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Holly LaFon
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David Rolfe Comments on Celgene

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January 12, 2018 | About:
Celgene (NASDAQ:CELG)

Celgene was a top detractor to performance due to a couple negative news events released during the quarter. The company announced they would discontinue a phase III trial for their drug GED-0301 in Crohn's disease (CD) and an extension trial, following a recommendation of the Data Monitoring Committee. They also decided that another phase 1 trial for Crohn's disease would not be initiated. While a phase II trial with GED-0301 in ulcerative colitis is still ongoing, the Company is currently awaiting review of data to determine their next steps for this indication. In the absence of any information on whether the trial failure was due to something specific to CD or the drug itself, it is currently assumed to be a high-risk program for that indication. This study was deemed a high risk/low-probability study, especially when compared to other IBD drugs. However, its success could have been a blockbuster Inflammation & Immunology (I&I) asset for the company, making its failure a disappointing loss.

In addition to these trial failures, during the third quarter earnings release, management brought down 2020 guidance, partially due to the discontinuation of GED-0301 program in CD. While sales were only modest in their 2020 model, management did forecast multibillion dollar peak sales potential for the drug. The largest impact to 2020 guidance, however, was weak performance of their existing drug Otezla, which experienced headwinds due to slowing growth and increased competition in the psoriatic arthritis and psoriasis markets. The updated guidance takes into account GED-0301, the market dynamics impacting Otezla, as well as reassesses the opportunities and risks associated with the remaining phase III studies expected to read out by the end of 2018. We believe management took a conservative stance with their update and yet the resulting guide maintains more than +14% revenue growth and nearly +20% earnings growth on a compounded annual basis through 2020.

We realize there will be phase III failures; and with each failure comes the potential for more risk and less growth. We reiterate that the Company has a very broad pipeline, with 12 phase 1 studies set to read out between now and the end of this year, making setbacks like these more manageable in the longer term. Celgene has substantially more phase III assets than any other biotech company. Several of these pipeline assets are not incorporated in the current 2020 guidance, as they read out at a date when any sales potential will contribute at future dates. With nearly +20% compounded annual earnings growth through 2020 and free cash flow generation of $100 billion over the next ten years, Celgene continues to offer a compelling growth opportunity.

From David Rolfe (Trades, Portfolio)'s fourth quarter 2017 shareholder commentary.


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