This morning, Celgene CEO Bob Hugin kicked off the 2012 J.P. Morgan Healthcare conference by pre-announcing 4Q11 results and providing 2012 guidance. While there was a 4Q11 Revlmid miss, we thought 2012 guidance was solid and should be received very positively. There was not much said on the EMEA review on the Revlimid first-line maintenance filing, but a decision is expected in 1H12 (importantly, there is only incremental sales in 2012 guidance assumptions from first-line EU maintenance – noted in breakout session). We expect ultimate approval with a broad label, which will be a key positive catalyst, in our view. We note that unlike 2011, 2012 is full of clinical catalysts (apremilast, Abraxane, Revlimid lymphoma). Of note, Celgene noted that pomalidomide filing in the US will be in 1Q12 (ahead of our expectations). Celgene continues to be one of our favorite names in biotech for 2012 and we are reiterating our Overweight rating on CELG shares.
Pre-announced 4Q11 results: Revlimid sales were $855M (JPMe-$847M; consensus-$870M), while total revenues were $1.28B (JPMe-$1.27B; consensus-$1.30B). Revlimid sales were impressive, in our view. 4Q11 EPS was $1.05 (JPMe-$1.06; consensus-$1.08).
2012 guidance solid: 2012 Revlimid guidance was $3.75-3.85B (JPMe-$3.8B; consensus: $3.8B), while total revenue guidance was $5.4-5.6B (JPMe-$5.2B; consensus-$5.4B). Importantly, we note, Revlimid guidance only incrementally includes sales from the first-line maintenance setting in the EU (EMEA decision expected 1H12 – noted in breakout session). 2012 EPS guidance of $4.70-4.80 was in line with expectations (JPMe-$4.20; consensus-$4.51.)
Other breakout session takeaways: Noted a need for a more aggressive emerging markets strategy. If a generic Vidaza is seen in 2H12, guidance would not change. Noted some growth in Japan and upside surprise from EU from Abraxane. Highlighted strong pomalidomide synergy with existing myeloma franchise, and we note that physicians have noted an unmet need in the highly refractory MM setting.
Pipeline: In the presentation, Celgene highlighted their late stage pipeline, which we note does have many meaningful catalysts in 2012. Pomalidomide approval potentially in 2013 in R/RMM (gained the fast track designation; filing before the end of 1Q12 in US). Abraxane phase 3 melanoma data is expected in mid-2012. Apremilast phase 3 trials in psoriatic arthritis and psoriasis are expected mid-2012 and 2H12, respectively (targeting filing in early-2013). Data from trials of Revlimid in lymphoma are expected in 2H12 (approval of different lymphoma subsets would potentially start in 2013 and extend though 2015).