criminal and civilliability for, among other things, willfully executing, or attempting to execute, a scheme to defraud any healthcarebenefit program and making false statements relating to healthcare matters. Similar to the federal Anti-KickbackStatute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it inorder to have committed a violation;·HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and itsimplementing regulations, which also imposes certain requirements on certain covered healthcare providers, healthplans, and healthcare clearinghouses, as well as their respective business associates that perform services for themthat involve the use, or disclosure of, individually identifiable health information, with respect to safeguarding theprivacy, security and transmission of individually identifiable health information;·the federal civil monetary penalties statute, which prohibits, among other things, the offering or giving ofremuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence thebeneficiary’s election of a particular supplier of items or services reimbursable by a Federal or state governmentalprogram;·the federal Physician Payment Sunshine Act, which requires certain manufacturers of drugs, devices, biologics andmedical supplies for which payment is available under Medicare, Medicaid or the Children’s Health InsuranceProgram (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 interestsheld by the physicians described above and their immediate family members;·federal consumer protection and unfair competition laws, which broadly regulate marketplace activities andactivities that potentially harm consumers;·federal government price reporting laws, which require drug manufacturers to calculate and report complex pricingmetrics to government agencies, including CMS, where such reported prices may be used in the calculation ofreimbursement and/or discounts on marketed products. Participation in these programs and compliance with theapplicable requirements may result in potentially significant discounts on products subject to reimbursement underfederal healthcare programs and increased infrastructure costs, and may potentially limit a drug manufacturer’sability to offer certain marketplace discounts; and·analogous state laws and regulations, such as state anti-kickback, false claims, consumer protection and unfaircompetition 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 servicesreimbursed by any third-party payer, including commercial insurers; state laws that require pharmaceuticalcompanies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevantcompliance guidance promulgated by the federal government that otherwise restricts payments that may be made tohealthcare providers and other potential referral sources; state laws that require drug manufacturers to file reportswith states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensationsand other remuneration and items of value provided to healthcare professionals and entities; and state lawsgoverning the privacy and security of health information in certain circumstances, many of which differ from eachother in significant ways and may not have the same effect, thus complicating compliance efforts.44 Table of Contents In addition, the research and development of our product candidates outside the United States, and any sales of ourproducts or product candidates once commercialized outside the United States will also likely subject us to foreignequivalents 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 substantialcosts, including investments in infrastructure and additional resources. Because of the breadth of these laws and thenarrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities, includingour consulting agreements and other relationships with physicians, could be subject to challenge under one or more of suchlaws. Governmental and enforcement authorities may conclude that our business practices do not comply with current orfuture statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If ouroperations are found to be in violation of any of the laws described above or any other governmental regulations that applyto 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 ouroperations, 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 limitcommercialization of our product candidates. We face an inherent risk of product liability. For example, we may be sued if any product we develop allegedly causesinjury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such productliability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherentin the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumerprotection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantialliabilities or be required to limit commercialization of our product candidates, if approved. Even successful defense wouldrequire significant financial and management resources. Regardless of the merits or eventual outcome, liability claims mayresult in:·decreased demand for our product candidates or products that we may develop;·injury to our reputation;·withdrawal of clinical trial participants;·initiation of investigations by regulators;·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 potentialproduct liability claims could prevent or inhibit the commercialization of products we develop. We have a program ofproduct liability insurance covering our ongoing clinical trials; however, the amount of insurance we maintain may not beadequate to cover all liabilities that we may incur. Although we maintain such insurance, any claim that may be broughtagainst us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by ourinsurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions, andwe may be subject to a product liability claim for which we have no coverage. We will have to pay any45 Table of Contentsamounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by ourinsurance, 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 securitybreaches. We and our business partners maintain sensitive company data on our computer networks, including our intellectualproperty and proprietary business information, as well as certain clinical trial information. Cybersecurity attacks arebecoming more commonplace and include, but are not limited to, malicious software, attempts to gain unauthorized access todata and other electronic security breaches that could lead to disruptions in systems, misappropriation of information andcorruption of data. Despite the implementation of security measures, our internal computer systems and those of our CROsand 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 systemfailure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it couldresult in a material disruption of our development programs and business operations. For example, the loss of clinical trialdata from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts andsignificantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were toresult 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. 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, wemay 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 intellectualproperty related to our technologies. Any disclosure to or misappropriation by third parties of our confidential proprietaryinformation could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding ourcompetitive position in our market. The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questionsand can be uncertain. The patent applications that we own or license may fail to result in issued patents in the United Statesor in other foreign countries. Even if the patents do successfully issue, third parties may challenge the validity, enforceabilityor scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. Two oppositions werefiled in the granted European counterpart of the rucaparib camsylate salt/polymorph patent on June 20, 2017. Furthermore,even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property orprevent others from designing around our claims. If the breadth or strength of protection provided by the patent applicationswe hold or pursue with respect to our product candidates is threatened, it could threaten our ability to commercialize ourproduct candidates. Further, if we encounter delays in our clinical trials, the period of time during which we could market ourproduct candidates under patent protection would be reduced. Since patent applications in the United States and most othercountries are confidential for a period of time after filing, we cannot be certain that we were the first to file any patentapplication related to our product candidates. Furthermore, an interference proceeding can be provoked by a third-party orinstituted by the United States Patent and Trademark Office (“U.S. PTO”) to determine who was the first to invent any of thesubject 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 agreementsto protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any otherelements of our drug development processes that involve proprietary know-how, information or technology that is notcovered 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 enterinto confidentiality agreements, we cannot be certain that our trade secrets and other confidential proprietary informationwill not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently developsubstantially equivalent information and techniques. Further, the laws of some foreign countries do not protect proprietaryrights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significantproblems in protecting and defending our intellectual property both in the United46 Table of ContentsStates and abroad. If we are unable to prevent material disclosure of the intellectual property related to our technologies tothird parties, we will not be able to establish or maintain a competitive advantage in our market, which could materiallyadversely 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 andpharmaceutical industries, including interference, inter parties review and reexamination proceedings before the U.S. PTO oroppositions and other comparable proceedings in foreign jurisdictions. Numerous United States and foreign issued patentsand pending patent applications, which are owned by third parties, exist in the fields in which we are developing productcandidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases thatour 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 bethird-party patents with claims to materials, formulations, methods of manufacture or methods for treatment related to the useor manufacture of our product candidates. Because patent applications can take many years to issue, there may be currentlypending 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 any of our productcandidates, any molecules formed during the manufacturing process or any final product itself, the holders of any suchpatents may be able to block our ability to commercialize such product candidate unless we obtain a license under theapplicable 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 formanufacture or methods of use, including combination therapy or patient selection methods, the holders of any such patentmay 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 alicense 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 abilityto further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of theirmerit, would involve substantial litigation expense and would be a substantial diversion of employee resources from ourbusiness. In the event of a successful claim of infringement against us, we may have to pay substantial damages, includingtreble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, limit our uses, payroyalties or redesign our infringing product candidates, which may be impossible or require substantial time and monetaryexpenditure. We cannot predict whether any such license would be available at all or whether it would be available oncommercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from thirdparties to advance our research or allow commercialization of our product candidates. We may fail to obtain any of theselicenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop andcommercialize one or more of our product candidates, which could harm our business significantly. The patent protection, patent prosecution and patent enforcement for some of our product candidates is dependent on thirdparties. While we normally seek and gain the right to fully prosecute, maintain and enforce the patents relating to our productcandidates, there may be times when platform technology patents that relate to our product candidates are controlled by ourlicensors. This is the case with the method of use patents licensed under the AstraZeneca license. This is also the case withour license to rociletinib, under which Celgene holds the right to prosecute and maintain the patents and patent applicationscovering its core discovery technology, including molecular backbones, building blocks and classes of compoundsgenerated by that technology, aspects of which relate to rociletinib. We have the right to jointly prosecute and maintain, andthe first right to enforce, the patent rights for the composition of matter for rociletinib. If AstraZeneca, Celgene or any of ourfuture licensing partners fail to appropriately prosecute, maintain or enforce, as applicable, patent protection for patentscovering any of our product candidates, our ability to develop and commercialize those product47 Table of Contentscandidates may be adversely affected and we may not be able to prevent competitors from making, using and sellingcompeting 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 maybe required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringementproceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable, or may refuse to stop theother party from using the technology at issue on the grounds that our patents do not cover the technology in question. Anadverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, heldunenforceable 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 priorityof inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome couldrequire us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our businesscould be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Litigation orinterference proceedings may fail and, even if successful, may result in substantial costs and distract our management andother employees. We may not be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidentialinformation, 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. Inaddition, there could be public announcements of the results of hearings, motions or other interim proceedings ordevelopments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverseeffect 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 prohibitivelyexpensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to developtheir own products and further, may export otherwise infringing products to territories where we have patent protection, butenforcement is not as strong as that in the United States. These products may compete with our products in jurisdictionswhere we do not have any issued patents and our patent claims or other intellectual property rights may not be effective orsufficient to prevent them from so competing. Many companies have encountered significant problems in protecting and defending intellectual property rights inforeign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor theenforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals, whichcould make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of ourproprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costand 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 thirdparties, 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 intosimilar licenses in the future. Under each of our existing license agreements we are subject to commercialization anddevelopment, diligence obligations, milestone payment obligations, royalty payments and other obligations. If we fail tocomply with any of these obligations or otherwise breach our license agreements, including by failing to use commerciallyreasonable efforts to develop or commercialize the product candidate, our licensing partners may have the right to terminatethe license in whole or in part. Generally, the loss of any one of our licenses or other licenses in the future could materiallyharm our business, prospects, financial condition and results of operations. 48 Table of ContentsIntellectual 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 propertyrights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage.The following examples are illustrative:·others may be able to make compounds that are similar to our product candidates but that are not covered by theclaims 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 issuedpatent 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 ofour inventions;·others may independently develop similar or alternative technologies or duplicate any of our technologies withoutinfringing 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, ormay 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 rightsand then use the information learned from such activities to develop competitive products for sale in our majorcommercial markets;·we may not develop additional proprietary technologies that are patentable; and·the patents of others may have an adverse effect on our business. 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 sharesof our common stock. Our common stock had not been publicly traded prior to our initial public offering in November 2011. An active tradingmarket for our common stock on the NASDAQ Global Select Market may not be sustained. As a result of these and otherfactors, you may be unable to resell your shares at a price that is attractive to you or at all. Further, an inactive market mayalso impair our ability to raise capital by selling shares of our common stock and may impair our ability to enter intostrategic 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 widefluctuations in response to various factors, some of which are beyond our control. During the 12-month period endedDecember 31, 2017, the price of our common stock on the NASDAQ Global Select Market ranged from $39.83 per share to$99.45 per share. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this report, these factorsinclude:·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 trialrequirements for approvals;49 Table of Contents·disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability toobtain 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 companiondiagnostic 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 mayprovide 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 orthe 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 ourcompetitors;·issuances of debt or equity securities;·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 ofresearch 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 inparticular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to theoperating performance of these companies. Broad market and industry factors may negatively affect the market price of ourcommon stock, regardless of our actual operating performance. The realization of any of the above risks or any of a broadrange of other risks, including those described in these “Risk Factors,” could have a dramatic and material adverse effect onthe market price of our common stock. Because our outstanding Notes are convertible into shares of our common stock, volatility or depressed prices of ourcommon stock could have a similar effect on the trading price of our Notes. In addition, the existence of the Notes mayencourage short selling in our common stock by market participants because the conversion of the Notes could depress theprice of our common stock. The conversion of some or all of the Notes may dilute the ownership interest of existing stockholders. Holders of theoutstanding Notes are able to convert them at any time prior to the close of business on the business day immediatelypreceding September 15, 2021. Upon conversion, holders of the Notes will receive shares of common stock. Any sales in thepublic market of shares of common stock issued upon conversion of such Notes could adversely affect the trading price ofour common stock. We cannot predict the size of future issuances or the effect, if any, that they may have on the50 Table of Contentsmarket price of our common stock. The issuance and sale of substantial amounts of common stock, or the perception thatsuch issuances and sales may occur, could adversely affect the market price of our common stock and impair our ability toraise 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 lawsuitshave been filed against us (see “Part I, Item 3-Legal Proceedings”). These proceedings and other similar litigation, ifinstituted against us, could result in substantial costs and diversion of management’s attention and resources, which couldmaterially 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 exertinfluence over matters subject to stockholder approval. Our executive officers, directors and their respective affiliates known to us beneficially owned approximately 6.7% of ourvoting stock as of February 21, 2018. These stockholders may have the ability to influence the outcome of matters submittedto our stockholders for approval. The interests of our executive officers, directors, and their affiliates might not coincide withthe interests of the other holders of our capital stock which may prevent or discourage unsolicited acquisition proposals oroffers 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. Shares of common stock that are either subject to outstanding options or reserved for future issuance under our equityincentive plans will become eligible for sale in the public market to the extent permitted by the provisions of various vestingschedules. 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 equityincentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause ourstock price to fall. We expect that significant additional capital will be needed in the future to continue our planned operations. To raisecapital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices andin a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in morethan one transaction, investors may be materially diluted by subsequent sales. Such sales may also result in material dilutionto our existing stockholders, and new investors could gain rights, preferences and privileges senior to those of holders of ourcommon stock. Pursuant to our equity incentive plan(s), our compensation committee (or its designee) is authorized to grant equity-basedincentive awards to our employees, directors and consultants. As of December 31, 2017, the number of shares of our commonstock available for future grant under our 2011 Stock Incentive Plan (“2011 Plan”) is 3,147,903. The number of shares of ourcommon stock reserved for issuance under our 2011 Plan will be increased (i) from time to time by the number of shares ofour common stock forfeited upon the expiration, cancellation, forfeiture, cash settlement or other termination of awards underour 2009 Equity Incentive Plan, and (ii) at the discretion of our board of directors, on the date of each annual meeting of ourstockholders, 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 restrictedstock unit, or RSU, grants and issuances of common stock under our 2011 Plan may have an adverse effect on the marketprice of our common stock. In addition, a substantial number of shares of our common stock are reserved for issuance uponconversion of the Notes. Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage anacquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by ourstockholders 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 benefitour stockholders or remove our current management. These provisions include:51 Table of Contents·authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares ofwhich 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 meetingof 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 transactionsthat result in a change of control; and·establishing advance notice requirements for nominations for election to the board of directors or for proposingmatters 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 managementby making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointingthe members of our management. Because we are incorporated in Delaware, we are governed by the provisions of Section 203of the Delaware General Corporation Law, which may discourage, delay or prevent someone from acquiring us or mergingwith us whether or not it is desired by or beneficial to our stockholders. Under Delaware law, a corporation may not, ingeneral, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held thestock for three years or, among other things, the board of directors has approved the transaction. Any provision of ourcertificate of incorporation or bylaws or Delaware law that has the effect of delaying or deterring a change in control couldlimit the opportunity for our stockholders to receive a premium for their shares of our common stock, and could also affectthe price that some investors are willing to pay for our common stock. Additionally, certain provisions of our outstandingNotes could make it more difficult or more expensive for a third party to acquire us. The repurchase price of the Notes mustbe paid in cash, and this obligation may have the effect of discouraging, delaying or preventing an acquisition of theCompany 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 analystspublish about us or our business. If one or more of the analysts who cover us downgrades our stock or publishes inaccurate orunfavorable research about our business, our stock price would likely decline. If one or more of these analysts ceasescoverage of our company or fails to publish reports on us regularly, demand for our stock could decrease, which might causeour 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 debtmay 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 mayrequire us to repurchase for cash all or any portion of the Notes at a fundamental change repurchase price equal to 100% ofthe principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamentalchange repurchase date. We may not have or be able to borrow the funds required to repurchase the Notes on the fundamentalchange repurchase date. In addition, our ability to repurchase the Notes may otherwise be limited by law, regulatoryauthority or agreements governing our future indebtedness. Our failure to repurchase the Notes at a time when the repurchaseis required by the indenture would constitute a default under the indenture. A default under the indenture or the fundamentalchange itself could also lead to a default under agreements governing our future indebtedness. If the repayment of the relatedindebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repaythe 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 maynot generate cash flow from operations in the future sufficient to satisfy our obligations under the Notes and any futureindebtedness we may incur. 52 Table of ContentsWe may incur substantial additional debt in the future, subject to the restrictions contained in any debt instruments thatwe enter into in the future, some of which may be secured debt. We are not restricted under the terms of the indenturegoverning the Notes from incurring additional debt, securing existing or future debt, recapitalizing our debt or taking anumber of other actions that are not limited by the terms of the indenture governing the Notes that could have the effect ofdiminishing our ability to make payments on the Notes when due. Our ability to refinance the Notes or future indebtednesswill depend on the capital markets and our financial condition at such time. In addition, agreements that govern any futureindebtedness that we may incur may contain financial and other restrictive covenants that will limit our ability to engage inactivities that may be in our long-term best interests. Our failure to comply with those covenants could result in an event ofdefault 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 five leased facilities, a 29,177 square foot facility in Boulder, Colorado used primarilyfor corporate functions, a 24,877 square foot facility in San Francisco, California and a 32,660 square foot facility inOakland, CA used for clinical development operations and research laboratory space, a 3,350 square foot facility inCambridge, United Kingdom used for our European regulatory and clinical operations and a 416 square foot facility inMilan, Italy used for clinical operations. These leases expire in January 2023, December 2021, April 2028, May 2019 andMarch 2018, respectively. We believe that our existing facilities are sufficient for our needs for the foreseeable future. ITEM 3.LEGAL PROCEEDINGS Rociletinib-Related Litigation Following Clovis’ regulatory announcement in November 2015 of adverse developments in its ongoing clinical trials forrociletinib, Clovis and certain of its current and former executives were named in various securities lawsuits, the largest ofwhich was a putative class action lawsuit in the District of Colorado (the “Medina Action”) which was settled on October 26,2017 (the “Medina Settlement”). The open actions currently pending against Clovis are discussed below. While otherentities have threatened to bring claims relating to rociletinib and the November 2015 announcement, none havecommenced litigation as of the date of this filing. On January 22, 2016, the Electrical Workers Local #357 Pension and Health & Welfare Trusts, a purported shareholder ofClovis, filed a purported class action complaint (the “Electrical Workers Complaint”) against Clovis and certain of itsofficers, directors, investors and underwriters in the Superior Court of the State of California, County of San Mateo (the“Electrical Workers Court”). The Electrical Workers Complaint purports to be asserted on behalf of a class of persons whopurchased stock in the July 2015 Offering. The complaint asserted claims under certain provisions of the Securities Act of1933 (the “Securities Act”) relating to a July 2015 follow-on offering of Clovis securities (the “July 2015 Offering”) based onsubstantially similar allegations to those asserted in the Medina Action. On June 30, 2016, the Electrical Workers Plaintiffsfiled an amended complaint adding new allegations (the “Amended Complaint”). On July 28, 2016, the defendants filed a motion to stay the Electrical Workers action pending resolution of the MedinaAction and a demurrer to the Amended Complaint. On September 23, 2016, after hearing oral argument, the ElectricalWorkers Court granted the motion to stay and reserved on issuing a ruling on defendants’ pending demurrer. The Company believes that the claims asserted in the Electrical Workers Action are released and barred by operation oflaw through the Medina Settlement, and accordingly plans to seek dismissal of the Electrical Workers Action on that basis. 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. TheAntipodean Complaint alleges that the defendants violated certain sections of the Securities Act by making allegedly falsestatements to Antipodean and in the offering materials for the July 2015 Offering relating to the53 Table of Contentsefficacy of rociletinib, its safety profile, and its prospects for market success. In addition to the Securities Act claims, theAntipodean Complaint also asserts Colorado state law claims and common law claims. Both the state law and common lawclaims are based on allegedly false and misleading statements regarding rociletinib’s progress toward FDA approval. TheAntipodean Complaint seeks compensatory, recessionary, and punitive damages. On December 15, 2016, the Antipodean Plaintiffs filed an amended complaint (the “Antipodean Amended Complaint”)asserting substantially the same claims against the same defendants and purporting to correct certain details in the originalAntipodean Complaint. On January 31, 2017, Defendants filed a motion to stay the Antipodean action pending resolution of the Medina Action inthe District of Colorado. Defendants also filed a motion to dismiss the Antipodean Amended Complaint on March 29, 2017. On March 14, 2017, the Clovis Defendants and Antipodean participated in a mediation, which did not result in asettlement. On August 8, 2017, the parties participated in a scheduled hearing on Defendants’ motion to stay and motion to dismissbefore Justice Masley of the New York Supreme Court, County of New York. At the hearing, Justice Masley grantedDefendants’ motion to stay. Per the Court’s August 10, 2017 order, Defendants’ motion to dismiss was held in abeyance anddeemed submitted on November 1, 2017. On November 1, 2017, the Defendants provided a status update to the Courtregarding the outcome of the hearing. The update informed the Court that Antipodean had excluded itself from the MedinaSettlement, as memorialized in the final judgment entered by the Medina Court. No date has been scheduled for argument onDefendants’ motion to dismiss. The Company intends to vigorously defend against the allegations in the Antipodean Amended Complaint. However,there can be no assurance that the defense will be successful. In March 2017, two putative shareholders of the Company, Macalinao and McKenry (the “Derivative Plaintiffs”), filedshareholder derivative complaints against certain directors and officers of the Company in the Court of Chancery of the Stateof Delaware. On May 4, 2017, the Macalinao and McKenry actions were consolidated for all purposes in a single proceedingunder the caption In re Clovis Oncology, Inc. Derivative Litigation, Case No, 2017-0222 (the “Consolidated DerivativeAction”). On May 18, 2017, the Derivative Plaintiffs filed a Consolidated Verified Shareholder Derivative Complaint (the“Consolidated Derivative Complaint”). The Consolidated Derivative Complaint generally alleged that the defendantsbreached their fiduciary duties owed to the Company by allegedly causing or allowing misrepresentations of the Company’sbusiness operations and prospects, failing to ensure that the TIGER-X clinical trial was being conducted in accordance withapplicable rules, regulations and protocols, and engaging in insider trading. The Consolidated Derivative Complaintpurported to rely on documents produced by the Company in response to prior demands for inspection of the Company’sbooks and records served on the Company by each of Macalinao and McKenry under 8 Del. C. § 220. The ConsolidatedDerivative Complaint sought, among other things, an award of money damages. On July 31, 2017, the defendants filed a motion to dismiss the Consolidated Derivative Complaint. Plaintiffs filed anopposition to the motion to dismiss on August 31, 2017, and the defendants filed a reply in further support of the motion todismiss on September 26, 2017. No date has been scheduled for argument on Defendants’ motion to dismiss the ConsolidatedDerivative Complaint. The Company intends to vigorously defend against the allegations in the Consolidated Derivative Complaint, but therecan be no assurance that the defense will be successful. On March 20, 2017, a purported shareholder of the Company, filed a shareholder derivative complaint (the “GuoComplaint”) against certain officers and directors of the Company in the United States District Court for the District ofColorado. The Guo Complaint generally alleged that the defendants breached their fiduciary duties owed to the Company byeither recklessly or with gross negligence approving or permitting misrepresentations of the Company’s business operationsand prospects. The Guo Complaint also alleged claims for waste of corporate assets and unjust enrichment. Finally, the GuoComplaint alleged that certain of the individual defendants violated Section 14(a) of the Securities Exchange Act, byallegedly negligently issuing, causing to be issued, and participating in the issuance of54 Table of Contentsmaterially misleading statements to stockholders in the Company’s Proxy Statement on Schedule DEF 14A in connectionwith the 2015 Annual Meeting of Stockholders, held on June 11, 2015. The Guo Complaint sought, among other things, anaward of money damages. On June 19, 2017, the parties filed a joint motion to stay the Guo action pending resolution of the motion to dismiss theConsolidated Derivative Complaint. On June 20, 2017, the court granted the motion to stay. The Company intends to vigorously defend against the allegations in the Guo Complaint, but there can be no assurancethat the defense will be successful. In addition, the Company has received inquiries and requests for information from governmental agencies, including theU.S. Securities and Exchange Commission and the U.S. Department of Justice, relating to the Company’s regulatory updateannouncement in November 2015 that the FDA requested additional clinical data on the efficacy and safety of rociletinib.The Company is continuing to cooperate with these agencies with respect to their investigations. The Medina Settlementdoes not resolve these inquiries and the Company cannot predict their timing or outcome. Director Compensation Litigation On May 10, 2017, John Solak, a purported shareholder of the Company, filed a shareholder derivative complaint in theCourt of Chancery of the State of Delaware (the “Solak Complaint”) against certain directors and an officer of the Company.The Solak Complaint generally alleged that the defendants breached their fiduciary duties owed to the Company byadopting a compensation plan that overcompensated the non-employee director defendants, in relation to companies ofcomparable market capitalization and size. The Solak Complaint also alleged claims of waste of corporate assets and unjustenrichment due to this allegedly wrongful compensation plan. The Solak Complaint sought, among other things, an award ofmoney damages and the imposition of corporate governance reforms. The Court has entered a number of orders extending the defendants’ time to respond to the Solak Complaint based on,among other factors, the fact that the parties are engaged in discussions in an effort to resolve the Solak action. On February14, 2018, the parties filed a joint letter to the Court requesting that all deadlines in the action be held in abeyance while theparties engaged in final settlement discussions. On February 26, 2018, the defendants entered into a stipulation of compromise and settlement with plaintiff that isintended to settle the Solak action. The proposed settlement is subject to Court approval upon the conclusion of a settlementhearing concerning the fairness of the terms of the proposed settlement, which will be scheduled following the provision ofnotice to shareholders of the Company. In accordance with the terms of the proposed settlement, the Company will present a new non-employee directorcompensation policy for shareholder vote at the next annual shareholder meeting. Under the proposed new non-employeedirector compensation policy, annual base compensation for incumbent non-employee directors would be set at an amountbetween $350,000 and $425,000, which would remain in place for a period between two and five years. Additionally, theproposed policy sets annual base compensation for new non-employee directors at an amount between $525,000 and$637,500 and includes fixed annual fees for board and committee service. The proposed settlement also sets forth a numberof corporate governance reforms that the Company will undertake, including, enhanced proxy disclosures, the codification ofthe Company’s stock ownership guidelines for directors, and enhanced disclosure requirements for certain forms of directorcompensation. While no cash payments will be made to investors as part of the proposed settlement, plaintiff’s counsel isexpected to file a fee application which the Company has agreed not to oppose up to an agreed-upon amount. The proposedsettlement contains no admission of wrongdoing. ITEM 4.MINE SAFETY DISCLOSURES Not applicable. 55 Table of Contents PART II ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS ANDISSUER 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 SelectMarket: HIGH LOW Balance, December 31, 2017 First Quarter $74.94 $39.83 Second Quarter $96.92 $45.42 Third Quarter $99.45 $64.61 Fourth Quarter $86.26 $57.33 Balance, December 31, 2016 First Quarter $34.75 $16.78 Second Quarter $20.90 $11.57 Third Quarter $40.29 $13.43 Fourth Quarter $46.97 $25.50 On February 21, 2018, there were approximately 24 holders of record of our common stock. The holders of record numberdoes not include a substantially greater number of holders whose shares are held of record in nominee or street name accountsthrough 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 fundsand any future earnings to support our operations and finance the growth and development of our business. We do not intendto pay cash dividends on our common stock for the foreseeable future. Any future determination related to our dividendpolicy will be made at the discretion of our board of directors and will depend upon, among other factors, our results ofoperations, financial condition, capital requirements, contractual restrictions, business prospects and other factors our boardof directors may deem relevant. Securities Authorized for Issuance Under Equity Compensation Plans Equity Compensation Plan InformationAs of December 31, 2017 Number of securities remaining available for issuance under equity compensation Weighted- plans Number of securities to average (excluding be issued upon exercise exercise price securities of outstanding options of outstanding reflected and restricted stock options in column (a)) Plan Category (a) (b) (c) Equity compensation plans approved by security holders (1) (2) 6,379,264 $46.77 3,147,903 Equity compensation plans not approved by security holders — — — Total 6,379,264 $46.77 3,147,903 56 Table of Contents(1)As of December 31, 2017, 9,590,378 shares were authorized for issuance under our 2011 Stock Incentive Plan (“2011Plan”), which became effective upon closing of our initial public offering in November 2011, including 192,185remaining shares available for future issuance under the 2009 Equity Incentive Plan (“2009 Plan”), which weretransferred to the 2011 Plan. The number of shares of our common stock reserved for issuance under the 2011 Plan willbe 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 ofour board of directors, on the date of each annual meeting of our stockholders, by up to the lesser of (x) a number ofadditional shares of our common stock representing 4% of our then-outstanding shares of common stock on such dateand (y) 2,758,621 shares of our common stock. (2)As of December 31, 2017, 558,870 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 ofour common stock reserved for issuance under the ESPP will be increased at the discretion of our board of directors, onthe date of each annual meeting of our stockholders, by up to the lesser of (x) a number of additional shares of ourcommon stock representing 1% of our then-outstanding shares of common stock on such date and (y) 344,828 shares ofour common stock. Performance Graph The following graph shows a comparison from December 31, 2012 through December 31, 2017 of the cumulative totalreturn on an assumed investment of $100 in cash in our common stock, the NASDAQ Composite Index and the NASDAQBiotechnology Index. Such returns are based on historical results and are not intended to suggest future performance. Datafor 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 ofSection 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities under thatSection, and shall not be deemed incorporated by reference into any filing of Clovis Oncology, Inc. under the SecuritiesAct of 1933, as amended. 57 (1)Table of Contents 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, 2017, 2016 and 2015and the historical balance sheet data as of December 31, 2017 and 2016 have been derived from our audited financialstatements, which are included elsewhere in this Annual Report on Form 10-K. The historical statement of operations datapresented below for the years ended December 31, 2014 and 2013 and the historical balance sheet data as of December 31,2015, 2014 and 2013 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 andAnalysis of Financial Condition and Results of Operations” and our financial statements and the related notes thereto, whichare included elsewhere in this Annual Report on Form 10-K. The selected historical financial information in this section isnot intended to replace our financial statements and the related notes thereto. Statement of Operations Data: Year Ended December 31, 2017 2016 2015 2014 2013 (in thousands, except per share amounts) Revenues: Product revenue, net $55,511 $78 $ — $ — $ — License and milestone revenue — — — 13,625 — Total revenues 55,511 78 — 13,625 — Operating expenses: Cost of sales - product 10,251 70 — — — Cost of sales - intangible asset amortization 1,486 — — — — Research and development 142,498 251,129 269,251 137,705 66,545 Selling, general and administrative 138,907 40,731 30,524 21,457 16,567 Acquired in-process research and development — 1,300 12,000 8,806 250 Impairment of intangible asset — 104,517 89,557 3,409 — Change in fair value of contingent purchaseconsideration — (24,936) (24,611) 707 405 Total expenses 293,142 372,811 376,721 172,084 83,767 Operating loss (237,631) (372,733) (376,721) (158,459) (83,767) Other income (expense): Interest expense (10,428) (8,491) (8,372) (2,604) — Foreign currency gain (loss) (82) (580) 2,740 3,580 (535) Legal settlement loss (105,477) — — — — Other income (expense) 3,643 633 416 (240) (178) Other income (expense), net (112,344) (8,438) (5,216) 736 (713) Loss before income taxes (349,975) (381,171) (381,937) (157,723) (84,480) Income tax benefit (expense) 3,578 32,034 29,076 (2,308) (52) Net loss $(346,397) $(349,137) $(352,861) $(160,031) $(84,532) Basic and diluted net loss per common share $(7.36) $(9.07) $(9.79) $(4.72) $(2.95) Basic and diluted weighted average common sharesoutstanding 47,047 38,478 36,026 33,889 28,672 58 Table of ContentsBalance Sheet Data: As of December 31, 2017 2016 2015 2014 2013 (in thousands) Cash, cash equivalents and available-for-salesecurities $563,731 $266,183 $528,588 $482,677 $323,228 Working capital 545,423 213,813 464,125 443,400 307,644 Total assets 735,230 364,557 713,386 786,206 649,635 Convertible senior notes 282,406 281,126 279,885 278,680 — Common stock and additional paid-in capital 1,887,249 1,174,989 1,130,016 785,123 762,204 Total stockholders’ equity (deficit) 367,636 (3,634) 300,650 331,630 497,886 59 Table of Contents ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OFOPERATIONS You should read the following discussion and analysis of our financial condition and results of operations together withour financial statements and related notes appearing at the end of this Annual Report on Form 10-K. Some of theinformation contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, includinginformation with respect to our plans and strategy for our business and related financing, includes forward-lookingstatements that involve risks and uncertainties. You should read the “Risk Factors” section of this report for a discussion ofimportant 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-canceragents in the United States, Europe and additional international markets. We target our development programs for thetreatment of specific subsets of cancer populations, and simultaneously develop, with partners, diagnostic tools intended todirect a compound in development to the population that is most likely to benefit from its use. Our marketed product Rubraca® (rucaparib) is approved on an accelerated basis in the United States by the Food andDrug Administration (“FDA”) as monotherapy for the treatment of patients with deleterious BRCA (human genes associatedwith the repair of damaged DNA) mutation (germline and/or somatic) associated advanced ovarian cancer who have beentreated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic forRubraca. Continued approval for this indication may be contingent upon verification and description of clinical benefit inconfirmatory trials. We launched Rubraca in the United States in December 2016 for this indication. The FDA is currently reviewing on a priority review timeline our sNDA for Rubraca as maintenance treatment of adultpatients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partialresponse to platinum-based chemotherapy. Our MAA submitted to the EMA for an ovarian cancer treatment indication for Rubraca is currently under review by theEMA’s CHMP. Following a Scientific Advisory Group - Oncology meeting and an oral explanation by us before the CHMPin February 2018, the CHMP has communicated a positive trend vote for the MAA and their intention to hold a final vote onthe treatment indication at their March 2018 meeting. In addition, we have two other product candidates: lucitanib, an oral inhibitor of the tyrosine kinase activity of vascularendothelial growth factor receptors (“VEGFR”) 1-3, platelet-derived growth factor receptors (“PDGFR”) alpha and beta andfibroblast growth factor receptors (“FGFR”) 1-3, and rociletinib, an oral mutant-selective inhibitor of epidermal growth factorreceptor (“EGFR”). While we have stopped enrollment in ongoing trials for each of these candidates, we continue to providedrug to patients whose clinicians recommend continuing therapy. We maintain certain development and commercializationrights 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 andin-licensing product candidates, performing development activities with respect to those product candidates and the generaland administrative support of these operations. Through December 31, 2017, we have generated $13.6 million in license andmilestone revenue related to our collaboration and license agreement with Servier and for the year ended December 31, 2017have generated $55.5 million product revenue related to sales of Rubraca, which we began to commercialize on December19, 2016. We have principally funded our operations using the net proceeds from the sale of convertible preferred stock, theissuance 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, 2017, we had an accumulated deficit of $1,447.4 million. Weincurred net losses of $346.4 million, $349.1 million and $352.9 million for the years ended December 31, 2017, 2016 and2015, respectively, and had cash, cash equivalents and available-for-sale securities totaling $563.7 million at December 31,2017. 60 Table of ContentsWe expect to incur significant losses for the foreseeable future, as we incur costs related to commercial activitiesassociated with Rubraca. In January 2017, we sold 5,750,000 shares of our common stock in a public offering at $41.00 pershare. The net proceeds from the offering were $221.2 million, after deducting underwriting discounts and commissions andoffering expenses. In June 2017, we sold 3,920,454 shares of our common stock in a public offering at $88.00 per share. Thenet proceeds from the offering were $324.6 million, after deducting underwriting discounts and commissions and offeringexpenses. Based on our current estimates, we believe that our cash, cash equivalents and available-for-sale securities willallow us to fund activities through at least the next 12 months. Until we can generate a sufficient amount of revenue fromRubraca, we expect to finance our operations in part through additional public or private equity or debt offerings and mayseek additional capital through arrangements with strategic partners or from other sources. Adequate additional financingmay not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have anegative impact on our financial condition and our ability to pursue our business strategy. We will need to generatesignificant revenues to achieve profitability, and we may never do so. Product License Agreements For a discussion of our product license agreements, see Note 13, License Agreements, in the Notes to ConsolidatedFinancial Statements included in Part II, Item 8, Financial Statements and Supplementary Data, of this Annual Report onForm 10-K. Financial Operations Overview Revenue During 2017, we recorded $55.5 million in revenue related to sales of Rubraca, which we began to commercialize onDecember 19, 2016. In addition, we distributed free drug to eligible patients through our patient assistance program thatrepresented approximately $14.1 million in commercial value. For further discussion of our revenue recognition policy, see“Critical Accounting Policies and Significant Judgments and Estimates” below. Our ability to generate revenue and becomeprofitable depends upon our ability to successfully commercialize products. Any inability on our part to successfullycommercialize Rubraca in the United States and any foreign territories where it may be approved, or any significant delay insuch approvals, could have a material adverse impact on our ability to execute upon our business strategy and, ultimately, togenerate sufficient revenues from Rubraca to reach or maintain profitability or sustain our anticipated levels of operations. Currently, we only recognize revenue on product sales once the product is sold to the patient or healthcare provider by thespecialty distributor or specialty pharmacy provider, therefore reducing the significance of estimates made for productreturns. Effective January 1, 2018, we adopted Accounting Standards Codification (“ASC”), Topic 606, “Revenue fromContracts with Customers”. Upon adoption, we will begin recognizing revenue when our customers, the specialty distributorsand specialty pharmacy providers, take control of our product. This will have the impact of us recognizing revenueapproximately two to four weeks earlier than before adopting the new standard and will also increase the significance ofestimating variable consideration, including product returns, rebates and chargebacks. We used the modified retrospective method to adopt the new standard. This means that we will not restate previouslyissued financial statements, but will record a one-time adjustment to retained earnings of $2.3 million. This adjustmentrepresents the sales of our product to our customers prior to January 1, 2018, that have not been sold to patients or healthcareproviders, offset by related gross-to-net adjustments and other direct costs, including royalties and sales incentivecompensation. During 2017, revenue was recognized for U.S. tax purposes when our product was sold to the specialty distributors andpharmacies, a method that differs from book treatment. This difference in revenue recognition resulted in the establishment ofthe deferred tax asset for the sales value of our product held by our specialty distributor and pharmacy providers at December31, 2017. The deferred tax asset was offset by a full valuation allowance and has no impact to our statement of operations.With the adoption of ASC 606 effective January 1, 2018, revenue will be recognized when our product is sold to thespecialty distributors pharmacies, which will match the tax treatment resulting in no deferred tax asset. 61 Table of ContentsFor a complete discussion of this adoption and the accounting for net product revenue, see Note 2, Summary ofSignificant Accounting Policies in the “Recently Issued Accounting Standards” section and Note 11, Revenue Recognition. Research and Development Expenses Research and development expenses consist of costs incurred for the development of our product candidates andcompanion diagnostics, which include:·license fees and milestone payments related to the acquisition of in-licensed products, which are reported on ourConsolidated Statements of Operations and Comprehensive Loss as acquired in-process research and development;·employee-related expenses, including salaries, benefits, travel and share-based compensation expense;·expenses incurred under agreements with 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-licensedproducts and technology are expensed if it is determined that they have no alternative future use. Costs for certaindevelopment activities, such as clinical trials and manufacturing of clinical supply, are recognized based on an evaluation ofthe progress to completion of specific tasks using data such as patient enrollment, clinical site activations or informationprovided to us by our vendors. As a result of the FDA approval of Rubraca and the discontinuation of enrollment inrociletinib, our research and development expenses decreased for 2017 as commercialization related expenses are classifiedas selling, general and administrative expenses and not research and development costs. Our research and developmentexpenses will increase in 2018 as our ongoing rucaparib studies progress. The following table identifies research and development and acquired in-process research and development costs on aprogram-specific basis for our products under development. Personnel-related costs, depreciation and share-basedcompensation 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. Year Ended December 31, 2017 2016 2015 (in thousands) Rucaparib Expenses Research and development $72,901 $101,598 $58,922 Acquired in-process research and development — 1,300 — Rucaparib Total 72,901 102,898 58,922 Lucitanib Expenses Research and development (a) (1,187) (1,337) 1,923 Lucitanib Total (1,187) (1,337) 1,923 Rociletinib Expenses Research and development 7,712 43,768 122,912 Acquired in-process research and development — — 12,000 Rociletinib Total 7,712 43,768 134,912 Personnel and other expenses 63,072 107,100 85,494 Total $142,498 $252,429 $281,251 (a)This amount reflects actual costs incurred less amounts due from Servier for reimbursable development expensespursuant to the collaboration and license agreement described in Note 13, License Agreements, to our auditedconsolidated financial statements included in this Annual Report on Form 10-K. For 2017 and 2016, research and development expenses have continued to decrease primarily due to decreaseddevelopment activities for the rociletinib program.62 Table of Contents 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 administrativeexpenses include facilities expenses, communication expenses, information technology costs, corporate insurance andprofessional fees for legal, consulting and accounting services. With the FDA approval of Rubraca on December 19, 2016, allsales and marketing expenses associated with Rubraca are included in selling, general and administrative expenses. Weanticipate that our selling, general and administrative expenses will continue to increase in the future in support of ourcommercial activities related to Rubraca in the U.S. and Europe. Acquired In-Process Research and Development Expenses Acquired in-process research and development expenses consist of upfront payments to acquire a new drug compound, aswell as subsequent milestone payments. Acquired in-process research and development payments are immediately expensedprovided that the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has noalternative 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 ofacquired in-process research and development (“IPR&D”) as of the acquisition date. The fair value was established basedupon discounted cash flow models using assumptions related to the timing of development, probability of development andregulatory success, sales and commercialization factors and estimated product life. During the second quarter of 2016, werecorded a $104.5 million impairment charge due to our and our development partner’s decision to discontinue thedevelopment of lucitanib for breast cancer. During the fourth quarter of 2015, we recorded an $89.6 million impairmentcharge to the IPR&D intangible assets. At December 31, 2017, the IPR&D intangible asset recorded on the ConsolidatedBalance Sheets was zero. 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 tothe estimated fair value of future payments that are contingent upon the achievement of various regulatory and salesmilestones. Subsequent to the acquisition date, we re-measure contingent consideration arrangements at fair value eachreporting period and record changes in fair value to change in fair value of contingent purchase consideration and foreigncurrency gains (losses) for changes in the foreign currency translation rate on the Consolidated Statements of Operations andComprehensive Loss. Changes in fair value are primarily attributed to new information about the likelihood of achievingsuch milestones and the passage of time. In the absence of new information, changes to fair value reflect only the passage oftime as we progress towards the achievement of future milestones. During the second quarter of 2016, we recorded a $25.5million reduction in the fair value of the contingent purchase consideration liability due to our and our developmentpartner’s decision to discontinue the development of lucitanib for breast cancer. During the fourth quarter of 2015, werecorded a $26.9 million reduction in the fair value of the contingent purchase consideration liability due to a change in theestimated probability-weighted future milestone payments, as well as the timing of such payments, for the lucitanib program.At December 31, 2017, the contingent purchase consideration liability recorded on the Consolidated Balance Sheetsremained at zero due to the uncertainty of achieving any of the lucitanib regulatory milestones, and therefore the remotelikelihood 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 withCROs, investigational sites and contract manufacturers where payments are made in currencies other than the U.S. dollar.Other expense also includes interest expense recognized related to our convertible senior notes. 63 Table of ContentsCritical 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 thesefinancial 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, includingthose related to revenue, intangible asset impairment, clinical trial accruals and share-based compensation expense. We baseour estimates on historical experience, known trends and events and various other factors that are believed to be reasonableunder the circumstances, the results of which form the basis for making judgments about the carrying values of assets andliabilities that are not readily apparent from other sources. Actual results may differ from these estimates under differentassumptions or conditions. Our significant accounting policies are described in more detail in the notes to our consolidated financial statementsappearing elsewhere in this Annual Report on Form 10-K. We believe the following accounting policies to be most critical tothe judgments and estimates used in the preparation of our financial statements. Revenue Recognition We are currently approved to sell Rubraca in the United States markets. We distribute our product principally through alimited number of specialty distributor and specialty pharmacy providers, collectively, our customers. Our customerssubsequently sell our products to patients and health care providers. Separately, we have arrangements with certain payorsand 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 andtitle of the product and associated risk of loss has passed to the customer, the price is fixed or determinable, collection fromthe customer has been reasonably assured and all performance obligations have been met and returns and allowances can bereasonably estimated. Product sales are recorded net of estimated rebates, chargebacks, discounts and other deductions aswell as estimated product returns. Estimating rebates, chargebacks, discounts, product returns and other deductions requiressignificant judgments about future events and uncertainties, and requires us to rely heavily on assumptions, as well ashistorical experience. We only recognize revenue on product sales once the product is sold to the patient or healthcareprovider by the specialty distributor or specialty pharmacy provider, therefore reducing the significance of estimates madefor product returns. For the year ended December 31, 2017, we recognized $55.5 million of product revenue. Based on our policy to expensecosts associated with the manufacture of our products prior to regulatory approval, certain of the costs of Rubraca unitsrecognized as revenue during the year ended December 31, 2017 were expensed prior to the December 19, 2016 FDAapproval, and a minimal amount is included in cost of sales during the current period. We expect cost of sales to increase inrelation to product revenues as we deplete these inventories. The majority of products sales were of pre-commercializationinventory in 2017. Revenue is recognized from milestone payments when the following criteria have been met: (1) persuasive evidence of anarrangement 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 thatservices have been delivered in accordance with the arrangement. We assess whether the fee is fixed or determinable based onthe payment terms associated with the transaction and whether the sales price is subject to refund or adjustment. We assesscollectability based primarily on the customer’s payment history and creditworthiness of the customer. Payments that arecontingent upon the achievement of a milestone will be recognized in the period in which the milestone is achieved. Accrued Research and Development Expenses As part of the process of preparing our financial statements, we are required to estimate our accrued expenses. This processinvolves reviewing open contracts and purchase orders, communicating with our personnel to identify services that havebeen performed on our behalf and estimating the level of service performed and the associated cost incurred for the servicewhen we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice usmonthly in arrears for services performed or when contractual milestones are met. We make64 Table of Contentsestimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstancesknown to us at that time. We periodically confirm the accuracy of our estimates with the service providers and makeadjustments 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 tocontracts with multiple CROs that conduct and manage clinical studies on our behalf. The financial terms of theseagreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may beinstances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of theclinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients andthe completion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will beperformed, enrollment of patients, number of sites activated and the level of effort to be expended in each period. If the actualtiming of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaidaccordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, ourunderstanding of the status and timing of services performed relative to the actual status and timing of services performedmay vary and may result in us reporting amounts that are too high or too low in any particular period. Share-Based Compensation Determining the amount of share-based compensation to be recorded requires us to develop estimates of the fair value ofstock options as of their grant date. Compensation expense is recognized over the vesting period of the award. Calculatingthe fair value of share-based awards requires that we make highly subjective assumptions. We use the Black-Scholes optionpricing model to value our stock option awards. Use of this valuation methodology requires that we make assumptions as tothe expected dividend yield, price volatility of our common stock, the risk-free interest rate for a period that approximatesthe expected term of our stock options and the expected term of our stock options. We utilize a dividend yield of zero basedon the fact that we have never paid cash dividends and have no current intention to pay cash dividends. The fair value of stock options for the years ended December 31, 2017, 2016 and 2015 was estimated at the grant dateusing the following weighted average assumptions for the respective periods: Year Ended December 31, 2017 2016 2015 Dividend yield — — — Volatility (a) 89% 93% 72%Risk-free interest rate (b) 2.16% 1.77% 1.77%Expected term (years) (c) 5.8 5.8 6.1 (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 whosematurity 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 $44.7 million, $39.8 million and $40.4 million forthe years ended December 31, 2017, 2016 and 2015, respectively. As of December 31, 2017, we had $89.4 million in totalunrecognized share-based compensation expense, net of related forfeiture estimates, which is expected to be recognized overa weighted-average remaining vesting period of 3.3 years. We expect our share-based compensation to continue to grow infuture periods due to the potential increases in the value of our common stock and headcount. We estimate the level of forfeitures expected to occur and record compensation expense only for those awards that weultimately expect will vest.65 Table of Contents 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. Eachsubsequent reporting period, the contingent consideration obligations are revalued and changes in fair value are recorded tochange in fair value of contingent purchase consideration and foreign currency gains (losses) for changes in the foreigncurrency translation rate on the Consolidated Statements of Operations and Comprehensive Loss. Changes to contingent consideration obligations can result from adjustments to discount rates and time periods, updatesin the assumed achievement or timing of any development milestone or changes in the probability of certain clinical eventsand regulatory approvals. The assumptions related to determining the value of contingent consideration require significantjudgment and changes to the assumptions may have a material impact on the amount of expense recorded in any givenperiod. The acquisition of EOS resulted in the recognition of a contingent consideration liability, based on assumptionsrelated to potential future payout amounts, estimated discount rate, probability of success for each milestone achievementand 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 purchaseconsideration due to our and our development partner’s decision to discontinue the development of lucitanib for breastcancer. At December 31, 2017, the contingent purchase consideration liability recorded on the Consolidated Balance Sheetsremained at zero due to the uncertainty of achieving any of the lucitanib regulatory milestones, and therefore the remotelikelihood 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-linebasis over their remaining useful lives, which are estimated to be the remaining patent life. If our estimate of the product’suseful life is shorter than the remaining patent life, then a shorter period is used. Amortization expense is recorded as acomponent of cost of sales in the Consolidated Statements of Operations and Comprehensive Loss. IPR&D assets were established as part of the acquisition of EOS in November 2013 and have not been amortized, but havebeen assessed for impairment. Intangible assets are evaluated for impairment at least annually in the fourth quarter or more frequently if impairmentindicators exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the decisionto discontinue the development of a drug, the receipt of additional clinical or nonclinical data regarding our drug candidateor a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or newinformation regarding potential sales for the drug. In connection with any impairment assessment, the fair value of theintangible assets as of the date of assessment is compared to the carrying value of the intangible asset. Impairment losses arerecognized if the carrying value of an intangible asset is both not recoverable and exceeds its fair value. During the secondquarter of 2016, we recorded a $104.5 million impairment charge to the IPR&D intangible assets due to our and ourdevelopment partner’s decision to discontinue the development of lucitanib for breast cancer, thereby reducing theremaining carrying value to zero. 66 Table of ContentsResults of Operations Comparison of the Year Ended December 31, 2017 to the Year Ended December 31, 2016 Change Year ended December 31, Favorable/(Unfavorable) 2017 2016 $ % Product revenue, net $55,511 $78 $55,433 71,068%Operating expenses: Cost of sales - product 10,251 70 10,181 14,544%Cost of sales - intangible asset amortization 1,486 — 1,486 100%Research and development 142,498 251,129 (108,631) (43)%Selling, general and administrative 138,907 40,731 98,176 241%Acquired in-process research and development — 1,300 (1,300) (100)%Impairment of intangible asset — 104,517 (104,517) (100)%Change in fair value of contingent purchase consideration — (24,936) 24,936 (100)% Total expenses 293,142 372,811 (79,669) (21)%Operating loss (237,631) (372,733) 135,102 (36)%Other income (expense): Interest expense (10,428) (8,491) (1,937) 23%Foreign currency gain (loss) (82) (580) 498 (86)%Legal settlement loss (105,477) — (105,477) 100%Other income (expense) 3,643 633 3,010 476%Other income (expense), net (112,344) (8,438) (103,906) 1,231%Loss before income taxes (349,975) (381,171) 31,196 (8)%Income tax benefit 3,578 32,034 (28,456) (89)%Net loss $(346,397) $(349,137) $2,740 (1)% Product Revenue, Net. Product revenue for the year ended December 31, 2017 was due to the recognition of $55.5 millionof net product revenue from the sale of Rubraca, which was approved for sale in the United States markets on December 19,2016. Revenue is recorded net of sales deductions comprised of rebates, chargebacks and other discounts. Sales deductionsrepresented approximately 8.1% of the gross product revenue recognized in the year ended December 31, 2017 andsummarized as follows: Year ended December 31, 2017 $ % of Gross Sales (in thousands) Gross product revenue $60,384 100.0% Sales deductions: Government rebates and chargebacks 2,575 4.3% Discounts and fees 2,298 3.8% Total sales deductions 4,873 8.1% Product revenue, net $55,511 91.9% Cost of Sales - Product. Product cost of sales for the year ended December 31, 2017 relate to freight and royalties costsassociated with Rubraca sales for the period. Based on our policy to expense costs associated with the manufacture of ourproducts prior to regulatory approval, certain of the costs of Rubraca units recognized as revenue during the year endedDecember 31, 2017 were expensed prior to the December 19, 2016 FDA approval, and therefore are not included in costs ofsales during the current period. We expect cost of sales to increase in relation to product revenues as we deplete theseinventories. The majority of product sales were of pre-commercialization inventory in 2017. Cost of Sales – Intangible Asset Amortization. For the year ended December 31, 2017, we recognized cost of sales of $1.5million associated with the amortization of capitalized milestone payments related to the FDA approval of Rubraca.67 Table of ContentsPrior to the FDA approval on December 19, 2016, all acquired license and milestone payments were expensed as incurred. Research and Development Expenses. Research and development expenses decreased during the year ended December31, 2017 compared to 2016 primarily due to lower research and development costs for rucaparib and rociletinib andclassification of commercialization related expenses associated with Rubraca in selling, general and administrative expensesrather than research and development expenses. In the year ended December 31, 2017, Rubraca commercialization costsincluded in selling, general and administrative expenses were $95.2 million. Clinical trial costs for rucaparib were $0.3 million lower compared to the same period a year ago due to completedenrollment in our ARIEL2 and ARIEL 3 studies, partially offset by higher costs from enrollment in ARIEL4, our confirmatoryovarian cancer trials, and enrollment in our TRITON2 and TRITON3 studies for prostate cancer. Diagnostic developmentcosts were $4.4 million lower compared to the prior year as the prior year included the costs associated with our collaborationwith Foundation Medicine, Inc. to develop a novel companion diagnostic test to identify patients most likely to respond torucaparib. Finally, clinical supply and related manufacturing development costs were $15.9 million lower than 2016 due tothe capitalization of these costs subsequent to the FDA approval of rucaparib. Clinical trial costs for rociletinib were $23.6 million lower than 2016 primarily due to the completion of patientenrollment for all of the TIGER studies in non-small cell lung cancer. Clinical supply and related manufacturingdevelopment costs were $6.6 million lower than 2016 driven by timing of production to support our clinical studies. Selling, General and Administrative Expenses. Selling, general and administrative expenses increased during the yearended December 31, 2017 compared to 2016 primarily due to classification of commercialization related expenses associatedwith Rubraca in selling, general and administrative expenses rather than research and development expenses. Acquired In-Process Research and Development Expenses. During 2016, we made a milestone payment of $0.3 millionto AstraZeneca upon the NDA submission for rucaparib and we made milestone payments totaling $1.0 million to Pfizerupon acceptance of the NDA and MAA for rucaparib by the FDA and EMA, respectively. No such payments occurred during2017. Impairment of Intangible Asset. During the second quarter of 2016, we recorded a $104.5 million impairment charge tothe IPR&D intangible asset relating to our lucitanib product candidate which reduced the carrying value of the intangibleassets related to the product to zero. This reduction in the estimated fair value of lucitanib was the result of our and ourdevelopment partner’s decision to discontinue the development of lucitanib for breast cancer. Change in Fair Value of Contingent Purchase Consideration. The fair value of contingent purchase considerationdecreased $24.9 million for the year ended December 31, 2016, which is due to a $25.5 million reduction in the fair value ofthe contingent purchase consideration liability we recorded during the second quarter of 2016 due to our and ourdevelopment partner’s decision to discontinue the development of lucitanib for breast cancer. Legal Settlement Loss, Net of Insurance Receivable. During 2017, we recorded a $105.5 million legal settlement loss, netof insurance receivable, related to a stipulation agreement of settlement whereby we issued the plaintiff and participatingclass members a total consideration comprised of $25.0 million in cash and the issuance of 1.5 million shares. The cashportion of the consideration was funded by Clovis’ insurance carriers. Other Income (Expense). Other income increased for the year ended December 31, 2017 compared to 2016 due to interestincome earned on our available-for-sale securities. Income Tax Benefit (Expense). For the year ended December 31, 2016, we recognized a $28.4 million deferred tax benefitassociated with the impairment of the IPR&D intangible assets recorded in the second quarter of 2016. In addition, during thefirst quarter 2016, we recognized a $3.6 million deferred tax benefit due to a reduction in the enacted corporate tax rate of aforeign jurisdiction in which we operate.68 Table of Contents Comparison of the Year Ended December 31, 2016 to the Year Ended December 31, 2015 Change Year ended December 31, Favorable/(Unfavorable) 2016 2015 $ % Product revenue, net $78 $ — $78 100%Operating expenses: Cost of sales - product 70 — 70 100%Research and development 251,129 269,251 (18,122) (7)%Selling, general and administrative 40,731 30,524 10,207 33%Acquired in-process research and development 1,300 12,000 (10,700) (89)%Impairment of intangible asset 104,517 89,557 14,960 17%Change in fair value of contingent purchase consideration (24,936) (24,611) (325) 1% Total expenses 372,811 376,721 (3,910) (1)%Operating loss (372,733) (376,721) 3,988 (1)%Other income (expense): Interest expense (8,491) (8,372) (119) 1%Foreign currency gain (loss) (580) 2,740 (3,320) (121)%Other income (expense) 633 416 217 52%Other income (expense), net (8,438) (5,216) (3,222) 62%Loss before income taxes (381,171) (381,937) 766 (0)%Income tax benefit 32,034 29,076 2,958 10%Net loss $(349,137) $(352,861) $3,724 (1)% Product Revenue, Net. Product revenue for the year ended December 31, 2016 was due to the recognition of $0.1 millionof net 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. Product cost of sales for the year ended December 31, 2016 relate to freight and royalties costsassociated with Rubraca sales for the period. Based on our policy to expense costs associated with the manufacture of ourproducts prior to regulatory approval, certain of the costs of Rubraca units recognized as revenue during the year endedDecember 31, 2016 were expensed prior to the December 19, 2016 FDA approval, and therefore are not included in costs ofsales during the current period. Research and Development Expenses. The decrease in research and development expenses for the year ended December31, 2017 compared to 2016 was primarily due to decreased development activities for the rociletinib program partially offsetby 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 enrollmentin the ARIEL2 and ARIEL3 studies in ovarian cancer. Market research, disease education and other commercial productplanning activities were $16.6 million higher than the prior year due to the preparation for the potential regulatory approvaland commercial launch of rucaparib. Clinical supply and related manufacturing development costs were $9.2 million higherthan the prior year, as we increased production to support the expanded clinical studies. In addition, diagnostic developmentcosts for rucaparib were $0.9 million higher than the prior year due to the advancement of our collaboration with FoundationMedicine, 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 drivenby increased headcount to support our expanded development and commercial planning activities. During the third quarterof 2015, we completed the hiring of our U.S. sales and marketing and medical affairs organization in preparation for thepotential 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 ofpatient enrollment in the TIGER-1, TIGER-2 and TIGER-X studies in non-small cell lung cancer. This decrease was69 Table of Contentspartially offset by higher clinical trial costs for the TIGER-3 study, which began enrolling patients during the second quarterof 2015. Market research, disease education and other commercial planning activities were $19.7 million lower than the prioryear. We incurred higher costs during 2015 due to the preparation for the potential regulatory approval and commerciallaunch of rociletinib. In addition, clinical supply and related manufacturing development costs were $17.2 million lowerthan the prior year driven by timing of production to support our clinical studies. Selling, General and Administrative Expenses. The increase in selling, general and administrative expenses for the yearended December 31, 2016 over 2015 was primarily due to $3.1 million of selling expenses related to the commercializationof Rubraca, $5.3 million higher legal expense and, to a lesser extent, higher personnel costs. Pre-commercialization activitiesfor Rubraca were included in research and development expenses. Acquired In-Process Research and Development Expenses. Acquired in-process research and development expensesdecreased for the year ended December 31, 2016 compared to 2015. During the third quarter of 2015, we made milestonepayments 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 NDAsubmission for rucaparib. During 2016, we made milestone payments totaling $1.0 million to Pfizer upon acceptance of theNDA and MAA for rucaparib by the FDA and EMA, respectively. Impairment of Intangible Asset. During the second quarter of 2016, we recorded a $104.5 million impairment charge tothe IPR&D intangible asset relating to our lucitanib product candidate which reduced the carrying value of the intangibleassets related to the product to zero. This reduction in the estimated fair value of lucitanib was the result of our and ourdevelopment partner’s decision to discontinue the development of lucitanib for breast cancer. During the fourth quarter of2015, we recorded an $89.6 million impairment charge to the IPR&D intangible asset relating to our lucitanib productcandidate. This reduction in the estimated fair value of lucitanib was the result of our and our development partner’s decisionto terminate the development of lucitanib for lung cancer, as well as updates to the probability-weighted discounted cashflow assumptions for the breast cancer indication. Change in Fair Value of Contingent Purchase Consideration. Change in fair value of contingent purchase considerationwas a decrease of $24.9 million for the year ended December 31, 2016 compared to a decrease of $24.6 million for the yearended December 31, 2015. During the second quarter of 2016, we recorded a $25.5 million reduction in the fair value of thecontingent purchase consideration liability due to our and our development partner’s decision to discontinue thedevelopment of lucitanib for breast cancer. During the fourth quarter of 2015, we recorded a $26.9 million reduction in thefair value of the contingent purchase consideration liability due to a change in the estimated probability-weighted futuremilestone payments, as well as the timing of such payments, for the lucitanib program. Other Income (Expense), Net. Other expense increased for the year ended December 31, 2016 compared to 2015. During2016, we recognized $0.6 million of foreign currency losses compared with $2.7 million of gains in 2015. The change in theforeign 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. Income Tax Benefit (Expense). For the year ended December 31, 2016, we recognized a $28.4 million deferred tax benefitassociated with the impairment of the IPR&D intangible assets recorded in the second quarter of 2016. In addition, during thefirst quarter 2016, we recognized a $3.6 million deferred tax benefit due to a reduction in the enacted corporate tax rate of aforeign jurisdiction in which we operate. For the year ended December 31, 2015, we recognized a $29.1 million deferred tax benefit primarily associated with theimpairment of the IPR&D intangible assets recorded in the fourth quarter of 2015. Liquidity and Capital Resources To date, we have funded our operations through the public offering of our common stock and the private placement ofconvertible debt securities and preferred stock. In January 2017, we sold 5,750,000 shares of our common stock in a publicoffering at $41.00 per share. The net proceeds from the offering were $221.2 million, after deducting underwriting discountsand commissions and offering expenses. In June 2017, we sold 3,920,454 shares of our common stock in a public offering at$88.00 per share. The net proceeds from the offering were $324.6 million, after deducting underwriting discounts andcommissions and offering expenses. As of December 31, 2017, we had cash, cash equivalents and available-for-sale securitiestotaling $563.7 million.70 Table of Contents The following table sets forth the primary sources and uses of cash for each of the periods set forth below: Year Ended December 31, 2017 2016 2015 (in thousands) Net cash used in operating activities $(260,904) $(266,680) $(253,066) Net cash (used in) provided by investing activities (54,102) 199,299 (254,578) Net cash provided by financing activities 562,075 5,176 304,480 Effect of exchange rate changes on cash and cashequivalents 943 (365) (757) Net increase (decrease) in cash and cash equivalents $248,012 $(62,570) $(203,921) Operating Activities Net cash used in operating activities for the year ended December 31, 2017 decreased by $5.8 million compared to 2016due to a decrease in net loss adjusted for non-cash items of $63.3 million, primarily due the recognition of $55.5 million ofrevenue during 2017, partially offset by inventory purchases and deposits of $48.0 million and the recognition of $6.2million in accounts receivable in 2017. Net cash used in operating activities increased $13.6 million for the year ended December 31, 2016 compared to 2015driven by an increase in payments for other accrued expenses related to the rociletinib program of non-clinical and clinicaldevelopment studies, for which enrollment was completed in 2016. Investing Activities Net cash used in investing activities for the year ended December 31, 2017 includes $263.5 million in purchases ofavailable-for-sale securities compared to no purchases in 2016. Net cash provided by investing activities for the year ended December 31, 2016 includes $200.0 million in sales ofavailable-for-sale securities compared to $251.5 million in net purchases in 2015. Financing Activities Net cash provided by financing activities for the year ended December 31, 2017 includes $545.8 million in net proceedsreceived from our common stock offerings in January and June 2017 and $16.2 million received from employee stock optionexercises and stock purchases under the employee stock purchase plan. Net cash provided by financing activities for the year ended December 31, 2016 is due to $5.2 million received fromemployee 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 proceedsreceived from our common stock offering in July 2015 and $6.0 million received from employee stock option exercises andstock 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 deleteriousBRCA mutation (germline and/or somatic) associated with advanced ovarian cancer, who have been treated with two or morechemotherapies, and selected for therapy based on FDA-approved companion diagnostic for Rubraca. We expect to incursignificant losses for the foreseeable future, as we commercialize Rubraca and expand our selling, general and administrativefunctions to support the growth in our commercial organization. Additionally, our operating plan for the next 12 monthsincludes a significant investment in inventory to meet the projected commercial requirements for Rubraca. We receive theactive pharmaceutical ingredient in Rubraca from one supplier and we experience long lead times associated with itsproduction. Accordingly, we expect to experience a decrease in our liquidity at the beginning of a production cycle and anincrease as the inventory produced is sold. 71 Table of ContentsAs of December 31, 2017, we had cash, cash equivalents and available-for-sale securities totaling $563.7 million and totalcurrent liabilities of $81.5 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 andcommissions and offering expenses. In June 2017, we sold 3,920,454 shares of our common stock in a public offering at$88.00 per share. The net proceeds from the offering were $324.6 million, after deducting underwriting discounts andcommissions and offering expenses. We intend to use the net proceeds of the offerings for general corporate purposes,including commercial planning and sales and marketing expenses associated with the launch of Rubraca in the United Statesand, if approved by the European Commission in Europe, funding of its development programs, selling, general andadministrative expenses, acquisition or licensing of additional product candidates or businesses and working capital. Basedon current estimates, we believe that our existing cash, cash equivalents and available-for-sale securities will allow us to fundour operating plan through at least the next 12 months. Because of the numerous risks and uncertainties associated with research, development and commercialization ofpharmaceutical products, we are unable to estimate the exact amounts of our working capital requirements. Our futurefunding 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 topartners pursuant to the terms of our license agreements;·the scope, progress, results and costs of researching and developing our product candidates and related companiondiagnostics and conducting clinical and non-clinical trials;·the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates and companiondiagnostics;·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, includinglitigation 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, 2017 (in thousands): Less than 1 More Than 5 Year 1 to 3 Years 3 to 5 Years Years Total Convertible senior notes $ — $ — $287,500 $ — $287,500 Interest on convertible senior notes 7,187 14,376 5,091 — 26,654 Operating lease commitments 3,050 7,646 6,374 11,563 28,633 Milestone payments (a) 23,000 — — — 23,000 Purchase and other commitments (b) 137,154 25,179 24,630 36,945 223,908 Total $170,391 $47,201 $323,595 $48,508 $589,695 (a)Amount relates to a $20 million milestone payment, which we have exercised the option to defer payment by agreeingto 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-exclusivethird-party supplier for the production of the active ingredient for rucaparib. Under the terms of the Agreement, we willprovide the third-party supplier a rolling forecast for the supply of the active ingredient in rucaparib that will be updatedby us on a quarterly basis. We are obligated to order material sufficient to satisfy an initial quantity specified in anyforecast. In addition, the third-party supplier will construct, in its existing facility, a production train that will beexclusively dedicated to the manufacture of the rucaparib active ingredient. We are obligated to make scheduled capitalprogram fee payments toward capital equipment and other costs associated with the construction of the dedicatedproduction train. Further, once the facility is operational, we are obligated to pay a fixed facility fee each quarter for theduration of the Agreement, which expires on December 31, 2025, unless extended by mutual consent of the parties. 72 Table of ContentsRoyalty and License Fee Commitments We have certain obligations under licensing agreements with third parties contingent upon achieving variousdevelopment, regulatory and commercial milestones. On August 30, 2016, we entered into a first amendment to theworldwide license agreement with Pfizer, which amends the June 2011 existing worldwide license agreement to permit us todefer payment of the milestone payments payable upon (i) FDA approval of an NDA for 1 Indication in US and (ii) EuropeanCommission approval of an MAA for 1 Indication in EU, to a date that is 18 months after the date of achievement of suchmilestones. In the event that we defer such milestone payments, we have agreed to certain higher payments related to theachievement of such milestones. On December 19, 2016, the FDA approved Rubraca tablets as monotherapy for the treatment of patients with deleteriousBRCA mutation (germline and/or somatic) associated with advanced ovarian cancer, who have been treated with two or morechemotherapies, and selected for therapy based on FDA-approved companion diagnostic for Rubraca. The FDA approvalresulted in a $0.75 million milestone payment to Pfizer as required by the license agreement. The FDA approval also resultedin the obligation to pay a $20.0 million milestone payment, in which we have exercised the option to defer payment byagreeing to pay $23.0 million within 18 months after the date of the FDA approval. These payments were recognized asintangible 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 milestonepayments 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 annualsales targets for rucaparib are met, which relate to annual sales targets of $250.0 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 onour net sales, with standard provisions for royalty offsets to the extent we need to obtain any rights from third parties tocommercialize 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 purchaseconsideration 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 €115.0million) if all regulatory and sales milestones are met, utilizing the translation rate at December 31, 2017. The estimated fairvalue of the liability was zero at December 31, 2017 due to the uncertainty of achieving any of the lucitanib regulatorymilestones, and therefore the remote likelihood of future milestone payout amounts to the former EOS shareholders. We arealso obligated to pay to Advenchen 25% of any consideration, excluding royalties, received pursuant to any sublicenseagreements 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 upto an additional aggregate of $98.0 million in regulatory milestone payments if certain clinical study objectives andregulatory 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, asdefined under the rules promulgated by the U.S. Securities and Exchange Commission. Tax Loss Carryforwards As of December 31, 2017, we have net operating loss (“NOL”) carryforwards of approximately $1.0 billion to offset futurefederal income taxes. We also have research and development and orphan drug tax credit carryforwards of $245.1 million tooffset future federal income taxes. The federal net operating loss carryforwards and research and development and orphandrug tax credit carryforwards expire at various times through 2037. 73 ststTable of ContentsWe believe that a change in ownership as defined under Section 382 of the U.S. Internal Revenue Code occurred as aresult of our public offering of common stock completed in April 2012. Future utilization of the federal net operating lossesand tax credit carryforwards accumulated from inception to the change in ownership date will be subject to annuallimitations to offset future taxable income. At this time, we do not believe this limitation will prevent the utilization of thefederal NOL or credit carryforward prior to expiration. It is possible that a change in ownership will occur in the future, whichwill limit the NOL amounts generated since the last estimated change in ownership. At December 31, 2017, we recorded a100% valuation allowance against our net deferred tax assets in the U.S. of approximately $561.1 million and a $3.0 millionvaluation allowance against tax assets in foreign jurisdictions, as we believe it is more likely than not that the tax benefitswill not be fully realized. In the future, if we determine that a portion or all of the tax benefits associated with our taxcarryforwards will be realized, net income would increase in the period of determination. Recently Adopted and Issued Accounting StandardsFor a discussion of recently adopted and issued accounting standards, see Note 2, Summary of Significant AccountingPolicies, in the Notes to Consolidated Financial Statements included in Part II, Item 8, Financial Statements andSupplementary Data, of this Annual Report on Form 10-K. 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, 2017, we had cash, cash equivalentsand available-for-sale securities of $563.7 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 tomeet operating needs. Our investment policy specifies credit quality standards for our investments and limits the amount ofcredit exposure to any single issue, issuer or type of investment. Our primary exposure to market risk is interest ratesensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because our investments are inshort-term securities. Our available-for-sale securities are subject to interest rate risk and will decline in value if marketinterest 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 wherepayments are made in currencies other than the U.S. dollar. In addition, on October 3, 2016, we entered into a Manufacturingand Services Agreement with a Swiss company for the production and supply of the active ingredient for rucaparib. Under theterms of this agreement, payments for the supply of the active ingredient in rucaparib as well as scheduled capital programfee payment toward capital equipment and other costs associated with the construction of a dedicated production train willbe made in Swiss francs. Once the production facility is operational, we are obligated to pay a fixed facility fee each quarterfor the duration of the agreement, which expires on December 31, 2025. As of December 31, 2017, $223.9 million of purchase commitments exist under the Swiss Manufacturing and ServicesAgreement and we are required to remit amounts due in Swiss francs. Due to other variables that may exist, it is difficult toquantify the impact of a particular change in exchange rates. However, we estimate that if the value of the US dollar was tostrengthen by 10% compared to the value of Swiss franc as of December 31, 2017, it would decrease the total US dollarpurchase commitment under the Swiss Manufacturing and Services Agreement by approximately $20.4 million. Similarly, a10% weakening of the US dollar compared to the Swiss franc would increase the total US dollar purchase commitment byapproximately $24.9 million. While we periodically hold foreign currencies, primarily Euro and Pound Sterling, we do not use other financialinstruments to hedge our foreign exchange risk. Transactions denominated in currencies other than the functional currencyare recorded based on exchange rates at the time such transactions arise. As of December 31, 2017 and 2016, approximately1% of our total liabilities were denominated in currencies other than the functional currency. 74 Table of Contents 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 onpage F-1. ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING ANDFINANCIAL DISCLOSURENone. 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 wefile or submit under the Securities Exchange Act of 1934, as amended (“Exchange Act”) is recorded, processed, summarizedand reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that suchinformation is accumulated and communicated to our management, including the Chief Executive Officer and the PrincipalFinancial and Accounting Officer, to allow timely decisions regarding required disclosures. Any controls and procedures, nomatter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective. As of December 31, 2017, our management, with the participation of our Chief Executive Officer and Principal Financialand Accounting Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controlsand procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Based on this evaluation, our ChiefExecutive Officer and Principal Financial and Accounting Officer concluded that, as of December 31, 2017, the design andoperation 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 forthe assessment of the effectiveness of internal control over financial reporting. Internal control over financial reporting is aprocess designed by, or under the supervision of, a company’s principal executive officer and principal financial officer andaffected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliabilityof financial reporting and the preparation of financial statements for external purposes in accordance with generally acceptedaccounting 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 anddispositions of our assets;·provide reasonable assurance that transactions are recorded as necessary to permit preparation of the consolidatedfinancial statements in accordance with generally accepted accounting principles, and that our receipts andexpenditures 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 ordisposition 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 inadequatebecause of changes in conditions or the degree of compliance with the policies or procedures may deteriorate. As of December 31, 2017, our management, with the participation of our Chief Executive Officer and Principal Financialand 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 InternalControl—Integrated Framework (2013 framework) issued by the Committee of Sponsoring Organizations of the TreadwayCommission. Based on its assessment, our management determined that, as of December 31, 2017, we maintained effectiveinternal control over financial reporting based on those criteria.75 Table of Contents In addition, the effectiveness of our internal control over financial reporting as of December 31, 2017 has been audited byErnst & Young, LLP, an independent registered public accounting firm. Changes in Internal Control Over Financial Reporting There were no changes in our internal controls over financial reporting during the quarter ended December 31, 2017 thathave materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.76 Table of ContentsReport of Independent Registered Public Accounting Firm The Stockholders and Board of Directors of Clovis Oncology, Inc. Opinion on Internal Control over Financial ReportingWe have audited Clovis Oncology, Inc.’s internal control over financial reporting as of December 31, 2017, based on criteriaestablished in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of theTreadway Commission (2013 framework) (the COSO criteria). In our opinion, Clovis Oncology Inc. (the Company)maintained, in all material respects, effective internal control over financial reporting as of December 31, 2017, based on theCOSO criteria. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States)(PCAOB), the consolidated balance sheets of the Company, as of December 31, 2017 and 2016, and the related consolidatedstatements of operations and comprehensive loss, stockholders' equity (deficit), and cash flows for each of the three years inthe period ended December 31, 2017, and the related notes and our report dated February 27, 2018 expressed an unqualifiedopinion thereon. Basis for OpinionThe Company’s management is responsible for maintaining effective internal control over financial reporting, and for itsassessment of the effectiveness of internal control over financial reporting included in the accompanying Management’sReport on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internalcontrol over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and arerequired to be independent with respect to the Company in accordance with the U.S federal securities laws and the applicablerules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and performthe audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained inall material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a materialweakness 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 areasonable basis for our opinion. Definition and Limitations of Internal Control Over Financial ReportingA company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding thereliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles. A company’s internal control over financial reporting includes those policies andprocedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect thetransactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded asnecessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and thatreceipts and expenditures of the company are being made only in accordance with authorizations of management anddirectors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorizedacquisition, 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 inadequatebecause of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. /s/ Ernst & Young LLP Denver, ColoradoFebruary 27, 2018 77 Table of Contents 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 byreference from our definitive proxy statement relating to our 2018 annual meeting of stockholders, pursuant to Regulation14A of the Securities Exchange Act of 1934, as amended, also referred to in this Form 10-K as our 2018 Proxy Statement,which we expect to file with the SEC no later than April 30, 2018. ITEM 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE Information regarding our directors, including the audit committee and audit committee financial experts, and executiveofficers and compliance with Section 16(a) of the Exchange Act will be included in our 2018 Proxy Statement and isincorporated herein by reference. We have adopted a Code of Business Ethics for all of our directors, officers and employees as required by NASDAQgovernance rules and as defined by applicable SEC rules. Stockholders may locate a copy of our Code of Business Ethics onour website at www.clovisoncology.com or request a copy without charge from: Clovis Oncology, Inc.Attention: Investor Relations5500 Flatiron Parkway, Suite 100Boulder, CO 80301 We will post to our website any amendments to the Code of Business Ethics and any waivers that are required to bedisclosed 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 2018 Proxy Statementand is incorporated herein by reference. ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT ANDRELATED STOCKHOLDER MATTERS The information required by this item regarding security ownership of certain beneficial owners and management will beincluded in the 2018 Proxy Statement and is incorporated herein by reference. ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTORINDEPENDENCE The information required by this item regarding certain relationships and related transactions and director independencewill be included in the 2018 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 2018 ProxyStatement and is incorporated herein by reference. 78 Table of Contents 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 theinformation 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.79 Table of ContentsINDEX TO EXHIBITS ExhibitNumber 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 MellonTrust Company, N.A. 10.1*(4) Amended and Restated Strategic License Agreement, dated as of June 16, 2011, by and between ClovisOncology, 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 Gillian C. Ivers-Read. 10.9+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Paul Klingenstein. 10.10+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and James C. Blair. 10.11+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Edward J.McKinley. 10.12+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Thorlef Spickschen. 10.13+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and M. James Barrett. 10.14+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Brian G. Atwood. 10.15+(1) Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Patrick J. Mahaffy. 10.16+(1) Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Erle T. Mast. 10.17+(1) Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Gillian C. Ivers-Read. 80 Table of ContentsExhibitNumber Exhibit Description10.18+(1) Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Andrew R. Allen. 10.19+(4) Clovis Oncology, Inc. 2011 Employee Stock Purchase Plan. 10.20+(4) Clovis Oncology, Inc. 2011 Cash Bonus Plan. 10.21+(6) Indemnification Agreement, dated as of March 22, 2012, by and between Clovis Oncology, Inc. and Steven L.Hoerter. 10.22+(2) Indemnification Agreement, dated as of June 13, 2013, between Clovis Oncology, Inc. and Ginger L. Graham. 10.23+(2) Indemnification Agreement, dated as of June 13, 2013, between Clovis Oncology, Inc. and Keith Flaherty. 10.24(7) Stock Purchase Agreement, dated as of November 19, 2013, by and among the Company, EOS, the Sellers listedon Exhibit A thereto and Sofinnova Capital V FCPR, acting in its capacity as the Sellers’ Representative. 10.25*(7) Development and Commercialization Agreement, dated as of October 24, 2008, by and between AdvenchenLaboratories LLC and Ethical Oncology Science S.p.A., as amended by the First Amendment, dated as of April13, 2010 and the Second Amendment, dated as of July 30, 2012. 10.26*(7) Collaboration and License Agreement, dated as of September 28, 2012, by and between Ethical OncologyScience S.p.A. and Les Laboratoires Servier and Institut de Recherches Internationales Servier. 10.27+(12) Indemnification Agreement, effective as of August 3, 2015, by and between Clovis Oncology, Inc. and LindseyRolfe. 10.28+(12) Employment Agreement, dated as of February 25, 2016, by and between Clovis Oncology, Inc. and LindseyRolfe. 10.29+(12) Indemnification Agreement, effective as of February 1, 2016, by and between Clovis Oncology, Inc. and DaleHooks. 10.30+(12) Employment Agreement, effective as of February 1, 2016, by and between Clovis Oncology, Inc. and DaleHooks. 10.31+(9) Indemnification Agreement, dated as of February 17, 2016, by and between Clovis Oncology, Inc. and DanielW. Muehl. 10.32+(15) Employment Agreement, dated as of July 6, 2017, by and between Clovis Oncology, Inc. and Daniel W. Muehl. 10.33+(10) Salary Waiver Letter, dated as of May 9, 2016, by and between Clovis Oncology, Inc. and Patrick J. Mahaffy. 10.34*(11) First Amendment to License Agreement, by and between Clovis Oncology, Inc. and Pfizer Inc., dated as ofAugust 30, 2016. 10.35+(13) Form of Clovis Oncology, Inc. 2011 Stock Incentive Plan RSU Agreement. 10.36*(13) Manufacturing Services Agreement, by and between Clovis Oncology, Inc. and Lonza Ltd, dated as of October3, 2016. 81 Table of ContentsExhibitNumber Exhibit Description10.37*(14) Strata Trial Collaboration Agreement, by and between Clovis Oncology, Inc. and Strata Oncology, Inc., datedas of January 30, 2017. 12.1 Computation of Ratios of Earnings to Fixed Charges 21.1(16) List of Subsidiaries of Clovis Oncology, Inc. 23.1 Consent of Independent Registered Public Accounting Firm 31.1 Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities ExchangeAct of 1934, as amended. 31.2 Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Actof 1934, as amended. 32.1 Certification of principal executive officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 ofthe Sarbanes-Oxley Act of 2002. 32.2 Certification of principal financial officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 ofthe 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.(13)Filed as an exhibit with the Registrant’s Annual Report on Form 10-K on February 23, 2017.(14)Filed as an exhibit with the Registrant’s Quarterly Report on Form 10-Q on May 4, 2017.(15)Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on July 7, 2017.(16)Filed as an exhibit with the Registrant’s Quarterly Report on Form 10-Q on August 3, 2017.+ Indicates management contract or compensatory plan.* Confidential treatment has been sought or granted with respect to portions of this exhibit, which portions have beenomitted and filed separately with the Securities and Exchange Commission.82 Table of Contents SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly causedthis report to be signed on its behalf by the undersigned, thereunto duly authorized. CLOVIS ONCOLOGY, INC. By:/S/ PATRICK J. MAHAFFY Patrick J. MahaffyDate: February 27, 2018 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 thefollowing persons on behalf of the registrant and in the capacities and on the dates indicated: Name Title Date /S/ PATRICK J. MAHAFFY President and Chief Executive Officer; Director(Principal Executive Officer) February 27, 2018Patrick J. Mahaffy /S/ DANIEL W. MUEHLDaniel W. Muehl Senior Vice President of Finance(Principal Financial Officer and Principal AccountingOfficer) February 27, 2018 /S/ BRIAN G. ATWOODBrian G. Atwood Director February 27, 2018 /S/ M. JAMES BARRETTM. James Barrett Director February 27, 2018 /S/ JAMES C. BLAIRJames C. Blair Director February 27, 2018 /S/ KEITH FLAHERTYKeith Flaherty Director February 27, 2018 /S/ GINGER L. GRAHAMGinger L. Graham Director February 27, 2018 /S/ PAUL KLINGENSTEINPaul Klingenstein Director February 27, 2018 /S/ EDWARD J. MCKINLEYEdward J. McKinley Director February 27, 2018 /S/ THORLEF SPICKSCHENThorlef Spickschen Director February 27, 2018 83 Table of ContentsINDEX TO CONSOLIDATED FINANCIAL STATEMENTS Index to Consolidated Financial Statements Report of Independent Registered Public Accounting Firm F-2 Consolidated Statements of Operations and Comprehensive Loss F-3 Consolidated Balance Sheets F-4 Consolidated Statements of Stockholders’ Equity (Deficit) F-5 Consolidated Statements of Cash Flows F-6 Notes to Consolidated Financial Statements F-7 F-1 Table of ContentsReport of Independent Registered Public Accounting Firm The Stockholders and Board of Directors of Clovis Oncology, Inc. Opinion on the Financial StatementsWe have audited the accompanying consolidated balance sheets of Clovis Oncology, Inc. (the Company) as of December 31,2017 and 2016, and the related consolidated statements of operations and comprehensive loss, stockholders' equity (deficit),and cash flows for each of the three years in the period ended December 31, 2017, and the related notes (collectively referredto as the consolidated “financial statements”). In our opinion, the consolidated financial statements present fairly, in allmaterial respects, the consolidated financial position of the Company at December 31, 2017 and 2016, and the consolidatedresults of its operations and its cash flows for each of the three years in the period ended December 31, 2017, in conformity ofU.S. generally accepted accounting principles. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States)(PCAOB), the Company’s internal control over financial reporting as of December 31, 2017, based on criteria established inInternal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission(2013 framework) and our report dated February 27, 2018 expressed an unqualified opinion thereon. Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinionon the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB andare required to be independent with respect to the Company in accordance with the U.S federal securities laws and theapplicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and performthe audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether dueto error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financialstatements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures includedexamining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits alsoincluded evaluating the accounting principles used and significant estimates made by management, as well as evaluating theoverall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2009. Denver, ColoradoFebruary 27, 2018 F-2 Table of Contents CLOVIS ONCOLOGY, INC. Consolidated Statements of Operations and Comprehensive Loss For the Year ended December 31, 2017 2016 2015 (in thousands, except per share amounts) Revenues: Product revenue, net $55,511 $78 $ — Operating expenses: Cost of sales - product 10,251 70 — Cost of sales - intangible asset amortization 1,486 — — Research and development 142,498 251,129 269,251 Selling, general and administrative 138,907 40,731 30,524 Acquired in-process research and development — 1,300 12,000 Impairment of intangible asset — 104,517 89,557 Change in fair value of contingent purchase consideration — (24,936) (24,611) Total expenses 293,142 372,811 376,721 Operating loss (237,631) (372,733) (376,721) Other income (expense): Interest expense (10,428) (8,491) (8,372) Foreign currency gain (loss) (82) (580) 2,740 Legal settlement loss (105,477) — — Other income 3,643 633 416 Other income (expense), net (112,344) (8,438) (5,216) Loss before income taxes (349,975) (381,171) (381,937) Income tax benefit 3,578 32,034 29,076 Net loss $(346,397) $(349,137) $(352,861) Other comprehensive income (loss): Foreign currency translation adjustments, net of tax 5,517 (357) (22,629) Net unrealized gain (loss) on available-for-sale securities, net of tax (110) 237 (383) Other comprehensive income (loss) 5,407 (120) (23,012) Comprehensive loss $(340,990) $(349,257) $(375,873) Loss per basic and diluted common share: Basic and diluted net loss per common share $(7.36) $(9.07) $(9.79) Basic and diluted weighted average common shares outstanding 47,047 38,478 36,026 See accompanying Notes to Consolidated Financial Statements.F-3 Table of Contents CLOVIS ONCOLOGY, INC. Consolidated Balance Sheets December 31, December 31, 2017 2016 ASSETS Current assets: Cash and cash equivalents $464,198 $216,186 Accounts receivable, net 6,181 121 Inventories 27,508 — Available-for-sale securities 99,533 49,997 Prepaid research and development expenses 1,559 6,427 Deposit on inventory 20,461 — Other current assets 7,500 6,679 Total current assets 626,940 279,410 Property and equipment, net 4,007 4,440 Intangible assets, net 19,561 21,047 Goodwill 65,217 57,192 Other assets 19,505 2,468 Total assets $735,230 $364,557 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable $15,147 $10,912 Accrued research and development expenses 18,465 35,198 Milestone liability 22,022 — Other accrued expenses 25,883 19,487 Total current liabilities 81,517 65,597 Milestone liability — 20,062 Convertible senior notes 282,406 281,126 Deferred rent, long-term 3,671 1,406 Total liabilities 367,594 368,191 Commitments and contingencies (Note 14) Stockholders' equity (deficit): Preferred stock, par value $0.001 per share; 10,000,000 shares authorized, no sharesissued and outstanding at December 31, 2017 and December 31, 2016 — — Common stock, $0.001 par value per share, 100,000,000 shares authorized atDecember 31, 2017 and December 31, 2016; 50,565,119 and 38,724,090 shares issuedand outstanding at December 31, 2017 and December 31, 2016 respectively 51 39 Additional paid-in capital 1,887,198 1,174,950 Accumulated other comprehensive loss (42,173) (47,580) Accumulated deficit (1,477,440) (1,131,043) Total stockholders' equity (deficit) 367,636 (3,634) Total liabilities and stockholders' equity (deficit) $735,230 $364,557 See accompanying Notes to Consolidated Financial Statements.F-4 Table of ContentsCLOVIS ONCOLOGY, INC. Consolidated Statements of Stockholders’ Equity (Deficit) Accumulated Additional Other Common Stock Paid-In Comprehensive Accumulated Shares Amount Capital Income (Loss) Deficit Total (in thousands, except for share amounts) Balance at January 1,2015 33,977,187 $34 $785,089 $(24,448) $(429,045) $331,630 Issuance of common stock, net of issuancecosts of $17,741 4,054,487 4 298,505 — — 298,509 Issuance of common stock under employeestock purchase plan 32,021 — 493 — — 493 Exercise of stock options 295,759 — 5,534 — — 5,534 Share-based compensation expense — — 40,357 — — 40,357 Net unrealized loss on available-for-salesecurities — — — (383) — (383) Foreign currency translation adjustments — — — (22,629) — (22,629) Net loss — — — — (352,861) (352,861) Balance at December 31, 2015 38,359,454 38 1,129,978 (47,460) (781,906) 300,650 Issuance of common stock under employeestock purchase plan 110,508 — 1,965 — — 1,965 Exercise of stock options 247,431 1 3,268 — — 3,269 Issuance of common stock from vesting ofrestricted stock units, net of shares withheldfor taxes 6,697 — (57) — — (57) Share-based compensation expense — — 39,796 — — 39,796 Net unrealized gain on available-for-salesecurities — — — 237 — 237 Foreign currency translation adjustments — — — (357) — (357) Net loss — — — — (349,137) (349,137) Balance at December 31, 2016 38,724,090 39 1,174,950 (47,580) (1,131,043) (3,634) Issuance of common stock, net of issuancecosts 9,670,454 10 545,828 — — 545,838 Issuance of common stock under employeestock purchase plan 51,681 — 2,312 — — 2,312 Exercise of stock options 465,690 1 13,924 — — 13,925 Issuance of common stock from vesting ofrestricted stock units, net of shares withheldfor taxes 180,912 — — — — — Share-based compensation expense — — 44,707 — — 44,707 Legal settlement 1,472,324 1 105,477 — — 105,478 Net unrealized loss on available-for-salesecurities — — — (110) — (110) Foreign currency translation adjustments — — — 5,517 — 5,517 Net loss — — — — (346,397) (346,397) Balance at December 31, 2017 50,565,151 $51 $1,887,198 $(42,173) $(1,477,440) $367,636 See accompanying Notes to Consolidated Financial Statements.F-5 Table of ContentsCLOVIS ONCOLOGY, INC. Consolidated Statements of Cash Flows Year ended December 31, 2017 2016 2015 (in thousands) Operating activities Net loss $(346,397) $(349,137) $(352,861) Adjustments to reconcile net loss to net cash used in operating activities: Share-based compensation expense 44,707 39,796 40,357 Depreciation and amortization 2,504 1,141 761 Amortization of premiums and discounts on available-for-sale securities 354 211 1,400 Amortization of debt issuance costs 1,279 1,242 1,205 Legal settlement loss 105,477 — — Impairment of intangible asset — 104,517 89,557 Change in fair value of contingent purchase consideration — (24,661) (27,792) Loss on disposal of property and equipment — 105 39 Deferred income taxes (3,218) (31,771) (28,874) Changes in operating assets and liabilities: Accounts receivable (6,061) (121) — Inventory (27,508) — — Prepaid and accrued research and development expenses (17,297) (15,364) 14,122 Deposit on inventory (20,461) — — Other operating assets (6,476) 1,039 (4,380) Accounts payable 5,637 (1,544) 8,105 Other accrued expenses 6,556 7,867 5,295 Net cash used in operating activities (260,904) (266,680) (253,066) Investing activities Purchases of property and equipment (487) (766) (3,035) Proceeds from sale of property and equipment — 65 — Deposits for purchases of property and equipment (2,515) — — Purchases of available-for-sale securities (263,500) — (392,540) Sales of available-for-sale securities 213,500 200,000 140,997 Acquired in-process research and development - milestone payment (1,100) — — Net cash (used in) provided by investing activities (54,102) 199,299 (254,578) Financing activities Proceeds from the sale of common stock, net of issuance costs 545,838 — 298,509 Proceeds from the exercise of stock options and employee stock purchases 16,237 5,176 5,971 Net cash provided by financing activities 562,075 5,176 304,480 Effect of exchange rate changes on cash and cash equivalents 943 (365) (757) Increase (decrease) in cash and cash equivalents 248,012 (62,570) (203,921) Cash and cash equivalents at beginning of period 216,186 278,756 482,677 Cash and cash equivalents at end of period $464,198 $216,186 $278,756 Supplemental disclosure of cash flow information: Cash paid for interest $7,188 $7,188 $7,307 Non-cash investing and financing activities: Acquired in-process research and development - milestone not paid as of periodend $ — $21,100 $ — Vesting of restricted stock units $12,170 $175 $ — See accompanying Notes to Consolidated Financial Statements.F-6 Table of Contents CLOVIS ONCOLOGY, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. Nature of Business We are a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-canceragents in the United States, Europe and additional international markets. We target our development programs for thetreatment of specific subsets of cancer populations, and simultaneously develop, with partners, diagnostic tools intended todirect a compound in development to the population that is most likely to benefit from its use. We have and intend tocontinue to license or acquire rights to oncology compounds in all stages of clinical development. In exchange for the rightto develop and commercialize these compounds, we generally expect to provide the licensor with a combination of upfrontpayments, milestone payments and royalties on future sales. In addition, we generally expect to assume the responsibility forfuture drug development and commercialization costs. We currently operate in one segment. Since inception, our operationshave consisted primarily of developing in-licensed compounds, evaluating new product acquisition candidates and generalcorporate activities. Our marketed product Rubraca® (rucaparib) is approved on an accelerated basis in the United States by the FDA asmonotherapy 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 morechemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Continued approvalfor this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Welaunched Rubraca in the United States in December 2016 for this indication. The FDA is currently reviewing on a priority review timeline our sNDA for Rubraca as maintenance treatment of adultpatients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partialresponse to platinum-based chemotherapy. Our MAA submitted to the European Union’s EMA for an ovarian cancer treatment indication for Rubraca is currentlyunder review by the EMA’s CHMP. Following a Scientific Advisory Group - Oncology meeting and an oral explanation byus before the CHMP in February 2018, the CHMP has communicated a positive trend vote for the MAA and their intention tohold a final vote on the treatment indication at their March 2018 meeting. Liquidity We have incurred significant net losses since inception and have relied on our ability to fund our operations through debtand equity financings. We expect operating losses and negative cash flows to continue for the foreseeable future. As wecontinue to incur losses, transition to profitability is dependent upon achieving a level of revenue from Rubraca adequate tosupport our cost structure. We may never achieve profitability, and unless and until it does, we will continue to need to raiseadditional 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 proceedsfrom the offering were $221.2 million, after deducting underwriting discounts and commissions and offering expenses. InJune 2017, we sold 3,920,454 shares of our common stock in a public offering at $88.00 per share. The net proceeds from theoffering were $324.6 million, after deducting underwriting discounts and commissions and offering expenses. We intend touse the net proceeds of the offerings for general corporate purposes, including commercial planning and sales and marketingexpenses associated with the launch of Rubraca in the United States and, if approved by the European Commission inEurope, funding of its development programs, selling, general and administrative expenses, acquisition or licensing ofadditional 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. F-7 Table of Contents 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in accordance with U.S. generally accepted accountingprinciples (“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. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates andassumptions that affect the reported amounts of assets, liabilities, expenses and revenue and related disclosures. On anongoing basis, we evaluate our estimates, including estimates related to revenue, intangible asset impairment, clinical trialaccruals and share-based compensation expense. We base our estimates on historical experience and other market-specific orother relevant assumptions that we believe to be reasonable under the circumstances. Actual results may differ from thoseestimates or assumptions. Revenue Recognition We are currently approved to sell Rubraca in the United States market. We distribute our product principally through alimited number of specialty distributor and specialty pharmacy providers, collectively, our customers. Our customerssubsequently sell our products to patients and health care providers. Separately, we have arrangements with certain payorsand 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 andtitle of the product and associated risk of loss has passed to the customer, the price is fixed or determinable, collection fromthe customer has been reasonably assured and all performance obligations have been met and returns and allowances can bereasonably estimated. Product sales are recorded net of estimated rebates, chargebacks, discounts and other deductions aswell as estimated product returns. Estimating rebates, chargebacks, discounts, product returns and other deductions requiressignificant judgments about future events and uncertainties, and requires us to rely heavily on assumptions, as well ashistorical experience. We only recognize revenue on product sales once the product is sold to the patient or healthcareprovider by the specialty distributor or specialty pharmacy provider, therefore reducing the significance of estimates madefor product returns. For the year ended December 31, 2017, we recognized $55.5 million of product revenue. Based on our policy to expensecosts associated with the manufacture of our products prior to regulatory approval, certain of the costs of Rubraca unitsrecognized as revenue during the year ended December 31, 2017 were expensed prior to the December 19, 2016 FDAapproval, and a minimal amount is included in cost of sales during the current period. We expect cost of sales to increase inrelation to product revenues as we deplete these inventories. The majority of products sales were of pre-commercializationinventory in 2017. Product revenue from each of our customers who individually accounted for 10% or more of total revenues consisted ofthe following: December 31, 2017Customer A 35%Customer B 27%Customer C 12%Customer D 10% Effective January 1, 2018, we adopted ASC 606, the new revenue recognition standard, using the modified retrospectivemethod. For a complete discussion of this adoption and the accounting for net product revenue, see the Recently IssuedAccounting Standards section below and Note 11, Revenue Recognition. F-8 Table of ContentsFair 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 valuegiven 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 becash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily incertificate 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 includedin accumulated other comprehensive loss on the Consolidated Balance Sheets. Realized gains and losses, amortization ofpremiums and discounts and interest and dividends earned are included in other income (expense) on the ConsolidatedStatements of Operations and Comprehensive Loss. The cost of investments for purposes of computing realized andunrealized gains and losses is based on the specific identification method. Investments with maturities beyond one year areclassified as short-term based on our intent to fund current operations with these securities or to make them available forcurrent operations. A decline in the market value of a security below its cost that is deemed to be other than temporary is charged to earningsand 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 businessprospects of the issuer; adverse changes in the general market conditions in which the issuer operates; and our intent andability to hold the security until an anticipated recovery in value occurs. Accounts Receivable As of December 31, 2017 and 2016, we had no allowance for doubtful accounts. We provide an allowance for doubtfulaccounts based on experience and specifically identified risks. Accounts receivable are carried at fair value and charged offagainst the allowance for doubtful accounts when we determine that recovery is unlikely and we cease collection efforts. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated usingthe straight-line method over the estimated useful lives of the assets. Equipment purchased for use in manufacturing andclinical trials is evaluated to determine whether the equipment is solely beneficial for a drug candidate in the developmentstage or whether it has an alternative use. Equipment with an alternative use is capitalized. Leasehold improvements areamortized over the economic life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed asincurred. The estimated useful lives of our capitalized assets are as follows: Estimated Useful Life Computer hardware and software 3 to 5 years Leasehold improvements 6 years Laboratory, manufacturing and office equipment 5 to 7 years Furniture and fixtures 10 years Long-Lived Assets We review long-lived assets for impairment when events or changes in circumstances indicate that the carrying value ofthe assets may not be recoverable. Recoverability is measured by comparison of the assets’ book value to future netundiscounted cash flows that the assets are expected to generate. If the carrying value of the assets exceed their future netundiscounted cash flows, an impairment charge is recognized for the amount by which the carrying value of the assetsexceeds the fair value of the assets. F-9 Table of ContentsIntangible Assets, Net Definite-lived intangible assets related to capitalized milestones under license agreements are amortized on a straight-linebasis over their remaining useful lives, which are estimated to be the remaining patent life. If our estimate of the product’suseful life is shorter than the remaining patent life, then a shorter period is used. Amortization expense is recorded as acomponent of cost of sales on the Consolidated Statements of Operations and Comprehensive Loss. Intangible acquired in-process research and development (“IPR&D”) assets were established as part of the acquisition ofEthical 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 impairmentindicators exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the decisionto discontinue the development of a drug, the receipt of additional clinical or nonclinical data regarding our drug candidateor a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or newinformation regarding potential sales for the drug. In connection with any impairment assessment, the fair value of theintangible assets as of the date of assessment is compared to the carrying value of the intangible asset. Impairment losses arerecognized if the carrying value of an intangible asset is both not recoverable and exceeds its fair value. During the secondquarter of 2016, we recorded a $104.5 million impairment charge to the IPR&D intangible assets, reducing the remainingcarrying value to zero (see Note 6, Intangible Assets and Goodwill). Previously, the Company recorded an $89.6 millionimpairment charge to the IPR&D intangible assets during the fourth quarter of 2015. Goodwill Goodwill represents the excess of the purchase price over the fair value of net assets acquired in a business combinationaccounted for under the acquisition method of accounting and is not amortized, but is subject to impairment testing at leastannually in the fourth quarter or when a triggering event is identified that could indicate a potential impairment. We areorganized as a single reporting unit and perform impairment testing by comparing the carrying value of the reporting unit tothe 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): December 31, December 31, 2017 2016 Receivable from partners $ 9 $2,882 Prepaid insurance 1,926 1,234 Prepaid expenses - other 3,355 2,109 Receivable - other 2,023 364 Other 187 90 Total $7,500 $6,679 F-10 Table of ContentsOther Accrued Expenses Other accrued expenses are comprised of the following (in thousands): December 31, December 31, 2017 2016 Accrued personnel costs $13,889 $15,850 Accrued interest payable 2,096 2,096 Income tax payable — 556 Accrued corporate legal fees and professional services 415 589 Accrued royalties 2,984 — Accrued sales deductions 1,008 — Payable to third party logistics provider 2,661 — Accrued expenses - other 2,830 396 Total $25,883 $19,487 Valuation of Contingent Consideration Resulting from a Business Combination Subsequent to the acquisition date, we re-measure contingent consideration arrangements at fair value each reportingperiod and record changes in fair value to change in fair value of contingent purchase consideration and foreign currencygains (losses) for changes in the foreign currency translation rate on the Consolidated Statements of Operations andComprehensive Loss. Changes in fair value are primarily attributed to new information about the IPR&D assets, includingchanges in timeline and likelihood of success, and the passage of time. In the absence of new information, changes in fairvalue reflect only the passage of time. During the fourth quarter of 2015, we recorded a $26.9 million reduction in the fairvalue of the contingent purchase consideration liability due to a change in the estimated probability-weighted futurediscounted milestone payments, as well as the timing of such payments, for the lucitanib program. Then, during the secondquarter of 2016, we recorded a $25.5 million reduction in the fair value of the contingent purchase consideration liabilitydue to our and our development partner’s decision to discontinue the development of lucitanib for breast cancer. AtDecember 31, 2017, the contingent purchase consideration liability recorded on the Consolidated Balance Sheets remainedat zero due to the uncertainty of achieving any of the lucitanib regulatory milestones, and therefore the remote likelihood offuture milestone payouts. Research and Development Expense Research and development costs are charged to expense as incurred and include, but are not limited to, salary andbenefits, share-based compensation, clinical trial activities, drug development and manufacturing, companion diagnosticdevelopment and third-party service fees, including contract research organizations and investigative sites. During 2015, wecompleted the hiring of our U.S. sales and marketing and medical affairs organizations in preparation for the potentialcommercial launch of Rubraca. These costs were also included in research and development expense before the FDAapproval of Rubraca. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress tocompletion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us byour vendors on their actual costs incurred. Payments for these activities are based on the terms of the individualarrangements, which may differ from the pattern of costs incurred and are reflected on the Consolidated Balance Sheets asprepaid 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. Theupfront payments to acquire a new drug compound, as well as subsequent milestone payments, are immediately expensed asacquired in-process research and development provided that the drug has not achieved regulatory approval for marketingand, absent obtaining such approval, has no alternative future use. Once regulatory approval is received, payments toacquire rights, and the related milestone payments, are capitalized and the amortization of such assets recorded to productcost of sales. F-11 Table of ContentsShare-Based Compensation Expense Share-based compensation is recognized as expense for all share-based awards made to employees and directors and isbased on estimated fair values. We determine equity-based compensation at the grant date using the Black-Scholes optionpricing model. The value of the award that is ultimately expected to vest is recognized as expense on a straight-line basisover 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 tothe regulatory approval of Rubraca, we incurred expenses for the manufacture of drug that could potentially be available tosupport the commercial launch of Rubraca. Until the first reporting period when regulatory approval has been received, werecord all such costs as research and development expense. We periodically analyze our inventory levels, and write downinventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and/orinventory in excess of expected sales requirements as cost of product revenues. Expired inventory would be disposed of andthe related costs would be written off as cost of product revenues. The active pharmaceutical ingredient in Rubraca is currently produced by a single supplier. At December 31, 2017, deposit on inventory on the Consolidated Balance Sheets is a cash deposit of $20.5 million madeto a manufacturer for the purchase of inventory which we expect to be converted to finished goods within the next twelvemonths. Concentration of Credit Risk Financial instruments that potentially subject us to concentrations of credit risk are primarily cash, cash equivalents andavailable-for-sale securities. We maintain our cash and cash equivalent balances in the form of money market accounts withfinancial institutions that we believe are creditworthy. Available-for-sale securities are invested in accordance with ourinvestment policy. The investment policy includes guidelines on the quality of the institutions and financial instruments anddefines allowable investments that we believe minimizes the exposure to concentration of credit risk. We have no financialinstruments 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 resultsof operations are translated at the average exchange rates for the reported periods. The resulting translation adjustments areincluded in accumulated other comprehensive loss on the Consolidated Balance Sheets. Transactions denominated incurrencies 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 Operationsand Comprehensive Loss. As of December 31, 2017 and 2016, approximately 1% of our total liabilities were denominated incurrencies other than the functional currency. Income Taxes We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for thefuture tax consequences attributable to differences between the financial statement carrying amounts of existing assets andliabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected toaffect taxable income. Tax benefits are recognized when it is more likely than not that a tax position will be sustained duringan audit. Deferred tax assets are reduced by a valuation allowance if current evidence indicates that it is considered morelikely than not that these benefits will not be realized. Recently Adopted Accounting Standards In March 2016, the FASB issued Accounting Standards Update No. 2016-09, Compensation – Stock Compensation(Topic 718): Improvements to Employee Share-Based Payment Accounting" (ASU 2016-09). ASU 2016-09 simplifies howseveral aspects of share-based payments are accounted for and presented in the financial statements. ASU 2016-09 is effectivefor public companies for annual reporting periods beginning after December 15, 2016. We adopted this ASUF-12 Table of Contentsin the first quarter of 2017. We had excess tax benefits for which a benefit could not be previously recognized ofapproximately $18.2 million. Upon adoption the balance of the unrecognized excess tax benefits were reversed with theimpact recorded to retained earnings including any change to the valuation allowance as a result of the adoption. Due to thefull valuation allowance on the U.S. deferred tax assets, there is no impact to the financial statements as a result of thisadoption. Recently Issued Accounting Standards In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, “Revenue from Contractswith Customers” and has subsequently issued several supplemental and/or clarifying ASUs (collectively, “ASC 606”). ASC606 prescribes a single common revenue standard that replaces most existing U.S. GAAP revenue recognition guidance. ASC606 is intended to provide a more consistent interpretation and application of the principles outlined in the standard acrossfilers in multiple industries and within the same industries compared to current practices, which should improvecomparability. Adoption of ASC 606 is required for annual and interim periods beginning after December 15, 2017. Uponadoption, we must elect to adopt either retrospectively to each prior reporting period presented or use the modifiedretrospective transition method with the cumulative effect of initial adoption recognized at the date of initial application. Wehave elected to apply the new standard using the modified retrospective method upon its adoption date on January 1, 2018. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in anamount that reflects the consideration which the entity expects to receive in exchange for those goods or services. Todetermine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entityperforms the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in thecontract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in thecontract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. ASC 606 also impacts certainother areas, such as the accounting for costs to obtain or fulfill a contract. The standard also requires disclosure of the nature,amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. We have examined our revenue recognition policy specific to revenue streams from representative contracts governingproduct sales from Rubraca and have come to conclusions on the impact of the new standard using the 5-step processprescribed by ASC 606. We have reviewed a representative sample of contracts, including our collaboration agreements withServier and Bristol-Myers Squibb discussed in Note 13, License Agreements, and determined the potential impact to ouraccounting policies, financial controls and operations. Our conclusions include recognizing revenue on product sales oncethe product is sold to the specialty distributor and specialty pharmacy providers. Currently, we anticipate the effects ofadoption to be as described in Note 11, Revenue Recognition. In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” which requires lessees to recognize assets andliabilities for the rights and obligations created by most leases on their balance sheet. The guidance is effective for fiscalyears beginning after December 15, 2018, including interim periods within those fiscal years. Early application is permitted.We plan to adopt on January 1, 2019. ASU 2016-02 requires modified retrospective adoption for all leases existing at, orentered into after, the date of initial application, with an option to use certain transition relief. We are currently evaluatingthe impact the standard may have on our consolidated financial statements and related disclosures. In January 2017, the FASB issued ASU No. 2017-01, “Clarifying the Definition of a Business,” which clarifies thedefinition of a business in ASC 805. The guidance is effective for fiscal years beginning after December 15, 2017, includinginterim periods within those fiscal years. Early application is permitted. We adopted this standard on January 1, 2018 and theadoption resulted in no change to our consolidated financial statements and related disclosures. In May 2017, the FASB issued ASU 2017-09, “Compensation – Stock Compensation (Topic 718): Scope of ModificationAccounting”, which amends the scope of modification accounting for share-based payment arrangements. The ASU providesguidance on the types of changes to the terms or conditions of share-based payment awards to which we would be required toapply modification accounting under ASC 718. Specifically, we would not apply modification accounting if the fair value,vesting conditions, and classification of the awards are the same immediately before and after the modification. The guidanceis effective for annual reporting periods, including interim periods within those annual periods, beginning after December 15,2017. Early adoption is permitted, including adoption in any interimF-13 Table of Contentsperiod. We adopted this standard on January 1, 2018 and the adoption resulted in no change to our consolidated financialstatements and related disclosures. 3. Property and Equipment Property and equipment consisted of the following (in thousands): December 31, 2017 2016 Laboratory, manufacturing and office equipment $2,853 $2,555 Leasehold improvements 2,285 2,276 Furniture and fixtures 1,416 1,411 Computer hardware and software 1,141 855 Total property and equipment 7,695 7,097 Less: accumulated depreciation (3,688) (2,657) Total property and equipment, net $4,007 $4,440 Depreciation expense related to property and equipment was approximately $1.0 million, $1.1 million and $0.8 millionfor the years ended December 31, 2017, 2016 and 2015, 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 exitprice) in the principal or most advantageous market for the asset or liability in an orderly transaction between marketparticipants 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 marketinvestments. 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 activemarkets or other inputs that are observable or can be corroborated by observable market data for substantially thefull term of the assets or liabilities. Our Level 2 assets consist of U.S. treasury securities. We do not have Level 2liabilities. Level 3:Unobservable inputs that are supported by little or no market activity. We do not have Level 3 assets. Thecontingent purchase consideration related to the undeveloped lucitanib product rights acquired with thepurchase of EOS in November 2013 is a Level 3 liability. The fair value of this liability is based on unobservableinputs and includes valuations for which there is little, if any, market activity. During the second quarter of2016, we recorded a $25.5 million reduction in the fair value of the contingent purchase consideration liabilitydue 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 31,2017. The change in the fair value of Level 3 instruments is included in change in fair value of contingent purchaseconsideration and foreign currency gains (losses) for changes in the foreign currency translation rate on theConsolidated Statements of Operations and Comprehensive Loss. F-14 Table of ContentsThe following table identifies our assets that were measured at fair value on a recurring basis (in thousands): Balance Level 1 Level 2 Level 3 December 31, 2017 Assets: Money market $433,136 $433,136 $ — $ — U.S. treasury securities 99,533 — 99,533 — Total assets at fair value $532,669 $433,136 $99,533 $ — December 31, 2016 Assets: Money market $202,361 $202,361 $ — $ — U.S. treasury securities 49,997 — 49,997 — Total assets at fair value $252,358 $202,361 $49,997 $ — There were no liabilities that were measured at fair value on a recurring basis as of December 31, 2017. There were notransfers between the Level 1 and Level 2 categories or into or out of the Level 3 category during the year ended December31, 2017.Financial instruments not recorded at fair value include our convertible senior notes. At December 31, 2017, the carryingamount of the convertible senior notes was $282.4 million, which represents the aggregate principal amount net of remainingdebt issuance costs, and the fair value was $388.3 million. The fair value was determined using Level 2 inputs based on theindicative pricing published by certain investment banks or trading levels of the convertible senior notes, which are notlisted on any securities exchange or quoted on an inter-dealer automated quotation system. See Note 7, Convertible SeniorNotes for discussion of the convertible senior notes. The carrying amounts of accounts payable and accrued expensesapproximate their fair value due to their short-term maturities. 5. Available-for-Sale Securities As of December 31, 2017, available-for-sale securities consisted of the following (in thousands): Gross Gross Aggregate Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. treasury securities $99,650 $ — $(117) $99,533 As of December 31, 2017, the fair value and gross unrealized losses of available-for-sale securities that have been in acontinuous unrealized loss position for less than 12 months were as follows (in thousands): Aggregate Gross Fair Unrealized Value Losses U.S. treasury securities $99,533 $(117) Our investments have been in an unrealized loss position for two months. Based upon our evaluation of all relevantfactors, we believe that the decline in fair value of securities held at December 31, 2017 below cost is temporary, and weintend 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, 2017, the amortized cost and fair value of available-for-sale securities by contractual maturity were (inthousands): Amortized Fair Cost Value Due in one year or less $99,650 $99,533 Due in one year to two years — — Total $99,650 $99,533 F-15 Table of Contents6. Inventories The following table presents inventories as of December 31, 2017 and December 31, 2016 (in thousands): December 31, 2017 2016 Work in process $24,721 $ — Finished goods 2,787 — Total $27,508 $ — At December 31, 2017, deposit on inventory on the Consolidated Balance Sheets is a cash deposit of $20.5 million madeto a manufacturer for the purchase of inventory which we expect to be converted to finished goods within the next twelvemonths. 7. Intangible Assets and Goodwill At December 31, 2017 and 2016, intangible assets related to capitalized milestones under license agreements consisted ofthe following (in thousands): December 31, 2017 2016 Intangible asset - milestones $21,100 $21,100 Accumulated amortization (1,539) (53) Total intangible asset, net $19,561 $21,047 The estimated useful lives of these intangibles assets extended through 2031. We recorded an amortization expense of $1.5 million and $0.053 million related to capitalized milestone paymentsduring the year ended December 31, 2017 and December 31, 2016, respectively. Estimated future amortization expense forintangible assets as of December 31, 2017 is as follows (in thousands): 2018 $1,486 2019 1,486 2020 1,486 2021 1,486 2022 1,486 Thereafter 12,131 $19,561 IPR&D assets and goodwill were established as part of the purchase accounting of EOS in November 2013, and consistedof the following (in thousands): December 31, 2017 2016 IPR&D assets: Balance at beginning of period $ — $101,500 Impairment of intangible asset (a) — (104,517) Change in foreign currency gains and losses — 3,017 Balance at end of period $ — $ — Goodwill: Balance at beginning of period $57,192 $59,327 Change in foreign currency gains and losses 8,025 (2,135) Balance at end of period $65,217 $57,192 F-16 Table of Contents(a)During the second quarter of 2016, we recorded a $104.5 million impairment charge due to our and our developmentpartner’s decision to discontinue the development of lucitanib for breast cancer. At December 31, 2017, the IPR&Dintangible 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 developmentpartner’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 andComprehensive Loss. As of December 31, 2017, no impairment to the carrying value of the goodwill was identified. 8. 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 offeringexpenses. In accordance with the accounting guidance, the conversion feature did not meet the criteria for bifurcation, andthe 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 MellonTrust 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 dayimmediately preceding the maturity date. Upon conversion, the holders will receive shares of our common stock at an initialconversion 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 theindenture, but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events thatoccur prior to the maturity date or upon our issuance of a notice of redemption, we will increase the conversion rate forholders who elect to convert the Notes in connection with such a corporate event or during the related redemption period incertain 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 priceof our common stock has been at least 150% of the conversion price then in effect for at least 20 trading days (whether or notconsecutive) during any 30 consecutive trading day period ending not more than two trading days preceding the date onwhich we provide written notice of redemption at a redemption price equal to 100% of the principal amount of the Notes tobe redeemed plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for theNotes. If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the Notes, holders mayrequire us to repurchase for cash all or any portion of the Notes at a fundamental change repurchase price equal to 100% ofthe principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamentalchange repurchase date. The Notes rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment tothe Notes; equal in right of payment to all of our liabilities that are not so subordinated; effectively junior in right ofpayment to any secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurallyjunior 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 areamortized as interest expense over the expected life of the Notes using the effective interest method. We determined theexpected life of the debt was equal to the seven-year term of the Notes. As of December 31, 2017 and 2016, theF-17 Table of Contentsbalance of unamortized debt issuance costs was $5.1 million and $6.4 million, respectively, and is recorded as a reduction tothe convertible senior notes at the Consolidated Balance Sheets. The following table sets forth total interest expense to the Notes and the milestone liability during the years endedDecember 31, 2017 and 2016 (in thousands): Year ended December 31, 2017 2016 2015Contractual interest expense $7,188 $7,187 $7,167Accretion of interest on milestone liability 1,961 62 —Amortization of debt issuance costs 1,279 1,242 1,205Total interest expense $10,428 $8,491 $8,3729. Stockholders’ Equity Common Stock In July 2015, we sold 4,054,487 shares of our common stock in a public offering at $78.00 per share. The net proceedsfrom 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 proceedsfrom the offering were $221.2 million, after deducting underwriting discounts and commissions and offering expenses. In June 2017, we sold 3,920,454 shares of our common stock in a public offering at $88.00 per share. The net proceedsfrom the offering were $324.6 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 stockare 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 includeschanges in a subsidiary’s functional currency, and unrealized gains and losses on available-for-sale securities. The accumulated balances related to each component of other comprehensive income (loss) are summarized as follows (inthousands): Foreign Currency Unrealized Total Accumulated TranslationAdjustments (Losses) Gains Other ComprehensiveLossBalance at December 31, 2015 $(47,077) $(383) $(47,460)Other comprehensive income (loss) (1,693) 224 (1,469)Total before tax (48,770) (159) (48,929)Tax effect 1,336 13 1,349Balance at December 31, 2016 (47,434) (146) (47,580)Other comprehensive income (loss) 8,735 (110) 8,625Total before tax (38,699) (256) (38,955)Tax effect (3,218) — (3,218)Balance at December 31, 2017 $(41,917) $(256) $(42,173) The other comprehensive income (loss) related to foreign currency translation adjustments was primarily due to thecurrency translation of the IPR&D intangible assets, goodwill and deferred income taxes (see Note 7, Intangible AssetsF-18 Table of Contentsand Goodwill). There were no reclassifications out of accumulated other comprehensive loss in the years ended December 31,2017, 2016 and 2015. 10. Share-Based Compensation Stock Options In August 2011, our Board of Directors approved the 2011 Stock Incentive Plan (the “2011 Plan”), which becameeffective upon the closing of our initial public offering in November 2011. The 2011 Plan provides for the granting ofincentive and nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, performanceawards and other share-based awards to our employees, directors and consultants. Common shares authorized for issuanceunder the 2011 Plan were 9,590,378 at December 31, 2017, which represents the initial reserve of 1,250,000 shares ofcommon 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 8,148,193 newshares authorized by the Board of Directors at the annual meetings of stockholders. Future forfeitures and cancellations ofoptions previously granted under the 2009 Plan were transferred to and also available for grant under the 2011 Plan. Stockoptions granted vest ratably over either a one-year period or three-year period for Board of Director grants. Employee stockoptions generally vest over a four-year period with 25% of the options cliff-vesting after year one and the remaining optionsvesting 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, 2017, 2016 and 2015, respectively, was recognizedin the accompanying Consolidated Statements of Operations and Comprehensive Loss as follows (in thousands): Year ended December 31, 2017 2016 2015 Research and development $20,335 $27,558 $27,321 Selling, general and administrative 24,372 12,238 13,036 Total share-based compensation expense $44,707 $39,796 $40,357 We did not recognize a tax benefit related to share-based compensation expense during the years ended December 31,2017, 2016 and 2015 as we maintain net operating loss carryforwards and have established a valuation allowance against theentire net deferred tax asset as of December 31, 2017. The following table summarizes the activity relating to our options to purchase common stock: Weighted Weighted Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Options Price Term (Years) (Thousands) Outstanding at December 31, 20165,520,482$42.00Granted1,048,70066.09Exercised(465,690)29.90Forfeited(313,757)49.20Outstanding at December 31, 2017 (a)5,789,735$46.777.1$145,067Vested and expected to vest at December 31, 20175,505,557$46.527.0$139,526Vested and exercisable at December 31, 20173,481,931$44.606.1$95,463(a)Includes 33,750 performance-based stock options granted to our executives in the first quarter of 2015, which vested onapproval by the FDA in December 19, 2016 to commercially distribute, sell or market Rubraca. Related stockcompensation 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$68.00 as of December 31, 2017, 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. F-19 Table of ContentsThe following table summarizes information about our stock options as of and for the years ended December 31, 2017,2016 and 2015: Year ended December 31, 2017 2016 2015 Weighted-average grant date fair value per share $48.79 $16.62 $52.70 Intrinsic value of options exercised $18,986,726 $3,118,097 $19,976,769 Cash received from stock option exercises $13,924,174 $3,267,721 $5,478,211 The fair value of each share-based award is estimated on the grant date using the Black-Scholes option pricing modelbased upon the weighted-average assumptions provided in the following table: Year ended December 31, 2017 2016 2015 Dividend yield — — — Volatility (a) 89% 93% 72%Risk-free interest rate (b) 2.16% 1.77% 1.77%Expected term (years) (c) 5.8 5.8 6.1 (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 whosematurity 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, 2017, 2016 and 2015 was $36.0million, $40.8 million and $36.5 million, respectively. Restricted Stock During 2016, we issued restricted stock units (“RSUs”) to certain employees under the 2011 Stock Incentive Plan. TheRSUs vest either (i) over two years, with 50% vesting one year from the date of grant and the remaining 50% vesting twoyears from the date of grant or (ii) over four years, with 25% vesting one year from the date of grant and the remaining 75%vesting ratably each subsequent quarter over the following three years, as defined in the grant agreement. Vested RSUs arepayable in shares of our common stock at the end of the vesting period. RSUs are measured based on the fair value of theunderlying stock on the grant date. The minimum statutory tax on the value of common stock shares issued to employeesupon vesting are paid by us through the sale of registered shares of our common stock. F-20 Table of ContentsThe following table summarizes the activity related to our unvested RSUs: Weighted Average Number of Grant Date Units Fair Value Unvested at December 31, 2016 562,458 $24.70 Granted 249,984 64.66 Vested (180,912) 23.83 Forfeited (42,001) 28.09 Unvested as of December 31, 2017 589,529 $41.67 Expected to vest after December 31, 2017 513,069 $41.40 Unrecognized share-based compensation expense related to non-vested options and RSUs, adjusted for expected forfeitures,was $89.4 million as of December 31, 2017. The unrecognized share-based compensation expense is expected to berecognized over the weighted-average remaining vesting period of 3.3 years. Common Stock Reserved for Issuance As of December 31, 2017, we reserved shares of common stock for future issuance as follows: Available for Grant Total Shares of CommonStock or Future Common Stock Outstanding Issuance Reserved 2009 Equity Incentive Plan 331,213 — 331,213 2011 Stock Incentive Plan 6,048,051 2,589,033 8,637,084 2011 Employee Stock Purchase Plan — 558,870 558,870 Total 6,379,264 3,147,903 9,527,167 Employee Stock Purchase Plan 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 ofadditional shares of our common stock representing 1% of our then-outstanding shares of common stock, (2) 344,828 sharesof our common stock and (3) a lesser number of shares as approved by the Board. The Purchase Plan provides for consecutivesix-month offering periods, during which participating employees may elect to have up to 10% of their compensationwithheld and applied to the purchase of common stock at the end of each offering period. The purchase price of the commonstock 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 thefair value of a share of common stock on the last trading day of the offering period. The Purchase Plan will terminate onAugust 24, 2021, the tenth anniversary of the date of initial adoption of the Purchase Plan. We sold 51,681 and 110,508shares to employees in 2017 and 2016, respectively. There were 558,870 shares available for sale under the Purchase Plan asof December 31, 2017. The weighted-average estimated grant date fair value of purchase awards under the Purchase Planduring the years ended December 31, 2017 and 2016 was $23.08 and $11.70 per share, respectively. The total share-basedcompensation expense recorded as a result of the Purchase Plan was approximately $1.0 million, $0.8 million and $0.9million during the years ended December 31, 2017, 2016 and 2015, respectively. F-21 Table of ContentsThe fair value of purchase awards granted to our employees during the years ended December 31, 2017, 2016 and 2015,respectively, was estimated using the Black-Scholes option pricing model based upon the weighted-average assumptionsprovided in the following table: Year ended December 31, 2017 2016 2015 Dividend yield — — — Volatility (a) 79% 92% 71%Risk-free interest rate (b) 0.90% 0.40% 0.11%Expected term (years) (c) 0.5 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 thecontractual term of the purchase right.(c)Expected term: The expected life of the award represents the six-month offering period for the Purchase Plan. 11. Revenue Recognition Effective January 1, 2018, we adopted ASC 606, the new revenue recognition standard, using the modified retrospectivemethod. Upon adoption, the accounting for net product revenue is as follows: Product Revenue, Net We are currently approved to sell Rubraca in the United States market. We distribute our product principally through alimited number of specialty distributor and specialty pharmacy providers, collectively, our customers. Our customerssubsequently sell our products to patients and health care providers. Separately, we have arrangements with certain payorsand other third-parties that provide for government-mandated and privately-negotiated rebates, chargebacks and discounts. Revenue from product sales are recognized when customers obtain control of our product, which occurs at a point in time,typically upon delivery to the customers. We expense incremental costs of obtaining a contract as and when incurred if theexpected amortization period of the asset that we would have recognized is one year or less. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variableconsideration for which reserves are established and which result from rebates, chargebacks, discounts, co-pay assistance,estimated product returns and other allowances that are offered within contracts between us and our customers, health careproviders, payors and other indirect customers relating to the sales of our product. These reserves are based on the amountsearned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payableto the customers) or a current liability (if the amount is payable to a party other than a customer). Where appropriate, theseestimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such asour historical experience, current contractual and statutory requirements, specific known market events and trends, industrydata and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount ofconsideration to which we are entitled based on the terms of the contract. The amount of variable consideration which isincluded in the transaction price may be constrained, and is included in the net sales price only to the extent that it isprobable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a futureperiod. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future varyfrom our estimates, we adjust these estimates, which would affect net product revenue and earnings in the period suchvariances become known. F-22 Table of ContentsRebates. Rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare coverage gapprogram. Rebates are amounts owed after the final dispensing of products to a benefit plan participant and are based uponcontractual agreements or legal requirements with the public-sector benefit providers. These reserves are recorded in the sameperiod the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a currentliability which is included in accrued expenses on the consolidated balance sheet. We estimate our Medicaid and Medicarerebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. The accrual forrebates is based on statutory discount rates and known sales to specialty pharmacy patients, or expected utilization forspecialty distributor sales to healthcare providers. As we gain more historical experience, the accrual will be based solely onthe expected utilization from historical data we have accumulated since the Rubraca product launch. Rebates are generallyinvoiced and paid quarterly in arrears so that the accrual balance consists of an estimate of the amount expected to beincurred for the current quarter’s activity, plus an accrual balance for known or estimated prior quarters’ unpaid rebates. Chargebacks. Chargebacks are discounts that occur when contracted customers, which currently consist primarily ofgroup purchasing organizations, Public Health Service organizations and federal government entities purchasing via theFederal Supply Schedule, purchase directly from our specialty distributors at a discounted price. The specialty distributor, inturn, charges back the difference between the price initially paid by the specialty distributor and the discounted price paid tothe specialty distributor by the healthcare provider. These reserves are established in the same period that the related revenueis recognized, resulting in a reduction of product revenue and accounts receivable. The accrual for specialty distributorchargebacks is estimated based on known chargeback rates and known sales to specialty distributors adjusted for theestimated utilization by healthcare providers. Discounts. Specialty distributors and specialty pharmacies are offered various forms of consideration, including servicefees and prompt pay discounts for payment within a specified period. We expect these customers will earn prompt paydiscounts and therefore, we deduct the full amount of these discounts from product sales when revenue is recognized. Servicefees are recorded as a selling expense when product sales occur. Co-pay assistance. Patients who have commercial insurance and meet certain eligibility requirements may receive co-payassistance. The intent of this program is to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are basedon actual program participation and estimates of program redemption using data provided by third-party administrators. Returns. Consistent with industry practice, we generally offer customers a limited right of return for product that has beenpurchased based on the product’s expiration date, which lapses upon shipment to a patient. To date, we have had minimalproduct returns and we currently do not have an accrual for product returns. We will continue to assess our estimate forproduct returns as we gain additional historical experience. Currently, we only recognize revenue on product sales once the product is sold to the patient or healthcare provider by thespecialty distributor or specialty pharmacy provider, i.e. when product is sold through the channel. Effective January 1, 2018,we will begin recognizing revenue when our customers, the specialty distributors and specialty pharmacy providers, takecontrol of our product or when product is sold into the channel. This will have the impact of us recognizing revenueapproximately two to four weeks earlier than before adopting the new standard and will also increase the significance ofestimating variable consideration. We used the modified retrospective method to adopt the new standard. This means that we will not restate previouslyissued financial statements, but will record a one-time adjustment to retained earnings of $2.3 million. This adjustmentrepresents the sales of our product to our customers prior to January 1, 2018, that have not been sold to patients or healthcareproviders, offset by related gross-to-net adjustments and other direct costs, including royalties and sales incentivecompensation. 12. Commitments and Contingencies We lease office space in Boulder, Colorado, San Francisco, California, Oakland, California, Cambridge, UK and Milan,Italy under non-cancelable operating lease agreements that expire through 2028. The lease agreements contain periodic rentincreases that result in the recording deferred rent over the terms of certain leases. F-23 Table of ContentsIn November 2017, we entered into a ten-year lease agreement for new office space in Oakland, California. Pursuant to theterms of the lease, the landlord will reimburse us for up to $2.5 million of leasehold improvement expenditures (“TenantImprovement Allowance”). Upon completion of construction, we will record the Tenant Improvement Allowance as deferredrent, which will be amortized as a reduction to rental expense over the lease term. Rental expense under these leases was $2.2 million, $2.2 million and $2.4 million for the years ended December 31, 2017,2016 and 2015, respectively. Future minimum rental commitments, by fiscal year and in the aggregate, for our operating leases are provided below (inthousands): December 31, 2017 2018 $3,050 2019 3,902 2020 3,744 2021 3,855 2022 2,519 Thereafter 11,563 Total future minimum lease payments $28,633 Manufacture and Services Agreement Commitments On October 3, 2016, we entered into a Manufacturing and Services Agreement (the “Agreement”) with a non-exclusivethird-party supplier for the production of the active ingredient for rucaparib. Under the terms of the Agreement, we willprovide the third-party supplier a rolling forecast for the supply of the active ingredient in rucaparib that will be updated byus on a quarterly basis. We are obligated to order material sufficient to satisfy an initial quantity specified any forecast. Inaddition, the third-party supplier will construct, in its existing facility, a production train that will be exclusively dedicatedto the manufacture of the rucaparib active ingredient. We are obligated to make scheduled capital program fee paymentstoward capital equipment and other costs associated with the construction of the dedicated production train. Further, oncethe facility is operational, we are obligated to pay a fixed facility fee each quarter for the duration of the Agreement, whichexpires on December 31, 2025, unless extended by mutual consent of the parties. As of December 31, 2017, $223.9 million ofpurchase commitments exist under the Agreement. Legal Proceedings We and certain of our officers were named as defendants in several lawsuits, as described below. We cannot reasonablypredict the outcome of these legal proceedings, nor can we estimate the amount of loss or range of loss, if any, that mayresult. An adverse outcome in these proceedings could have a material adverse effect on our results of operations, cash flowsor financial condition. Rociletinib-Related Litigation Following Clovis’ regulatory announcement in November 2015 of adverse developments in its ongoing clinical trials forrociletinib, Clovis and certain of its current and former executives were named in various securities lawsuits, the largest ofwhich was a putative class action lawsuit in the District of Colorado (the “Medina Action”) which was settled on October 26,2017 (the “Medina Settlement”). The open actions currently pending against Clovis are discussed below. While otherentities have threatened to bring claims relating to rociletinib and the November 2015 announcement, none havecommenced litigation as of the date of this filing. On January 22, 2016, the Electrical Workers Local #357 Pension and Health & Welfare Trusts, a purported shareholder ofClovis, filed a purported class action complaint (the “Electrical Workers Complaint”) against Clovis and certain of itsofficers, directors, investors and underwriters in the Superior Court of the State of California, County of San Mateo (the“Electrical Workers Court”). The Electrical Workers Complaint purports to be asserted on behalf of a class of persons whopurchased stock in the July 2015 Offering. The complaint asserted claims under certain provisions of the Securities Act of1933 (the “Securities Act”) relating to a July 2015 follow-on offering of Clovis securities (theF-24 Table of Contents“July 2015 Offering”) based on substantially similar allegations to those asserted in the Medina Action. On June 30, 2016,the Electrical Workers Plaintiffs filed an amended complaint adding new allegations (the “Amended Complaint”). On July 28, 2016, the defendants filed a motion to stay the Electrical Workers action pending resolution of the MedinaAction and a demurrer to the Amended Complaint. On September 23, 2016, after hearing oral argument, the ElectricalWorkers Court granted the motion to stay and reserved on issuing a ruling on defendants’ pending demurrer. The Company believes that the claims asserted in the Electrical Workers Action are released and barred by operation oflaw through the Medina Settlement, and accordingly plans to seek dismissal of the Electrical Workers Action on that basis. 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. TheAntipodean Complaint alleges that the defendants violated certain sections of the Securities Act by making allegedly falsestatements to Antipodean and in the offering materials for the July 2015 Offering relating to the efficacy of rociletinib, itssafety profile, and its prospects for market success. In addition to the Securities Act claims, the Antipodean Complaint alsoasserts Colorado state law claims and common law claims. Both the state law and common law claims are based on allegedlyfalse and misleading statements regarding rociletinib’s progress toward FDA approval. The Antipodean Complaint seekscompensatory, recessionary, and punitive damages. On December 15, 2016, the Antipodean Plaintiffs filed an amended complaint (the “Antipodean Amended Complaint”)asserting substantially the same claims against the same defendants and purporting to correct certain details in the originalAntipodean Complaint. On January 31, 2017, Defendants filed a motion to stay the Antipodean action pending resolution of the Medina Action inthe District of Colorado. Defendants also filed a motion to dismiss the Antipodean Amended Complaint on March 29, 2017. On March 14, 2017, the Clovis Defendants and Antipodean participated in a mediation, which did not result in asettlement. On August 8, 2017, the parties participated in a scheduled hearing on Defendants’ motion to stay and motion to dismissbefore Justice Masley of the New York Supreme Court, County of New York. At the hearing, Justice Masley grantedDefendants’ motion to stay. Per the Court’s August 10, 2017 order, Defendants’ motion to dismiss was held in abeyance anddeemed submitted on November 1, 2017. On November 1, 2017, the Defendants provided a status update to the Courtregarding the outcome of the hearing. The update informed the Court that Antipodean had excluded itself from the MedinaSettlement, as memorialized in the final judgment entered by the Medina Court. No date has been scheduled for argument onDefendants’ motion to dismiss. The Company intends to vigorously defend against the allegations in the Antipodean Amended Complaint. However,there can be no assurance that the defense will be successful. In March 2017, two putative shareholders of the Company, Macalinao and McKenry (the “Derivative Plaintiffs”), filedshareholder derivative complaints against certain directors and officers of the Company in the Court of Chancery of the Stateof Delaware. On May 4, 2017, the Macalinao and McKenry actions were consolidated for all purposes in a single proceedingunder the caption In re Clovis Oncology, Inc. Derivative Litigation, Case No, 2017-0222 (the “Consolidated DerivativeAction”). On May 18, 2017, the Derivative Plaintiffs filed a Consolidated Verified Shareholder Derivative Complaint (the“Consolidated Derivative Complaint”). The Consolidated Derivative Complaint generally alleged that the defendantsbreached their fiduciary duties owed to the Company by allegedly causing or allowing misrepresentations of the Company’sbusiness operations and prospects, failing to ensure that the TIGER-X clinical trial was being conducted in accordance withapplicable rules, regulations and protocols, and engaging in insider trading. The Consolidated Derivative Complaintpurported to rely on documents produced by the Company in response to prior demands for inspection of the Company’sbooks and records served on the Company by each of Macalinao and McKenry under 8 Del. C. § 220. The ConsolidatedDerivative Complaint sought, among other things, an award of money damages. F-25 Table of ContentsOn July 31, 2017, the defendants filed a motion to dismiss the Consolidated Derivative Complaint. Plaintiffs filed anopposition to the motion to dismiss on August 31, 2017, and the defendants filed a reply in further support of the motion todismiss on September 26, 2017. No date has been scheduled for argument on Defendants’ motion to dismiss the ConsolidatedDerivative Complaint. The Company intends to vigorously defend against the allegations in the Consolidated Derivative Complaint, but therecan be no assurance that the defense will be successful. On March 20, 2017, a purported shareholder of the Company, filed a shareholder derivative complaint (the “GuoComplaint”) against certain officers and directors of the Company in the United States District Court for the District ofColorado. The Guo Complaint generally alleged that the defendants breached their fiduciary duties owed to the Company byeither recklessly or with gross negligence approving or permitting misrepresentations of the Company’s business operationsand prospects. The Guo Complaint also alleged claims for waste of corporate assets and unjust enrichment. Finally, the GuoComplaint alleged that certain of the individual defendants violated Section 14(a) of the Securities Exchange Act, byallegedly negligently issuing, causing to be issued, and participating in the issuance of materially misleading statements tostockholders in the Company’s Proxy Statement on Schedule DEF 14A in connection with the 2015 Annual Meeting ofStockholders, held on June 11, 2015. The Guo Complaint sought, among other things, an award of money damages. On June 19, 2017, the parties filed a joint motion to stay the Guo action pending resolution of the motion to dismiss theConsolidated Derivative Complaint. On June 20, 2017, the court granted the motion to stay. The Company intends to vigorously defend against the allegations in the Guo Complaint, but there can be no assurancethat the defense will be successful. In addition, the Company has received inquiries and requests for information from governmental agencies, including theU.S. Securities and Exchange Commission and the U.S. Department of Justice, relating to the Company’s regulatory updateannouncement in November 2015 that the FDA requested additional clinical data on the efficacy and safety of rociletinib.The Company is continuing to cooperate with these agencies with respect to their investigations. The Medina Settlementdoes not resolve these inquiries and the Company cannot predict their timing or outcome. Director Compensation Litigation On May 10, 2017, John Solak, a purported shareholder of the Company, filed a shareholder derivative complaint in theCourt of Chancery of the State of Delaware (the “Solak Complaint”) against certain directors and an officer of the Company.The Solak Complaint generally alleged that the defendants breached their fiduciary duties owed to the Company byadopting a compensation plan that overcompensated the non-employee director defendants, in relation to companies ofcomparable market capitalization and size. The Solak Complaint also alleged claims of waste of corporate assets and unjustenrichment due to this allegedly wrongful compensation plan. The Solak Complaint sought, among other things, an award ofmoney damages and the imposition of corporate governance reforms. The Court has entered a number of orders extending the defendants’ time to respond to the Solak Complaint based on,among other factors, the fact that the parties are engaged in discussions in an effort to resolve the Solak action. On February14, 2018, the parties filed a joint letter to the Court requesting that all deadlines in the action be held in abeyance while theparties engaged in final settlement discussions. On February 26, 2018, the defendants entered into a stipulation of compromise and settlement with plaintiff that isintended to settle the Solak action. The proposed settlement is subject to Court approval upon the conclusion of a settlementhearing concerning the fairness of the terms of the proposed settlement, which will be scheduled following the provision ofnotice to shareholders of the Company. In accordance with the terms of the proposed settlement, the Company will present a new non-employee directorcompensation policy for shareholder vote at the next annual shareholder meeting. Under the proposed new non-employeedirector compensation policy, annual base compensation for incumbent non-employee directors would be set at an amountbetween $350,000 and $425,000, which would remain in place for a period between two and five years. Additionally, theproposed policy sets annual base compensation for new non-employee directors at an amount between $525,000 and$637,500 and includes fixed annual fees for board and committee service. The proposed settlement alsoF-26 Table of Contentssets forth a number of corporate governance reforms that the Company will undertake, including, enhanced proxydisclosures, the codification of the Company’s stock ownership guidelines for directors, and enhanced disclosurerequirements for certain forms of director compensation. While no cash payments will be made to investors as part of theproposed settlement, plaintiff’s counsel is expected to file a fee application which the Company has agreed not to oppose upto an agreed-upon amount. The proposed settlement contains no admission of wrongdoing. 13. License Agreements Rucaparib In June 2011, we entered into a license agreement with Pfizer Inc. to obtain the exclusive global rights to develop andcommercialize Rubraca. 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 and are required to makeadditional payments to Pfizer for the achievement of certain development and regulatory and sales milestones and royaltieson sales as required by the license agreement. Prior to the FDA approval of Rubraca, we made milestones payments of $1.4million, which 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 theJune 2011 existing worldwide license agreement to permit us to defer payment of the milestone payments payable upon (i)FDA approval of an NDA for 1 Indication in US and (ii) European Commission approval of an MAA for 1 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 milestonepayments, we have agreed to certain higher payments related to the achievement of such milestones. On December 19, 2016, the FDA approved Rubraca as monotherapy for the treatment of patients with deleterious BRCAmutation (germline and/or somatic) associated with advanced ovarian cancer, who have been treated with two or morechemotherapies, and selected for therapy based on FDA-approved companion diagnostic for Rubraca. The FDA approvalresulted in a $0.75 million milestone payment to Pfizer as required by the license agreement, which was paid in the firstquarter of 2017. The FDA approval also resulted in the obligation to pay a $20.0 million milestone payment, for which wehave exercised the option to defer payment by agreeing to pay $23.0 million within 18 months after the date of the FDAapproval. These payments were recognized as intangible assets and amortized over the estimated remaining useful life ofrucaparib. We are obligated under the license agreement to use commercially reasonable efforts to develop and commercializeRubraca and we are responsible for all ongoing development and commercialization costs for Rubraca. We are required tomake regulatory milestone payments to Pfizer of up to an additional $69.75 million in aggregate if specified clinical studyobjectives and regulatory filings, acceptances and approvals are achieved. In addition, we are obligated to make salesmilestone payments to Pfizer if specified annual sales targets for Rubraca are met, which relate to annual sales targets of$250.0 million and above, which, in the aggregate, could amount to total milestone payments of $170.0 million, and tieredroyalty payments at a mid-teen percentage rate on our net sales, with standard provisions for royalty offsets to the extent weneed to obtain any rights from third parties to commercialize Rubraca. The license agreement with Pfizer will remain in effect until the expiration of all of our royalty and sublicense revenueobligations to Pfizer, determined on a product-by-product and country-by-country basis, unless we elect to terminate thelicense agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure withinspecified time periods, Pfizer can terminate the agreement, resulting in a loss of our rights to Rubraca and an obligation toassign or license to Pfizer any intellectual property rights or other rights we may have in Rubraca, including our regulatoryfilings, regulatory approvals, patents and trademarks for Rubraca. In April 2012, we entered into a license agreement with AstraZeneca UK Limited to acquire exclusive rights associatedwith Rubraca under a family of patents and patent applications that claim methods of treating patients with PARP inhibitorsin certain indications. The license enables the development and commercialization of Rubraca for the uses claimed by thesepatents. Pursuant to the terms of the license agreement, we made an upfront payment of $0.25 million upon execution of theagreement. During the second quarter of 2016, we made a milestone payment of $0.3 million to AstraZeneca upon the NDAsubmission for Rubraca. These payments were recognized as acquired in-process research and development expense. TheFDA approval of Rubraca on December 19, 2016 resulted in a final $0.35 million milestone payment to AstraZeneca asrequired by the license agreement. This payment was recognized inF-27 ststTable of Contentsintangible assets and amortized over the estimated remaining useful life of Rubraca. AstraZeneca also receives royalties onnet sales of Rubraca. 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 developand commercialize lucitanib in markets outside the U.S. and Japan were sublicensed by EOS to Servier in exchange forupfront milestone fees, royalties on sales of lucitanib in the sublicensed territories and research and development fundingcommitments. In October 2008, EOS entered into an exclusive license agreement with Advenchen to develop and commercializelucitanib on a global basis, excluding China. We are obligated to pay Advenchen tiered royalties at percentage rates in themid-single digits on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, after giving effectto the first and second amendments to the license agreement, we are required to pay to Advenchen 25% of any consideration,excluding royalties, received pursuant to any sublicense agreements for lucitanib, including the agreement with Servier. Weare obligated under the agreement to use commercially reasonable efforts to develop and commercialize at least one productcandidate containing lucitanib, and we are also responsible for all remaining development and commercialization costs forlucitanib. In the first quarter of 2014, we recognized acquired in-process research and development expense of $3.4 million, whichrepresents 25% of the sublicense agreement consideration of $13.6 million received from Servier upon the end of oppositionand 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 toAdvenchen, determined on a product-by-product and country-by-country basis, unless we elect to terminate the agreementearlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within specified timeperiods, 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 toServier exclusive rights to develop and commercialize lucitanib in all countries outside of the U.S., Japan and China. Inexchange for these rights, EOS received an upfront payment of €45.0 million. We are entitled to receive additional paymentsupon 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 milestonepayments if specified annual sales targets for lucitanib are met, which, in the aggregate, could total €250.0 million. We arealso 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 Servierto us if certain milestones are achieved in the future. These milestones, if achieved, are substantive as they relate solely topast performance, are commensurate with estimated enhancement of value associated with the achievement of each milestoneas a result of our performance, which are reasonable relative to the other deliverables and terms of the arrangement, and areunrelated 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 isresponsible for all of the global development costs for lucitanib up to €80.0 million. Cumulative global development costsin excess of €80.0 million, if any, will be shared equally between us and Servier. During the second quarter of 2016, we andServier agreed to discontinue the development of lucitanib for breast cancer. We are continuing to evaluate what, if any,further development of lucitanib will be pursued. During 2017, we completed the committed on-going developmentactivities in 2017 and received full reimbursement of our development costs from Servier. Reimbursements are recorded as areduction to research and development expense on the Consolidated Statements of Operations and Comprehensive Loss. We recorded a $0.0 and $1.3 million receivable at December 31, 2017 and 2016, respectively, for the reimbursabledevelopment costs incurred under the global development plan, which is included in other current assets on theConsolidated Balance Sheets. During the years ending December 31, 2017, 2016 and 2015, we incurred ($0.2) million,F-28 Table of Contents$7.7 million and $13.7 million, respectively, in research and development costs and recorded reductions in research anddevelopment expense of $1.0 million, $9.0 million and $11.8 million, respectively, for reimbursable development costs duefrom Servier. Rociletinib In May 2010, we entered into an exclusive worldwide license agreement with Celgene to discover, develop andcommercialize 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 paymentin 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 thirdquarter of 2015, we made milestone payments totaling $12.0 million upon acceptance of the NDA and MAA for rociletinibby the FDA and EMA, respectively. We recognized all payments prior to commercial approval as acquired in-processresearch and development expense. During the second quarter of 2016, we received a CRL from the FDA for the rociletinib NDA. We terminated enrollment inall sponsored clinical studies, although we continue to provide drug to patients whose clinicians recommend continuingrociletinib therapy. We are continuing analyses of rociletinib data to determine whether certain populations of patients mayrepresent 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 ofannual net sales achieved. We are required to pay up to an additional aggregate of $98.0 million in development andregulatory milestone payments if certain clinical study objectives and regulatory filings, acceptances and approvals areachieved. In addition, we are required to pay up to an aggregate of $120.0 million in sales milestone payments if certainannual sales targets are achieved, which relate to annual sales targets of $500.0 million and above.14. Net Loss Per Common Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstandingduring the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of commonshare equivalents outstanding using the treasury-stock method for the stock options and the if-converted method for theNotes. As a result of our net losses for the periods presented, all potentially dilutive common share equivalents wereconsidered 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 thecalculation of diluted net loss per share due to their anti-dilutive effect (in thousands): Year ended December 31, 2017 2016 2015 Common shares under option 4,260 3,398 2,031 Convertible senior notes 4,646 4,646 4,646 Total potential dilutive shares 8,906 8,044 6,677 F-29 Table of Contents15. Income Taxes We are subject to U.S. federal, state and foreign income tax. The geographical components of income (loss) before incometaxes consisted of the following (in thousands): Year ended December 31, 2017 2016 2015 Domestic $(351,338) $(277,776) $(290,342) Foreign 1,363 (103,395) (91,595) Total loss before income taxes $(349,975) $(381,171) $(381,937) The income tax provision consists of the following current and deferred tax (benefit) expense amounts (in thousands): Year ended December 31, 2017 2016 2015 Current tax: U.S. Federal & State $ — $ — $ — Foreign (360) 64 — Total current (benefit) expense (360) 64 — Deferred tax: U.S. Federal & State (3,218) — — Foreign — (32,098) (29,076) Total deferred (benefit) (3,218) (32,098) (29,076) Total income tax (benefit) $(3,578) $(32,034) $(29,076) A reconciliation of the U.S. federal statutory income tax rate to our effective tax rate is provided below: Year ended December 31, 2017 2016 2015 Federal income tax benefit at statutory rate (34.0)% (34.0)% (34.0)%State income tax benefit, net of federal benefit (3.2) (3.6) (3.0) Tax credits (1.2) (10.8) (13.6) Limitation on future foreign tax credits — (5.9) (5.0) Change in uncertain tax positions 0.2 4.2 — Other (1.1) 2.3 0.4 Tax impact of Tax Cuts and Jobs Act of 2017 46.4 — — Change in valuation allowance (8.1) 39.4 47.6 Effective income tax rate (1.0)% (8.4)% (7.6)% F-30 Table of ContentsThe significant components of our deferred tax assets and liabilities are as follows (in thousands): December 31, 2017 2016 Deferred tax assets: Net operating loss carryforward $272,710 $275,898 Tax credit carryforwards 222,150 217,948 Intangible assets 29,900 42,745 Share-based compensation expense 27,844 31,390 Foreign currency translation 3,012 10,510 Product acquisition costs 5,881 9,764 Accrued liabilities and other 3,879 5,384 Total deferred tax assets 565,376 593,639 Valuation allowance (564,122) (592,423) Deferred tax assets, net of valuation allowance 1,254 1,216 Deferred tax liabilities: Prepaid expenses and other (1,254) (1,216) Total deferred tax liabilities (1,254) (1,216) Net deferred tax liability $ — $ — On December 22, 2017, President Trump signed into law the Tax Cuts and Jobs Act (the “Act”), a tax reform bill which,among other items, reduces the current corporate federal income tax rate to 21% from 35%. The rate reduction is effectiveJanuary 1, 2018. We believe the Act will cause us to revalue our deferred tax assets and liabilities to the lower federal taxrate. Deferred income taxes result from temporary differences between the tax basis of assets and liabilities and their reportedamounts in the financial statements that will result in taxable or deductible amounts in future years. Deferred tax assets andliabilities are measured using enacted tax rates expected to apply to taxable income in years in which those temporarydifferences are expected to be recovered or settled. As changes in tax laws or rates are enacted, deferred tax assets andliabilities are adjusted through income tax expense. Pursuant to the SEC Staff Accounting Bulletin ("SAB") No. 118, "Income Tax Accounting Implications of the Tax Cutsand Jobs Act" ("SAB 118"), we may select one of three scenarios to determine a reasonable estimate arising from the Tax Act.Those scenarios are (i) a final estimate which effectively closes the measurement window; (ii) a reasonable estimate leavingthe measurement window open for future revisions; and (iii) no estimate as the law is still being analyzed. We were able toprovide a reasonable estimate for the revaluation of deferred taxes by recording a net tax provision of $162.2 million in theperiod ending December 31, 2017, which is offset by a change in valuation allowance with no net impact to tax expense.Other impacts of the Act including, but not limited to, provisional transition tax, expensing of qualified property and interestlimitations are not expected to have a material impact to our financial statement presentation or disclosures. The final impactof the Act may be different from the provisional amounts reported due to changes in interpretations and assumptions of thecurrent guidance available as well as the issuance of new regulatory guidance in the future. We anticipate the full financialimpact will be determined at the time our 2017 U.S. corporate income tax return is filed in 2018. The realization of deferred tax assets is dependent upon a number of factors including future earnings, the timing andamount of which is uncertain. A valuation allowance was established for the net deferred tax asset balance due tomanagement’s belief that the realization of these assets is not likely to occur in the foreseeable future. We recorded a netdecrease to the valuation allowance of $28.3 million for the year ended December 31, 2017, due to the revaluation of our netdeferred tax assets resulting from the reduction to the corporate federal tax rate to 21% offset by the growth in net operatinglosses and credit carryforwards during the year. The increase of $143.3 million recorded to our valuation allowance duringthe year ended December 31, 2016 was due primarily to the 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 relevanttaxing 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 largestamount above the greater than 50% likelihood threshold at time of settlement. The balance of unrecognized tax benefits atDecember 31, 2017 of $24.5 million, if recognized, would not impact the Company’s effective tax rate asF-31 Table of Contentslong as they remain subject to a full valuation allowance. The following table summarizes the gross amounts of unrecognizedtax benefits (in thousands): Year endedDecember 31, 20172016 Balance at beginning of year $24,075 $ — Additions related to prior periods tax positions — 17,844 Additions related to current period tax positions 437 6,231 Settlements with tax authorities — — Expiration of statute of limitations — — Balance at end of year $24,512 $24,075 As of December 31, 2017, we had approximately $1.0 billion, $1.2 billion and $0.4 million of U.S. federal, state andforeign net operating loss carryforwards, respectively. The U.S. federal net operating losses will expire from 2029 to 2037 ifnot utilized and the U.S state net operating losses will expire from 2024 to 2037 if not utilized. We have research anddevelopment and orphan drug tax credit carryforwards of $245.1 million that will expire from 2029 through 2037 if notutilized. We believe that a change in ownership as defined under Section 382 of the U.S. Internal Revenue Code occurred as aresult 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 annuallimitations to offset future taxable income. At this time, we do not believe this limitation will prevent the utilization of thefederal NOL or credit carryforward prior to expiration. It is possible that a change in ownership will occur in the future, whichwill limit the NOL amounts generated since the last estimated change. Our federal and state income taxes for the period frominception to December 31, 2017 remain open to an audit. Our foreign subsidiaries are also subject to tax audits by taxauthorities in the jurisdictions where they operate for the periods from December 31, 2011 to December 31, 2017. We may be assessed interest and penalties related to the settlement of tax positions and such amounts will be recognizedwithin income tax expense when assessed. To date, no interest and penalties have been recognized. 16. Employee Benefit Plans We maintain a retirement plan, which is qualified under section 401(k) of the Internal Revenue Code for ourU.S. employees. The plan allows eligible employees to defer, at the employee’s discretion, pretax compensation up to the IRSannual limits. We matched contributions up to 4% of the eligible employee’s compensation or the maximum amountpermitted by law. Total expense for contributions made to U.S. employees was approximately $1.9 million, $1.6 million and$0.8 million for the years ended December 31, 2017, 2016 and 2015, respectively. Our international employees participate inretirement plans or postretirement life insurance plans governed by the local laws in effect for the country in which theyreside. We made contributions to the retirement plans or postretirement life insurance plans of international employees ofapproximately $0.3 million, $0.2 million and $0.2 million for the years ended December 31, 2017, 2016 and 2015,respectively.F-32 Table of Contents17. Quarterly Information (Unaudited) The results of operations on a quarterly basis for the years ended December 31, 2017 and 2016 were as follows (inthousands): March 31, June 30, September 30, December 31, March 31, June 30, September 30, December 31, 2017 2017 2017 2017 2016 2016 (1) 2016 2016 Revenues: ` Product revenue, net $7,045 $14,620 $16,806 $17,040 $ — $ — $ — $78 Operating expenses: Cost of sales -product 1,163 2,730 3,026 3,332 — — — 70 Cost of sales -intangible assetamortization 372 372 372 370 — — — — Research anddevelopment 32,447 33,108 38,924 38,019 74,608 67,729 54,338 54,454 Selling, general andadministrative 29,224 36,149 35,011 38,523 9,827 9,552 9,162 12,190 Acquired in-processresearch anddevelopment — — — — — 300 500 500 Impairment ofintangible asset — — — — — 104,517 — — Change in fair valueof contingentpurchaseconsideration — — — — 516 (25,452) — — Total expenses 63,206 72,359 77,333 80,244 84,951 156,646 64,000 67,214 Operating loss (56,161) (57,739) (60,527) (63,204) (84,951) (156,646) (64,000) (67,136) Other income(expense): Interest expense (2,581) (2,598) (2,618) (2,631) (2,104) (2,106) (2,108) (2,173) Foreign currencygain (loss) (159) 76 (44) 45 (551) 183 (66) (146) Legal settlement loss — (117,000) — 11,523 — — — — Other income(expense) 354 594 1,291 1,404 25 196 252 160 Other income(expense), net (2,386) (118,928) (1,371) 10,341 (2,630) (1,727) (1,922) (2,159) Loss before incometaxes (58,547) (176,667) (61,898) (52,863) (87,581) (158,373) (65,922) (69,295) Income tax (expense)benefit 83 1,281 1,234 980 4,181 29,059 227 (1,433) Net loss $(58,464) $(175,386) $(60,664) $(51,883) $(83,400) $(129,314) $(65,695) $(70,728) Basic and diluted netloss per common share $(1.33) $(3.88) $(1.24) $(1.04) $(2.17) $(3.37) $(1.70) $(1.83) Basic and dilutedweighted averagecommon sharesoutstanding 44,039 45,176 48,917 49,973 38,360 38,389 38,538 38,624 (1)In the second quarter of 2016, we recorded a $104.5 million impairment charge to the IPR&D intangible asset related toour lucitanib product candidate. F-33Exhibit 12.1Clovis Oncology, Inc.Computation of Deficiency of Earnings to Fixed Charges Year ended December 31, 2017 2016 2015 2014 2013 Earnings (loss): Loss before income taxes $(349,975) $(381,171) $(381,937) $(157,723) $(84,480) Fixed charges (from below) 10,988 9,119 8,824 2,698 85 Total loss $(338,987) $(372,052) $(373,113) $(155,025) $(84,395) Fixed charges: Interest expense $9,148 $7,249 $7,167 $2,236 $— Amortization of debt issuance costs 1,279 1,242 1,205 368 — Interest portion of rent expense 561 628 452 94 85 Total fixed charges $10,988 $9,119 $8,824 $2,698 $85 Coverage deficiency $349,975 $381,171 $381,937 $157,723 $84,480 Exhibit 23.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in the following Registration Statements: (1) Registration Statements (Form S-3 Nos. 333-211947 and 333-215400) of Clovis Oncology, Inc., and (2) Registration Statements (Form S-8 Nos. 333-219046, 333-211948, 333-178283, 333-182278, 333-190565, 333-198022,and 333-206193) pertaining to the 2009 Equity Incentive Plan, 2011 Stock Incentive Plan and 2011 EmployeeStock Purchase Plan of Clovis Oncology, Inc.; of our reports dated February 26, 2018, with respect to the consolidated financial statements of Clovis Oncology, Inc., andthe effectiveness of internal control over financial reporting of Clovis Oncology, Inc., included in this Annual Report (Form10-K) for the year ended December 31, 2017. /s/ Ernst & Young LLP Denver, ColoradoFebruary 27, 2018Exhibit 31.1 I, Patrick J. Mahaffy, certify that: 1.I have reviewed this annual report on Form 10-K of Clovis Oncology, Inc. for the year ended December 31, 2017; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state amaterial fact necessary to make the statements made, in light of the circumstances under which such statements weremade, not misleading with respect to the period covered by this report; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairlypresent in all material respects the financial condition, results of operations and cash flows of the registrant as of, andfor, the periods presented in this report; 4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controlsand procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financialreporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to bedesigned under our supervision, to ensure that material information relating to the registrant, including itsconsolidated subsidiaries, is made known to us by others within those entities, particularly during the periodin which this report is being prepared; b.Designed such internal control over financial reporting, or caused such internal control over financialreporting to be designed under our supervision, to provide reasonable assurance regarding the reliability offinancial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles; c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this reportour conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the periodcovered by this report based on such evaluation; and d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurredduring the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annualreport) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal controlover financial reporting; and 5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internalcontrol over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board ofdirectors (or persons performing the equivalent functions): a.All significant deficiencies and material weaknesses in the design or operation of internal control overfinancial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process,summarize and report financial information; and b.Any fraud, whether or not material, that involves management or other employees who have a significant rolein the registrant’s internal control over financial reporting. Date: February 27, 2018 /s/ PATRICK J. MAHAFFY Patrick J. MahaffyPresident and Chief Executive Officer Exhibit 31.2 I, Daniel W. Muehl, certify that: 1.I have reviewed this annual report on Form 10-K of Clovis Oncology, Inc. for the year ended December 31, 2017; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state amaterial fact necessary to make the statements made, in light of the circumstances under which such statements weremade, not misleading with respect to the period covered by this report; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairlypresent in all material respects the financial condition, results of operations and cash flows of the registrant as of, andfor, the periods presented in this report; 4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controlsand procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financialreporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to bedesigned under our supervision, to ensure that material information relating to the registrant, including itsconsolidated subsidiaries, is made known to us by others within those entities, particularly during the periodin which this report is being prepared; b.Designed such internal control over financial reporting, or caused such internal control over financialreporting to be designed under our supervision, to provide reasonable assurance regarding the reliability offinancial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles; c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this reportour conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the periodcovered by this report based on such evaluation; and d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurredduring the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annualreport) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal controlover financial reporting; and 5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internalcontrol over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board ofdirectors (or persons performing the equivalent functions): a.All significant deficiencies and material weaknesses in the design or operation of internal control overfinancial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process,summarize and report financial information; and b.Any fraud, whether or not material, that involves management or other employees who have a significant rolein the registrant’s internal control over financial reporting. Date: February 27, 2018 /s/ DANIEL W. MUEHL Daniel W. MuehlSenior Vice President of Finance andPrincipal Financial and Accounting Officer Exhibit 32.1 CERTIFICATIONS PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002(18 U.S.C. SECTION 1350) In connection with the Annual Report of Clovis Oncology, Inc., a Delaware corporation (the “Company”), on Form 10-K forthe year ended December 31, 2017, as filed with the Securities and Exchange Commission (the “Report”), Patrick J. Mahaffy,as Chief Executive Officer of the Company, does hereby certify, pursuant to §906 of the Sarbanes-Oxley Act of 2002 (18U.S.C. §1350), that to his knowledge: (1)The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and results ofoperations of the Company. Date: February 27, 2018 /s/ PATRICK J. MAHAFFY Patrick J. MahaffyPresident and Chief Executive Officer Exhibit 32.2 CERTIFICATIONS PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002(18 U.S.C. SECTION 1350) In connection with the Annual Report of Clovis Oncology, Inc., a Delaware corporation (the “Company”), on Form 10-K forthe year ended December 31, 2017, as filed with the Securities and Exchange Commission (the “Report”), Daniel W. Muehl,as Senior Vice President of Finance and Principal Financial and Accounting Officer of the Company, does hereby certify,pursuant to §906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350), that to his knowledge: (1)The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and results ofoperations of the Company. Date: February 27, 2018 /s/ DANIEL W. MUEHL Daniel W. MuehlSenior Vice President of Finance andPrincipal Financial and Accounting Officer 

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