|OPKO Looks Lucrative as Acquired hGH-CTP Moves Into Phase III Trials|
|By Brian Wilson - Lead Contributor|
|Thursday, 06 June 2013 10:22|
As you can see, the next-generation human growth hormone product hGH-CTP is the most matured development program, has orphan drug status in the US/EU, and remains vital to the valuation of PROLOR (and now OPKO) due to the sheer size of the therapeutic market and the competitive advantages that are introduced with PROLOR’s technology. The company’s CTP (carboxyl terminal peptide) platform allows for the development of controlled release injections of therapeutic proteins, which offers patients an equivalent dosing in a weekly injection as opposed a daily injection. Human growth hormone, which is injected daily into patients with stunted growth, can now be injected in a far more convenient weekly version.
We saw a similar improvement made with sleeper-hit company Regeneron’s (NASDAQ: REGN) wet AMD drug EYLEA, which offered a more convenient dosing regimen relative to another VEGF inhibitor LUCENTIS which had comparable efficacy and pricing. Since Wall Street did not anticipate the huge implications of EYLEA’s competitive advantage against LUCENTIS, it wouldn’t be surprising if we saw a similar situation play out between hGH-CTP and hGH. As they say, history tends to repeat itself.
It’s hard to determine at this point what kind of market penetration we’d see once hGH-CTP is launched and fully saturated into the hGH market, although the general consensus amongst analysts is that the product should come to represent about one third of the hGH-related revenues - if not more. Based on PROLOR’s estimates, this implies that the product can generate close to $1 B in annual revenues in a few years.
Applying a generous 15% discount rate over what could be three years until introduction to the market, and another 25% devaluation due to the risk of FDA rejection (arriving at $230 M in “current” revenues), we can infer that the hGH-CTP program should be worth something closer to $1 B. Based on this, I find it surprising that OPKO’s overall valuation suffered as a result of the PROLOR acquisition, and that bears are willing to short the company up to 20% of float despite the $2 B market capitalization.
Worth noting about hGH-CTP is that PROLOR announced the initiation of a pivotal Phase III study for hGH-CTP, which may bring more market attention to the undervaluation of this development program after the publication of top-line results that can establish the relative efficacy of hGH-CTP and standard hGH injections.
On top of this, OPKO’s recent acquisition streak could prove very beneficial to the company’s valuation over the next few years. The strategic buyout of the Brazilian pharmaceutical company Silcon Comércio, for instance, aids in the market penetration of OPKO’s 4Kscore diagnostic test for prostate cancer where significant unmet need still exists.
Another deal worth mentioning was the “pooling” of OPKO’s and early-stage developer RXi Pharmaceuticals’ (RXII) RNAi pipelines, which resulted in a significant (50 M share) stake in RXi for OPKO. More recently, we also saw a deal made with Tesaro (NASDAQ: TSRO) for shared development of rolapitant, under which OPKO can receive $121 M in milestone payments plus full rights to market in Latin America.
Looking at OPKO’s balance sheet, we can also see some notable improvements after the company’s 3% convertible debt auction earlier in the year. As of March 31st 2013, the company held $182 M in cash, and $238 M in current assets. The biggest liability on the balance sheet at this point is the big pool of convertible notes (valued at $196.4 M), although the interest rate is quite favorable and it must be noted that the debt doesn’t expire until 2033.
OPKO is a heavily shorted biopharmaceutical holding company that is often misunderstood and underestimated, as was the case for previous companies that had been acquired and controlled by the multibillionaire healthcare investor Dr. Phillip Frost. Recent and promising acquisitions by OPKO have been on very favorable terms, and the company’s financials were drastically improved after the company’s convertible debt auction. Of particular interest on the acquisition front is hGH-CTP from the PROLOR pipeline, which justifies half the $2B valuation of OPKO single-handedly.