conference date: February 15, 2007 @ 2:00 Pacific Time
for quarter ending: December 31, 2006 (4th Quarter)
Overview: Nexavar sales are increasing rapidly in partnership with Bayer, but are still not sufficient to provide Onyx with revenues. Ramping up research programs (and presumably R&D costs).
Bayer's Nexavar revenue was $63.7 million, up 40% from $45.4 million in Q3.
Interest income was $3.0 million. Operating expenses were $23.7 million.
Net loss was $20.7 million, compared to loss of $20.1 million in Q3 and $38.4 million in Q4 2005.
Earnings per share were negative $0.47.
Cash and marketable securities ended at $271.4 million, including $4.4 million long-term securities.
Not providing at this time due to rapid changes in industry.
Net loss for quarter included $3.2 million in employee stock-based compensation.
GAAP R&D expenses were $6.9 million. SG&A (selling, general and adminstrative) expense was $13.1 million.
Net expense from the Nexavar unconsolidated joint business was $3.8 million, up slightly from Q3. The full cost of the partnership program was $90.2 million.
Repeated the good news that advanced liver cancer trial was stopped early due to demonstrated survival benefit. Also a Phase 2 trial showed some activity for Nexavar combined with chemotherapy for metastatic melanoma. Working to make Nexavar for standard treatment for multiple types of cancer. Revisited earlier trial announcements.
Nexavar is now approved and available in 50 countries worldwide. Pricing approvals are generally in line with U.S. prices.
Partnering with Bayer to ramp up multifaceted research program for Nexavar, including lung and breast cancers.
Nexavar profit split with Bayer is 50/50.
Over 10,000 patients have now been treated with Nexavar.
Received one-time $5.2 million order with another drug company for Nexavar to use to test in combination with one of its drugs in clinical trials.
Full year Nexavar sales were $165.0 million.
Renal market trends in Europe? $28 million Q4 revenues in EU. Increased penetration in established German market. Launched in France and Italy. Spain began this (Q1) quarter.
US market share? About 35% of market.
Commercial infrastructure? It is basically in place; Bayer's too.
Duration of therapy trend? Not much difference between first and second line patients; not going public with data beyond that.
Japan? Application is filed, hope it happens some time this year.
Colorectal cancer plans? Nothing specific.
Outside label use for melanoma? Do not encourage. Need to complete trial.
Growth potential for currently approved uses is mainly in Europe for now. In long term is for multiple indications.
Q4 cost of sales increase? World-wide launch costs.
Any expense guidance? No, it is a very fluid situation because we may have to launch in a second indication.
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Copyright 2007 William P. Meyers