Pharmaceutical companies with a set Phase III data release date usually have a run-up leading into the release date. I usually try to buy the stocks 3-9 months before the catalyst date to make profit from the run-up. I screened for companies that have a Phase III data release date set for this year. I wrote the Part I of "5 Pharmaceutical Companies With Phase III Clinical Study Catalysts This Year" on August 10 and part II on August 13. Here is a look at 5 additional companies that I found.
1. GlaxoSmithKline (NYSE:GSK)
Upcoming Phase III milestones
Overall, by the end of 2012, GSK expects further read-outs on six of the ongoing Phase III assets UMEC/VI (LABA/LAMA), migalastat, dolutegravir, Mosquirix, '968 and Votrient) and expects Phase III registration programmes to complete for three further products and indications: UMEC/VI (LABA/LAMA), dolutegravir and Mosquirix.
The company reported the second-quarter financial results on July 25 with the following highlights:
|Net income||$0.4 per share|
|Book value||$4.48 per share|
The stock has a $54 price target from the Point and Figure chart. The stock is currently trading at a forward P/E of 10.56. I believe the $54 price target is reasonable for the stock. I am not expecting the stock to move much from each of these separate Phase III catalyst given the size of the company and its pipeline. Even if one or two of these four trials will fail the stock could reach the $54 price target.
2. Merck (NYSE:MRK)
Upcoming Phase III catalysts
On July 11 Merck announced an update on the Phase III trial assessing fracture risk reduction with odanacatib, Merck's investigational cathepsin K (cat-K) inhibitor. The Data Monitoring Committee [DMC] for the study recently completed its first planned interim analysis for efficacy and recommended that the study be closed early due to robust efficacy and a favorable benefit-risk profile. As a result, Merck will begin taking steps to close the trial. Merck expects the process of closing this large, multi-center trial to take a number of months.
Merck anticipates submitting regulatory applications for approval of odanacatib in the U.S., European Union (NYSEARCA:EU) and Japan in the first half of 2013.
The Phase III randomized, placebo-controlled trial with over 16,000 patients was designed to assess the safety and efficacy of odanacatib in reducing fracture risk in post-menopausal women with osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The interim analysis was conducted by the DMC as planned when approximately 70 percent of the targeted number of hip fractures had been reported.
The company reported the second-quarter financial results on July 27 with the following highlights:
Merck continues to expect full-year 2012 non-GAAP EPS to be between $3.75 and $3.85 and the 2012 GAAP EPS range to be $2.04 to $2.30. The 2012 non-GAAP range excludes acquisition-related costs and costs related to restructuring programs.
Merck continues to expect full-year 2012 revenues to be at or near 2011 levels on a constant currency basis. At current exchange rates, sales would be affected unfavorably by approximately 6 percent for the third quarter and more than 3 percent for the full year.
In addition, the company expects full-year 2012 non-GAAP R&D expenses to be slightly higher than the 2011 level. The company now expects the full-year 2012 non-GAAP tax rate to be approximately 25 percent.
The stock has a $78 price target from the Point and Figure chart. The stock is currently trading at a forward P/E of 11.94. I believe the $78 price target is achievable during the next 12-24 months. I am not expecting the Phase III trial data to move the stock more than $5.
3. Onyx Pharmaceuticals (NASDAQ:ONXX)
Upcoming Phase III milestones
Helen Torley, Chief Commercial officer and Executive Vice President, commented at the second-quarter earnings call:
Looking forward, a key upcoming event for Nexavar is a DECISION data readout expected in Q4. If registration-supporting, this could add an additional indication for Nexavar in patients with differentiated thyroid cancer where there have been no new therapies approved for patients in over 30 years.
The company reported the second-quarter financial results on August 1 with the following highlights:
|Net loss||$0.68 per share|
N. Anthony Coles, M.D., president and chief executive officer of Onyx commented:
Onyx's transformation in 2012 has been remarkable, with the recent accelerated approval of Kyprolis in the United States and the continued momentum with several upcoming regulatory and data milestones. As part of our growth strategy, we are making important investments in developing Kyprolis across additional lines of therapy and advancing our oral proteasome inhibitor, oprozomib, to further unlock the value of our pipeline. In our kinase inhibitor franchise, Nexavar is contributing increasing cash flow and Bayer's regorafenib is under FDA priority review, setting our business up for future success globally.
The stock has a $61 price target from the Point and Figure chart. The stock has seen quite heavy insider selling during the last month above $70 level. I believe it is prudent to wait for a pullback to the $60 level before entering long the stock. If the Phase III trial data is positive the stock could challenge the $100 mark.
4. Sunesis (NASDAQ:SNSS)
Upcoming Phase III catalysts
Daniel Swisher, Chief Executive Officer of Sunesis, commented on August 9:
Next month, the independent Data and Safety Monitoring Board will conduct, in its single pre-planned interim analysis, the first efficacy review of the Phase 3 VALOR trial in acute myeloid leukemia. The DSMB will examine pre-specified unblinded efficacy and safety data sets and decide whether to stop the study early for efficacy or futility, continue the study as planned or implement a one-time sample size adjustment of 225 additional evaluable patients. This important milestone will determine timing of the final outcome of this pivotal study and enable our plans for future regulatory filings and commercialization of vosaroxin.
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is expected to enroll 450 evaluable patients at more than 110 leading sites in the U.S., Canada, Europe, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized one to one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. Additionally, the VALOR trial employs an innovative, adaptive trial design that allows for a one-time sample size adjustment by the Data and Safety Monitoring Board [DSMB] at the interim analysis to maintain adequate power across a broader range of survival outcomes. The trial's primary endpoint is overall survival.
The company reported the second-quarter financial results on August 9 with the following highlights:
|Net loss||$0.20 per share|
The stock has a $8.25 price target from the Point and Figure chart. I do not expect the target price to be reached at least before 2013 and the final data from the VALOR trial. If the interim data is good, we could see $5-$6 this year.
5. Roche (OTCQX:RHHBY)
Upcoming Phase III catalysts
HERA is a large international phase III study with over 5000 patients enrolled. The study is assessing the benefits of adjuvant Herceptin treatment in women with HER2 positive early breast cancer. The primary endpoint is disease-free survival [DFS], the secondary endpoint is overall survival [OS]and cardiac safety. Roche is expecting results from the Phase 3 HERA study during second half of 2012.
The company reported the second-quarter financial results on July 26 with the following highlights:
|Earnings per share||$6.94|
|Operating free cash flow||$7.2 billion|
Roche confirms its full-year outlook for 2012. Barring unforeseen events, Roche expects low to mid-single-digit sales growth at constant exchange rates for the Group and the Pharmaceuticals Division in 2012. Sales by the Diagnostics Division are expected to again outpace the market. Despite a challenging market environment, based on the expected sales growth and continued efficiency improvements, Roche is aiming for a high single-digit increase in core earnings per share at constant exchange rates. Roche will continue its attractive dividend policy.
The stock has a $31 price target from the Point and Figure chart. If the price target will be reached, I would be looking to be a buyer. I am skeptical that the price target will be reached this year. I am not expecting the Phase III trial data to move the stock more than $5.