Biocryst - Focus Money 45/2005 - 500 Beiträge pro Seite

[sadtrader]

Hallo zusammen, bin letzte Woche auf einen sehr interessanten Artikel über einen Wert aus der Biotechnologie gestoßen. Es handelt sich um die Aktie von Biocryst, die kurz vor der Zulassung eines Vogelgrippe Medikaments steht und ein lt. Focus Money Potenzial von bis zu 200% haben könnte. Weiteres entnehmt Ihr bitte aus nachfolgendem Artikel

Hier der vollständige Aritikel aus Focus Money Ausgabe 45/2005

Effektive Waffe
Biocryst steht vor der Zulassung des Vogelgrippe-Medikaments Peramivir. Analysten erwarten einen Kurssprung um 200 Prozent
Das Jahr 2000 war für Charles Bugg, Gründer und Chef des amerikanischen Biotech Unternehmens Biocryst, das schlimmste in seiner Karriere. Der Pharmakonzern Johnson&Johnson, einziger Unterstützer und Finanzierer des forschungsintensiven Grippemittels Peramivir, kündigte Bugg die Zusammenarbeit auf. Zuvor hatten die US Behörden die Zulassung des Medikaments verweigert. Die Folge: Binnen Tagen verlor die Biocryst-Aktie 80 Prozent ihres Wertes. Vor der Zulassung. Heute hat sich das Papier nicht nur von dem dramatischen Kurssturz erholt, es notiert sogar auf einem 5- Jahres-Hoch. Grund ist wieder Peramivir. Das Medikament, das Biocryst gegen die Vogelgrippe entwickelt, steht erneut vor der Zulassung des Gesundheftsministeriums. Experten sind sicher, dass es klappen wird — auch weil die Pandemie diesmal vor der Tür steht. "Das Mittel ist die günstigste, vielversprechendste und effektivste Waffe gegen den Vogelgrippekillervirus H5N1", sagt John McCamant, Herausgeber des US-Branchenmagazins "Medical Technology. Bekomme Biocryst noch 2005 die Zulassung, könne der Konzern bereits 2006 die Produktion auf 120 Millionen Einheiten hochfahren.
Analysten sind optimistisch: Vinny Jindal von der U5-lnvestmentbank Wedbush Morgan Securities erwartet 2006 rund 380 Millionen Euro Umsatz mit dem Grippemittel. 2004 betrug der Gesamtumsatz — ohne Peramivir— 535000 Euro. „Der faire Wert der Aktie liegt bei 35 Euro, sagt Jindai 200 Prozent über der aktuellen Notierung.
Branchenexperten gehen im Fall einer Pandemie davon aus, dass die US-Regierung Peramivir vor Tamiflu des Schweizer Pharmakonzerns Roche und Relenza des britischen Gesundheitsunternehmens GlaxoSmithKline bestellen wird. Dafür sprechen nach Angaben McCamants die abgeschlossenen und erfolgreichen Tests mit Tieren. "Die Erfolgsquote bei Biocryst warum ein Vielfaches höher als bei den anderen Herstellern", sagt der Biotech-Experte. Zu dem sei Peramivir, das per Spritze verabreicht wird, deutlich schneller und günstiger herzustellen als die Roche-Pille Tamiflu. Peramivir kostet nicht einmal ein Zehntel von Tamiflu, sagt McCamant "Biocryst bekommt Flügel!". Kein Wunder, dass sich die Empfehlungen für Biocryst häufen: Die drei lnvestmenthäuser Leerink Swann&Company, Wedbush Morgan Securities und Rodman&Renshaw raten zum Kauf der Aktie. Daneben sind fast alle amerikanischen Börsenbriefe und Tageszeitungen vom Erfolg Biocrysts überzeugt. Selbst das konservative US-Magazin Business Week lobte den Konzern vergangene Woche in höchsten Tönen. Uberschrift des Artikels: "Biocryst bekommt Flügel"

Ende des Artikels.

Anmerkung von mir: Sollt die Zulassung für das Medikament erfolgen, so werden wir sicherlich die 200% Plus erreichen, falls nicht so könnte es wiederum den gleichen Absturz wie im Jahr 2000 geben. Meine Einschätzung die Chancen stehen 80 zu 20 für eine Zulassung vor allem vor dem Hintergrund einer anstehenden Pandamie und mit dem Wissen, das die Amerikaner lieber in eigene Firmen investieren als in Ausländische.

[janfer]

[posting]18.632.059 von sadtrader am 07.11.05 11:59:45[/posting]Hallo, KW 45-05 ist diese Woche. Morgen werden die Magazine an die Abonnenten zugestellt? Woher wissen was was morgen drinne steht?

[schwede07]

ist aus der aktuellen ausgabe

[sadtrader]

[posting]18.632.172 von janfer am 07.11.05 12:10:58[/posting]Kann Hellsehen - Nein mal im Ernst, der Artikel stand in der oben genannten Ausgabe vom 02.11.2005, habe mich aber erst jetzt dazu entschieden das alles zu Posten da ich mir eigentlich gedacht habe es würde mehrere geben die die Story gut fänden und einen Thread eröffnen würden. Aber nun gut vielleicht schadet es auch gar nicht wenn Biocryst nur wenigen wirklich interessierten ein Begriff ist.

[gogomane]

Wenn Biocryst die Zulassung bekommt, gehts ab wie ne Rakete Leute. Und das schönste ist, daß die Zulassung eventuell noch dieses Jahr erfolgen kann. Hi Leute merkt denn keiner von Euch, welch Chance in Biocryst steckt???

[miristegal]

hi all

hab heute d. artikel v. Fr. Hörrlein "Schreckgespenst Vogelgrippe" Teil 1 gelesen.
sie meint bcrx hat gute chance aud die zulassung.
leider kann ich den artikel nicht mehr finden.
wenn stelle ihn rein.

ansonsten


Stock News : Althea Chang
Email This Story Print This Story

Resurgent BioCryst at It Again

By Althea Chang
TheStreet.com Staff Reporter
11/30/2005 6:20 PM EST
Click here for more stories by Althea Chang

Updated from 3:56 p.m. EST

The power of promise is immense in the biotech universe, a place where no-name companies can be made celebrities overnight, has-been stocks can rebound as must-haves and laggards can be transformed into leaders in the blink of an eye.

As evidence, there`s BioCryst Pharmaceuticals (BCRX:Nasdaq - commentary - research - Cramer`s Take), a firm that traded north of $30 at the outset of the millennium but has gone as low as $3.68 in the last 52 weeks.



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However, with the help of two big developments, BioCryst has turned from a straggler to a sprinter in just a few short months. The latest news involves a deal in which the Swiss pharmaceutical giant Roche agreed to pay BioCryst $30 million for the worldwide rights to an early-stage immune system drug.

BioCryst said Roche`s payments could reach $530 million based on various milestones, not including possible royalty payments if the drug reaches the market.

The arrangement sent shares of the Birmingham, Ala., biotech soaring 37.5% to $16.24 on more than 10 times its average trading volume.

Roche bought an exclusive license to BioCryst`s BCX-4208 compound, a so-called PNP-inhibitor that the companies hope will help transplant patients avoid having the new organ rejected.

For five years, Roche will have a right of first negotiation on other PNP inhibitors BioCryst is already working on for autoimmune diseases or transplant rejections. BioCryst retained the right to co-promote BCX-4208 in the U.S. for several indications. Any new PNP inhibitor discovered after the agreement will be exempt.

BioCryst has completed an early-stage dosing trial for the compound this year and has started a trial to evaluate the safety and tolerability of multiple oral doses of BCX-4208. The company is hoping its product proves to be more effective in treating autoimmune diseases and transplant rejections than drugs that are currently available.

Go to NEXT PAGE

MFG

[miristegal]

[posting]19.195.085 von miristegal am 07.12.05 23:00:00[/posting]den artikel v . Fr. Hörrlein habe ich als werbung mit
foto zwischen den postings gefunden.

[Gedi01]

[posting]19.195.401 von miristegal am 07.12.05 23:27:34[/posting]Hier ist Tel 2 Zu finden:

http://www.red-shoes.de/shoerrlein2.htm

Schreckgespenst Vogelgrippe - Teil 2 Sonntag, 04.12.2005 - 20:00 Uhr


Die Profiteure

Gilead - bereits jetzt ein Profiteur!
Dass Gilead Sciences (Nasdaq: GILD) zu den Profiteuren der Vogelgrippehysterie zählen wird, daran besteht wohl kaum ein Zweifel. Schließlich ist das von den Amerikanern, die mittlerweile mit zu den am höchsten bewerteten Biotech Unternehmen zählen, entwickelte antivirale Medikament Tamiflu derzeit der größte Hoffnungsträger gegen das Virus H5N1. Tamiflu, das als Grippeprävention vom Kooperationspartner Roche vermarktet wird, hat sich seit Beginn des Jahres vom Ladenhüter zum potenziellen Blockbuster gemausert.

Die Wirkung von Tamiflu beruht darauf, dass alle Erreger auf ihrer äußeren Oberfläche das Enzym Neuraminidase tragen. Das Medikament blockiert diese zu den Eiweißen gehörende Verbindung, die ihrerseits wie eine Schere wirkt und dem Virus den Eintritt in die Zelle ermöglicht, wo dieses sich unbehelligt von der Immunabwehr des Körpers vermehren kann. Die Angst vor einer Vogelgrippe-Pandemie hat die Aktie von Gilead Sciences seit Jahresbeginn um 49 Prozent, und damit wirklich beträchtlich klettern lassen. Auch wenn dies im Vergleich zum Amex Biotech Index (+23%) sowie zum S&P 500 (+2%) ein bereits grandioser Kursanstieg ist, spricht einiges dafür, dass das Ende der Fahnenstange noch nicht erreicht ist. Skeptiker und sicherheitsbewusste Anleger sollten aber gegebenenfalls auf einen günstigeren Einstiegskurs warten, bzw. dem Optionsschein den Vorzug geben. Bei letzterem wären vorübergehende Verluste leichter zu verschmerzen.

Bis vor kurzem galt Tamiflu mit einem Quartalsumsatz von gerade einmal 20 Mio. Euro noch als Ladenhüter. In den ersten sechs Monaten 2005 hat sich der Tamiflu-Umsatz mit 384 Millionen Euro im Vergleich zum Vorjahr bereits mehr als vervierfacht. Die Milliardendollar-Grenze sollte Tamiflu in den nächsten Jahren knacken, denn in in-vitro Studien zeigte sich das Präparat auch wirksam gegen das Vogelgrippevirus H5N1, was jüngst zu wahren Panikkäufen beigetragen hat.

Vor allem die Amerikaner sollten Tamiflu noch einen Umsatzschub verschaffen. Im Gegensatz zu Europa hat Amerika die Problematik bis dato nämlich heruntergespielt. Gerade einmal 2 Prozent der US-Bevölkerung könnten aktuell mit Tamiflu behandelt werden. Doch nun will man die Lager ganz massiv von etwa 13 Millionen auf 81 Millionen Dosen Tamiflu aufstocken. Tamiflu könnte sich so in den nächsten Jahren zu einem Milliardenpräparat entwickeln. Roche hat bereits mitgeteilt, die Produktion bis Mitte 2006 zu verzehnfachen und Lizenzen an die Hersteller von Generika zu vergeben, was sich auch in der Höhe der Tantiemen an Gilead widerspiegeln wird.



Spekulativ - der potenzielle Profiteur BioCryst!?

Doch auch kleine Unternehmen, die mit neuen antiviralen Wirkstoffen locken, haben, wegen der weltweiten Nachfrage, gute Chance zu einem der Profiteure zu werden. Die kleine Company BioCryst Pharmaceuticals (BCRX:Nasdaq) wird meiner Meinung nach zu diesen Profiteuren zählen, denn mit Peramivir hat das Unternehmen bereits ein potenzielles Produkt im Portfolio. Peramivir, das gemeinsam mit Johnson & Johnson entwickelt wurde, zeigte sich schon 2001 in Mäusen wirksam gegen das Vogelgrippevirus, weshalb der Aktienkurs schon damals die 30 Dollarmarke knacken konnte. In Phase III konnte das Präparat dann leider nicht überzeugen, da bei der oralen Verabreichung zu wenig aktiver Wirkstoff in den Blutkreislauf gelangte. J&J kündigte daraufhin die Partnerschaft mit BioCryst, das als Folge davon den Wirkstoff auf Eis legte. Ein Kurssturz bei BioCryst war die Folge, von dem sich das Unternehmen lange Zeit nicht mehr erholen konnte.

Doch die Angst vor der Vogelgrippe hat bei BioCryst seit Beginn des Jahres einen echten „Turnaround“ eingeleitet. Vom 52-Wochentief von 3,68 Dollar stieg die Aktie lediglich wegen dem Hoffnungsträger Peramivir auf mehr als 11 Dollar und konnte sich damit verdreifachen. Obwohl das schon eine ganze Menge Vorschusslorbeeren waren, könnte die erfolgreiche Zulassung des antiviralen Wirkstoffes einen weiteren Kurssprung nach sich ziehen. Zwar hat erst vor wenigen Tagen der Abschluss eines 30 Millionen-Dollar-Deals mit Pharmagigant Roche, den Kurs erneut um satte 37% auf über 14 Dollar klettern lassen, doch die Zulassung von Peramivir könnte die alten Höchststände aus dem Jahr 2000 von 30 Dollar wieder in greifbare Nähe rücken.

Die Chancen für eine Zulassung stehen nicht schlecht, zumal BioCryst Peramivir nun nicht mehr als Tablette, sondern als Injektion verabreichen will. Damit soll gewährleistet werden, dass ausreichend Wirkstoff in die Patienten gelangt. Die jüngsten Tierversuche mit injiziertem Peramivir zeigten eine gute Wirksamkeit gegen tödliche Grippeviren. Mit diesen Daten hat das Unternehmen vor wenigen Tagen erste Studien am Menschen beantragt.

Demnächst wird die US-Gesundheitsbehörde, FDA, also darüber entscheiden, ob diese Versuche wie geplant Anfang nächsten Jahres beginnen werden. Die Wahrscheinlichkeit ist ziemlich hoch, da die Gefahr einer Pandemie kontinuierlich wächst und Tamiflu kurzfristig nicht in ausreichenden Mengen produziert werden kann. Die Studien werden außerdem in Kooperation mit den staatlichen Instituten NIH (National Institutes of Health) durchgeführt, was ebenfalls ein positives Zeichen darstellt. Bei erfolgreichem Abschluss der Studien dürfte zudem gesichert sein, dass Peramivir in das Regierungsprogramm, eine ausreichende Menge an präventiven Wirkstoffen anzuhäufen, aufgenommen werden.

Für einen möglichst günstigen Einstiegskurs schauen Sie sich die demnächst auf dieser Seite veröffentlichte Technische Analyse der beiden Werte an.

[daktuell]

Buy BioCryst under $20!!!

[dachluke]

heute ein sattes Plus von derzeit 17%

Wissen die in AmiLand mehr als wir?

Was ist denn aus der Zulassung für das Medikament gg. H5N1 geworden?


Dach-Luke

[daktuell]

...BioCryst Pharmaceuticals Inc. has been granted "fast track" status by the U.S. Food and Drug Administration for its drug Peramivir, which is designed to treat influenza infections.
The proposed drug has shown preclinical promise in the treatment of multiple flu strains, including the H5N1 strain, commonly known as avian flu...

...weiter - weiter...

[Onkel_Tuca]

Interessante Aktie ! Bin nur zuspät darauf gestossen....
schade eigentlich.
mfg Onkel

[miristegal]

[posting]19.758.866 von Onkel_Tuca am 17.01.06 22:18:15[/posting]ich aber früh. leider nicht gekauft

MFG

[dachluke]

kann mir wer den heutigen kursverlust von 10% erklären?

macht nicht wirklich sinn, wenn H5N1 immer mehr in Europa zum Ausbruch kommt?

Gruß
Dach-Luke

[mz41]

Hallo,

kann ich auch nicht erklären. ich muss nur feststellen, daß hier in diesem Thread kaum was los ist. Es ist kein Penny Stock, weil zu teuer dafür, es gibt keine Liebhaber. Es gibt keine statements, also mal abwarten. Eigentlich ein gutes Zeichen.

Und dann gibt es noch CHNR oder in FfM A0DNRG da fehlt mir auch eine Info.

Gruß

mz41

[miristegal]

[posting]19.919.953 von mz41 am 27.01.06 21:56:15[/posting]Press Release Source: China Natural Resources, Inc.

China Natural Resources, Inc. Acquires 100% Equity Interest in Feishang Mining Holdings Ltd., a Mining Enterprise
Thursday January 26, 3:22 pm ET

HONG KONG, Jan. 26 /PRNewswire-FirstCall/ -- China Natural Resources, Inc. (Nasdaq: CHNR - News), a company based in the People`s Republic of China (PRC), today announced that, on January 24, 2006, China Natural Resources entered into an Acquisition Agreement with Feishang Mining Holdings Limited ("Feishang") and Feishang Group Limited (the "Feishang Shareholder") pursuant to which China Natural Resources will acquire 100% of the issued and outstanding capital stock of Feishang from the Feishang Shareholder. As consideration, at the closing of the acquisition, China Natural Resources will issue to the Feishang Shareholder common shares of China Natural Resources representing approximately 86.4% of its issued and outstanding common shares, and will issue to the Feishang Shareholder warrants to purchase an additional 4,500,000 common shares. Closing of the acquisition is expected to take place on or prior to February 3, 2006.

ADVERTISEMENT
Feishang, through its wholly owned subsidiary, Wuhu Feishang Mining Development Co., Ltd. ("Wuhu"), a company established under the laws of the People`s Republic of China ("PRC"), owns the mining rights to two mines in the PRC, containing iron and zinc minerals. For the year ended December 31, 2004, Wuhu reported net sales revenue of RMB77.9 million (US$9.4 million) and net income of RMB42.0 million (US$5.1 million), based on the exchange rate of US$1.00=RMB8.28 as at December 31, 2004.

China Natural Resources, Inc. has offices in Hong Kong and the Hainan Province of the PRC. Currently, the Company`s active business operations consist of its advertising, promotion and public relations business.

This press release includes forward-looking statements within the meaning of Federal securities laws. These forward-looking statements involve risks and uncertainties that may cause actual results of operations to differ materially from the forward-looking statements. Among the risks and uncertainties that could cause our actual results to differ from our forward- looking statements are our intent, belief and current expectations as to business operations and operating results of the Company, uncertainties regarding the governmental, economic and political circumstances in the People`s Republic of China and other risks detailed from time to time in the Company`s Securities and Exchange Commission filings. Although the Company`s management believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct.


Source: China Natural Resources, Inc.


mfg

[miristegal]

[posting]19.915.195 von dachluke am 27.01.06 17:32:11[/posting]es ist so:
es gibt unzählige firmen , die auf H5N1 umgestellt haben.
eine davon ist auch BCRX , die durch zufall endeckt hat , das ihr nicht zugelassene impfstoff , positiv gegen H5N1 reagiert.

andere wollen halt mit der panik geld verdienen .

eine SVA - Sinovac ist ein Chinariese , der am ort arbeitet,
und die aktie ist sehr volatil.

Hier ein beispiel , das die interrese gross ist , und nicht vergessen von wo BRCX nach oben kam.

:10 PM PST, January 26, 2006
latimes.com
Print E-mail story Most e-mailed Small Text SizeSmall Text Size Regular Text SizeRegular Text Size Large Text SizeLarge Text Size Change text size
New Bird Flu Vaccine Is 100 Percent Effective in Animal Tests
By Thomas H. Maugh II, Times Staff Writer

Pennsylvania researchers have produced a bird flu vaccine made from a genetically engineered human cold virus and shown that it protected 100 percent of vaccinated mice and chickens.

While production of a conventional flu vaccine requires months of work and large numbers of fertilized chicken eggs, the researchers reported Thursday that they prepared their vaccine in only 36 days, growing it in a laboratory dish.

ADVERTISEMENT
The ability to produce a new vaccine so quickly could give public health officials a powerful new tool to combat the H5N1 bird flu virus if it should mutate and begin infecting humans widely.

The team is working with the Food and Drug Administration to begin human tests of the vaccine, said Dr. Andrea Gambotto of the University of Pittsburgh Medical Center, who led the team. He said those trials could begin within weeks.

He said the vaccine should be equally effective in humans because it is based on a human virus.

Gambotto`s research, conducted in conjunction with scientists from the Centers for Disease Control and Prevention, is scheduled to be published in the Feb. 15 issue of the Journal of Virology and was made available early online.

The Pittsburgh team worked with a human cold virus, called an adenovirus, that had been stripped of the genes required for it to cause a respiratory infection.

Using genetic data from the CDC, they constructed the gene for a bird flu protein called hemagglutinin in the laboratory and added it to the adenovirus. The hemagglutinin protein allows the bird flu virus to bind to and enter cells that it infects.

The whole process of producing the vaccine took 36 days from the time the researchers received the DNA sequence information, Gambotto said.

Mice injected with the vaccine were 100 percent protected against the bird flu virus, the team reported, while those injected only with an unaltered adenovirus all died within a few days of being exposed to the bird flu virus.

Studying the mice, the team found that the vaccine produced two types of immunity -- antibodies that block the hemagglutinin and prevent it from binding to cells, and T-cells that attack the invading virus.

"This means that this recombinant vaccine can stimulate several lines of defense against the H5N1 virus, giving it greater therapeutic value," said microbiologist Simon Barratt-Boyes of the University of Pittsburgh Graduate School of Public Health and a member of the team.

"More importantly, it suggests that even if H5N1 mutates, the vaccine is still likely to be effective against it," he said.

When the vaccine was given to chickens as a mist administered through the nose, about half the birds were protected from the flu. But when they were injected with the vaccine, they were 100 percent protected.

"This is a very potent vaccine," Gambotto said. "The results of this animal trial are very promising."

The team is not sure why the intranasal administration was not as protective, he added.

So far, the bird flu virus has infected mostly birds, although 152 humans have contracted it and more than 80 have died, according to the World Health Organization. Experts fear, however, that the virus will mutate slightly, allowing it to infect humans more easily and leading to a pandemic.

The virus originated in southeast Asia but has now spread to other areas, including Turkey, Siberia and Kazakhstan.

PS. sehe viele fehler in meinem text. entsch.

mfg

[daktuell]

Achtung - Augenmerk auf Mittwoch!!!

--<BioCryst to Release Fourth Quarter and Year-End 2005 Financial Results on Wednesday, February 8, 2006; Conference Call and Webcast to Follow

[daktuell]

BioCryst loses $26 million in 2005; CEO lauds clinical gains



BioCryst Pharmaceuticals Inc. reported a fourth-quarter loss of $7.2 million, or 27 cents per common share, compared with a loss of $5.3 million, or 24 cents per share, in the fourth quarter of 2004.

The company attributed the decline, in part, to higher research and development costs and a loss of revenue from the completion of work related to a National Institutes of Health grant for the company`s hepatitis C program.

Revenues decreased to $21,000 in the fourth quarter, down from $178,000 in the fourth quarter of 2004.

Expenses for R&D increased nearly 29 percent to $6 million in the quarter, compared with $4.7 million in the year-earlier period, due largely to contract research and toxicology expenses on the company`s Fodosine, peramivis and BCX-4208 drug candidates and higher employee costs.

Charles E. Bugg, the company`s chairman and CEO, said in a news release that 2005 was "a year of significant clinical and corporate achievements at BioCryst. We continued to move our scientific programs forward while strengthening our resources through strategic financing, the addition of key persons to our team and board, and through synergistic corporate collaborations."

ENDE DER DURCHSAGE!

--> Kauf an schwachen Tagen...

[daktuell]

...Byers and Kleiner partner Beth Seidenberg spent six months talking to infectious disease experts at places like the World Health Organization and the United Nations. "We`ve done a map of where the innovation gaps are, and there are a lot of them," said Byers. He added that the fund will likely be making 10 to 12 investments in later-stage companies. The fund`s first investment was in BioCryst Pharmaceuticals (nasdaq: BCRX - news - people ), which needed additional funding to pursue clinical trials for its antiviral drug candidate Peramivir. The U.S. Food and Drug Administration has granted BioCryst "fast track" status for its Peramivir trials because it may work in treating avian influenza...

Kurse unter 20 Dollar sind Kaufkurse!

[mz41]

[posting]20.234.063 von daktuell am 16.02.06 12:30:33[/posting]Na denn man los

mz 41

[daktuell]

der start ist gemacht! --> aufbruch zu fernen ufern!

[sebcoe]

nette Kaufempfehlung am Freitag von Unterberg Tobin.
Am Wochenende steht die Vogelgrippe im Focus des öffentlichen Interesses.Hinzu jommt, dass die Aktie Freitag gegen Handelsende technische Stärke gezeigt hat.
Piramivir sorgt auf jeden Fall für Phantasie.Makaber, aber wenn die Vogelgrippe auch die USA erreichen sollte...
Die Höchststände aus 2000/2001 sind auch noch ein ganzes Stück entfernt...

[daktuell]

Die Analysten von CE Unterberg Towbin stufen die Aktie von BioCryst Pharmaceuticals (ISIN US09058V1035/ WKN 896047) in einer Ersteinschätzung mit "buy" ein. Das Kursziel werde bei 23 USD gesehen.

Was ist euer Kursziel ( 12 Monate )


Ich denke da steckt mehr drin! ( mein KZ 35 USD )

[daktuell]

Quarterly Report



Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
This Quarterly Report on Form 10-Q contains certain statements of a forward-looking nature relating to future events or the future financial performance of the Company. Such statements are only predictions and the actual events or results may differ materially from the results discussed in the forward-looking statements. Factors that could cause or contribute to such differences include those discussed below as well as those discussed in other filings made by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K.

Overview

Since our inception in 1986, we have been engaged in research and development activities and organizational efforts, including:

• identifying and licensing enzyme targets;

• drug discovery;

• structure-based design of drug candidates;

• small-scale synthesis of compounds;

• conducting preclinical studies and clinical trials;

• establishing collaborative relationships with third parties for contract research related to the development of our drug candidates to support manufacturing, clinical development and regulatory compliance;

• establishing collaborative relationships with biotechnology or pharmaceutical companies and governmental agencies or other third parties for the further development and potential commercialization of our compounds;

• recruiting our scientific and management personnel;

• establishing laboratory facilities; and

• raising capital.

Our revenues have generally been limited to license fees, milestone payments, research and development fees, and interest income. Revenue is recognized in accordance with SAB No. 104 and EITF Issue 00-21. License fees, future event payments, and research and development fees are recognized as revenue when the earnings process is complete and we have no further continuing performance obligations or we have completed the performance obligations under the terms of the agreement. Fees received under licensing agreements that are related to future performance are deferred and recognized as earned over an estimated period determined by management based on the terms of the agreement and the products licensed. For example, in the Roche and Mundipharma license agreements announced in November 2005 and February 2006, respectively, we have determined to defer the upfront payments over the remaining life of the patents which are 17 years (through August 2023) and 12 years (through October 2017), respectively. In the event a license agreement contains multiple deliverables, we evaluate whether the deliverables are separate or combined units of accounting in accordance with EITF Issue 00-21. Revisions to revenue or profit estimates as a result of changes in the estimated revenue period are recognized prospectively.

Future event payments are recognized as revenue upon the achievement of specified events if (1) the event is substantive in nature and the achievement of the event was not reasonably assured at the inception of the agreement and
(2) the fees are non-refundable and non-creditable. Any event payments received prior to satisfying these criteria are recorded as deferred revenue.

Significant direct costs incurred upon entering into a licensing arrangement, such as our sublicense fees to AECOM and IRL, are deferred and charged to expense in proportion to the revenue recognized. Under the guidance of EITF Issue 99-19, and EITF Issue 01-14, reimbursements received for direct out-of-pocket expenses related to research and development costs are recorded as revenue in the income statement rather than as a reduction in expenses.

Royalty revenue is recognized based on estimates of royalties earned during the applicable period and adjusted for differences between the estimated and actual royalties in the following period. If royalties can not be reasonably estimated, revenue is recognized upon receipt of royalty statements from the licensee. We have not received any royalties from the sale of licensed pharmaceutical products.

It could be several years, if ever, before we will recognize significant revenue from royalties received pursuant to our license agreements or revenue directly from product sales. Future revenues, if any, are likely to fluctuate substantially from quarter to quarter.

We have incurred operating losses since our inception. Our accumulated deficit at March 31, 2006 was $159.7 million. We expect to incur substantial expenditures relating to the development of our current and future drug candidates. During the three years ended December 31, 2005, we spent 54.6% of our research and development expenses on contract research and development, including:

• payments to consultants;

• funding of research at academic institutions;

• toxicology studies on existing and potential drugs;

• manufacturing of our raw materials, drug substance and drug products;

• large scale synthesis and formulation of compounds;

• preclinical studies;

• engaging investigators to conduct clinical trials;

• hiring contract research organizations for regulatory and clinical functions; and

• using statisticians to evaluate the results of clinical trials.

The above expenditures for contract research and development for our current and future drug candidates will vary from quarter-to-quarter depending on the status of our research and development projects. For example, during the third quarter of 2005, we initiated a Phase I trial in healthy volunteers for our lead drug candidate, forodesine hydrochloride ("Fodosine™"), an inhibitor of purine nucleoside phosphorylase ("PNP"). Results from this trial will be used to assist in facilitating the design of a proposed Phase IIb pivotal clinical program in patients with T-cell leukemia, using a combination of intravenous and oral formulations of Fodosine™. In addition, during the third quarter of 2005, we initiated a Phase II clinical trial of Fodosine™ in patients with advanced, fludarabine-refractory chronic lymphocytic leukemia ("CLL") and in the fourth quarter of 2005 we announced the initiation of a Phase I/II clinical trial of Fodosine™ in patients with B-cell acute lymphoblastic leukemia. We began clinical development of our neuraminidase inhibitor, peramivir, by starting the first clinical trial with an intravenous formulation during the first quarter of 2006. As these trials progress and additional trials are started in other indications, our costs for clinical studies will increase significantly. In addition, the costs associated with the manufacturing of Fodosine™, peramivir and BCX-4678, our hepatitis C ("HCV") drug candidate, will increase as we scale up to the larger production runs required for both clinical development and additional toxicology studies required for each of these programs.

Changes in our existing and future research and development and collaborative relationships also will impact the status of our research and development projects. For example, in November 2005 we entered into a license agreement with Roche for the worldwide development and commercialization for our second PNP inhibitor, BCX-4208. In addition to an upfront payment plus an advance payment for some manufacturing we will perform, Roche will take over the development and pay all costs associated with this program. In February 2006, we licensed Fodosine™ to Mundipharma for the development and commercialization of this drug in Europe, Asia and Australasia. In addition to the upfront payment of $10 million, Mundipharma will pay 50% of the clinical development costs we will incur for Fodosine™ on existing and planned clinical trials, but their portion shall not exceed $10 million.

Although we may, in some cases, be able to control the timing of development expenses, in part by accelerating or decelerating certain of these costs, many of these costs will be incurred irrespective of whether we are able to discover drug candidates or obtain collaborative partners for commercialization. As a result, we believe that quarter-to-quarter comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of future performance. If we fail to meet the research, clinical and financial expectations of securities analysts and investors, it could have a material adverse effect on the price of our common stock.

Results of Operations (three months ended March 31, 2006 compared to the three months ended March 31, 2005)

Collaborative and other research and development revenues increased to $771,000 in the three months ended March 31, 2006 compared to $41,000 in the three months ended March 31, 2005, due to the recognition of revenue related to our recently announced collaboration with Mundipharma for the development and commercialization of forodesine hydrochloride (Fodosine™) in Europe and Asia. For this collaboration, we began recognizing the $10 million up front payment in February 2006, which will continue until it is fully recognized in October 2017. During the first quarter of 2006, we also began recognizing revenue on clinical expenses that will be reimbursed by Mundipharma according to the terms of the collaboration.

Research and development ("R&D") expenses increased 55.4% to $8,043,000 in the three months ended March 31, 2006 from $5,175,000 in the three months ended March 31, 2005. The increase is primarily attributable to expenses for contract research and synthesis of compound related to the clinical development and manufacturing of our drug candidates, Fodosine™ and peramivir.

We are currently in several additional clinical trials with Fodosine™ as compared to the same period in 2005 and we have also started the process of manufacturing validation for both Fodosine™ and peramivir. There was also an increase in compensation cost for the first quarter of 2006 compared to the first quarter of 2005, primarily related to the Company's adoption of Statement No. 123R, which resulted in $179,000 of share-based compensation expense.

General and administrative expenses for the three months ended March 31, 2006 increased 114.8% to $1,495,000 as compared to $696,000 for the same period in 2005, primarily due to $241,000 of share-based compensation related to the adoption of Statement No. 123R, additional compensation expense related to an increase in personnel and an increase in professional fees primarily related to our Mundipharma collaboration.

Interest income for the three months ended March 31, 2006 was $885,000, a 378.4% increase as compared to the same period in 2005. This increase was due to a higher average cash balance during the first quarter of 2006 resulting from the upfront payments from the Roche and Mundipharma collaborations.

Liquidity and Capital Resources

Cash expenditures have exceeded revenues since our inception. Our operations have principally been funded through public offerings and private placements of equity and debt securities. For example, during December 2005, we raised $30.0 million (approximately $29.9 million net of expenses) through a sale of 2,228,829 shares of our common stock. Other sources of funding have included the following:

• equipment lease financing;

• facility leases;

• collaborative and other research and development agreements (such as the Roche and Mundipharma licenses);

• research grants; and

• interest income.

In addition, we have attempted to contain costs and reduce cash flow requirements by renting scientific equipment and facilities, contracting with other parties to conduct certain research and development and using consultants. We expect to incur additional expenses, potentially resulting in significant losses, as we continue to pursue our research and development activities, undertake additional preclinical studies and clinical trials of compounds which have been or may be discovered and as we increase the manufacturing of our compounds for clinical trials and toxicology studies. We also expect to incur substantial expenses related to the filing, prosecution, maintenance, defense and enforcement of patent and other intellectual property claims and additional regulatory costs as our clinical products advance through later stages of development.

We invest our excess cash principally in U.S. marketable securities from a diversified portfolio of institutions with strong credit ratings and in U.S. government and agency bills and notes, and by policy, limit the amount of credit exposure at any one institution. These investments are generally not collateralized and mature within three years. We have not realized any losses from such investments. In addition, at March 31, 2006, approximately $34.2 million was invested in the Merrill Lynch Premier Institutional Fund, a money market mutual fund that invests in near cash securities with weighted average maturities of less than 90 days. The Merrill Lynch Premier Institutional Fund is not insured.

We have financed some of our equipment purchases with lease lines of credit. In July 2000, we renegotiated our lease for our current facilities, which will expire on June 30, 2010. We have an option to renew the lease for an additional five years at the current market rate in effect on June 30, 2010 and a one-time option to terminate the lease on June 30, 2008 for a termination fee of approximately $124,000. The lease, as amended effective December 1, 2005 for a reduction of 7,200 square feet, requires us to pay monthly rent starting at $36,855 per month in December 2005 and escalating annually to a minimum of $41,481 per month in the final year, plus our pro rata share of operating expenses and real estate taxes in excess of base year amounts. As part of the lease, we have deposited a U.S. Treasury security in escrow for the payment of rent and performance of other obligations specified in the lease. This pledged amount is currently $196,000, which can be decreased by $65,000 annually throughout the term of the lease. Currently, we have approximately 3,600 square feet being subleased, which can be terminated with 30 days written notice.

We have not incurred any significant charges related to new equipment or building renovations since 2001 and currently have no plans for any significant renovations, but our purchases of additional equipment during 2006 could exceed $1 million.

At December 31, 2005, we had long-term operating lease obligations, which provide for aggregate minimum payments of $533,904 in 2006, $486,119 in 2007 and $496,834 in 2008. These obligations include the future rental of our operating facility.

We plan to finance our needs principally from the following:

• our existing capital resources and interest earned on that capital;

• payments under collaborative and licensing agreements with corporate partners; and

• lease or loan financing and future public or private financing.

As of March 31, 2006, we had $88.0 million in cash, cash equivalents and securities. We believe that our currently available funds will be sufficient to fund our operations at least through mid-2008. However, this is a forward looking statement, and there may be changes that would consume available resources significantly before such time. Our long-term capital requirements and the adequacy of our available funds will depend upon many factors, including:

• the progress and magnitude of our research, drug discovery and development programs;

• changes in existing collaborative relationships;

• our ability to establish additional collaborative relationships with academic institutions, biotechnology or pharmaceutical companies and governmental agencies or other third parties;

• the extent to which our collaborators, including governmental agencies will share in the costs associated with the development of our programs or run the development programs themselves;

• our ability to negotiate favorable development and marketing strategic alliances for our drug candidates;

• the scope and results of preclinical studies and clinical trials to identify drug candidates;

• the scope of manufacturing of our drug candidates to support our preclinical research and clinical trials;

• the scope of validation for the manufacturing of our drug substance and drug products required for future NDA filings;

• competitive and technological advances;

• the time and costs involved in obtaining regulatory approvals;

• the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims;

• our dependence on others for development and commercialization of our product candidates; and

• successful commercialization of our products consistent with our licensing strategy.

To date, we have financed our operations primarily from sale of our equity securities and, to a lesser extent, revenues from collaborations and interest. In 2005, our operations consumed approximately $2.0 million per month. Our current projection for 2006 is that our average net burn rate for 2006 will be approximately $3.0 million per month. We expect that our monthly cash used by operations will continue to increase for the next couple of years as our clinical programs are expanded. We are planning to be in a Phase IIb pivotal trial with Fodosine™ in 2006 in T-cell leukemia and are in the early stages of clinical trials in several other indications with Fodosine™. In addition, we began clinical development of our neuraminidase inhibitor, peramivir, by starting the first clinical trial with an intravenous formulation during the first quarter of 2006.

As these trials increase in size and patient enrollment increases, our costs will increase. We also expect our HCV drug candidate, BCX-4678 to be in clinical trials later in 2006. Our current and planned clinical trials plus the related manufacturing, personnel resources and testing required to support these trials will consume significant capital resources and will increase our expenses and our net loss.

This monthly burn rate could vary significantly depending on many factors, including our ability to raise additional capital, the development progress of our existing partnerships for our drug candidates, the amount of funding or assistance we receive from governmental agencies or other new partnerships with third parties for the development of our drug candidates in general and for peramivir specifically, the progress and results of our current and proposed clinical trials for Fodosine™, peramivir and BCX-4678, the progress made in the manufacturing of our products and the progression of our other programs.

The collaboration with Roche for the worldwide development and commercialization of BCX-4208 provided an upfront payment plus an advance payment for specific manufacturing we will perform. This initial $30 million was recorded as a receivable on our balance sheet at December 31, 2005 and was received in January 2006. Roche will take over the development and pay all costs associated with this program. The agreement also provides for future event payments and royalties to be made by Roche upon the achievement of certain clinical, regulatory and sales events.

In February 2006, we licensed Fodosine™ to Mundipharma for the development and commercialization of this drug in Europe, Asia and Australasia. In addition to the upfront payment of $10 million which was received in February 2006, Mundipharma will pay 50% of the clinical development costs we will incur for Fodosine™ on existing and planned clinical trials, but their portion shall not exceed $10 million. In addition, Mundipharma will conduct additional clinical trials at their own cost up to a maximum of $15 million. The agreement also provides for future event payments and royalties to be made by Mundipharma upon the achievement of certain clinical, regulatory and sales events.

Due to the nature of the potential milestones in our collaborations, it is difficult to predict if and when particular milestones will be achieved by us or our collaborators. However, we hope to reach at least one milestone in each of the collaborations during 2006, which would provide additional cash upon the achievement of the specific milestone reached. All future event payments are non-refundable under our current collaborations, net of sublicense payments, and have been taken into consideration in the projection of our burn rate.

We will be required to raise additional capital to complete the development and commercialization of our current product candidates. Additional funding, whether through additional sales of securities or collaborative or other arrangements with corporate partners or from other sources, may not be available when needed or on terms acceptable to us. The issuance of preferred or common stock or convertible securities, with terms and prices significantly more favorable than those of the currently outstanding common stock, could have the effect of diluting or adversely affecting the holdings or rights of our existing stockholders. In addition, collaborative arrangements may require us to transfer certain material rights to such corporate partners. Insufficient funds may require us to delay, scale-back or eliminate certain of our research and development programs.

Off-Balance Sheet Arrangements

As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities ("SPEs"), which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. As of March 31, 2006, we are not involved in any material unconsolidated SPE or off-balance sheet arrangements.

Contractual Obligations

A summary of our obligations to make future payments under contracts existing as of December 31, 2005 is included in Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2005. For the three months ended March 31, 2006, the Company has entered into various contracts in the ordinary course of business for several R&D related items, including manufacturing of various compounds, additional toxicology studies and clinical trials and has already paid for some of the obligations disclosed at December 31, 2005. The net effect of these changes was to increase the purchase obligations disclosed at December 31, 2005 by a total of approximately $8.0 million. These obligations could change during the course of the year depending on the status of each of our development programs.

For purposes of our disclosure of contractual obligations, purchase obligations include commitments related to clinical development, manufacturing and research operations and other significant purchase commitments.

In addition to the contractual obligations disclosed, we have committed to make potential future "sublicense" payments to third-parties related to the in-licensing for some of our development programs. Payments under these agreements generally become due and payable only upon achievement of certain developmental, regulatory and/or commercial milestones. Because the achievement of these milestones is neither probable nor reasonably estimable, such contingencies have not been recorded on our balance sheet.

Critical Accounting Policies

We have established various accounting policies that govern the application of accounting principles generally accepted in the United States, which were utilized in the preparation of our financial statements. Certain accounting policies involve significant judgments and assumptions by management that have a material impact on the carrying value of certain assets and liabilities; management considers such accounting policies to be critical accounting policies. The judgments and assumptions used by management are based on historical experience and other factors, which are believed to be reasonable under the circumstances. Because of the nature of the judgments and assumptions made by management, actual results could differ from these judgments and estimates, which could have a material impact on the carrying values of assets and liabilities and the results of operations.

While our significant accounting policies are more fully described in Note 1 to our financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2005, we believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating our reported financial results and affect the more significant judgments and estimates that we use in the preparation of our financial statements.

Revenue Recognition

Our revenues have generally been limited to license fees, milestone payments, research and development fees, and interest income. Revenue is recognized in accordance with SAB No. 104 and EITF Issue 00-21. License fees, event payments, and research and development fees are recognized as revenue when the earnings process is complete and we have no further continuing performance obligations or we have completed the performance obligations under the terms of the agreement. Fees received under licensing agreements that are related to future performance are deferred and recognized as earned over an estimated period determined by management based on the terms of the agreement and the products licensed. For example, in the Roche and Mundipharma licenses agreements, we have determined to defer the upfront payments over the remaining life of the patents which are 17 years (through August 2023) and 12 years (through October 2017), respectively. In the event a license agreement contains multiple deliverables, we evaluate whether the deliverables are separate or combined units of accounting in accordance with EITF Issue 00-21. Revisions to revenue or profit estimates as a result of changes in the estimated revenue period are recognized prospectively.

Future event payments are recognized as revenue upon the achievement of specified events if (1) the event is substantive in nature and the achievement of the event was not reasonably assured at the inception of the agreement and
(2) the fees are non-refundable and non-creditable. Any event payments received prior to satisfying these criteria are recorded as deferred revenue.

Significant direct costs incurred upon entering into a licensing arrangement, such as our sublicense fees to AECOM and IRL, are deferred and charged to expense in proportion to the revenue recognized. Under the guidance of EITF Issue 99-19, and EITF Issue 01-14, reimbursements received for direct out-of-pocket expenses related to research and development costs are recorded as revenue in the income statement rather than as a reduction in expenses.

Royalty revenue is recognized based on estimates of royalties earned during the applicable period and adjusted for differences between the estimated and actual royalties in the following period. If royalties can not be reasonably estimated, revenue is recognized upon receipt of royalty statements from the licensee. We have not received any royalties from the sale of licensed pharmaceutical products.

Research and Development Expenses

Major components of R&D expenses consist of personnel costs, including salaries and benefits, manufacturing costs, clinical, regulatory, and toxicology services performed by contract research organizations (CRO's), materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. We charge these costs to expense when incurred, consistent with Statement of Financial Accounting Standards No. 2, Accounting for Research and Development Costs. These costs are a significant component of R&D expenses. Most of our manufacturing and our clinical and preclinical studies are performed by third-party CRO's. We accrue costs for studies performed by CRO's over the service periods specified in the contracts and adjust our estimates, if required, based upon our on-going review of the level of services actually performed by the CRO. We expense both our internal and external research and development costs as incurred. We expect our research and development expense to increase as we continue to develop our drug candidates.

Additionally, we have license agreements with third parties, such as AECOM . . .