Nature of Business | 1. Nature of Business Clovis Oncology, Inc. (together with its consolidated subsidiaries, the “Company,” “Clovis,” “we,” “our,” “us”) is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and additional international markets. We target our development programs for the treatment of specific subsets of cancer populations, and simultaneously develop, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. We have in-licensed or acquired rights to oncology compounds in all stages of development. In exchange for the right to develop and commercialize these compounds, we have provided the licensor with a combination of upfront payments, milestone payments and royalties on future sales. In addition, we have assumed the responsibility for future drug development and commercialization costs. We currently operate in two segments. Since inception, our operations have consisted primarily of developing in-licensed compounds, evaluating new product acquisition candidates and general corporate activities and since 2016 we have also marketed and sold products. Our marketed product Rubraca ® BRCA In May 2020, the FDA approved Rubraca for the treatment of adult patients with mCRPC associated with a deleterious BRCA In Europe, the European Commission granted a conditional marketing authorization in May 2018 for Rubraca as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA BRCA BRCA Beyond our labeled indications, we continue to evaluate Rubraca in the ATHENA Phase 3 study under a clinical collaboration with Bristol Myers Squibb Company (“Bristol Myers Squibb”) to evaluate its immunotherapy OPDIVO® (nivolumab) in combination with Rubraca in front-line ovarian cancer maintenance treatment. On March 31, 2022, we announced positive top-line data from the monotherapy portion of the ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating that Rubraca as maintenance treatment successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival (“PFS”) compared with placebo. Benefit was observed in both primary efficacy analyses of newly-diagnosed patients with advanced ovarian cancer following successful treatment with platinum-based chemotherapy: those who had homologous recombination deficiency (HRD-positive), including deleterious BRCA BRCA BRCA BRCA BRCA Based on the results of ATHENA-MONO, we submitted a supplemental New Drug Application (“sNDA”) to the FDA and a Type II variation to the European Medicines Agency (“EMA”) for a first-line maintenance treatment indication for women with advanced ovarian cancer who have responded to first-line platinum-based chemotherapy in August 2022. In early May 2022, the FDA recommended that we should not submit the first line maintenance sNDA until overall survival (“OS”) data from the ATHENA-MONO trial are as much as 50% mature, and if we do choose to submit prior to that, we should expect the FDA to require a discussion at an Oncologic Drugs Advisory Committee (“ODAC”) meeting in connection with its review of such sNDA submission. In addition, the FDA will consider OS data from other rucaparib clinical trials when it reviews the ATHENA-MONO dataset. On November 4, 2022, we received from the FDA the Day-74 letter, which notifies an applicant of issues identified during the filing review phase. The letter confirmed that the sNDA has been accepted for a standard review with a PDUFA date of June 25, 2023. The FDA reiterated that the current OS data from the ATHENA-MONO trial are immature and expressed the view that the current trends of certain OS HR estimates indicate that there may be potential harm for patients in certain sub-groups. The OS data submitted in the sNDA application were immature at 15.8% (HRD) and 24.7% (ITT) with no statistically significant differences between rucaparib and control. Our initial estimates suggest that we would reach 50% maturity in approximately 1.5 years. The FDA further indicated that PFS improvement alone may not be sufficient to support an overall positive benefit-risk assessment in a maintenance treatment setting, as, in the FDA’s opinion, Rubraca is adding toxicity during a time when patients would otherwise not be on any treatment. While the letter did not refer to an ODAC, there can be no assurances regarding whether an ODAC will be scheduled, or the timing or outcome of the FDA review of the sNDA submission and the timing or outcome of the EMA review of the Type II variation submission. The timing for the Phase 3 data readouts from the ATHENA-COMBO trial is contingent upon the occurrence of the protocol-specified PFS events, currently estimated to occur in the fourth quarter of 2023. We hold worldwide rights to Rubraca. FAP-2286 is our initial product candidate to emerge from our targeted radionuclide collaboration with 3B Pharmaceuticals GmbH (“3BP”). FAP-2286 is a peptide-targeted radionuclide therapy (“PTRT”) and imaging agent targeting fibroblast activation protein (“FAP”). PTRT uses cancer cell-targeting peptides to deliver radiation-emitting radionuclides specifically to tumors. Following the clearance by the FDA of two INDs submitted in December 2020 to support the use of FAP-2286 as an imaging and treatment agent, we initiated the Phase 1 portion of the LuMIERE clinical study in June 2021. LuMIERE is a Phase 1/2 study of FAP-2286 labeled with lutetium-177 ( 177 68 We presented Phase 1 clinical data from LuMIERE in an oral presentation at the Society of Nuclear Medicine & Molecular Imaging (“SNMMI”) 2022 Annual Meeting in June. In October 2022, we presented updated Phase 1 clinical data from LuMIERE at the 35th Annual European Association of Nuclear Medicine (“EANM”) Congress. In addition to investigating for therapeutic use FAP-2286 labeled with the beta particle-emitting lutetium-177, we are also exploring FAP-2286 labeled with the alpha particle-emitting actinium-225 (Ac-225). We hold US and global rights to FAP-2286, excluding Europe (defined to include Russia, Turkey, and Israel), where 3BP retains rights. We are also collaborating with 3BP on a discovery program directed to up to three additional, undisclosed targets for targeted radionuclide therapy, to which we would have global rights for any resulting product candidates. Lucitanib, another of our small molecule product candidates, is an investigational, oral, potent angiogenesis inhibitor which inhibits vascular endothelial growth factor receptors 1 through 3 (“VEGFR1-3”), platelet-derived growth factor receptors alpha and beta (“PDGFR α/β”) and fibroblast growth factor receptors 1 through 3 (“FGFR1-3”). Lucitanib inhibits the same three pathways as Lenvima ® ® We hold the global (excluding China) development and commercialization rights for lucitanib. Going Concern and Management Plans We require significant cash resources to execute our business plans. Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023. Given the recent regulatory developments that may have significant impact on current revenues and the commercial potential of Rubraca and the continuing challenges we face in raising additional capital, including as a result of the uncertain market potential of Rubraca, a potential bankruptcy filing in the very near term looks increasingly probable as a way to preserve the value of our business and assets for the benefit of our stakeholders, as further described below, though we continue to evaluate our strategic options and continue to discuss in and out of bankruptcy financing options with our creditors and other parties. We have incurred significant net losses since inception and have relied, almost entirely, on debt and equity financings to fund our operations. We expect operating losses and negative cash flows to continue for the foreseeable future even with Rubraca generating revenues. Rubraca revenues have not been consistent in prior quarters and have been trending downward during the past two years, initially as a result of the impact of COVID-19 pandemic on patient visits and diagnoses, but more recently primarily as a result of competition from other products on the market, including the impact on second-line maintenance that may result from an increase in first-line maintenance treatment of ovarian cancer (indications for which competing products are approved). Moreover, over the past few months, a new focus by the FDA and the EMA on mature OS data for drugs previously approved based on achieving PFS as a primary endpoint has led to withdrawals of certain later line indications in ovarian cancer for Rubraca and each of the other PARP inhibitors on the market with a later line treatment indication in ovarian cancer. In addition, FDA had scheduled an ODAC meeting in November 2022 to review another PARP-inhibitor, Zejula (niraparib) (GlaxoSmithKline (“GSK”)), to seek advice on whether its second-line maintenance indication in ovarian cancer should be withdrawn from the labeling on the basis of the final OS data from the trial that supported approval for Zejula in that indication. In late October 2022, the FDA cancelled that ODAC meeting, indicating that it was no longer necessary. While neither the FDA nor GSK have publicly stated the reason for cancelation of the meeting, if the outcome of discussions between the FDA and GSK is a withdrawal or narrowing of that indication, we cannot assure you that the FDA would not seek to similarly limit our second line maintenance indication in ovarian cancer. As a substantial portion of our Rubraca revenue is attributable to that indication, we would expect that a limiting of our second line maintenance indication could result in a significant impact on our revenue, although the timing and magnitude of such impact is not currently ascertainable. This focus by the FDA on OS data has created uncertainty with respect to the timing, likelihood and scope of an approval for the sNDA we filed with the FDA, and may result in uncertainty with respect to the Type II variation we filed with the EMA, for first-line maintenance treatment indication in ovarian cancer, which we had been planning on to finally level the competitive landscape with our two competitors that have existing and established labels in the first-line maintenance treatment indication setting. This new regulatory framework has created an uncertain commercial landscape for Rubraca (and to a certain extent, other PARP inhibitors) and has impacted the perceived market opportunity and revenue potential for Rubraca (and to a certain extent, other PARP inhibitors). We require significant cash resources to execute our business plans, and our revenues are a significant portion of those cash resources. Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we must raise additional capital in the near term in order to fund our operating plan and to continue as a going concern beyond January 2023. It appears increasingly unlikely that additional funding will be available on acceptable terms or at all outside of a Chapter 11 bankruptcy process. Our ability to raise capital is severely limited. We have not been able to access the equity capital markets that we have traditionally relied on in sufficient amount to fund our operating plan given our low stock price over the past six months and the generally unfavorable market conditions, particularly in the biopharma sector. Also, we only have a small number of unissued shares of common stock that we are authorized to issue, and once again this year our stockholders did not approve an amendment to our certificate of incorporation to increase our authorized capital stock. Given our current circumstances, it is highly unlikely that we will be able to access our previously established “at-the-market” offering program (“ATM Program”) in the near future. In light of our inability to raise sufficient capital through equity offerings (or offerings of securities convertible into equity securities), we are considering other sources of funding, potentially through incurring further indebtedness or entering into strategic partnerships or licensing arrangements for one or more of our products or product candidates in which we may have to give up certain of our future commercialization or other rights to obtain interim funding. During the past quarter, we advanced our previously announced efforts to explore our strategic options, including identifying potential partners and/or purchasers for our products and development programs. We are in active discussions on a potential sub-licensing arrangement for Rubraca outside the US, but the regulatory uncertainty around our ability to obtain a more competitive label for Rubraca has made it more difficult to reach agreement on financial terms and on timing of a transaction. Additionally, we are also in active discussions for a sale of our license rights to FAP-2286, for which we seek consideration such as an upfront payment and additional payments in the form of milestones and research and development support. However, we expect that a significant portion of the consideration in both transactions would be contingent on future events. No assurances can be made that we will be successful in reaching agreement or entering into such potential transactions, or that if we do enter into a definitive agreement, that the timing and amounts of such payments, including contingent payments, would be sufficient to meet our liquidity needs in the absence of other sources of funding. These discussions have also been hampered by concerns raised by these potential partners and purchasers about our liquidity position and ability to continue as a going concern. During the past quarter, we have also continued to aggressively manage our expenses. We implemented a workforce reduction in the US on November 7, 2022 consisting of 115 employees, which we anticipate will yield annual cost savings of approximately $29 million per year (excluding one-time severance costs of $4.0 million related to such terminations), but the full impact of those cost savings will not be realized until 2023. We have also reduced discretionary selling, general, and administrative and research and development expenses. We have engaged financial, restructuring, and legal advisors to assist us in, among other things, analyzing various strategic alternatives to address our liquidity and capital structure. During the quarter, we also engaged in further discussions and negotiations with certain of our existing creditors, lenders and vendors to defer certain of our obligations and/or to loan us additional funds to bridge our cash requirements until we can reach definitive agreements on our partnering and sale of assets transactions and potentially to a further point until we have greater clarity from the FDA and EMA on the potential to receive approval for first-line maintenance treatment for Rubraca in the second quarter of 2023. However, we have not been able to reach agreement on such additional financing on terms that we view as reasonable and preserves the value of our assets and business for the benefit of all our relevant stakeholders. We did however elect to not make the interest payment in the amount of $1.9 million in respect of our 1.25% Convertible Senior Notes due 2025 that was due on November 1, 2022. Under the indenture governing these notes, we have a 30-day strategic alternatives. Separately, we are in discussions with Pfizer, Inc. to defer certain royalty payments due under our in-license agreement in respect of sales of Rubraca during the quarter ended September 30, 2022 in the amount of $4.3 million and the quarter ending December 31, 2022 until March 31, 2023, plus interest thereon from the date such payments would otherwise be payable under the license agreement until actually paid. The aforementioned factors, which are largely outside of our control, raise substantial doubt about our ability to continue as a going concern in the near term, and certainly within one year from the date of filing of this quarterly report. Given the concerns about our long term viability raised by our partners and potential purchasers of our assets and the high cost and what we view as unreasonable terms of the additional debt financing that may be available to us, a Chapter 11 bankruptcy filing in the very near term, while we have sufficient cash on hand and/or access to debtor in possession financing to be able to implement an orderly restructuring of our liabilities and/or a sale of our assets through a court supervised process, looks increasingly probable. We also believe, however, that such a path may be the best way to preserve the value of our business and assets for the benefit of our stakeholders. Such a filing would subject us to risks and uncertainties associated with bankruptcy proceedings, and may place holders of our common stock at significant risk of losing all of their investment in our shares. However, together with our financial and restructuring advisors, we continue to evaluate our strategic options and continue to discuss in and out of bankruptcy financing options with our creditors and other parties. Basis of Presentation All financial information presented includes the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The unaudited financial statements of Clovis Oncology, Inc. included herein reflect all adjustments that, in the opinion of management, are necessary to fairly state our financial position, results of operations and cash flows for the periods presented herein. Interim results may not be indicative of the results that may be expected for the full year. Certain information and footnote disclosures normally included in audited financial statements prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”) have been condensed or omitted pursuant to the rules and regulations of the US Securities and Exchange Commission (“SEC”). These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto which are included in our 2021 Form 10-K for a broader discussion of our business and the opportunities and risks inherent in such business. Use of Estimates The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and revenue and related disclosures. On an ongoing basis, we evaluate our estimates, including estimates related to revenue deductions, intangible asset impairment, clinical trial accruals and share-based compensation expense. We base our estimates on historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. |