Aus Amiforum:
Mark stated lots of controversy around CMS, opioids, and debt maturities but pipeline continues to mature and shape up nicely. Not being appreciated due to opioid litigation. He expected these uncertainties to clear in next few months.
Mark believes there may be a way for Mallinckrodt to settle the opioid litigation globally because of discussions with plaintiffs, but this discussion could fall apart anytime.
Mark said the JNJ settlement should not be compared to a Mallinckrodt standpoint. He believes there is a path for Mallinckrodt, but no read-through on settlement amount. Global settlement could likely be in months. People should not extrapolate the Ohio settlement to a Mallinckrodt global settlement as otherwise Mallinckrodt should just declare bankruptcy.
He stressed the need to separate the two businesses to concentrate on developing the branded pipeline and new product launches. The plan is to launch 3-5 new branded products in next 12 months. Mallinckrodt is not constrained in R&D investments ? will start phase 3 of MNK6105 by yearend. Goal is to build a long-term specialty business to drive organic growth. Mallinckrodt already has the commercial infrastructure for the science to fit into.
Mallinckrodt is not going to wait forever on the April 2020 debt maturity. It is trading at a discount and the company has financial capacity ? a receivable securitization could also be an option. Opioid litigation will also play a factor.
Update on previously stated objectives. Potentially see separation and opioid resolution as simultaneous. Liabilities should be attached to the assets. The two businesses already operate independently.
Acthar has performed less than expectations in 2019 as sales will not be in excess of $1 billion due to CMS issues. However positive clinical data correlates to prescription volume and company has seen uptick in prescription volume after data is released. Restriction at payer level is main concern. Impact of new data takes longer to go through payers than through subscribers. There are 4-5 clinical trials for Acthar coming out over next 12 months - this will drive future trajectory of Acthar as these are modern randomized trials. Company is also developing Acthar self-injector.
CMS resolution expectation should be straightforward and expect judgment by end of year but no guarantees. On a go forward could be a $90-100 million hit in worst case. Once judgment comes forward, company has a range of options.
Severance package was simply trying to create uniformity across various categories of employees and did not change the value of the packages. These packages were not done overnight and were being developed over a long period of time.DR Romano stated pipeline assets are being overlooked because of opioid cloud and good news is not having the expected reaction. Terlipressin is tremendous opportunity as there is no alternative for this product. Stratagraph is also very key product. Silence Therapeutics has opportunities to generate various new products. Therakos gets almost no coverage ? it has low patient penetration in the USA but gaining share. Company published interesting data on Therakos and signed development agreement with TransImmune. This product has solid growth behind it.
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