Sun’s senior management fielded a number of questions around US President Donald Trump’s MFN pricing target for drug manufacturers and its potential impact on the company’s specialty portfolio, especially addressing any price differential for products like Ilumya (tildrakizumab).

Like the rest of the industry, Sun’s chairman and managing director Dilip Shanghvi said that the firm was awaiting greater clarity on how things will finally shape up under the MFN pricing plan and pointed out that it appears to be “at a voluntary level,” at least currently.

“All branded products will have significant difference in the prices between US as well as Europe. This is not only our product. Only thing we have to keep in perspective is that [and for reasons I don't understand, he remarked] stock prices of big pharma companies have not changed,” Shanghvi stated, without going into specifics.

To an analyst’s query on certain nuances wherein Sun sells Ilumya in the US but the product isn’t technically sold by the Indian company in Europe, Sanghvi maintained that there are “many issues that we can go into,” but there isn’t still much clarity on how the MFN plan will be implemented and on what condition, provisions etc.

Tildrakizumab is sold as Ilumetri by Sun’s partner Almirall in Europe. Almirall which sees sustained momentum of Ilumetri in the short- to mid-term, recently upped its peak sales guidance for the product to above €300m ($340m) by 2030.

“If you see the IRA [Inflation Reduction Act] when they wanted to implement, they gave a significant amount of time and very great level of clarity as to how, what negotiation and how it will be done. So that level of clarity doesn't exist here,” Sun’s chief noted.

The US Department of Health and Human Services said on 20 May it expects manufacturers to commit to “aligning US pricing for all brand products across all markets that do not currently have generic or biosimilar competition with the lowest price of a set of economic peer countries.”

The MFN target price is the lowest price in an OECD country with a GDP per capita of at least 60% of the US GDP per capita, it explained.

BofA Securities said that though there are limited details on the MFN drug pricing order, it is a potential risk to Sun’s US specialty business, given dependence in Medicare on some of its large products (BofAe 40-75% of 2022 sales for three key products).

On tariffs and the option of shifting manufacturing of certain products to the US, Shanghvi said that for biological products like Ilumya and given the kind of quantities involved, it is not easy to identify a contract development and manufacturing organization which can do that in the US.

“It's not a question of where we do fill-finish. We will have to manufacture the full product in the US, starting with the active substance,” he explained. It could take at least 2.5 to three years before the new source is approved by the regulatory agency and would cost “a lot of money,” he added.

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