If blockbuster rivals – the anti-PCSK9 drugs – arrive at end of 2015 and 2016, how can AEGR possibly close the gap between its $1 billion market cap and $75 million 12 mo trailing sales?
Brazilian regulator – ANVISA – rejected AEGR’s drug. The “named patient option” remains, but requires the patient to take legal action. Payments have been delayed due to the Brazilian Gov. investigation of AEGR via a new Anti-corruption law (enacted in Jan. 2014). The law involves bribery. If AEGR sales depended on such, then prior sales numbers will probably not return. The penalty in Brazil is up to 20% of revenue.)
Due to AEGR’s botched dossier, German Regulator -- G-BA – classified the drug as having “no additional benefit.”
Europe is making no significant contributions to revenue, and is not expected to make an impact in the near future.
Japan has required additional study.
The sales force behind rival drug, Kynamro, has been increased by Genzyme and will directly compete with Aegerion’s Juxtapid … at a much cheaper price.
Management’s version of the addressable market is at odds with the very scientists working on its drug by 1,000%. Risk of off-label promotion.
The scientists on AEGR’s drug claim that there are approx. 300 US HoFH patients in the USA; commercial management claims there can be 3,000. Even Nobel Prize winners use the number 300 when speaking of USA HoFH sufferers.
If the scientists are correct, and management incorrect, then AEGR’s proactive reach for more than 300 presents a serious risk of off-label marketing.
In fact, the Department of Justice is currently investigating Aegerion for its marketing and sales practices.
If sales depended on off-label promotion, then present scrutiny and a return to compliance could seriously reduce sales.
There has been no investor closure with the FDA Warning. If scrutiny is ongoing, sales efforts may be curtailed to insure compliance.
Sentiment: Strong Sell
It all adds up, Matt BerryBashWang (He's Jetmanbash and many other profiles including AdamWang) - you hate $AEGR because you lost all of your remaining money (after $OGXI tanked) in $ISIS. Yet you do realize OGXI tanked because it bought an ISIS drug candidate which failed in the clinic? Thus, all of your hate roads actually lead to ISIS - not AEGR. Do think about it, but this is the end of today's counseling session about your misplaced anger. We'll see you next week.
All good and valid points. This is a very high risk investment that has become even riskier with Mr. Beer at the helm. At the beginning of the year they had the risk of a 20 year old drug held together with a cotton candy patent. They now have risks of running out of money before they can really make a profit. They have ONE shot on goal and that is it. I wouldn't count on Germany changing their stance, and I wouldn't count on the companies goal of having no country undersell the price in the US by more than 20%. t
Wow - the Brazilian penalty is only up to 20%. Not bad at all on a drug that is 75%+ profit. Of course, that is a Matt fact. So is the German Regulator classifying Juxtapid as having "no additional benefit" when the full story is this was due to incomplete information on a needed comparison study (which is another great reason to fire CEO Marc Beer). Europe granted $AEGR approval - $ISIS was not. Also, pharmaceuticals are an intense regulatory area. You stated "Japan had required additional study", but once you've had some pharmaceutical experience, you'll realize Japan always requires a mainland study due to its population genetic variance. Your patient # speech has already been disproven. Overall rating here - 3 and 3 quarters yawns.
"Wow - the Brazilian penalty is only up to 20%. Not bad at all on a drug that is 75%+ profit. Of course, that is a Matt fact."
These are not my facts. Search terms: Brazil +anti-corruption law. This NEW law was enacted January 2014. You will find articles and papers on both sides of the border outlining its scope and penalties.
"So is the German Regulator classifying Juxtapid as having "no additional benefit" when the full story is this was due to incomplete information on a needed comparison study (which is another great reason to fire CEO Marc Beer)."
The full story is that this botched attempt with the German regulators results in yet another delay in another country.
"Europe granted $AEGR approval - $ISIS was not."
What percentage of AEGR sales come from Europe? When does AEGR expect any sales? Almost all sales were coming from the USA then Brazil, and now both governments are investigating AEGR's practices. The problem seems systemic.
" Also, pharmaceuticals are an intense regulatory area. You stated "Japan had required additional study", but once you've had some pharmaceutical experience, you'll realize Japan always requires a mainland study due to its population genetic variance. "
Anti-PCSK9 drugs are showing promise and can enter the market around 2016. These international delays are not immaterial to the value of Aegerion as a company, given the limited time available before this serious threat appears.
"Your patient # speech has already been disproven."
Show me published "proof" that AEGR has not funded? And it is not my speech but facts presented by the scientists working on AEGR's drug and Nobel Prize winners working with the disease. I merely presented the facts that they use.