Everyone that has invested in EXEL should listen to this, and maybe twice! It's only 53 minutes long and it is filled with lot's of info and lots of good news. The numbers they go thru are very promising for RCC patients with regards to Cabo.
Will the market figure this out, probably not right away, since the glittery object of OS found in Checkmate will out sparkle the great Cabo results. Everyone involved in the briefing is highly confident that Cabo will get to that point too.
This was mentioned earlier, but I think it bears repeating. The companies that will be interested in buying EXEL will be focusing in on all the great numbers presented in the briefing, they won't care about Cabo not yet having proven OS, they know it's a virtual certainty. The decision is do you wait for the OS results to be safe, but may much more, or try to put an offer on the table in the next couple of months.
I also liked how excited Toni was about how well the sub set of patients did who had only had Sunitinib as their prior therapy. They achieved a PFS of 9.1 which is as good as Sunitinib when used as first line therapy. You mention how Cabo will end up as 2/3 line. I think it will end up being used as a first line eventually. Sunitinib has a worse SE profile and may end up having no better PFS or OS than Cabo.
I also liked the dig Toni gave out when on slide 33. This is when he mentions that the ORR was independently verified with the Meteor trial and only by the investigator in the Checkmate trial.
This is a very interesting video where they discuss Cabo starting at around 9minuted. Yahoo won't let me post a link but go to PracticeUpdate the roundtable from 10/26.
The lead Dr wanted to prescribe Nivo but insurance turned him down, instead offering Cabo. The Dr's talk about maybe this is because Cabo is less. The patient responded strongly and is doing well so far. Started him at 20 and have moved up to 40 with no AR's.
Your statement of 40% adverse side effects caused by Cobi is not correct. They recorded all effects whatever the cause. It was a more rigid trial that I think in the end will help EXEL.
Not exactly. All we had before was the presentation. Now we have something afterwards that anyone can listen to/see. This tells me they want to get the news out to everyone, quickly. I read this as very positive.
I will disagree. Even a company looking to sell itself can't act like it - business as usual is the MO. It's like dating, if you act desperate no one is interested in you. Confidence and a seeming lack of interest is like honey to a bee.
Abstract 4LBA Cabozantinib versus everolimus in patients with advanced renal cell carcinoma: Results of the randomized phase 3 METEOR trial. Presented by T Choueiri
•In this phase III trial, researchers randomized 658 patients with clear cell renal cell carcinoma to receive cabozantinib or everolimus. Median progression-free survival was 7.4 months with cabozantinib compared with 3.8 months with everolimus. Overall survival was not determined. Cabozantinib was associated with abdominal pain (3%), pleural effusion (2.7%), and diarrhea (2.1%). Everolimus was associated with anemia (3.7%), dyspnea (3.7%), and pneumonia (3.7%).
•Cabozantinib improved progression-free survival and objective response rate compared with everolimus in patients with advanced clear cell renal cell carcinoma.
Patients were randomized 1:1 to receive cabozantinib at 60 mg by mouth per day or everolimus, with the primary endpoint of progression-free survival. The study demonstrated a progression-free survival of 7.4 months for patients receiving cabozantinib vs 3.8 months for patients receiving everolimus, with a hazard ratio of 0.58 and a 95% confidence interval staying comfortably below 1. The toxicity profile with regard to treatment discontinuation and grade 3 and 4 toxicities was similar between the two arms; put to rest was one of the major concerns about cabozantinib being an unacceptably toxic agent. Overall, and once again, this was a groundbreaking study, and once approved this agent will see broad usage.
I feel certain that by now they have been sending out feelers to see who is interested. They will not agree to sell and more importantly no own would buy them until more results are in.
I think once the ECC presentations are over and the assumed good info is out the SP moves up to 8.50. The JV happens next (sometime this year) and adds another 50 cents. The melanoma approval is already baked in at these prices. This is when I think discussions start with EXEL saying if/when approved in RCC this is what we will be looking for.
By next year the NDA for Cabo in RCC has submitted and the decision will be known in the third quarter. If approved and the OS results are close to Nivo's the SP moves up to 11-12 and a deal would be announced shortly afterwards for 15-16.
Lots of assumptions to the positive but that is what I am hoping for.
Really like the last two sentences, word is getting out and this guy is no lightweight. He is:
Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine; Director, VHL Clinical Center, The University of Texas MD Anderson Cancer Center, Houston, Texas
This has been on the horizon ever since the ACC passed. More news articles getting pushed writing about "excessive" drug costs. GILD got hammered over it's CURE for Hep C. but nobody talked about how it will be saving money long term by needing many fewer hospitalizations and liver transplants.
Before the ACC it was just insurance companies complaining, and nobody listens to them. Heck Bernie Sanders advocated for breaking GILD's patent for Solvadi recently because it was costing the government too much. Sure -you can argue he's a socialist but still he's a sitting US Senator arguing for breaking the law (see Article 1 Section 8 Clause 8).
It would not surprise me to see the idea floated by politicians in the next 10 years a formula that gave the allowed pricing for each additional month of life a drug gave according to it's Ph 3 results. It would spell the end of private research and cause a huge drop in new drugs being developed, but at least the government would be saving money - short term that is.
That will be the big number everyone will fixate on, but don't forget to look at the patient response rate from memory EXEL was a bit higher (7% I think) and PFS which EXEL was much longer. There will be room for both drugs in 2nd line therapy.
The principal investigator of the trial is Dr Choueiri. Here is the info on him from the DF Cancer Inst. Not a light weight so this should be interesting!
Dr. Toni K. Choueiri is Associate Professor of Medicine at Harvard Medical School and Attending Physician in the Division of Solid Tumor Oncology at Dana-Farber Cancer Institute (DFCI). He also serves as the co-director of the Tissue Acquisition, Pathology, and Clinical Data Core of the Kidney SPORE at Dana-Farber/Harvard Cancer Center and is the leader of the Kidney Cancer Center at DFCI and Brigham and Women's Hospital (BWH). Clinically and academically, Dr. Choueiri's efforts have largely centered on improving the care of patients with renal cell carcinoma (RCC).
Dr. Choueiri's research focuses on clinical trials with aims to improve the treatment of patients with advanced renal cell carcinoma as well as the development of novel agents for this disease. Dr. Choueiri is currently involved in collaborative efforts with basic scientists to analyze clinical, tissue, and serum biomarkers to optimize the administration of targeted therapeutic agents in renal cell carcinoma. In addition, he has also established several collaborations to characterize the side effects and risks of antiangiogenic agents used in RCC using a large scale approach, such as meta-analyses from available published trials or national databases such as the SEER database
I think this is the largest trade I have seen and it was afterhours - at 4:30 3.9 million shares traded hands. Did not move the share price so I guess it was just some hedging.
Agreed! If they ever want to present at ECC again you don't pi## them off by releasing something big 10 days ahead.
The price will move up in anticipation what we need is results so good there is no sell on the news effect. I could see it at 7 before ECC
I'll take us even more off topic. I believe we are entering the beginnings of a golden age of medical advances. Genome sequencing is fast becoming cheap and if targeted therapies will become more common. Yes there will be enormous pressure to keep costs down... but I think that will happen naturally as long as the research keeps up.
I'll compare it to a much simpler technological advance - TV's. The first plasma TV I ever saw in a house was in 1999 a Sony that was about 24 inches dia. and 6 inches deep. I was told by the AV co doing the install it cost 10,000. It had #$%$ blacks and was 480i. FF 16 years and 5,000 get you a 4K top of the line Samsung.
Yes medicine is much more complicated, but much more money is being spent trying to figure our bodies out and in some very targeted ways.
More interesting data to add to all the other tidbits of info floating around. Which piece will be the catalyst to ignite the share price? The updated results coming out at the ECC will be Huuuuge as Donald Trump would say;) but when will the whole story of Cabozantinib be known? 2017/18.
As Tom Petty would say "the waiting is the hardest part"
I'm in at almost 50,000 - way too high a percentage of my portfolio but in order to leverage down I kept buying in the 2's and 3's - which lowered my ASP to around 5 bucks.
Agree about less risk and less upside but want to add that the reduced upside is not just dilution but the fact they are not a legitimate threat to make it on their own. Unfortunately the dilution was a necessary evil to stay in business not grow the company.
They can not make it on their own so they will be up for sale.The question is can they find more than one co that wants to purchase them and leverage that into a higher sale price. Roche is the obvious #1. My VRTX took a beating on Fri after the GILD CEO mentioned they want to strengthen their Oncology division thus they were not interested in VRTX - which I never thought was a good fit/buy anyway. Let's hope they get involved EXEL is spare change for them - even at 3B.
I would also think that Jonathan Berndt , who left GILD to become ELEL's VP of sales talked to Chris Senner who also recently left GILD to become EVP and CFO at EXE to get the info on EXELL.I don't know if they knew each other at GILD, I doubt it, but I still think they discussed what its like working at EXEL and what the prospects are moving forward.
I'm still hoping GILD becomes a bidder later next year, however unlikely.
If I had the money and time to spare I would fly in and bribe the maitre d hotel to find out where they are dining the night before, then book a table at the same restaurant and see what their mood is like.