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What happened?
Following the completion of a planned acquisition and the report of an upcoming phase 3 trial for its long-lasting human growth hormone, and ahead of key late-stage trial data later this year, shares in Opko Health (OPK -0.73%) jumped 14% last month, according to S&P Global Market Intelligence.
So What?
On Aug. 31, Opko Health completed its $60 million, all-stock acquisition of Transition Therapeutics. The deal expands Opko Health's research pipeline into diabetes treatment with three drugs, the most intriguing of them of which is TT401, a once-weekly therapy for type 2 diabetes that targets GLP-1 and glucagon receptors.
In phase 2 trials, TT401 reduced body weight more than placebo, and matched the performance of the diabetes drug Bydureon in improving HbA1c levels. Nevertheless, those results failed to convince Eli Lilly & Co. to continue developing TT401, and in April, Eli Lilly gave its rights to the drug back to Transition Therapeutics.
Opko Health's acquisition of Transition suggests it thinks that Lilly's decision created an opportunity to buy TT401 on the cheap; based on the stock-price move last month, investors appear to agree.
Shares also traded higher last month following Opko Health's presentation at the European Society for Paediatric Endocrinology. At that conference, the company presented results from a mid-stage study evaluating its once-weekly human growth hormone, hGH-CTP, in children. A phase 3 pediatric study is scheduled to begin soon.
Opko Health also expects to report phase 3 results from a trial evaluating the use of hGH-CTP in adults before year's end. If those results are good, then Opko Health's hGH-CTP may eventually win market share away from Pfizer's Genotropin, which is dosed daily.
To protect its market share, Pfizer licensed rights to hGH-CTP in December 2014, and as part of that agreement, Pfizer agreed to pay Opko Health up to $275 million in regulatory approval milestones and double-digit royalties on future global sales. Pfizer also agreed to split future profit on both hGH-CTP and Genotropin with Opko Health, if hGH-CTP eventually wins approval for use in children.
Now what?
There's no guarantee that TT401 will put up strong enough data in phase 3 trials to eventually win away market share from Bydureon. However, the acquisition could pay off big, given its low cost and the fact that Bydureon hauls in more than $500 million in sales annually.
Opko Health's opportunity in human growth hormone is even bigger. The human growth hormone market is valued at $3 billion annually, and Genotropin, which has 23% market share, racked up $617 million in sales last year.
While investors wait to see what happens with TT401 and hGH-CTP, they could still be rewarded with additional upside.
Opko Health is collecting royalties from Tesaro on Varubi, a drug for chemotherapy-induced nausea and vomiting that launched last year, and it should soon begin recording sales from Rayaldee, a vitamin D prohormone that recently won FDA approval. Additionally, last year's acquisition of BioReference Labs could catapult Opko Health to profitability in 2017 for the first time in its history.
Overall, Opko Health's irons in the fire mean there are plenty of market-moving catalysts, and that suggests to me that risk-tolerant investors may want it in their portfolios.
