Mallinckrodt's Full Statement/Response to Citron's Andrew Left

The below statement comes from a

Mallinckrodt PLC

MNK

spokesperson.

"We appreciate the opportunity to correct some of the misstatements on the earlier CNBC segment. Mallinckrodt has made great strides in successfully transforming itself into a well-diversified specialty pharmaceutical company that is consistently meeting or exceeding expectations. This is evidenced by our most recent quarterly results, released on May 3, in which we reported net sales of $918 million, up double-digit percentages for the quarter and the year-to-date. We also raised our fiscal 2016 adjusted EPS guidance for the second time since providing initial guidance in October 2015. Our Specialty Brands segment demonstrated strong volume-driven growth across the portfolio in hospital and autoimmune and rare disease products – expanding patient access to powerful, potentially life-changing therapies, including fragile infants suffering from devastating conditions. Our growth plan is based on volume. Pricing is a consideration only where a product may be undervalued in the market or to maintain sustainability. Any modest price increases we do take is offset by contracting discounts offered to managed care. We're pleased to report we now have the majority of covered commercial lives under contract for Acthar, a product frequently prescribed as a third or fourth line treatment, used after other treatments have become ineffective or failed, and patients have few remaining options to help them manage what are often serious, devastating conditions. In 2010, the FDA modernized the Acthar label through a data-based review when the infantile spasms indication was approved along with retention of the 18 other indications currently on the label. Specific to Acthar research under Mallinckrodt, we are investing in company-sponsored controlled clinical trials for lupus and for a key nephrotic syndrome condition called FSGS – with first patient announcement expected very soon. We also continue to evaluate opportunities to conduct Acthar phase four controlled clinical trials in other key disease areas. Simultaneously, we continue to generate additional data sets for Acthar, including pre-clinical and clinical data, patient registries and health economic assessments, as well as sponsoring investigator-initiated trials. In the first half of fiscal 2016, we had approximately 40 data presentations and publications, with about half related to Acthar. "

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