Biotech-Aktien (US)

http://seekingalpha.com/article/...rnings-call-transcript?source=feed  

Mh...11 Cent loss...Naja...Warten wir Q1 ab...Aber es ergibt sich wieder die Chance günstig nachzukaufen...Bei 2,80 lade ich nochmal nach...  

Absolute Einkaufspreise...Wahnsinn...Hätte echt nicht gedacht das sie die nochmal so drücken...  

Könnte charttechnisch (ohne entsprechende News) noch bis 3,40$ runter gehen. Ist ja auch noch ein offenes Gap vorhanden (Zulassungstag).

Trotzdem, auf Jahressicht sollten diese Kurse bald der Vergangenheit angehören. Ich denke beim nächsten CC zu den Q-Ergebnissen können konkretere Aussagen zum Verkaufsstart gemacht werden. Wenn die dann nicht enttäuschen, geht's up.

Liege bei 3,43$ auf der Lauer zum Nachladen ;-)  

Ich denke auch...Hier kann man nur gewinnen...Ich schau mal wann ich Nachlade...  

Man, man, man...Seit Mitte Januar gehts beständig bergab...Mittlerweile habe schon Kurse wie vor der Zulassung...Ist doch nicht normal...  

Interessanter Artikel...

Link : http://seekingalpha.com/article/...icals-full-steam-ahead?source=feed  

da hat wohl jemand Dein Grollen vernommen.
Könnte gestern ev.der Wendepunkt gewesen sein.
Bin mal auf nachher gespannt.
Gruß Wilbär.

 

Hoffen wirs, das die Shorter bald brennen werden...Der gestrige Rücksetzer ist dem hier anzulasten....

Link: http://www.thestreet.com/story/11132797/1/...rice.html?cm_ven=RSSFeed  

Week Ending WTRx WNRx
21. Jan 11 5 5
28. Jan 11 38 38
04. Feb 11 25 25
11. Feb 11 61 61
18. Feb 11 88 87
25. Feb 11 110 103
04. Mrz 11 131 96
11. Mrz 11 172 145
18. Mrz 11 181 144
25. Mrz 11 237 206
01. Apr 11 222 178
08. Apr 11 289 212
15. Apr 11 266 198
22. Apr 11 268 197
29. Apr 11 261 189
06. Mai 11 335 230
13. Mai 11 419 274
20. Mai 11 425 310

ein schön stetiger Anstieg der Rezepte, scheint langsam was zu werden.

Selbst die Kongressuntersuchung bzgl. des (angeblich) zu hohen Preises von Nuedexta scheint den Kurs nicht zu beeindrucken. Er will nach oben. Ebenfalls eine steigende Insti-Quote. Allerdings bleibt die Anzahl geshorteter Aktien ebenfalls hoch (könnte deshalb auch zu einem schönen Shortsqueeze kommen).

Settlement Date Short Interest Avg Daily Share Volume Days To Cover
5/13/2011 32,890,324 7,878,041 4.174937
4/29/2011 33,037,971 7,958,736 4.151158
http://www.nasdaq.com/aspxcontent/...&selected=AVNR#ixzz1Nqs3olXN

Bin froh, vor 2 Wochen noch mal ordentlich unter 4$ zugeschlagen zu haben ;-)  

Japp...Die Daten sprechen ganz klar für uns...Und die Führung mauert ja noch extrem...Aber mit den nächsten Q Zahlen geraten die Shorter mächtig unter Druck...
Vielleicht auch schon eher, sollten wir die 5 Dollar Marke nehmen...  

May 31, 2011

NUEDEXTA Scripts Growth Strong —
Weekly Pill Counts Up Sharply

• As we previewed, weekly NUEDEXTA scripts were strong for the week of May 20th with an increase of ~4000 new
pills prescribed, this week alone. This represents the largest week-over-week increase in pill count since launch. The
Wolters Kluwer end-user demand estimate for the week of May 20th is $184 thousand and it appears that the launch curve is
steepening, given a near doubling in the run-rate since the beginning of the quarter.

• We believe, NUEDEXTA sales are on track to meet or exceed our end-user estimate of $1.6 million for the quarter,
given weekly sales to date. Given that PBA is a condition for which no prior therapies existed and that physicians may
have rarely, if ever, screened for the condition, the pace of the launch may not be indicative of the overall success of
NUEDEXTA.

• The lower repeat Rx’s noted in this week’s data are not a concern to us, given that declines in repeat Rxs had also
occurred in prior weeks and were followed by strong upticks. Repeat Rx numbers should be interpreted with caution.
in our opinion. given that many may represent multi-month mail orders and that pill counts may better reflect sales.
Lumpiness in the launch metrics at this stage in the launch is typical.

• The company has noted that MS and ALS physicians have been recommending NUEDEXTA to their colleagues
treating stroke and traumatic brain injury patients. It appears that, given new evidence that MS and ALS physicians
may be more conservative in their prescribing practices than originally thought, the company is beginning to tweak their
launch plans. Part of this unanticipated prescribing behavior may have resulted in the initially slow launch.

• We currently model the markets for NUEDEXTA in the stroke and traumatic brain injury indications at twice the size
of the market for ALS and MS. Recall, as a base-case scenario, we had projected that peak sales in MS and ALS alone
would reach $500 million in 2017; accelerated adoption in these other settings could represent upside to our sales
estimates. Considering stroke, AD, traumatic brain injury and PD, we estimate peak sales could be in excess of $1 billion in
the US and EU.

• AVNR’s development pipeline remains robust and its “pipeline in a pill” provides an efficient reduced-risk path to
additional sales of NUEDEXTA for other indications. As part of its strategy, the company is looking to expand
NUEDEXTA into MS-related pain, diabetic peripheral neuropathic pain and behavioral disorders associated with dementia;
and may initiate trials in 2011.

• The MS-related pain program is particularly promising, in our opinion, given that NUEDEXTA is a non-opioid and
may find a significant market with off-label use. While we don’t model these opportunities yet, over 50% of the 200-
400K MS patients suffer from chronic pain and no therapies are currently approved for this indication.

• AVNR holds patents for NUEDEXTA in the US and EU, expiring in 2026 and 2023, respectively. Although, prior art has
existed in some capacity given that NUEDEXTA is a combination therapy, we are confident the USPTO was fully apprised of
existing prior art. Below we summarize the key NUEDEXTA patents:
1) In Jun. 2008, the European Patent Office (“EPO”) granted a new patent (1.539.166) which potentially extends the
period of commercial exclusivity for NUEDEXTA into 2023. This European patent expands the available NUEDEXTA
dose ranges under prior patent protection and encompasses a range of indications, including PBA, DPN pain, and other
neurologic conditions.
2) In Feb. 2010, the United States Patent and Trademark Office (“USPTO”) granted a new patent (7,659,282) which
extends the period of commercial exclusivity for NUEDEXTA into 2025 and subsequent to Feb 2010, the period of
commercial exclusively for NUEDEXTA was extended an additional year to 2026. The U.S. patent expands the
available NUEDEXTA dose ranges under prior patent protection and encompasses AVNR’s current clinical
development programs in PBA and other neurologic conditions.

• We maintain our OUTPERFORM rating and our $13 price target. We derive our $13 price target by applying a 6x multiple to
2015 revenues of ~$670 million, discounted by 25% annually.

Risks to our price target include the depth of penetration and timing of market adoption of NUEDEXTA for the treatment of PBA
in the various setting in which it is indicated.  

Hier mal ein Chart zu den Verschreibungszahlen von Nuedexta...

https://spreadsheets.google.com/...p;hl=en&authkey=CO6fi6YC#gid=1  

http://sites.google.com/site/avanirinvestorsite/

hier kann man u.a. auch die ISM-Script-Zahlen sehen, die mittlerweile > 500/ week sind.

bleibe dabei, Kurziel Ende des Jahres > 4€ (> 6$)  

http://www.youtube.com/watch?v=GApXXbmHWHs  

Diese Aussichten finde ich auch gut...Mal schauen wann die Shorties eins auf die Mütze bekommen...

June 28, 2011 8:33 AM EDT

Canaccord Genuity reiterates a 'Buy' on Avanir Pharmaceuticals (NASDAQ: AVNR), PT $6.

Canaccord analyst, Ritu Baral, says, "Reiterate rating, target on ultimate Nuedexta commercial potential. Nuedexta is Avanir’s drug for pseudobulbar affect, emotional lability seen in ALS, MS, and stroke and other neurodegenerative diseases. Launch has been slow but steady, and we still predict peak annual sales of $350M US and $300M EU."

For more ratings news on Avanir Pharmaceuticals click here and for the rating history of Avanir Pharmaceuticals click here.

Shares of Avanir Pharmaceuticals closed at $3.71 yesterday, with a 52 week range of $1.31-$5.80.


LINK: http://www.streetinsider.com/Analyst+Comments/...+Growth/6605614.html  

House/Senate Inquiry Into Pricing of NUEDEXTA Cancelled as Anticipated

Avanir Pharmaceuticals (AVNR - OUTPERFORM): House/Senate Inquiry Into Pricing of
NUEDEXTA Cancelled as Anticipated; Next Up Earnings

Price: $3.69 12-Month Price Target: $13

• As we anticipated the House/Senate inquiry into NUEDEXTA pricing has been canceled. Today, the Senate
committee on aging posted a summary of their conclusions on their site http://aging.senate.gov/events/hr236rpt.pdf
The committee concluded that “From the recent investigation into URL Pharma and Avanir, we have learned that drug
companies charge prices based mostly on what the market will bear without strong pushback from purchasers, and less on
what the drug costs to develop, market or manufacture.” Recall in May the House/Senate Committee on Aging initiated an
Inquiry into NUEDEXTA pricing in May.

• In responding to the committee AVNR provided additional information regarding possible compounding of the two
components that make NEUDEXTA as well as the co-pay assistance that have befitted several patients.
Specifically regarding compounding the company noted “. . .that compounders started making the medication, which is
comprised of two common and inexpensive ingredients, for former participants of Avanir’s clinical trials after the trials
ended”. Additionally “the company stated to staff in briefings that FDA treated the drug as a new entity”. In terms of co-pay
assistance the document noted that “. . .as of the end of June 2011, 343 patients have used this program”.

• The key metric for the stock is weekly script data, and we continue to believe that based upon trends noted since
launch that Monday’s script numbers will be strong.

• We maintain our OUTPERFORM rating and our $13 price target. We derive our $13 price target by applying a 6x
multiple to 2015 revenues of ~$670 million, discounted by 25% annually.

• Risks to our price target include the depth of penetration and timing of market adoption of NUEDEXTA for the treatment
of PBA in the various setting in which it is indicated.  

http://www.reuters.com/finance/stocks/AVNR.O/key-developments

Avanir Pharmaceuticals announced several positive developments regarding its anticipated European regulatory filing of NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules for the treatment of pseudobulbar affect (PBA). Earlier company officials met with the European Medicines Agency (EMA) to discuss plans for filing a marketing authorization application (MAA) for NUEDEXTA for the treatment of PBA. Based on the outcome of the meeting, the Company plans to request an accelerated review process and to file for approval of NUEDEXTA using the data package which served as the basis for the U.S. Food and Drug Administration approval of NUEDEXTA. The timing of the Company's MAA filing is subject to reaching an agreement with the EMA on a pediatric investigation plan (PIP) for NUEDEXTA which may occur before the end of calendar year 2011.  

Das klingt doch gut...Wenn das EU Geschäft noch kommt, gehts weiter aufwärts...Das wird noch teuer hier....  

Avanir Pharma Reveals Positive CHMP Opinion For NUEDEXTA Approval In Europe

WASHINGTON (dpa-AFX) - Avanir Pharmaceuticals Inc. (AVNR) said the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion for NUEDEXTA, recommending NUEDEXTA be approved to treat pseudobulbar affect or PBA, irrespective of neurologic cause. Further, the CHMP recommended approval of two dose strengths of NUEDEXTA; 20/10 mg and 30/10 mg capsules.

PBA is a neurologic condition characterized by outbursts of uncontrollable crying or laughing that are often contrary or exaggerated to the patient's inner mood state.

The European Commission, which is authorized to approve medicines for use in the European Union, follows the recommendations of the CHMP and typically renders a final decision within three months of the CHMP opinion. If the CHMP recommendation is formally adopted by the European Commission, NUEDEXTA would be approved for marketing in all 27 member states of the European Union plus Iceland and Norway.

Joao Siffert, chief scientific officer of Avanir noted, 'We will continue to work with the European Medicines Agency and the European Commission toward the marketing authorization so that patients suffering from PBA have ready access to NUEDEXTA in Europe.'



Copyright(c) 2013 RTTNews.com. All Rights Reserved

Copyright RTT News/dpa-AFX  

 

Na...Kommt jetzt doch noch die faire Bewertung von 7 Dollar...?  

Das wussten wohl schon viele in den letzten Tagen...Jetzt kanns vorwärts gehen...  

Die Zahlen sehen vielversprechend aus, die schwarze Null rückt näher und die Pipeline ist gefüllt...

Q3 zahlen
http://www.sec.gov/Archives/edgar/data/858803/...-13-321542-index.htm