8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): January 11, 2021 (January 11, 2021)

Clovis Oncology, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-35347	90-0475355
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

5500 Flatiron Parkway, Suite 100 Boulder, Colorado	80301
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (303) 625-5000

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock par Value $0.001 per Share	CLVS	The NASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Item 2.02 Results of Operations and Financial Condition.

On January 11, 2021, Clovis Oncology, Inc. (the “Company”) issued a press release announcing certain unaudited preliminary financial results for the quarter and fiscal year ended December 31, 2020. A copy of the press release is attached as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 2.02 of Form 8-K and the information incorporated by reference herein, including Exhibit 99.1 attached hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 7.01 Regulation FD Disclosure.

The Company will participate in the 39th Annual J.P. Morgan Healthcare Conference on January 11-14, 2021. The Company’s President and Chief Executive Officer, Patrick J. Mahaffy, will make a presentation on Tuesday, January 12, 2021 at 4:30 p.m. ET using the slides attached to this Current Report on Form 8-K as Exhibit 99.2 (the “Conference Slides”), which is incorporated herein by reference. The presentation will address, among other things, the Company’s products and clinical development programs. The information contained in the Conference Slides is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the U.S. Securities and Exchange Commission and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise this information.

The information in this Item 7.01 of Form 8-K and the information incorporated by reference herein, including Exhibit 99.2 attached hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On January 11, 2021, the Company announced preliminary estimated unaudited global product revenues for Rubraca in the range of $43.0 million to $43.5 million for the quarter ended December 31, 2020 (which included estimated U.S. product revenues in the range of $36.3 million to $36.7 million and estimated ex-U.S. product revenues in the range of $6.5 million to $6.8 million for such quarter) and $164.2 million to $164.7 million for the year ended December 31, 2020. On January 11, 2021, the Company also announced that it had approximately $240 million (preliminary unaudited) in cash and cash equivalents as of December 31, 2020. The financial information presented herein is preliminary and is subject to adjustment as a result of completion of customary quarterly review and audit procedures.

The Company also announced that in December 2020 it filed with the FDA two Investigational New Drug applications (“IND”) for FAP-2286 labeled with gallium-68 (⁶⁸Ga-FAP-2286) for imaging and FAP-2286 labeled with lutetium-177 (¹⁷⁷Lu-FAP-2286) for treatment. The INDs are under review by the FDA and will become effective pending submission of ⁶⁸Ga-FAP-2286 CMC data from clinical sites. The Company intends to initiate the FAP-2286 clinical development program in the first half of 2021 with the LuMIERE Phase 1 study.

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Item 9.01 Financial Statements and Exhibits.

(d) Exhibits:

99.1	Press Release, dated January 11, 2021.
99.2	Conference Slides used in connection with the Company’s presentation at the 39th Annual J.P. Morgan Healthcare Conference.
104	The cover page from this Current Report on Form 8-K, formatted in Inline XBRL (included as Exhibit 101).

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 11, 2021

CLOVIS ONCOLOGY, INC.
By:	/s/ Paul Gross
Name:	Paul Gross
Title:	Executive Vice President and General Counsel

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EX-99.1

Exhibit 99.1

Clovis Oncology Announces Preliminary Product Revenues

for the Fourth Quarter and Full Year 2020

• Estimated $43.0M - $43.5M in Rubraca^® (rucaparib) global sales for Q4 2020 and $164.2M - $164.7M for FY 2020

• Q4/FY 2020 Operating Results call planned for February 23, 2021

• Company to present at J.P. Morgan Healthcare Conference on Tuesday, January 12

BOULDER, Colo., January 11, 2021 – Clovis Oncology, Inc. (NASDAQ:CLVS) today announced its preliminary, unaudited global product revenues for the fourth quarter and full year ended December 31, 2020. The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures.

Unaudited preliminary results include:

• $43.0M - $43.5M in estimated Rubraca^® global product revenues for the fourth quarter of 2020 compared to $38.8M for Q3 2020 and $39.3M for Q4 2019;

• U.S. product revenues of approximately $36.3M - $36.7M and E.U. of $6.5M - $6.8M

• Highest quarterly global and E.U. product revenues to date

• $164.2M - $164.7M in estimated Rubraca product revenues for FY 2020 compared to $143.0M for FY 2019

• Approximately $240M in cash and cash equivalents at December 31, 2020 which is expected to fund the Company’s operating plan into early 2023 based on current revenue and expense forecasts

Clovis plans to discuss these results with investors this week at the 39^th Annual J.P. Morgan Healthcare Conference which is being held virtually January 10-14, 2021.

“We are pleased with our strong finish to a challenging year, including achieving record quarterly and annual sales,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We believe we have set the stage for an important year in 2021, as we seek to continue to grow Rubraca sales and advance our pipeline, including plans to report top-line ATHENA monotherapy data in the second half of the year, initiate a clinical development program for FAP-2286 in the first half of the year, and show initial efficacy data for the LIO-1 lucitanib and Opdivo combination trial at a medical meeting this year.”

Clovis Oncology to Present at 39^th Annual J.P. Morgan Healthcare Conference on January 12

Clovis’ President and CEO, Patrick J. Mahaffy, will present at the 39^th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12 at 4:30 p.m. ET. A live webcast of the presentation/Q&A session can be accessed through the investor relations section of the Company’s website at clovisoncology.com. Approximately 24 hours following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

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Fourth Quarter and Full Year 2020 Financial Results Release Planned for February 23

The Company plans to report financial results for the fourth quarter and full year ended December 31, 2020 on Tuesday, February 23, 2021, before the open of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the Company’s results in greater detail.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

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About Lucitanib

Lucitanib is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/ß) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two parts; a peptide that binds to FAP and a linker and site that can be used to attach radiation for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.ⁱ Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey and Israel.

FAP-2286 is an unlicensed medical product.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in the U.S. and Europe. Please visit clovisoncology.com for more information.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our preliminary estimates of fourth quarter and fiscal year 2020 revenue and cash, cash equivalents and available for sale securities, and our expectations for our future cash position, commencement of clinical trials, availability of study data and submission of regulatory filings. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the impacts of the COVID-19 pandemic and disruption related to efforts to mitigate its spread on our business, results of operations or financial condition, including impacts on the vendors or distribution channels in our supply chain, impacts on our contract manufacturers’ ability to continue to manufacture our products, impacts on our ability to continue our development activities, impacts on the conduct of our clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites or monitoring of data and impact on the ability and timing of our field personnel to conduct their activities with health care providers, the uncertainties inherent in the effect our future revenues or expenses may have on our cash position, the market potential of our approved drug, including the performance of our sales and marketing efforts and the success of competing drugs and

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therapeutic approaches, changes in gross-to-net or free drug provided through our patient assistance program, the availability of reimbursement and insurance coverage, the timing of availability of data from our clinical trials, the uncertainties inherent in actions or decisions by the FDA, the EMA or other regulatory authorities regarding whether to accept or approve drug applications that may be filed, including delays or denials of regulatory approvals, clearances or authorizations for applications, as well as their decisions regarding drug labeling, reimbursement and pricing. Furthermore, we are in the process of finalizing our financial results for the fourth quarter and fiscal year 2020, and therefore our finalized and audited results and final analysis of those results are not yet available. The preliminary expectations regarding 2020 revenue and year-end cash, cash equivalents and available for sale securities are subject to management’s review and actual results could differ from management’s expectations. The actual results are also subject to audit by our independent registered public accounting firm and no assurance is given by our independent registered public accounting firm on such preliminary expectations. You should not draw any conclusions as to any other financial results as of and for the year ended December 31, 2020 based on the foregoing estimates. These forward-looking statements speak only as of the date hereof. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

Contacts:

Breanna Burkart	Anna Sussman
303.625.5023	303.625.5022
bburkart@clovisoncology.com	asussman@clovisoncology.com

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ⁱ  Rettig WJ et al. Regulation and Heteromeric Structure of the Fibroblast Activation Protein in Normal and Transformed Cells of Mesenchymal and Neuroectodermal Origin. Cancer Res. 1993;53:3327–3335.

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EX-99.2

39th Annual J.P. Morgan Healthcare Conference January 12, 2021 Exhibit 99.2

To the extent that statements contained in this presentation are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this presentation include, among others, statements regarding our expectations for commercial launches, availability of study data and submission of regulatory filings. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, whether future study results will support continued development, the timing of availability of data from our clinical trials, the uncertainties inherent in actions or decisions by the FDA, the EMA or other regulatory authorities regarding whether to accept or approve drug applications that may be filed, including delays or denials of regulatory approvals, clearances or authorizations for applications, as well as their decisions regarding drug labeling, reimbursement and pricing. These forward-looking statements speak only as of the date hereof. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K. Forward-looking Statements

Investment Highlights Oncology Focused A biopharmaceutical company focused on the development and commercialization of innovative anti-cancer therapies Financial Resources Based on current revenue and expense forecasts, existing cash and equivalents expected to fund operating plan into early 2023 Rubraca: Commercial Drug with Potential Label Expansions Oral, small molecule PARP inhibitor approved for multiple indications in the U.S. and Europe Data from Phase 3 ATHENA trial of Rubraca® (rucaparib) as 1LM OC monotherapy anticipated 2H21 LODESTAR tumor-agnostic study may be registration-enabling with potential regulatory filing in 2H21 or 1H22 Additional trials ongoing in multiple indications as monotherapy and in combinations Commitment to Targeted Radionuclide Development Peptide-targeted radionuclide therapeutics represent promising new field of oncology development Initial target is FAP which is highly expressed in many epithelial cancers, including more than 90% of breast, lung, colorectal and pancreatic carcinomas Phase 1/2 LuMIERE study of 177Lu-FAP-2286 to begin 1H 2021 Ongoing discovery program to identify additional peptide-targeted radionuclide development targets Novel TKI and IO Combo Novel angiogenesis inhibitor lucitanib being studied in combination with Opdivo® (nivolumab) in Phase 1b/2 study LIO-1 in gynecologic cancers Phase 2 now enrolling, interim data anticipated at a 2021 medical meeting 1LM = first line maintenance, OC = ovarian cancer, FAP = fibroblast activation protein, TKI = tyrosine kinase inhibitor, IO = immuno‑oncology 

Rubraca: Multiple Approved Indications Source: Rubraca [prescribing information]. Boulder, CO; Clovis Oncology.

The Oncology Marketplace in the U.S. is Evolving; Commercial Organization Aligned with Changing Dynamics Physicians increasingly prefer digital communications and virtual peer-to-peer interactions Substantially limited in-person sales calls COVID-19 has accelerated this trend 150% Increase in engagement across digital platforms 20% Increase in average time spent with digital pharma content 58% Increase in peer-to-peer patient information exchange Restructured commercial organization in November 2020 to adapt to changing physician preferences Hybrid Approach Prioritized Digital Promotion Peer-to-Peer Collaboration, Custom Digital Resources, and Interactive Scientific Information Limited and Focused In-person Promotion Source: Survey conducted by MDcentRX

Ovarian Cancer Remains a Difficult Diagnosis; Rubraca Offers Clear Therapeutic Option to Women with Recurrent Disease Estimated 21,750 new cases and 13,940 deaths in the U.S. in 2020 More than 75% of women are diagnosed at an advanced stage, and patients who are diagnosed with advanced ovarian cancer have a 70 to 95% chance of recurrence Up to 60% of patients with ovarian cancer may be HR-deficient HR = homologous recombination, PFS = progression free survival, INV = investigator assessed, IRR = independent radiologic review, ITT = intent to treat. Sources: NCI. SEER cancer stat facts: ovarian cancer. http://seer.cancer.gov/statfacts/html/ovary.html. Accessed January 2020. Ovarian Cancer Reseach Alliance. https://ocrahope.org/patients/about-ovarian-cancer/. Accessed January 2020. Mukhopadhyay A, et al. Clin Cancer Res. 2010;16(8):2344‐235. Rubraca [prescribing information]. Boulder, CO; Clovis Oncology. Data on file. Clovis Oncology; Boulder, CO.

Rubraca in Europe for Recurrent Ovarian Cancer Maintenance Treatment Indication In January 2019, the European Commission approved the use of Rubraca for its second indication With the maintenance treatment indication, Rubraca is available to eligible patients regardless of their BRCA mutation status Rubraca commercially available in Germany, United Kingdom, Italy, France, Spain, Netherlands and pending in Switzerland Commercially Available Pending Reimbursement Source: Rucaparib Summary of Product Characteristics. May 2019. Clovis Oncology, Inc.

Rubraca U.S. Approval for mCRPC in May 2020 Rubraca FDA-approved as treatment for patients with BRCA1/2-mutant mCRPC previously treated with androgen receptor-directed therapy and taxane-based chemotherapy First approval for PARP inhibitor in prostate cancer setting Foundation Medicine’s plasma-based companion diagnostic approved late August 44% confirmed ORR (N=62; 95% CI 31, 57) by blinded-IRR 7 complete responses (11.3%); 20 partial responses (32.3%) Median DOR by blinded-IRR was not evaluable at data cut-off (N=62; 95% CI 6.4 months, NE) DOR was 1.7-24+ months 55% confirmed PSA response rate (N=115); 95% CI 45, 64) Safety data for men with mCRPC were consistent with prior safety reports for patients with ovarian cancer and other solid tumors mCRPC = metastatic castration resistant prostate cancer, ORR = overall response rate, IRR =  independent radiologic review, DOR = duration of response, PSA = prostate-specific antigen Source: Rubraca [prescribing information]. Boulder, CO; Clovis Oncology. Anscher et al., The Oncologist 2020; 9999. Data on file. Boulder, CO; Clovis Oncology. FoundationOne® Liquid CDx Technical Information

Ongoing Rubraca Clinical Trials Confirmatory Phase 3 of Rubraca versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of therapy ARIEL4: Successfully met primary PFS endpoint December 2020 Phase 3 study in first line maintenance treatment ovarian cancer setting evaluating Rubraca plus Opdivo in newly diagnosed patients who have completed platinum-based chemotherapy ATHENA: Monotherapy data ~2H21; Combo data +1 year or later Phase 3 evaluating Rubraca vs physician’s choice of chemotherapy in patients with mCRPC with BRCA and ATM gene alterations TRITON3: Enrolling Phase 2 trial to evaluate Rubraca in patients with solid tumors with deleterious mutations in homologous recombination repair (HRR) genes LODESTAR: Enrolling ARIEL4 clinicaltrials.gov identifier NCT02855944 ATHENA clinicaltrials.gov identifier NCT03522246 TRITON3 clinicaltrials.gov identifier NCT02975934 Phase 3 Alliance-sponsored trial to evaluate the benefit of adding Rubraca to enzalutamide for men with metastatic prostate cancer that has become resistant to testosterone-deprivation therapy CASPAR: Planned LODESTAR clinicaltrials.gov identifier NCT04171700 CASPAR clinicaltrials.gov identifier NCT04455750

Peptide-Targeted Radionuclide Therapy is Emerging as a New Therapeutic Class of Drugs to Treat Patients with Cancer Peptide-targeted radionuclide therapy (PTRT) uses cancer cell-targeting peptides to deliver radiation-emitting radionuclides specifically to tumors When injected into patient’s bloodstream, the targeting peptide attaches to cancer cells, delivering high dose of radiation to tumor while sparing normal tissues Examples of radiopharmaceuticals for other cancer targets include: LUTATHERA®: radiolabeled somatostatin analog approved for the treatment of midgut carcinoid tumors 177Lu-PSMA-617: radiolabeled prostate specific membrane antigen (PSMA) binding dipeptide in Phase 3 for mCRPC Clovis has U.S. and ex-European rights to FAP-2286, a PTRT targeting fibroblast activation protein (FAP), and global rights to a discovery program with partner 3B Pharmaceuticals for three additional candidates Clovis expects to be first to initiate clinical development of a peptide-targeted radionuclide therapy targeting FAP Source: Lutathera USPI; clinicaltrials.gov accessed Dec 2020; https://snmmi.files.cms-plus.com accessed Dec 2020

Fibroblast Activation Protein is a Pan-Tumor Target Highly Expressed in Cancer-Associated Fibroblasts Fibroblast activation protein (FAP) is highly expressed in cancer-associated fibroblasts (CAFs) which are found in the majority of cancer types, potentially making it a suitable target across a wide array of tumors – FAP has limited expression on normal fibroblasts reducing the potential for FAP-targeted agents having effects in normal tissue Sources: ESMO 2020, Zboralski et al. Rettig et al, Clin Cancer Research 1993. Clovis internal data: Tumor microarrays (TMAs) were stained with FAP antibody SP325 (HistoGenX) Representative images of FAP-expressing tumors by IHC Cancer cells Tumor FAP Cancer cells Blood flow CAF CAFs HNSCC Pancreatic Mesothelioma Bladder

FAP-2286 is a Potent and Selective FAP Targeting Agent with a Promising Preclinical Profile for PTRT FAP-2286 consists of two parts: 1) A peptide that binds to FAP and 2) A linker and site that can be used to attach radioactive isotopes for imaging (e.g. Gallium-68; 68Ga) or therapeutic (Lutetium-177; 177Lu) use Nonclinical studies have demonstrated that FAP-2286 potently and selectively binds to FAP FAP-2286 FAP binding peptide* Targets FAP expressing cancer associated fibroblasts and tumor cells Radionuclide emits ionizing radiation that cause DNA damage and cell death Source: ESMO 2020, Zboralski et al. * FAP binding peptide image added for illustrative purposes only. Does not represent actual sequence of FAP lead candidate; %ID/g, percent injected dose of test article per gram of tissue. In vivo imaging in mice after IV showed 177Lu-FAP-2286 uptake in FAP-positive HEK-FAP xenografts at all time points evaluated 177Lu-FAP-2286 SPECT/CT imaging in FAP+ve tumor model 3 hr 24 hr 48 hr 140 hr Uptake %ID/g 0.5 15 FAP expressing tumor

Anti-tumor Efficacy of 177Lu-FAP-2286 Observed in FAP-Expressing Tumor Models A single, IV dose of 177Lu-FAP-2286 resulted in statistically significant tumor growth inhibition in two different xenograft models: 1) HEK293 cells stably transfected with human FAP (HEK-FAP); and 2) Sarcoma Sarc4809 patient-derived xenograft model with endogenous FAP expression Source: ESMO 2020, Zboralski et al. When tumors reached a mean tumor volume of 160±44 mm3 (HEK-FAP) and 187±124 mm3 (Sarc4809), mice (n=10/group) were treated with a single dose of the indicated agents. Statistically significant tumor regression was observed at both dose levels of 177Lu-FAP-2286 evaluated in the HEK-FAP (P<0.05) and Sarc4809 (P<0.0001) models. HEK-FAP Sarc4809

68Ga-FAP-2286 Imaging Shows Encouraging Tumor Accumulation and Specificity in Multiple Cancer Indications Eleven patients with advanced solid tumors imaged with 68Ga-FAP-2286 and/or treated with 177Lu-FAP-2286 under named patient use guidance by Prof. Dr. Richard Baum in Bad Berka, Germany Prof. Dr. Baum administered treatment independent of Clovis/3BP, not part of a Clovis-sponsored clinical trial FAP-2286 imaging consistent with standard-of-care 18F-FDG-PET/CT scans in the same patients Encouraging tumor accumulation and specificity in multiple cancer indications 68Ga-FAP-2286 imaging in additional tumor types Breast Pancreatic Colorectal Source: Baum RP. ICPO Foundation Symposium, 2019. Adapted with permission from Prof. Dr. Baum 68Ga-FAP-2286 and 18F-FDG imaging in a breast cancer patient

Broad FAP-2286 Clinical Development Program Planned FAP-2286 imaging and therapeutic INDs both submitted to FDA in Q4 2020 INDs to be effective pending 68Ga-FAP-2286 CMC data from clinical sites LuMIERE Phase 1 study planned to start 1H 2021 to determine the dose of 177Lu-FAP-2286 to be used in Phase 2 development as a FAP-targeted therapeutic agent Phase 2 expansion cohorts planned in multiple tumor types 68Ga-FAP-2286 will be utilized as a FAP-targeted imaging agent to identify tumors that contain FAP for treatment in the Phase 1 study Studies of FAP-2286 linked to an alpha-emitter and combination studies are under consideration Potential for accelerated approvals in multiple tumor types Investigator-initiated trial (IIT) ongoing at UCSF: Phase 1 single-arm imaging study with dosimetry and imaging cohorts using 68Ga-FAP-2286 in patients with solid tumors Data will be used to inform indication selection for LuMIERE Phase 2 expansion cohorts Clinicaltrials.gov identifier for UCSF IIT: NCT04621435

Lucitanib: Novel Oral Tyrosine Kinase Inhibitor Investigational angiogenesis inhibitor which inhibits vascular endothelial growth factor receptors 1-3 (VEGFR1-3), platelet derived growth factor receptors (PDGFR) α/β and fibroblast growth factor receptors 1-3 (FGFR1-3) Kinase Kd (nM) FGFR1 21 FGFR2 41 FGFR3 51 VEGFR1 1 VEGFR2 1.1 VEGFR3 7.1 PDGFRα 0.43 PDGFRβ 0.26 Kinome profiling Kinase binding profiling Sources: Clovis internal data; KINOMEscan kinase profiling of 456 kinases with 100 nM lucitanib performed at DiscoveRx; Clovis internal data; Kinase binding performed at DiscoveRx. Percent Control 0% 0.1% 0.1-1% 1-5% 5-10% 10-35% > 35%

Strong Rationale for Combinations of Lucitanib and Nivolumab Lucitanib inhibits the same three pathways as lenvatinib, which showed encouraging results when combined with PD-1 inhibitor pembrolizumab Preclinical data for lucitanib in combination with PD-1 inhibitor demonstrated enhanced anti-tumor activity compared to that of single agents Illustration Source: ESMO 2020, Concin et al.

LIO-1: Phase 1b/2 Study Evaluating Lucitanib and Opdivo in Gynecologic Cancers Now Enrolling Phase 2 Recommended Phase 2 dose of oral Lucitanib established as 6 mg once daily Across 3 dose levels, only 1 dose-limiting toxicity observed No apparent differences in TEAE frequencies between dose levels Initial data shows evidence of antitumor activity: 1 Confirmed Complete Response 1 Confirmed Partial Response Updated interim data from LIO-1 study to be submitted for presentation at a 2021 medical meeting Time on Treatment and Best Confirmed Response to Date (LIO-1 Phase 1b) Source: ESMO 2020, Hamilton et al. LIO-1 clinicaltrials.gov identifier NCT04042116 Initial Phase 1b data in advanced metastatic solid tumors presented at ESMO 2020

Financial Overview Q4 2020 global net revenues in range of $43.0M-$43.5M U.S. product revenue ~$36.3M-$36.7M; EU revenue ~$6.5M-$6.8M Highest quarterly global and EU product revenues to date FY 2020 global net revenues in range of $164.2M-$164.7M Cash and equivalents expected to fund operating plan into early 2023 Cash and equivalents as of 12/31/2020 approximately $240M Based on current revenue and expense forecasts, existing cash and equivalents expected to fund operating plan into early 2023 Complete Q4/FY 2020 financial results to be announced Tuesday, February 23 COVID-19 disruption likely to continue through 2021

Clovis Oncology Focused on innovative anti-cancer therapies Rubraca approved in the U.S. and Europe for multiple indications Data from ATHENA Phase 3 front-line switch maintenance study in OC comparing Rubraca monotherapy vs placebo expected 2H21; Rubraca/Opdivo combo vs Rubraca mono expected one year or more later Commitment to peptide-targeted radionuclide therapeutics FAP-2286 first peptide-targeted radionuclide candidate targeting FAP to enter clinic; Phase 1/2 LuMIERE study to begin 1H21 Discovery program focused on three additional unnamed targets Opportunity to be a leader in an important new field of oncology therapy Interim data from LIO-1 Phase 1b/2 study of lucitanib and Opdivo in combination for gynecologic cancers expected at a 2021 medical meeting Based on current revenue and expense forecasts, existing cash and equivalents expected to fund operating plan into early 2023

XML

Document and Entity Information	Jan. 11, 2021
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001466301
Document Type	8-K
Document Period End Date	Jan. 11, 2021
Entity Registrant Name	Clovis Oncology, Inc.
Entity Incorporation State Country Code	DE
Entity File Number	001-35347
Entity Tax Identification Number	90-0475355
Entity Address, Address Line One	5500 Flatiron Parkway
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Boulder
Entity Address, State or Province	CO
Entity Address, Postal Zip Code	80301
City Area Code	(303)
Local Phone Number	625-5000
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock par Value $0.001 per Share
Trading Symbol	CLVS
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false