Mallinckrodt plc beats by $0.24, beats on revs; raises FY19 EPS above consensus; partnered pivotal Phase 3 trial of CPP-1X/Sulindac in Patients with Familial Adenomatous Polyposis misses primary endpoint (16.39)
- Reports Q1 (Mar) earnings of $1.94 per share, excluding non-recurring items, $0.24 better than the S&P Capital IQ Consensus of $1.70; revenues rose 4.7% year/year to $791 mln vs the $766.27 mln S&P Capital IQ Consensus. Acthar Gel net sales were $223.9 million, an 8.2% decrease, primarily driven by the annual benefit reset process impacting returning patients while navigating continued payer scrutiny on overall specialty pharmaceutical spending. The company continues to expect the product to exceed $1 billion in net sales for 2019. INOMAX (nitric oxide) gas, for inhalation, net sales were $151.1 million, up 8.1% due to continued, consistent demand and contract renewals fueled by the product's differentiated total service model. OFIRMEV (acetaminophen) injection net sales were $95.6 million, an increase of 16.6%, benefiting from continued strong demand and order timing.
- Co issues upside guidance for FY19, sees EPS of $8.30-8.60, excluding non-recurring items, vs. $8.21 S&P Capital IQ Consensus; reaffirms specialty brands segment +1-4%, raises specialty generics and Amitiza to +2-5% from +1-4%
- Cancer Prevention Pharmaceuticals and its partner Mallinckrodt Plc announced that CPP's pivotal phase 3 clinical trial, CPP FAP-310, of the investigational drug CPP-1X/sulindac in patients with familial adenomatous polyposis (FAP), did not meet its primary endpoint. Specifically, the reduction of time to the first occurrence of an FAP-related event for the combination of CPP-1X (eflornithine) and sulindac (a nonsteroidal anti-inflammatory drug) did not reach statistical significance compared to the two control arms. CPP FAP-310 included only active comparator arms and was the largest and longest study ever conducted in patients with FAP