In a true testament to what a community of people committed to advocating for patient access can do, Eli Lilly announced today that single-dose vials (2.5mg and 5mg) will be released in the coming weeks in the United States.
HOW IT STARTED
Back in the spring of 2024 when supplies of tirzepatide (Zeobound and Mounjaro) were nearly impossible to find at your pharmacy of choice, On The Pen launched a viral campaign for Eli Lilly to #ReleaseTheVials. Today, Eli Lilly announced they are doing just that.
Stay tuned below for live updates on the 2024 Q2 Eli LIlly Earnings call!
Live Updates (central time):
Q2 Highlights
11 new molecules in development
Orforglipron in phase 3 in DM2 and Obesity - mid next year top lin
Retatrutide in obesity, OSA, osteoarthritis, cardiovascular, renal, DM2 outcomes readouts in 2026
Lebanon factory build to expand Zepbound and Mounjaro manufacturing infrastructure
Ramping production with contract manufacturing and Indiana and NC
Tirzepatide launched in Kwik-pen In ex US markets
Zepbound will be launching in single dose vials in US
Financials
Mounjaro and Zepbound driving revenue
46% revenue growth
Back orders of incretins largely resolved
Certain supply tightness will continue across different presentations
Launch of 2.5mg and 5mg single dose vials in the coming weeks
Mounjaro approved in China for DM2 and Obesity, no launch date announced
$3.1B in sales globally for Mounjaro
Mounjaro Kwik Pen in Germany, UK, UAE, Spain, more markets to come
Zepbound $1.2B in sales in Q2
86% access for patients with obesity coverage For Zepbound
$3B increase in projected revenues for 2024
Single dose vials will make 1.5x the sellable doses as the were available in 2023
Research and Development
Tirzepatide reduced risk of worsening heart failure by 38%
Tirzepatide improved symptoms and mobility 24.8% improvement vs 15% with placebo
Tirzepatide 15% weight reduction
Detailed results to FDA starting later this year, full result to come soon
Cardiometabolic Health
Tirzepatide OSA results presented at ADA
All primary endpoints met
Tirzepatide shows that 51% met criteria of disease resolution
Breakthrough therapy designation granted by FDA by end of year!
MASH with stage 2 or 3 fibrosis - 1/2 of patients showed improvements
Investing in approaches like islet cell therapies for type 1 diabetes
Additional incretins entering phase 1
GLP1/NPA2 entering phase 1 small molecule non peptide oral - phase 2 later this year
GLP1 co agonist 3 next gen dual agonist weekly and monthly dosing exploration given longer half-life
NRG4 agonist stopped due to lack of efficacy
Question and Answer
Does guidance for 1.5 increase in sellable doses include starter Zepbound vials?
The vials are a part of that but there is a limit to how much of that will ship. Early 2025 is when the new form ramps. Mostly coming from expanded capacity.
Defending Lilly’s position in obesity with new drugs in trials: Lilly has a deep bench of assets in trials, including phase 3 (Orforglipron and Retatrutide). They are waiting to see more robust phase 2 data from competetors. Gaining access for patients is a huge hurdle that Lilly has a major leg up on. More emphasis on the importance of orals, which will make a huge difference. Scaling manufacturing will be a challenge for latecomers to the game.
Compounders of GLP-1 like Hims, how does this not infringe on patent protection, will this get educated in the courts?: Lilly has been watching carefully, not because of an impact of bottom line, but patient health. Lilly has been analyzing them. They are finding many that are entirely different chemicals, or versions that are full of impurities including bacteria. Lilly will be active, tasking public positions, working with regulators, and considering legislation. Lilly acknowledges 503a as being legal (though he posits he doesn’t know what would precipitate a need), but contests the validity of mass production from 503b. Acknowledgement that shortages lead to this, but contends shortages are largely held up by enforcement of sterile product factories. Lilly will be stepping up efforts to address. Making huge strides in supply, including vials. Working to expand coverage to make medications more affordable.
Will ex US markets track with the uptake of Tirzepatide? UK, UAE, and Saudi have achieved leading shares of overal market growth in incretins (Mounjaro). Growth will continue to come from markets they’ve already launched in.
Engagement with regulatory agencies on Reta and Tirz in MASH studies: Current standard of liver biopsy is a challenge and barrier to phase 3 trials. Patient consent makes is heard. Working to develop non-invasive biomarkers.
Catalent and Novo merger concerns: Lilly remains concerned, not as concerned about ramping of drugs, they rely on one site. They dont like their competitor becoming a supplier given the current contracts in place. Also the constraint of development of
What is Lilly doing to tell the story of increased worker productivity with Zepbound: Working with payers to examine the benefits of increased productivity. Consumers staying on the meds is obviously important to Lilly, and they are working on telling the story of the benefits of continued use of tirzepatide
What will competition look like and how should investors consider what is important to look at: Inturpriting data especially as it relates to orals, they see a lot of GLP-1 focus and don’t see a lot of innovation or changes, only more options coming. Tolerability is important, and so half life is important to consider. Lilly believes longer half life’s are going to be better long term for reducing side effects. They are looking to see orals that combine multiple incretins that could combine GIP in addition to GLP and get orals to the level that injectable tirzepatide is at. Current aims for orals include targets for injectable semaglutide.
Amylin GIP GLIP combos may help preserve muscle mass, how does eloralintine + tirzepatide fit into that equation: No preconceived notions on what to expect regarding lean mass vs fat loss. Dual amylin + calcitonin (DACRA) may be more beneficial. Bimagrumab acquired from Versanis is moving to phase 2 with semaglutide. Tirzepatide shows improved functional outcomes so there is not really concern about the quality, could there be improvement is the question they are investigating.
FDA Shortage seems to imply LIlly is meeting demand, how is this defined by the FDA or Lilly. Does Lilly agree? Lilly can fill orders as received, does not mean all pharmacies have their medications. Because there is not an abundance, there will still be delays at pharmacies. Vials will add to that picture, but so will demand. Lilly feels they are doing well, Lilly contends that pharmacy shortages are not tantamount to the definition of their ability to provide supply to pharmacies.
Is lean mass preservation importance to development of obesity drugs? Yes, and they are developing options for the future
So you're the one to blame! Dispensing the drugs in vials with syringes improves things for those whose Zepbound is covered who have difficulties getting Zepbound or Mounjaro from their pharmacies. However, having available stocks of those drugs makes if more likely the FDA will take both drugs off the shortage list. That will lead to people being unable to receive the drugs from compounding pharmacies. For those people, things will cost more. I'm not seriously criticizing you; there is a huge need for more drug to be provided. But you may have increased costs for me.