By Gene Marcial Because of the big decline in the shares of Spectrum Pharmaceuticals, the company has become even more vulnerable as a takeover candidate. But the company may opt to get bigger and have a larger presence in the industry by acquiring another company with a promising innovative drug — and think of a merger or sale afterward. …read more
Source: FULL ARTICLE at Forbes Health
By Business Wirevia The Motley Fool
Filed under: Investing
Spectrum Pharmaceuticals Initiates Phase 2 Study of Long-Acting GCSF Drug Candidate, SPI-2012, for the Treatment of Chemotherapy-Induced Neutropenia
HENDERSON, Nev.–(BUSINESS WIRE)– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the Company has initiated a Phase 2 clinical program for SPI-2012 (also referred to as “LAPS-GCSF”), a drug candidate for the treatment of chemotherapy-induced neutropenia that utilizes partner Hanmi Pharmaceutical Company‘s proprietary LAPSCOVERY™ Technology. This technology, as shown in preclinical models, permits greater marrow penetration and retention of G-CSF when compared to naked CSF and avoids elimination through kidney. In a previous Phase 1 trial in healthy volunteers SPI-2012 showed increase in neutrophil count similar to Neulasta® (pegfilgrastim) at one-third the dose.
“We are excited to begin mid-stage clinical studies for a drug candidate that can become a key component of Spectrum’s long-term growth,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Chemotherapy-induced neutropenia constitutes a large global market estimated to be over $5 billion, and there is preliminary evidence showing SPI-2012 may have advantages over the comparator regarding the intensity and duration of neutrophil recovery. We look forward to the continued study of this product candidate, which we believe has the potential to address continued unmet medical needs by studying the opportunity to minimize the risks from chemotherapy induced neutropenia.”
Spectrum’s phase 2 trial is a multicenter, open label, dose-ranging study, with a non-inferiority design to compare the effectiveness of SPI-2012 relative to a fixed and standard dose of pegfilgrastim as a concurrent active control to each dose of SPI-2012. The primary objective and endpoint of this study is to assess the effect of test doses of SPI-2012 on the mean duration of severe neutropenia during Cycle 1 in patients with breast …read more
Source: FULL ARTICLE at DailyFinance
By Sean Williams, The Motley Fool
Filed under: Investing
Although the Nasdaq Composite is the only major U.S. index that’s nowhere near its all-time high, it still turned in an impressive gain of 8.2% for the quarter. Gains were broad-based, with everything from technology and health care to energy and financials helping the index.
However, the optimism among investors wasn’t shared by some. Weakening consumer-confidence figures in recent months would suggest that consumers are more cautious about the overall economy — a perfect scenario to persuade short-sellers to dig in their claws. Here’s a look at the five most hated stocks in the Nasdaq Composite that have drawn the ire of short-sellers:
|
Company |
Short Interest As a % of Shares Outstanding |
|---|---|
|
Coinstar |
50.12% |
|
Spectrum Pharmaceuticals |
44.47% |
|
Questcor Pharmaceuticals |
43.10% |
|
Uni-Pixel |
42.73% |
|
SodaStream International |
39.96% |
Source: S&P Capital IQ.
As we’ve done previously, I suggest we look at the various reasons why short-sellers may have homed in on these five companies and decide whether the pessimism is justified.
Coinstar
Why are investors shorting Coinstar?
Is this short interest deserved?
Spectrum Pharmaceuticals
Why are investors shorting Spectrum Pharmaceuticals?
Is this short interest deserved?
Questcor Pharmaceuticals
Why are investors shorting …read more
Source: FULL ARTICLE at DailyFinance
By Business Wirevia The Motley Fool
Filed under: Investing
Hagens Berman Reminds Spectrum Pharmaceuticals Investors of May 13, 2013, Deadline in Securities Lawsuit
BERKELEY, Calif.–(BUSINESS WIRE)– Hagens Berman Sobol Shapiro LLP, a national investor-rights law firm, reminds Spectrum Pharmaceuticals, Inc. (NAS: SPPI) investors of the May 13, 2013, lead plaintiff deadline in a pending lawsuit filed on their behalf. Investors who suffered financial losses can contact Hagens Berman Partner Reed Kathrein, who is leading the firm’s investigation, by emailing SPPI@hbsslaw.com.
The lawsuit filed in U.S. District Court identifies a class of Spectrum investors who purchased stock in the company between August 8, 2012, and March 12, 2013, inclusive (the “class period”). Investors who wish to move to be a lead plaintiff in the case may also contact the firm by calling (510) 725-3000 and must move the court no later than May 13, 2013. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member.
On March 12, 2013, Spectrum disclosed to investors that it would significantly lower its 2013 revenue guidance on concerns that sales of its drug FUSILEV would be lower than expected. Following the disclosure, Spectrum’s stock price fell dramatically, from a close of $12.43 per share on March 12 to a close of $7.79 per share on March 13. The stock has continued to trade at or around $7.00 since the disclosure.
Hagens Berman‘s investigation centers around whether Spectrum knew and failed to disclose to investors concerns about the sales of FUSILEV.
Hagens Berman reminds whistleblowers with inside information that rewards may be available to individuals who report information leading to a successful enforcement action by the Securities and Exchange Commission. Under the new SEC whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC.
More information about this investigation is available at http://www.hb-securities.com/investigations/SPPI.
Hagens Berman Sobol Shapiro LLP is an investor-rights class-action law firm with offices in 10 cities. The Firm represents investors, whistleblowers, workers and consumers in complex litigation. More about the law firm and its successes can be found at www.hbsslaw.com. The Firm’s securities law blog is at http://www.meaningfuldisclosure.com.
By Keith Speights, The Motley Fool
Filed under: Investing
What a month! The Dow set all-time highs. So did the S&P 500. But March wasn’t so great for everyone. While the big indexes enjoyed the thrill of victory, these three biotechs experienced the agony of defeat. Here’s what happened.
Serious impact
Impax Laboratories suffered from a comedy of errors. Unfortunately, the impact on its shares wasn’t so funny. Shares sank more than 22% during the month.
The culprit for the stock decline was none other than Impax itself. Back in March of last year, the Food and Drug Administration conducted an inspection of the company’s manufacturing facility in Hayward, Calif. Impax Labs had plenty of time to correct those problems. However, when the FDA completed its follow-up inspection earlier this month — one year later, three of the same problems were cited again. To make things worse, the FDA found nine new issues.
In response to the problems, CEO Larry Hsu stated that the company “committed significant resources in [its] efforts to meet FDA requirements.” Obviously, those resources and efforts weren’t enough.
A long fuse
With a long fuse on a stick of dynamite, you know the explosion is still coming, even if it might take a little longer. The same type of situation has applied for Spectrum Pharmaceuticals . Many observers have expected for quite a while that Fusilev sales would eventually bomb. The explosion finally came in March, resulting in about a 35% drop in Spectrum’s shares.
Critics have been saying for months that sales for non-Hodgkin’s lymphoma drug Fusilev would fall as providers turned to generic alternatives. Fusilev enjoyed an extended period of high sales volumes resulting largely from shortages of generic leucovorin, driving Spectrum’s revenue up tremendously. However, that shortage ultimately ended as Teva and Sagent Pharmaceuticals cranked out more supply.
The anticipated firestorm hit in mid-March after Spectrum announced revenue guidance 40% lower than previously expected.This huge guidance cut stemmed from hospitals that switched to generics. No surprise there. Spectrum insisted that demand for Fusilev in clinics was “stable” and that “solid demand” was anticipated for 2013. Unfortunately for Spectrum, “stable” and “solid” aren’t words that can be accurately used to describe its stock these days.
The biggest crash of all
Impax and Spectrum might have had bad months, but at least they still look better than Ziopharm Oncology . Ziopharm’s stock collapsed more than 60% in March following bad news from a late-stage clinical trial this week.
The company had high hopes that palifosfamide would prove to be a potent treatment for metastatic soft tissue sarcoma. However, the drug failed to significantly improve progression-free survival, the primary endpoint of the phase 3 clinical study. Despite the study’s independent data monitoring committee’s recommendation for continued analysis to follow up on overall survival rates, Ziopharm decided to pull the plug on the program entirely.
What’s next for Ziopharm? The company says it will now regroup and focus on its synthetic biology programs.
Rising from the ashes<br …read more
Source: FULL ARTICLE at DailyFinance
By Business Wirevia The Motley Fool
Filed under: Investing
CORRECTING and REPLACING Abraham, Fruchter & Twersky, LLP Announces That a Class Action Lawsuit Has Been Filed against Spectrum Pharmaceuticals, Inc.
NEW YORK–(BUSINESS WIRE)– Fourth graph, first sentence of release should read: If you purchased the common stock of Spectrum from August 8, 2012 through March 12, 2013 (the “Class”) and you wish to serve as lead plaintiff in this action, you must move the Court no later than May 13, 2013. (sted May 16, 2013).
The corrected release reads:
ABRAHAM, FRUCHTER & TWERSKY, LLP ANNOUNCES THAT A CLASS ACTION LAWSUIT HAS BEEN FILED AGAINST SPECTRUM PHARMACEUTICALS, INC.
Abraham, Fruchter & Twersky, LLP announces that a securities class action lawsuit has been filed in the United States District Court for the District of Nevada on behalf of all persons or entities who purchased the common stock of Spectrum Pharmaceuticals, Inc. (“Spectrum” or the “Company”) (NAS: SPPI) from August 8, 2012 through March 12, 2013, inclusive (the “Class Period“). The complaint alleges violations of Section 10(b) of the Securities and Exchange Act of 1934 and Rule 10b-5, promulgated thereunder, against the Company and certain of its officers and directors.
The complaint alleges that throughout the Class Period, defendants made false and misleading statements to the investing public by dismissing concerns that sales of FUSILEV® (an oncology drug manufactured by Spectrum) would be adversely affected by increased supplies of leucovorin (a generic and competing drug of FUSILEV) and concealing the impact that the increased availability of leucovorin would have on FUSILEV sales. The complaint alleges that the defendants knew that when the availability of leucovorin increased, Spectrum would not be able to sustain its business outlook and revenue projections.
After the market closed on March 12, 2013, Spectrum surprised the market by reporting in a press release that sales of FUSILEV would be dropping significantly due to “a change in ordering patterns of FUSILEV.” The Company also decreased their full-year 2013 revenues forecast to a range of $160 to $180 million, significantly lower than analysts’ revenue expectations of $297.33 million. In a reaction to this news, shares of Spectrum common stock fell $4.64 per share, or 37%, on extremely high trading volume of 22.5 million shares.
If you purchased the common stock of Spectrum from August 8, 2012 through March 12, 2013 (the “Class”) and you wish to serve as lead plaintiff in this action, you must move the Court no later than …read more
Source: FULL ARTICLE at DailyFinance
By Business Wirevia The Motley Fool
Filed under: Investing
Abraham, Fruchter & Twersky, LLP Announces That a Class Action Lawsuit Has Been Filed against Spectrum Pharmaceuticals, Inc.
NEW YORK–(BUSINESS WIRE)– Abraham, Fruchter & Twersky, LLP announces that a securities class action lawsuit has been filed in the United States District Court for the District of Nevada on behalf of all persons or entities who purchased the common stock of Spectrum Pharmaceuticals, Inc. (“Spectrum” or the “Company”) (NAS: SPPI) from August 8, 2012 through March 12, 2013, inclusive (the “Class Period“). The complaint alleges violations of Section 10(b) of the Securities and Exchange Act of 1934 and Rule 10b-5, promulgated thereunder, against the Company and certain of its officers and directors.
The complaint alleges that throughout the Class Period, defendants made false and misleading statements to the investing public by dismissing concerns that sales of FUSILEV® (an oncology drug manufactured by Spectrum) would be adversely affected by increased supplies of leucovorin (a generic and competing drug of FUSILEV) and concealing the impact that the increased availability of leucovorin would have on FUSILEV sales. The complaint alleges that the defendants knew that when the availability of leucovorin increased, Spectrum would not be able to sustain its business outlook and revenue projections.
After the market closed on March 12, 2013, Spectrum surprised the market by reporting in a press release that sales of FUSILEV would be dropping significantly due to “a change in ordering patterns of FUSILEV.” The Company also decreased their full-year 2013 revenues forecast to a range of $160 to $180 million, significantly lower than analysts’ revenue expectations of $297.33 million. In a reaction to this news, shares of Spectrum common stock fell $4.64 per share, or 37%, on extremely high trading volume of 22.5 million shares.
If you purchased the common stock of Spectrum from August 8, 2012 through March 12, 2013 (the “Class”) and you wish to serve as lead plaintiff in this action, you must move the Court no later than May 16, 2013. Any member of the proposed class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain a member of the proposed class.
If you would like to discuss this action or if you have any questions concerning this notice or your rights as a potential class member or lead plaintiff, you may contact: Arthur J. Chen of Abraham, Fruchter & Twersky, LLP toll free at (800) 440-8986, or via e-mail at info@aftlaw.com or achen@aftlaw.com.
Abraham, Fruchter & Twersky, LLP has extensive experience in securities class action cases, and …read more
Source: FULL ARTICLE at DailyFinance
By Business Wirevia The Motley Fool
Filed under: Investing
Hagens Berman Notifies Spectrum Pharmaceuticals Investors of Pending Class-Action Lawsuit and May 13, 2013, Lead Plaintiff Deadline
BERKELEY, Calif.–(BUSINESS WIRE)– Hagens Berman Sobol Shapiro LLP, a national investor-rights law firm, is investigating Spectrum Pharmaceuticals, Inc. (NAS: SPPI) (“Spectrum” or “The Company”) following the filing of a class-action lawsuit on behalf of investors. The firm encourages those who have suffered losses to contact Hagens Berman Partner Reed Kathrein, who is leading the Firm’s investigation, by emailing SPPI@hbsslaw.com.
A class-action lawsuit filed in U.S. District Court identifies a class of Spectrum investors who purchased stock in the company between August 8, 2012, and March 12, 2013, inclusive (the “class period”). Those who suffered significant losses and wish to move to be a lead plaintiff may also contact the firm by calling (510) 725-3000.
Investors who wish to serve as lead plaintiff in the case must move the court no later than May 13, 2013. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member.
On March 12, 2013, Spectrum disclosed to investors that it would significantly lower its 2013 revenue guidance on concerns that sales of its drug FUSILEV would be lower than expected. Following the disclosure, Spectrum’s stock price fell dramatically, from a close of $12.43 per share on March 12 to a close of $7.79 per share on March 13. The stock has continued to trade at or around $7.00 since the disclosure.
Hagens Berman‘s investigation centers around whether Spectrum knew and failed to disclose to investors concerns about the sales of FUSILEV.
“We are concerned that Spectrum knew that generic competition would substantially impact the company’s revenues and failed to disclose these concerns to investors,” said Mr. Kathrein. “We believe the company’s alleged failure to come clean with investors about these issues may have artificially inflated the stock price, resulting in very significant investor losses.”
Hagens Berman reminds whistleblowers with inside information that rewards may be available to individuals who report information leading to a successful enforcement action by the Securities and Exchange Commission. Under the new SEC whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC.
More information about this investigation is available at http://www.hb-securities.com/investigations/SPPI.
By Business Wirevia The Motley Fool
Filed under: Investing
Spectrum Pharmaceuticals Shareholder Alert: Briscoe Law and Powers Taylor Investigate Possible Breaches of Fiduciary Duty by Officers and Directors
DALLAS–(BUSINESS WIRE)– Former United States Securities and Exchange Commission attorney Willie Briscoe, founder of The Briscoe Law Firm, PLLC, and the securities litigation firm of Powers Taylor, LLP announce that a federal class action lawsuit has been filed against Spectrum Pharmaceuticals, Inc. (“Spectrum Pharmaceuticals” or “Company”) (NasdaqGS: SPPI). The firms are investigating additional legal claims against the officers and Board of Directors of Spectrum Pharmaceuticals during the period of August 8, 2012 to March 12, 2013 (the “Class Period”).
If you are an affected investor and you want to learn more about the lawsuit or join the action, contact Willie Briscoe at The Briscoe Law Firm, PLLC, (214) 239-4568, or via email at WBriscoe@TheBriscoeLawFirm.com, or Zachary Groover at Powers Taylor, LLP, toll free (877) 728-9607, via email at zach@powerstaylor.com. There is no cost or fee to you.
In a recently filed federal class action complaint, Spectrum Pharmaceuticals and certain of its officers and directors were charged with violating certain provisions of the Securities Exchange Act of 1934. Specifically, the complaint alleges that among other things, defendants’ misrepresented and/or failed to disclose that: (a) Spectrum’s sales of FUSILEV would drastically decline once the generic folate analong, leucovorin, was made available; (b) despite advertised advantages of FUSILEV over leucovorin, it would not be enough to convince clinics and hospitals to continue to use the more expensive FUSILEV once leucovorin was available in larger quantities; and (c) based upon the above, the defendants lacked a reasonable basis for their positive statements about the Company and its revenue earnings during the class period. According to the complaint, when the positive statements were released, the stock rose to a high of $13.05, but once the true facts were discovered, the price of Spectrum Pharmaceuticals stock fell significantly and closed at $7.79.
Shareholder rights attorney Willie Briscoe said, “Recent revelations about alleged improper business practices and procedures regarding key aspects of Spectrum Pharmaceuticals‘ business and other misleading financial statements have prompted the firms to investigate possible breaches of fiduciary duties and other violations of state law by Spectrum Pharmaceuticals‘ officers and directors. Based on our investigation, we are prepared to pursue litigation to preserve the company and the value of Spectrum Pharmaceuticals stock for all shareholders.”
The Briscoe Law Firm, PLLC is a full service business litigation, commercial transaction, and public advocacy firm with more than 20 years of experience in complex …read more
Source: FULL ARTICLE at DailyFinance
By Business Wirevia The Motley Fool
Filed under: Investing
Spectrum Pharmaceuticals to Present Corporate Update at the 25th Annual ROTH Conference in Laguna Niguel on March 20th
HENDERSON, Nev.–(BUSINESS WIRE)– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that an overview of the Company’s business strategy and commercial and development-stage programs will be given at the 25th Annual ROTH Conference being held at The Ritz-Carlton Hotel in Laguna Niguel, California. The Company presentation is on Wednesday, March 20, 2013, at 11:00 AM PT.
A live webcast of Spectrum’s presentation will be available at http://www.sppirx.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market three oncology drugs ─ FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights. Spectrum’s strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. These statements include, but are not limited to, statements that relate to our business and its future, including certain company milestones, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be …read more
Source: FULL ARTICLE at DailyFinance
By David Williamson, The Motley Fool
Filed under: Investing
Wednesday was a bad day for investors of Spectrum Pharmaceuticals as it toppled more than 35% due to a significant reduction of estimated sales of its flagship product, Fusilev. Generic leucovorin, which had been absent from the market started to return and materially affected orders for Spectrum’s branded drug.
In this video, Motley Fool analyst David Williamson recaps the recent news and picks up the pieces for investors taking a look at the drugs in Spectrum’s pipeline, including cancer drug Apaziquone, which it recently regained the rights to from Allergan.
Is Spectrum a buy at these new lower prices, or should investors proceed with caution? Watch and find out.
Before investing in a stock like Spectrum, I urge you to read this brand-new Motley Fool special free report, “What’s Really Eating at America’s Competitiveness.” Find out what has Warren Buffett concerned for the future of the U.S. and discover a little-known stock poised to profit from a major government initiative to combat this looming crisis. Grab your free copy today by clicking here.
The article Picking Up the Pieces of Shattered Spectrum originally appeared on Fool.com.
David Williamson has no position in any stocks mentioned. Follow David on Twitter @MotleyDavid. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.
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Source: FULL ARTICLE at DailyFinance
By Dan Caplinger, The Motley Fool
Filed under: Investing
Every investor would love to stumble upon the perfect stock. But will you ever really find a stock that provides everything you could possibly want?
One thing’s for sure: You’ll never discover truly great investments unless you actively look for them. Let’s discuss the ideal qualities of a perfect stock, then decide if Spectrum Pharmaceuticals fits the bill.
The quest for perfection
Stocks that look great based on one factor may prove horrible elsewhere, making due diligence a crucial part of your investing research. The best stocks excel in many different areas, including these important factors:
With those factors in mind, let’s take a closer look at Spectrum Pharmaceuticals.
|
Factor |
What We Want to See |
Actual |
Pass or Fail? |
|---|---|---|---|
|
Growth |
5-year annual revenue growth > 15% |
103.5% |
Pass |
|
1-year revenue growth > 12% |
38.7% |
Pass |
|
|
Margins |
Gross margin > 35% |
82.6% |
Pass |
|
Net margin > 15% |
35.3% |
Pass |
|
|
Balance sheet |
Debt to equity < 50% |
26.3% |
Pass |
|
Current ratio > 1.3 |
2.06 |
Pass |
|
|
Opportunities |
Return on equity > 15% |
40% |
Pass |
|
Valuation |
Normalized P/E < 20 |
9.19 |
Pass |
|
Dividends |
Current yield > 2% |
0% |
Fail |
|
5-year dividend growth > 10% |
0% |
Fail |
|
|
Total score |
8 out of 10 |
Source: S&P Capital IQ. Total score = number of passes.
Since we looked at Spectrum Pharmaceuticals last year, the company has picked up a point, with its valuation having fallen. Yet that valuation drop cost the stock 40% of its value over the past year, and most of it came just yesterday as the company announced some troubling news.
Spectrum has benefited greatly from its Fusilev cancer treatment, which has driven sales growth over the years. Even though a …read more
Source: FULL ARTICLE at DailyFinance
By Business Wirevia The Motley Fool
Filed under: Investing
Spectrum Pharmaceuticals Gains Rights to Pivotal-Stage Captisol-Enabled ® Melphalan
HENDERSON, Nev.–(BUSINESS WIRE)– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the Company has gained global development and commercialization rights to Ligand Pharmaceuticals’ (NAS: LGND) Captisol-enabled®, propylene glycol-free (PG-free) melphalan. Captisol-enabled melphalan is currently in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma.
Spectrum is assuming the responsibility for the ongoing pivotal clinical trial and will be responsible for filing an NDA, which is anticipated in the first half of 2014. Under the license agreement, Ligand will receive a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.
“We are pleased to add this late-stage program to our portfolio, which includes belinostat, for which we anticipate an NDA filing mid-year, and apaziquone, for which we expect to file an NDA in 2014,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Captisol-enabled melphalan is designed to meet the need for a formulation of melphalan that is free of propylene glycol, which has been associated with renal and cardiac side effects. The Captisol technology may allow longer duration of administration and slower infusion rates, potentially enabling a higher dose intensity of pre-transplant chemotherapy to optimize efficacy. We look …read more
Source: FULL ARTICLE at DailyFinance
By Business Wirevia The Motley Fool
Filed under: Investing
Ligand Signs Global License Agreement with Spectrum Pharmaceuticals for Captisol-Enabled ® Melphalan
Ligand to Receive License Fee, Eligible for Milestones and Royalties
Raises Full Year Revenue and Earnings Guidance and Provides First Quarter Forecast
SAN DIEGO–(BUSINESS WIRE)– Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announces the signing of global license and supply agreements with Spectrum Pharmaceuticals, Inc. (NAS: SPPI) for the development and commercialization of Ligand’s Captisol-enabled®, propylene glycol-free (PG-free) melphalan. Under the terms of the license agreement, Ligand is entitled to receive a license fee and is eligible to receive more than $50 million in potential milestone payments. Ligand is also eligible to receive royalties on future net sales of Captisol-enabled melphalan. Further details regarding the transaction are provided in Ligand’s Form 8-K that is being filed today.
The Captisol-enabled melphalan program is currently in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. Spectrum will immediately assume all development of the program as a result of this license.
“We are pleased to have forged this agreement,” commented John Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals. “Spectrum has an established oncology and hematology business, and this melphalan product is an ideal complement to their two commercial hematology products, Zevalin and Folotyn, including an expected high degree of commercial call overlap. Spectrum’s highly experienced, oncology-focused R&D team is committed to the efficient development of Captisol-enabled melphalan, and has established relationships with key investigators.”
Full Year 2013 Revenue and Earnings Guidance and First Quarter Forecast
Ligand now expects 2013 total revenues to be in the range of $43 million to $46 million, versus previous guidance of $41 million to $44 million. Earnings per share for 2013 are expected to be in the range of $0.47 to $0.51, versus previous guidance of $0.35 to $0.39. Ligand estimates revenue for the first quarter of 2013 to be in the range of $10 million to $11 million, with first quarter earnings per share in the range of $0.10 to $0.13. Earnings per share guidance does not include the effects of any increase or decrease in contingent liabilities.
About Captisol-enabled Melphalan
…read more
Source: FULL ARTICLE at DailyFinance
By Selena Maranjian, The Motley Fool
Filed under: Investing
Every quarter, many money managers have to disclose what they’ve bought and sold, via “13F” filings. Their latest moves can shine a bright light on smart stock picks.
Today, let’s look at the D. E. Shaw company, founded by David E. Shaw and with a reportable stock portfolio totaling $41 billion in value as of Dec. 31, 2012.
Shaw is known as a math wizard and a quantitative investing pioneer. His firm is reportedly extremely selective, hiring less than 1% of applicants — and Amazon.com CEO Jeff Bezos once made the cut.
Interesting developments
So what does D. E. Shaw’s latest quarterly 13F filing tell us? Here are a few interesting details:
The biggest new holdings are Kraft Foods Group and ADT. Other new holdings of interest include Spectrum Pharmaceuticals . Spectrum has been experiencing strong growth due to the success of its colorectal cancer drug Fusilev, but that was partly due to a supply shortage faced by generic competitors. With that issue going away, Spectrum recently trimmed its growth expectations, sending the heavily shorted stock down sharply. Still, it has more than a dozen other drugs in development in its pipeline, and has broadened its scope with the recent purchase of Allos Therapeutics, which is expected to help cut costs and also includes the lymphoma drug Folotyn. Spectrum also recently secured rights for the bladder-cancer drug apaziquone.
Among holdings in which D. E. Shaw increased its stake was Acadia Pharmaceuticals , which has tripled in value over the past year, on high hopes for its pimavanserin drug, which treats psychosis in patients with Parkinson’s disease and is nearing the phase 3 trial finish line. If the drug gains FDA approval, it will enjoy little competition and could be a big winner for Acadia. The company thinks the drug also might be effective against psychosis related to Alzheimer’s Disease and is conducting trials for that as well.
D. E. Shaw reduced its stake in lots of companies, including Mesabi Trust and Molycorp . With a recent hefty dividend yield of 8.2%, Mesabi Trust is a royalty trust collecting a cut of the proceeds from iron mined by a Cliffs Natural Resources subsidiary — and then paying them out to shareholders. Unlike many companies with fixed payouts, Mesabi’s fluctuate over time, along with the fortunes of the mines, and while royalty trusts often have expiration dates, Mesabi’s expiration isn’t happening anytime soon. A possible downside for the stock is a slowdown in demand for ore, particularly in China, which has been one of several issues for Cliffs.
Molycorp has been struggling in a tough environment and recently worried investors with a surprisingly large share offering and debt issuance. (Some worry about further capital needs, too, and don’t like its negative free cash flow.) Still, for those who can accept considerable risk and volatility, there’s a lot of promise in Molycorp, in part due to its acquisition of Neo Materials …read more
Source: FULL ARTICLE at DailyFinance
By Brian Pacampara, Pacampara, The Motley Fool
Filed under: Investing
Although we don’t believe in timing the market or panicking over market movements, we do like to keep an eye on big changes — just in case they’re material to our investing thesis.
What: Shares of pharmaceutical company Spectrum Pharmaceuticals plummeted 36% today after issuing a full-year revenue outlook that disappointed Wall Street.
So what: Spectrum that said that 2013 sales of its chemotherapy side-effect drug Fusilev will be in the range of only $80 million-$90 million (representing a whopping 56% decline from 2012), forcing analysts to drastically recalibrate their valuation estimates. While demand from doctors remains stable, management admitted that hospitals are certainly shifting to generics, reinforcing serious concerns over Fusilev’s peak sales potential.
Now what: Management now sees 2013 total revenue of $160 million-$180 million, down about a third from 2012 and well below Wall Street‘s view of $297 million.
“The Company believes the majority of the impact from the change in ordering patterns will be reflected in the first half of 2013 and expects to return to a run-rate that more closely aligns with end-user demand by the end of the year,” Spectrum reassured investors in a statement.
So while the stock remains a bit too speculative for conservative Fools, today’s pullback might be a tasty opportunity for less risk-averse, short-term-oriented contrarians.
If you’re interested in bigger-picture macro trends, Warren Buffett referred to one as “the tapeworm that’s eating at American competitiveness.” Find out what it is in our free report: “What’s Really Eating At America’s Competitiveness.” You’ll also discover an idea to profit as companies work to eradicate this efficiency-sucking tapeworm. Just click here for free, immediate access.
The article Why Spectrum Shares Got Spanked originally appeared on Fool.com.
Fool contributor Brian Pacampara has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.
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Source: FULL ARTICLE at DailyFinance
By Dan Caplinger, The Motley Fool
Filed under: Investing
After six straight record highs for the Dow Jones Industrials , the market finally looks like it’s running out of steam. Even though positive data on U.S. retail sales showed a continuing willingness among American consumers to keep spending, nearly half of the 1.1% increase came from the impact of gasoline, which has seen prices rise substantially so far this year. Perhaps more importantly, after such a long run of strong performance, investors might simply be taking a break. By 10:45 a.m. EDT, the Dow was down a modest 14 points, with broader markets also falling slightly.
Alcoa is one of the biggest losers in the Dow, falling about 1%. The aluminum giant didn’t have any company-specific news to explain the move, but weakness in international stock markets points to the macroeconomic fears of sluggish growth in emerging-market countries and the potential for an even worse recession in Europe. Until global markets start to rebound more convincingly, it’ll be hard for Alcoa to expect better conditions in the aluminum market.
Elsewhere, Spectrum Pharmaceuticals plunged more than 36% following warnings that its lead product Fusilev is finally seeing sales succumb to generic competition. Spectrum enjoyed a long run of strong sales due to shortages of leucovorin, the generic version of the drug, but now Spectrum says the good times may be coming to a halt as hospitals and other customers find new supplies of the generic and cutt back on more expensive Fusilev.
Finally, Dole Food fell 7.3% after posting a worse-than-expected loss and falling well short of analysts’ sales estimates. The company cited “banana market conditions” for the decline, but the key for the company going forward is how it will adjust to the sale of its packaged-foods and Asian fresh-fruit business units to Itochu. With much lower debt after the sale, Dole needs to demonstrate that the strategic move wasn’t a mistake.
Is Alcoa worth your investment dollars?
Even with its recent woes, Alcoa is in prime position to take advantage of growth that some expect for aluminum in the long run. In our premium research report on Alcoa, we examine a number of company-specific factors to conclude that for most investors, Alcoa is certainly worth a closer look. For a Foolish investment perspective on this global giant, simply click here to get started.
var FoolAnalyticsData = FoolAnalyticsData || []; FoolAnalyticsData.push({ …read more
Source: FULL ARTICLE at DailyFinance
By Brian Orelli, The Motley Fool
Filed under: Investing
Spectrum Pharmaceuticals is hurting today after dialing back guidance for the year. Apparently the increased production by Sagent Pharmaceuticals of generic leucovorin, a less purified version of Spectrum’s Fusilev, is cutting into Fusilev sales .
Don’t say I didn’t warn you.
October 2011: “How do you guess when Teva Pharmaceuticals and others will get their act together? And then when — dare I say, if — they do, how do you estimate how many doctors will head back to the generic?”
July 2012: “If you can confidently say that Fusilev sales are here to stay for the long term, Spectrum is probably a good buy at this point. I don’t have that confidence.”
Spectrum claims that doctors actually want to buy the product, but that hospitals that stock the drug are cutting back on Fusilev now that the generic is more readily available.
The biotech is guiding for Fusilev sales of $10 to $15 million for the first quarter of the year, and approximately $80 to $90 million for the full year 2013. Spectrum claims sales will stabilize in the second half as inventory is drawn down and sales match demand.
That could be wishful thinking. Even if it hits that goal, assuming $30 million in the first half and $50 million in the second half, we’re still a run rate of just half the over $200 million worth of Fusilev sold last year.
Fusilev is Spectrum’s top-selling drug by far, so the drop in sales hurts overall sales. Last month, Spectrum guided for 2013 revenue above the $268 million it brought in last year. Now it’s looking for revenue in the $160 million to $180 million range.
If Spectrum can stabilize sales and get things moving back in the right direction, it might be worth picking through this train wreck looking for some value. But that’s a pretty monumentous task. Risk-adverse investors would be best off watching from the sidelines for a few quarters until things stabilize.
We know what’s eating at Spectrum’s sales, but do you know “What’s Really Eating at America’s Competitiveness“? In this brand new special free report by The Motley Fool you’ll find out what has Warren Buffett concerned for the future of the U.S. and discover a little-known stock poised to profit from a major government initiative to combat this looming crisis. Grab your free copy today by clicking here.
The article Down 35%! This Is a Biotech Trainwreck originally appeared on Fool.com.
Fool contributor Brian Orelli has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © …read more
Source: FULL ARTICLE at DailyFinance
By David Williamson, The Motley Fool
Filed under: Investing
Just 10 days ago, I examined the bear thesis on Spectrum Pharmaceuticals as, amazingly, over half of its float was sold short. It looks like those short sellers were on to something after all.
Spectrum tonight announced a crushing 40% guidance reduction for 2013, setting a revenue target between $160 million to $180 million, compared to Wall Street‘s roughly $300 million estimate. The stock is currently down nearly 40% in after-hours trading. The culprit is steeply lower Fusilev sales, a branded drug that took full advantage of generic leucovorin’s unavailability to rack up $204 million in 2012 sales. Short sellers saw this as just a temporary bonanza while bullish investors believed that Spectrum could hold on to those market share gains.
The announcement is a dramatic change of tune from Feb. 21, when during Spectrum’s fourth-quarter conference call CEO Rajesh Shrotriya confidently declared, “We expect 2013 revenues to grow” on the back of strong January trends. I’m guessing February and March were trending worse than Seth MacFarlane’s Oscar performance.
Perhaps putting too much faith in management’s comments from the conference call, I concluded my video from earlier this month that while the growth days of Fusilev were over, generics weren’t poised to immediately decimate its market share. Oops. However, I did at least argue that, over the longer haul, short sellers would be vindicated, potentially sooner if insurance reimbursement pressure hastened the switch to lower-cost generics from companies such as Sagent Pharmaceuticals .
Spectrum’s valuation may be shattered, but it doesn’t mean the stock is finished. Fusilev is still expected to bring in $85 million in 2013. Spectrum also has two other drugs on the market, albeit neither are great sellers, a handful of phase 2 and phase 3 cancer assets, and about $60 million in net cash to help develop them.
Even for investors who believe in those late-stage assets, the valuation of this company is still murky given that Fusilev sales could decline worse than estimated. I recommend staying away from falling knife stocks, unless you like getting cut.
Before investing in a stock like Spectrum, I urge you to read this brand-new Motley Fool special free report, “What’s Really Eating at America’s Competitiveness.” Find out what has Warren Buffett concerned for the future of the U.S. and discover a little-known stock poised to profit from a major government initiative to combat this looming crisis. Grab your free copy today by clicking here.
The article Why Bears Are Devouring Spectrum originally appeared on Fool.com.
David Williamson has no position in any stocks mentioned, and neither does The Motley Fool. Follow David on Twitter @MotleyDavid.
Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright …read more
Source: FULL ARTICLE at DailyFinance
By David Williamson, The Motley Fool
Filed under: Investing
In this video, Motley Fool health-care analyst David Williamson discusses Spectrum Pharmaceuticals , and why more than 50% of the stock‘s float is sold short. The company took off in 2011, when production problems with the generic drug Leucovorin gave it a chance to get doctors to switch to its more expensive branded drug, Fusilev, but sales of Fusilev have flagged lately. David tells investors whether Fusilev’s days of sales growth are over, and what else Spectrum has up its sleeve that may prove the shorts wrong.
While you can certainly make huge gains in biotech and pharmaceuticals, the best investing approach is to choose great companies and stick with them for the long term. The Motley Fool‘s free report “
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The article Are Short Sellers Right About Spectrum? originally appeared on Fool.com.
David Williamson and The Motley Fool have no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools don’t all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.
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Source: FULL ARTICLE at DailyFinance
