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Companies
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Biotechnology Companies
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Written by Hugh McManus
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Sunday, 16 May 2010 15:24 |
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Pfizer is a major pharmaceutical company headquartered in New York. Founded in 1849, Pfizer evolved into the pharmaceutical behemoth it is today through internal innovation and, more recently, acquisition. Based on revenues, Pfizer is today the second largest pharmaceutical company in the world. Only Johnson & Johnson is larger.
Pfizer has languished in the past few years: hit by imminent patent expirations and a lack luster development pipeline, the stock hasn’t performed well. Is there hope for this former bellwether of the pharmaceutical industry? Even though Lipitor is expiring, it's beginning to look as if things are improving for Pfizer. Pfizer is one of the more widely held companies among individual investors. A member of the Dow Jones Industrial Average since April of 2004, Pfizer has a long history of innovation and growth. For almost seventy years, Pfizer distinguished itself in having a steadily increasing dividend: this trend stopped abruptly when the company merged with Wyeth and the dividend was summarily cut in half. The current drug portfolio of Pfizer illustrates both its recent acquisitions and the range of its internal research capabilities: a range that is currently being reined in. Its major blockbuster drug, Lipitor a $12 billion blockbuster, was introduced into the Pfizer portfolio through the merger with Warner Lambert, which was announced in 1999. Other leading drugs include Caduet in the cardiovascular market, Celebrex a leading drug in the osteoarthritis market, Chantix to suppress the desire to smoke, Detrol in the bladder control market, Enbrel for in the rheumatoid arthritis market, Lyrica in the pain market, Norvasc in the hypertension market, Spiriva for breathing concerns, Viagra, the drug which made Pfizer a household name in 1998, in the erectile dysfunction market, Zeldox in the CNS market and Zyvox in the antibacterial market. The fact that many of these branded drugs are household names is testament to the marketing budget, in fact the size, of this company. While Pfizer has a strong discovery arm, the company is first and foremost a successful marketing company. It often enjoys pride of place in many therapy classes thanks in no small measure to its acumen in direct-to-consumer (DTC) marketing. Part of this skill involves recognizing opportunities. For many years, Pfizer was a company that grew organically; this situation changed in the 1990s through successive mergers with other companies, each of which had a leading drug that was added to the Pfizer franchise. The first major merger occurred in 2000 with Warner Lambert, followed a few years later with Pharmacia. The most recent merger, which closed recently, was with Wyeth. While Pfizer has been successful in its efforts with major companies, it also has development or marketing deals with scores of emerging pharmaceutical companies. When I recently ran through a database of major deals involving Pfizer, well over one hundred programs in the clinic passed the screen. The Wyeth merger is interesting in that it’s unlikely to return all the benefits discussed when the deal was first announced. In the late 90s the Economist magazine ran an interesting analysis of pharmaceutical company mergers which illustrated that they essentially destroyed shareholder value. Of course, the big imponderable is what would have occurred had the merger never happened. Nonetheless, the analysis belied the promises of management about the synergistic benefits to shareholders of such combinations. In Pfizer’s case, it can be argued that the merger with WL increased shareholder value: PFE had a much more ambitious marketing program for Lipitor than did the innovator of the drug. The deal increased Pfizer’s revenues by a cumulative value in excess of $60 billion. The Pharmacia deal probably bought less value, but at least shareholders ended up with Monsanto, which outperformed pharma companies for many of the past few years. Wyeth does a number of things for Pfizer. The cynic in me says that a merger buys management more time: whatever happens to the stock price, blame the merger and refer to experts that assure you that mergers take two to three years to work—true, but not that gratifying. It shores up company financials; something that Pfizer needs with the pending loss of Lipitor. It also introduces Pfizer into macromolecules, an area where Wyeth is experienced. The merger complements the current offerings of Pfizer and introduces the company into markets such as vaccines where it had little if any presence. Pfizer may also have some small wins. Wyeth enjoyed a philosophy of outsourcing the bulk of its manufacturing needs; Pfizer has excess capacity. It may be possible for Pfizer to bring material in-house giving better capacity utilization, thus avoiding having to either shutter or sell more capacity in a market where there’s a glut of such offerings. The first quarter results recently reported by the company were important as they highlighted the fact that the company was on track to make its 2010 numbers. I have looked at the likely revenue growth of the combined companies, together with the profit margin. Pfizer should hit $2.17 in earnings this year and would be closer to $2.25 in 2011: it’s a paltry 3.6% increase but keep in mind it includes the loss of a major, $12 b franchise, Lipitor. Based on its historic PE behavior and its projected earnings growth, I believe that Pfizer should see improved fortunes, with the stock trading in the $19 to $25 range. On Friday, the stock closed at $16.20: hitting the median projected price of $22 in 2011 represents an increase of 36%; $19 is a more modest but still impressive 17%. I am continuing to add Pfizer when its stock dips below $16: it’s a long-term investment. I think in the next two or three years as Pfizer realizes the benefits of the recent merger, the company should start to turn around. The bottom line is that Pfizer looks like a buy right now for those with a long-term investing horizon. The company should return 17% in the next twelve to eighteen months. Dividends should give that return an extra four to six percentage points over the same period. |
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Biotechnology Companies
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Written by Hugh McManus
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Sunday, 16 May 2010 14:13 |
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Keryx is an emerging pharmaceutical company headquartered in New York. It’s not an innovator company, instead Keryx acquires pharmaceutical products, then develops and commercializes them. The company has had a rocky few years, but recently, the news has improved for Keryx. Keryx is an emerging pharmaceutical company based in New York City. The company is virtual in that it appears to have minimal internal capabilities outsourcing its activities to third party CROs and CMOs instead. The company has two clinical programs, discussed in a moment, Zerenex (ferric citrate) for patients in end-stage renal disease and perifosine (KRX-0401) undergoing two phase III trials, one for multiple myeloma and another for colorectal cancer. Additionally, perifosine is in some other phase II trials for various cancers. The company enjoyed revenues of $25 million in 2009 with net income of over $10 million. No revenues were reported in either of the last two quarters. The company has a relatively healthy balance sheet with assets of $40 million and little long-term debt. The company had negative cash flow of over $3.5 million in the most recent quarter. ZerenexZerenex is an oral compound, ferric citrate, that binds phosphate. As kidney failure progresses, various toxins amass in the blood stream; there are various ways to fight this problem. A tablet which allows the absorption of ferric citrate into the bloodstream is a simple solution. The company is currently engaged in a phase III clinical trial under a Special Protocol Assessment (see the glossary) with the FDA on January 5, 2010. The implication of this agreement being that if safety and efficacy are demonstrated as well as a positive risk/benefit assessment, then the clinical trial is sufficient to realize marketing approval for the drug. Interestingly, I haven’t been able to find mention of this NDA on the FDA website, which isn’t a concern. The company announced a registration program for the trial on May 6. Here’s the link to that trial: http://www.clinicaltrials.gov/ct2/show/NCT01074125?term=keryx&rank=11 PerifosinePerifosine (octadecyl-(N,N-dimethylpiperidino-4-yl)phosphate) is a small molecule drug active, it appears, against different cancers. The molecule appears to characteristics of a cellular membrane causing inhibition of cell growth. There are currently seven, ongoing clinical trials with this API. The mechanism of action of this drug is such that it could play a role in a great many different cancers. The company reported that in its extensive clinical trials the drug doesn’t seem to induce the side effects seen in many competing therapies. The company has an ongoing phase III trial in refractory multiple myeloma. The FDA has given both Orphan Drug and Fast Track status for this indication. Last April, registration started on a phase III trial for colorectal cancer. Additionally, there is a phase I/II trial for recurrent or progressive malignant glioma; a phase II trial in small lymphocytic lymphoma; a phase I trial in various forms of leukemia; and two phase I trials in the area of solid tumors. For Keryx, renal failure is a good market, but it’s not going to drive the company to the next level; Keryx must be successful in the cancer market. To date, indications are very positive for KRX-0401, but the true test of any drug is the phase III trial. It’s impossible to predict the outcome. Many promising drugs have crashed and burned in the clinic. While its challenging enough trying to decipher the science, one also has to divine human behavior and determine what the masses are going to do with Keryx. It looks to me as if Zerenex could get approved. If it doesn’t, I don’t see it as being a good, but not great drug. In fact, approval could be an anticlimax; it could be even better for the average investor if the FDA turns the drug down. We have to wait first for the results of the ongoing trial, then the verdict of the FDA. If the trial results are good, then I think there’s a ninety percent chance that the FDA will approve the drug. The next thing to watch will be the clinical trial results, then the FDA filing for KRX-0401. At the current level, based on the financials alone, KERX seems overpriced to me. I am inclined to wait, hoping that the stock might retrench to the $3 range before splurging on this company. Every drug that I have ever seen has some sort of glitch or hiccup in the approval process. It’s very rare to see a drug go through all the steps unscathed. I’d expect Keryx to enjoy a similar experience. The investigational drugs that this company has, particularly those targeting cancer, look good; if they continue towards approval, they have the potential to generate at least $300 to $500 million each. For now, I am putting Keryx on my watch list. If the stock price retreats, I will move in; I need more news. |
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Biotechnology Companies
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Written by Hugh McManus
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Saturday, 15 May 2010 14:07 |
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I have been following Poniard Pharmaceuticals for a few years; this company appears to be at a turning point. The webcast last Monday was interesting; it’s clear that the company is at a crossroads. Like many biotech companies in the Bay Area, Poniard has had a storied history; you might remember the company as NeoRX. The company has been around longer than many of its peers: it’s over twenty years old—ancient by biotech standards and a little sad too. Companies that old have either succeeded wildly or been absorbed into a larger, more successful entity; most have died. A few, like Poniard, linger on hoping for that great break in the clinic. Platinum has had a long history as an agent to fight cancer. Picoplatin is an organic complex of this metal designed to act as a chemotherapeutic agent against cancer, particularly in solid tumors where platinum resistance is observed. Most recently, Poniard used the material in an unsuccessful trial to fight small cell lung cancer: the company failed to meet the endpoint. Management has expressed the likely legitimate concern that the way cancer is treated in Europe versus the US essentially messed up the results. The company believes that treatment with the drug showed a trend towards a survival advantage; the post treatment chemotherapy in Europe favored patients that received the standard or care, the control group, over those on Picoplatin. Incidentally, Pharmacyclics had a similar issue after its failed phase III trial. For the case of Pharmacyclics, the company claimed that analyzing a subset of data clearly demonstrated the efficacy of the drug in the phase III trial. The FDA doesn’t permit this sort of retrospective analysis. Poniard is caught in a similar trap—at least that’s the sense of the argument provided by management. The company has one more last shot: a phase III trial on colorectal cancer—quite a big market. Poniard presented results for its phase II colorectal cancer trial this summer; the data were pretty impressive. The company is now working with the FDA towards staging the required Phase III trials, which, if successful, would help secure approval for the drug. The company is short of cash, but it has had some moderate good news in the past few months. Just over $6 million were raised through the sale of shares of common stock to a value fund. The company received a composition of matter patent, which covers the use of picoplatin in any cancer. The patent covers the drug through early 2016 and the potential exists for an additional five year extension under the Waxman Hatch Act. The company is also seeking marketing partners for picoplatin. While the clinical results are ambiguous, the drug is certainly not dead. A better designed protocol may help address concerns about picoplatin for small cell lung cancer; the upcoming phase III trial for colorectal cancer is critical. Licensing the drug for a specific therapy could be a way to generate the cash this company needs to survive. Poniard is a high risk investment—maybe one should wait for another clinical result before investigating this company further. If the company manages to secure a partnership, with some of the risk mitigated, PARD would be in inviting investment opportunity. |
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Biotechnology Companies
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Written by Hugh McManus
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Saturday, 15 May 2010 11:54 |
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Pharmacyclics is an emerging, small molecule pharmaceutical company located in the environs of Silicon Valley in California. The company had been public for almost fifteen years and has enjoyed both good and bad times. It’s currently recovering from a failed attempt to have a potentially potent anti-cancer drug approved by the FDA. Pharmacyclics has been around for many years. It’s had a difficult time with its lead drug, Motexafin gadolinium (MGd) which it tried to get approved by the FDA: no dice. The drug itself has a novel and interesting mode of action against cancer cells—specifically brain cancer. MGd differentially accumulates in the cells and enhances the effects of ionizing radiation on the cells causing apoptosis or cell death. Clinical trial showed an extension of life of many months for patients suffering from this fatal disease. The drug is back in the clinic undergoing two Phase II trials sponsored by the NCI (National Cancer Institute).
Pharmacyclics filed an NDA for Motexafin gadolinium, trade name Xcytrin, on December 22, 06 for the treatment of non-small cell lung cancer patients with brain metastases. If you’re a chemist by trading, check out Motexafin gadolinium on Wikipedia and imagine the synthetic route to that beast. The company received a refusal-to-file letter (see glossary) on February 21, 2007. The FDA refused to file citing failure to demonstrate statistically significant differences between treatment arms in the primary endpoint of the pivotal study to support approval. The company refiled on April 23 using a mechanism called “over protest,” which means that it disagreed with the initial screening and requested that the entire NDA be judged on its merits—a very risky approach! In the meantime, the company continued to announce other successful phase 2 trials for Xcytrin.
On December 21, 2007, a year after it filed the NDA, Pharmacyclics received its non-approvable letter from the FDA. What was interesting if you follow these things is that the stock didn’t drop dramatically when Pharmacyclics tried to essentially overrule the FDA the first time, it cratered after December 21. April 23 was a good time to be purchase PUTs or sell short—a very good time.
On September 11, 2008, good news: there was a major shakeup on the board and the CEO resigned. The CEO had been engaged in public criticism of the FDA; it was time for him to go. The stock hovered around $1.
Under normal circumstances with its lead drug in critical care and running short of cash, the company would fold; however, Pharmacyclics in-licensed some novel, small molecules, which it is currently developing. The stock has done well too, increasing form a low of $1 to a respectable $7 today.
The company is in relatively good shape: it has three active programs; it’s not flush with cash, but it has sufficient to ride out the next six months—with a stock price on the rise, it could go back and raise more funds. In fact, it needs more funds: it secured financing when the stock was at a low; trading at $7 today, the company could raise more cash without serious dilution.
There is still risk, much risk associated with this company; however, its lead programs, PCI-32765 is in phase I for oncology; PCI-27483 targets tumor growth and metastases. All is not lost for Motexafin gadolinium. I have been following this molecule since 1997: it is a drug; it just needs a successful trial.
I have Pharmacyclics in my wait-and-see pile. I believe it will go out and raise more cash in the short term. I also believe it will publish at least one successful clinical trial result. I want to wait until the stock moves back into the $3 to $5 range. I am hoping all this happens before news on MGd takes off. If I can purchase this company in the $3 to $4 range, I expect it to move into the high teens ($15 to $17) when MGd successfully completes its current phase II trials and moves into two phase III trials. I have a twelve to eighteen month time horizon on his company. |
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Biotechnology Companies
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Written by Hugh McManus
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Thursday, 13 May 2010 12:06 |
The review panel published its opinion of naproxcinod yesterday and gave the drug a thumbs down. The stock dropped over fifty percent in response settling with a loss for the day of 40%.
The FDA published a background document for the panel on Monday. As I said on Monday, the analysis wasn't very flattering for the drug: it doesn't work better than the current standard of care; it didn't function as a antihypertensive agent.
The FDA is still free to approve the drug, but with a 16-1 vote against the therapy by the review panel, I'd deem it unlikely that this drug will receive marketing approval.
The PDUFA date for this drug is July 24. |
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