En af de mest omtalte biotek selskaber på denne kanal har tidligere været Dendreon. De kom på markedet efter stor drama med masser af tovtrækkeri med FDA. Nu er de så godkendt og er på markedet. Og problemerne er langt fra slut. På trods af en pæn stigning i omsætning på 66% til 80 mill dollar, bliver der stadig brændt voldsomt mange penge i kvartalet. Og vi er nede på en cash beholdning der kan holde 5 kvartaler til. Det er et kapløb med tiden. Nu skærer man så også i nogle af sine produktionsfaciliteter.
Det er nok engang værd at holde fast i sondringen mellem omsætning og royalty. En har en Margin, den anden ikke og det på den gode måde idet 100% ikke har nogen Margin
SEATTLE--(BUSINESS WIRE)-- July 30, 2012--Dendreon Corporation (NASDAQ:DNDN) today reported results for the quarter ended June 30, 2012. Net product revenue for the quarter was $80.0 million compared to $48.1 million for the quarter ended June 30, 2011, up 66% year over year and down 2.4% on a sequential basis.
Net loss in the second quarter of 2012 was $96.1 million or $0.65 per share, compared to a net loss of $116.0 million, or $0.79 per share, for the same period in 2011. The current period includes approximately $5.2 million in cash and non-cash severance expenses. Excluding these expenses, the company had a net loss of $90.9 million or $0.61 per share.
As of June 30, 2012, Dendreon had approximately $509.7 million in cash, cash equivalents, and short-term and long-term investments compared to $617.7 million as of December 31, 2011.
Recent Highlights:
Announced strategic restructuring to accelerate path to profitability and future growth:
The Company expects to reduce costs by approximately $150 million annually.
The Company expects a reduction in headcount of more than 600 positions, including contractors, over the next 12 months.
The Company expects to reduce its cost of goods sold (COGS) to less than 50 percent of net product revenue following the closure of the Morris Plains, NJ facility.
Full implementation of the restructuring is expected to take 12 months. Once implemented the Company will be positioned to be cash flow positive when net product revenue reaches approximately $100 million in a quarter, a 20% improvement from prior guidance.
Continued new physician interest in PROVENGE® (sipuleucel-T):
Added 115 new accounts in the second quarter, up from 84 new infusing accounts last quarter. Total number of infusing accounts in now at 687.
Reimbursement landscape remains stable for physicians:
Reported average time to payment remains less than 30 days for physicians
Q-Code remains in effect and CMS are updating coverage policies for PROVENGE
Presented important findings at the American Urological Association and American Society of Clinical Oncology annual meetings:
Retrospective analysis of IMPACT trial by baseline PSA quartile suggested PROVENGE extended median overall survival in all subgroups with a trend toward an increased magnitude of treatment benefit in patients with a lower baseline PSA.
Patients with localized prostate cancer in an open-label Phase 2 trial called NeoACT, received three infusions of PROVENGE prior to radical prostatectomy. Investigators found significant increases ( > 3-fold) in CD3+ and CD4+ T-cells populations at the tumor rim between the interface of benign and malignant tissue when compared with the pretreatment biopsy tissue. Results from these analyses support further evaluation of PROVENGE in the neoadjuvant setting. PROVENGE is not currently indicated for neoadjuvant treatment of localized prostate cancer.
"We are confident in the long-term opportunities for PROVENGE," said John H. Johnson, chairman, president and chief executive officer. "We believe the strategic restructuring plan announced today will accelerate our path to profitability and future growth as we execute on our core mission of providing PROVENGE to patients around the world. By re-configuring our manufacturing model, strengthening our commercial organization and lowering our overall cost structure, we believe we can deliver Value to our shareholders and our physician customers and their patients."
Det er nok engang værd at holde fast i sondringen mellem omsætning og royalty. En har en Margin, den anden ikke og det på den gode måde idet 100% ikke har nogen Margin
SEATTLE--(BUSINESS WIRE)-- July 30, 2012--Dendreon Corporation (NASDAQ:DNDN) today reported results for the quarter ended June 30, 2012. Net product revenue for the quarter was $80.0 million compared to $48.1 million for the quarter ended June 30, 2011, up 66% year over year and down 2.4% on a sequential basis.
Net loss in the second quarter of 2012 was $96.1 million or $0.65 per share, compared to a net loss of $116.0 million, or $0.79 per share, for the same period in 2011. The current period includes approximately $5.2 million in cash and non-cash severance expenses. Excluding these expenses, the company had a net loss of $90.9 million or $0.61 per share.
As of June 30, 2012, Dendreon had approximately $509.7 million in cash, cash equivalents, and short-term and long-term investments compared to $617.7 million as of December 31, 2011.
Recent Highlights:
Announced strategic restructuring to accelerate path to profitability and future growth:
The Company expects to reduce costs by approximately $150 million annually.
The Company expects a reduction in headcount of more than 600 positions, including contractors, over the next 12 months.
The Company expects to reduce its cost of goods sold (COGS) to less than 50 percent of net product revenue following the closure of the Morris Plains, NJ facility.
Full implementation of the restructuring is expected to take 12 months. Once implemented the Company will be positioned to be cash flow positive when net product revenue reaches approximately $100 million in a quarter, a 20% improvement from prior guidance.
Continued new physician interest in PROVENGE® (sipuleucel-T):
Added 115 new accounts in the second quarter, up from 84 new infusing accounts last quarter. Total number of infusing accounts in now at 687.
Reimbursement landscape remains stable for physicians:
Reported average time to payment remains less than 30 days for physicians
Q-Code remains in effect and CMS are updating coverage policies for PROVENGE
Presented important findings at the American Urological Association and American Society of Clinical Oncology annual meetings:
Retrospective analysis of IMPACT trial by baseline PSA quartile suggested PROVENGE extended median overall survival in all subgroups with a trend toward an increased magnitude of treatment benefit in patients with a lower baseline PSA.
Patients with localized prostate cancer in an open-label Phase 2 trial called NeoACT, received three infusions of PROVENGE prior to radical prostatectomy. Investigators found significant increases ( > 3-fold) in CD3+ and CD4+ T-cells populations at the tumor rim between the interface of benign and malignant tissue when compared with the pretreatment biopsy tissue. Results from these analyses support further evaluation of PROVENGE in the neoadjuvant setting. PROVENGE is not currently indicated for neoadjuvant treatment of localized prostate cancer.
"We are confident in the long-term opportunities for PROVENGE," said John H. Johnson, chairman, president and chief executive officer. "We believe the strategic restructuring plan announced today will accelerate our path to profitability and future growth as we execute on our core mission of providing PROVENGE to patients around the world. By re-configuring our manufacturing model, strengthening our commercial organization and lowering our overall cost structure, we believe we can deliver Value to our shareholders and our physician customers and their patients."
31/7 2012 13:54 TheBekkers 2
59565 Ja, det siger jo rigtigt meget omkring deres dyre produktionsmetode, at de skal op på en omsætning på 100 mio. $ per kvartal for at være cashflow neutrale.
Vil gerne påpege to ting i relation til BAVA og Denderon, og når man sammenligner dem.
1. Vedr. omsætningen, så er det relevant at sammenligne dem, da vi får et indblik i cancervacciners potentialle, hvis PROSTVAC godkendes.
2. Vedr. Margin per solgt enhed, dvs. virksomhedernes overskud som følge af en godkendelse, så kan BAVA og Denderon ikke sammenlignes. BAVA produkt er langt billigere / nemmere at fremstille, hvilket BAVA senest har bevist ved deres kostpris på en Imvamune-vaccine.
Så de to aktier skal være korreleret i forhold til Aktiekurs, men altså kun hvis årsagen til op- og nedjusteringerne hos Dendereon sker på punkt 1 men ikke som følge af punkt 2. Det er lidt ærgeligt, når journalisten misser denne pointe.
/TheBekkers
Vil gerne påpege to ting i relation til BAVA og Denderon, og når man sammenligner dem.
1. Vedr. omsætningen, så er det relevant at sammenligne dem, da vi får et indblik i cancervacciners potentialle, hvis PROSTVAC godkendes.
2. Vedr. Margin per solgt enhed, dvs. virksomhedernes overskud som følge af en godkendelse, så kan BAVA og Denderon ikke sammenlignes. BAVA produkt er langt billigere / nemmere at fremstille, hvilket BAVA senest har bevist ved deres kostpris på en Imvamune-vaccine.
Så de to aktier skal være korreleret i forhold til Aktiekurs, men altså kun hvis årsagen til op- og nedjusteringerne hos Dendereon sker på punkt 1 men ikke som følge af punkt 2. Det er lidt ærgeligt, når journalisten misser denne pointe.
/TheBekkers
31/7 2012 20:30 fistandanti 059594 Ja, Provenges omsætning vil give et billed af det potentielle marked for Prostvac, hvilket tilsyneladende ikke tegner lovende. Ingen tvivl om at en del af årsagen tilskrives provenges besværlige fremstillings- og behandlingsprocedure, men andre forhold gør sig også gældende og på disse områder differentierer Prostvac sig ikke.
1) Urologer/onkologer er stadig skeptiske overfor cancervacciner, der ses ikke målbare forandringer (PSA stiger stadig, ingen tumor-reduktion, PFS uændret). Mangelfuld screening til at identificere PS patienterne indenfor label´en
2) Øgede kompetetive omstændigheder pga. Zytiga off-label, som muligvis kan nå en godkendelse i præ-kemo gruppen, samt forventet nyt produkt fra Medivation (Enzalutamid). Dette betyder at det potentielle behandlingsvindu for Prostvac også indskrænkes.
DNDN understreger at det skuffende salg (som faldt 2,4 % Q2 i forhold til Q1), ikke skyldes konkurrence fra Zytiga. De nævner at Provenge og Zytiga i stedet kan supplere hinanden, men investorerne er forståelig nok skeptiske.
1) Urologer/onkologer er stadig skeptiske overfor cancervacciner, der ses ikke målbare forandringer (PSA stiger stadig, ingen tumor-reduktion, PFS uændret). Mangelfuld screening til at identificere PS patienterne indenfor label´en
2) Øgede kompetetive omstændigheder pga. Zytiga off-label, som muligvis kan nå en godkendelse i præ-kemo gruppen, samt forventet nyt produkt fra Medivation (Enzalutamid). Dette betyder at det potentielle behandlingsvindu for Prostvac også indskrænkes.
DNDN understreger at det skuffende salg (som faldt 2,4 % Q2 i forhold til Q1), ikke skyldes konkurrence fra Zytiga. De nævner at Provenge og Zytiga i stedet kan supplere hinanden, men investorerne er forståelig nok skeptiske.
Hej PI´er, fandt lige denne artikel der blev skrevet lige efter regnskabet.
Tak for godt indhold i jeres indlæg, det hjælper meget for en newbie som mig.. :)
"The biggest question facing Dendreon is how big the demand for Provenge is - and it's difficult to be certain what the answer is".
http://www.forbes.com/sites/matthewherper/2012/07/31/the-key-question-for-dendreon-is-there-demand-for-provenge/
Venlig hilsen Bosack.
Tak for godt indhold i jeres indlæg, det hjælper meget for en newbie som mig.. :)
"The biggest question facing Dendreon is how big the demand for Provenge is - and it's difficult to be certain what the answer is".
http://www.forbes.com/sites/matthewherper/2012/07/31/the-key-question-for-dendreon-is-there-demand-for-provenge/
Venlig hilsen Bosack.
