conference date: February 6, 2008 @ 5:30 AM Pacific
for quarter ending: December 31, 2007 (4th quarter)
At least at the time this summary was written.
Overview: Looks like a great quarter at with Tysabri showing rapid revenue growth.
Revenues were $893 million, up 26% from $708 million year-earlier quarter.
Net income was $201.2 million, up 69% sequentially from $119 million and up 85% from $108.6 million year-earlier.
EPS (earnings per share) were $0.67, up 63% sequentially from $0.41 and up 109% from $0.32 year-earlier.
Full 2008 GAAP diluted EPS of $2.23 to $2.38. Revenue up 15% to 20% from 2007. Capital expenditures of $210 to $260 million. R&D as a percent of revenue will decrease to 26-28%. Non-GAAP EPS $3.20 to $3.35.
Tysabri reached an annual end-market run rate of $0.5 billion by the end of Q4 and turned profitable for Biogen. Its global market share is now 5%. Avonex remains the most prescibed MS therapy, with 26% y/y growth in Q4.
We had a very strong fourth quarter. Achieved long term goals set out at merger 4 years ago. 2008 plan is in line to achieve 2010 plan outlined last year.
Pipeline advanced nicely with 15 products in Phase II and beyond. This is going to be a very exciting year for clinical data.
Reviewed the history of talk of Biogen-Idec's possible acquisition by a larger company. No company put a bid on the table, probably because of the percieved risk profile of Tysabri. So we are executing our growth plan to maximize value for shareholders. Our future is extremely bright.
Tysabri will continue to build momentum in 2008. It is the most switched to product in MS. Physicians already prescribing indicate they intend to prescibe it more. Geographic rollout continues. Indications will continue to expand, with Crohn's Disease approved by FDA on January 14th and to roll out in February. Since MS is a chronic disease patients will need more than one therapy over the course of their lives.
Rituxan had good clinical results this quarter. In fact there are far too many pipeline results to report in this brief summary. Will see results from about 8 trials in 2008. See Biogen-Idec Pipeline page for current status.
Non-GAAP numbers are: net income of $266 million. EPS $0.89. Excluded from GAAP numbers were $107 R&D acquisition charge, other acquisition income of $34 million, stock-based compensation expense of $9 million, and a "tax effect" of $16 million.
30% growth in MS franchise revenue.
$503 million Avonex revenue 15% above year-earlier.
$90 million Tysabri revenue, up from $17.6 million year-earlier. This included $37 million from sales by Elan in U.S. and $53 million from product sold in Europe.
$2.6 million Zevelin revenue, but sold late in quarter for $10 million up-front.
$9 million Fumaderm, tripling year-earlier sales.
Zevalin had $2.6 million in sales.
Rituxan $254 million revenues (of $596 million sales by partner Genentech).
We expect to make $10 million in milestone payments for licensed products in Q1.
Lumilixomab enrollment? Going well. A clinical readout likely around Q1 2009. Galiximab data not until 2010.
Pricing environment in U.S.? The environment is still fairly good in U.S. Not much change in international market.
Any change in inventory that might have spiked Q4 international numbers? Not that we can see.
UK, Italy traction for Tysabri? Same patterns as in U.S. after 6 months. UK tends to lag because of 22 regions of NHS that have to approve reimbursement. Patients are 80% new to our franchise. A lot are switching from other therapies.
Concern about melanoma in trials? Only one case, and the patient had a lesion before receiving the first dose.
Reviewed possible sale of company.
Reviewed possible acquisition of pipeline drugs. Must be strategic fit and attractive valuation.
Primary progressive MS? 150,000 patients in North America and Europe. So positive results for Rituxan trials could cause an uptake.
Lupus market size for Rituxan? 425,000 diagnosed patients in U.S. There is already some off-label use. Lupus has been a particularly difficult condition to get good trial results for.
Did Avonex scripts decline sequentially in Q4? No inventory changes that we saw.
Benefit from written-off inventory? 10% of Avonex revenue growth y/y fo Q4 was due to currency exchange benefit. We did benefit from Tysabri inventory that had been written off, but don't expect that in the future.
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