Onyx: Initial Kyprolis Sales Blow Past Estimates

SOUTH SAN FRANCISCO (TheStreet) -- Onyx Pharmaceuticals (ONXX)posted $18.6 million in Kyprolis sales in the third quarter -- a strong start to the launch of the new multiple myeloma drug.

FDA approved Kyprolis on July 20 for the treatment of multiple myeloma patients who no longer respond to Takeda's Velcade and Celgene's (CELG) Revlimid or Thalomid.

The $18.6 million in Kyprolis sales for the September quarter easily surpassed the Street consensus estimate of $7 million (although the whisper number was in the $12-15 million range.)

On its conference call, Onyx said Kyprolis had quickly garnered 10% market share in third-line multiple myeloma, suggesting the drug still had lots of room to grow given the estimated 10,000 to 15,000 multiple myeloma patients eligible for third-line treatment.

No future sales guidance for Kyprolis was given Thursday.

Onyx is running clinical trial to expand Kyprolis into earlier lines of multiple myeloma therapy. One such ongoing trial, dubbed ASPIRE, combines Kyprolis with Celgene's Revlimid. On Thursday, Onyx said interim results from the ASPIRE trial would likely be delayed to the fourth quarter 2013 or later because patients enrolled are progressing slower than expected. Onyx was careful to note that the study is blinded so it's impossible to determine what is causing the slower progression.

Another phase III study, FOCUS, is fully enrolled with interim results expected in the second half of 2013. If positive, Kyprolis data from this study will be used to seek European approval.

At next month's American Society of Hematology (ASH) meeting, Onyx will be presenting early data on oprozomib, an oral proteasome inhibitor for multiple myeloma. In June, Takeda announced the start of a phase III trial of its own oral proteasome inhibitor in multiple myeloma.

In the third quarter, Onyx reported a non-GAAP net loss of $51.8 million, or 79 cents per share, compared to a non-GAAP net loss of $19.5 million, or 31 cents per share, for the same period of 2011. Street consensus was looking for a net loss of 90 cents per share.

Total revenue in the September quarter was $89.5 million, up 19% year over year, including $70.7 million in revenue recorded from the joint venture with Bayer that covers the sale of the cancer drug Nexavar. Nexavar global sales totaled $208.2 million in the third quarter, flat from the year-ago period.

Sales of the colon cancer drug Stivarga, also sold in a partnership with Bayer, were $100,000 in the quarter. The drug was approved on Sept. 27.

Onyx shares were closed Thurday up 2.5% to $80.33 and were up another 1% to $81 in after-market trading.

-- Reported by Adam Feuerstein in Boston.

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