With more than 250 companies presenting at this year’s American Society of Clinical Oncology Conference(ASCO June 5 - 7, Chicago), the world's leading professional organization for all oncology subspecialties, one company undoubtedly among the busiest will be Exelixis, Inc. (NASDAQ:EXEL). With 12 presentations on Exelixis compounds, four on XL184 alone, Exelixis will have a great presence at this year’s ASCO conference to be held in Chicago between June 5 - 7, 2010. XL184 is one of the key compounds of Exelixis which is in the clinical phase(Phase II and Phase III), for various types of cancers, in collaboration with Bristol-Myers Squibb Company (NYSE:BMY).
In the recent Quarterly earnings on May 11, 2010, The CEO of Exelixis mentioned that a lot of clinical data is to be released next month and the amount of data they are presenting is more substantive than they have previously, and are looking at ASCO as an important event for the company. He also mentioned they believe that data going to be presented at ASCO will reflect the potential of XL184 in unresectable, locally advanced, or metastatic medullary thyroid cancer (Currently in Phase III trails), in progressive or recurrent Glioblastoma(Brain Cancer, Currently in Phase II trails), and beyond those first indications in some of the major tumor types as well. The company might also present the progress on phase I b/II trial of XL184 with erlotinib in non-small cell lung cancer (NSCLC) patients.
A phase 3 trial of XL184 is ongoing. The phase 3 trial is a randomized, placebo-controlled, double-blinded study of XL184 as single-agent therapy in 315 patients with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Patients are randomized in a 2:1 ratio to receive XL184 or placebo administered as a daily oral dose. The primary endpoint is duration of progression-free survival. Secondary endpoints will include overall survival, objective tumor response rate, and changes in serum biomarkers (carcinoembryonic antigen and calcitonin).
Apart from these, Exelixis, Inc. ( NASDAQ:EXEL) will also present the data from various of its key compounds XL147, XL765, XL228, and XL139 which are in phase 1b/II and Phase 1 for various types of Cancers. Exelixis is working in collaboration with all major Pharmaceutical companies like Sanofi-aventis (NYSE:SNY), Bristol-Myers Squibb Company (NYSE:BMY), Genentech now Roche (OTC:RHHBY), GlaxoSmithKline (NYSE:GSK), and Wyeth now Pfizer (NYSE:PFE), on most of these investigational drug compounds. It is not uncommon for a development stage biotech company to have partnerships with a big pharma but the level of these numerous partnerships with almost all the major players in the industry only overstates and underscores the potential of Exelixis’s deep pipeline.
Shares of this biotechnology company recovered from a recent slide Wednesday, a day after reporting a larger first-quarter loss because of restructuring charges.The stock had fallen 11.5 percent since the company announced cost cutting measures in March. William Blair & Co. analyst John Sonnier said he thinks Exelixis has successfully reduced its cost structure, and should get more money from its collaborations in future quarters.
After the market closed Tuesday, the South San Francisco, Calif., company reported a net loss of $43.2 million, or 40 cents per share, in the three months ended March 31 compared with a net loss of $36.2 million, or 34 cents per share, a year ago. Revenue rose to $42.2 million from $25.3 million. The latest results included $16.1 million in restructuring costs. In March, the company said the job cuts would result in a one-time charge of $15 million in the first quarter. It also said it would focus on developing cancer drugs through partnerships with Sanofi-Aventis SA and Bristol-Myers Squibb Co. Its contract revenue nearly tripled to $19.7 million in the first quarter, and license revenue grew 32 percent to $24.6 million.
Piper Jaffray & Co. recently upgraded Exelixis, Inc. (NASDAQ: EXEL) to Overweight from Neutral. Piper analyst says, "We believe the recent pull back in shares of EXEL offers an attractive buying opportunity ahead of a busy ASCO meeting in June with 12 abstracts further validating the pipeline. Importantly, Exelixis' burn rate is being brought under control due to increased R&D reimbursement and lower expenses. We look for Exelixis to continue to partner discovery capabilities and drug candidates as the company progresses toward pivotal data and 1st product launch in the next 2 years."
Exelixis, Inc. also announced that for fiscal 2010, it expects revenue in the range of $210 to $240 million, which is much above the analyst estimates. According to Reuters Estimates, analysts were expecting the Company to report revenue of $196 million for fiscal 2010.
As a typical development stage biotechnology company, though the balance sheet is not that strong, given deep pipeline and the busiest ASCO and ahead of the various presentations of key data for it various drug compounds currently in phase III and II for various types of cancers, and given the short interest of close to 8%, the stock seems to be a great buy at the current price.
Some of the other small biotech companies which are presenting at the ASCO include Keryx Biopharmaceuticals (NASDAQ:KERX), Vical Incorporated (NASDAQ:VICL), ImmunoGen, Inc (NASDAQ:IMGN), Ziopharm Oncology Inc. (NASDAQ:ZIOP)
Disclosure: Author Long on EXEL
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