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Clovis Oncology's Rubraca Revenues Decline 16 Percent

NEW YORK – Clovis Oncology on Wednesday reported that its fourth quarter revenues from the PARP inhibitor Rubraca (rucaparib) declined 16 percent.

For the three months ended Dec. 31, the company recorded sales of $36.0 million, compared to $43.3 million in Q4 2020, and below analysts' consensus estimate of $37.7 million. Rubraca revenues were within the range Clovis had projected in January when it announced preliminary Q4 and 2021 earnings estimates.

Rubraca, Clovis' only marketed product, 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 third-line treatment for BRCA1/2-mutated ovarian cancer and for BRCA1/2-mutated, metastatic castration-resistant prostate cancer, or mCRPC, previously treated with an androgen receptor treatment or taxane-based chemo. The company attributed the lower revenues primarily to fewer ovarian cancer patients being diagnosed and treated in the US due to the COVID-19 pandemic.

Clovis' Q4 net loss was $64.4 million, or $.50 per share, compared to a net loss of $99.0 million, or $1.02 per share, in Q4 2020. Analysts on average had expected a loss per share of $.57.

R&D expenses were $41.8 million in Q4, down 26 percent from $56.7 million in the prior year's quarter. Clovis reduced its selling, general, and administrative expenses by 18 percent to $33.3 million from $40.8 million a year ago.

For full year 2021, product revenues from Rubraca amounted to $148.8 million, down 10 percent from $164.5 million in 2020, and below analysts' consensus estimate of $150.3 million.

In 2021, the company had a net loss of $264.5 million, or $2.29 per share, compared to a net loss of $369.2 million, or $4.38 per share, in 2020. Analysts on average had expected a loss per share of $2.33.

Full-year R&D costs declined 28 percent to $186.6 million from $257.7 million, while SG&A expenses were down 22 percent to $128.4 million from $163.9 million.

Looking ahead, Clovis has said that 2022 promises to be a big year in terms of data readouts from several studies that may allow the firm to market Rubraca in other indications, including the two-part Phase III ATHENA trial and the Phase III TRITON3 trial.

In the first part of ATHENA (dubbed ATHENA-mono), Clovis is comparing single-agent Rubraca against placebo in the first-line ovarian cancer maintenance setting. In the second part, the drugmaker is studying the activity of Rubraca with the checkpoint inhibitor Opdivo (Bristol Myers Squibb's nivolumab) against Rubraca monotherapy in the same first-line maintenance setting. "Based on a slower-than-expected progression-free survival event count, we're now expecting data from ATHENA-mono in the second quarter of 2022," Lindsey Rolfe, Clovis' chief medical officer, said during a call to discuss the company's financials.

In TRITON3, Clovis is comparing Rubraca against physicians' choice of chemotherapy or second-line androgen deprivation treatment in metastatic castration-resistant prostate cancer patients with BRCA1/2 or ATM mutations. The firm expects to report data from this study in Q2 this year. According to Rolfe, data from this trial may allow the company to expand the use of Rubraca to the second-line mCRPC setting.

Following data readouts from ATHENA and TRITON3, Clovis hopes to quickly file supplemental new drug applications for Rubraca in these new indications, Rolfe said.

This year, the company will also provide a first look at clinical data from the Phase I/II LuMIERE trial of its investigational FAP-targeting imaging agent and radionuclide therapy FAP-2286. When FAP-2286 is labeled with gallium-68, it serves as the imaging agent that identifies patients with FAP-positive tumors for the LuMIERE trial. Subsequently, patients with FAP-positive tumors will receive the therapeutic agent labeled with lutetium-177.

Clovis has said its ambition is to become a leading provider of radionuclide therapies. CEO Patrick Mahaffy said during the call that while the company is exploring the therapeutic activity of FAP-2286 in multiple tumor types within the LuMIERE trial, it is also interested in potentially launching gallium-labeled FAP-2286 as a standalone imaging diagnostic. "We have been evaluating, at the guidance and request of the clinical community, … whether or not FAP-2286 could be seen on its own as an imaging modality particularly in tumor types where standard imaging, for instance, FDG-PET, is not as effective," Mahaffy said. "It clearly has emerged as a potential opportunity."

In evaluating the market opportunity, the company has determined that the cost of developing FAP-2286 as a standalone imaging agent would be "markedly lower" and the path to market would be quicker compared to developing and launching a radionuclide therapy. The imaging agent may allow Clovis to begin generating revenues from FAP-2286 well before the therapeutic reaches the market, Mahaffy said, but added: "We haven't made a firm commitment yet to entering this field, but we're getting there."

As of Dec. 31, 2021, Clovis had $143.4 million in cash and cash equivalents. The company said that in the fourth quarter, it raised $3.0 million in net proceeds, and in Q1 2022, so far it has raised $27.2 million in net proceeds through its at-the-market equity offering program and can issue additional shares of common stock through this program. "Clovis remains focused on its liquidity position and is committed to raising additional capital in the near term in order to fund its operating plan for the next 12 months and beyond," the company said in a statement.

Clovis also inked a financing program in 2019 with affiliates of TPG Sixth Street Partners for up to $175 million to pay for the ongoing ATHENA clinical trial of Rubraca. Clovis has drawn $147.2 million through this program and still has $27.8 million available.