Totgesagte und Auferstehung - DENDRREON

DNDN hat ein first-in-class-Medikament gegen eine der häufigsten Krebsarten bei Männern auf dem Markt, zugelassen in den USA und - seit Ende 2013 - auch in Europa.

DNDN reduziert seinen Cash-Burn. Überflüssige Produktionsstätten - in rosigeren Zeiten entstanden - wurden verkauft, Mitarbeiter entlassen.

DNDN hält Patente und hat Know-How.

Möglich Szenarien (meine Gedanken)?

Szenario 1:
DNDN rettet sich aus eigener Kraft durch zusätzliche Umsätze in Europa (hier steht man ja mehr auf "Bio" und "kein Gift"). Zudem laufen Studien, die Provenge in Kombi mit Konkurrenzprodukten prüfen. Sollte hier ein deutlicher Zusatznutzen nachgewisen werden, dürfte das ebenfalls den Umsatz steiger. Bei leicht steigendem Umsatz und gesenktem Cash-Burn könnte dies gelingen. Die Schulden bleiben ein Problem, allerdings sollte das bei steigenden Kursen und steigendem Interesse an dem Unternehmen lösbar sein.

Szenario 2
Eine Übernahme findet statt. Beim derzeitigen Kurs hat DNDN eine MK von unter $ 500 Mio. Die Schulden sind für eine große Firma kein PRoblem, die mindern lediglich die Seuern und verbilligen sich somit enorm für den Käufer. Der kann Provenge in sein Sortiment eingleidern und ohne zusätzliche Vetriebsstrukturen verticken, so dass die Margen steigen. Im Falle einer Übernahme sind da 10 $ leicht gerechtfertigt, mehr als 300 % vom derzeitigen Kursniveau entfernt.

Es ist außerdem damit zu rechnen, dass bei positiven Nachrichten jeglicher Art ein Short-Squeeze einsetzt, bei derzeit 35 % leer verkauften Aktien. Seit ich DNDN kenne, war die Firma bereits2 x totgesagt und hat sich dann vom Low vervielfacht. Derzeit ist es wieder mal so weit und viele setzen auf den Untergang. Beim derzeitgen Kursniveau halte ich DNDN aber für so überverkauft und unterbewertet, dass bereits ein kleiner Funke fette Gewinne bringen würde.

Es handelt sich hier um meine persönliche Meinung und ich persönlich trage hier auch mein Risiko. Es kann auch schief gehen. Ich will niemanden anhalten, einzusteigen. Das muss jeder mit sich selber ausmachen, allein.

Gruß s19


 

I believe the success of Provenge along with Dendreon's intellectual property will lead to a buyout. The management of Dendreon believes this also since they are working with JP Morgan to help find a suitable buyer. JP Morgan can use a very recent takeover bid for Algeta as a comparable valuation for Dendreon. Bayer offered $2.4 billion for Algeta, the maker of Xofigo which is another prostate cancer medicine, but an analyst at UBS AG believes the bid will need to be raised to $3 billion. Xofigo is expected to produce revenues in the $600-700 million range by 2016 or roughly 2x current Provenge revenues. Now that Provenge has European approval, it can be expected to have significantly increased revenues by 2016. If the two drugs have equal revenues by 2016 then this comparable sale puts the value of Dendreon in the $2.4 - 3.0 billion range also, 5x - 6x higher than current market capitalization. This value is still significantly lower than the median cost of new drug development by major pharmaceutical companies. Dendreon also has a very enticing net operating loss (NOL) of $2.16 billion that can be used to offset profits from the acquiring company.

Provenge is especially interesting to big pharmaceuticals since it is actually profitable in the hands of Dendreon. Product revenue of $68 million in the most recent quarter is $3.5 million over the costs of product revenue plus research and development. Dendreon's Price/Sales ratio is also one of the lowest in the biotechnology industry at 1.51x vs. 85.84x. In the possession of a large pharmaceutical company, Provenge could be much more profitable. According to estimates compiled by Bloomberg, Provenge may have sales over $370 million since it is now approved in Europe and the U.S. Jason Kolbert, an analyst at Maxim in New York, believes that a company like Johnson & Johnson or Astellas could buy Dendreon and significantly lower costs.

But won't Dendreon run out of cash or go bankrupt without a buyer?

Dendreon has over $233 million in cash, cash equivalents, and short/long term investments. Unfortunately, Dendreon also has high cash burn with a loss from operations of $53.9 million in the three months ended September 30, 2013. The cash burn is something Dendreon is trying to get under control with cost cutting, layoffs, and the sale of facilities.

The acid-test ratio is an indicator of a firm's ability to cover immediate liabilities without selling inventory. It is calculated by:

Dendreon easily passes the test with a value of 1.50 using financials from the 10Q quarterly report. Companies with a ratio less than 1 may have trouble paying current liabilities and should be viewed with caution.

David Strupp, managing director of the life sciences group at Canaccord Adams, says that bankruptcies are rare with biotechnology companies. Biotechs will usually stay in business through mergers, licensing, development deals, or future placements, according to Strupp.

Final thoughts

Dendreon is attractively priced for the speculative investor. Short interest has decreased recently but is still over 35% as a percentage of float. Any strong signals of a buyer could start a major short squeeze while an actual buyout could bring a stock price 5x current levels.

Risks include the lack of a buyer and continued competition from current and future products. If no buyer is found and revenues do not significantly increase, then Dendreon would need to obtain new equity or debt financing. Any new equity financing will dilute the value of current shares.

Plans to present data from ongoing immuno-oncology trials, which further elucidate the product potency and mechanism of PROVENGE, and surrounding investigational compound DN24-02, at ASCO-GU later this month
"Our preliminary fourth quarter results were driven by strong growth in our oncology accounts as well as improvements in urology and academic accounts," said John H. Johnson, chairman, president and chief executive officer of Dendreon. "The DTC campaign is achieving expectations and we continue to experience growth in large accounts, where we see the greatest opportunity. With the increasing amount of data surrounding PROVENGE coming to the marketplace along with a broader understanding of immunotherapy in cancer, we continue to see our KOL support strengthening."

Mr. Johnson concluded, "As we work to accelerate our financial progress, we are pleased to report that our automation efforts are moving forward. Once implemented, we expect automation to significantly lower our cost of goods sold, enabling us to accelerate our path to profitability, which remains a key goal."

Dendreon will present at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA, on January 15, 2014 at 2:30 p.m. PT. The presentation will be webcast live and available for replay from Dendreon's website, www.dendreon.com. If you are unable to listen to the live webcast, it will be archived on the site following the presentation. To access the replay, go to the Investor Relations section of the website.

PROVENGE Indication and Important Safety Information

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1,500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

For more information on PROVENGE, please see the full prescribing information at www.provenge.com or call 1-877-336-3736.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington, and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit www.dendreon.com/.

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements regarding the expected benefits of the recent and prior restructurings, the timing and elements of the restructurings, the timing and form of related charges, the expected annual operating expense reductions, expectations and beliefs regarding Dendreon's financial position, profitability and Dendreon's ability to break even and achieve improved performance as a result of the restructurings, statements regarding sequencing studies, statements regarding studies to advance understanding of immunotherapy and the treatment of advanced prostate cancer, statements regarding biomarkers, expectations about automation or the early detection study, expectations about advancing our pipeline, expectations regarding reductions of cost of goods sold, expectations regarding reimbursement approvals of PROVENGE® in Europe or Dendreon's ability to launch and commercialize PROVENGE in Europe, expectations regarding the presentation of clinical data, developments affecting Dendreon's U.S. and global business and prospects, beliefs and expectations regarding potential revenue and earnings from product sales, including beliefs regarding Dendreon's ability to grow sales, expectations regarding market size, target market, and market opportunity, beliefs regarding the impact of our direct to consumer advertising, expectations with respect to our sales force execution and effectiveness, progress generally on commercialization efforts for PROVENGE, and expectations about clinical trial enrollments. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Dendreon's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, our inability to achieve and sustain commercial success for PROVENGE; the identification of efficacy, safety or other issues with PROVENGE; a slower than anticipated adoption by treating physicians of PROVENGE for the treatment of patients with advanced prostate cancer for a variety of reasons, including competing therapies, instability in our sales force, the risk that we cannot replace vacant sales positions on a prompt basis, perceived difficulties in the treatment process, delays in obtaining reimbursement or for other reasons; any promotional limitations imposed by the FDA or the EU on our ability to commercialize and market PROVENGE; unexpected difficulties and costs associated with the rapid expansion of our commercial operations to support the commercial launch of PROVENGE; the impact of competing therapies on sales of PROVENGE, the failure to achieve reimbursement approvals in Europe, manufacturing or quality difficulties, disruptions or delays and other factors discussed in the "Risk Factors" section of Dendreon's Annual Report on Form 10-Q for the quarter ended September 30, 2013. All forward-looking statements are qualified in their entirety by this cautionary statement. Dendreon is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.



Dendreon Corporation
Corporate Communications
Lindsay Rocco, 862-596-1304
media@dendreon.com

Source: Dendreon Corporation

perfekter Einstieg.
jetzt musst Du nur noch einen guten Ausstieg erwischen.
( ist mir leider nicht gelungen. War mal 1300% (!!) im plus,
 und bin heute knapp im roten Bereich )

Wird interessant, wie sich die Shorties jetzt verhalten...

LG
keyar

mal schaun, es bleibt weiter eine spekulation, auch, wenn die heutige meldung licht am horizont erkennen lässt.  ich bleibe schon noch long. ein partner ins boot oder eine übernahme und peng - dann zieht der kurs durch. das risiko bleibt hoch.
lg
s19

       Recently conducted a constructive meeting with the FDA regarding automation of the PROVENGE manufacturing process; Agency expressed its support for this effort
   Cash on hand of approximately $199 million as of December 31, 2013
   Continue to develop clinical data in the active cellular immunotherapy space
   Plans to present data from ongoing immuno-oncology trials, which further elucidate the product potency and mechanism of PROVENGE, and surrounding investigational compound DN24-02, at ASCO-GU later this month

Dendreon analysts were looking for revenues of $72.89 million, so Dendreon beat by a little less than $2 million. Analysts were looking for a loss of $0.37, but Dendreon did not provide any earnings data with this report. Additionally, CEO John Johnson provided the following commentary on the quarter:

       "Our preliminary fourth quarter results were driven by strong growth in our oncology accounts as well as improvements in urology and academic accounts."

       "The DTC campaign is achieving expectations and we continue to experience growth in large accounts, where we see the greatest opportunity. With the increasing amount of data surrounding PROVENGE coming to the marketplace along with a broader understanding of immunotherapy in cancer, we continue to see our KOL support strengthening."

       "As we work to accelerate our financial progress, we are pleased to report that our automation efforts are moving forward. Once implemented, we expect automation to significantly lower our cost of goods sold, enabling us to accelerate our path to profitability, which remains a key goal."

Good, but not great:

This is the first time that Dendreon beat revenue estimates since the previous year's fourth quarter report, so that is a positive. As Dendreon pointed out, revenues were up approximately 10% over the Q3 period. The Q4 revenue number was also the best quarterly number of 2013, although that is not saying much since revenues for the year were down more than 12% over 2012 levels.

So why I am not extremely impressed by these results? Well, you have to put them in perspective. Although Dendreon beat analyst estimates as of Monday, the quarter still represented a more than $10 million decline over the prior year period, which was above $85 million. Q4 year over year revenues were still down by about 12.5%. Additionally, going into the Q3 report, Dendreon analysts were expecting more than $81 million in revenues. So while Dendreon beat, you have to realize that Q4 expectations came down by almost $9 million between the Q3 report and Monday.

The other item we have to look at is the account data. The following table shows the number of net new accounts over the past six quarters.

Yes, 31 net new accounts was more than the 27 in Q3. But the Q4 number was still the 2nd worst number of 2013, and the 2nd worst of the past six quarters. Additionally, let me go back to the bullet about large accounts.

   100 large accounts in Q4, up from 94 in Q3, 85 in Q2 and 54 in Q1.

So after an increase of 31 large accounts in Q2 and 9 in Q3, just 6 were added in the fourth quarter. In both numerical and percentage terms, that is a slowdown. Again, this goes back to the notion that Q4 was good, but not great. Were Dendreon to come in closer to $80 million in revenues, it would have been a great number. But the company still has not cracked $75 million.

Finally, keep things in perspective. Back in June 2012, analysts were looking for 2013 revenues of more than $507 million. By August 2013, that number was down to about $306.5 million. Dendreon will end up around $285 million or so for 2013. Just think logically. If analysts reduce estimates enough, a beat will be guaranteed. This beat has more to do with estimates plunging than Dendreon having a spectacular quarter.

Update on the financial condition:

One of the reasons I have been so negative on Dendreon is that the company's balance sheet has been getting weaker by the quarter. The company has continued to lose large sums of money, and also burn through cash. Dendreon's original goal was to be cash flow positive from US operations at a $100 million quarterly run rate. Remember, Dendreon is at $75 million now. However, Dendreon announced a new restructuring plan at the Q3 report, and it is working to automate the manufacturing process which will save additional money. That should help cash flow as well. The following table shows key balance sheet numbers at the end of Q3. Dollar values in thousands.

In Monday's press release, Dendreon said that the company had cash on hand of approximately $199 million at the end of the year. That would be down about $34 million from the end of Q3. That would be the best quarterly cash burn number of the year, but it still is not good. Additionally, working capital has been even less than the cash balance. I'm very curious to see all of the balance sheet data.

Dendreon still has a debt payment of nearly $28 million due in a few months. This payment will eat up approximately 14% of Dendreon's cash balance, based on the end of 2013 number. The company's cash number is probably even lower now, because the company is still burning through cash. Dendreon management will need to address these financial concerns on the Q4 conference call. Remember, the company also has debt due in 2016, which was more than $550 million at the end of Q3, and increasing by the quarter. Stockholder's equity is also negative, and getting worse, meaning Dendreon has a lot more liabilities than total assets.

Shorts already covering:

Dendreon has a lot of non-believers, and with good reason as the stock has gone from the $50s to just $3.00 in a few years. The number of short sellers was almost 60 million a couple of months ago. But as I stated in a recent article, the number came down a bit at the end of 2013. More than 11.6 million shares short were covered towards the end of the year, as seen in the chart below.

The end of December short interest number was the first time since February 2013 that the number was under 50 million. Sentiment appeared to be shifting a little as 2013 ended, and I'll have more on the stock price later.

Important questions still remain:

Again, this was a good quarter, but not a great one. I think that is totally fair to say. There are a number of key questions that still need to be answered. Here are the most important ones for Dendreon when it announces the official quarterly result and hold the call. I won't go into detail on these, as I've covered them extensively in this article or past ones.

   How have results in 2014 fared so far?
   When do you expect automation to begin? Do you have any numerical data on how this will impact results?
   What do you plan to do with the 2014 notes due?
   What's the new cash flow breakeven number?
   When is profitability expected?
   Can you update us on the bad inventory?

Dendreon needs to follow through into 2014. If the first quarter of 2014 doesn't show more improvement, then Q4 was just a head fake. The company is still getting closer to the point of needing more cash, so maybe there is an equity offering coming soon. I thought that Dendreon should have announced one last year when the stock was at $5.00 or higher, but it didn't. That might cause a little extra dilution now with the stock a bit lower.

Reaction to stock price:

When I wrote my last Dendreon article in December, I recommended that the stock be shorted but that investors hedge with February $3 call options. At that point, the stock was right around $3.00. Despite Dendreon shares going higher initially after my article, they quickly came back down to around $2.80 last week, at which point I issued the following StockTalk on Seeking Alpha.

Closing out the short position would have made you about 15-25 cents on the short side of the trade if you shorted the day of my article. If you decided to hold those $3 call options, you would have been nicely rewarded on Monday. Had you closed out the options position last week, your net gain on the entire trade would have been 10-15 cents depending on when the trade was executed. Considering how high this market has been going, any chance to make money on a short trade would have been pretty good.

As of 11:10 am on Monday, Dendreon shares were up 35 cents to $3.34. Monday's high was $3.48, which was slightly below the $3.51 December high, and the 200-day moving average around $3.55. It will be interesting to see if Dendreon can break through this technical level in the next few days. It might all depend on any analyst notes that come out.

Final thoughts:

Dendreon announced good results for Q4, which was a pleasant surprise for investors on Monday. However, investors should realize that this report was not great, and Dendreon stock is not going to double overnight on this news. The company still has a long way to go to achieve profitability and positive cash flow. Dendreon may be starting to turn things around, but this is just one quarter. Continued progress needs to be made in Q1 and beyond, and the company might still need to raise some cash. Dendreon shares rallied on Monday and rightly so, and some further short covering may take place. I wouldn't be surprised if shares headed towards $4.00 a share, which is why I'm tagging this article as "Long Ideas", but this company is not out of the woods just yet. There may still be some chances to short Dendreon, and I'll come back if I feel the time is right. Q4 was a step in the right direction, but it is just one step, so investors should not go all in just yet. Dendreon still has a lot to prove.

LG
S19

finance.yahoo.com/news/...n-provenge-sipuleucel-130000408.html

ja, man darf gespannt sein, ob sich aus den neuen daten auch neues umsatzpotenzial ableiten lässt. die allesentscheidende frage ist, ob dndn wieder steigende umsätze und damit ein überleben winken. und da ist der makt bei 29 % shortquote offenbar geteilter meinung (allerdings ist die shortquote zuletzt wieder deutlich gesunken, zuvor war die schon mal bei 35 %).

ich kann aus meiner wahrnehmung heraus investierten derzeit nur empfehlen, die nerven zu behalten. hin- und her ist auf diesem kurslevel riskant, die wahrscheinlichkeit blöd auszusteigen ist hoch. denn: noch immer kann eine positive news das blatt wenden.

es bleibt riskant: das geld ist knapp, die schulden sind hoch, die umsätze gesunken.

aber das kann sich ändern. eeine kooperation, eine zusätzliche indikation für provenge, neue erkenntnisse über die langzeiteffekte von provenge, positive erkenntnisse über kombibehandlungen mit provenge (+ xtandi), eine übernahme, frisches geld usw.).

dann wären fette gewinne die folge, schon wegen der ganzen shorties, die dann ihre positionen eindecken müssen. auf diesen gewinn spekuliere ich.

die volatilität wird hoch bleiben. dndn ist definitiv kein stock, mit dem guter schlaf gefördert wird. wer aber zuvor keine schmerzen erlitten hat, der wird später auch den sieg nicht feiern können.

glück auf,
s19

That's not to say a corner isn't turning for Dendreon. However, it may suggest that investors should consider the quarterly improvement in a broader context. For example, the 10% fourth-quarter lift in the drug's sales is about in line with the 9.6% quarter-over-quarter improvement in the fourth quarter of 2012 and trails the 19.75% sequential change notched in the fourth quarter of 2011.

Since there may be some aspect of seasonality helping drive the sequential lift, it may be helpful to consider how the drug's performance matches up year over year. Unfortunately, that comparison is a bit disheartening, considering that fourth-quarter sales of nearly $75 million last quarter were 12% lower than the $86 million generated in the fourth quarter of 2012. Quarterly sales also trailed the $77 million produced in fourth quarter of 2011.

It's certainly possible that doctors who tried Zytiga and Xtandi last year based on their newness will switch back to Provenge this year. It's also possible that Provenge will see sales benefit from launches overseas. The company won the necessary marketing authorization from EU regulators in September and is probably knee-deep in negotiating with each country's price watchdogs.

It's probably a good bet that Dendreon will face some challenges during those negotiations, since the treatment sells for $93,000 in the United States. It's not uncommon for regulators in the U.K., for example, to balk at such high-priced treatments.

Assuming those price worries can be resolved through discounting, Dendreon has inked a two-year deal with PharmaCell to manufacture the drug in Europe.
However, how much Provenge the company can sell overseas remains uncertain. The company's filing for EU approval sat unaddressed since 2012, while competitors J&J and Medivation got the go-ahead. That's given those two therapies first-to-market footholds that may be hard for Provenge to dislodge.

Dendreon may be on a path to profitability thanks to a dramatic cost-cutting plan launched last summer; this includes cutting 150 jobs and reducin annual costs by $125 million. Benefits from those moves should begin to be felt this year.

That said, there are questions that need to get answered in 2014. Will fourth-quarter momentum continue in Q1? Will countries like the U.K. pay for Provenge? And will eventual EU market share move the profit needle? Until we have those answers, investors may want to take a wait-and-see approach to Dendreon.

Zahlen + Ausblick. Lässt ja ein wenig hoffen...

investor.dendreon.com/releasedetail.cfm?ReleaseID=829488

Dendreon auf die watchlist setzen,wird abgehen heut! ;)