Gary, as I have been saying his current metric is tied to increase in shareholder value per percentage increase in share price higher than an increase in Biotech index. If increase in Bio Index is 20%, his metric is a 30-40% increase in Arena price as an example. The year before it was a "cake" metric.
I would get metrics like increase in sales, increase in net revenue, increase in inventory turns and increase in design wins. These were nationwide goals. I also had a metric for turnover rate for the organization I was responsible for leading/managing.
Jack's and Craig's metrics should be tied to growth of net revenue that will tied them directly in with Eisai and make them accountable for driving Eisai's performance. They need to be active as opposed to passive participants in Eisai's sales/marketing efforts.
ODS does not guarantee any accelerated approval process. Probability of approval as Gary states is much greater. In the last presentation, for some reason 811 was not highlighted as a priority focus while ADP334 was stated as the key focused drug in the PL. In addition, Temanogrel was not mentioned in the last two presentations.
I think Arena is thinking of doing the sales and marketing of 811. Pulmonary Doctor's are the primary targets. If approved, ADP811 will be sought out by Lung Docs. Arena should try to get Breakthrough Drug Status for 811. That status would move the stock price over $10.00 imo.
Gary, having researched this, I have found that Orphan drug status does not mean an acceleration in the approval process. Now ONCE has a drug that has both ODS and Breakthrough Drug Status by the FDA may get fast tracked for that drug, but it has not happened yet. ONCE btw has a great management team and is strongly affiliated with CHOP.
The ODS will allow Arena to get fee reimbursement from the FDA and they also can apply for a grant from the NIH.
A buyout is just as likely. At this point in time, ADP334 is the most likely candidate to be partnered first and earlier than the other drug candidates. But I suspect that a BP will likely want the whole shooting match.
The only thing marginal is your post. Many Belviq users have lost well over 35 pounds. Jack Lief lost 55 pounds. That is not marginal weight loss. Now your brain which weighs 1oz is very marginal.
Unfortunately concerning yourself with MS at this stage is meaningless. What is needed is massive script growth to drive stock prices not MS. MS at this stage only drives some longs to delusional wrong conclusions.
The numbers are factual, not debating that but to try and glean anything positive about of this up one week and down the next week roller coaster is not realistic. The other fact is that Eisai (all I am concerned with since I don't own OREX or Vivus) is continuing to have a pitiful sales and marketing effort with Belviq.
When Jublia TV ads are seen constantly on primetime TV for Toenail/Fungus infection and Belviq TV ads are a rarity, it is a disgrace on the part of Eisai. When a freaking big foot with a big toe in a football helmet gathers more attention and awareness with the American Public than a serious weight loss drug with many more benefits, that tells me that Eisai has sheet the bed. It tells me for Jack to continue to do the happy dance and tell us how well Eisai is doing that he needs to be fired. Before I said he should step down and stay on as Chairman, but if he does not take actions to stop this ongoing train wreck of a drug campaign (you can't really call it a launch anymore, when it is closing in on 2 years) by serving notice to Eisai that they get their act together or Arena will pursue termination of the partnership agreement. At the current rate of sales of Belviq, Arena can take over the sales and marketing of Belviq themselves. They don't need 450 ineffective sales people and however many people are in the Eisai marketing group since Joe the Monkey in the Zoo could develop a better TV ad campaign and all they need to pay him are bananas.
Dave: None of the drugs in the pipeline have been fast tracked and likely will not be fast tracked. Even the SC indication is 2.5 years away and this from the mouth of Craig Audet of Arena. There is some hope for partnerships that will be needed as these pipeline drugs approach phase III since Arena at the present pace will not receive enough revenue from Belviq to cover all of the company's expenses, thus they will continue to have a negative cash flow situation. That means the likelihood of additional stock dilutions.
If you looked a few year back, you would see messages from me that said Arena's stock would be over $50.00 by now. Guess what and you don't have to guess, just look at the stock price to see the actual outcome.
To summarize, none of the pipeline drugs is close to approval, most are entering phase II. After each study is done, results have to be analyzed normally by a CRO (Contract Research Organization) that takes 3-6 months. If the results are good, then another phase II study may be needed before moving on to phase III. At that time, Arena needs to meet with the FDA to review the phase III study design and protocol. That takes 3+ months. The phase III study assuming a 52 week study which takes longer than 52 weeks for patients enrolled in the study to complete or dropout. Then again you have a CRO do all of the data analysis from the study. If all is looking good, then Arena has to put together the NDA package, another 2-3 months. They then submit to the FDA, one month for the FDA to accept the NDA. Nine months for review until the PDUFA date assuming approval. If a CRL is issued, another ~ 18 months is in the works unless Arena decides to not go forward.
If you were counting the number of months, we are looking at 30+ months at least.
This is a long time from now. My guess is that you and most of the other longs that really don't have a clue about how the drug approval process really works won't be posting here anymore..
I received this from another Arena Long and wanted to share. Dr. Sharma does have a website that you can googletofind.
The Lancet’s 2015 Take On Obesity
Posted By Arya M. Sharma, MD
In 2011, The Lancet dedicated a special issue to the topic of obesity – the general gist being that obesity is a world wide problem which will not be reversed without government leadership and will require a systems approach across multiple sectors. The Lancet also noted that current assumptions about the speed and sustainability of weight loss are wrong.
This week, The Lancet again dedicates itself to this topic with ten articles that explore both the prevention and management of obesity.
According to Christina Roberto, Assistant Professor of Social and Behavioural Sciences and Nutrition at the Harvard T H Chan School of Public Health and a key figure behind this new Lancet Series, “There has been limited and patchy progress on tackling obesity globally”.
Or, as Sabine Kleinert and Richard Horton, note in their accompanying commentary, “While some developed countries have seen an apparent slowing of the rise in obesity prevalence since 2006, no country has reported significant decreases for three decades.”
As Kleinert and Horton correctly point out, a huge part of this lack of progress may well be attributable to the increasingly polarised false and unhelpful dichotomies that divide both the experts and the public debate, thereby offering policy makers a perfect excuse for inaction.
These dichotomies include: individual blame versus an obesogenic society; obesity as a disease versus sequelae of unrestrained gluttony; obesity as a disability versus the new normal; lack of physical activity as a cause versus overconsumption of unhealthy food and beverages; prevention versus treatment; overnutrition versus undernutrition.
I have yet read to read all the articles in this series and will likely be discussing what I find in the coming posts but from what I can tell based on a first glance
Sharon - who cares? What you should care about is that Belviq is down. President's Day and Weather are just excuses. I get refills for my meds by just calling my Doctor's office and they electronically send it to my pharmacy that is close by where I live.
Until the issue of Consumer Awareness is adequately addressed regarding Obesity and treatment modalities and it needs to be addressed at several levels. If Arena and Eisai were smart, they would work to form a coalition of anti-obesity forces that includes the public and private sectors and their competitors to run an "Anti-Obesity" campaign just like the "Anti-Smoking" Council has done for years.
Do you think as an example that the Eisai Voices website is going to work? I don't, it is not user-friendly and every responder has their comments followed by all of the warnings. Arena and Eisai need to really sit down and not high five each other but get serious about what efforts are needed to at least get 5%+ of the addressable market aware of Belviq. That should be a goal that has Jack's and whomever the head Eisai U.S. person's at the moment paycheck tied to that goal; like 25% of their paycheck.
The dog just plain ain't hunting. Job #1 for both Jack and Eisai is get the awareness much greater of Belviq, if they can get that done, then the scripts will great improve. Without action at several levels, we will be having this same conversation ad nauseam.
We need a much greater number of scripts, market share is not that important at this time. If you took the time to read my financial analysis to your post yesterday where you declared Q1 would show a lot of growth, you would know that this drop in the weekly number makes it even more likely that your projection is not going to happen. Whatever happened to this being the "Weight Loss Season"?
Meditation and B-12 complex vitamin. I do mindfulness meditation focusing on a combination of breathing and visualization. I also mix in some Tai Chi exercises like moving mountains, reaching for the moon, etc.
I grew up in Kensington. I was just at Holt Cigar Store on 1522 Walnut on Wed. Upper Germantown is being revitalized. Many other sections as well. After 22 years in Cali, it is fun getting to know the city again.
Thanks to all for the good wishes. This is his second time around and he has a good handle of what needs to be done. Unfortunately the ballot position is one of the keys. It is selected by a drawing. He has been a Asst. DA, City Attorney, teaches Law, Risk Management and Corporate Ethics at two Univ. in Phila. Area. In addition, does consulting with two CP Judges and has his own Law Practice. Chairman of a Charter School.
Well you never met Andy Grove, John Young, Sean Powers, Bob Throop, Greg Provenzano, Karen Worley - they were all great CEO's that grew shareholder value by increasing the price of their companies' shares severalfold.
He is not a great CEO and you are full of BS S9, your crybaby talk is nonsense.
I challenge you to tell me if Jack has performed up to his stated performance objectives of achieving shareholder value by an increase in share price that is greater then the percentage increase in the BioTech Sector? Simple question, but you don't answer it because the facts are that he has not met his objectives and has missed them for over two years.
Instead, S9, your only comeback is to call people weasels/crybabies and other utter pure nonsense. In addition, you have your trading account (nothing wrong with that) where you make money on the ups and downs. Again that is fine, but it also makes you a hypocrite when several intelligent longs (a lot don't post here or on IVB) believe with good reason that Jack has failed his responsibility to the stockholders of Arena. Remember when at the last ASM, a shareholder not me asked him the status of the EU, Jack responded he did not know and deflected the question to Craig Audet. A great CEO would know the answer.
A great CEO would have the confidence of WS such that the stock price of Arena would be at least $10.00 or higher. A great CEO would have sued Consumer Reports and their henchmen for the "hit piece" in their two unanswered articles. A great CEO would not have left the first AdCom instead of staying to support the other Arena employees. A great CEO would have taken a pay cut after letting several employees go a few times. Layoffs happen, but Jack never cut one dime from his salary. A great CEO would have kicked Eisai squarely in the groin of their ineptness of the belviq launch. A great CEO would have known that Lonnel Coats was a "Sham" and not fell for his BS. No, you never have met a great CEO!
I think it is certainly possible that IlDong could get to a $4M+ per quarter and then grow from there. BTW, thanks for this good information.
The insurance/uninsured split is about 60-65%/35-40%. Said another way, 65% of all bottles sales generate $95.00 per bottle or about a $15.00 hit prior to the price reduction - again I'm assuming that insurance companies re-negotiated a lower reimbursement rate, 35% generate $42.00 per bottle, about a $68.00 hit from what was received in net revenue prior to the price reduction.
Now here is an example. In Q1'15, let's say that the scripts generated 200K bottles sold (what complicates this is the fact that Arena/Eisai use POP (point of presence) or what is sold to Distributors. But for this example, we will use POS (point of sale). Now using the estimated split of 65/35. 130K bottles would have generated net revenue of $95.00 x 130K or 12.350M plus 70K bottles generating net revenue of $42.00 x 70K = 2.94M. The total would be $15.29M. Arena's revenue would be $4.82M. Compare to what would have been generated without the price reduction (I know, maybe the sales would be less.).
The net revenue number was about $111.00 x 200K = $22.2M or $7M for Arena. A difference of $2.18M.
I think the real number for bottle sales in Q1'15 will be closer to 175K bottles, if I am correct then the revenue will be lower.
The bottom line Joel is that your revenue projection is not going to happen. Now next quarter is another story with South Korea in the mix.
I would also note that it would make sense for Eisai to adjust/lower the wholesale price per bottle from $199.50 to a more reasonable number. One could argue that the gross revenue number is higher but after all of the discounts, returns, etc. are taken out you end up close to my above estimates for net revenue per bottle which in the end is all that matters.
$124.50 would be a more reasonable whole price going forward.