Specialist
Former VP at Mallinckrodt plc
Agenda
- Overview of the generic and speciality pharmaceuticals market and Mallinckrodt's competitive positioning
- Chapter 11 bankruptcy litigation update, including RSA (restructuring support agreement), opioid settlement and read-through to other players
- Additional claims pending litigation
- Specialty brands performance – Acthar (corticotropin), Inomax (nitric oxide), Ofirmev (acetaminophen) and Therakos
- Core business analysis, focusing on the generics segment and potential spin-off
- Turnaround expectations after Chapter 11
- H1 2022 outlook and challenges and limitations for new developments
Questions
1.
What went wrong with Mallinckrodt and why we are at the point where we find ourselves today?
2.
Could you give your updated thoughts on Mallinckrodt? How should we assess the company and the sector as a whole? How has its prospects changed in the past couple of years?
3.
What is your assessment of Mallinckrodt positioning vs peers? What competitor, if any, do you believe has benefited most from the hurdles the company has been facing?
4.
What are your key insights into the opioid litigation landscape, specifically the ongoing litigation that Mallinckrodt is facing across several states and any recent updates and settlements?
5.
Were you surprised at all when Mallinckrodt filed for bankruptcy?
6.
It seems as though Mallinckrodt is on its way to completing a Chapter 11 reorganisation, as it revealed in September 2021 it had reached settlements with creditors that would reduce the company’s debt by roughly USD 1.3bn. Last week it made its final case for approval of the bankruptcy opioid deal. Do you think that Mallinckrodt will emerge from bankruptcy claim-free? What is your overall outlook on the company as it aims to exit?
7.
How would you expect Mallinckrodt to try and grow, given these limitations? It seems like it is in a pretty limited space here. What are your expectations into avenues it could take to possibly grow its pipeline or bring in more expertise?
8.
Are there any other headwinds Mallinckrodt could face as it emerges from bankruptcy? Do you have any differentiated thoughts on litigation risks that others might be missing?
9.
Mallinckrodt announced that it would spin off its specialty generics and API business in 2018, but this was suspended due to market conditions and its ongoing opioid litigation. What is your assessment of the company’s decision to do this? Do you believe that this was the right decision at the time and could have resulted in the greatest value accretion for its portfolios?
10.
Could you discuss Mallinckrodt’s specialty generics portfolio, speaking about the relative positioning, competitive threats or any opportunities, unexpected growth or decline outlook?
11.
Could you outline the branded portfolio on a drug-by-drug basis, touching on Acthar, Therakos, Inomax and terlipressin and highlighting your thoughts on the sales outlook and margin for each?
12.
How low do you think the floor really is for Acthar, and do you believe it has stabilised at all? Do you have any other thoughts on the ANI competitor?
13.
You mentioned StrataGraft could be a moderate contributor to growth but could take some time? Could you quantify what the peak sales opportunity could be for the drug? Do you have any more specific estimate on time frame here?
14.
Could you discuss the R&D culture at Mallinckrodt? Do you believe that it has the talent to develop a strong pipeline? What do you think happened with the R&D spend on Acthar? It seems like a lot of money was spent, but not a lot of results were yielded.
15.
What is your assessment of the management team and their main strengths and weaknesses? What do people say in general about the management team?
16.
What revenue gap would you expect over the next 2-3 years across the two portfolios? Could you perhaps quantify that for us?
17.
Could you highlight any best- or worst-case scenarios, as well as anything else we have yet to touch on today that you think is important to highlight?
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