With the new year off to an amazingly bullish start and the JPMorgan Healthcare Conference now a thing of the past, we can turn our attention to four events -- two FDA drug decisions and two big earnings reports -- bound to turn investors' heads next week.
On Wednesday, biotech Santarus (NASDAQ: SNTS) will step in front of the firing squad and either receive an open-arms approval for its mild-to-moderate ulcerative colitis drug, Uceris, or the highly dreaded complete response letter. In trials, Uceris had a statistical benefit over the placebo in terms of percentage of patients reaching the primary endpoint, but combining the clinical and endoscopic trials after eight weeks produced less conclusive results. The PDUFA date for Uceris has already been pushed back 90 days (from Oct. 16 to Jan. 16), and it's uncertain whether an FDA approval is likely given the data. If I had to flip a coin, I'd bet on seeing a CRL.
On Thursday, NuPathe (NASDAQ: PATH) shareholders will be crossing their fingers and toes as the FDA rules on Zecuity (formerly NP101), a one-use transdermal migraine patch. This is a resubmission for NuPathe, which received a CRL in August 2011. Thankfully, the CRL had nothing to do with efficacy and was in relation to chemistry, manufacturing, and safety concerns. In phase 3 trials, 18% of patients treated with Zecuity were pain-free two hours after treatment, compared with just 9% for the placebo. Considering that NuPathe has patent protection on Zecuity through June 2028 and it appears to have addressed the FDA's previous issues, the chances of approval appear better than 50-50.
On the earnings front, investors can expect the smallest big pharma around, Forest Laboratories (NYSE: FRX), and insurance heavyweight UnitedHealth Group (UNH 0.76%), to report quarterly results on Tuesday and Thursday, respectively.
Forest Labs' quarterly figures should be particularly interesting since the company lost patent protection on its blockbuster depression drug, Lexapro, last year. Current Wall Street projections are counting on a 37% reduction in sales and a loss of $0.13 per share for Forest. This might be a rare case where the actual results matter very little as long as some of Forest's newer drugs show signs of life. Forest's Linzess, an irritable bowel syndrome and constipation treatment developed with Ironwood Pharmaceuticals (IRWD -17.00%), and Tudorza, a bronchospasm inhibitor for those diagnosed with COPD, are two drugs to watch closely. Forest is a long way away from replacing Lexapro; and even if does find a combination of drugs to take its place, it'll then be losing its other revenue maker, Namenda, in 2015.
UnitedHealth Group's quarterly results should really set the tone for health-benefits sector as we head into what will be a very transitional 2014 with the full enactment of the Affordable Care Act. UnitedHealth has been adjusting its operations in anticipation of the pending changes since 2010, so I don't anticipate too many surprises. For the quarter, UnitedHealth is expected to grow sales by about 8.5% as EPS jogs higher by 2%. Given that UnitedHealth has handily trounced Wall Street's expectations over the past year and that it's been plumping up its payout to shareholders, I'm looking for this to be a very optimistic report.
