Mallinckrodt (MNK) Tops Q4 EPS by 3c; Therakos Production Issues Noted

November 29, 2016 6:01 AM EST
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Mallinckrodt (NYSE: MNK) reported Q4 EPS of $2.04, $0.03 better than the analyst estimate of $2.01. Revenue for the quarter came in at $887.2 million versus the consensus estimate of $880.1 million.

H.P. Acthar Gel (repository corticotropin injection) net sales were $327.0 million in the quarter, a 19.3% increase over $274.2 million. Mallinckrodt’s second largest product, INOMAX (nitric oxide) gas, for inhalation, generated net sales of $126.9 million, up 22.4% over $103.7 million, with constant-currency growth of 22.4%. In the quarter the U.S. Patent and Trademark Office and its Patent Trial and Appeal Board affirmed the validity of multiple INOMAX drug and device patents, enhancing the company’s confidence in the intellectual property estate surrounding INOMAX to at least 2031. Turning to OFIRMEV (acetaminophen) injection, net sales were $75.6 million compared with $61.4 million, an increase of 23.1%.

Net sales of the Therakos immunotherapy platform were $54.5 million, with constant-currency pro forma basis growth of 24.1%. The business has recently experienced temporary, third-party manufacturer production issues with kits supporting its first-generation UVAR XTS® photopheresis system. Mallinckrodt is working diligently to mitigate the shortage. While it’s possible the situation could continue into the second quarter of 2017, the company believes its efforts will successfully resolve the issue sooner. Overall revenue impact is expected to be between $5 to $10 million in each of the December 2016 and March 2017 quarters. Importantly, management believes it will be able to offset most of the earnings impact in the December quarter from strength in the rest of its businesses.

“Mallinckrodt finished fiscal 2016 with solid performance in the fourth quarter driven by an ongoing focus on execution in the Specialty Brands segment, which contributed over 70% of our total net sales. Our Acquire to Invest strategy continues to produce benefits as our scientific organization generates compelling new data and clinical evidence for key brands, and our commercial teams bring this data to physicians and their patients to help them make better informed treatment decisions," said Mark Trudeau, President and Chief Executive Officer. “Each of our key branded drugs -- Acthar®, INOMAX®, OFIRMEV®, and Therakos® -- contributed volume-led, double-digit net sales growth in the quarter, even excluding the extra week. By following our strategy and focusing on execution, we are making steady progress in building a leading specialty pharmaceutical company and are creating near- and long-term value for patients with high unmet medical needs.”

Trudeau continued, “We’re increasingly focused, too, on building a robust, organic pipeline in Specialty Brands -- developing new indications and products in areas where patients currently have few alternatives and are in need of better options. This is evidenced, in part, by our recent acquisition of the investigational skin substitute product StrataGraft® and the broader development platform of regenerative skin substitutes that have the potential to transform the standard of burn treatment and wound healing.”

For earnings history and earnings-related data on Mallinckrodt (MNK) click here.

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