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Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Entries in dndn (14)

Monday
Apr092012

DD Education: Which Cell Therapy companies present the best value? Part 2

We developed an analysis using public filings and annualizing the most recent quarters as of 12/31/11. As such, the accuracy is subjective to our proprietary algorithm, and this list is not mean to be all comprehensive.

We conclude that ex leaders Dendreon and MesoBlast make the space very inexpensive. The sample below represents just over $500 million in market cap for eight of the selected public companies (ex DNDN and MSB). These companies have 3 - PIII trials, 5 PII trials and several P1 trials (based on these crude metrics).

We conclude that is worth investors time to understand among these companies in terms of what they are doing and the associated probabilities of success of their trials. Recent data peaks from the Cardiology space suggests that Baxter (BAX) and their CD34 cell type may be very viable. NeoStem has a very similar approach. The retrenchment in MesoBlast shares since that company presented data at AHA in November is of concern. Cytori, Aastrom, Athersys all have active programs in cardiology while Athersys lead program is partnered with Pfizer for Ulcerative Colitis and Aastrom is entering a Phase 3 trial in CLI.

By price ($), Osiris, MesoBlast, and Dendreon are the highest $ priced stocks:

But that starts to change as we migrate to market cap:

And if we eliminate Mesoblast and Dendreon we get a better picture of the rest of the field:


And that picture changes as we adjust for debt and cash: (enterprise value). In all fairness here, we know that NeoStem with $20-$30 million in value from their China generic company, could be the cheapest name and others are / will raise capital but ex China, Athersys is the “cheapest name”.

Looking at R&D spending: IMUC, Prima and NeoStem are among the most efficient but in fairness one must adjust for the fact that Aastrom is embarking on a pivotal trial versus Prima just starting their P3 and NeoStem their P2.

Revenues: Here we have excluded NeoStem’s $65 million from China which means PCT (Cell Therapy CMO) is running at close to $10 million in annual revenues (currently).

Monday
Apr092012

Which Cell Therapy companies present the best value?

In the wake of a robust season of financings, and low valuations we revisit the basic questions in the cell therapy space, updating our tables for year end reported financials. Our numbers are forward looking and subjective to our proprietary algorithm, and this list is not mean to be all comprehensive.

Dendreon and MesoBlast remain the market leaders, but the best values by far are in the micro-cap space with names like Aastrom and PluriStem funded with strong balance sheets.

The sample below represents just over $875 million in market cap for eight of the selected public companies (ex DNDN and MSB). These companies have 3 - PIII trials, 5 PII trials and several P1 trials (based on these crude metrics).

We conclude that is worth investors time to understand among these companies in terms of what they are doing and the associated probabilities of success of their trials.

By price ($), Osiris, MesoBlast, and Dendreon are the highest $ priced stocks: 

By Price ($), Osiris , MesoBlast and Dendreon are the highest $ price:

But that starts to change as we migrate to market cap:

And if we eliminate Mesoblast and Dendreon we get a better picture of the rest of the field:

And that picture changes as we adjust for debt and cash (enterprise value):

Looking at R&D spend gives us an idea of who is spending what on clinical programs:


Tuesday
Apr032012

Stemline Announces Plans to IPO 

Stemline Therapuetics has announced their plans to raise up to $50 million in an IPO. JMP Securities and Oppenheimer have been selected as the banks.

The company hopes to begin a Phase IIb trial next year for two products:SL-401 (third-line acute myelogenous leukemia AML); and SL-701 for newly diagnosed brainstem glioma and second-line glioblastoma multiforme (GBM). Immunocellular (IMUC) is pursuing a similiar indication.  SL-401 is an IL-3 receptor targeting agent. SL-701 is a vaccine composed of alpha-type-1-polarized dendritic cells loaded with synthetic peptides for glioma-associated antigen epitopes plus adjuvant poly-ICLC

Researchers have identified Cancer Stem Cells (CSCs) as the highly malignant "seeds" of tumors, typically comprising 1-5% of the tumor, that give rise to the majority (95-99%) of other tumor cells known as the "tumor bulk".  While standard therapies, including chemotherapy and radiation, may initially shrink tumors by killing tumor bulk, the failure of these therapies to eradicate CSCs may be a major contributor to treatment failure, tumor relapse and poor survival.

Accordingly, we believe that new therapies designed to target CSCs, in addition to tumor bulk, may represent a major advance in the fight against cancer. This premise has formed the basis of our drug development strategy, as illustrated.

Thursday
Mar222012

ImmunoCellular Therapeutics ($IMUC) licenses EphA2 from University of Pittsburgh 

ImmunoCellular Therapeutics (OTCBB: IMUC) has entered into an agreement with University of Pittsburgh under where Pitt has licensed intellectual property to the company surrounding EphA2, a tyrosine kinase receptor that is highly expressed by ovarian cancer and other advanced and metastatic malignancies.

This agreement grants a world-wide exclusive license to the Pitt intellectual property for ovarian and pancreatic cancers, and a world-wide non-exclusive license to the Pitt intellectual property for brain cancer.

Financial terms of the agreement were not disclosed. The company will employ the Pitt intellectual property in the development and commercialization of ICT-140, a multivalent, dendritic cell-based vaccine for the treatment of ovarian cancer.

Please see our other post(s) on IMUC, PrimaBioMed and Merck KG (StimuVax).

Friday
Mar092012

The clock is ticking on Provenge; Dendreon Corp. ($DNDN)

Dendreon Corp. (NASDAQ:DNDN) is a biotechnology company focused on targeting cancer and transforming lives through the discovery, development, commercialization, and manufacturing of novel therapeutics that may significantly improve cancer treatment options for patients. Dendreon's first product, PROVENGE® (sipuleucel-T), is the first autologous cellular immunotherapy to receive FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. 

A North America Equity Research report by JP Morgan released last week evalutes the impact of the Independent Data Monitoring Committee's unanimous recommendation to unblind "the Phase 3 trial of Zytiga in pre-chemo metastatic castration-resistant prostate cancer (mCRPC) patients – the market currently served by DNDN’s Provenge." 

The report states:

"Ultimately we believe CRPC patients are likely to receive several drugs (including DNDN’s Provenge and JNJ’s Zytiga) during the course of their disease (as none of them are “cures”) and note that DNDN is currently conducting a sequencing trial with Provenge and Zytiga (data expected later this year). Today’s news doesn’t impact our valuation as this development was already built into our assumptions. While our overall view is unchanged, we believe the clock is ticking on DNDN to cement use of Provenge into CRPC treatment practice before approval of other drugs in the pre-chemo setting."

Read the full report below. 

JP Morgan Dendreon Report

Friday
Mar092012

Dendrion ($DNDN): J&J unblinds Zytiga trial in chemo-naive CRPC

Johnson & Johnson (NYSE:JNJ) unblinded the Phase III COU-AA-302 trial in chemotherapy-naive castration-resistant prostate cancer after Zytiga plus prednisone showed "evidence of clinical benefit" on the co-primary endpoints of radiographic progression-free survival (PFS) and overall survival (OS) vs. prednisone alone. J&J based the decision on the recommendation of an independent DMC, which conducted an interim analysis. Details of the analysis were not disclosed. The trial enrolled 1,088 chemotherapy-naive patients with asymptomatic or mildly asymptomatic metastatic CRPC.

Zytiga is approved in the U.S. in combination with prednisone to treat patients with metastatic CRPC who have received prior chemotherapy containing docetaxel. Next half, J&J plans to submit an sNDA to FDA, as well as worldwide regulatory applications, for Zytiga to treat men with metastatic CRPC who have not yet received chemotherapy. J&J gained Zytiga through its 2009 acquisition of Cougar Biotechnology Inc., which received rights to the product from BTG in 2004. BTG was up 15.30 to 365p on Thursday. Zytiga is an inhibitor of steroidal enzyme 17 alpha-hydroxylase/C17, 20 lyase (CYP17).

Zytiga would be a potential competitor to Provenge sipuleucel-T, which is marketed by Dendreon Corp. (NASDAQ:DNDN) for asymptomatic or minimally symptomatic metastatic CRPC. Dendreon fell as much as 17% on Thursday before closing off 7%, or $0.76, to $10.11. Provenge consists of autologous dendritic cells loaded with a fusion protein of prostatic acid phosphatase and an immunostimulatory cytokine

Monday
Feb272012

Dendreon Reports- Street is dissapointed by $DNDN

Daily Dose Conclusion: Dendreon reported sales of $77 million, annualizing that would be approx. > $300 mln in rev's. The stock trades today at a $1.8 bln market cap. at 5 x revenues = $1.5 bln but the current revenue run rate is likely to climb as the product penetrates deeper into the market place. A few of the wall street firms have been out with negative to neutral comments and the stock is trading lower, but longer term, we would expect to see DNDN trade up based on traditional valuation metrics.

Dendreon Reports Fourth Quarter and 2011 Year End Financial Results

SEATTLE--(BUSINESS WIRE)-- February 27, 2012--Dendreon Corporation (Nasdaq: DNDN) today reported results for the year and quarter ended December 31, 2011. Product revenue for the year ended December 31, 2011 was $213.5 million compared to $48 million for the year ended December 31, 2010. Product revenue for the fourth quarter of 2011 was $77 million compared to $25 million for the quarter ended December 31, 2010.

The net loss for the year ended December 31, 2011 was $337.8 million, or $2.31 per share, compared to $439.5 million, or $3.18 per share for the year ended December 31, 2010. Net income in the fourth quarter of 2011 was $38.1 million or $0.26 per share, compared to a net loss of $91.8 million, or $0.64 per share, for the same period in 2010. The fourth quarter of 2011 included a royalty payment of $125 million associated with the sale of our VICTRELIS™ (boceprevir) royalty interest. Dendreon's total operating expenses, including cost of product revenue, for the year ended December 31, 2011 were $633.3 million compared to $340.2 million in 2010.

As of December 31, 2011, Dendreon had approximately $617.7 million in cash, cash equivalents, and short-term and long-term investments compared to $277.3 million as of December 31, 2010.

Recent Highlights:

  • Announced the election of John H. Johnson to the position of president and chief executive officer (CEO) and Mitchell H. Gold, MD, as executive chairman, who will serve in that role until June 30, 2012, at which point he will continue to serve as a director and Mr. Johnson will become chairman.
  • At the end of the fourth quarter, completed in-servicing for more than 840 total sites, of which:
    • More than 590 sites have infused PROVENGE® (sipuleucel-T).
    • Approximately 615 sites have either infused the product or have their patients scheduled for their first PROVENGE regimen.
  • Improved PROVENGE reimbursement landscape for customers and patients:
    • Reported average time to payment is less than 30 days for physicians, which is better than industry standard, reflecting an improved reimbursement landscape due to a national coverage decision and activation of a Q-code that accelerates electronic adjudication of claims.
    • The Centers for Medicare and Medicaid Services (CMS) updated their coverage policy to now cover the infusion costs associated with the administration of PROVENGE. With this decision, the coverage of PROVENGE is now consistent with all other infused biologics.
    • A recent analysis suggests that approximately 75% of patients had minimal or no out-of-pocket costs for PROVENGE.
  • Filed the marketing authorization application (MAA) for PROVENGE with the European Medicines Agency, which was validated in January.
  • Began enrollment in its clinical study evaluating PROVENGE and abiraterone.

"Dendreon has embraced the challenge of introducing an entirely new treatment paradigm for an entirely new market and has made important progress towards establishing PROVENGE as the foundation of care," said John H. Johnson, president and chief executive officer.

Wednesday
Feb222012

Dendreon (DNDN): Reports Monday Feb 27 at 9:00 am

Dendreon Announces New Time for Fourth Quarter and Year-End Financial Results Conference Call and Webcast Presentations at Upcoming Conferences

Call to be held on Monday, February 27, 2012, at 9:00 a.m. ET

SEATTLE--(BUSINESS WIRE)-- February 22, 2012 — Dendreon Corporation (Nasdaq: DNDN) today announced that management will host a conference call on Monday, February 27, 2012, at 9:00 a.m. ET to review fourth quarter and year-end financial results. This conference call was previously scheduled at 4:30 p.m. ET on the same date.

Access to the discussion may be obtained as follows:

Time:

 

 

 

 

 

9:00 a.m. ET / 6:00 a.m. PT

Date:

         

February 27, 2012

Dial-in:

         

1-877-548-9590 (domestic) or +1-720-545-0037 (international);

           

conference pass code: 46511476

Webcast:

         

www.dendreon.com (homepage and investor relations section)

           

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-800-585-8367 or +1-404-537-3406 for international callers; the conference ID number is 46511476. The replay will be available from 12:00 p.m. ET on Monday, February 27, until 11:59 p.m. ET on Monday, March 5. In addition, the webcast will be archived for on-demand listening for 90 days at www.dendreon.com.

In addition, Dendreon Corporation also announced that management will present at the following conferences:

  • RBC Capital Markets' Healthcare Conference in New York City, on February 28, 2012, at 3:35 p.m. ET
  • Citi 2012 Global Healthcare Conference in New York City, on February 29, 2012, at 2:00 p.m. ET

The presentations will be audio webcast live and available for replay from Dendreon's website, www.dendreon.com. If you are unable to listen to the live webcasts, they will be archived on the site following the presentation. To access the replays, go to the Investor Relations section of the website.

Daily Dose Conclusion: Look for strong numbers this time around in Dendreon but remember that good numbers are baked intot he current share price that has rebounded from the lows this summer.  Immunocellular (IMUC) is a compelling value play to Dendrion these days.