Analyst Conference Call Summary

biotechnology

conference date: November 1, 2012 @ 1:30 PM Pacific Time
[originally scheduled for October 30, 2012 @ 2:00 PM Pacific Time]
for quarter ending: September 30, 2012 (Q3, third quarter 2012)

Forward-looking statements

Overview: Started to sell Kyprolis in the quarter, but not enough to get to true profitability. A $95.8 million tax benefit resulted in GAAP results being much better than non-GAAP

Basic data (GAAP) :

Revenues were $89.5 million, up 23% sequentially from $72.7 million, and up 19% from $75.0 million in the year-earlier quarter.

Net income was $17.4 million, up sequentially from negative $106.1 million and also up from negative $36.9 million year-earlier.

EPS (earnings per share) were $0.25, up sequentially from negative $1.65, also up from negative $0.58 year-earlier.

Guidance:

No change: for the full year 2012, global Nexavar sales by Bayer are expected between $840 and $860 million, with a commercial margin of 61% to 63%. Non-GAAP net income will be a loss.

Conference Highlights:

Kyprolis was approved for sale in the U.S. for multiple myeloma by the FDA on July 20, 2012. It was launched commercially in Q3 and generated $18.6 million in revenue. Adoption broadened throughout the quarter. Most new patients are third line. All twelve Medicare administrative carriers have approved reimbursement. $5 million of shipments to distributors was put in deferred revenue.

Nexavar (sorafenib) for liver cancer and kidney cancer revenues from partner Bayer were $70.7 million, down from $75.0 million year-earlier. Total Bayer Nexavar revenue was $208 million, about flat from year-earlier, partly due to currency exchange rate negative impact. Growth in liver cancer use has been seen in the U.S. Revenues grew in Asia, dropped in Europe.

Royalty revenue from Bayer for Stivarga for colorectal cancer was less than $200,000 as launched late in quarter following FDA approval. Onyx receives a 20% royalty on Bayer's net sales of Stivarga. Bayer is making progress on global filings. Potential is for 20,000 to 30,000 patients annually in the United States.

Non-GAAP numbers: net income negative $51.8 million, down sequentially from negative $43.6 million and down from negative $19.5 million year-earlier. EPS was negative $0.79, down from negative $0.31 year-earlier.

Cash and equivalents balance ended at $573.0 million, down sequentially from $593.8 million.

Nexavar Phase 3 data for thyroid cancer results should be available in Q4 this year. In advanced breast cancer trial enrollment should complete in the first half of 2013.

Oprozomib, an oral therapy for multiple myeloma, is in a Phase 1b/2 trial with data possible by the end of 2012, at ASH in December.

Kyprolis trials to extend the label are underway, including a trial comparing it to Velcade.

See also Onyx Pharmaceuticals clinical pipeline.

Cost of goods sold was $0.5 million. Research and development expense was $85.7 million. Selling, general and administrative expense was $61.7 million. Contingent consideration $9.8 million. Amortization of acquired intangible asses was $4.1 million. Total operating expenses were $161.9 million, leaving a loss from operations of $72.4 million. Investment income was $0.6 million. Interest expense $5.5 million. Other expense $1.2 million. Income tax benefit $95.8 million.

Q&A:

ASPIRE interim delayed to Q4 2013? It is event driven, so should be due to delayed events, but the trial is blinded, so Onyx does not have the specific data.

Kyprolis dosing in real world? We see it predominantly used according to the label.

How to think about Kyprolis revenue launch? There was anticipation for the launch in August. In September new adopters came on board every week. In October we continued to have new adopters coming onboard.

Any discontinuation rates on Kyprolis yet? Too early for discontinuation data.

Kyprolis dose in frontline setting? We have not yet finalized, probably between 20 mg and 56 mg/meter squared.

Oprozomib trial? We are attempting to optimize the dosing, but then move rapidly into Phase II.

Onyx 360 copays? We have seen some robust enrollment for referals to transportation assistance and for copays.

When would we see full cost of goods for Kyprolis? It is not yet possible to determine when we will hit a lower, steady-state cost of goods, but it will be several quarters. It should be typical of a small molecule therapeutic in the steady-state.

Kyprolis once weekly (instead of twice) Phase II trial? We are looking to identify the optimal dose when given weekly, followed by a Phase II expansion.

ASH will be puting up information on the presentations in a few days.

$27 million Nexavar sales in China in the quarter by Bayer, it has been ramping up.

No comment on possible pomalidamide approval and any competitive impact it might have.

It is too early to give Kyprolis revenue guidance. We know you want it.

European filing for Kyprolis? FOCUS trial should have sufficient data to qualify for EMA potential approval.

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