Good call. Most all the senior analysts participated themselves for a change rather than sending surrogates. I expect a positive reaction from the market tomorrow, following the answers given by Leiden and his team, which certainly voiced optimism about the expected revenue growth to be generated by Orkambi,
Leiden clearly articulated Orkambi revenue will be financing the ongoing clinical trials in both CF an non CF drugs in development this year and next. While specific metrics about Orkambi sales during the first few weeks of the launch were not discussed, I did not sense that there was any denials or unexpected delays from health insurers paying for the care of 508dd CF patients in the U.S. who are being prescribed Orkambi since the launch less than one month ago. That's good news for CF patients and VRTX investors
Papa, it's certainly your right to criticize the company anytime you like. I agree that the company needs to achieve timely approvals of the rest it's pipeline to deliver sustained growth and profitability for shareholders. However, it's not 'too late' for such progress and the VRTX pipeline now will have the funding needed without further dilution (unlike GLPG) to develop these drugs. I guess one would like as a shareholder a smooth predictable flow of clinical trials to insure one's investment. As evidenced by the slowing growth at BIIB on Friday, it's never easy or smooth for the most successful companies. Perhaps at next week's Q2 conference call we will get more information about the timing and progress for clinical trials in both CF and non CF assets at VRTX. as well as the projections for growth from Kalydeco and Orkambi.
If VRTX various projects in oncology, influenza, spinal cord injury, Huntington's, chronic MS, as well as it's next generation CF treatments start clinical trials over the next 12 months, I believe that the long term growth plans expected from management will, eventually be successful. It just takes one or two blockbusters to make it to the top tier of companies in pharma. Any success in it's pipeline of drugs offering breakthroughs in such difficult to treat to treat conditions will likely continue VRTX growth. In the meantime, I enjoy the moments like this where VRTX has delivered a success that means so much to CF patients and their families, as well as to long term shareholders as ourselves, and is just in the first innings (to use the baseball analogy) of the development of this market.
How ironic that this thread starts with the topic 'historic day' and shares the hope and happiness of mblock66, redsox2004, and the happiness of Verity over the fact that 508dd CF patients are finally receiving without delay by health insurers, prescriptions of Orkambi in the first weeks of launch following FDA approval giving them hope that their loved ones can live a longer and more healthy life.
And then we have upset with investors on this board, apparently not satisfied with the fact this company, even after a horrible week for biotech in general, has a market cap of over $30 billion, attributable only to it's CF drugs. These drugs are not considered by Vertex critics as being cost effective or sufficiently beneficial to justify the current market cap.
Let's consider the facts: successful companies in the orphan drug markets e.g. ALXN, have been priced at even greater valuations than VRTX because they offer the possibility of breakthrough treatments in lethal diseases that have until now have had no real treatment for the underlying cause of the disease. VRTX took the financial risk to spend the last 15+ years to develop (with the assistance of the CFF funding less than 10% of the total cost) Ivacaftor, lumacaftor, VX 661, and the second generation correctors after acquiring Aurora Biosciences. Since becoming CEO, Leiden has focused the cash resources available to VRTX (following the loss of the market for telaprevir) on getting FDA approval of the CF drugs to achieve the needed revenue that will now permit the clinical development of the rest of the VRTX pipeline. He out-licensed VX 787 to JNJ/Jansen to accelerate monetization of that asset for VRTX without draining it's cash resources needed to develop the CF drugs. The proceeds from the CF drugs will now finance the future clinical trials for all the drugs in the VRTX pipeline. Simply put, VRTX's future R&D success will be financed by Leiden's focus on succeeding in CF. IMHO a good strategy
FWIW, Smurph 3 posted this morning on Yahoo 'market pulse' blog for VRTX the following data likely taken from IMS prescription data tracking service:
"Orkambi scripts in second week of launch were 145, up from 14 prior week"
Thanks Verity. Good to know that CF doctors are prescribing Orkambi ASAP, and not waiting for routine appointments to start their 508dd patients on this treatment. Hopefully their medical insurance is approving the treatment quickly after it is prescribed, without too much red tape.
You will likely get a number on July 29 from the company during it's Q2 conference call. Initial Orkambi prescriptions are being given to patients at their normal scheduled follow up visits to their CF clinics, so I anticipate that if the visits occur routinely on quarterly basis, most patients will be getting prescriptions in the first 6 months, and the only limiting factor will be processing paperwork for insurance approval, which may drag out the actual approval process a bit longer, especially for Medicaid patients who have more bureaucracy to deal with. In one year, most US 508dd CF patients will be on Orkambi, and EU regulatory approval for Orkambi by year end will allow EU CF patients to start getting treatment next year as well.
Excellent 2nd qtr results and management's presentation today and at next week's investor meeting in Atlanta may generate even greater positive analyst interest in Quidel.
Barron's on online article yesterday about Vertex was released about the time the stock made most of it's upward move yesterday. Perhaps today's early move up is follow through on yesterday's move up in price thanks to that article's remarks about orkambi earnings for H2 2015 more likely to beat analyst's revised estimates. VRTX is now being judged by the growth in it's revenues and earnings as it turns profitable on a sustained basis. Take over speculation may also be a factor but the timing of the Barron's article seems to be the current catalyst for the move up in price.
The final Pharion 1037 Phase 2 CF trial and the Phase 2B VX 787 influenza trial results are also due in May 2016 according to clinical trials.gov website, making the first half of next year important for showing the progress in the VRTX pipeline of drugs coming into Phase 3 trials in the second half of next year, and the prospects for further revenue growth thereafter.
You are assuming I have never "taken some off the table". FYI, I have sold some shares at approximately half the current stock price when last year Geoff Porges, the Bernstein analyst, who had been a VRTX bullish analyst, raised doubts about the likelihood of the FDA approving Orkambi. Just a month or two ago, the same Geoff Porges has recommended GILD buy VRTX at $185 per share based on his expectations of the FDA's approval of Orkambi, and the potential of the rest of the VRTX pipeline. Some of the money I 'took off the table' has been reinvested in other stocks some of which have gone up and some not. The overall return of this reallocation of investment dollars does not match return of the core investment I have kept in VRTX over the past year. Diversification may reduce risk but is not as profitable when you are reducing your position in the company that has the best potential for growth..
The point is trading is not everyone's philosophy of how to invest. Buy and hold investing in a company with a successful long term growth strategy can pay off handsomely for the patient long term investor who does not panic over the gyrations of the market that are inevitable over the years one holds a stock. I have definitely gotten 'older' over the past 15 years, watching my investment in VRTX run from an average price of $17 to it's current value, with a lot of ups and downs in the process of going up almost 8 times my purchase price to date. They did not pay me a dividend while waiting, but my dividend paying stocks have not delivered a total return anywhere close to
VRTX, a company whose growth as a commercially successful pharmaceutical company is just beginning.
The market is signaling approval on the PDUFA date (if not earlier) and early approval is not an important issue in the commercial success of Orkambi. Down the road (years away) there may be competition, but not for years. In the meantime VRTX execs, well aware of the risks of a short product lifecycle from the telaprevir experience, are proceeding aggressively with improvements on it's own existing approved and nearly approved CF treatments with combination treatments of 661 and 770, 2nd gen correctors with orkambi or 661/770, and adding EnAc inhibitors from Parion into the mix to show further clinical endpoint improvements to enhance benefit to CF patients and remain competitive in the CF market. The non CF pipeline of drugs as you noted in your May 12 post may be even greater revenue creators for the company. "Expert" opinions that are bothering you regarding the 'small' 3% improvement in FEV-1, are missing the more important point. Orkambi is the first breakthrough drug in the treatment of 508dd CF patients to slow the progression of the disease. 30-40% reduction in exacerbations is meaningful in patients with just a few years left in their life expectancy, and is a significant pharmaco-economic benefit in terms of negotiating pricing. It will likely be improved on further with the combination of drugs being developed by VRTX. Breakthroughs in pharma usually generate competition. The key is VRTX is going to aggressively try to improve on it's own success in the treatment of CF and not sit back and wait to see if any competitors can do it better.
Rojo, you seemed very optimistic and hopeful for Vertex on May 12. Reread your post below, which I agree with, and remember the market would not be giving VRTX a $32 billion market cap for no reason. GLPG/ABBV CF drugs, if successful, will take years to get approval and VRTX as you note in your post below has a deep and competitive pipeline for multiple drugs for both improving and expanding indications for treatment of subpopulations of CF patients and the non CF drugs which will be breakthroughs in so many other disease states.
37 Billion company for sure
by rojospan • May 12, 2015 7:36 PM Flag
10% royalities for VX Ivacaftor, Orkambi and VX 661 were sold by CF foundation for 3.7 billion in Nov 2014. Guess what simple math tells me ? 37 B only for CF franchise. VX 661 is positive in 2 phase II trial consistenly and its failure chances are very low after Orkami almost approval.
VX 970 ( ART inhibitor) is another blockbuster ready for intial read out. VX 787 is progressing nicely and Cethrin should start phase II b in July 2015. I can almost bet you that VX 745 will score big in Alzheimer Dementia and John Alum will sell his virtual company EIP biopharm and Alzheimer patents to VRTX.
I am expecting huge run from here. VRTX is a long term buy and shorting it is equal to losing your luck. Institutions owns it any way and they will do their math and initial manipulations to get cheap retail shares.
Congratulations to all my long friends including thirdme ( smarty), Dr. harveysmith, gladpick, verity and last but not least my positive approach friend qdelfan.
VRTX is next DNA ( Genentech)
Enjoy the ride up in share price.
Savanah coming next.
Difficult to say which assay is 'better' since Van Goor's lab has been working to develop these tests for the past 15 to 20 years, and they have consistently predicted positive clinical trials of the drugs being vetted by VRTX for clinical use as potentiators and correctors in CF. Obviously GLPG has similar assays since these assays are published scientific techniques discussed in scientific meetings by CF researchers for years. The point of GLPG emulating Van Goor's lab work IMHO is that it shows the confidence potential competitors like GLPG have in Van Goor's lab results, since they are employing similar techniques to predict which drug candidates to test in clinical CF trials. The main difference so far is that GLPG HBE assays do not yet have the track record of VRTX's CF lab in terms of late stage clinical trial results to give them a proven record of success. Of course that does not mean they will not have a good predictive value, it just means 'time will tell' after the GLPG clinical trials are completed in the next few years. In the meantime, VRTX execs have stated just last week (Ian Smith at the GS healthcare conference) that they are monitoring GLPG results closely and are aggressively working to improve the results of it's own CF cocktail with it's own pipeline of second gen correctors and with collaborations with companies like Parion using drugs with complementary mechanisms to augment clinical benefit across all CF mutations and with possible applications to non-CF chronic lung disease. VRTX is certainly on the right track given the fact this potentialcompetitor is using thesame techniques and similar types of drugs. Vertex is not standing idly by waiting to see is GLPG CF pipeline is better and certainly seems to be pushing forward with it's own efforts to have competitive combinations of drugs to improve treatment to as many CF patients as possible. All good news for the CF community.
N30's GSNOR inhibitor was tested as monotherapy in CF patients last year, given as an IV infusion, and did not demonstrate much efficacy. Combining N30's drug with Orkambi or Kalydeco in CF patients already getting proven benefit fromVRTX drugs is trying to justify getting N 30's drugs approved as an add-on treatment to boost clinical benefit to VRTX drugs, much the same as Parion's drugs are being tested. Clearly, the n30 drugs did not 'measure up' to meriting investment by VRTX. They likely failed to show the sufficient evidence to predict clinical benefit in the HBE assay in Van Goor's lab, where Parion's drugs did. VRTX execs have been talking for most of last year about meeting with various other companies to discuss collaboration to enhance the clinical benefit to CF patients with it's drugs. The winners and losers in that dialog are becoming more evident based on the science that predicts clinical trial outcomes from the testing of these compounds in the HBE assay in VRTX CF research lab.