CLVS Clovis Oncology Inc

Item 7.01 Regulation FD Disclosure.

As previously disclosed, on December 11, 2022, Clovis Oncology, Inc. (the “Company”) and certain of its subsidiaries (such subsidiaries being Clovis Oncology Ireland Limited (“Clovis Ireland”) and Clovis Oncology UK Limited (“Clovis UK”) filed voluntary petitions under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware (such court, the “Court” and such cases, the “Cases”).

On February 9, 2023, the Company, Clovis UK and Clovis Ireland each filed their monthly operating reports (collectively, the “Monthly Operating Reports”), with the Court for the reporting month ended December 31, 2022, copies of which are attached hereto as Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3, respectively, and are incorporated herein by reference.

The Company expects to file future Monthly Operating Reports and other documents with the Court while the Cases remain pending. The filing of such reports and other documents may not be accompanied by a Form 8-K filing. The reports and other documents will also be available for review free of charge at https://cases.ra.kroll.com/Clovis/. Investors should review this website for additional information regarding the Company and the Cases.

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Cautionary Note Regarding the Monthly Operating Reports

The Company cautions investors and potential investors not to place undue reliance upon the information contained in the Monthly Operating Reports, which were not prepared for the purpose of providing the basis for an investment decision relating to the Company’s securities. The Monthly Operating Reports are limited in scope and have been prepared solely for the purpose of complying with requirements of the Court. The Monthly Operating Reports were not reviewed by independent accountants, are in a format prescribed by applicable bankruptcy laws, and are subject to future adjustment. The financial information in the Monthly Operating Reports are not prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and, therefore, may exclude items required by GAAP, such as certain reclassifications, eliminations, accruals, valuations and disclosures. The Monthly Operating Reports also relate to periods that are different from the historical periods required in the Company’s reports pursuant to the Securities Act of 1933, as amended, or the Exchange Act.

Limitation on Incorporation by Reference

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 is being furnished for informational purposes only and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as otherwise expressly stated in such filing. The filing of this current report (including Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3 attached hereto) will not be deemed an admission as to the materiality of any information required to be disclosed solely by Regulation FD.

standard review timelines, FDA may have held its internal Mid-Cycle Meeting for the pending sNDA, and the Company awaits receipt of the Mid-Cycle Communication, which would be expected to provide an update on the review status of the application. Additionally, as previously disclosed, the Company concluded discussions with the FDA on a revised label to limit Rubraca’s use in the second-line ovarian cancer maintenance indication to the tBRCA mutation patient population only, and the revised label was approved on December 21, 2022. With respect to the Type II variation submitted to EMA, the Company received the assessment report including requests for supplementary information on December 15, 2022. Although the report stated that the benefits of rucaparib in the claimed indication could be considered meaningful with a manageable safety profile, it also stated that there are still some uncertainties that need to be resolved before a positive recommendation could be made. The report described the lack of mature OS data as the main limitation and contains a number of requests for supplementary information. As is often the case at this stage of an assessment procedure, the report stated that the overall benefit/risk of Rubraca in the front line maintenance setting is currently negative. The Company expects to provide the requested supplementary information to EMA in March 2023.

The Company is seeking to sell its assets through a court supervised sales process in the Cases. On December 11, 2022, the Company entered into a “stalking horse” purchase and assignment agreement with Novartis Innovative Therapies AG (“Novartis”) to sell substantially all of its rights to its pipeline targeted radionuclide therapy clinical development program, FAP-2286, including the Company’s in-licensing agreement with 3B Pharmaceuticals GmbH. The transaction is part of a sale process under Section 363 of title 11 of the United States Code (the “Bankruptcy Code”) that is subject to approval by the Court and compliance with agreed upon and Court-approved bidding procedures allowing for the submission of higher or otherwise better offers, and other agreed-upon conditions. In accordance with the sale process under Section 363 of the Bankruptcy Code, notice of the proposed sale to Novartis has been given to third parties and competing bids are being solicited. The deadline to submit competing bids for the FAP-2286 assets has been set for March 7, 2023 by the Court in the bidding procedures order. The transaction is subject to a number of closing conditions, including among others, (i) the accuracy of representations and warranties of the parties; (ii) the entry into a transition services agreement mutually acceptable to the parties; (iii) material compliance with the obligations of the parties set forth in the purchase agreement, including achievement of certain milestones by the Company related to the Cases and the sales process on a timely basis; (iv) no Material Adverse Effect (as defined in the purchase agreement) having occurred to the transferred assets; and (v) payment of cure costs in respect of any assigned contract related to the FAP-2286 assets.

Separately, the Company is also actively engaged in discussions with a number of interested parties with respect to a potential sale of its Rubraca assets and business. That sale would also be subject to review and approval by the Court and compliance with Court-approved bidding procedures. The deadline to submit bids for the purchase of the Company’s Rubraca assets and business has been set for March 21, 2023 by the Court in the bidding procedures order. The Company will manage the bidding process and evaluate the bids, in consultation with its advisors and other primary constituents and as overseen by the Court. There can be no assurances that any qualified or acceptable bids will be received or, even if received, the Company will be able to agree upon definitive terms with any such bidders and, even if a definitive agreement is entered into, there can be no assurances that it would be approved by the Court or that it would ultimately be consummated.

In connection with the sale process, the Debtors have filed notices with the Court (and have delivered notices to counterparties to the Debtors’ contracts) detailing the Debtors’ estimated amounts necessary to cure any defaults under the Company’s executory contracts and unexpired leases that could potentially be assumed and assigned to the purchasers of the FAP-2286 and/or Rubraca assets.

Cautionary Statements Regarding Trading in the Company’s Securities

The Company’s securityholders are cautioned that trading in the Company’s securities during the pendency of the Cases is highly speculative and poses substantial risks. Trading prices for the Company’s securities may bear little or no relationship to the actual recovery, if any, by holders thereof in the Cases. The Company cannot be certain that holders of the Company’s common stock will receive any payment or other distribution on account of those shares in the Cases given the expected sales proceeds (including the highly contingent nature of certain later milestone payments) and the amount of the Debtors’ liabilities to more senior creditors. Accordingly, the Company urges extreme caution with respect to existing and future investments in its securities.

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Cautionary Note Regarding Forward-Looking Statements

This Form 8-K includes statements that are, or may be deemed, “forward-looking statements.” In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or, in each case, their negative or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These forward-looking statements reflect the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity and the development of the industry in which we operate may differ materially from the forward-looking statements contained herein. Any forward-looking statements that we make in this Form 8-K speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Form 8-K or to reflect the occurrence of unanticipated events. The Company’s forward-looking statements in this Form 8-K include, but are not limited to, statements about the Company’s plans to sell its assets pursuant to Chapter 11 of the U.S. Bankruptcy Code and the timing of such sales and ability to satisfy closing conditions; the Company’s intention to continue operations during the Chapter 11 case; the Company’s belief that the sale process will be in the best interest of the Company and its stakeholders; and other statements regarding the Company’s strategy and future operations, performance and prospects among others. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting the Company will be those anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks associated with the potential adverse impact of the Chapter 11 filings on the Company’s liquidity and results of operations; changes in the Company’s ability to meet its financial obligations during the Chapter 11 process and to maintain contracts that are critical to its operations; the outcome and timing of the Chapter 11 process and any potential asset sale; the effect of the Chapter 11 filings and any potential asset sale on the Company’s relationships with vendors, regulatory authorities, employees and other third parties; possible proceedings that may be brought by third parties in connection with the Chapter 11 process or the potential asset sale; uncertainty regarding obtaining Court approval of a sale of the Company’s assets or other conditions to the potential asset sale; and the timing or amount of any distributions, if any, to the Company’s stakeholders.

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