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Clovis' Q3 Rubraca Sales Drop 2 Percent

NEW YORK – Clovis Oncology on Wednesday reported a 2 percent decline in revenues in the third quarter from its PARP inhibitor rucaparib (Rubraca), lower than analysts' consensus estimate.

For the three months ended Sept. 30, the Boulder, Colorado-headquartered firm reported revenues from its singular marketed product rucaparib of $37.9 million compared to $38.8 million in Q3 2020. Analysts had expected product revenues of $39.5 million.

Of the $37.9 million in global rucaparib sales in Q3, $28.7 million were recorded in the US and $9.2 million were due to sales in international markets. Although rucaparib's Q3 sales were up 3 percent compared to the $36.8 million for the drug in Q2, the company attributed the lower year-over-year performance to fewer ovarian cancer patients being diagnosed and treated due to the ongoing COVID-19 pandemic.

The company reported a net loss of $67.4 million, or $.56 per share, in Q3 2021, compared to a net loss of $78.7 million, or $.89 per share, in Q3 2020. On average, analysts had estimated a loss of $.48 per share.

Its R&D expenses declined 27 percent to $46.2 million in the quarter compared to $62.9 million in the year-ago period, which the company attributed to lower spending on rucaparib clinical trials. Selling, general, and administrative expenses were $32.2 million in Q3 2021, down 17 percent from $38.6 million in Q3 2020. The company said it expects its full-year R&D and selling, general, and administrative expenses to be lower for 2021 compared to 2020.

Looking ahead to 2022, Clovis is focused on expanding rucaparib's indication into earlier treatment settings, which if successful, could bolster its revenues. Rucaparib is currently approved in the US as a maintenance treatment for platinum-responsive recurrent ovarian cancer patients regardless of their biomarker status. The drug is also approved as a treatment for BRCA1/2-mutated ovarian cancer patients who have previously gotten two or more chemotherapies, and BRCA1/2-mutated, metastatic castration-resistant prostate cancer (mCRPC) patients who previously received androgen receptor treatment or taxane-based chemo.

Despite the challenges presented by the pandemic, "we've set the stage for a very important year to come," Clovis CEO Patrick Mahaffy said during a call to discuss the company's financials. In 2022, the company hopes to present top-line data from three Phase III rucaparib studies.

Clovis is expecting data from the two-part Phase III ATHENA trial, which is exploring single-agent rucaparib as a first-line maintenance treatment for ovarian cancer patients and comparing first-line rucaparib plus Bristol Myers Squibb's checkpoint inhibitor nivolumab (Opdivo) against just rucaparib. Additionally, TRITON3 will readout next year, data from which may allow Clovis to extend rucaparib's use as a second-line treatment for mCRPC patients with BRCA1/2 or ATM mutations.

Additionally, next year, the company will present data from the Phase I portion of the Phase I/II LuMIERE trial of its FAP-targeting theranostic FAP-2286. FAP is expressed in fibroblasts in many kinds of tumors, and only patients with FAP-positive tumors will be enrolled in the study. FAP-2286 labeled with gallium-68 will be the PET imaging agent that identifies patients with FAP-positive tumors, who will then receive the radioactive therapeutic agent labeled with lutetium-177.

The company's goal is to be the first to market with this therapy in the FAP-targeted radionuclide space. "If any company has learned the advantages of being first [to market] and the disadvantages of being third, it's us, given our experience … with Rubraca," said Mahaffy. In the crowded PARP inhibitor market, rucaparib competes with AstraZeneca's PARP inhibitor olaparib (Lynparza) and GlaxoSmithKline's niraparib (Zejula).

"As a consequence, we're really informed by this and are actively pursuing an aggressive development program for FAP-2286 that not only keeps us first but keeps us first in multiple tumor types and keeps us first with potential combinations that may add to the monotherapy benefit of FAP-2286," Mahaffy said.

Clovis CSO Thomas Harding noted during the call that there are more than a dozen radionuclide therapies in development targeting FAP, but a big hurdle for all these therapies is that they don't stay in the tumor for long. "We're using a fundamentally different approach for FAP-2286, which is a constrained peptide ring … [that] gives a differentiated preclinical profile in terms of tumor retention and anti-tumor efficacy compared to other small molecular FAP radiotracers."

"We don't know everything we need to know about this drug, but we know a couple of things for sure," Mahaffy added. "We know it gets to the tumor and we know it stays in the tumor, and those are the two most important ingredients for an effective radionuclide."

Clovis Chief Medical Officer Lindsey Rolf said during the call that while the Phase I portion of the LuMIERE trial will enroll patients with a variety of FAP-positive tumor types in order to establish a Phase II dose of FAP-2286, in the second phase of the trial, Clovis will enroll patients with specific kinds of FAP-expressing cancers that it has chosen to advance clinically based on ongoing research.

During the third quarter, Clovis established an at-the-market equity offering program with the capacity to issue $125 million in shares of common stock. It raised $41.5 million in net proceeds through this equity offering program in Q3.

Clovis ended the quarter with $171.9 million in cash and cash equivalents, as well as $118.0 million in working capital.

On Wednesday morning trading on the Nasdaq, Clovis shares were trading at $4.43, down around 7 percent.