BMRN - Sector: Healthcare---Industry: Biotechnology & Drugs

[fous]

This company made a huge bull run in 05, i think it can continue in 06. Im buying on a breakout of the symmetrical triangle.

Lots of things goin on here to speculate on:

BioMarin drug Naglazyme gets EU approval
Mon Jan 30, 2006 4:26 PM ET

NEW YORK, Jan 30 (Reuters) - BioMarin Pharmaceutical Inc. (BMRN.O: Quote, Profile, Research) on Monday said European regulators approved its drug Naglazyme to treat a rare genetic disease with orphan drug status, giving the company 10 years of market exclusivity.

BioMarin said the drug has been approved in the 25 member states of the European Union, Iceland and Norway for long-term enzyme replacement therapy in patients with a disease called mucopolysaccharidosis VI.

BioMarin said it expects 2006 sales of Naglazyme to be in a range of $28 million to $32 million, and sales of its drug Aldurazyme to be in a range of $90 million to $100 million.

...

FDA grants speed review to BioMarin PKU treatment
Wed Jan 25, 2006 4:49 PM ET

LOS ANGELES, Jan 25 (Reuters) - BioMarin Pharmaceutical Inc. (BMRN.O: Quote, Profile, Research) said on Wednesday that the U.S. Food and Drug Administration has granted "fast track" review of Phenoptin, an experimental treatment for phenylketonuria, or PKU.

PKU, a genetic disorder affecting approximately 50,000 diagnosed patients in the developed world, is caused by a deficiency of an enzyme required to metabolize an essential amino acid found in most protein-containing foods.

...

BioMarin Establishes Commercial Operations in Europe
Tue Jan 10, 2006 4:00 PM ET

William Aliski Appointed Vice President and General Manager, European
Operations

   NOVATO, Calif., and LONDON, Jan. 10 /PRNewswire-FirstCall/ -- BioMarin
Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that it has
established commercial operations in Europe in anticipation of receiving
European marketing approval for Naglazyme(TM) (galsulfase), an enzyme
replacement therapy for the treatment of mucopolysaccharidosis VI (MPS VI;
Maroteaux-Lamy syndrome), in the first quarter of 2006.  BioMarin Europe Ltd.
is headquartered in London, with branch offices located in Spain, Switzerland
and Italy.
   William E. Aliski has been appointed Vice President and General Manager of
European Operations, responsible for overseeing European commercialization
efforts.  Prior to joining BioMarin, Mr. Aliski served as Vice President of
Commercial Operations at Transkaryotic Therapies, a biotechnology company
that, prior to its acquisition by Shire Pharmaceuticals Group in July 2005,
focused on the development and commercialization of products to treat rare
diseases.  In this role, Mr. Aliski managed worldwide drug distribution,
inventory management and patient support for the company's lead product,
Replagal, an enzyme replacement therapy for Fabry disease.  Earlier in his
career, Mr. Aliski worked at Genzyme Corporation, a biopharmaceutical company
focused on serious diseases, including genetic disorders, where he served as
Vice President of Health Systems and Vice President of Patient and Product
Services, responsible for overseeing the development and implementation of
reimbursement planning and launch for multiple products, including Cerezyme
and Ceredase.
   "We are pleased that Mr. Aliski has joined the BioMarin team and believe
that his experience in the global commercialization of products for rare
diseases further positions us for a successful European commercial launch of
Naglazyme for MPS VI, pending final regulatory approval," stated Steve
Aselage, Senior Vice President of Global Commercial Operations of BioMarin.
"With BioMarin Europe now in place, we look forward to commencing our first
European product launch and to making Naglazyme available to the European MPS
VI community in the not too distant future."
   BioMarin Europe, an Irish subsidiary, will be responsible for overseeing
the sales and distribution of Naglazyme to the 25 member states of the
European Union, Iceland and Norway.  Those wishing to correspond with BioMarin
Europe should contact:
...

BioMarin Pharmaceutical, Inc. Announces U.S. FDA Acceptance Of Orapred ODT Filing
2005 Oct 19 8:00 PM

BioMarin Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets), a new formulation of Orapred (prednisolone sodium phosphate oral solution). Prednisolone is commonly used to reduce inflammation seen in numerous medical conditions including asthma, arthritis and cancer. The FDA will take action on the application, under the Prescription Drug User Fee Act (PDUFA), by June 1, 2006.

[fous]

Price action broke out of the ascending triangle and and MACD making a bullish cross. Though volume was lacking on this breakout so im still debating  whether to enter this from a technical perspective yet. Still waiting for my filter to be done, i only have enought mone for one more position so if theres nothing more attractive than this i will likely fill a position tomorrow.

-fous

[fous]

Buying BMRN at the open. Good luck to anyone if they decide to join me on this venture

-fous man

[fous]

resistence seems to be building at 12.07. A close above that point and i believe this bull run will continue its ascent. Earning for 05 and q4 are on thursday. I think they will be positive results and get the volume back above average on this one.

Link to webcast for thurs: http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=106657&eventID=1173665

-fous

[fous]

Still holding onto this one for now. Releasing Earnings tomorrow after the close 5pm ET.

Price action forming an ascending triangle on the verge of a break out.

-fous

[fous]

BMRN delivered positive earnings yesterday after the close and the market reacted well thus continuing this bullish run.

BioMarin Announces Fourth Quarter and Year-End 2005 Financial Results
Thu Feb 23, 2006 4:00 PM ET

Significant Reduction in Net Loss Projected for 2006

    NOVATO, Calif., Feb. 23 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical
Inc. (Nasdaq and SWX: BMRN) today announced results for its fourth quarter and
year ended December 31, 2005. The net loss was $15.0 million ($0.20 per share)
for the fourth quarter of 2005 compared to $82.4 million ($1.28 per share) for
the fourth quarter of 2004. The net loss was $74.3 million ($1.08 per share)
for the year ended December 31, 2005 compared to a net loss of $187.4 million
($2.91 per share) for the year ended December 31, 2004.
    "Over the past year, we successfully advanced our product pipeline while
significantly reducing our net loss.  During this time, we achieved key
company milestones, including the approval of Naglazyme in both the United
States and Europe, the completion of the double-blind portion of the Phase 3
clinical trial of Phenoptin for PKU, and the initiation of our program for 6R-
BH4 for the treatment of several cardiovascular indications," stated Jean-
Jacques Bienaime, Chief Executive Officer of BioMarin.  "Looking ahead in
2006, we expect the growing sales of Aldurazyme and Naglazyme and the revenue
from our Phenoptin development collaboration to substantially offset
development spending, leading to a significant reduction in our projected 2006
net loss as compared to 2005."
    Net sales of Naglazyme(TM) (galsulfase), an enzyme replacement therapy for
mucopolysaccharidosis VI (MPS VI), for the fourth quarter and year ended
December 31, 2005 were $3.7 million and $6.1 million, respectively.  Naglazyme
was approved by the U.S. Food and Drug Administration (FDA) on May 31, 2005
and launched by BioMarin's U.S.-based sales force on June 20, 2005.
    Net sales of Aldurazyme(R) (laronidase), an enzyme replacement therapy for
mucopolysaccharidosis I, (MPS I) by BioMarin/Genzyme LLC increased 36 percent
to $21.2 million for the fourth quarter of 2005, compared to $15.6 million in
the fourth quarter of 2004. Net sales for the year ended December 31, 2005
were $76.4 million compared to $42.6 million for the same period in 2004,
representing an increase of 79 percent. BioMarin's share of the profit of
BioMarin/Genzyme LLC was $3.1 million for the fourth quarter of 2005, compared
to $1.0 million for the fourth quarter of 2004. BioMarin's share of the profit
of BioMarin/Genzyme LLC for the year ended December 31, 2005, was $11.8
million, compared to a loss of $3.0 million for the year ended December 31,
2004.
    Net sales of Orapred(R) (prednisolone sodium phosphate oral solution),
including the branded and authorized generic products, were $0.4 million for
the fourth quarter of 2005, compared to $13.9 million for the fourth quarter
of 2004. Orapred net sales recorded by BioMarin for the 12 months ended
December 31, 2005 were $6.9 million compared to $18.6 million for the same
period in 2004. This decrease in net sales can be attributed to the
introduction of generic competitors that entered the market in late 2004.
BioMarin began recording sales of Orapred in May 2004 at the time the product
was acquired.
    As of December 31, 2005, BioMarin had cash, cash equivalents, short-term
investments and cash balances related to long-term debt of approximately
$64.8 million.
    2006 Projected Net Product Sales
    In a company press release issued January 30, 2006, BioMarin provided the
following net sales guidance for 2006:
     *    BioMarin estimates sales of Naglazyme for 2006 to be in a range of
          $28 million to $32 million.
     *    BioMarin and Genzyme estimate sales of Aldurazyme by the joint
          venture for 2006 to be in a range of $90 million to $100 million.

    2006 Projected Net Loss
    BioMarin projects that the GAAP net loss for 2006 will be between
$49 million and $52 million, which includes $5.9 million of expenses related
to the 2004 acquisition of Orapred and $7.5 million of expenses related to
stock option compensation.
    Recent Events and Fourth Quarter 2005 Highlights

     *    On January 30, 2006, BioMarin announced that the European Commission
          had granted marketing authorization for Naglazyme for the treatment
          of MPS VI.
     *    On January 25, 2006, BioMarin announced that the FDA had granted
          Fast Track designation for Phenoptin(TM) (sapropterin
          dihydrochloride), a Phase 3 investigational product candidate for
          the treatment of phenylketonuria (PKU).
     *    On January 10, 2006, BioMarin announced that it had established
          operations for BioMarin Europe Ltd., positioning the company to
          launch Naglazyme in the European Union and to partner with companies
          looking to bring other products for rare diseases to the European
          marketplace.
     *    On October 19, 2005, BioMarin announced that the FDA had accepted
          for filing the new drug application submitted for Orapred ODT(TM)
          (prednisolone sodium phosphate orally disintegrating tablets).  The
          FDA will take action on the application, under the Prescription Drug
          User Fee Act (PDUFA), by June 1, 2006.

    Upcoming Company Milestones
    BioMarin expects to continue to advance its clinical-stage product
candidates in the coming months. The following is a list of the company's
projected near-term milestones:
     *    Announce results from the double-blind, placebo-controlled portion
          of the Phase 3 clinical trial of Phenoptin for PKU in late March
          2006; and
     *    Initiate a Phase 2 clinical trial of 6R-BH4 in poorly controlled
          hypertension in the second or third quarter of 2006 and a Phase 2
          clinical trial of 6R-BH4 in peripheral arterial disease in the
          fourth quarter of 2006.

[fous]

price action still reacting niceley to positive earnings. I think this well perform well into 06'

-fous

[fous]

Strong uptrend still in force for BMRN. 13.67 looks to be a strong area of resistence and will need to push through that to keep headin north for 06'

-fous

[fous]

Big news! Big Movements

BioMarin Soars on Trial Results

By Althea Chang
TheStreet.com Staff Reporter
3/15/2006 6:16 PM EST
Click here for more stories by Althea Chang

BioMarin Pharmaceutical (BMRN:Nasdaq - commentary - research - Cramer's Take) and its partner Serono (SRA:NYSE ADR - commentary - research - Cramer's Take) said an experimental drug for treating a rare genetic disorder met the goals of a late-stage study.

The drug, Phenoptin, is designed for patients with phenylketonuria, or PKU, a genetic condition that can cause brain damage, severe mental retardation, mental illness, seizures and tremors.

Shares of BioMarin soared $2.55, or 20.5%, to $15 in after-hours trading. The stock had lost 49 cents to $12.45 in the regular session. Serono added 40 cents, or 2.2%, to $18.47.

About 50,000 cases of PKU have been diagnosed in developed nations. The disease is caused by the deficiency of an enzyme that's required for metabolizing phenylalanine, an amino acid found in most protein-containing foods. If not enough of the enzyme is present, phenylalanine accumulates to abnormally high levels in the blood and brain, resulting in a variety of complications.

BioMarin said data from a Phase III study found that participants taking Phenoptin had a statistically significant reduction in their blood phenylalanine levels after six weeks of treatment compared with those receiving the placebo.

Phenoptin received orphan drug designation to treat PKU from both the Food and Drug Administration and regulators in Europe. If Phenoptin becomes the first drug approved for treating the disease, it would have seven years of market exclusivity in the U.S. and 10 years in the European Union.

The FDA has granted Phenoptin fast-track status, which is meant to hasten the review of drugs intended to treat serious or life-threatening conditions and that might address an unmet medical need.

BioMarin and Serono expect to apply for the drug's approval in the U.S. and European Union in 2007. BioMarin has licensed the exclusive rights for Phenoptin outside of the U.S. and Japan to Serono.

Separately, BioMarin said it's selling certain rights to its pediatric asthma drug Orapred. Privately held Alliant Pharmaceuticals will acquire the North American rights to the drug, and BioMarin will receive various payments and royalties. BioMarin will retain commercial rights to the drug outside of North America.

"Orapred no longer fits well with our core business of developing and commercializing novel products for serious genetic and metabolic diseases," said BioMarin CEO Jean-Jacques Bienaime.

[fous]

BMRN made a big rally AH on the news and retraced during the day quite a bit though showed support from a long term prior resitence area wich is now acting as support. Friday then made a nice rally, I think this has portential to be past $15 in the near future.

-fous

[Lucas Scott]

Nice one Fous. Set up kinda like ARNA was 3 months ago.

[sebfr]

Hi,

Good stock...A continuation gap is appeared...Buy again

[David Randolph]

This Analysis was requested a while ago in the «Analysis on Demand» thread, which is available only for 3SOF Premium Members (14-Day Free Trial available).

1. Profile

BioMarin Pharmaceutical, Inc. (BMRN) develops and commercializes biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprised of approved products and various investigational product candidates. Approved products include Naglazyme (galsulfase), a recombinant form of N-acetylgalactosamine 4-sulfatase enzyme used for the treatment of genetic disease called mucopolysaccharidosis VI; and Aldurazyme that is used for the treatment of mucopolysaccharidosis I caused by the deficiency of a lysosomal enzyme called alpha-L-iduronidase. It also develops various investigational product candidates for the treatment of genetic diseases, including Kuvan (sapropterin dihydrochloride), formerly referred to as Phenoptin, a proprietary oral form of tetrahydrobiopterin (6R-BH4 or BH4), for the treatment of Phenylketonuria (PKU); and Phenylase (phenylalanine ammonia lyase), an enzyme substitution therapy for the treatment of phenylketonurics, who are not 6R-BH4 responsive. Further, BioMarin Pharmaceutical evaluates preclinical development of various other enzyme product candidates for genetic and other diseases, as well as an immune tolerance platform technology to overcome limitations associated with the delivery of existing pharmaceuticals. The company also holds rights to receive payments and royalties related to Orapred (prednisolone sodium phosphate) and Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) subsequent to the sublicense of North American rights. It sells its products to specialty pharmacies, hospitals acting as retailers, and pharmaceutical wholesalers in the United States, Japan, and European Union. BioMarin Pharmaceutical, Inc. has strategic alliance with Merck Serono. The company was founded in 1996 and is headquartered in Novato, California.

2. Stock price history since IPO



BMRN's IPO was back in 1999 and the stock debuted at $15. Today it stands at $22.23, a 48% rise in about eight years. However, the company's value, given by the market cap, increased a lot more than that, because the share count rose every year (the numbers in red below the price chart are the share count - in millions).

In 1999 the market cap was $15*35 M = $525 M. Today it is $22.23*96 M = $2.13 B, that is, 306% more than in 1999.

This is just for us to understand what dilution makes to returns over the long term.

BMRN being a biotechnology company with dilutive habits I would reject it right away, but I must say that generally I dislike the biotech sector (also because I don't know how to value it well). But let me try to take a look at BMRN with an open mind.

The rise on point 1 was due to the late 1999, early 2000 technology bubble. Back then the company had $12 M in annual revenue and $37 M in losses. The bubble collapsed and BMRN fell 91% on phase 2 on the chart. Phase 3 was a 283% rebound in about a year. I don't see any fundamental reason for this rise, other than the stock had been down 90% plus previously. Because there wasn't a fundamental back up BMRN fell back down in phase 4, to a low of $3.88 in November 2004. That was the low, the stock rose ever since ...

2.1. Medium term chart



I see revenues rising and losses diminishing quarter after quarter. Here are analysts expectations for the current year and 2008:



So, we're talking about $0.36 EPS estimate for 2008. This means the forward earnings multiple is 62. I don't understand this valuation, I think it is absurd, like I do for most biotechnology companies, I'm sorry.

3. Conclusion

Perhaps BMRN's pipeline of new drugs, or existing drug's potential justifies this kind of valuation, but I don't have enough knowledge to value that.

I try to avoid businesses I don't understand, especially if the company is a "diluter".

My overall opinion on BMRN is negative, even though I recognize it is made out of insufficient knowledge. Good luck if you know it well and own it

Thanks for your suggestions


This Analysis was requested a while ago in the «Analysis on Demand» thread, which is available only for 3SOF Premium Members (14-Day Free Trial available).

[David Randolph]

The following analysis was written on September 11th, 2007:

BMRN

1. Profile

BioMarin Pharmaceutical, Inc. (BMRN) develops and commercializes biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprised of approved products and various investigational product candidates. Approved products include Naglazyme (galsulfase), a recombinant form of N-acetylgalactosamine 4-sulfatase enzyme used for the treatment of genetic disease called mucopolysaccharidosis VI; and Aldurazyme that is used for the treatment of mucopolysaccharidosis I caused by the deficiency of a lysosomal enzyme called alpha-L-iduronidase. It also develops various investigational product candidates for the treatment of genetic diseases, including Kuvan (sapropterin dihydrochloride), formerly referred to as Phenoptin, a proprietary oral form of tetrahydrobiopterin (6R-BH4 or BH4), for the treatment of Phenylketonuria (PKU); and Phenylase (phenylalanine ammonia lyase), an enzyme substitution therapy for the treatment of phenylketonurics, who are not 6R-BH4 responsive. Further, BioMarin Pharmaceutical evaluates preclinical development of various other enzyme product candidates for genetic and other diseases, as well as an immune tolerance platform technology to overcome limitations associated with the delivery of existing pharmaceuticals. The company also holds rights to receive payments and royalties related to Orapred (prednisolone sodium phosphate) and Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) subsequent to the sublicense of North American rights. It sells its products to specialty pharmacies, hospitals acting as retailers, and pharmaceutical wholesalers in the United States, Japan, and European Union. BioMarin Pharmaceutical, Inc. has strategic alliance with Merck Serono. The company was founded in 1996 and is headquartered in Novato, California.

2. Stock price history since IPO



BMRN's IPO was back in 1999 and the stock debuted at $15. Today it stands at $22.23, a 48% rise in about eight years. However, the company's value, given by the market cap, increased a lot more than that, because the share count rose every year (the numbers in red below the price chart are the share count - in millions).

In 1999 the market cap was $15*35 M = $525 M. Today it is $22.23*96 M = $2.13 B, that is, 306% more than in 1999.

This is just for us to understand what dilution makes to returns over the long term.

BMRN being a biotechnology company with dilutive habits I would reject it right away, but I must say that generally I dislike the biotech sector (also because I don't know how to value it well). But let me try to take a look at BMRN with an open mind.

The rise on point 1 was due to the late 1999, early 2000 technology bubble. Back then the company had $12 M in annual revenue and $37 M in losses. The bubble collapsed and BMRN fell 91% on phase 2 on the chart. Phase 3 was a 283% rebound in about a year. I don't see any fundamental reason for this rise, other than the stock had been down 90% plus previously. Because there wasn't a fundamental back up BMRN fell back down in phase 4, to a low of $3.88 in November 2004. That was the low, the stock rose ever since ...

2.1. Medium term chart



I see revenues rising and losses diminishing quarter after quarter. Here are analysts expectations for the current year and 2008:



So, we're talking about $0.36 EPS estimate for 2008. This means the forward earnings multiple is 62. I don't understand this valuation, I think it is absurd, like I do for most biotechnology companies, I'm sorry.

3. Conclusion

Perhaps BMRN's pipeline of new drugs, or existing drug's potential justifies this kind of valuation, but I don't have enough knowledge to value that.

I try to avoid businesses I don't understand, especially if the company is a "diluter".

My overall opinion on BMRN is negative, even though I recognize it is made out of insufficient knowledge. Good luck if you know it well and own it

Tomorrow I'll write about CNXT, requested by sfhappyfish88. Thanks for your suggestions

[David Randolph]

3. Conclusion

Perhaps BMRN's pipeline of new drugs, or existing drug's potential justifies this kind of valuation, but I don't have enough knowledge to value that.

I try to avoid businesses I don't understand, especially if the company is a "diluter".

My overall opinion on BMRN is negative, even though I recognize it is made out of insufficient knowledge. Good luck if you know it well and own it

I didn't understand why, but that didn't stop BMRN from continuing its long term bull run. It's actually one of the few stocks trending higher in the Watch List at this moment.

The news out on that gap day was:

• BioMarin Surges On FDA Okay
at Forbes.com (Fri, Dec 14)