Last week was another big week in biotech, as a host of key data releases coupled with a few major earnings reports injected some considerable volatility into the space. As we head into a fresh week, what are the movers and shakers in the sector? Let’s take a look.
Neos Therapeutics, Inc. (NASDAQ:NEOS)
First up we’ve got Neos. Back in July, Neos submitted an NDA to the FDA for its lead development pipeline candidate, NT-0202. The treatment is an oral amphetamine designed to target attention deficit disorder (ADHD). The treatment has dogged Neos for a while now, with the company initially filing an NDA for its consideration back in late 2012, and receiving a complete response letter stating the company need resubmit with extra pharmacokinetic and supply line data. For those not familiar, a complete response letter is basically the FDA’s way of saying “not this time, but try again”. Shire plc (NASDAQ:SHPG) also sued Neos over a reported patent infringement on the drug back in 2014, but this was pretty quickly overcome. Anyway, on Monday evening, we got word that the FDA had notified Neos of some deficiency related to the labelling of the product in its NDA – not what specifically, but a deficiency nonetheless. The review date is set for January 27, 2016, and if the deficiency is a serious one, the FDA could push the drug back to Neos and either a) decline it outright or b) demand a fresh (or at least amended NDA). Either option would be a disaster for Neos, as investors are already losing patience with a treatment that should have been approved in 2013. The company has one thing going for it, however, it already generates revenues from its generic version of Tussionex (essentially a souped up cough medicine). That said, the revenues (circa $0.5 million per quarter at last count) are not enough to fund further investigation into NT-0202, if demanded by the FDA. The company is down close to 25% on the latest announcement, and looks set to fall further during today’s session. There may be an opportunity to get in at a discount if the labelling deficiencies are minor and amendable before the fixed PDUFA date, but before we get more detail, this is a very risky play. Watch this space.
Horizon Pharma plc (NASDAQ:HZNP)
Going slightly larger cap now, let’s look at Horizon. During Monday’s session, Horizon lost more than 16% of its market cap to bring it to trade a little ahead of $16 a share. The decline comes as the latest in a string of similar declines, with the company already having lost close to 50% of its market cap in September, and about 28% between mid Jul – mid Aug. The interesting thing here, is that nobody really knows what’s driving the dips. Obviously we have seen some overarching bearish momentum in the biotech space, but Horizon is down 50% across a period during which it announced a spate of positive releases, and is pushing an aggressive takeover, of which it seems to be under control. We got record Q2 financials reported earlier this year, with the company pulling in $31 million net income on $172.8 million net sales – a 254% and 161% change on over the comparable period a year earlier respectively. Shortly before this, the company announced a $33 per share offer for DepoMed Inc. (NASDAQ:DEPO) – a company that pulled in a net income of $131.7 million. Despite resistance, meetings have been set up between Depomed shareholders and Horizon management that could see the hostile takeover complete before the end of the year. In short, this looks to be a real opportunity to pick up a cheap exposure to a company that not only has strong financials, but is also set to expand its operations through a hostile takeover. All this, and we haven’t even mentioned its development pipeline. The company announced earlier this year that it was kicking off a phase III for one of its lead candidates – Actimmune – with a target indication of Friedreich’s Ataxia sufferers (the latter is an inherited disease that does nerve system damage). The treatment is fast tracked by the FDA, which means the company can submit bits of data as they come in. This not only means that we could get a quicker approval when it comes to submitting the NDA (assuming trial success, of course) but also that we have the potential for a spate of upside catalysts over the coming quarters. Again, this is a stock down more than most, and could be a great opportunity to get in cheap ahead of some upside. There may, of course, be something we are missing. The company’s CEO has been relatively quiet in the wake of the decline, and it might be worth seeing what he has to say at the upcoming special shareholder meetings (if we can get access to what’s discussed) before picking up an exposure.