The Food and Drug Administration added Celgene Corporation (NASDAQ:CELG)’s Pomalyst to the list of approved drugs last Friday. The drug has been approved for myeloma patients who stop showing a response to other cancer therapies. Revlimid is still the main revenue driver of the company and faces tough competition from Johnson & Johnson (NYSE:JNJ) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX). It is single handedly responsible for more than two thirds of Celgene’s entire revenue.
Therefore, the health of Revlimid is extremely important to the survival of the company. The drug currently faces tough competition from J&J’s Velcade and Kyprolis of Onyx. Kyroplis has recently received FDA approval and is the most serious threat to Revlimid, but currently it is only approved as a third-line treatment for relapsed patients previously on Velcade and Revlimid. The newly approved Pomalyst has opened up a new target market for Celgene of patients who have stopped responding to either Revlimid or competing treatments.
Celgene
Celgene is a biopharmaceutical company involved in the discovery, development and commercialization of drugs to treat immune inflammatory and cancer-related diseases. The company has already successfully launched Revlimid, which is an immunomodulatory aimed primarily at treating patients with multiple syndromes (MDS) and myeloma. Other drugs in the commercial stage include Abraxane, Vidaza, Istodax, and Thalomid. The company has a number of candidates in various stages of clinical trials, a detailed list of which can be found here.
FDA approval
The company has recently received FDA approval for its candidate Pomalyst (pomalidomide). The drug has been approved for difficult to treat patients, i.e. patients whose disease has worsened after being treated with other cancer drugs. During the trials a total of 191 patients were evaluated, out of which 34% of these patients showed a positive response to the treatment as compared to only 13% responding to treatment of pomalidomide. The newly approved Pomalyst will cost around $10,500 for each cycle of treatment, and total treatment cost is estimated at $52,500.
The primary contradictions of Pomalyst revolve around pregnant women, and therefore it will carry a boxed warning for such patients. Pomalyst belongs to the same family as Celgene’s Revlimid, but is successful with patients who have stopped responding to Revlimid. According to the company CEO, the drug has a peak sale potential of $1 billion.
Valuations
The stock is currently trading at a P/E of 14x, which is below the industry average of 25x and market average of 19x. The stock is also trading at a 9% discount to its mean sell side target price of $109. As the table below shows, if we use a P/E of 20x and average EPS, the following price targets can be calculated. If valued on a P/E of 20x, the stock is trading at a 13% discount to its 2013 valuations and at a 36% discount to its 2014 valuations.
| 2013 | 2014 | |
| EPS est | $5.66 | $6.82 |
| Target Price | $113 | $136 |
| Discount | 13% | 36% |
According to sell side estimates, the newly approved drug has the potential to generate approximately $500 million in sales by the end of 2015. The strong pipeline and current dominance of Revlimid over alternatives by J&J and Onyx makes me bullish on Celgene as a long term investment.
The article More Upside on this Biotechnology Giant originally appeared on Fool.com and is written by Mohsin Saeed.
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