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On Zepbound? Here's Why April 30th Matters to You

This will be the 6th Eli Lilly earnings call we have covered at On The Pen. Over the past year and a half we have learned a lot of exciting things through that coverage. We learned and reported on exciting advancements with the triple agonist Retatrutide, the novel non-peptide GLP-1 pill Orforglipron, as well as new use cases for existing drug Tirzepatide (Zepbound and Mounjaro).

These earnings calls are designed for investors who are seeking to learn more about the future financial performance of the company, but there are many things we can glean from the patient perspective that are not always obvious, and we are here to tell that side of the story.


So what am I looking forward to hearing from Eli Lilly on April 30th? Let's unpack that a bit. together.




SLEEP APNEA FDA SUBMISSION

A couple of weeks ago Lilly announced top line trial data on their obstructive sleep apnea study. This type of information is usually reserved for earnings calls, however, it would seem as this information was dropped to coincide with the massive update on Zepbound and Mounjaro shortages that dropped on the same day. This was presumably to offset the negative press regarding the shortages.


From the patient perspective, what will be interesting to hear is just how much Lilly sees this affecting sales of Zepbound and how soon? This will depend on a couple factors. Number one, how soon do they anticipate the FDA granting approval for Zepbound for the treatment of OSA? Number two, how soon after that do they anticipate a potential addition of Zepbound to certain Medicare part D formularies.


Unfortunately for many patients looking to seek access to Zepbound via an OSA diagnosis, this will likely take some time. After Tuesday, I hope we will have more clarity.



HEART FAILURE DATA

The SUMMIT trials studying patients using Tirzepatide for the treatment of heart failure with preserved ejection infraction (similar to the recently reported and FDA approved STEP trials for Semaglutide), are ongoing but wrapping up soon. We are likely to hear when the top-line data will be reported, and a potential time line for an FDA approval of this indication.


If we follow the semaglutide STEP trial timeline, we could potentially see Zepbound hit Medicare formularies for the treatment of HFpEF in late 2024 or early 2025 opening back door access for those seeking coverage through part D plans.


ACQUISITIONS OF MANUFACTURING PLANTS

In addition to several other recent acquisitions, this past week Lilly announce the acquisition of an FDA approved manufacturer of injectable medications. Zepbound and Mounjaro have been named as the medications that will be manufactured there. Notably, Nexus (the previous owner) is known for manufacturing injectables in vial form. Lilly has previously stated that they do not expect the plant to contribute to the supply until late 2025. I will be looking forward to hearing more about why the plant could not be contributing sooner. I expect investors will want to know the same, considering how far demand is outpacing the supply.


RETATRUTIDE & ORFORGLIPRON TRIAL UPDATES

This is always a favorite topic to cover. Pipeline medications are always of particular interest to investors, and potential patient beneficiaries as well. As a slow responder to the current therapies, drugs like Retatrutide offer a glimmer of hope that the diseases that I have can be dealt with without the need for invasive surgery. Typically earnings calls will give insight into trial advancements and hiccups. Phase 3 trials for Retatrutide are ramping up, and they have been ongoing with Orforglipron.



SHORTAGES: RELEASE THE VIALS

Lilly will not be able to skirt around providing concrete answers to how they intend to deal with the shortages. The previous answers of "the Concord plant is coming along nicely" will not suffice. Not when they are likely to report to investors around 100,000 new rx of Zepbound are being written weekly.


A little over a month ago, I started a viral TikTok campaign to encourage Eli Lilly leadership to #ReleaseTheVials. Since then the campaign has garnered national attention both in Bloomberg and on Yahoo Finance. At a minimum, I believe we will hear an acknowledgement from Lilly brass on the issue. The noise is too big to ignore. At a maximum, I believe we could hear that single-dose vials of Zepbound and or Mounjaro will be coming to a pharmacy near you. And soon.


So will they, or won't they?



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