LLY Faces Setbacks, but the Investment Thesis Still Holds
It’s no secret that big pharmaceutical companies like $Eli Lilly(LLY)$ need to get regulators to agree that their drugs are safe and effective before they can make money. But regulators aren’t the only group companies need to appease before shareholders see returns.
On October 23, Eli Lilly’s Alzheimer’s drug Kisunla was approved in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA), following in the footsteps of the US Food and Drug Administration (FDA) and Japanese regulators. UK regulators agreed with clinical trial results that showed the drug was somewhat effective in slowing or stopping the rate of cognitive decline associated with the disease for up to about seven months. They also found that treatment-related side effects, while potentially life-threatening, were acceptable given the benefits it provides.
But at the same time, the UK’s National Institute for Health and Care Excellence (NICE) issued draft guidance stating that the drug is not suitable for coverage within the country’s public healthcare system, mainly considering the modest benefits and the onerous medical testing requirements for patients, which makes it uneconomical to use.
NICE estimates that about 70,000 patients living in the UK will be eligible for the drug. According to $Eli Lilly(LLY)$ , the direct cost of the drug is $32,000 per patient per year, but from the perspective of a public healthcare system like the UK, there are also a ton of associated indirect costs, such as the medical monitoring that patients need to undergo.
It now looks like Kisunla has little chance of realizing its potential revenue. Worse, it’s now clear that regulators in other countries with public healthcare systems may be inclined to agree with NICE and refuse to cover Kisunla. In other words, Lilly’s attempts to bring the drug to international markets may end in failure. And that will become a new headwind to its revenue growth, and therefore its share price.
Keep the big picture in mind
Even though the drug may lose the UK market, Lilly is not helpless, and if Lilly’s R&D pipeline continues to produce blockbuster drugs for other indications, Kisunla may not actually be a noticeable drag on Lilly’s revenue growth.
But it’s important to remember that Kisunla will always be just a small component of the company’s revenue, especially considering the many other drugs it will launch between now and 2029.
The company still has 20 programs in Phase 3 clinical trials, including one for Alzheimer's disease based on a different molecule than Kisunla. Many of these programs will go on to receive marketing approval.
In other words, while it's impossible to interpret this new development as good news for shareholders, the investment thesis for this stock remains very much alive.
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