In fiscal 2018, Mallinckrodt’s (MNK) revenue fell 0.19% YoY (year-over-year) to $3.22 billion. Its adjusted diluted EPS rose 6.94% YoY to $8.01.
In its fourth-quarter conference call, Mallinckrodt identified its fiscal 2019 priorities as maximizing the value of its inline portfolio, which comprises hospital-based products such as Inomax and Ofirmev, and stabilizing its Acthar franchise. The company’s hospital-based portfolio sales grew by a high-single-digit percentage YoY in fiscal 2018, and Mallinckrodt expects to maintain this pace in fiscal 2019.
During the conference call, Mallinckrodt said it expects in fiscal 2019 to complete several Phase 4 studies evaluating its injectable therapy, Acthar, in multiple sclerosis and rheumatoid arthritis indications. The company has so far invested $0.5 billion in clinical studies of Acthar, for which readouts are anticipated by 2020. These trials are expected to create awareness among prescribers and payers about the targeted patient population and indications that benefit the most from this therapy. Mallinckrodt has guided for more than $1.0 billion in Acthar sales in fiscal 2019, and is planning to introduce an Acthar self-injector to the market in fiscal 2020.
Mallinckrodt said in its conference call that it is currently enrolling patients in a pivotal Phase 3 trial to evaluate its investigational therapy, Terlipressin, for type 1 hepatorenal syndrome. Mallinckrodt also reported that it is enrolling patients in a Phase 3 study evaluating its investigational therapy, StrataGraft, for deep partial-thickness burns, and that it is advancing its Phase 2 trial evaluating StrataGraft for full-thickness burns. Favorable trial results could mean regulatory approval for these products in fiscal 2020.
Mallinckrodt, which reduced its debt by $400 million in fiscal 2018, stated in its conference call that debt reduction is its fiscal 2019 capital allocation priority. The company aims to pay back $1.0 billion of debt in fiscal 2019 from cash flow and proceeds from the separation of its specialty generics and Amitiza businesses into an independent company.