Clovis (CLVS) Q1 Loss Narrows, Rubraca Off To A Good Start

Clovis Oncology, Inc. (NASDAQ:CLVS) reported first-quarter 2017 loss of $1.33 per share, which was narrower than the Zacks Consensus Estimate of a loss of $1.43 as well as the year-ago loss of $2.17 per share.

In Dec 2016, Clovis received accelerated approval from the FDA for its PARP inhibitor, Rubraca (rucaparib) for the treatment of advanced ovarian cancer in patients who have been treated with two or more chemotherapies. The first quarter of 2017 represented a full quarter of product revenues for Rubraca.

Net product revenues, entirely from Rubraca, were approximately $7.05 million in the quarter, which beat the Zacks Consensus Estimate of $6.03 million.

In the year-ago quarter, Clovis did not generate any revenues.

Clovis’ share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical and Genetics industry, having surged 20% this year so far, while the industry rose 5.2%.

Quarter in Detail

During the reported quarter, research & development expenses decreased 56.6% year over year to $32.4 million, primarily due to decreased development activities related to Rubraca and rociletinib programs. General and administrative (G&A) expenses increased 198% year over year to $29.2 million, reflecting commercialization costs for Rubraca launch.

Cash used in operating activities in the quarter was $80.4 million, less than $83.7 million in the year-ago quarter.

The company ended the quarter with $408.8 million of cash equivalents and available-for-sale securities supported by the proceeds raised through a share offering in January.

Update on Rubraca

At the conference call, the company said that over 300 different healthcare practitioners had prescribed Rubraca in the quarter with over 350 new patients starting therapy.

Meanwhile, Rubraca is also under review in the EU for a comparable ovarian cancer indication. Clovis expects EU approval in the first quarter of 2018 and is establishing the commercial infrastructure for the same.

In order to convert the accelerated approval to a continued approval, Clovis is running confirmatory studies. The company said that it has received certification from the Independent Data Monitoring Committee or IDMC that the target progression events in a pivotal maintenance confirmatory study - ARIEL3 - on Rubraca were achieved in mid April. Management remains blinded to the data.

Top-line data from ARIEL3 is expected to be available by the end of June. If the data are positive, Clovis intends to submit a supplemental new drug application (sNDA) for a second line or later maintenance indication for advanced ovarian cancer. The ARIEL4 phase III treatment confirmatory study evaluating Rubraca versus chemotherapy in patients who have failed two prior lines of therapy is open for enrolment.

Meanwhile, Clovis is looking to expand Rubraca’s label into additional indications like prostrate, breast and pancreatic cancers, among others, either as monotherapy or in combination with other agents.

Several clinical studies were initiated in early 2017, including TRITON2 and TRITON3 in prostate cancer and a Tecentriq- Rubraca combination study in gynecologic cancers, which is sponsored by Roche Holding (SIX:ROG) AG (OTC:RHHBY) .

Clovis Oncology, Inc. Price, Consensus and EPS Surprise

Clovis Oncology, Inc. Price, Consensus and EPS Surprise | Clovis Oncology, Inc. Quote

Clovis carries a Zacks Rank #3 (Hold). Better-ranked stocks in the pharmaceutical sector are Aeglea BioTherapeutics (NASDAQ:AGLE) and Akari Therapeutics, Plc (NASDAQ:AKTX) , both with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Aeglea have increased 52.8% this year so far while loss estimates for 2017 have narrowed by almost 32% in the past 30 days.

Shares of Akari Therapeutics have risen 110.9% this year so far.

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