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The Obesity Drug Chessboard after ADA2025 with Q2 Earnings in Play ♟️

Quick status check on Novo, Lilly, and rivals after ADA 2025 – just ahead of Q2 earnings.

Introduction

Novo Nordisk and Eli Lilly will release their Q2 results on 6 and 7 August.
ADA 2025, which wrapped at the end of June, delivered a blitz of new obesity data. Below is a look at every major piece now on the board—and the ones most likely to move next in this century-old contest between the two weight-loss giants. (Need a refresher on the previous board set-up? Check the earlier post.)

The Next Wave of Obesity Drugs: Opportunities and Risks for Investors 🌊

Candidates and products on the board

After ADA 2025 we got fresh topline data on three fronts:
• Amycretin (Novo Nordisk, phase 1 – weekly shot and daily pill)
• MariTide / Maridebart cafraglutide (Amgen, phase 2 – monthly shot)
• Orforglipron (Eli Lilly, phase 3 – daily pill in T2D patients).

The first table summarises the key pieces now in play. Except for Orforglipron (a small-molecule GLP-1) and Bimagrumab (a muscle-preserving mAb), every candidate is a GLP-1 receptor agonist or combo. Bimagrumab stays on the board because the phase 2 BELIEVE read-out of the bima + sema combo (NCT05616013) was showcased at ADA 2025, and analysts see a > $30 billion market for muscle-preserving obesity drugs by 2035.

The second table drills into weight-loss studies that excluded hyperglycaemic/diabetic patients.

Drug	Company	Mechanism	Type	Administration	Primary Obesity Trial	Products	Other Names	Weight Loss %
Amycretin	Novo Nordisk	Dual GLP1 + amylin	Peptide	Subcutaneous	NCT06064006	N/A	NN9487	24.3%
Retatrutide	Eli Lilly	Triple GLP1 + GIP + GCG	Peptide	Subcutaneous, weekly	NCT04881760	N/A	LY3437943	24.2%
CagriSema	Novo Nordisk	Combo GLP1 + amylin	Peptide	Subcutaneous, weekly	NCT05567796	N/A	NN9838	22.7%
Tirzepatide	Eli Lilly	Dual GLP1 + GIP	Peptide	Subcutaneous, weekly	NCT04184622	Zepbound	LY3298176	22.5%
Semaglutide	Novo Nordisk	GLP1	Peptide	Subcutaneous, weekly	NCT05646706	Wegovy	NN9535	20.7%
Maridebart cafraglutide	Amgen	Dual GLP1 + GIP	Peptide + mAB	Subcutaneous, monthly	NCT05669599	N/A	AMG133	19.9%
Semaglutide	Novo Nordisk	GLP1	Peptide	Oral	NCT05035095	N/A	NN9924	16.6%
Orforglipron	Eli Lilly	GLP1	SMD	Oral	NCT05051579	N/A	LY3502970	14.7%
Amycretin	Novo Nordisk	Dual GLP1 + amylin	Peptide	Oral	NCT06064006	N/A	NN9487	10.4%
Liraglutide	Novo Nordisk	GLP1	Peptide	Subcutaneous, daily	NCT01272219	Saxenda	NN2211	8.0%
Bimagrumab	Eli Lilly	Activin-II	mAB	Intravenous	NCT06643728	N/A	LY3985863	N/A

Sponsor	Compound	Administration	Phase	Dose (mg)	Trial Name	OT WL %	IT WL %	Weeks	Completion	NCT ID	Participants
Novo Nordisk	Amycretin	SubQ, weekly	1	60	– ^🔗📄	24.3	N/A	36	2025-06-20	NCT06064006	125
Eli Lilly	Retatrutide	SubQ, weekly	2	12	TRIUMPH-Obesity ^🔗📄	24.2	20.9	48	2023-06-26	NCT04881760	338
Novo Nordisk	CagriSema	SubQ, weekly	3	2.4, 2.4	REDEFINE-1 ^🔗📄	22.7	20.4	68	2024-12-20	NCT05567796	3417
Eli Lilly	Tirzepatide	SubQ, weekly	3	15	SURMOUNT-1 ^🔗📄	22.5	20.9	72	2022-06-04	NCT04184622	2539
Novo Nordisk	Semaglutide	SubQ, weekly	3	7.2	STEP-UP ^🔗📄	20.7	18.7	72	2025-01-17	NCT05646706	1407
Amgen	Maridebart cafraglutide	SubQ, monthly	2	420	– ^🔗📄	19.9	16.2	52	2025-06-23	NCT05669599	592
Novo Nordisk	Semaglutide	SubQ, weekly	3	2.4	STEP-1 ^🔗📄	16.9	14.9	68	2021-02-21	NCT03548935	1961
Novo Nordisk	Semaglutide	Oral, daily	3	25	OASIS-4 ^🔗	16.6	13.6	64	2024-10-23	NCT05564117	307
Eli Lilly	Orforglipron	Oral, daily	2	45	– ^🔗📄	14.7	N/A	36	2023-06-23	NCT05051579	272
Novo Nordisk	Amycretin	Oral, daily	1	50	– ^🔗📄	10.4	N/A	12	2024-01-09	NCT05369390	144
Novo Nordisk	Liraglutide	SubQ, daily	3	3	SCALE-Obesity ^🔗📄	8.0	8.0	56	2015-07-02	NCT01272219	2432

OT and IT refer to On-Treatment and Intent-to-Treat weight loss, respectively. OT reflects participants who completed treatment, while IT includes all who were randomised.

What to listen for on the Q2 earnings calls

Novo Nordisk — 6 Aug

CEO hand-off – any hint on who follows Lars Fruergaard Jørgensen?
Manufacturing headroom – has Wegovy capacity finally outpaced demand, and will it scale for Amycretin?
Amycretin phase 3 design – trial size, endpoints, and the split between oral and injectable arms.
CagriSema filing – timeline clarity after the REDEFINE data.
Oral sema 25 mg – likely no news; FDA already accepted the OASIS-4 filing, PDUFA sits in Q4.

Eli Lilly — 7 Aug

Orforglipron phase 3 – guidance now or pushed to the promised Q3 update?
Bimagrumab phase 3 – has the trial design been finalised with FDA, or is it still pencilled in for Q4?
Retatrutide phase 3 – first-patient-in date, dosing cadence, any early enrolment colour?

Wild-cards

Amgen – could outline the MariTide phase 3 program (monthly shot).
Boehringer Ingelheim / Zealand – may drop an enrolment update on Survodutide’s SYNCHRONIZE-1 trial in non-T2D patients.

End-game snapshot – who is up on the board?

Current position

Lilly is a pawn ahead in market play: Zepbound still edges Wegovy on kilos lost.
Novo answered with a bold move: the Amycretin shot posted -24.3 % in phase 1 and, after buying Catalent, Novo controls more fill-finish capacity to feed future demand.

Key squares to watch next turn

Safety file – GI events and dropout rates at high doses.
CVOT lane – hard-outcome trials will crown the real king.
Manufacturing lane – Catalent integration must unblock Wegovy and prep Amycretin.

Scorecard

In-market pieces: advantage Lilly.
Late-stage pipeline: even – Retatrutide vs Amycretin.
Oral game: Lilly up a tempo with SMD Orforglipron; Novo’s high-dose oral sema trails, Amycretin pill is the dark horse.

Next move (Q2 calls, 6-7 Aug)
Updates on supply chain, phase 3 starts, CV signals, and CEO succession (Novo) could swing initiative. The first player to pair mega weight loss with clean CV data will own the board.

Appendix

Below the weight loss curves for Amycretin, CagriSema, Retatrutide, Orforglipron, Tirzepatide and Semaglutide are shown.

Amycretin, phase 1, subcutaneous (36 weeks) and oral (12 weeks)

Amycretin, phase 1, subcutaneous, bodyweight change

Amycretin, phase 1, oral, bodyweight change

CagriSema, phase 3, 68 weeks

CagriSema (Cagrilintide-Semaglutide), phase 3, bodyweight change

Retatrutide, phase 2, 48 weeks

Orforglipron, phase 2, 36 weeks

Orforglipron, phase 2, bodyweight change

Tirzepatide, phase 3, 72 weeks

Semaglutide, phase 3, 68 weeks

The Next Wave of Obesity Drugs: Opportunities and Risks for Investors 🌊

Riding the First Wave: Wegovy® and Zepbound® 🏄

GLP-1 weight loss drugs Wegovy® (semaglutide) and Zepbound® (tirzepatide) from Novo Nordisk and Eli Lilly hit markets like a tsunami, when they were approved in June 2021 and November 2023, due to their unprecedented weight-loss efficacy 🌊 The next waves might not be as colossal, but they still hold potential for investors navigating these waters.

Riding the Wave: Recent Developments

December 2024 brought two consecutive waves of news for investors. First, Eli Lilly unveiled phase 3b SURMOUNT-5 trial results for Zepbound® (tirzepatide), showing a 20.2% superior weight loss (72 weeks, 15 mg, n=741, baseline obese) – well above 13.7% for Wegovy®. Soon after, Novo Nordisk released data from its phase 3 REDEFINE-1 trial for CagriSema (cagrilintide + semaglutide). While the reported 20.4% weight loss (68 weeks, 2.4 mg, n=3,417, baseline 106.9 kg) was strong, it fell short of the anticipated 25%, fueling disappointment and contributing to a ~20% stock price drop.

Taken back-to-back, these developments underscored how quickly sentiment can shift in the fiercely competitive GLP-1 landscape – and just how high investor expectations have become.

Product Portfolios: A GLP-1 Tidal Shift

Recent figures show GLP-1 therapies now make up 80% of Novo Nordisk’s total revenue and 55% of Eli Lilly’s—highlighting how both companies rely heavily on these blockbuster weight loss medications. For Novo Nordisk in particular, semaglutide has become the flagship product that needs replacing or reinforcing once its patents run aground.

Figure 1. Novo Nordisk GLP-1 percentage of sales.

Figure 2. Lilly GLP-1 percentage of sales.

Anchoring Success: Approved Medications

These anchor therapies—Saxenda®, Wegovy®, and Zepbound®—have already reshaped the obesity market by delivering significant weight loss. As one can see in Table 1, looming patent expirations and emerging competition could stir up choppier waters, pushing companies to innovate or risk losing their edge.

Company	Name	Generic	Doses	Administration	FDA Approval	Weight Loss	Patent Expiration
Novo Nordisk	Saxenda®	Liraglutide	3mg	Daily Injection	2014	~8% (56 weeks)	2024
Novo Nordisk	Wegovy®	Semaglutide	2.4mg	Weekly Injection	2021	14.9% (68 weeks)	2026
Eli Lilly	Zepbound®	Tirzepatide	15mg	Weekly Injection	2023	20.9% (72 weeks)	2039

Table 1. GLP-1 medications already approved for the treatment of obesity. Despite their success in recharting the obesity-treatment landscape, upcoming patent deadlines mean new challengers—or generic versions—could soon shake up the market once again.

Pipeline Candidates: Innovation on the Horizon

While Wegovy®, Saxenda®, and Zepbound® have already proven the market’s appetite for GLP-1 therapies, a new fleet of candidates is gearing up to reshape the obesity landscape. From dual and triple hormone agonists to next-generation oral formulations, each entry in Table 2 could represent the next wave – if their clinical trials keep delivering smooth sailing.

Candidate	Sponsor	Type	Receptors	Administration
CagriSema	Novo Nordisk	Peptides (GLP-1 and Amylin)	GLP-1 (Semaglutide) + Amylin (Cagrilintide)	Subcutaneous
Amycretin (NNC0487-0111)	Novo Nordisk	Peptide (Amylin)	GLP-1, Amylin	Oral / Subcutaneous
Survodutide (BI 456906)	Boehringer Ingelheim	Peptide (Glucagon)	GLP-1, GCG	Subcutaneous
Retatrutide (LY3437943)	Lilly	Peptide	GLP-1, GIP, GCG	Subcutaneous
Orforglipron (LY3502970)	Lilly	SMD	GLP-1	Oral

Table 2. Select pipeline candidates hoping to sail into a highly competitive market by offering even greater efficacy and convenience.

Mapping the Waters: Insights from Clinical Trials

As competition in the obesity-drug space intensifies, clinical trial data can make or break a company’s voyage. Table 3 compares superior weight loss percentages, doses, and timelines across recent mostly phase 3 (and 3b) trials. Notably, candidates like Amycretin and CagriSema are hitting impressive numbers above 20% – but each new wave of data also raises the tide of investor expectations.

Candidate	Superior Weight Loss	Dose	Weeks	Baseline	Date
Amycretin	22.0%	20mg	36	92.7kg	2025-01-24
Semaglutide	20.7%	7.2mg	72	113kg	2025-01-17
CagriSema	20.4%	2.4mg	68	106.9kg	2024-12-20
Tirzepatide	20.2%	15mg	72	Obese	2024-12-04
Retatrutide	24.2%	12mg	48	BMI>27	2023-06-26
Survodutide	14.9%	4.8mg	46	Obese	2023-06-23
Orforglipron	14.7%	45mg	36	109kg	2023-06-23

Table 3 – Phase 3 and 3b clinical trial results. Note: Amycretin’s 22% was achieved by subcutaneous – not oral – administration in a phase 1b/2a study, while Orforglipron was administered orally.

Plotting the Course: Clinical Trial Highlights

Building on these outcomes, Table 4 charts the finer points of key trials—from participant profiles and dosage regimens to primary outcomes. Navigating this data reveals not only each therapy’s potential but also the crowded seas ahead, where even a small setback can send ripples across the market.

Candidate	Trial	Primary Outcome	Participants	Weeks	Sample Size
Semaglutide	STEP-1	Weight loss vs placebo	Adults with obesity or overweight	68	1,961
Semaglutide	STEP-2	Weight loss vs placebo	Adults with obesity or overweight with type 2 diabetes	68	1,210
Semaglutide	STEP-3	Weight loss vs placebo as adjunct to intensive lifestyle intervention	Adults with obesity or overweight	68	611
Semaglutide	STEP-4	Weight loss maintenance vs placebo	Adults with obesity or overweight	68	902
Semaglutide	STEP-UP	Superiority of semaglutide 7.2 mg vs placebo on weight loss	Adults with BMI ≥30 kg/m² without diabetes	72	1,407
Semaglutide	STEP-UP T2D	Superiority of semaglutide 7.2 mg vs placebo on weight loss	Adults with obesity and type 2 diabetes	72	512
Semaglutide	OASIS-1	Weight loss vs placebo	Adults with overweight or obesity	68	1,102
Semaglutide	OASIS-2	Weight loss maintenance vs placebo	Adults with obesity	52	921
CagriSema	REDEFINE 1	Efficacy and safety of CagriSema vs semaglutide 2.4 mg vs placebo	Adults with obesity or overweight and comorbidities without T2D	68	3,400
CagriSema	REDEFINE 2	Efficacy and safety of CagriSema vs placebo	Adults with T2D and obesity or overweight	68	1,200
CagriSema	REDEFINE 3	Cardiovascular outcomes of CagriSema vs placebo	Adults with CVD with or without T2D	Event-driven	7,000
CagriSema	REDEFINE 4	Efficacy and safety of CagriSema vs tirzepatide 15 mg	Adults with obesity	72	800
Tirzepatide	SURMOUNT-1	Superiority of tirzepatide vs placebo on weight loss	Adults with obesity or overweight without diabetes	72	2,539
Tirzepatide	SURMOUNT-2	Superiority of tirzepatide vs placebo on weight loss	Adults with obesity or overweight with T2D	72	938
Tirzepatide	SURMOUNT-3	Efficacy of tirzepatide as an adjunct to intensive lifestyle intervention	Adults with obesity	72	669
Tirzepatide	SURMOUNT-4	Weight loss maintenance with tirzepatide vs placebo	Adults with obesity	52	783
Tirzepatide	SURMOUNT-5	Superiority of tirzepatide vs Wegovy® (semaglutide 2.4 mg)	Adults with obesity or overweight	72	741
Retatrutide	TRIUMPH	Superiority of retatrutide vs placebo on weight loss	Adults with obesity or overweight
Survodutide	VOLITION	Superiority of survodutide vs placebo on weight loss	Adults with obesity or overweight without diabetes	46	650
Orforglipron	ATTAIN	Superiority of orforglipron vs placebo on weight loss	Adults with obesity or overweight	36	272

Table 4. Clinical Trial Details.

Navigating Choppy Seas: Risks and Opportunities for Novo Nordisk

Despite commanding a leading position in the GLP-1 space, Novo Nordisk faces several challenges that could roil its outlook:

1️⃣ Regulatory Headwinds

FDA Approval of Generic Liraglutide (December 2024) 🗜️
Generic competition will likely squeeze prices and margins.
Medicare Price Negotiations (January 2025) 💵
Wegovy® entering Medicare negotiations adds another layer of pricing pressure.

2️⃣ Market Competition

Tirzepatide’s Sleep Apnea Approval 😴
Lilly’s Zepbound® success in December 2024 in a major comorbidity (sleep apnea) extends its lead.
Limited Diversification 🚨
Novo Nordisk’s heavy reliance on GLP-1 therapies leaves it vulnerable if competitors advance other modalities.

3️⃣ The Patent Cliff Beyond 2032

No Clear Ozempic®/Wegovy® Successor 🧑‍🔬
The pipeline has promising candidates, but no obvious megablockbuster appears ready to replace semaglutide yet.

Wegovy® Patent Expiration ⏳
Losing patent protection could significantly erode market share and revenue after 2032.

4️⃣ Additional Wildcards

Potential US–Denmark Conflict 🇬🇱
Geopolitical tensions, however speculative, can create market uncertainty.

Amycretin’s Subcutaneous Results 💉
Oral formulations lag behind, making the latest data less game-changing than some hoped.

So, Is It Still Worth the Voyage?

Stock Volatility and Lower Multiples (Figure 3) 📉
Novo Nordisk’s share price has plunged ~50% since summer 2024, lowering valuations. These wild fluctuations underscore how difficult it is to extrapolate earnings beyond Wegovy®’s 2032 patent expiration.

Enormous Market 🌍
Over 813 million individuals worldwide are affected by obesity.

Low Penetration 🚀
Only 1 million patients currently use obesity drugs—indicating vast room for growth.

Dueling Giants 🌌
Only Lilly and Novo Nordisk have approved GLP-1 obesity therapies, and both are far ahead of competitors in development and market presence.

Yes, Novo Nordisk’s near-term prospects may look cloudy: the company faces patent cliffs, new competition, and regulatory hurdles. But given the scope of the global obesity crisis and Novo’s proven GLP-1 expertise, the waters ahead might still offer lucrative opportunities—if investors are prepared to weather the volatility.

Figure 3. Time series for price to earnings multiple as well as nominator (price) and denominator (earnings per share). The Novo Nordisk stock price has experienced a sharp 50% drop since the summer 2024.

Disclaimer: This post is for informational purposes only and does not constitute financial advice.

Will regional banks survive and thrive after the 2023 banking crisis?

Introduction

The 2023 banking crisis has led to the collapse of some prominent regional banks, raising concerns about the future of this sector. This post will explore the reasons behind the collapse of Silicon Valley Bank ($SIVB), Signature Bank ($SBNY), and First Republic Bank ($FRC), and analyze whether other regional banks such as Pacific Western ($PACW) and Western Alliance ($WAL) are at risk.

The Collapse of Silicon Valley Bank, Signature Bank, and First Republic Bank

Silicon Valley Bank ($SIVB) collapsed in March as part of the 2023 banking crisis due to the overweight of held-to-maturity securities on its balance sheet and a withdrawal of deposits not insured by the Federal Deposit Insurance Corporation (FDIC).

Figure 1. $SIVB non-realized losses on held-to-maturity securities.

Figure 2. Ratio between unrecognized losses on HTM securities and cash equivalents for selected regional banks.

Silicon Valley Bank was acquired by First Citizens Bank ($FCNCA). Signature Bank ($SBNY) quickly followed suit for the same reason and was acquired by New York Community Bank ($NYCB). And just a week ago the majority of assets of First Republic Bank ($FRC) were acquired by JPMorgan ($JPM).

Figure 3. First Citizens Bank transaction overview following acquisition of parts of Silicon Valley Bank.

Figure 4. New York City Bank transaction overview following acquisition of parts of Signature Bank.

Figure 5. JPMorgan transaction overview following acquisition of parts of First Republic Bank.

All three collapsed banks were components of the S&P 500 and large in terms of asset size.

Figure 6. Asset size and development of selected regional banks as a time series.

Leading up to the collapse and in the aftermath the share price of many regional local banks has also suffered.

Figure 7. Development of share price of selected regional banks as a time series.

Does that mean all regional banks are poor investments? And are banks such as Pacific West ($PACW) and Western Alliance ($WAL) particularly vulnerable? Both banks this week had to deny rumors about their imminent sale.

The Financial Times’ report today that Western Alliance is considering a potential sale of all or part of its business is categorically false in all respects. There is not a single element of the article that is true. Western Alliance is not exploring a sale, nor has it hired an advisor to explore strategic options.It is shameful and irresponsible that the Financial Times has allowed itself to be used as an instrument of short sellers and as a conduit for spreading false narratives about a financially sound and profitable bank.We are considering all of our legal options in response to today’s article.
Western Alliance press release from May 4th

The bank has not experienced out-of-the-ordinary deposit flows following the sale of First Republic Bank and other news. Core customer deposits have increased since March 31, 2023, with total deposits totaling $28 billion as of May 2, 2023 with insured deposits totaling 75% vs. 71% at quarter end and 73% as of April 24, 2023. In addition, the company recently paid down $1 billion of borrowings with our excess liquidity. Our cash and available liquidity remains solid and exceeded our uninsured deposits, representing 188% as of May 2, 2023.
Pacific West press release from May 3rd

And since the end of 2022 both banks have increased their proportion of insured deposits (both to 73%) and increased their uninsured deposit liquidity coverage ($WAL to 158% and $PACW to 180%). And since March 20th both banks have actually seen deposits increase despite a further reduction in uninsured deposits.

Figure 8. Slide from the Western Alliance earnings call on April 19th.

Figure 9. Slide from the PacWest earnings call on April 25th.

Furthermore it is unlikely that the FED will increase interest rates aggressively from here and add further press to the fair value of HTM securities.

If no solution is found to the debt ceiling issue, then all bets are off the table. But otherwise based on all of the above I find it unlikely that $PACW and $WAL will collapse the same way their share price has. I also find it unlikely they will be acquired at their current low prices. But whether they will thrive going forward is less certain, as there has been some reshuffling and sales of assets. And congress might impose legislation upon the banks following the recent failures.

Jamie Dimon likewise predicted no further banks will collapse. Below quotes from the May 1st conference call following the acquisition of First Republic Bank.

Well, no crystal ball is perfect. But, yes, I think the banking system is very stable. You guys have reported already on tons of regional banks who actually had good results, very modest outflow. A lot of the deposit outflow was because of quantitative tightening, it wasn’t because people are having runs.
There are only so many banks offsides this way and I think this is – there may be another smaller one, but this pretty much resolves them all. But this part of the crisis is over. That does not – down the road, there are rates going way up, real estate, recession – that’s a whole different issue, but for now, everyone should just take a deep breath.
I was reading all the regional bank reports from you and some of the analysts out there. They’re all mostly – some of the banks are down 2% or 3% – a lot had to do with QT. They were not having runs. The runs were really limited to the people who had too big uninsured deposits and money that can move very quickly and stuff like that. So, yeah, I think that’s over. And obviously, there’s always future issues, but I think that’s mostly over.
Jamie Dimon – May 1st on conference call following the acquisition of the remnants of First Republic Bank by JPMorgan.

Warren Buffett has perhaps expressed the sentiment amongst investors towards banking the best.

I don’t like the banking business as much as I did before.
Warren Buffett – April 12th 2023 on CNBC after selling the majority of the shares of BNY Mellon ($BK) and US Bancorp ($USB) in the third and fourth quarter of 2022 previously held by Berkshire Hathaway.

2023-04-12 CNBC – Warren Buffett on banking crisis fallout and why he sold most of his bank stocks except one

Conclusion

Based on the analysis, it does not seem very likely to me that regional banks like $PACW and $WAL will collapse or be acquired at their current low prices. However, their future performance remains uncertain as they face challenges such as potential legislation and market changes. The 2023 banking crisis has undoubtedly shaken investor confidence in the banking sector, as Warren Buffett’s recent comments reflect.

What happens next following FDA approval of Mounjaro® from Eli Lilly for diabetes?

The FDA on May 13th approved the dual GIP-GLP1-agonist Mounjaro® (tirzepatide) from Eli Lilly for diabetes following the completion of the SURPASS studies (e.g. SURPASS-2 NCT03987919).

Mounjaro® is administered as a weekly injection just like the GLP1-agonist Ozempic® (semaglutide) from Novo Nordisk for diabetes. The table below summarizes products from Eli Lilly and Novo Nordisk that have already been granted FDA approval or candidates still in the drug pipeline.

Semaglutide from Novo Nordisk has also been approved for obesity (Wegovy®) and an oral formulation for diabetes (Rybelsus®).

Company	Drug	FDA approval	Administration	Indication
Novo Nordisk	Ozempic®	2017	Weekly Injection	Diabetes
Eli Lilly	Mounjaro®	2022	Weekly Injection	Diabetes
Novo Nordisk	Wegovy®	2021	Weekly Injection	Obesity
Eli Lilly	Tirzepatide	Phase 3	Weekly Injection	Obesity
Novo Nordisk	Rybelsus®	2019	Daily Oral	Diabetes
Novo Nordisk	Semaglutide	Phase 3	Daily Oral	Obesity
Novo Nordisk	Insulin Icodec	Phase 3	Weekly Injection	Diabetes
Novo Nordisk	IcoSema	Phase 3	Weekly Injection	Diabetes
Eli Lilly	Trulicity®	2014	Weekly Injection	Diabetes
Novo Nordisk	Victoza®	2010	Daily Injection	Diabetes
Novo Nordisk	Saxenda®	2014	Daily Injection	Obesity

Selected FDA approved products and drug candidates in phase 3 for the treatment of either type 2 diabetes or obesity.

Phase 3

Eli Lilly has injected Tirzepatide for obesity in phase 3 (e.g. SURMOUNT-1 NCT04184622) and Novo Nordisk has oral Semaglutide for obesity in phase 3 (OASIS-1 NCT05035095).

Novo Nordisk had the long acting once-daily insulin Tresiba® approved in 2015 and now has the long acting once-weekly Insulin Icodec in phase 3. Novo Nordisk also has a combination drug of Semaglutide and Insulin Icodec – IcoSema – in phase 3; comparison with Insulin Icodec (COMBINE-1 NCT05352815), Semaglutide (COMBINE-1 NCT05259033) and Insulin Glargine + Insulin Aspart (COMBINE-3 NCT05013229).

Phase 2

Both companies have various candidates in phase 2 for the treatment of type 2 diabetes and obesity:

Eli Lilly – LY3437943 GGG (GIP/GLP-1/Glucagon) Tri-Agonist for the treatment of diabetes (NCT04867785) and obesity (NCT04881760).

Eli Lilly – LY3502970 (GLP-1 Receptor Non-peptide Agonist) for diabetes (NCT05048719) and obesity (NCT05051579).

Novo Nordisk – FDC Sema – OW GIP – A combination of semaglutide and novel GIP (NNC0480-0389?) intended for once-weekly treatment of diabetes – NCT05144984

Novo Nordisk – CagriSema in T2D – A combination of amylin analogue cagrilintide and GLP-1 analogue semaglutide intended for once-weekly treatment of diabetes – NCT04982575

Novo Nordisk – PYY 1875 – A novel analogue of the appetite-regulating hormone, PYY (NNC0165-1875), intended for once-weekly treatment of obesity – NCT04969939

Conclusions

The FDA will likely grant approval to Eli Lilly of injected Tirzepatide for obesity and to Novo Nordisk of oral Semaglutide for obesity, so the big difference between Novo Nordisk and Eli Lilly in the GLP-1 space going forward is that Novo Nordisk will be able to offer tablets, and Eli Lilly will only be able to offer subcutaneous administration. Going forward Novo Nordisk continues to look like the stronger competitor in both the diabetes and obesity arena, despite Eli Lilly securing FDA approval of Mounjaro® and also having SGLT2 and DPP4 anti-diabetic products.

Revenue from different GLP1 drugs in different geographies.

Revenue from different diabetes drug classes in different geographies across companies.

Novo Nordisk 2021Q3 – Wegovy® bottlenecks

Novo Nordisk continues to succeed in the GLP-1 space with semaglutide (Ozempic®, Rybelsus® and Wegovy®).

Highlights of the quarter include initiation of phase 3a trials with oral semaglutide in obesity and ziltivekimab in cardiovascular disease. Novo Nordisk now has late stage clinical trials in all of their therapy areas.

Highlights of the third quarter and the first nine months of 2021

Ozempic® continues to be one of the fastest growing drugs in the world. It was approved in China in May 2021, but is still outsold by Victoza® there, whereas it is the best selling GLP-1 for Novo Nordisk in all other markets.

Rybelsus® was approved in the EU in April 2020, but it is yet to pick up momentum there. Sales in the US have reached DKK 1,199 (USD 189M).

Wegovy® has experienced an excellent launch with ~17k prescriptions 19 weeks after launch. There are currently production bottlenecks. The CEO hopes for supply to catch up with demand by early 2022. The CEO encourages competition to grow the obesity category. Reported sales are currently lumped together with Saxenda®, but a sales breakdown will be made in 2022 according to the CEO. The STEP5 clinical trial results were released, in which Wegovy® demonstrated significant and sustained weight loss in two-year study in adults with obesity.

Tresiba® is growing in all markets except the US. The growth is happening at the expense of Levemir®. Looking at the US implosion of insulin sales this might lead one to question, whether there is a particularly bright future for glucose sensitive insulin (phase 1) and once-weekly insulin icodec (phase 3a).

Pipeline

With initiation of two phase 3 programs within obesity and other serious chronic diseases, Novo Nordisk now has ongoing late-stage clinical trials within all of its therapy areas. The new phase 3 trials are the OASIS I trial (NCT05035095) for oral semaglutide in obesity and the ZEUS trial (NCT05021835) for Ziltivekimab.

Ziltivekimab

Novo Nordisk acquired Ziltivekimab from Corvidia Therapeutics in 2020 to expand their presence in cardiovascular disease.

The ZEUS clinical trial (NCT05021835) is a research study to look at how Ziltivekimab works compared to placebo in people with cardiovascular disease, chronic kidney disease and inflammation.The study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease (CVD), chronic kidney disease (CKD) and inflammation.

It follows the completion of the phase 2 RESCUE trial. The aim is to have at least one CVD product approved and launched between 2024 and 2028.

Oral semaglutide in obesity

The OASIS I trial (NCT05035095) investigates oral semaglutide in terms of weight loss in overweight individuals. The trial has an estimated completion date in H1 2023 just like the SURMOUNT-4 study (NCT04660643) of Tirzepatide in obesity from Eli Lilly. Semaglutide would be the first oral GLP1 in obesity.

Competition

Jardiance® from Boehringer Ingelheim and Eli Lilly is the best selling SGLT2 drug and has recently shown consistent cardio-renal benefits in adults with heart failure.

Tirzepatide from Eli Lilly was shown in March in the SURPASS-2 study (NCT03987919) to achieve superior A1C and body weight reductions compared to injectable semaglutide in adults with type 2 diabetes. FDA and EMA approval and launch is expected in 2022. A priority review is expected 8 months after submissions.

Danuglipron (PF-06882961) in type 2 diabetes is a small molecule drug (SMD) and GLP1 receptor agonist. It is being developed by Pfizer and phase 1 results have been published.

Links

Transcript at fool.com.

Blog post on previous quarter.

Reuters summary of the quarter.

Appendix

Sales of anti-diabetic drugs by geography for Novo Nordisk

Trailing twelve months sales of anti-diabetic drugs by Novo Nordisk.

Sales of anti-diabetic drugs across companies

Trailing twelve months sales of anti-diabetic drugs by geography across a subset of companies.

Sales of anti-diabetic drugs by class

Nov Nordisk trailing twelve months sales of anti-diabetic drugs by drug class.

Trailing twelve months sales of anti-diabetic drugs by drug class across a set of companies.

Sales of anti-diabetic drugs by company

Sales of drugs for Novo Nordisk

Sales of best selling anti-diabetic drugs across companies

Sales of anti-diabetic and anti-obesity GLP1 by drug across companies

Trailing twelve months sales of GLP1 by drug.

Sales of anti-diabetic and anti-obesity GLP1 drugs by company

Trailing twelve months sales of GLP1 by company.

Sales of insulin by drug across companies

Trailing twelve months sales of insulin by drug.

Sales of insulin by company

Novo Nordisk Q2 saw approval of Wegovy® and continued growth of Ozempic® sales

Novo Nordisk sales and operating profit grew at 12% and 9%, respectively, at constant exchange rates. The FDA approved the once-weekly injectable anti-obesity drug Wegovy® (semaglutide) on June 4th.

The figures below summarize the global sales for Novo Nordisk by geography, by drug and by drug class. All geographic markets have experienced growth, but Victoza® and Levemir® have curbed growth in the US.

Within the injectable GLP1 class Ozempic® sales continue to grow at the expense of Victoza®. Within the insulin class Tresiba® sales continue to grow at the expense of Levemir®, although it is less pronounced than within the GLP1 class.

Novo Nordisk can attribute the majority of its growth to the GLP1 class.

Diabetes

The global GLP1 market share has increased from 49.1% to 51.5% led by Ozempic® in all markets, whereas the insulin market share has decreased from 44.6% to 43.9%.

Novo Nordisk and Eli Lilly continue to see growth thanks to the GLP1 class (Ozempic® and Trulicity®), whereas sales of Januvia® at Merck and Lantus® at Sanofi is deteriorating.

An old pencil drawing of Don Quixote and Sancho Panza sitting on their horses, by Wilhelm Marstrand.

Obesity

The FDA approved Wegovy® – once-weekly injectable semaglutide – on June 4th. Wegovy added more than 8,000 prescriptions within the first five weeks; it took Saxenda® (once-daily injectable liraglutide) 4 years to achieve the same. The STEP trials showed semaglutide to be superior to liraglutide in terms of weight loss. Wegovy® might cannibalize Saxenda®. However, 50% of Wegovy® prescriptions (TRx) are new to the anti obesity medication class in the US.

Final Remarks

Novo Nordisk is not cheap at a forward P/E of 30. And the current share price does probably not offer the best entry point, but it’s worth remembering that Novo Nordisk has various moats and advantages. It is protected by high barriers to entry for biosimilars, has a long history of organic growth, has a focused approach with diabetes, obesity and cardiovascular diseases, has low costs and has little debt to name just a few.

Novo Nordisk gains GLP-1 market share within and outside the US despite seeing new GLP-1 prescriptions curbed by COVID-19

Novo Nordisk has gained market share in diabetes (29.2%), GLP-1 (49.9%) and insulin (44.5%).

The gain in market share has happened with a change in market value in the US as a backdrop; i.e. GLP-1 up and insulin down. As a consequence approximately 70% of sales in the US did not exist 5 years ago.

Diabetes and GLP-1

In the US Novo Nordisk GLP1s command a 60.2% NBRx and 49.6% TRx market share, which is driven by Ozempic® (once weekly injected semaglutide) and Rybelsus® (oral semaglutide).

GLP-1 NBRx and TRx market share in the US.

The uptake of Rybelsus® has however been curbed by COVID-19, but market access in the US is now approximately 85%.

In a similar fashion sales of Trulicity® have increased by 9% but it has lost market share as a proportion of both prescriptions and market value.

Ozempic® might face competition from Tirzepatide in the future.

Eli Lilly Tirzepatide pipeline (part 1 of 2).

Eli Lilly Tirzepatide pipeline (part 2 of 2).

Diabetes and insulin

As already mentioned insulin is deteriorating rapidly in the US, which is thanks to biosimilars such as Basaglar® and Admelog®.

Insulin icodec phase 3 clinical trial results might be available in the second half of 2021.

The glucose sensitive insulin NN1845 has been added to phase 1.

Obesity

The uptake of Saxenda® has been put on hold by COVID-19 as demonstrated by the reduction in new prescriptions and sales.

A decision on injected semaglutide for obesity is expected in Q4 or Q1. Getting oral semaglutide approved for obesity would be the next logical step. Eli Lilly is expecting their phase 3 primary endpoint results on Tirzepatide for obesity in June 2022.

Visualization of growth in the COVID-19 impacted quarters

The first and second quarter of 2020 were unusual in many ways. More than a third of S&P500 companies temporarily or permanently withdrew guidance for the full year due to uncertainty surrounding impacts from COVID-19 according to FactSet. This article seeks to visualize the growth in each of the two quarters by sector and industry.

The bubble plot below shows the growth in Q1 on the x-axis and Q2 on the y-axis for selected sectors, industries and companies of the S&P 500 and the Russell 3000. The marker sizes represent market capitalization. The colors represent sectors.

Bubble plot of growth in Q1 and Q2 for the S&P 500.

Bubble plot of growth in Q1 and Q2 for the Russell 3000.

Some companies are outliers and are not displayed in the bubble charts. Instead a time series of their revenue is plotted below. Zillow ($ZG) is one of these outliers. In Q1 revenue increased by 148% due to Zillow Offers growing 499%. Vertex ($VRTX) had Trikafta® approved in October 2019 and it is currently one of the fastest growing drugs. Beyond Meat ($BYND) grew by triple digits in Q1. Beyond Meat ($BYND) grew by triple digits in Q1 and is an outlier.

Time series of revenue at companies with revenue growth falling outside the visible ranges of the bubble plots.

Basic Materials

In Basic Materials the copper miner Freeport McMoran ($FCX) experienced a slump. The copper price has since rebounded by 50% from $2 to $3 per pound.

Communication Services

COVID-19 did not affect all entertainment companies. The concerts of Live Nation ($LYV), the Grands Prix of Formula One ($FWONA) and the theme parks of Disney ($DIS) were affected, whereas streaming services such as Netflix ($NFLX) and Spotify ($SPOT) and gaming thrived. The real estate service Zillow ($ZG) grew by triple digits in Q1 and is an outlier.

Time series of revenue in the entertainment industry.

Consumer Cyclical

The Consumer Cyclical sector saw some big shifts within and between industries in Q1 and Q2.

Some of the industries most impacted by COVID-19 were Casinos & Resorts – e.g. Las Vegas Sands ($LVS), Wynn Resorts ($WYNN), MGM Resorts ($MGM), Caesars Entertainment ($CZR) – Travel Services – e.g. Booking ($BKNG), Expedia ($EXPE), TripAdvisor ($TRIP) – Cruise Lines – e.g. Royal Caribbean ($RCL), Norwegian Cruise Line ($NCLH), Carnival ($CCL) – Hotels – e.g. Hilton ($HLT), Hyatt ($H), Marriott ($MAR).

Time series of revenue in the hotel industry.

Time series of revenue in the casino industry.

Retail

The internet retailer Overstock ($OSTK) experienced triple digit growth in Q2. Amazon ($AMZN) continued its growth trajectory in Q1 and Q2.

The retailer Dick’s Sporting Goods ($DKS) is predominantly brick and mortar, but it saw triple digit online growth in Q2. Other retailers that saw growth in Q2 include Tractor Supply Company ($TSCO) and the home improvement retailers Lowe’s ($LOW) and Home Depot ($HD).

Residential Construction

Residential Construction such as Pulte Homes ($PHM) has done well in the previous two quarters, which is probably attributable to the low interest environment and the low mortgage rates. PennyMac Financial Services ($PFSI) and other mortgage finance companies also experienced growth in Q2.

Restaurants

Restaurants not doing deliveries lost revenue. Starbucks ($SBUX) and McDonald’s ($MCD) revenue fell by 38% and 30% respectively in the quarter ended June, whereas Domino’s Pizza ($DPZ) did much better with 16% growth in Q2.

Time series of revenue in the restaurant industry.

Auto and RV manufacturers

The auto manufacturer Tesla ($TSLA) experienced a halted revenue growth in Q2. The US, German and Japanese auto manufacturers such as Ford ($F), GM ($GM), Fiat Chrysler ($FCAU), Toyota ($7203.T), Volkswagen ($VOW.DE), Daimler ($DAI.DE) and BMW ($BMW.DE) have experienced a slump in Q2, which quickly manifested itself in railroad volumes, which are again returning to normal.

Time series of revenue for US and other auto manufacturers.

EV registrations in Europe were up 131% YoY in July, but Tesla unit sales imploded by 76% YoY in Europe in July.

Time series of Tesla automotive revenue per geographic segment.

RV manufacturers such as Winnebago ($WGO) and Thor Industries ($THO) did not see a contraction of revenue like the auto manufacturers.

Time series of revenue for recreational vehicles.

Consumer Defensive

In Consumer Defensive the bleach boom lifted sales at Clorox ($CLX). The companies Chegg and 2U operating in the industry Education & Training Services outpaced all other companies.

Lockdowns of on-site premises have affected the breweries. Despite this the brewer Boston Beer ($SAM) saw its sales increasing in Q2 and not only due to the acquisition of Dogfish Head.

In retail grocery stores such as Kroger ($KR) and discount stores such as Walmart ($WMT) experienced growth in both Q1 and Q2. The discount store Dollar General ($DG) grew the fastest and experienced comparable sales growth of 21.5% in May, 17.9% in June and 17.2% in July.

Time series of revenue for grocery stores and discount stores.

Energy

The plunge in oil prices affected Oil & Gas that coincided with the outbreak of COVID-19 and the oil price war between Russia and Saudi Arabia. In Energy most Oil & Gas companies took a severe beating, when oil futures briefly went to single digits in mid April. Q2 revenue at Exxon Mobil and Chevron dropped by more than 50%. Exxon Mobil leaves the Dow Jones Industrial Average at the end of August. Exploration & Production and Refining & Marketing was in general more affected than Midstream and Equipment & Services.

Financial Services

Financial Services was a mixed bag. COVID-19 affected credit card companies such as Visa ($V), Mastercard ($MA) and American Express ($AXP). On the contrary PayPal ($PYPL) continued its growth trajectory. The increased trading had a positive effect on exchanges ($CBOE, $NDAQ, $ICE). Morgan Stanley ($MS) and Goldman Sachs ($GS) both experienced negative growth in Q1 but positive growth in Q2 as did the low cost broker Interactive Brokers ($IBKR) and JP Morgan ($JPM).

Increased commission fees drove the growth at Interactive Brokers.

Healthcare

In Healthcare the companies Moderna ($MRNA), Translate Bio ($TBIO), Novavax ($NVAX) doing COVID-19 vaccine research saw triple- and quadruple-digit growth in Q2 due to government grants and collaborations with big pharma and they have thus been excluded. Due to new collaborative agreements the outliers Assembly Biosciences ($ASMB) and ChemoCentryx ($CCXI) have also been excluded. Qiagen ($QGEN), which nixed their merger agreement with ThermoFisher ($TMO), experienced growth due to COVID-19 testing. No healthcare company experienced as much revenue growth in Q2 as Teladoc Health ($TDOC), which was already growing at a steady rate just like Dexcom ($DXCM) and Tandem Diabetes Care ($TNDM), which both operate in the diabetes field. Other fast growers are Twist Bioscience ($TWST), NovoCure ($NVCR), CareDx ($CDNA) and Veeva Systems ($VEEV).

Industrials

Lots of industrial companies have been affected by COVID-19, but none as much as the airlines ($LUV, $AAL, $UAL, $DAL, $JBLU, etc.) and the aviation industry; e.g. Boeing ($BA), General Electric ($GE), Spirit AeroSystems ($SPR), etc.

Time series of revenue in the airline industry.

The railroads experienced a steep decline in traffic in Q2, but weekly volumes have recovered significantly since then.

Time series of revenue in the railroad industry.

Railroad revenue shrank due to auto volumes.

Time series of CSX revenue from products and services.

Real Estate

In Real Estate the Hotel & Motel REITs ($APLE, $HST, $RHP, $PK) have seen revenue declines of nearly 100% in Q2. The retail REITs have seen their revenue decline in Q2 due to some tenants being unwilling to pay the rent and others going bankrupt. The merger between the retail REITs Simon Property Group ($SPG) and Taubman Centers ($TCO) was cancelled.

Technology

In Technology Microsoft ($MSFT) was one of many software companies growing in Q1 and Q2. The semiconductor companies Intel ($INTC), KLA Corp ($KLAC), AMD ($AMD), Teradyne ($TER) all experienced positive revenue growth in Q1 and Q2 despite some of them having murky clouds ahead of them. The ride sharing services Uber ($UBER) and ($LYFT) saw their revenue plummeting in Q1 and Q2. Uber experienced less of a decline due to deliveries with Uber Eats.

Utilities

In Utilities the water utilities ($AWK, $AWR, $CWT) have been less affected than the gas utilities.

Notes

More than 90% of all Russell 3000 companies have now reported a full quarter impacted by COVID-19; whether it’s from March to May – e.g. General Mills ($GIS) and Adobe ($ADBE) – April to June (i.e. most companies) or May to July – e.g. Walmart ($WMT) that reported on August 18th. Broadcom ($AVGO), Campbell Soup ($CPB) and Cooper Companies ($COO) will report for the fiscal quarter ended at the end of July on September 3rd. The figures will be updated accordingly.

The data is obviously backward looking, but data are available on a more current basis (e.g. weekly and monthly) for discount stores (e.g. Costco), railroads (e.g. reports from Association of American Railroads and Surface Transportation Board), auto manufacturers, etc.

Some companies such as industrials might have had large backlogs and will only have their revenue affected in upcoming quarters. It’s more relevant to look at guidance and outlook for the future in these cases.

Acquisitions and divestitures

The displayed growth is the non-organic GAAP growth. Significant acquisitions and divestitures within the past six quarters disqualified companies from inclusion. Some of these are Bristol-Myers ($BMY) acquiring Celgene ($CELG), AbbVie ($ABBV) acquiring Allergan ($AGN), Occidential ($OXY) acquiring Anadarko ($APC), FIS ($FIS) acquiring Worldpay ($WP), Fiserv ($FISV) acquiring First Data ($FDC), Wabtec $(WAB) acquiring GE Transportation, Transdigm ($TDG) acquiring Esterline ($ESL), Walt Disney ($DIS) acquiring 21st Century Fox by Disney, Truist ($TFC) after merger between BB&T ($BBT) and SunTrust Banks ($STI), ViacomCBS ($VIAC) after merger between Viacom and CBS. The gold miner Newmont Mining ($NEM) is excluded, because it acquired the Peñasquito gold mine in Mexico from Goldcorp in April 2009. DowDuPont ($DWDP) spun of Corteva ($CTVA) and DuPont ($DD) in 2019 and was renamed Dow Chemical ($DOW) and neither of these companies are displayed. NortonLifeLock ($NLOK) sold Symantec to Broadcom. VF Corp ($VFC) divested Kantoor Brands ($KTB).

Shareholder dilution

Not all growth creates value and in some cases growth is actually negative when adjusted for shareholder dilution. The table below summarizes the shareholder dilution and revenue growth YoY for Q2.

	Dilution (%)	Growth (%)
CVNA	43.5	13.4
W	30.4	83.7
TSLA	16.9	-4.9
MRNA	15.8	407.7
CRM	15.1	30.2
RNG	14.6	29.3
AMD	10.6	26.2
TWLO	10.1	45.8
OKTA	8.8	46.4
NOW	7.5	28.4
ROKU	7.0	42.4
COUP	6.6	46.9
DOCU	6.4	38.8
WDAY	4.5	23.4
SQ	4.0	63.9
SPOT	3.9	13.3

YoY Q2 shareholder dilution and revenue growth.

Best selling and fastest growing drugs in the 2nd quarter of 2020

Best selling drugs

Once more Humira® from AbbVie is the best selling drug of the quarter ($4,837M) despite headwinds in Europe from biosimilars Amgevita®, Amsparity®, Halimatoz®, Hefiya®, Hulio®, Hyrimoz®, Idacio® and Imraldi®. In the US Humira® will in 2023 lose market exclusivity to the biosimilars Amjevita®, Cyltezo®, Hyrimoz®, Hadlima®, Abrilada® and Hulio®. AbbVie upon acquisition of Allergan has become less dependent on the patent expiration of Humira®.

Keytruda® from Merck continues to receive FDA approvals and could perhaps be the best selling drug in the world before the end of next year.

Quarterly sales of best selling drugs (USDm).

The best selling antidiabetic and antiviral drug is still the GLP1 receptor agonist Trulicity® (dulaglutide) from Eli Lilly and Biktarvy® from Gilead Sciences, respectively. The combined sales of the GLP1 receptor agonists Ozempic® (once weekly subcutaneous semaglutide) and Victoza® (once daily subcutaneous liraglutide) from Novo Nordisk however exceed that of Trulicity®.

Biktarvy® is currently the best selling oral drug ($1604M). In the future it could perhaps be the antidiabetic drug Rybelsus® (semaglutide) from Novo Nordisk. The antidiabetic drugs Januvia® and Janumet® from Merck reached combined annual peak sales of approximately $6B. The GLP1 receptor agonist semaglutide is a peptide, but it is available as a tablet (Rybelsus®) thanks to advances in oral peptide therapeutics.

Below the best selling drugs are visualized by company and by therapeutic area and vice versa.

Visualization of sales per drug in 2020Q2 grouped and colored by therapeutic area.

Visualization of sales per pharmaceutical company in 2020Q2 grouped and colored by therapeutic area.

Visualization of sales per drug in 2020Q2 grouped and colored by company.

Visualization of sales per therapeutic area in 2020Q2 grouped and colored by company.

Fastest growing drugs

The fastest growing drug value wise is the triple combination drug Trikafta®/Kaftrio® (ivacaftor+tezacaftor+elexacaftor) from Vertex Pharmaceuticals for the treatment of cystic fibrosis, which was approved by the FDA less than a year ago and by the EMA less than three months ago, followed by Keytruda® from Merck, Biktarvy® from Gilead Sciences, Dupixent® from Sanofi and Ozempic® from Novo Nordisk.

Ozempic® is the fastest growing drug percentage wise (~108%) followed by Venclexta® from AbbVie (~79%) and Dupixent® (~71%).

The details on semaglutide as a subcutaneous (Ozempic®) and oral (Rybelus®) antidiabetic drug and the clinical trials as an antiobesity drug are covered in different blog posts on Novo Nordisk.

Novo Nordisk grows GLP-1 market share in Q2 in the US with Ozempic® and Rybelsus®

Novo Nordisk has reported their 2nd quarter results.

Financials

For the 2nd quarter sales were DKKm 30,006 (-0%), gross profit was DKKm 25,234 and operating income was DKKm 13,838 (+3%).

In the US GLP1 for diabetes increased by 19%, whereas insulin decreased by 34%.

CEO Lars Fruergaard Jørgensen
“The U.S. sales decline was driven by lower realized prices due to an unfavorable channel mix, rebate enhancements, the launch of additional affordability programs and changes in coverage gap legislation.”

Sales of Ozempic® increased in the US and EMEA, whereas sales of Levemir® and Victoza® decreased in the US.

Diabetes – GLP1s – Ozempic® and Victoza®

In the US once-weekly injected GLP-1 Ozempic® grew (93%) at the expense of once-daily Victoza® (-34%). In EMEA sales of Ozempic® increased by more than 200% to DKKm 604. Sales of Ozempic® were registered for the first time in China, where Victoza® currently has more than of 90% of the GLP-1 market share by value.

Insulins – Levemir® and Tresiba®

In the US the insulins Levemir® (-57%) and Tresiba® experienced negative growth of -57% and -37%, respectively. Sales of Levemir® decreased by approximately 20% in EMEA.

Diabetes – GLP1 – Rybelsus®

Rybelsus® (oral semaglutide) was approved for the treatment of adults with type 2 diabetes in the US on September 20th, 2019, in the EU on April 4th, 2020 and in Japan on June 29th, 2020. Sales have not yet exceeded $100M.

Obesity – GLP1 – Saxenda®

Novo Nordisk thanks to Saxenda® has a market share of 60.5% of the global obesity prescription drug market. Saxenda® was impacted by fewer patients initiating treatment due to COVID-19. New guidelines in Canada are the first to recognize obesity as a chronic illness, which if followed by the US and others could grow the market value significantly; a market which Novo Nordisk expects to at least double.

CEO Lars Fruergaard Jørgensen
Sales growth was negatively impacted by fewer patients initiating treatment due to COVID-19. Our strategic aspiration is to move to more than is to more than double sales in obesity by 2025. In support of that, Saxenda has been launched in 48 countries globally, and we continue to invest in market development activities.

Hemophilia – NovoSeven® and NovoEight®

The market share in hemophilia is mostly decreasing due to the growth of Hemlibra® from Roche rather than the decline of NovoSeven® and NovoEight®.

CEO Lars Fruergaard Jørgensen
For hemophilia, the declining sales of 1% were driven by lower NovoSeven sales, partly reflecting reduced elective surgeries and bleedings due to lockdowns, but partly offset by the continued global rollout of the new products, Refixia and Esperoct.

Pipeline

Obesity – Semaglutide

In May and June the weight loss results from the previously discussed STEP1, STEP2, STEP3 and STEP4 phase 3 trials on injected semaglutide for obesity were released. Injected semaglutide for obesity could happen in 2021. The SELECT trial (NCT03574597) regarding cardiovascular outcomes is estimated to be completed by 2023.

The SUSTAIN FORTE study (NCT03989232) compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D) and results are expected in Q4.

CSO Mads Krogsgaard Thomsen
So I can say with the confidence that the SUSTAIN FORTE trial, in my mind, will show a very powerful lowering both of glucose and body weight.

Obesity – AM833 and AM833+semaglutide

On June 18th Novo Nordisk reported on the completion of the AM833 phase 2 trial and the AM833+semaglutide phase 1 trial. The weight loss with the peptide AM833 exceeds that of liraglutide. The weight loss with AM833+semaglutide exceeds that of semaglutide alone.

Novo Nordisk has discontinued trials on their co-agonist and tri-agonist.

Novo Nordisk CSO Mads Krogsgaard Thomsen
Regarding some other GLP-1-related clinical obesity projects we’ve been pursuing, namely, the coagonist and tri-agonist projects, we’ve decided to terminate both projects. This decision is based on the strong obesity data obtained for semaglutide and AM833 that, in aggregate, have raised the innovation bar for future Novo Nordisk obesity care and we’ve, therefore, prioritized our resources accordingly to achieve the best possible patient outcomes and product benefit risk profile.

This follows the discontinuation of the oral GLP-1 analogue OG2023SC in 2019Q3 because of better oral formulations of semaglutide. At Eli Lilly the dual GIP/GLP1 agonist Tirzepatide is in phase 3 (diabetes and obesity) and phase 2 (NASH). The phase 3 tirzepatide cardiovascular outcome study SURPASS-CVOT has been initiated.

Tirzepatide was mentioned on both the Novo Nordisk and Eli Lilly earnings calls.

Eli Lilly SVP Michael B. Mason
For tirzepatide, we’re glad to see that you were wowed by our type our Phase II data in for patients living with type two diabetes. I think the best thing really to do is to go back and take a look at the Phase II clinical studies. I mean we saw at the 15-milligram dose up to 2.4% A1c reduction and weight loss up to 12.7% versus placebo in just six months of study. So we’re excited to see how tirzepatide can perform in this patient population and longer studies in Phase III. There’s nothing to tell us that we won’t see exciting data coming out of the Phase III. We don’t have any new information that suggests otherwise. So we are incredibly confident about tirzepatide, not only in type two diabetes, but also we’re excited to see its potential in NASH and obesity. So our enthusiasm remains very, very high.

Novo Nordisk CSO Mads Krogsgaard Thomsen
Obviously, tirzepatide being a GLP-1/GIP agonist will, in my mind, based on data we’ve seen so far, unlike the combination of AM833 and sema, which is an amylin analogue and a GLP-1 analogue, there will probably be additivity of the GI side effect profiles of the GIP and the GLP-1 components. At least this is what we have seen both in a trial we’ve conducted ourselves years back with MAR709, our dual-agonist, but also so far in the trial in Phase II and the escalation trials that our colleagues at Eli Lilly have done. But we will see the data late this year and I guess during the course of next year.

Hemophilia A – Mim8 and gene editing

Growth hormone deficiency – Somapacitan

Novo Nordisk thanks to Norditropin® remains the leader in the human growth hormone disorder market with a value market share of 34.2%. Somapacitan has entered phase 3 (REAL4 and REAL5 trials).

Diabetes – Insulin Icodec

The phase 3 trial on once-weekly insulin icodec is expected to start before the end of the year. On June 14th Novo Nordisk reported that once-weekly insulin icodec showed comparable efficacy and safety to once-daily insulin glargine U100 in phase 2 trial.

Acquisitions

On June 11th Novo Nordisk announced the $2.1B acquisition of Corvidia Therapeutics and their lead candidate ziltivekimab, which is a monocloncal antibody targeting IL-6 and reducing cardiovascular events.

This follows the agreements in Q4 of 2019 with Dicerna to discover and develop RNAi therapies for liver-related cardio-metabolic diseases and with bluebird bio to develop in vivo genome editing candidates for hemophilia and other severe genetic diseases.

Appendix

https://twitter.com/MidgardFinance/status/1291266515560538112