1/8 CagriSema data – better than the market reaction This is a longer analyse of the CagriSema Redefine 1 data. Enjoy your reading and please don’t hold your comments back. "I will throughout this analyze try and show what that “extra” potential WL looks like. I also zoom in at one of the most often conclusions I have seen. “Only 57% finished the trial at max dose CagriSema. That means it had seriously tough side effects”. I believe that is both a hasty and wrong conclusion." $NVO $LLY $VKTX $GUBRA $ZEAL @GLP1

$GUBRA had CMD today. First time I have seen WL curve for ABBV-295 12/13w P1b. About 10% WL. Both as once weekly and bi-weekly at 14mg. 8mg monthly still reached 7.9% This with 88% men and BMI29 There’s another P1b ongoing. 20W. Higher share of women, higher BMI, and higher doses than 14mg. Data from that will arrive 1. Half 27. $ABBV already has P2b ongoing. 52w with 360 patients testing multiple different dosing schedules including bi-weekly and monthly. 32w is primary data. That will inform of doses for P3 32w data likely in Q4 27. And then potential P3 start in Q2 28 As mentioned in earlier post today, then ABBV has already planed to test ABBV-295 together with multiple other molecules. So they see great potential in it/amylin. $NVO $VKTX

$ABBV about to start P2 with their P3 molecule Lutekazumab in combination with ABBV-295. Their amylin from $GUBRA. ABBV just last week reported 31% of ⁠patients treated with lutikizumab achieved at least a 75% reduction in inflammatory skin lesions after 16 weeks, compared with 23% of those on placebo. Citi analyst Geoffrey Meacham in a note ahead of the readout said that a more than 15-percentage-point improvement versus placebo ‌would represent a clear win on the main goal. Now they will combine lutikizumab with an amylin in hidradenitis suppurativa, ⁠or acne inversa, a condition marked by small, painful lumps to form under the skin. This is first time I have seen an amylin for this indication. And ABBV have said they will start more trials with ABBV-295 in combination with other molecules as well. Now we start to see why $ABBV and $RHHBY have paid so much for amylins. The upcoming P2 will start by year end. We don’t know how much Gubra will get in milestones. But they got $50 million when P2b was initiated in obesity. I would assume the amount would be lower here finance.yahoo.com/healthcare…

Wegovy HD launched today in Denmark. At a price about $460 More than 100,000 Dane’s is currently on wegovy. Wegovy HD will be launched in more than 30 countries by year end. $LLY $NVO $VKTX

Here’s a good analysis of TRx movements in US GLP1 space. Definitely worth a read $LLY $NVO $VKTX

Ozempic pill NBRx is up 70% since Rybelsus got rebranded to Ozempic pill. $NVO shared these data at CMD. What’s even more interesting is that 60% Of those NBRx have never used GLP1 before….. So here we have people with diabetes, but obviously have not been interested in using an injection through either Ozempic pen or Mounjaro. So by just rebranding Rybelsus to Ozempic pill, many more have learned it’s possible to get an GLP1 in a pill. Weekly TRx have for long time hovered about 50k. That’s now increased to 64k. Or about 30% increase. That’s more than $200 million extra revenue per year. And the best part is that Ozempic 25mg is not even launched yet. Approval is expected late 26 and with launch early 27. I expect to see a big marketing push when 25mg Ozempic pill will be launched. And thereby Ozempic pill will be one of the growth drivers in 2027. TRx 100k in average throughout 2027 will lift NVO revenue about 2%. Mitigate some of the revenue loss from Ozempic pen. NVO already has approval for 25mg and 50mg in T2D in Europe. But currently no official plans for launch. But I will not be surprised if we see launch in a few selected countries. However Rybelsus is still the brand name in Europe for oral T2D semaglutide $LLY $VKTX

WegovAmy - new name for CagriSema? $NVO has per 10/20 got Wegovamy registered as brand name. They filed the brand name 5/20. No direct ties to CagriSema yet. NVO naturally wants to leverage the very strong brand name Wegovy in CagriSema. Last year they also registered Wegovy PLUS. IF possible that would be the name I would use. But FDA might not approve that. The new Wegovamy is a combination of wegovy and Amylin (Cagrilintide being an Amylin) If they go with that name I would write it WegovAmy. NVO has also registered WegovAmy domain. CagriSema approval is expected in December. And we will likely not get the official name until then But WegovAmy is a good guess. Great find @peter_torngren $LLY $VKTX

Portugal will start reimbursing obesity meds (15% of cost ) from Feb 2027. But requirements are very strict for inclusion. Only patients at specialised obesity hospitals can be included. Access to specialized hospital units (EMO): To be referred to specialized hospital obesity units (Equipa Multidisciplinar de Obesidade), patients generally require a BMI ≥ 40, or a BMI ≥ 35 with severe comorbidities (such as type 2 diabetes, hypertension, or severe sleep apnea). So while this obviously is a step in the right direction, then it sounds as a bottleneck with the hospital requirement. 15% reimbursement is also very small. But it sounds as Portuguese health authorities will negotiate overall lover prices for the program $LLY $NVO $VKTX

I see several posts about wegovy pill launch next week in Isreal. I can’t find anywhere that says it’s even approved yet. We have see fast launch in US and UK within 1-2 weeks from approval. But October 28 seems unlikely without any approval yet. More and more Rumours about a wegovy pill launch imminent in several countries. France and Mexico is 💯 Then there’s not yet confirmed launch in Israel, Polen, Denmark, Norway, Italy and Spain. $LLY $NVO $VKTX

Women in 68w CagriSema Redefine 1, lost in average 25% of their body weight vs 3% in placebo. 2,309 women participated in the trial. 2.4mg wegovy reached 19% WL. So Cagrisema in this patient population delivered 6% higher WL than wegovy. And as can be seen CagriSema WL had not plateaued yet by week 68. $NVO presented those data yesterday in a post hoc analysis of R1 data. Further analysis of WL based on menopause status 26.7% wl Pre-menopause 24.8% wl Peri-menopause 23.1% WL Post-menopause 25.6% WL Hormone therapy use While this will not be included in CagriSema label, it’s interesting since 70-75% of wegovy and Zepbound (non diabetic) users are women. NVO warming up for CagriSema launch 1 January or 4 January. $LLY $VKTX

So essentially RFK jr is saying $LLY should just launch Retatrutide and EloraTZP tomorrow….. no need to do clinical trials anymore. Doesn’t matter if it has been proven safety bc people will just import illegal gray market from China. Safe or not safe. And instead of dealing with the illegal then let’s just legalise all peptides. Hes such a clever man that RFK jr dude Now imagine a number of BP and biotech agreed to do a joint write up to the clever clever RFK jr. dude, saying they will not develop and file/launch any new drug in US before things has been normalised. That what is blatantly illegal will also be treated as illegal. That no peptide or other molecule can be legalised without standard proper clinical trials and FDA scrutiny. Enough with this corruption

Finally we start to see actions against all that illegal imported “GLP1’

French $NVO wegovy pill launch is just around the corner. Will launch in 13 days at 2/11. We don’t know the exact price yet. But should be about same price as wegovy pen (€147-195) this would be significantly cheaper than for instance Germany. Theres 10 million living with obesity in France. However neither mounjaro nor wegovy have yet seen the uptake we see in many other countries. For instance there’s about the same number of people on wegovy pen as in Denmark. Even though there’s almost twice as many with obesity in France as the total population in Denmark….. Maybe a pill options could ignite a larger share of French being on active glp1 obesity treatment? Anyway selling in to pharmacies startet a week ago. There’s rumours about that going better than expected. But obviously difficult to quantify that when we don’t know what their expectations were. I still think we will see more launches than only France and Mexico in November. (Mexico could potentially see significant uptake with all halo effects from US launch) I still think Denmark, Norway, Italy and Spain could be next. However I have not heard anything conclusive yet. But IF today’s news out from Polen is not just parallel import of wegovy pill from Germany, then we might see a bit broader launch in November. I am cautious though since that was not the signal from CMD. And I would speculate it’s less likely to see new launches into December. The most expensive months with all Christmas gifts and also the delicious Christmas food. If not launched the first 2-3 weeks of November then my guess would be next wave 4 January. Ohh and then we should also see more wegovy HD launches throughout November. In US alone there’s close to 100,000 on Wegovy HD. Growing every week. And with a run rate about $500 million. $LLY $VKTX

If $NVO Polen will launch wegovy pill this year, that would definitely be a surprise for me. But it could also just be parallel import that we have already seen in Denmark and Sweden. $LLY $VKTX

Wegovy pill just launched in Bahrain. Bahrain is the fifth country that now has launche wegovy pill Small country but high obesity rate. So Mexico was after all not the next market to launch. Mexico and France will launch in two weeks. $LLY $NVO $VKTX gccbusinessnews.com/bahrain-…

This weeks detailed $NVO and GLP1 post of the most important news throughout the week

Even when wegovy pen TRx drops, wegovy HD still fares better More HD launches coming up

Here’s a really good article about how $NVO ended in two years massive headwind. Much of it self inflicted. Since Mike took office they have purposely lowballed guidance. They have already upgraded twice and will do again with Q3 ER. Also the 2026-2030 guidance. $NVO EVP Thilde Hummel Bøgebjerg (head of IT (including AI) and quality. ) gave last week her first interview ever. To the biggest Danish business newspaper Borsen. The theme was AI and how that would transform the company the coming years. She’s asked if AI will mean more layoffs. "We are going to grow so much that we will need the capacity," she says. “We are going to Grow so much”. That’s not exactly the framing from CMD that NVO would only grow at same pace as its peers. 5-6% per year until 2030. Analysts are still significantly underestimating the new capacity coming online and its impact. But NVO needs to deliver. With this bad sentiment it’s hardcore facts that will change the sentiment. And that will not happen overnight $LLY $VKTX

$NVO has started “pre marketing” of CagriSema through awareness campaigns on the benefits of Amylins and the research behind. It’s natural illegal to directly advertise for a yet unapproved medicine. But the medical community as well as consumers already know GLP1 semaglutide. Now NVO has started this awareness campaign on Amylin quite early. Trying to see if they can prepare consumers and thereby get off to a good launch start. Whether or not it will be a strong launch right of the gate will remain to be seen. I think that also will be influenced by what brand name CagriSema will get. NVO would for sure try to incorporate Wegovy brand if allowed. They already have secured Wegovy PLUS brand name. Typically you would see a soft launch the first 4- 6 months when it’s an all new brand name. Bc you need to visit many of the prescribers before starting big advertising campaigns. Prescribers need to learn about the new medicin to fell comfortably writing prescriptions. That’s also the main reason $LLY did not start broad advertising campaigns for Orforglipron until Bridge launched. And thereby one of the reasons Orforglipron had such slow launch compared with wegovy pill that had a very familiar brand name. NVO being NVO they have not included much CagriSema sales in 2027 forecasts (said at CMD) as they did not include any significant wegovy pill revenue. With Wegovy pill sales being the main reason for the 2 upgrades if 2026 guidance. So brand name will also influence launch readiness. I think CagriSema will be launched either 1/1-2027 or 1/4-2027 $VKTX

FDA found black mold and bogus records at 2 Chinese suppliers of (grey market compounding) weight loss API for Semaglutide and Tirzepatide “When inspectors reached Chengdu Shengnuo Biopharm Co. in southwest China in August, they observed quality control staff carrying documents out of their lab and concealing them in lockers in an adjacent room” “Inspectors also witnessed workers disposing of product samples down sinks in what appeared to be a deliberate” $LLY $NVO $VKTX

While most obesity biotechs are have a rough period with suppressed SP, I must say I’m pretty surprised how $VKTX SP has evolved since 33w data. SP hitting lowest for last 12 months….. Some of it is successful shorting. But I don’t believe that’s only reason dropping from +40 to 25. With most biotechs down there will also be people with margin calls. Pressed to reduce. I’m in that boat with 10% reduction. (I’m naturally the only one in here 🙂) And most is underwater at SP 25. As many are pressed or just red across several of their biotech investments, then I also think more would be acceptable to a potential lower BO. IF there’s actual ongoing concretely negotiations taking place, I could also see a scenario where a potential bidder places that offer publicly. Will we eventually see an offer? Nobody knows. But I think mgmt has set to high expectations for upfront payments. But current sentiment can erode earlier positions. Time will tell $LLY $NVO