NEW YORK – Clovis Oncology on Wednesday reported before markets opened an 8 percent decline in revenues from its PARP inhibitor rucaparib (Rubraca), lower than analysts' consensus estimate.
For the three months ended June 30, Clovis reported revenues from its only marketed product rucaparib of $36.8 million compared to $39.9 million in Q2 2020. Analysts had expected product revenues of $41.1 million. "The decrease was primarily due to fewer diagnoses and fewer patient starts, due to the ongoing COVID-19 pandemic," the company said in a statement announcing its Q2 financials.
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, or mCRPC, patients who previously received androgen receptor treatment or taxane-based chemo.
Despite the negative impact from the pandemic, particularly in the ovarian cancer setting, Clovis CEO Patrick Mahaffy said during a call to discuss quarterly financial results that the company maintained its market share for rucaparib in the competitive US PARP inhibitor market and achieved "meaningful sales growth" in Europe in the second-line maintenance ovarian cancer setting. Of the $36.8 million in rucaparib revenues, $36.7 million were attributed to US sales and $3.2 million came from drug sales outside of the US.
Another PARP inhibitor, AstraZeneca's olaparib (Lynparza), is also marketed in the US as a maintenance treatment for advanced ovarian cancer patients following first-line platinum chemotherapy, but they must have BRCA1/2 mutations, or homologous recombination deficiency-positive tumors if they're receiving olaparib in combination with bevacizumab (Genentech's Avastin). In Q2, olaparib sales grew 40 percent year over year to $588 million. Drug sales grew in the prostate cancer indication in the US and had good performance in Europe in the first-line ovarian and prostate cancer indications.
The company reported a net loss of $66.5 million, or $.61 per share, in Q2 2021, compared to $92.2 million, or $1.15 per share, in Q2 2020. On average, analysts had estimated a loss of $.56 per share.
Its R&D expenses declined 35 percent to $45.8 million in the quarter compared to $69.9 million in the year-ago period, which the company attributed to lower spending on rucaparib clinical trials. Selling, general, and administrative expenses were $32.9 million in Q2 2021, down 21 percent from $41.9 million in Q2 2020. The company is trying to reduce its overall costs and expects selling, general, and administrative expenses to continue to decline for the rest of the year compared to 2020.
"We anticipate that when patient visits begin to rise, as diagnoses increase, and the urgent need to more actively manage this often fatal disease growth, the maintenance treatment of ovarian cancer patients will increase, including its use in women with BRCA1/2 [mutations] and advanced disease," Mahaffy said.
Despite lower R&D spending this past quarter, Mahaffy said that Clovis was able to maintain clinical trial enrollment amid the pandemic. Additionally, Clovis is trying to expand rucaparib's indication in several ongoing studies. "We're ever closer to not one, but three Phase III readouts for Rubraca in the next six to 18 months," Mahaffy said.
In Q1 2022, the company is expecting top-line data from the Phase III ATHENA trial exploring rucaparib as a first-line maintenance treatment option for ovarian cancer patients. In the second half of 2022, the combination portion of ATHENA, comparing rucaparib with Bristol Myers Squibb's checkpoint inhibitor nivolumab (Opdivo) against just rucaparib will read out.
Additionally, TRITON3, which will likely confirm the activity of rucaparib in mCRPC (an indication that has accelerated approval from the FDA) and enable Clovis to extend its use as a second-line treatment, is slated to read out in Q2 2022. The Phase III trial is evaluating rucaparib against physicians' choice of chemo or second-line androgen deprivation treatment in mCRPC patients with BRCA1/2 or ATM mutations.
"The three anticipated data readouts, ATHENA monotherapy, ATHENA combination and TRITON3, provide the potential to reach larger patient populations in earlier lines of therapy for ovarian and prostate cancers, in which Rubraca is currently approved in later-line indications," Clovis said in a statement.
Clovis is also hoping to establish itself as a leader in the emerging field of targeted radionuclide therapies, Mahaffy said, adding that the next 18 months will be potentially "transformational" for its lead FAP-2286 program.
During the second quarter, Clovis began studying its FAP-targeting imaging agent and radionuclide therapy FAP-2286 in the Phase I/II LuMIERE trial. FAP is expressed in fibroblasts in many kinds of common tumors. In the study, FAP-2286 labeled with gallium-68 will be the PET imaging agent that identifies patients with FAP-positive tumors, who will receive the radioactive therapeutic agent labeled with lutetium-177.
Clovis CSO Thomas Harding also highlighted during the call that researchers at the University of California, San Francisco are studying FAP expression in multiple tumor types using FAP-2286 labeled with gallium-68. This trial is currently enrolling.
Clovis licensed FAP-2286 in 2019 from the German biotechnology company 3B Pharmaceuticals. According to Harding, Clovis and 3B are collaborating on a radionuclide therapy discovery program involving three additional targets to which Clovis has global rights. Harding added that Clovis may file an investigational new drug application for a second agent in the second half of 2022.
During the second quarter, Clovis raised $72.5 million in net proceeds through its "at-the-market" equity offering program. The company ended the quarter with $230.2 million in cash and cash equivalents, as well as $122.5 million in working capital.