NEW YORK – Clovis Oncology on Wednesday reported a 10 percent decline in sales for its only marketed product, the PARP inhibitor Rubraca (rucaparib), missing the Wall Street consensus estimate.
The Boulder, Colorado-based firm reported $34.2 million in product revenues for the three months ended March 31, compared to $38.1 million in Q1 2021. On average, analysts had expected revenues of nearly $37.0 million.
Rubraca is approved in the US for the treatment of patients with BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer and BRCA-mutant metastatic castration-resistant prostate cancer. The treatment is also approved as a maintenance therapy for ovarian, fallopian tube, or primary peritoneal cancer regardless of BRCA-mutation status.
Rubraca sales continue to be negatively impacted by fewer ovarian cancer diagnoses due to the COVID-19 pandemic, Clovis CEO Patrick Mahaffy said during a call to discuss the company's financial performance. Mahaffy noted that ovarian cancer diagnoses have fallen by 29 percent compared to before the pandemic and new patient starts on PARP inhibitors across indications have fallen 19 percent since Q1 2021.
"We do believe this impact will moderate over the course of this year, as the pandemic hopefully recedes," Mahaffy said. "We do expect the need for maintenance treatment of advanced ovarian cancer patients to increase as patient visits and diagnosis eventually grow."
The firm will present detailed data from the Phase III ATHENA trial of Rubraca monotherapy versus placebo as maintenance treatment following response to first-line platinum-based chemotherapy in ovarian cancer next month. Treatment with Rubraca had a median progression-free survival of 20.2 months compared to 9.2 months in the placebo group. A subgroup of patients with homologous recombination deficiency (HRD)-positive ovarian cancer had a median progression-free survival of 28.7 months vs 11.3 months in the HRD-positive placebo group.
Mahaffy said the firm intends to submit a supplemental new drug application to the US Food and Drug Administration for Rubraca as a first-line maintenance treatment for women with advanced ovarian cancer who have responded to first-line platinum-based chemotherapy. Clovis also plans to begin discussions with the European Medicines Agency to expand Rubraca's indication based on this data, he said.
The company is also expecting to present data on its targeted radionuclide therapy, FAP-2286, later this year. Clovis is evaluating FAP-2286 in two clinical trials: the Phase I LuMIERE trial, which is exploring the drug as a treatment for advanced solid tumors; and a Phase I study of FAP-2286 plus the imaging agent gallium-68 to detect metastatic solid tumors. Mahaffy said initial data from the LuMIERE study will be presented in June, and he expects the Phase II portion of the study to begin in the fourth quarter of 2022.
"We entered 2022 knowing that it would be the most significant year for clinical data readouts in our history, and we're very pleased that the results from the Athena monotherapy study of Rubraca, the first of those readouts, performed as well as it did," he added. "These anticipated pipeline events and our commitment to improving our balance sheet support our efforts to execute our three core strategies: expand the Rubraca label to drive revenue growth, emerge as a leader in targeted radionuclide therapy, and achieve longer term financial stability."
Clovis reported a net loss of $60.2 million in Q1 2022, or $.44 per share, compared to a net loss of $66.3 million, or $.64 per share, a year ago. Net loss for the quarter factored in a share-based compensation expense of $6.6 million, compared to $4.0 million for the same period last year. Analysts, on average, had expected a loss of $.43 per share.
The firm spent $42.3 million on R&D in Q1 2022, a 20 percent decrease compared to $52.8 million in Q1 2021. During the same period, selling, general and administrative expenses also dipped 2 percent to $29.2 million from $29.9 million a year ago.
As of March 31, Clovis had $122.2 million in cash and cash equivalents, and $18.6 million available through a financing program inked in 2019 for the ongoing ATHENA trial for Rubraca.