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What Investors Should Like About Eli Lilly's Q3 Update

By Keith Speights and Brian Orelli, PhD – Nov 4, 2021 at 7:02AM

Key Points

  • Lilly delivered strong revenue growth of 18% in Q3.
  • The company plans to use a priority review voucher to speed up the review of diabetes drug tirzepatide.
  • Lilly also hopes to win accelerated approval for Alzheimer's disease drug donanemab.

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Lilly reported solid growth, but its pipeline updates could be even more interesting.

Eli Lilly (LLY -0.47%) recently reported its third-quarter earnings results. In this Motley Fool Live video recorded on Oct. 27, Motley Fool contributors Keith Speights and Brian Orelli discuss what investors should like about Lilly's Q3 update.

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Keith Speights: Well, Brian, we're in the thick of earnings season, obviously. We've had one major earnings update in the healthcare sector so far this week, at least one that I can think of.

On Tuesday, Eli Lilly reported its Q3 results. What were the highlights from Lilly's update? Did you see any surprises there?

Brian Orelli: On the financial side, revenue increased 18% and some of that was due to its COVID antibody therapies. But if you exclude those from the sales were still up 11%, which is pretty impressive for a large pharmaceutical company. Anytime a large pharmaceutical company can have double-digit increases in their revenue, I think that's pretty impressive.

Diabetes drug Trulicity, Taltz, which treats an autoimmune disease, breast cancer drug Verzenio, and migraine treatment Emgality-- all of those grew more than 30% and those helped drive that 11% growth. Adjusted earnings per share were up 38% so growing faster than the top-line growth of 18%.

I think the pipeline updates, probably are almost more interesting than the actual financials. The company said it's using a priority review voucher to accelerate the review of its type 2 diabetes drug tirzepatide and then it's also starting a rolling submission for donanemab, which they're submitting to the FDA for accelerated approval in Alzheimer's disease.

Then it's also running head-to-head study of that same Alzheimer's disease drug against Biogen's (BIIB -1.43%) Aduhelm. That'll be really interesting. I think that was news at least to me.

Speights: Brian, did they happen to mention when they expect to complete the rolling submission for the Alzheimer's disease drug?

Orelli: I didn't catch it when they announced. Probably a couple of months, I would think.

Speights: Yeah, we're probably looking at either by the end of this year or early 2022.

Orelli: The other weird thing was, I saw somebody did some math and it's going to take some while for them to submit and then take a little while for the FDA to review it. By that time, there's only going to be about a year between when they could potentially get the accelerated approval and when they will get the Phase III data.

There probably wouldn't be too much in terms of sales between those two things. I'm not really sure if it's really necessary that they do the rolling submission, but maybe it makes it easier for the ramp-up when they get the data. In theory, they could see some ramp up in sales as doctors analyze the phase 3 data on their own before the FDA has a chance to analyze the data and then update the label with the phase 3 data.

In theory, they might be able to get some sales if they have an accelerated approval on the drugs in the market, they will be able to get some sales during that six to 10 months that it would take for the FDA to actually approve if they didn't have the accelerated approval.

Speights: We've talked about some of Biogen's challenges with Aduhelm with sales not being nearly what the company had hoped. At this point, if Lilly ends up winning FDA approval sometime next year for its Alzheimer's disease drug, that could even complicate matters even more for Biogen, couldn't it?

Orelli: Yeah, I think definitely.

Speights: This is an interesting space to watch for sure.

Keith Speights has no position in any of the stocks mentioned. The Motley Fool recommends Biogen. The Motley Fool has a disclosure policy.

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