GLP-1 Drugs: Can Amgen Sustain Its Competitive Edge?

Current Market Landscape for GLP-1 Drugs

The current market landscape for GLP-1 drugs shows significant growth, with Novo Nordisk's Ozempic leading at 46.6% market share and Eli Lilly advancing with innovative treatments like tirzepatide. Emerging data supports the efficacy of GLP-1 mechanisms in obesity management, indicating a competitive and evolving environment.

"Doug Langa: Thank you, Camilla. Please turn to the next slide. Sales in North America is driven by market share gains and healthy prescription volume growth of the GLP-1 class above 10% in the second quarter this year compared to the second quarter last year." --- (NVO, earning call, 2024/Q2)

"Tirzepatide is the only approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) treatment for chronic weight management, commercialized as Zepbound® in the U.S. and Mounjaro® in some global markets outside the U.S. Lilly submitted tirzepatide for the treatment of moderate-to-severe OSA and obesity to the U.S. Food and Drug Administration (FDA) with regulatory action anticipated as early as the end of this year." --- (LLY, press release, 2024/06/21)

"Murdo Gordon: Yes. Thanks, Jay. I think the data continue to emerge in the obesity and obesity-related conditions landscape, and show a clear benefit that reducing weight will indeed -- with GLP-1-based mechanisms will indeed improve outcomes in many disease settings." --- (AMGN, earning call, 2024/Q2)

"Ozempic continues its GLP-1 market leadership with 46.6% market share. We also pleased to see Rybelsus increasing its market share to more than 16%, driven by solid uptake across geographies. And with that, I will hand" --- (NVO, earning call, 2024/Q2)

"We also highlight today the GLP-1 coagonist III, which is a next-generation dual agonist molecule and we are planning to explore weekly and monthly dosing given its longer halfway." --- (LLY, earning call, 2024/Q2)

Competitive Analysis of GLP-1 Drug Manufacturers

The competitive landscape for GLP-1 drugs is intensifying, with AstraZeneca and Eli Lilly focusing on innovative combinations and rapid pipeline advancements. Meanwhile, Amgen faces concerns over manufacturing capacity, Novo Nordisk manages supply strategically, and Sanofi highlights significant market potential, indicating a dynamic and competitive environment.

"So very high potential for this molecule. On the right, we could combine this drug with our GLP-one glucagon and this would be for very competitive weight loss in the extreme end where you need to lose a lot of weight, but also very good organ protection, cardiometabolic risk reduction and fat specific weight loss." --- (AZN, event transcript, 2024/05/21)

"Barry Taylor: I think with regard to how quickly we can continue to move forward, RLT programs that are in the discovery phase of our pipeline, The intense focus we bring to all of the other therapeutic modalities to get them to patients in a competitive timeframe, we apply to the RLTs and several of those programs depending on the specific question and feature of the molecule we're optimizing for can be moved along quite quickly actually." --- (LLY, event transcript, 2024/06/03)

"I'd remind you to help us understand the manufacturing capacity and your ability to make this drug if you didn't have the confidence and the green light to do that if the data weren't what you say they were." --- (AMGN, conference, 2024/06/06)

"And then secondly on supply, it's great to see the 0.5 mg and 1 mg doses of Wegovy coming off the FDA drug shortage list, although it does seem like you're voluntarily keeping the 0.25 dosage capped in order to limit new patients." --- (NVO, earning call, 2024/Q2)

"So far, the drug is only a EUR 1 billion in sales if we analyze where it is, but the in-roads indication is probably at least a couple of billion in potential." --- (SNY, earning call, 2024/Q2)

Amgen's Product Pipeline and Innovation

Amgen is focused on sustaining its competitive edge through a robust and innovative product pipeline, addressing serious illnesses across multiple therapeutic areas. The company expresses excitement about upcoming developments and maintains a strong growth outlook driven by both its pipeline and existing products.

"We're driving growth in our marketed products and driving our innovative pipeline." --- (AMGN, conference, 2024/06/06)

"Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases." --- (AMGN, press release, 2024/08/06)

"You'll hear more about that pipeline shortly on this call. All in all, this is a very exciting time for us at Amgen." --- (AMGN, earning call, 2024/Q2)

"Our strong growth outlook is driven across each of our 4 therapeutic pillars by our innovative pipeline and in-market portfolio products, which serve patients with serious illnesses around the globe." --- (AMGN, earning call, 2024/Q1)

"Now, we are very organized at Amgen around the study of the CD19 pathway. We have the 2 agents FDA approved and a strong pipeline behind those as well." --- (AMGN, conference, 2024/06/10)

Pricing Strategies for GLP-1 Drugs

Pricing strategies for GLP-1 drugs are increasingly influenced by government regulations, such as the Medicare Drug Price Negotiation Program and the Inflation Reduction Act, which impose significant price controls. Companies must navigate these complexities while considering the cost and competitive dynamics of their products.

"In particular, the nine-year timeline to set prices for medicines approved under a New Drug Application reduces the attractiveness of investment in small molecule innovation." --- (LLY, sec filing, 2024/Q2)

"Could you help us understand how complicated or simpler it is versus the traditional GLP-1s peptide base in terms of complexity as well as cost?" --- (AMGN, earning call, 2024/Q1)

"In August 2023, the Biden Administration unveiled the first ten medicines subject to the Medicare Drug Price Negotiation Program (the Program), which requires manufacturers of select drugs to engage in a process with the federal government to set new Medicare prices which would go into effect in 2026." --- (PFE, sec filing, 2024/Q2)

"Among other measures, the IRA requires the U.S. Department of Health and Human Services (HHS) to effectively set prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D. Generally, these government prices apply nine years (for medicines approved under a New Drug Application) or thirteen years (for medicines approved under a Biologics License Application) following initial FDA approval and will be set at a price that is likely to represent a significant discount from existing average prices to wholesalers and direct purchasers." --- (LLY, sec filing, 2024/Q1)

"In the U.S., we expect to see continued focus by Congress and the Presidential Administration on regulating drug pricing regardless of which party comes to power following" --- (PFE, sec filing, 2024/Q2)

Key Trends Influencing GLP-1 Drug Adoption

Key trends influencing GLP-1 drug adoption include the need for robust clinical confidence and operational support, as emphasized by Amgen's strategies. Additionally, Eli Lilly highlights the competitive landscape and the importance of drug efficacy and tolerability, alongside supply-demand dynamics that may affect availability.

"to help navigate the complexities of transitioning between inpatient and outpatient care, answering questions about access and reimbursement and, of course, treatment logistics.Overall, we believe our strategy of cultivating widespread clinical confidence, bolstering health care provider education to instill trust in Imdelta's safety profile and offering robust operational support will lead to broad adoption across academic and community centers alike." --- (AMGN, event transcript, 2024/05/20)

"Chris Schott: And congrats all the progress. There seems to be a broader debate on the role emerging earlier-stage competition in the obesity market could play where that fits in the market broadly." --- (LLY, earning call, 2024/Q2)

"And so though the Phase 3 study doesn't compare directly to dupilumab, which would I think really answer your question, we hope to give the clinicians managing this disease the optionality with a strong efficacy and tolerability signal if this should replicate from our Phase 2 work, and there's no reason it" --- (AMGN, conference, 2024/06/10)

"And we've heard very clearly this drug has overcome that barrier. We've identified efficacy CNS activity, activity in previously treated patients and now tolerability that together allow us to combine with immunotherapy." --- (LLY, event transcript, 2024/06/03)

"While supply and demand have come into better balance, expected increases in demand may result in periodic supply tightness for certain presentations and dose levels." --- (LLY, sec filing, 2024/Q2)

Future Growth Opportunities for GLP-1 Drugs

Amgen sees significant future growth opportunities for GLP-1 drugs, emphasizing confidence in long-term business expansion through these medicines. The company plans to explore new markets and additional launches, aiming for sustained growth through the end of the decade and beyond.

"We see future growth opportunities for LUMAKRAS coming from the launches in new markets and additional" --- (AMGN, earning call, 2024/Q1)

"We're confident that through these medicines and beyond we're on a path to deliver long term growth to the business at the end of this decade and through the end of this decade and beyond and look forward to sharing more updates in the other pillars in the fullness of time." --- (AMGN, event transcript, 2024/05/20)

Impact of Market Entry of New Competitors

The entry of new competitors in the GLP-1 market is expected to create pricing pressure and supply challenges, as noted by Amgen and other industry players. Competitors are struggling to maintain supply, which may impact their market share and pricing strategies, ultimately affecting Amgen's competitive edge.

"Factors that may affect our estimates include generic competition, seasonality of products, price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations." --- (BMY, sec filing, 2024/Q1)

"We've -- not lost on us that these competitors who are in the market now have found it difficult to maintain supply of these medicines, and I'm sure that's not lost in the patients either." --- (AMGN, earning call, 2024/Q1)

"And then, of course, the market is also defined through competition and competitive entry." --- (NVO, earning call, 2024/Q1)

"We think there's going to continue to be pricing pressure, particularly from our rebating because we're seeing competition there, not just from a Tesla in the oral market, but you're also seeing competition from the biologics as well." --- (BMY, conference, 2024/05/15)

"And then second question on oral therapy. So obviously, there's been some competitor data, some early competitor data that's been on the market recently." --- (NVO, earning call, 2024/Q2)