There seems to have been a lot of writing recently about the lack of merger activity and what may be possible. Amgen seems to be getting a bit of ink too, but, then that one always seems to. First, Julie MacIntosh of the Financial Times published an interesting piece (http://www.ft.com/cms/s/0/57ccbec6-db91-11dd-be53-000077b07658.html ) concerning this subject on their website this January 6th. Her take was that the mergers and acquisitions market would be slow in coming back as companies assess risks and investment advisors want to appear cautious in recommending deals. Earlier in the week, Andrew Jack, also of the Financial Times speculated (http://www.ft.com/cms/s/0/20d8f19e-da8a-11dd-8c28-000077b07658.html ) about Pfizer entering into a large acquisition of a rival and what it might lead to in a pharmaceutical industry shying away from the large deals that spawned many of today’s Big Pharma companies. His musings were based on comments by Jeff Kindler, Pfizer’s CEO. He noted debates in the investment community about Pfizer acquiring Amgen. (CNBC had also reported this story.) As I wrote earlier, that’s an old story heard many times before.
What I find interesting here is how from very substance, a lot of speculation is going on. As I blogged earlier, I don’t think there is much of a market for large deals in the pharmaceutical industry right now. I find myself more in agreement with Julie MacIntosh about deal prospects in the industry. That is, the length and breadth of this recession will determine people’s willingness to return to the deal markets. Like I wrote earlier, she quotes Mark Shafir, the global mergers and acquisitions head at Citibank, who believes that bankrupt or near bankrupt companies will provide the first wave of opportunities. He goes further saying that cash rich companies may then begin to prowl for values. But, all this will take time. While these activities may start this year, I don’t think that they will culminate in any significant deal activity until 2010 at the earliest.
I know that some people have been writing about 2009 being the big year for drug company acquisitions. I’m just not buying into it. Let’s see what comes of these vaunted pipelines. Let’s see what happens when a President Obama instructs Medicare to negotiate drug prices with the drug companies. (I’ve always found it interesting that when corporations squeeze their vendors for lower costs, it’s capitalism; when the government does it, it’s Marxism.) As this blog has repeatedly said over the last year, there is too much capacity in the drug industry. Whatever deals happen this year will be restructurings designed to handle this fundamental problem.
As always, we welcome your feedback. Please contact us at larryrothmansblog@gmail.com. We look forward to hearing from you.
Contributed by Guy de Lastin
Showing posts with label Pharmaceutical Research. Show all posts
Showing posts with label Pharmaceutical Research. Show all posts
Friday, January 9, 2009
Monday, December 8, 2008
The Convergence of Two Perfect Storms—The Drug Industry and The Outsourcing Businesses
The Convergence of Two Perfect Storms—The Drug Industry and The Outsourcing Businesses
by Larry Rothman
We like and fear the term “Perfect Storm”, it conjures up severe disruption if not destruction. We wonder if the drug industry is in the midst of not just one but perhaps a double perfect storm and here's why we think so.
Severin Schwan recently named Chief Executive for Roche Holding AG was quoted in the December 8th issue of the Wall Street Journal saying: “As the global pharmaceutical market gets tougher, some drug makers probably will fail because they won't have enough innovative medicines that health insurers will be willing to pay for”. He goes on to say “Some drug makers might be forced into bankruptcy in coming years. Others could be forced into mergers, or to diversify into other businesses.”
The Perfect Storm causing this is a combination of rare circumstances coming together simultaneously including, but not limited to:
1.Researcher productivity as measured by number of new drug entities approved is at or near an all time low.
2.Discovery and development of new, novel, cost effective compounds is not happening despite great advances in technology as well as all the supposed process improvements made by spending hundreds of millions on outside experts (e.g consultants).
3.Stricter regulations and enforcement (and the promise of more to come) from regulatory authorities, much emanating from the US FDA, but certainly not limited to this country, rather a global phenomenon.
4.The likelihood that in the US (based on President-elect Obama's promises) that the government will soon step in with some form of price controls and the increasing pressures by PBM's and insurance companies to be unwilling to pay for newer drugs without clear benefit and the compounding of the strong push toward generics and there is challenge on the horizon.
5.Oh yes, let's add a global economic downturn that promises to be the worst in 30-70 years.
We do have great respect for the industry and its attempts to focus on these issues, so to suggest a failure of management similar to the US Auto Industry would not be totally fair. However, one of the major tools for cos reduction that the drug industry has deployed is outsourcing and that business is itself facing challenges of the same magnitude as the pharmaceutical industry.
The Outsourcing Industry has its own perfect storm in the making including:
1.The recent tragic events in Mumbai will cause a natural reluctance to place mission critical work in what is perceived as “harms way”, in other words, offshore from the US.
2.Clinical trials have been viewed as an area of great promise both as a globalization vehicle and certainly as a way to lower drug development costs. HOWEVER, there is a perception that despite lower costs and faster recruitment for clinical trials in developing countries that the results may not be “at standard” or even worse as clinicians eager to please their sponsors may “unintentionally” skew results. (We will follow-up separately on this issue and to be fair—suspicions and perceptions are just that, there may be no factual basis to these claims).
3.Talent pools are getting scarcer and their cost is escalating so that many of the outsourcing companies are trying to find the optimum mix of geographies, skills, costs and capabilities. This is easy to describe but very difficult to manage.
4.Finally, at least in the US, there is a political backlash to sending “US jobs” overseas.
So where do they go from here. We'll discuss our opinions in the coming weeks. What do you think?
by Larry Rothman
We like and fear the term “Perfect Storm”, it conjures up severe disruption if not destruction. We wonder if the drug industry is in the midst of not just one but perhaps a double perfect storm and here's why we think so.
Severin Schwan recently named Chief Executive for Roche Holding AG was quoted in the December 8th issue of the Wall Street Journal saying: “As the global pharmaceutical market gets tougher, some drug makers probably will fail because they won't have enough innovative medicines that health insurers will be willing to pay for”. He goes on to say “Some drug makers might be forced into bankruptcy in coming years. Others could be forced into mergers, or to diversify into other businesses.”
The Perfect Storm causing this is a combination of rare circumstances coming together simultaneously including, but not limited to:
1.Researcher productivity as measured by number of new drug entities approved is at or near an all time low.
2.Discovery and development of new, novel, cost effective compounds is not happening despite great advances in technology as well as all the supposed process improvements made by spending hundreds of millions on outside experts (e.g consultants).
3.Stricter regulations and enforcement (and the promise of more to come) from regulatory authorities, much emanating from the US FDA, but certainly not limited to this country, rather a global phenomenon.
4.The likelihood that in the US (based on President-elect Obama's promises) that the government will soon step in with some form of price controls and the increasing pressures by PBM's and insurance companies to be unwilling to pay for newer drugs without clear benefit and the compounding of the strong push toward generics and there is challenge on the horizon.
5.Oh yes, let's add a global economic downturn that promises to be the worst in 30-70 years.
We do have great respect for the industry and its attempts to focus on these issues, so to suggest a failure of management similar to the US Auto Industry would not be totally fair. However, one of the major tools for cos reduction that the drug industry has deployed is outsourcing and that business is itself facing challenges of the same magnitude as the pharmaceutical industry.
The Outsourcing Industry has its own perfect storm in the making including:
1.The recent tragic events in Mumbai will cause a natural reluctance to place mission critical work in what is perceived as “harms way”, in other words, offshore from the US.
2.Clinical trials have been viewed as an area of great promise both as a globalization vehicle and certainly as a way to lower drug development costs. HOWEVER, there is a perception that despite lower costs and faster recruitment for clinical trials in developing countries that the results may not be “at standard” or even worse as clinicians eager to please their sponsors may “unintentionally” skew results. (We will follow-up separately on this issue and to be fair—suspicions and perceptions are just that, there may be no factual basis to these claims).
3.Talent pools are getting scarcer and their cost is escalating so that many of the outsourcing companies are trying to find the optimum mix of geographies, skills, costs and capabilities. This is easy to describe but very difficult to manage.
4.Finally, at least in the US, there is a political backlash to sending “US jobs” overseas.
So where do they go from here. We'll discuss our opinions in the coming weeks. What do you think?
Wednesday, July 16, 2008
Insights from a Top Five Star Fund Manager on Drug Pipelines (Part II)
Recently, Larry and I met with an interesting person, Ken Kam. Ken manages the Masters 100 Fund (MOFQX) and is a Morningstar Five Star fund manager. He has been regularly beating the S&P 500 Composite Stock Price index. Ken believes that his approach to investments using virtual portfolios to derive real investment decisions will be the wave of the future. Ken’s approach can be checked out at www.marketocracy.com. Earlier in his career, he had managed a technology and healthcare fund and had also run a medical devices company. During our meeting, we learned about his current holdings and what he thinks about the future of the pharmaceutical industry. This is the second of three blogs based on that interview.
In my last blog, I introduced Ken Kam, the fund manager of the Marketocracy’s Masters 100 Fund (MOFQX) and reviewed his position in Elan Corporation PLC, his thoughts on its drug, Tysabri,(Bapinuezumab) and its current prospects. In this entry, I will go over Ken’s future prospects for Elan and Tysabri.
Since taking his first in Elan in June 2005, the stock has doubled several times. Ken thinks that it could double again. Larry and I queried him about this and he gave us his reasons. First, Elan is conducting trials for Tysabri for use with Alzheimer’s disease. Unlike the multiple sclerosis space where Tysabri has three other competitive drugs to go against there are no others in the Alzheimer’s space to contend with. For this reason alone, Ken thinks Elan could double. He likes the Alzheimer’s story and thinks that it could make Elan another Amgen.
Next, Ken is taking a longer view on Elan. It possesses nanocrystal technology which allows the manufacture of nano-sized versions of existing drugs. This increases the surface area of the drug permitting a more effective dosage with reduced side effects. This is fundamental technology that can be applied to many other drugs, that are coming off patent. Other companies would have to do the research to see of their drugs were effective. Elan could either acquire other drugs coming off patent and make nano-sized versions or license the technology to the other drug manufacturers. Manufacturers with drugs coming off patent are looking at ways to make their drugs more effective. Nanocrystal technology offers the chance to extend a patent for another ten years Ken explained to us. This is what Ken sees as the future pipeline for Elan and explains his optimistic future for the company.
In my next and final blog based on Larry’s and my meeting with Ken Kam, I’ll write about Ken’s thoughts on the drug industry and its future.
As always, we welcome your feedback. Please contact us at larryrothmansblog@gmail.com. We look forward to hearing from you.
Contributed by Guy de Lastin
In my last blog, I introduced Ken Kam, the fund manager of the Marketocracy’s Masters 100 Fund (MOFQX) and reviewed his position in Elan Corporation PLC, his thoughts on its drug, Tysabri,(Bapinuezumab) and its current prospects. In this entry, I will go over Ken’s future prospects for Elan and Tysabri.
Since taking his first in Elan in June 2005, the stock has doubled several times. Ken thinks that it could double again. Larry and I queried him about this and he gave us his reasons. First, Elan is conducting trials for Tysabri for use with Alzheimer’s disease. Unlike the multiple sclerosis space where Tysabri has three other competitive drugs to go against there are no others in the Alzheimer’s space to contend with. For this reason alone, Ken thinks Elan could double. He likes the Alzheimer’s story and thinks that it could make Elan another Amgen.
Next, Ken is taking a longer view on Elan. It possesses nanocrystal technology which allows the manufacture of nano-sized versions of existing drugs. This increases the surface area of the drug permitting a more effective dosage with reduced side effects. This is fundamental technology that can be applied to many other drugs, that are coming off patent. Other companies would have to do the research to see of their drugs were effective. Elan could either acquire other drugs coming off patent and make nano-sized versions or license the technology to the other drug manufacturers. Manufacturers with drugs coming off patent are looking at ways to make their drugs more effective. Nanocrystal technology offers the chance to extend a patent for another ten years Ken explained to us. This is what Ken sees as the future pipeline for Elan and explains his optimistic future for the company.
In my next and final blog based on Larry’s and my meeting with Ken Kam, I’ll write about Ken’s thoughts on the drug industry and its future.
As always, we welcome your feedback. Please contact us at larryrothmansblog@gmail.com. We look forward to hearing from you.
Contributed by Guy de Lastin
Monday, July 14, 2008
Insights from a Top Five Star Fund Manager on Drug Pipelines (Part I)
Recently, Larry and I met with an interesting person, Ken Kam. Ken manages the Masters 100 Fund (MOFQX) and is a Morningstar Five Star fund manager. He has been regularly beating the S&P 500 Composite Stock Price index. Ken believes that his approach to investments using virtual portfolios to derive real investment decisions will be the wave of the future. Ken’s approach can be checked out at www.marketocracy.com. Earlier in his career, he had managed a technology and healthcare fund and had also run a medical devices company. During our meeting, we learned about his current holdings and what he thinks about the future of the pharmaceutical industry. This is the first of three blogs based on that interview.
Ken Kam manages the Marketocracy Masters 100 Fund (MOFQX) that has a Morningstar Five Star for three year returns. The fund’s objective is to seek capital appreciation in common stocks of domestic and foreign companies of any size, seeking to outperform the S&P 500 Composite Stock Price index. What brought Larry and I to meet with Ken was his position in Elan Corporation PLC. Elan has been conducting clinical trials on a drug, bapineuzumab, for Alzheimers patients, and they currently market Tysabri, to treat multiple sclerosis. Elan represents the largest holding of MOFQX at about 9½ % of its entire portfolio. What had brought Elan to Ken’s attention was two of the virtual portfolio managers who use his website (www.marketocracy.com). In March 2005, these two virtual fund managers made Elan 25% of their test portfolios. They were betting their long term track records on this stock. (One had been running cash at 22% of his portfolio, a fairly conservative position.) In addition, 1,500 of 80,000 virtual investors at www.marketocracy.com had Elan in their portfolios. Elan’s clinical trials on their drug, Tysabri, for use with multiple sclerosis had been proving successful. However, because of a one in one thousand chance of a fatality, the FDA had ordered the drug withdrawn.
Ken decided to do more research on the drug. What separates Ken from other stock researchers is his use of the Internet. He e-mailed 1,500 people on the Internet to solicit their feedback. Approximately five hundred responded of whom, one hundred were MS patients and some had been participants in Tysabri’s clinical trials. All were waiting for their insurance companies to approve the drug for use despite the risk of fatality. Ken’s research approach took him in a different direction from other Wall Street analysts who normally talk with the neurologists. Being doctors, they reply that there isn’t information yet to give an opinion.
With this research behind him, Ken took his initial position two months after Elan first came to his attention. Since then the stock has doubled several times after the FDA ban was lifted and Ken is hopeful for the future.
Several things caught my attention during our meeting. First, the use of the Internet to bring together virtual investors to develop stock picks. Next, Ken’s use of the Internet to take advantage of his in depth understanding of clinical trials to conduct original patient research on Tysabri’s effectiveness. In the next several blogs, I will write about what Ken thinks about Elan’s future pipeline and the drug industry in general.
As always, we welcome your feedback. Please contact us at larryrothmansblog@gmail.com. We look forward to hearing from you.
Contributed by Guy de Lastin
Ken Kam manages the Marketocracy Masters 100 Fund (MOFQX) that has a Morningstar Five Star for three year returns. The fund’s objective is to seek capital appreciation in common stocks of domestic and foreign companies of any size, seeking to outperform the S&P 500 Composite Stock Price index. What brought Larry and I to meet with Ken was his position in Elan Corporation PLC. Elan has been conducting clinical trials on a drug, bapineuzumab, for Alzheimers patients, and they currently market Tysabri, to treat multiple sclerosis. Elan represents the largest holding of MOFQX at about 9½ % of its entire portfolio. What had brought Elan to Ken’s attention was two of the virtual portfolio managers who use his website (www.marketocracy.com). In March 2005, these two virtual fund managers made Elan 25% of their test portfolios. They were betting their long term track records on this stock. (One had been running cash at 22% of his portfolio, a fairly conservative position.) In addition, 1,500 of 80,000 virtual investors at www.marketocracy.com had Elan in their portfolios. Elan’s clinical trials on their drug, Tysabri, for use with multiple sclerosis had been proving successful. However, because of a one in one thousand chance of a fatality, the FDA had ordered the drug withdrawn.
Ken decided to do more research on the drug. What separates Ken from other stock researchers is his use of the Internet. He e-mailed 1,500 people on the Internet to solicit their feedback. Approximately five hundred responded of whom, one hundred were MS patients and some had been participants in Tysabri’s clinical trials. All were waiting for their insurance companies to approve the drug for use despite the risk of fatality. Ken’s research approach took him in a different direction from other Wall Street analysts who normally talk with the neurologists. Being doctors, they reply that there isn’t information yet to give an opinion.
With this research behind him, Ken took his initial position two months after Elan first came to his attention. Since then the stock has doubled several times after the FDA ban was lifted and Ken is hopeful for the future.
Several things caught my attention during our meeting. First, the use of the Internet to bring together virtual investors to develop stock picks. Next, Ken’s use of the Internet to take advantage of his in depth understanding of clinical trials to conduct original patient research on Tysabri’s effectiveness. In the next several blogs, I will write about what Ken thinks about Elan’s future pipeline and the drug industry in general.
As always, we welcome your feedback. Please contact us at larryrothmansblog@gmail.com. We look forward to hearing from you.
Contributed by Guy de Lastin
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