Good News for Spectrum Pharma – Analyst Blog
Spectrum Pharmaceuticals (SPPI) recently received encouraging news in the form of the acceptance of its supplemental New Drug Application (sNDA) for cancer candidate Fusilev (levoleucovorin). The application has been considered as a Class II re-submission, implying an early response within 6 months (target date: April 29, 2011).
Spectrum Pharma is looking to expand the label of Fusilev, an injectable drug, and get it approved as a combination therapy in patients suffering from advanced metastatic colorectal cancer.
Spectrum Pharma had received a complete response letter (CRL) for the candidate in October 2009. While the US regulatory body asked the company to submit additional data, the company was not asked to conduct additional efficacy studies. Spectrum Pharma submitted its response to the CRL in October 2010.
We note that Fusilev is already available in US markets since 2008 for rescue in osteosarcoma (a form of bone cancer) patients following treatment with a high-dose of chemotherapy drug, methotrexate. Fusilev is also approved to diminish the toxic effects of methotrexate and counteract the effects of impaired methotrexate elimination and unintentional excessive dosage of folic acid antagonists.
In ex-US territories, Fusilev has been marketed for more than a decade by Wyeth (now a part of Pfizer (PFE)) , Sanofi-Aventis (SNY) and Takeda, among others.
Apart from Fusilev, Spectrum Pharma’s other FDA approved product is Zevalin, which is for treating patients suffering from non-Hodgkin’s lymphoma (NHL). Moreover, the company has a deep pipeline primarily focusing on oncology and hematology. The successful development and commercialization of the robust pipeline would help drive long-term growth at Spectrum Pharma.
Moreover, the company’s efforts to expand Fusilev's label are also encouraging. Approval for the additional indication would help drive revenues of the product.
Currently, we are Neutral on Spectrum Pharma which is supported by the Zacks#3 Rank (‘short-term Hold rating) carried by the company.
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Neutral on Kansas City Southern – Analyst Blog
We reiterate our long-term Neutral recommendation for Kansas City Southern (KSU), which implies the stock will perform mostly in line with the broader market. The company’s third quarter 2010 net earnings soar, easily beating the Zacks Consensus Estimate.Improvement in business volumes, effective cost control measures, and solid pricing environment are the primary reasons for this excellent result.
During the third quarter of 2010, Kansas City Southern achieved several operating milestones. Quarterly operating ratio was 73.5% compared to 78.3% in the prior-year quarter. Total business volume in the reported quarter was 459,400, up 9% year over year. Operating income in the same quarter was $116 million, up 38.3% year over year.
All these results were achieved in spite of facing a devastating Hurricane Alex in the Mexican cost that resulted in the third quarter revenue loss of $33 million and negatively affected earning by 14 cents per share.
An improving U.S. economy, surge in automotive shipments, and a rebound in many of the company’s end-markets will help in sustaining its businesses in the long run. Mexico has become a huge growth engine for the company.
Management is expecting the revival of the Mexican economy will generated low double-digit top-line growth in 2011. Furthermore, labor cost in Mexico is much cheaper than the U.S. which will also boost the company’s bottom line.
Nevertheless, railroads are subject to the ratification of laws by Congress that could increase regulation of the industry. A recent report presented by the U.S. Senate Commerce Committee stated that the discretionary pricing power enjoyed by the Class I freight rail transport companies are putting excessive pressure on freight customers.
The committee has decided that the railroads have become financially stable and a higher transportation rate is actually impacting household budgets. It remains to be seen how the railroad industry maintains growth if any adverse changes occur related to its discretionary pricing policy.
At the same time, the stock price has moved up by nearly 71% in the last year. According to our assessment, current valuation is fairly reflecting all the positives leaving little room for above market gain. Kansas City Southern competes with other freight railroad operators in the U.S. like Union Pacific Corp. (UNP), CSX Corp. (CSX), and Norfolk Southern Corp. (NSC).
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Mindray M7 & DC-7 Upgrades at RSNA – Analyst Blog
Leading Chinese medical devices maker Mindray Medical International Limited (MR) has announced major upgrades to its ultrasound systems at the ongoing Radiology Society of North America (“RSNA”) annual meeting in Chicago. The company will showcase two significant enhancements for its M7 and DC-7 ultrasound platforms at the RSNA.
Mindray will unveil several new upgrades including a broad variety of transducers (devices that converts energy into ultrasonic sound waves) and calculation packages for its M7 and DC-7 systems. The company will also feature two black and white ultrasound systems at the meeting. The new transducers for the M7 system will support a vast range of applications including obstetrics and interventional radiology.
Mindray launched the M7 ultrasound system in the U.S. in August 2010. This novel system leverages the company’s high-performance “System On Chip (SOC)” technology enabling a high level of imaging capability to a portable system. The M7 system integrates several sophisticated imaging features. The company believes that the M7 system provides good value to the customer by combining economy and differentiating attributes.
This higher-end segment of the ultrasound business has recently experienced tremendous growth as more and more healthcare providers acquire sophisticated capability but in compact and portable form. Mindray hopes to capitalize on this shift in hospital purchasing behavior with its M7 offering, which combine value and quality features, not always found in portable machines.
Besides the M7 and DC-7 systems, Mindray will also feature its coveted M5 ultrasound system at the RSNA. The company remains committed to providing clinicians with the latest technology that enhances patient care. Mindray believes that its progress, with the M7 and M5 systems, demonstrates its keenness to impart diagnostic confidence to clinicians using the company’s products. The company’s state-of-the-art ultrasound systems are enjoying significant traction in North America.
With its operational headquarters in Shenzhen, China, Mindray is a global Chinese medical devices company. It operates through three segments: Patient Monitoring and Life Support Products, In-Vitro Diagnostic Products and Medical Imaging Systems.
Besides China, Mindray operates in North America, Europe and other Asian countries. The company competes with global devices manufacturers such as General Electric (GE), Philips (PHG) and Siemens (SI).
Mindray has a strong position in the low and mid segments of the medical devices market in China and is poised to benefit from the solid fundamentals of the Chinese health care sector. Its new product development initiatives, expanding international footprint (and revenues) and solid sales infrastructure remain encouraging.
Although Mindray’s strength is currently in the low and mid-end segments, the companyis looking to carve a niche in the high-end markets. Moreover, Mindray is well positioned to benefit from the health care reforms in China.However, the company is exposed to intense competition-driven pricing pressure.
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Neutral on Principal Financial – Analyst Blog
We remain neutral on Principal Financial Group (PFG), concerned as we are about higher delinquencies in its commercial mortgage portfolio as well as persistentlyhigh unemployment levels that restrict participation in the existing employee benefit plans.
Principal’s investment portfolio is highly exposed to commercial real estate. Commercial mortgage loans and commercial mortgage-backed securities (CMBS) represent over 20% of the company’s investment portfolio.
We expect the increasing delinquency rate and defaults under its commercial mortgage loan portfolio to keep the company’s financial strength and profitability under pressure.
The weak economy has restricted the plan sponsors to change their retirement plan providers. Also, the current unemployment is reducing the number of participants in existing employee benefit plans. Consequently, we do not expect any significant improvement in earnings in the near term.
However, Principal’s strong franchise within the pension sector, aided by its diversification in both products and geography, positions it to benefit from the gradual recovery of the credit market.
Principal Financial exited the medical insurance business (insured and self-insured). The medical business has been declining over some years. Following the divestiture, the company will now focus its capital and other resources on strategic opportunities in the growing asset accumulation and asset management businesses.
The company will release between $100 million and $120 million of capital over the next three years. The exit from the group medical insurance business will also result in a curtailment of pension and other post-retirement benefits of the affected employees, thereby resulting in a gain to the company.
Principal Financial’s third quarter earnings surpassed the Zacks Consensus Estimate primarily due to solid performance at Global Asset Management, International Asset Management and Accumulation segments. The company also expects full year 2010 Full Service Accumulation sales to be 15%–20% higher than the 2009 level, resulting in positive cash flows.
Lincoln National Corporation (LNC), which competes with Principal Financial, posted operating earnings way behind the Zacks Consensus. Results were largely affected by the company’s annual comprehensive review of actuarial assumptions and model work, which resulted in a net charge of $72 million or 22 cents per share. Also, the current low interest rate environment has added to the adverse results.
The Zacks Consensus Estimate for fourth-quarter 2010 is 66 cents per share. For full years 2010 and 2011, the Zacks Consensus Estimates are, respectively, $2.63 per share and $2.83 per share.
The quantitative Zacks #3 Rank (short-term Hold rating) indicates no clear directional pressure on the shares over the near term.
Based in Des Moines, Iowa, Principal Financial Group Inc. provides an expansive range of retirement savings, investment and insurance products and services through its various subsidiaries.
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Setback for Noble in Ecuador – Analyst Blog
Noble Energy Inc. (NBL) encountered a setback in Ecuador, when the national government terminated the Block 3 production sharing contract (PSC) with the company's subsidiary EDC Ecuador Ltd. The company operates this block with a 100% working interest.
The Ecuadorian government enacted a new hydrocarbon reform bill, by which it will replace all production-sharing deals with service contracts, turning all operators into service providers. Noble's existing contract for Block 3 is yet to be renegotiated. The net book value of the company’s investment in Ecuador was $59 million as of September 30, 2010.
The company is still trying to negotiate with the Ecuadorian government to renew the deal. However, the company's total production would be impaired if it fails to come to a resolution. Total production of the company during the third quarter 2010 was 232,000 barrels per day (Boe/d.)
We note that some international energy companies have also failed to renegotiate with the Ecuadorian government with the latter expecting an orderly withdrawal of the companies that fail to sign the new contracts. Significant oil majors that are yet to sign the deal are Brazil's state-run Petroleo Brasileiro S.A. (PBR) and China National Petroleum Corp.
The adjusted earnings per share of Noble Energy at the end of third-quarter 2010 were $1.27 compared with $1.10 in the year-ago comparable period. The Zacks Consensus Estimates for fourth quarter 2010, fiscal year 2010 and fiscal year 2011 are 94 cents per share, $4.01 per share and $4.34 per share, respectively.
Noble currently retains a Zacks #3 Rank (short-term Hold rating). We maintain a Neutral rating on the stock.
Based in Houston, Texas, Noble Energy operates internationally and engages in the acquisition, exploration, development, production, and marketing of crude oil, natural gas, and natural gas liquids.
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Raytheon Gets Army Contract – Analyst Blog
Defense prime Raytheon Company (RTN) has been awarded a follow-on $42.9 million delivery order for 57 Common Sensor Payload electro-optical and infrared sensor systems. The order is part of the contract awarded by the U.S. Army in November 2007, with potential future follow-on contracts worth up to $1.2 billion.
The systems will be deployed to support U.S. troops engaged in Operation Enduring Freedom and Operation Iraqi Freedom for maintaining peace and order in civilian areas. The sensor will help security forces on the ground to recognize threats early and respond promptly and accurately.
Raytheon Intelligence and Information Systems segment (IIS) subsequent to winning the contract in 2007, has delivered 28 system development and demonstration units to the U.S. Army.
Raytheon IIS segment headquartered in Garland, Texas, is a leading provider of intelligence and information solutions specializing in ground processing, unmanned ground systems, cyber-security solutions, homeland-civil security and other markets. Key customers include the U.S. Intelligence Community, U.S. Department of Defense (DoD) agencies, the Federal Bureau of Investigations (FBI), the National Oceanographic and Atmospheric Association (NOAA), and the United Kingdom Home Office.
Based in Waltham, Massachusetts, Raytheon Company, along with its subsidiaries, provides electronics, mission systems integration, apart from other capabilities in the areas of sensing, effects, command, control, communications and intelligence systems, as well as mission support services to its global customers.
Raytheon is one of the best-positioned companies among the large-cap defense players due to its non-platform-centric focus, strong order bookings and order backlog of $35.7 billion at the end of the third quarter 2010. Revenue and earnings growth continue to be driven by a strong presence in the current focus areas of Intelligence, Surveillance and Reconnaissance; missile defense; border security; training and mission support; and cyber security.
On the near-term horizon, the delay in the passing of fiscal 2011 defense budget raises some doubts about the expected level of growth. The Obama Administration is asking for $548.9 billion for the Department of Defense Base Budget in 2011, $15 billion more than the $533.7 billion Department of Defense Base Budget for 2010. However, until the U.S. Congress actually passes the bill, there remains enough reason to keep defense companies in general and Raytheon in particular perturbed.
Raytheon currently retains a Zacks #3 Rank (short-term Hold rating) in line with its closest peers L-3 Communications Holdings Inc. (LLL) and Herley Industries Inc. (HRLY). We presently maintain a Neutral rating on the stock.
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MeadWestvaco to Shed Envelope Biz – Analyst Blog
MeadWestvaco Corporation (MWV) announced that it has agreed to sell its Envelope Products Group to Stamford, Connecticut-based leading graphic communications company Cenveo Inc. (CVO). The sale is expected to close by the end of 2010.
The Envelope Products Group commands a leading position and produces high quality envelope products suited for diverse business customer needs. This business is part of MeadWestvaco’s Consumer & Office Products wing.
The Consumer & Office Products division manufactures, sources, markets and distributes school and office products, time-management products and envelopes in North America and Brazil through both retail and commercial channels. Its brands include Mead, Five Star, AT-A-GLANCE, DayMinder, Cambridge, Academie, Day Runner and Amcal among others.
In the third quarter of fiscal 2010, the Consumer & Office Products segment contributed 18.5% to MeadWestvaco’s total revenue. Segment sales dropped 5% from the year-earlier quarter to $288 million. Despite a strong back-to-school season in North America with its Mead, FiveStar and Trapper Keeper line-up, the segment was affected by lower envelope volumes compared with 2009.
Sales of envelopes and office products have been reportedly weak in 2009 as well, due to the weak global economic environment. The envelope business was particularly affected by sluggish demand from financial services customers who significantly reduced their direct mail offerings in 2009.
Following a strategic review of its businesses, MeadWestvaco has decided to exit unprofitable businesses and product lines to refocus on growth markets. The divestment of the envelope business is hence in sync with the company’s strategy.
In the third quarter of fiscal 2010, MeadWestvaco divested its global media and entertainment packaging business to Atlas Holdings LLC for $68 million in cash, resulting in an after-tax loss on a disposal value of $122 million. The business was previously included in the Consumer Solutions segment and specialized in innovative packaging for DVDs, music and video games.
We appreciate the company’s efforts to shed its unprofitable businesses as it will help it focus on businesses that generate attractive returns. We also like the company’s increasing investments in emerging markets. Since the beginning of 2009, the company has implemented various cost reduction and productivity improvement initiatives that would fetch cumulative savings of around $250 million in 2010. Complemented by MeadWestvaco’s financial strength, the company is in a sound position to capitalize on the economic recovery. We currently have a Zacks #2 Rank (short-term Buy recommendation) on the stock.
Richmond, Virginia-based MeadWestvaco Corporation provides solutions to companies operating in the health care, beauty and personal care, food, beverage, home and garden, tobacco, and commercial print industry. The company’s segments include Packaging Resource, Consumer Solutions, Consumer & Office Products, Specialty Chemicals, Community Development and Land Management. It competes with International Paper Co. (IP), Smurfit-Stone Container Corp. (SSCC) and Weyerhaeuser Co. (WY).
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Asia, Europe, U.S. Dollar & QE-2 Make the World Go Around – Voice of the People
Zacks' Voice of the People Highlights user inthemoneystocks: "Asia, Europe, U.S. Dollar & QE-2 Make the World Go Around" from the People & Picks community.For more Voice of the People, visit http://at.zacks.com/?id=5851
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Asia, Europe, U.S. Dollar & QE-2 Make the World Go Around
Where do we begin when trying to talk about this global soap opera? Lets start in Europe. Ireland is now on the official bailout list with Portugal, Spain, Italy and Belgium being adding to the list of the next countries to need a bailout. Gold has surged to a new high versus the Euro currency. In other words panic is starting to set in and this problem is starting to hit the fan.
The big question that everyone is asking is, will there be enough money available to bail out these countries? Perhaps the Federal Reserve can bail them out if they have not already. Today the Currencyshares Euro Trust (FXE) is trading lower by $1.32 to $129.41. On November 4th, 2010 the popular FXE was trading at $142.28. When the Euro declines it means that the U.S. Dollar climbs and this is what deflates the global markets.
Yesterday the Chinese central bank (People's Bank of China) said that loose monetary policy must change. This means interest rates will go higher and easy credit will not be as readily available. This could certainly hurt the industrial commodity stocks. Leading stocks such as U.S. Steel Corp. (X), and Cliffs Natural Resources Inc. (CLF) could be negatively effected. However, it is still the movement in the U.S. Dollar Index that will likely drive the commodity stocks higher or lower.
North Korea and South Korea tensions seem to be increasing. China says that they want peace and will mediate the talks between the two countries. However, many experts believe that China supports the North Korean actions while the United States obviously supports the South Koreans. This story is far from over and will probably continue to unfold over the next few months.
Now on to the U.S. Dollar Index. When the U.S. Dollar Index declines the stock markets will rally and inflate higher. Even this morning as the U.S. Dollar Index pulls back intra-day the major stock market indexes bounce off the morning lows. The opposite occurs when the U.S. Dollar Index rallies or trades higher the major stock indexes simply deflate and trade lower. The U.S. Dollar Index holds all the cards to whether this stock market trades higher or lower. In my opinion all the rest of the news is minuscule when compared to the action in the U.S. Dollar Index. Just remember the stock market trades inverse to the U.S. Dollar.
Let us not forget the Federal Reserve Bank's quantitative easing operation. This is where the central bank will buy $600 billion in U.S. Treasuries in order to stimulate the economy. This is really just more support for the large major banks. These institutions that sell the U.S. Treasuries to the Federal Reserve Bank are expected to buy stocks and inflate the stock market back up. Just look at how the NASDAQ 100 stocks surge higher after a POMO operation.
Well, this is what makes the financial world go around at this time. While Asia, Europe, and QE-2 are all important it is the U.S. Dollar Index that is the most dominant market mover at this time. When the U.S. Dollar Index falls the major stock market indexes inflate and trade higher. The opposite is true when the U.S. Dollar Index rallies, the major stock market indexes will deflate and decline. Therefore, this environment remains a traders market.
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TransDigm Raises Debt for Acquisition – Analyst Blog
TransDigm Group Inc (TDG) is raising senior subordinated debt of $780 million due in 2018, in a private arrangement exempt from registration requirements.
The company intends to utilize the loan amount, together with borrowings under a new credit facility, to finance the acquisition of McKechnie Aerospace Holdings, Inc., to repay a portion of debt under an existing credit facility, to inject cash into its balance sheet and pay transaction-related expenses.
The company has announced the acquisition of the actuation business of Telair International Inc., a subsidiary of Teleflex Incorporated (TFX), for approximately $94 million.
The target manufactures precision engineered electro-mechanical products and other components for commercial and military aircraft.
The company has large and renowned customers in the aerospace/defense sector. These include: (1) distributors of aerospace components; (2) worldwide commercial airlines, including national and regional airlines; (3) large commercial transport and regional and business aircraft OEMs; (4) various armed forces of the United States and friendly foreign governments; (5) defense OEMs; (6) system suppliers; and (7) various other industrial customers.
The industry's stringent regulatory, certification and technical requirements, and large investments necessary for the development and certification of products, create barriers to entry for potential new competitors.
As long as customers receive products that meet or exceed expectations and performance standards, they will have little to no incentive to certify another supplier because of the cost and time of the technical design and testing certification process. In addition, concerns about safety and flight delays if products are unavailable or undependable are reasons for its customers to continue long-term supplier relationships.
TransDigm's business is sensitive to the number of flight hours of its customers' planes, the size and age of the worldwide aircraft fleet and customers’ profitability. These items are, in turn, affected by general economic conditions. Its business is directly affected by changes in revenue passenger miles (RPMs), the size and age of the worldwide aircraft fleet, and to a lesser extent on changes in the profitability of the commercial airline industry, among other factors.
RPMs and airline profitability have historically been correlated with the general economic environment, although national and international events also play a key role. As a result of the substantial reduction in airline traffic resulting from these events, the airline industry incurred, and some in the industry continue to incur, large losses and financial difficulties.
Some carriers have also idled or retired a portion of their fleets and have reduced workforces and flights. During periods of reduced airline profitability, some airlines may delay purchases of spare parts, preferring instead to deplete existing inventories.
TransDigm Group Inc is a leading global designer, producer and supplier of highly engineered aircraft components for use on nearly all commercial and military aircraft in service today. Its business is well diversified due to the broad range of products it offers to its customers. Goodrich Corporation (GR) is a major competitor.
More than 95% of net sales for fiscal year 2009 were generated by proprietary products for which it owns the design. In addition, for fiscal year 2009, the company generated approximately 80% of its net sales from products for which it is the sole source provider.
We currently have a Neutral recommendation on TransDigm Group Inc.
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Good News for Merit Medical – Analyst Blog
Recently, Merit Medical Systems (MMSI) received approval from the US Food and Drug Administration (FDA) for the phase III clinical trial protocol to treat primary liver cancer with QuadraSphere microsphere for delivery of doxorubicin.
The approval is significant since the late-stage study in the US will be the first to compare drug-eluting microspheres to conventional chemoembolization (cTACE) in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. At present, according to Merit Medical, there is no FDA-approved embolic for the treatment of liver cancer in the US.
QuadraSphere is indicated for embolization of hypervascular tumors and peripheral arteriovenous malformations. While QuadraSphere has a long way to go before receiving the US approval, a similar product, HepaSphere is marketed in Europe since 2007 for embolization of HCC and hepatic metastases.
The phase III study is aimed at investigating HepaSphere/QuadraSphere microspheres for delivery of doxorubicin to treat HCC. While survival is the primary end-point of the study, secondary end-points include tumor response by mRECIST criteria, safety, resource utilization and adverse events. Approximately 500 patients are expected to be enrolled for the study at clinical sites across the US, Europe and South America.
Merit Medical had included microsphere products to its line of tumor treatment options with the acquisition of BioSphere Medical which was completed in September 2010. Through this acquisition, the company gained access to BioSphere’s embolotherapy technology platform. This technology finds applications in treating uterine fibroids and primary liver cancer, representing a global market potential of $650 million and $380 million, respectively.
Viewing the untapped potential in the liver cancer market, it is expected that successful commercialization of microspheres in the US will be beneficial to Merit Medical over the long term. While liver cancer is the third leading cause of cancer deaths globally, its occurrence has increased with rise in hepatitis C infections, alcohol consumption and obesity.
Although liver transplantation or tumor resection is considered a curative treatment; only 25% of liver cancers are diagnosed when they can be treated surgically. It has been witnessed that in cases where surgery is not a viable option, TACE has shown promising results.
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