|mib - Montag, 7. Januar 2002 - 01:38|
|Kauf von 70 Stk., Amarin, AMRN, zu 18.39 U$|
|mib - Montag, 7. Januar 2002 - 01:40|
| [We asked Joseph Dancy of the LSGI Technology Venture Fund to give us his "best idea" for 2002. The following is his selection] |
To identify attractive investments we look for several factors: (1) profitability, (2) below average valuation based on price/earnings, price/sales, and price/book ratios, (3) above average revenue growth, (4) high or increasing relative strength, in (5) the most inefficent part of the market - the small and microcap sector. Using these factors we identified Amarin Corporation (AMRN - $18.39) as our best idea for 2002, and set a 12 month price target of $38.
Amarin is a specialty pharmaceutical company that targets the neurology and pain management markets, two markets that are substantial in size and have a limited number of specialists that are easy to effectively target in a cost-effective manner.
Amarins strategy is to acquire under-marketed or niche products from larger pharmaceutical companies. These acquired products are ideally highly promotion sensitive, are clinically effective, and meet specific needs in the target sectors.
We interviewed Amarin CEO Rick Stewart this month, and the reasons we like the company are apparent from his answers:
Q: Rick, Amarin added a sales force to help increase growth this quarter. This group began actual sales operations in November we understand. Can you tell us if the new sales force is meeting expectations, and are they optimizing the sales of the Amarin product line?
A: The Amarin salesforce was deployed only 40 days ago - the anecdotal evidence from the field is very positive and neurologists appear to be receptive to the Amarin approach. We are not disclosing details of the Amarin approach; due to competitive reasons. The sales force is actually exceeding expectations in terms of the establishment or reinforcement of relationships with neurologists. We expect solid data on the impact of the salesforce in the first quarter of 2002 - every indication so far is positive.
Q: At a Salomon Smith Barney conference in New York City held on October 29th Amarin issued guidance that it would earn $1.20 to $1.25 this fiscal year. Is that guidance still accurate, or would you like to revise it?
A: Guidance for 2002 is reiterated at $1.20-$1.25 EPS. We have given guidance of a 15%-20% increase for 2002.
Q: Going forward there is a concern of some investors about the ability of Amarin to continue to grow revenues and earnings. Can you address this concern, and share Amarin's long term guidance? How is Amarin doing compared to your competitors?
A: Medium term drivers are leveraging the sales force and the successful filing of 2 NDA's in 2002. We expect Zelapar to be filed in the first half of 2002 and hopefully LAX-101 in late second half of 2002 after completion of the Phase III trials at the end of July. EPS guidance for 2002 is $1.45-$1.50.
Q: How is the approval of your morphine pain product proceeding with the FDA? Has the company experienced any FDA related issues?
A: We are looking to add Phase III products in neurology and pain to the pipeline in 2002. These are lower risk propositions where earlier stage risk has been removed. We believe there has never been any valuation for the pipeline incorporated in our stock price.
Q: Compared to competitors it appears that Amarin is quite a bit undervalued. Can you tell us why you are valued so much more cheaply than competitors? Is it because you are a small capitalization firm headquartered outside of the United States, a lack of institutional interest, or something else?
A: Amarin is currently trading on aprice/earnings ratio of 14 which is low compared to our competitors such as First Horizon or Shire. I think the main reason is that the stock has risen from $2.50 at the beginning of the year to a high of $28.40 and fallen backrecently is that many retail investors have sold to lock in their profits. The heavy volumes are also from a large number of relatively small lots.
This follows a similar pattern to last year when there was a sell-off at year end and a rapid increase in the New Year. A recent Forbes.com article valued Amarin at $41 per share - an effective price/earnings ratio of 34!
We initiated a low intensity investor relations campaign in the third quarter which yielded good results and the shareholder base is transitioning towards astronger institutional base. We are fortunate to have solid support from these shareholders which are buying on the current relative weakness.
Amarin is a very conservative company and we are reluctant to oversell the story because of the inevitable downside risk to the stock, however making sure the proper story is told is a key feature in 2002.
Q: Recently the share price has been quite volatile on both the upside and the downside. Investors are elated when we have strong upside moves, but are concerned when we have the inevitable pull-backs occur. Realizing that shares in small capitalization firms are by nature volatile, can you address recent share volatility?
A: One of the benefits of a retail investor base is the strong support it gives the price on the upside however the opposite can be said on the downside so we are seeking to reduce the retail reliance. The volatility in the stock price will be reduced as the transition to an institutional base occurs. Also we expect analyst cover to commence in February which will remove some of the misleading information from the market.
Overall, 2001 has been a great year for Amarin and its shareholders. We have exceeded our strategic objectives and have raised the bar for 2002. Our goal of leadership in the neurology therapeutic category is well on its way to achievement.
Q: Permax is obviously an important product to Amarin - can you tell us more about it and its position in the Parkinsons marketplace?
A: Permax is a dopamine agonist with approximately 24% market share in the Dopamine agonist market. Competitor products are Mirapex from Pharmacia and Requip from GlaxoSmithkline (approximately 48% & 28% market share respectively).
All dopamine agonists became first line therapy in 2002 following additional studies. Other Parkinsons treatments includecarbidopa-levidopa, MAO-B inhibitors and COM-T therapies. All therapies have some degree of side effect profile some more profound than others. The various treatments can be used at different stages of progression of the disease.
The Amarin salesforce started detailing Permax to neurologists in early November after approximately 18 months of non-promotion. The response so far has been encouraging and we expect the impact to be evident in the first quarter.
Q: What is Amarin's overall strategy in neurology?
A: Amarin intends to establish a leadership position in neurology and has started this process in movement disorder (Parkinsons & Huntington's) with 3 products. One marketed and two in late stage development. We aim to add further products in this area or inother smaller neurology sub-categories in 2002 to leverage the sales force. We said earlier this year that the sales force was intended to be the elite neurology sales force and we have achieved that goal.
Q: Thanks Rick!
|mib - Dienstag, 8. Januar 2002 - 15:09|
| The Growth Report January 8th 2001 |
Vol. 2 Issue 2
“Selling Old Drugs A New Way”
Despite warnings issued last month by Merck [MRK: NYSE], Growth Report has continued its search to identify undervalued pharmaceutical companies that should outperform the overall market over the coming year. This week we turn our attention to one such overlooked company that we feel deserves to be on your radar screen.
Amarin Corporation plc [AMRN: NASDAQ]
$19.49 Close January 7th 2002
$28.84 52wk high $2.50 52wk low
6.87 million shares outstanding
$133.9 million market capitalization
Amarin focuses on pain management and neurological drug treatments. The company has been extremely successful at strengthening its balance sheet as it builds on a strategy of acquiring branded drug products from larger pharmaceutical companies that have not been marketed to their full potential. Notwithstanding the success that Amarin has had in selling other companies drugs, the Company has its own product lines which are being developed in-house in its European-based development division.
Amarin, although U.K.-based, is aggressively marketing a portfolio of products in the U.S., which have been acquired over the last few years from companies such as Elan Corporation [ELN: NYSE]. The Company’s U.S. subsidiary, Amarin Pharmaceuticals Inc., based in Warren, New Jersey, is the cornerstone of Amarin’s success in recent years. This success has brought Amarin growing revenues and five consecutive quarters of profitability – and we all know how tough the last five quarters have been for many companies!
The marketing of these brand name prescription and over-the-counter drugs is conducted through direct marketing initiatives targeting high prescribing primary care and specialty physicians. This aggressive promotion, including use of the Internet, has been proven to be a highly successful approach.
Amarin’s key products include the anti-diarrhea drug Motofen®, the migraine and tension headache products Phrenilin® and Phrenilin Forte® and the anti-obesity agent Bontril®. These drugs all have one thing in common, a distinct lack of marketing for quite some time prior to their acquisition by Amarin. In the future, the range of drugs marketed by Amarin’s U.S. subsidiary should be broadened to cover products treating oncological, neurological and gastroenterological conditions.
Amarin has as part of its strategic vision, the acquisition of late stage development products with applications in its target therapeutic categories. The company has recently announced the licensing of two important new products, each of which is currently in phase III clinical trials. With the licensing of these products, Amarin is positioning itself to be a leader in the field of movement disorder.
Amarin has licensed exclusive U.S. rights for LAX-101, a novel therapy for the treatment of Huntington's disease, a devastating and ultimately fatal neurodegenerative condition. There are no known approved treatments. About 30,000 Americans have the disease and another 150,000 have a 50/50 chance of inheriting it from an affected parent.
The Company has also acquired the U.S. rights to Moraxen, a novel severe pain therapy already licensed in Europe and entering Phase III clinical trials in the U.S. Moraxen is a 24-hour controlled-relief morphine suppository which has already been approved in the U.K. and Ireland and is expected to enter phase III clinical trials in the U.S. in the first half of next year.
With a corporate strategy to invest in marketing of drug treatments rather than attempt to bring to market unproven (but potentially more valuable) drug products, Amarin can prudently build its business model without putting too much capital risk. In the 3rd quarter, revenues grew 191% to $15.6 million with net income of $3.1 million, equivalent to $0.28 per fully diluted share. Amarin now presides over an enviable cash and receivables position of $38.2 million or roughly $5.60/share.
These results are exceptional given that the period included the investment in launching Amarin’s new 24-member U.S. neurology sales force (press release) that has been instrumental in promoting the use of Permax tablets, a widely used drug used in the treatment of Parkinson’s disease. Amarin also gained exclusive U.S. marketing, sales and distribution rights to Permax from Elan Corporation in a transaction announced earlier this year (press release). In addition to securing exclusive U.S. rights to Permax, Amarin acquired the rights to ZelaparTM, currently in late-stage development for the treatment of Parkinson’s disease.
Leading specialty pharmaceutical company Elan owns 9% undiluted and 47% fully diluted of Amarin, through financing arrangements and stock issuances as part of the acquisition by Amarin of numerous products from Elan. This partnership represents tremendous ongoing strength for Amarin and the arrangement should benefit both companies in the years to come. Given the prospects for increased sales penetration by the new neurological marketing team and impressive growth from a business model that is perhaps putting larger pharmaceutical companies to shame, Growth Report expects Amarin to be an earnings-driven story that is unlikely to surprise on the negative side. We expect the company to retest its highs over the coming year and recommend the shares as a Speculative Buy with a 12-18 month target of $28/share.
We appreciate your feedback! Please send your comments or questions to email@example.com
|mib - Mittwoch, 23. Januar 2002 - 15:41|
| Wednesday January 23, 7:15 am Eastern Time |
SOURCE: Amarin Corporation plc
Amarin Announces Positive Results of Phase II Studies in Huntington's Disease
- LAX-101 and NPLs Demonstrate Benefit in the Treatment of Huntington's Disease in Separate Phase II Studies -
LONDON, Jan. 23 /PRNewswire-FirstCall/ -- Amarin Corporation plc (Nasdaq: AMRN - news; ``Amarin'') announced that positive results of two separate Phase II studies were published in the January 21st issue of NeuroReport. The studies examined the effects of LAX-101 (and a LAX-101 prototype), a novel and proprietary potential treatment for Huntington's disease (HD), individually and as part of a mix of neuroactive polyunsaturated lipids (NPLs).
LAX-101, a novel and proprietary compound that inhibits certain harmful enzymes including phospholipases and caspases, represents a new class of drugs sometimes referred to as NPLs. This class may function as ``neuroprotectants'' and appears to inhibit degradation of brain tissue by a variety of proposed mechanisms, including stabilization of the phospholipid components of cell membranes and mitochondria, cell structures that are important in cell regulation and brain function.
The first article details a six-month randomized, double-blind, placebo-controlled study of seven patients with advanced Huntington's disease (three received LAX-101, and four received placebo). Dr. Basant Puri, et al conducted the study at Hammersmith Hospital in London. After six months of treatment, all three patients receiving LAX-101 showed significant improvement on the orofacial component of the Unified Huntington's Disease Rating Scale (UHDRS), a commonly used measure of HD severity. All four patients receiving placebo demonstrated an expected worsening of their disease, as measured by the orofacial component of the UHDRS. This result represents a mean 34% improvement for the patients receiving LAX-101 versus a mean 23% decline for the patients receiving placebo. The study did not report on adverse events associated with the treatment.
In addition to the orofacial component, the total movement score of the UHDRS showed significant improvement in the LAX-101 patients compared to the patients receiving placebo (a mean 16% improvement for the LAX-101 group versus a mean 38% decline for the placebo group). These clinical data were further supported by brain MRI scans of four patients (two in each group). The MRI scans of two patients receiving LAX-101 each demonstrated a decrease in the size of the brain's central fluid-filled cavity, which correlates to an increase in overall brain size. The brain scans of two patients on placebo each showed a decrease in brain size, consistent with neurodegenerative progression in patients with Huntington's disease.
``These strikingly positive results, albeit in a small group of patients, demonstrate the significant potential clinical benefit of LAX-101 in the treatment of Huntington's disease,'' stated Rick Stewart, CEO of Amarin. ``There are no approved treatments for this progressive, fatal neurodegenerative disease. If these results are confirmed in the ongoing Phase III study, LAX-101 will represent a breakthrough in the treatment of Huntington's disease. Enrolment in the Phase III trials finished in July 2001 and the study is expected to be completed by the end of this year.'' LAX-101 has received Orphan Drug designation in the U.S. and in Europe. Amarin licensed the U.S. marketing rights from U.K.-based Laxdale Ltd (``Laxdale'').
The same issue of NeuroReport describes a second randomized, double-blind, placebo-controlled clinical study conducted by Dr. Vaddadi, et al. at Monash University, Melbourne, Australia, in which seventeen Huntington's disease patients were treated for nineteen to twenty months. This study, begun four years before the Hammersmith study, tested a LAX-101 prototype that contained a mix of neuroactive polyunsaturated lipids. Pre-clinical studies performed by Laxdale indicated that a LAX-101 prototype was a major active component of this mixture. LAX-101 was chosen for further development in the Hammersmith study as well as in the ongoing Phase III study. When the Hammersmith study results became available, the Monash study was halted on ethical grounds in order to offer treatment with LAX-101.
The Monash study provides further support for the potential of LAX-101 in the treatment of HD. On the UHDRS Motor sub-scale, one of the two primary end-points for this Phase II study, seven of eight patients on placebo deteriorated during the trial, whereas five of nine patients receiving active drug improved. The other primary measurement was the Rockland-Simpson Dyskinesia Rating Scale. In the placebo group, six of eight patients deteriorated, and in the active group, seven of nine improved. Results in other UHDRS endpoints showed positive trends but were not statistically significant. The study noted no serious treatment-related adverse events.
Huntington's disease is an autosomally-dominant inherited genetic disease currently diagnosed in approximately 30,000 patients in the U.S. The gene for HD causes the formation of abnormal proteins containing an excess number of the amino acid glutamine. This is due to multiple repeats in a segment of the DNA of afflicted patients. In the U.S. it is estimated that, in addition to the 30,000 patients with a clinical diagnosis of HD, there are roughly 70,000 individuals with the HD gene who are pre-symptomatic, who will eventually develop the disease. HD generally strikes patients during their peak earning potential years (30-50 years old), and patients with end-stage disease require continuous nursing care, often in institutions. As a result, the annual cost to the U.S. economy for HD has been estimated to be as high as $2.5 billion.
Amarin Corporation plc is a specialty pharmaceutical company focused on neurology and pain management. The company plans to become a leader in these therapeutic categories by providing innovative products and solutions that address significant unmet medical needs.
Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties which may cause the Company's actual results in future periods to be materially different from any performance suggested herein. Such risks and uncertainties include, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialization, the impact of competitive products and patents, as well as other risks and uncertainties detailed from time to time in periodic reports. For more information, please refer to Amarin Corporation's Annual Report for 2000 or 20-F and its Form 6-Ks as filed with the U.S. Securities and Exchange Commission. The Company assumes no obligation to update these statements.
SOURCE: Amarin Corporation plc