Pharming Group (PHARM)

[plumo]

go pharming,go pharming
we fly away today.

[plumo]

Pharming Announces Nine Month Financial Report 2010


Leiden, The Netherlands, October 21, 2010. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today published its financial report for the nine month period ended September 30, 2010.

FINANCIAL HIGHLIGHTS FIRST NINE MONTHS

•Income from grants and license fees for the nine month period of €0.7 million (9M 2009: €0.5 million)
•Received US$15.0 million (€11.7 million) non refundable and non off-settable upfront payment from Santarus for the commercialization of Rhucin® in North America
•Received € 3.0 million upfront payment from SOBI for commercialization of Ruconest in the EU
•Significant decrease in operating cash outflows (€3.4 million in first nine months of this year compared to €18.4 million in the same period 2009)
•Operating loss of €18.3 million (9M 2009: €21.0 million)
•Cash at September 30, 2010 of €17.0 million)
•Bondholders converted all of the €7.5 million bonds issued in January 2010


OPERATIONAL HIGHLIGHTS IN THIRD QUARTER

•Agreement entered with Santarus for the commercialization of Rhucin in North America)
•Signed manufacturing agreement with Sanofi Chimie for the drug substance of Ruconest™
•Dr Karl Keegan joined the Company as Chief Financial Officer (CFO)
•Intention to submit BLA to the FDA to obtain US marketing approval for Rhucin announced
•Spin off of DNage successfully completed


SUBSEQUENT TO SEPTEMBER 30, 2010

•Shareholders approved appointment Dr Keegan as CFO and member of Pharming’s Management Board
•Shareholders also approved increase of the authorized share capital at Company’s EGM
•Published peer reviewed randomized clinical trial results with recombinant human C1 esterase inhibitor in Journal of Allergy and Clinical Immunology
•Anticipated exercise of the put option by the 2007 public bondholders to repay the remaining outstanding 2007 convertible bonds per 31 October 2010 was confirmed


Sijmen de Vries, CEO, commented: “The first nine months of 2010 have been an important period for Pharming, during which we have consistently delivered on our stated targets of progressing our lead asset through the requisite developmental and regulatory pathways and maintaining tight control of our cost base. We believe that the progress we have made during the period is an endorsement of management’s strategic focus. We look forward to working with our marketing partners towards the first commercial launch of our lead program, an historic point in Pharming’s history and an important step towards bringing the Company to financial stability.”

FINANCIAL HIGHLIGHTS FIRST NINE MONTHS
Pharming’s income from grants and license fees were €0.7 million for the nine month period ended September 30, 2010. In the same period of 2009, Pharming recognized €0.5 million.

Operating loss decreased to €18.3 million from the €21.0 million recorded for the corresponding period in 2009. The decrease is mainly a result of timing of (pre)clinical and regulatory activities, our continued strong focus on cost savings and control, as well as the implementation of a strategic focus of our business resulting in the spin out of DNage. In the nine month period, operating losses attributable to DNage were approximately €2.0 million compared to €2.8 million in the first three quarters of 2009. General and administrative costs remained broadly constant but R&D expenses declined by €4.5 million in the nine month period 2010 compared to the corresponding period in 2009.

In the nine month period to September 30, 2010, Pharming recorded a net loss of €34.6 million compared to a net loss of €23.1 million for the same period in 2009. The vast majority of this loss was attributable to financing measures and their consequences that were triggered by financing activities during 2010. The net loss per share was €0.15 for the first nine months of 2010 compared to €0.22 in the first nine months of 2009. At the end of the period, the number of shares outstanding was 358,800,199 compared to 120,850,520 at the end of the corresponding period in 2009.

The increase in the current number shares by 3,018,702 from 355,781,497 on September 2, 2010 results from 2,171,117 shares in relation to exercise of cashless warrants and 847,585 shares issued to the Board of Management and various employees in settlement of bonuses due.

Pharming ended the nine month period with a cash position of €17.0 million, compared to a €10.6 million cash balance on September 30, 2009 and €2.3 million on December 31, 2009.

Pharming has recorded a significant decrease in operating cash outflows (€3.4 million in first nine months of this year compared to €18.4 million in the same period 2009). This achievement is primarily related to the receipt of upfront cash payments from SOBI and Santarus. The US$15.0 million (€11.7 million) non refundable and non off-settable upfront payment from Santarus is detailed in the consolidated statement of cash flows for the third quarter. The €3.0 million upfront from SOBI was recognized similarly in Q2 2010. In accordance with International Financial Reporting Standards, Pharming will recognize these upfront payments in the consolidated statement of income from Q4 2010 onwards as the amount received spread evenly over a period of approximately 10 years.

OPERATIONAL HIGHLIGHTS IN THIRD QUARTER
Pharming entered into an agreement with specialty biopharmaceutical company Santarus, Inc for the commercialization of Rhucin in North America (the United States, Canada and Mexico) for the treatment of acute attacks in HAE patients and other future indications.

Pharming signed a manufacturing agreement with Sanofi Chimie, wholly owned subsidiary of sanofi-aventis to increase the production capacity of the drug substance of Ruconest. This will improve Ruconest cost of goods and competitiveness and will put Pharming in the position to satisfy future global demand.

Pharming announced that it intends to submit the Biologic License Application to the FDA to obtain marketing approval for Rhucin for the treatment of acute angioedema attacks in patients with HAE. Following pre-BLA discussions with the FDA, Pharming is preparing the BLA dossier for submission towards the end of this year but no later than January 2011.

The spin off of DNage was completed and all earn-out liabilities due by Pharming to former DNage shareholders were fully settled.

SUBSEQUENT TO SEPTEMBER 30, 2010
Dr Karl Keegan was appointed to the role of CFO and member of Pharming’s Board of Management. Also, the increase of the authorized share capital from 400 million to 500 million shares was confirmed. These decisions were taken by the Shareholders at an Extraordinary General Meeting held on 1 October 2010.

The publication of the integrated analysis of Pharming’s randomized placebo-controlled clinical trials with recombinant human C1 esterase inhibitor for treatment of acute angioedema attacks in HAE patients in the October issue of the peer-reviewed Journal of Allergy and Clinical Immunology.

The anticipated exercise of the put option by the 2007 public bondholders to repay the remaining outstanding 2007 convertible bonds per October, 31, 2010 was confirmed.

OUTLOOK Q4 2010 AND BEYOND
Ruconest in Europe
Following the positive opinion on the Marketing Authorization Application for Ruconest earlier this year, Pharming is anticipating the Market Authorization by the European Commission within the next few weeks. As stated previously, the main focus in Q4 2010 will continue to be on the market launch of Ruconest, which is on track. This pivotal event in Pharming’s evolution will be marked by an associated milestone payment from SOBI upon European Market Authorization.

DNage
We have performed an impairment review on the intangible assets and goodwill capitalized with respect to DNage, which as previously announced is seeking additional funding through a combination of investors and government support.

Given that these financing activities are ongoing and given the uncertainty on the valuation ascribed to DNage by third party investors in any such financing, we have impaired the carrying value of goodwill associated with DNage in the balance sheet. This leads us to include a non cash impairment charge in the Q3 2010 financial statements.

Finances
As announced to the market, the Company has received confirmation of the put option from the bond holders. Thus, repayment of the remaining outstanding 2007 convertible bonds in cash and accrued interest (€11.3 million on aggregate) will occur by October 31, 2010. Pharming anticipates further cost savings from finalizing regulatory EU and US submission activities, co-funding development of rhC1INH for additional indications and further streamlining of the organization.

LIST OF USED ABBREVIATIONS AND TERMS
BLA Biologic License Application
DNage DNage BV (Pharming has 51% stake)
EGM Extraordinary General Meeting of Shareholders held on 1 October 2010
FDA US Food and Drug Administration
HAE Hereditary Angioedema
rhC1INH Pharming’s recombinant human C1 esterase inhibitor
Rhucin® Registered name in non-European countries for recombinant human C1 esterase inhibitor or rhC1INH for treatment of acute attacks of HAE

Ruconest™ Trademark for European marketing of recombinant human C1 inhibitor for treatment of acute attacks of HAE
Sanofi Chimie Wholly owned subsidiary of sanofi-aventis (NYSE Euronext: SAN, NYSE: SNY)
Santarus Specialty biopharmaceutical company Santarus, Inc (NASDAQ: SNTS)
SOBI Specialty pharmaceutical company Swedish Orphan Biovitrum (STO: BVT)

[plumo]

my too,
epar not tomorrow,friday.

[pedromm]

The cash flow should be excellent.

But i really want to know about the market authorization

[plumo]

yes i know it.
pharming: surprise me tomorrow

good luck

[pedromm]

October 21, Publication Q3 2010 Financial Results

[pedromm]

New buys coming also

[pedromm]

Profit taking going on.

[plumo]

nice
go pharming

[pedromm]

Encrease Price Target to 0,30 to 0,35€

All recomendations with buys from boursorama

http://www.boursorama.com/infos/consensus/consensus_analystes.phtml?symbole=1rAPHARM

[pedromm]

ok, thank you for the information.

[SpeedStone]

The EPAR is published on the website of the EMA when the European Commission has granted the Marketing Authorisation.

Example of EPAR from last week:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001195/human_med_001376.jsp&mid=WC0b01ac058001d125&murl=menus/medicines/medicines.jsp


This is what we are waiting for... but Ruconest is still under "Pending EC decision":

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001223/smops/Positive/human_smop_000111.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d127

[SpeedStone]

Yes, but the EPAR will be posted on the website of the EMA.

[pedromm]

CHART AND CONSIDERATIONS

[pedromm]

SpeedStone...We are waiting the decision from the european comissian and not ema (this one already adopted a positive opinian)

[SpeedStone]

Follow the news of the EMA online:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/landing/whats_new.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c4

[SpeedStone]

We could expect more at the close... but at the end, it is good to have the consolidation now, and to be ready for a new run on Monday...

No news today, Rhucin/Ruconest still in te "pending EC decisions":

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001223/smops/Positive/human_smop_000111.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d127

[plumo]

translate with google pedromm

[pedromm]

What are the main headlines. I can´t understand?

[plumo]

Pharming heeft nog EUR15-20 mln nodig - AEK
Pharming has EUR15-20 million needed
15 oktober 2010, 14:21 uur | DJ
AMSTERDAM (Dow Jones)--Pharming (PHARM.AE) heeft nog euro 15-20 mln nodig om de periode tot winstgevendheid te overbruggen, schat analist Bernd Hilhorst van AEK. Hij verwacht dat het Leidse bedrijf vanaf het vierde kwartaal Ruconest in de Europese Unie zal verkopen, gevolgd door de Verenigde Staten in het eerste kwartaal van 2013. Nu voor de belangrijkste markten commerciele deals zijn gesloten, lijkt Pharming alleen nog kapitaal op te kunnen halen door de uitgifte van nieuwe aandelen of schuld, aldus de analist. Het concern zou hiervoor de financieringsovereenkomst met Yorkville kunnen gebruiken, maar kan ook een nieuwe kredietfaciliteit afsluiten. AEK berekent een fair vaulue van euro 0,38 per aandeel. Het advies blijft outperformer. Vrijdag omstreeks 14.15 uur noteert het aandeel 9,3% hoger op euro 0,25, terwijl de ASX met 0,3% stijgt. (BTZ)



Dow Jones: [phone]; [e-mail]

[pedromm]

What a beatiful day trade.

[pedromm]

Where it is the sell of.

[pedromm]

and you are already making money.

Good luck

[pedromm]

Next resistance only around 0,29€

That what i see in the charts

[plumo]

i am back at 0.25 pedromm

[pedromm]

And an excellent volume today.

[pedromm]

and good support now at 0,25

[SpeedStone]

It's broken....

[pedromm]

1.2Million at 0,25 to break

[pedromm]

If it is a good news, it won´t came at friday.

Only in the begining of the week....Thats my opinian.

[plumo]

i have a buy order after we break the 0.25

[plumo]

mayby or not
it will not take long

[pedromm]

After ten news??

Are we expecting news today

[plumo]

yes but already sold
i am waiting for a next run to step in again
good luck

[pedromm]

Yes is possible.

Have you bought?

[plumo]

i am expect a big sell after ten news.
You have been warned pedromm !!!!!!

strong pharming
buy on the rumor
sell on the news !!!!!!!!!

[pedromm]

Investors are all buying waiting for that.

[SpeedStone]

News is coming... today or next week for sure!

With the marketing authorization the price will jump to 0,4-0,5 euro in 1 day...

[pedromm]

This has so much to climb....

[pedromm]

Excellent. Thats what i was expecting!

[plumo]

crazy day !!!!!!!!

[plumo]

are we going break the wall of 0.25
yes we can !!!!!!

[plumo]

today 0.25 and more ? or not ?

[SpeedStone]

French and Dutch speaking... English third language.

See also my discussions about Pharming on www.zonebourse.com

http://www.zonebourse.com/PHARMING-GROUP-6340/forum_action/-92845/action=showtopic

[SpeedStone]

Yes

[plumo]

break the wall 0.24

[plumo]

0.24 is coming !!!!!!!!

strong pharming

[plumo]

speedstone are you from Europe?

[plumo]

tomorrow we going higher and higher !!!!!!
wake up and make money with pharming !!!!!!!!!!!!

long and strong pharming

[plumo]

Dutch group to sell GM animal drugBy Andrew Jack in London

Published: October 14 2010 19:35 | Last updated: October 14 2010 19:35

The first European company to produce a drug from a genetically modified animal is to begin distributing its treatment to patients in the coming weeks.

Pharming, based in the Netherlands, is set to be the world’s first pharmaceutical group to derive a medicine from transgenic rabbits, using the milk they produce as the basis for its drug to treat a rare genetic disease.

EDITOR’S CHOICE
Cattle plague wiped out, says FAO - Oct-14Analysis: HIV / Aids: Discordant visions - Jul-22Disease takes toll on Japanese beef exports - Jul-18Science podcast: Online healthcare ethics - Jun-04Drought: Battered by climate extremes - Oct-28It will be only the second medicine cleared by regulators from a transgenic animal, after GTC Biotherapeutics of the US received authorisation to produce its ATryn drug, to prevent blood clots, from the milk of genetically modified goats.

After decades of research, the move could herald a new era of drugs using small, rapidly reproducing transgenic animals as “living factories”, though risking criticism from animal rights activists.

Pharming has 200 rabbits kept indoors in secured hygienic conditions. The animals have been bred with DNA modified so their mammalian glands release milk containing a protein that is then purified as the basis for the drug Ruconest.

The medicine treats hereditary angioedema, a rare genetic disease that causes uncomfortable and sometimes life-threatening swelling, pain and obstruction of the airways.

The product, approved by the European Medicines Agency in June, requires a final formal ratification from the European Commission, which is expected by the start of November. Under the brand name Rhucin, it will be submitted for US regulatory approval by the end of this year.

Production in rabbits allows high volume manufacture of the protein that is the basis of the drug. The milk is extracted using a mechanised pump, a modified version of those used by dairy farmers for cows.

Volumes can be expanded quickly through additional breeding, compared with costly and cumbersome alternative manufacturing processes using fermenters.

Pharming has refused to disclose the exact location of its factory, mindful of potential threats from animal rights activists.

Helen Wallace, head of GeneWatch UK, a research body critical of the “overuse of genetic solutions”, said: “We are concerned about the impact on animal welfare. Normally there are other ways to produce drugs. No production in this way has proved cost effective?...?There are many examples of experimental attempts which have ultimately ended in failure.”

But Sijmen de Vries, chief executive of Pharming, stressed that the rabbits were well cared for and showed no evidence of side effects from genetic modification, which he said only affected the mammalian glands producing milk. “We are constantly monitoring each animal,” he said. “They are checked daily.”

He added that the production method was low cost, that there was no evidence of any disease that had passed into humans from transgenic products, and that milk was itself an immune-privileged substance that would protect its contents from infection.

The idea for the use of transgenic animals came from researchers in the 1980s at Genentech, the US biotech group now owned by Roche of Switzerland, seeking to avoid the use of biological fermenters.
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