Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...) ARIAD Pharmaceuticals is an oncology company focusing on treating cancer patient's unmet medical conditions. The company has an FDA approved drug known as Iclusig® being marketed in U.S. and Europe. The company's performance has been deteriorating owing to the hold on the phase III trials of Iclusig EPIC study. The impending catalysts may help to salvage the stock prices of the company.
The Business
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ARIAD Pharmaceuticals Inc. (ARIA) is a global oncology company that focuses on the discovery, development and commercialization on breakthrough medicines for cancer patients. The company is working on the development of new medicines that can help advance the treatment of different forms of leukemia, lung cancer and other hard to treat cancers. ARIAD, by using computational and structural approaches designs small-molecule drugs that regulate cell signaling that helps to overcome the resistance to the existing cancer medicines.
ARIAD has two categories of candidates in its pipeline; viz. Iclusig® (ponatinib) and AP26113 that are further divided into different studies, has an approved drug viz. Iclusig® (ponatinib); developed for treating adult patients suffering from chronic, accelerated or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), both of which are intolerant or resistant to prior tyrosine kinase inhibitor (TKI) therapy.
ARIAD has been awarded "The 2013 Gold Stevie Award for the Company of the Year, Pharmaceuticals." The CEO Dr. Harvey Berger received "The 2013 Ernst & Young Biotech Entrepreneur of the Year Award in New England" and "The 2013 Gold Stevie Award for the Executive of the Year, Pharmaceuticals."
The competitors of ARIAD include Takeda Pharmaceutical Company Limited, Novartis AG (NVS), Zeltia S.A., Astellas Pharma Inc., Chugai Pharmaceutical Company Limited ad Pfizer Inc. (PFE).
Candidates
Iclusig® (ponatinib) is an FDA approved drug to treat chronic myeloid Leukemia, developed and marketed by ARIAD. It treats aggressive forms of Leukemia in patients who have failed other forms of treatment. The drug is sold in the United States and Europe. The revenue from Iclusig for the six month period of 2013, ended June 30th was $20.298 million. It's a high priced drug, where ARIAD claims that the clinical benefit of the drug has made it a cost effective treatment.
Ponatinib was being studied for treatment of newly diagnosed CML, but the results came out to be negative in the Phase III of the trials. Thus the study was recently put on hold by FDA for further clinical trials on newly diagnosed CML patients, since the patients were suffering from side effects like heart attack and blood clotting.
The Ponatinib is in phase 1/2 of study for the CML in Japanese patients. The study is currently enrolling in multiple sites in Japan. The study focuses on the patients suffering from CML or Ph+ALL, who have failed prior tyrosine kinase inhibitors.
Ponatinib is also being studied for the treatment of the following, lung cancer (FGFR), in the Phase II of study; Ph+ALL (newly diagnosed) in Phase II of study; gastrointestinal stromal tumors (KIT) in Phase II; AML (FLT3) also in phase II; Lung cancer (RET) and Medullary thyroid cancer (RET) both in phase II of study.
The second candidate of ARIAD is AP26113 in Phase I/II study, which targets the unique genetic features of cancer cells, and is an internal discovery of ARIAD scientists. It is an investigational tyrosine-kinase inhibitor of anaplastic lymphoma kinase (ALK) and epidermal factor growth receptor (EGFR) and c-ros oncogene 1 (ROS1). Abnormal expression of ALK has found to be a major driver of certain types of non-small cell lung cancer (NSCLC), anaplastic large-cell lymphoma (ALCL) and neuroblastomas.
Market Performance
The share prices of ARIAD have seen an almost -78.57% dip in the year-to-date performance. The share prices took a nosedive from $22 to almost $3 per share, following the hold on the clinical trials of Iclusig EPIC study by the FDA in early October 2013. The share prices are yet to recover after this event.
Analysts have set a high price target of $12 and low target of $2 on the share prices of ARIAD. The mean price target is $5.53. And the mean recommendation is 2.8 harboring towards holding the shares, since the future prospects of the company are a little unclear.
Upcoming Events
The company will announce the 3rd Quarter earnings report on the 6th of November, 2013. This will be followed by a conference call discussing the results and to provide a corporate update. This call holds significant importance because of the deteriorating stock conditions of the company. Any positive news from this call will act as a helpful catalyst for the stock prices.
The most imminent catalyst at the moment is the shares bought by the hedge fund Sarissa Capital Management LP. They acquired a 6.2% stake in the company which is facing a downward trend in the share prices. This purchase may help the stock prices to recover slightly, if not substantially.
The trial data from the gastrointestinal stromal tumors (GIST) study is expected in early 2014. The data would then allow the company to decide which direction to take with the GIST trials. This could prove to be an important catalyst if the results are positive.
ARIAD is keen to roll out Iclusig in Europe over the next few months. Further, it is looking for assessment approval by the regulatory authorities in Switzerland by the end of 2013. The company also has plans to file the drug in Australia and Canada, and expecting approvals in the first half of 2014. After the data is obtained from the ongoing clinical trials in Japan, ARIAD expects to file for the drug in Japan in the second half of 2014. These events will result in a cash inflow for the company and may prove to be positive catalysts for the share prices.
Fundamentals and Potential Risks
ARIAD has over $350 million in cash and equivalents, as of June 30th, 2013 and is anticipated to fare well through 2014. The 2013 guidance provides cash usage of approximately between $245 and $255 million. The cash will be employed for the clinical trials underway and also for the commercialization of Iclusig. However, the company has to depend on itself for cash generation, since there are no collaborations and in case of any setback, as mentioned below, the company has the probability of running out of necessary cash.
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