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Dendreon Regnskab


44642 4/8 2011 10:07
Oversigt

Dendreon Reports Second Quarter 2011 Financial Results
- Gross Revenue of Approximately $51MM in Q2 -
- Shift in Launch Trajectory Based on More Gradual Adoption -
- Recent Positive Reimbursement Changes Expected to Have Significant Impact -
- Company Expects Modest Quarter over Quarter Revenue Growth for Remainder of 2011 -
SEATTLE, Aug. 3, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN) today reported results for the second quarter ended June 30, 2011. Net revenue for the quarter ended June 30, 2011 was $49.6 million compared to $2.8 million for the quarter ended June 30, 2010. This included a $1.9 million reserve for estimated rebates and chargebacks associated with either Medicaid patients or other pricing discounts offered pursuant to mandatory federal and state government programs. Gross revenue for the quarter ended June 30, 2011, excluding the impact of $1.9 million in estimated rebates and chargebacks, was $51.4 million compared to $2.8 million for the quarter ended June 30, 2010. Net revenue for the six months ended June 30, 2011 was $77.6 million compared to $2.8 million for the six months ended June 30, 2010. Gross revenue for the six months ended June 30, 2011, excluding the impact of $2.3 million in estimated rebates and chargebacks, was $79.9 million.

Dendreon recorded a GAAP net loss for the quarter ended June 30, 2011 of $114.6 million, or $0.79 per share compared to a net loss of $142.6 million, or $1.04 per share for the quarter ended June 30, 2010. GAAP net loss for the six months ended June 30, 2011 was $226.4 million, or $1.55 per share compared to $268.3 million, or $2.00 per share for the six months ended June 30, 2010.

On a pro-forma basis, excluding non-cash expenses associated with depreciation and amortization, non-cash imputed interest expense, and non-cash deferred stock compensation, Dendreon's net loss for the quarter ended June 30, 2011 was $83.5 million, or $0.57 per share, compared to $130.5 million, or $0.96 per share for the quarter ended June 30, 2010, which included a $0.55 charge for warrant revaluation. The non GAAP net loss for the six months ended June 30, 2011 was $168.9 million , or $1.16 per share, compared to $246.7 million, or $1.84 per share for the six months ended June 30, 2010, which included a $1.06 charge for warrant revaluation. The warrants were exercised during the second quarter of 2010 and as such, the Company will not be recording any further non-cash charges associated with the revaluation of its warrant liability.

Dendreon's total operating expenses for the quarter ended June 30, 2011 were $123.6 million compared to $68.4 million for the three months ended June 30, 2010. Dendreon's total operating expenses for the six months ended June 30, 2011 were $236.5 million compared to $126.1 million for the same period in 2010.

As of June 30, 2011, Dendreon had $673.9 million in cash, cash equivalents, and short-term and long-term investments compared to $277.3 million as of December 31, 2010.

"We believe the market potential for PROVENGE is substantial, and the primary issue affecting the dynamics of our launch is the reimbursement knowledge around PROVENGE. We anticipate the positive National Coverage Determination (NCD) and Q-code will have a significant impact on increased physician adoption. However, we believe this will take time, and for the remainder of 2011, the launch trajectory will reflect a more gradual adoption of PROVENGE as physicians gain confidence in this positive reimbursement landscape," said Mitchell H. Gold, MD, president and chief executive officer. "With the number of infusion sites increasing substantially, our principal objective continues to be ensuring all eligible patients have access to PROVENGE."

Dendreon expects that adoption of the new reimbursement paradigm will take time. Accordingly, Dendreon is withdrawing its previous guidance of $350-400 million in revenue for 2011 and currently expects modest quarter over quarter revenue growth for the remainder of this year.

The Company expects to reduce expenses, including workforce reductions, to align with its near-term manufacturing requirements.

"Our accomplishments this year are foundational as we introduce an entirely new treatment paradigm for patients with advanced prostate cancer," continued Dr. Gold. "These position us well to realize the significant market potential of PROVENGE, and we have identified a solid and clear path to ensuring that the many men who can benefit from it have access to our life-extending drug."

Recent Highlights:

On June 30, 2011, the Centers for Medicare and Medicaid Services (CMS) issued a final NCD for PROVENGE, requiring Medicare contractors to cover on-label use of PROVENGE. The NCD clarifies and simplifies reimbursement for PROVENGE by aligning reimbursement criteria with the FDA label.
On July 1, 2011, PROVENGE was issued a product specific Q-code that allows for electronic submission of claims and accelerates time to payment for physicians; in some cases physicians have seen reimbursement in as little as two weeks.
There is strong physician interest in PROVENGE, as Dendreon has exceeded its projections of number of accounts infusing the product.
The number of accounts infusing PROVENGE at the end of the second quarter increased from approximately 135 to more than 265, exceeding the Company's guidance of 225.
At the end of July, the Company had more than 300 accounts that have infused PROVENGE. In addition, at the end of July there were more than 500 total sites that have completed the in servicing process, of which approximately 360 have either infused the product or have their patients scheduled for their first PROVENGE regimen.
On June 29, 2011, the U.S. Food and Drug Administration (FDA) approved Dendreon's Seal Beach, CA immunotherapy manufacturing facility. The Seal Beach facility, located just outside of Los Angeles, includes 36 workstations.
In April, Dendreon filed a post-approval supplement for its Atlanta facility, for which there is an FDA action date of August 28, 2011.



4/8 2011 10:12 044643



Læg iøvrigt mærke til omsætningen og burn. Omsætningen er 51 MUSD, mens burn er hele 115 MUSD, med 673 MUSD i kassen og forventninger om moderate growth er investorerne lige vågnet op til et chok. Der er penge til 6 kvartaler! Så nu er vi måske lige kommet i emissions territorium.

Læg iøvrigt mærke til DNDN relative valuering på (inden dagens forventede kursfald) på over 5 mia dollars. Det skal ses i relation til Genmab 400 mio dollar. Man kan spørge sig selv om det er fordi Genmab er for lavt værdisat eller DNDN for højt.



4/8 2011 10:17 collersteen 044644



Ja, det var noget af en skuffelse på uptaket. Rundt regnet ender de vel kun omkring 200-250mio USD i år mod 350-400 som forventet.
De skyder skylden på reimbursement - eller den manglende viden derom.

Det lyder altsammen bekendt ift. en anden cancer-behandling som vi ofte diskuterer herinde....

Spgm. er nu om man skal sætte spgm. ved de næste par års uptake som jeg husker som meget kraftigt. Mener der var flere analyser der opererede med 1+mia USD i omsætning årligt indenfor ganske kort tid.



4/8 2011 10:20 044645



Store salgsomkostninger også, så der skal nogle kvartaler med heftig vækst til. Det der undrer er udsigten til moderat vækst?

Vi hørte jo for 4-5 kvartaler, Witty fra GSK, sige at uptake generelt var undertrykt i forhold til det man så tidligere. Den her trend virker konsistent hermed

DNDN




4/8 2011 10:33 044646



Se transcript her for en uddybning af hvad der rører sig i kvartalet. Det er nogle helt specifikke oplysninger om salgstal, salgspris, patienter, antal behandlingssteder etc.

http://www.thestreet.com/story/11209453/4/dendreon-corps-ceo-discusses-q2-2011-results--earnings-call-transcript.html



4/8 2011 10:34 044647



Det er seeking alpha, det gode site, der har det hele:

http://seekingalpha.com/article/284445-dendreon-corp-s-ceo-discusses-q2-2011-results-earnings-call-transcript?source=thestreet



4/8 2011 10:38 044649



Der er tale om lidt af en trukken håndbremse pludselig:

It wasn't until the July revenue was known, and the trends for early August orders came in that we realized the growth would be more gradual than we had anticipated.

Another important question is when will these headwinds subside? We believe that the reimbursement headwinds will indeed subside as physicians gain more experience and more confidence with the new clear and consistent reimbursement environment. But until we can see clear evidence of that changing, we are withdrawing our previous guidance for this year. For the remainder of this year, you should expect to see modest quarter-over-quarter revenue growth while we are resolving these issues.

For the month of August, we continue to see growth with total patients already booked at higher levels than the prior two months. However, the reality is we have staffed our facilities to support the capacity needed for our previous guidance. Given this shift today, we need to reduce expenses, including our workforce to support our near-term capacity and manufacturing requirements. This is clearly a difficult decision and a difficult message to deliver to our employees who are dedicated to our patients.



4/8 2011 11:10 troldmanden 044652



Det må være forventningerne der har været skruet alt for højt op. En vækst på 56% i forhold til forrige Q er da slet ikke dumt



4/8 2011 10:35 collersteen 044648



Her et lille snapshot fra en JPM analyse fra august 2010 med overweight target 66.
Den er sikkert uaktuel nu, men giver nok et fint billede af hvilke forventninger der i hvert fald har været til uptake.... 488 mio USD i 2011. Av av av.

DNDN




4/8 2011 10:43 044650



Iøvrigt apropos royalty rate etc. interessant at se at deres gross Margin faktisk er temmelig lav.

For the quarter, we had a cost of goods sold of approximately $28.8 million, and as a percent of revenue, cost of goods sold was 58%. For the six months ended June 30, 2011, we had a cost of goods sold of approximately $47 million, and as a percent of revenue, cost of goods sold for the first six months was 61%. We saw a slight improvement in our cost of goods sold this quarter as our volumes ramped.



4/8 2011 10:46 044651



Og lidt der smager af J-Code problematik her:

Well, it's a series of things, Cory. First, while we're in capacity-constrained environment, these issues didn't pop up, but it was really as we started to add new accounts online, we moved from the academic medical centers into the community setting, into the community urology and the oncology setting. And the NCD and Q-code just recently got issued and what we are seeing from doctors that are out just today is the community urologist and the community oncologist are much more concerned about the cost entity issue that I described to you than the academic centers. In fact, if you look at our highest volume prescribers today the vast majority of that were in the academic medical centers where they don't have the same imbursement concerns as the community urologist and oncologist.

When we look in the community and we get a sense of how many of them are familiar with the positive reimbursement changes that exist today, only 25% of them are aware of it. The 35% of them that we need to reach out to and educate are confident that we can do that. But, we also know that they're going want to see several incidences of patients moving through and getting positive experiences and positive coverage from their payers and (inaudible) to get comfortable with this new paradigm.

And so what we see in the community that do they these patients sitting in their practices that described to you for earlier, large community oncology account there are about a 1,000 patients there.

But approximately 10% come with programs prescription and the reason is there is patients on the PROVENGE until they get comfortable with this new reimbursement paradigm and they will be more confident that they're going to get paid for these patients.



4/8 2011 11:14 troldmanden 044653



Ja det er netop Provenges store udfordring. For husk på det ikke blot er en masse produktion. Hver eneste behandling skal ind forbi deres produktion og speciel laves til lige præcis denne ene patient. Så det giver bla store logistik omkostninger. Bavarian Nordic mener de f.eks har en god mulighed for næste at kunne udkonkurrere provenge (forsat gode fase 3 data) ved blot at sætte prisen langt lavere. For Dendron kan ikke følge så langt ned




4/8 2011 12:22 troldmanden 044654



Er det mon pga Dendron/Provenge Bava falder med 8%??? I så fald mener jeg det er helt forkert. For Prostvac har som sagt en lang række fordele, herunder ikke mindst muligheden for kun at sælge til den halve pris af Provenge og stadig holde en høj Margin



4/8 2011 12:37 044655



Det er ikke marginerne der presser dendreins kurs mest, men derimod den manglende vækst. Så derfor er det on med bava fald

sent from iPhone



4/8 2011 12:43 troldmanden 044656



Bava er kun værdisat til en brøkdel af Dendron. Så det burde virkligt ikke have nogen effekt. Det er analytikerne der har skruet forventningerne for højt op med en oms på næsten 500 mio dollars. Ved ikke hvad de har tænkt på. Men de har trods alt stadig vækstet 56% i forhold til sidste Q



4/8 2011 12:49 044657



Det er helt ok at bava falder når vi ser på værdisætningen i dansk biotek. Du kan fra collers indlæg se at de skulle ramme 488 før man kunne forsvare kurs 66. Istedet ryger man ud med en melding om 250. Det er halvdelen af estimaterne. Så analytikernevil også med bava tænke 2 ting. Dobbelt så langt uptake eller halvt så stort marked. Når det ryger ind i regnearkene gør det rigtigt rigtigt ondt. Derfor skal bava efter min mening falde idag

sent from iPhone



4/8 2011 12:54 troldmanden 044658



Jeg mener stadig det er de amerikanske analytikere der har skudt over målet med så stor en forventet vækst. Det tror jeg bestemt ikke har været indregnet i Bava. For i så fald ville kursen have været væsentligt højere nu, hvorfor faldet så skulle ske.






4/8 2011 14:30 troldmanden 044665



Puha bava nu nede med 20%......

Nogen der har pre market kurser på dendreon? Hvor meget bliver den handlet ned?



4/8 2011 14:45 044666



kurs 12,9. Nede med Pandora agtige 64%



4/8 2011 14:58 troldmanden 044668



Det er nu stadig vildt at et selskab som har en mcap på 25 mia på den måde skal få så stor betydning på et selskab med en mcap på 1,5 mia. Vi taler jo 2 MEGET forskellige produkter



4/8 2011 13:02 le 044660



det ligner lidt en pandora eller vestas

markedet og folk er ikke i stand til at bedømme vækstaktier korrekt

jeg vil nok ikke købe dndr nu, men synes da at de skal på min obs liste over knækkede aktiekurser for vækstaktier, men nu skal den jo lige åbne først

det er ofte der man kan score gevinster på længere sigt



5/8 2011 18:04 fistandanti 044726



Sikke noget L... med DNDN!!

Nu får DNDN åbenbart også et sagsanlæg på halsen, pga. meget dårlig og misledende guidance. Ved ikke hvor meget kød der er på det eller om man bare ønsker at spinde guld på utilfredse investorer.
http://finance.yahoo.com/news/Kahn-Swick-Foti-LLC-Former-pz-3329819347.html?x=0&.v=1

Jeg tror på sigt at provenges kæmpe markedspotentiale stadig er intakt og at patient efterspørgelsen er der. Udfordringen ligger formodentlig i en bedre og mere informativ kampagne mht. produktet, så flere og flere urologer/onkologer i private regi bliver bedre til at screene de patienter som ligger inde for label use. Nu er der jo også tale om et helt unikt produkt, den første cancervaccine på markedet, som selv FDA i sin tid havde problemer med at klassificere. Og med det velkendte turbulente forløb for provenge indtil nu (2007 ueninghed mellem de to FDA paneler og Medicares høring sidste år) er det forståelig nok at der kan være en skepsis hos lægerne. Ydermere er j og q code først for nyligt trådt i kraft, hvilket også burde lette "salget" af provenge.



5/8 2011 18:25 troldmanden 044729



Det er nærmest standard praksis i US at sagsøge selskaberne hvis de ikke kan leve op til deres budget. Det er jo en national sport at sagsøge folk derover. Jeg ved der også er et søgsmål mod vestas derover fra nogle sure aktionær der ikke forstod hvordan Vestas kunne nedjustere sidste år.

Jeg har endnu ikke helt fået forståelsen for hvordan J code fungere i praksis. For Genmab(Arzerra) har det i hvert fald ikke rigtig haft nogen indflydelse her 6 mdr efter den blev tildelt.



5/8 2011 18:32 collersteen 044731



Det er meget standard, når der sker lidt uventede ting i en given Aktie - se f.eks. her nederst til højre under pressemeddelelser. Allerede få timer efter earnings fra DNDN er den første pressemeddelelse ude fra et advokatfirma.
http://www.marketwatch.com/investing/stock/DNDN




5/8 2011 19:11 fistandanti 044739



Ok, det havde jeg også regnet med.

Fint link som forklarer de forskellige codes i praksis :
http://www.reimbursementcodes.com/



10/8 2011 21:36 collersteen 144916



En lille biotek-huskekage mere!

http://www.marketwatch.com/story/adventrx-plunges-57-on-fda-setback-2011-08-10

Håber godt nok, at vi en dag bliver grundigt belønnet for den risiko vi tager herhjemme i GEN, Bava, Topo, m.fl. så det ikke kun er stifterne og folk med de store drømme der scorer kassen.... og de der fejleksekverer i ledelsen undervejs i processen.



10/8 2011 21:45 troldmanden 044917



Denderon har lige været under $10....

Talte med en biotech analytiker i går. Han ser faktisk Dendreon som en af de pt mest interessante køb overhovedet derude. Så måske man skal til at kigge lidt nærmere på selskabet...... HVIS bare de kan komme 50% indenfor det analytikerne regner med om 2-3 år så er der i hvert fald masser af luft opad



10/8 2011 22:57 butterboy 044921



Jeg har også købt lidt - men igen for tidligt....



10/8 2011 23:10 troldmanden 044923



Ja falder 8,4% i dag til 9,91 og mcap på 1,445 mia



TRÅDOVERSIGT

44642 Dendreon Regnskab
4/8 10:07 1






44647 Det er seeking ..
4/8 10:34 0