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Pharming Group N.V. (PHGUF) RSS Feed

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PHGUF: Ready for the Restart and the FDA;
Reiterate Buy; Target to $0.16


http://www.pharming.com/index.php

Pharming Group NV
T: +31 (0)71 5247 400
F: +31 (0)71 5247 445
E:  info@pharming.com

Visiting Address
Darwinweg 24
2333 CR Leiden
The Netherlands

Postal Address
PO Box 451
2300 AL Leiden
The Netherlands

Based on recent positive Phase III data for Ruconest (under SPA) and a $10
million milestone cash infusion from partner Santarus, we believe Pharming
is poised for an important restart. We anticipate BLA filing for acute attacks
of HAE in 1H13 and U.S. approval in 1H14.
We believe Ruconest represents
a competitive threat to Cinryze and Berinert based on both efficacy and a
differentiated safety profile. We reiterate our Buy rating.

Event
Following recent positive Phase III data for Ruconest (under SPA) and
management meetings we believe Pharming is poised for an important
"restart" as well as anticipated U.S. approval of Ruconest. Earlier this month,
confirmatory Phase III (Study 1310, under SPA) met its primary endpoint
of time to beginning of symptom relief in treatment of acute attacks in
HAE patients (p=0.031). Partner Santarus (SNTS - Buy) and Pharming are
expected to file the BLA in 1H13. Pharming received a $10 million milestone
payment from Santarus for the positive study and two key milestones are still
anticipated; $5 million for accepted BLA filing and $20 million for U.S. approval.




At Pharming we concentrate on our core competencies and form strategic partnerships in other fields. Pharming has several partnerships and collaborations in the fields of:
 
  • marketing and distribution (Swedish Orphan Biovitrum International, Santarus and Eczacıbaşı İlaç Pazarlama, Megapharm)
  • manufacturing (a.o. MSD and Sanofi Chimie)


Impact
We believe that Pharming's value proposition has changed dramatically and
will be an important fuel for the company's restart. While our fundamental
thesis remains unchanged regarding the prospects for Ruconest, Pharming
has had to weather an underlying financial storm, raising sufficient funds to
get them to the Phase III data and are now looking to emerge with a U.S.
approval for Ruconest with positive randomized data in hand and continuing
commitment from partner Santarus. We believe that the drug is poised to
take over a significant share of the HAE market, given its low COGS allowing
for competitive pricing, its safety, convenience, and potentially higher efficacy.
We believe the safety profile cannot be understated relative to Cinryze and
Berinert with Ruconest seeing no thromboembolic events to date (>1,000
administrations) and we attribute this to the purity of the product compared to
the plasma derived profile of Cinryze and Berinert with 20-25% impurities in
their formulations.

Action
We reiterate our Buy rating and are lowering our price target from $0.35
to $0.16 due primarily to increased share count. The company's strategy to
expand geographies through collaborations and to develop therapies for rare
diseases will bear fruit over the long term, in our opinion. Given the pricing
power of orphan drugs and the expanding markets in these indications due to
better diagnoses, we believe that Pharming is well-positioned for commercial
success.
What is and is not priced in, in our opinion (Roth Cap.)
• We believe the stock has been pricing in a slow and frustrating launch of Ruconest in the E.U. based mainly 
on differing regulations and reimbursement policies among the different territories. We believe this has led to 
an overall negative sentiment in the commercial potential for Ruconest. 
• We believe the stock is not pricing in three key factors; 1) positive Phase III data (under SPA) in the U.S., 2) 
anticipated U.S. approval with our perception of a much more favorable commercial landscape than the E.U. 
and 3) strong support from U.S. partner Santarus for potential strong commercialization efforts and a 
remaining $25 million in anticipated regulatory milestone payments over the relative near term to Pharming. 
• We believe the stock is not pricing in that Pharming now has consistent efficacy data from three randomized 
clinical studies in the acute setting of HAE as well as what we consider to be a differentiated safety profile 
compared to competitors.
Next Steps 
With the Phase III data in hand, Santarus and Pharming are to file the BLA in 1H13 (targeting by the end of 1Q13). 
The $10 million milestone payment on the positive Phase III data was an important cash infusion for the company, 
and a $5 million milestone payment is expected to be received upon BLA filing. The company's cash resources are 
expected to be almost entirely utilized for building commercial stocks of Ruconest, specifically paying Sanofi to 
process product from frozen milk stocks in anticipation of the drug's U.S. launch. We conservatively estimate that 
Ruconest will receive a standard FDA review, which  would have it on the market in 1H14. Upon approval, the 
company is also eligible to receive a $20 million milestone payment from Santarus.
 
Views towards prophylaxis 
While we look for Ruconest to gain traction in the  acute HAE setting, we believe an area of significant upside 
potential exists in the prophylaxis market and that Ruconest could pose a significant threat to ViroPharma's Cinryze. 
Considering the profile of more chronic use, Ruconest could look again to differentiate itself on both the efficacy and 
safety standpoints. To this end, evidence to date supports the potential of dosing even higher then 50 U/kg with 
Ruconest, whereas we perceive the dosing of Cinryze to be capped to potential safety issues such as 
thromboembolic events at higher concentrations. On  the safety point, as mentioned above, after >1,000 
administrations, Ruconest has not seen any thromboembolic events whereas Cinryze and Berinert are known to have 
that risk (in clinical studies Cinryze saw 3.4% incidence). Though not officially proven yet, we attribute these safety 
differences primarily to the fact that Ruconest is a purified recombinant C1 inhibitor, whereas Cinryze and Berinert 
are plasma derived proteins whose formulations contain 20-25% "impurities" many of which are unknown (beyond 
infectious disease testing that is part of purification process). 
While Santarus/Pharming's focus is not currently (publicly) on the prophylaxis opportunity, we believe that 
background activities are already in full force in  prepping for planned FDA discussions. In considering a potential 
Phase III, we believe that the study would be in the 30-60 patient range and cost in the €5-10 million range. It is 
possible, though remains to be seen, that Pharming and Santarus would split the cost of this study 50/50. 
 
Santarus commitment 
In September 2010, Pharming commenced a partnership with Santarus for development and commercialization of 
Ruconest in the U.S. in HAE and other future indications. Pharming is eligible for a $5.0 million milestone payment 
upon FDA acceptance of a BLA for Ruconest and up to $30 million payments if regulatory requirements such as the 
Phase III study, and commercial objectives are successfully met. Pharming is also eligible for sales-performance 
milestones up to a total of $45 million, should net sales exceed $500 million during a single calendar year. The supply 
price paid by Santarus to Pharming will also be tiered, based on a percentage of potential net sales of Ruconest. 
 
Valuation Update 
We reiterate our Buy rating and are lowering our price target from $0.35 to $0.16. This chance in target price is based 
primarily on significantly increased share count, increasing the chance of success for Ruconest in the U.S. from 85% 
to 95%. We are currently using the share count equaling the maximum authorized shares at the company which 
totals 1.3 billion shares of common stock. 


 
Our valuation of Pharming is based on our probability-weighted clinical net present value (NPV) valuation model. We 
believe this method is appropriate in capturing the value of the clinical stage pipeline. It allows for the flexing of 
assumptions based on key factors such as chance of success, peak sales estimates, and year of commercial launch. 
Our current valuation of Pharming is based entirely on the Ruconest opportunity for HAE in the acute setting. We 
believe that Pharming offers a compelling valuation at current levels, based on the anticipated overcoming of hurdles 
in the ongoing E.U. launch and the anticipated 2014 launch in the U.S. Importantly, we currently do not include the 
HAE prophylaxis market in our estimates, which we believe represents a significant market based on Ruconest's purity,
efficacy and differentiated safety profile. Longer term we believe the core technology of recombinant protein 
production offers untapped upside potential. A level of conservatism in our valuation model comes from our assigned 
multiple and discount rate for which we apply the historical values for large pharma (17.0x P/E and 15% discount 
rate) rather than the sometimes inflated non-profitable biotech multiples in the 30-40x range.
Pharming Clinical NPV Valuation Model 
Source: ROTH Capital Partners estimates 
Drug name Indication/ Indication Status / Status Launch / Launch Success (US$m) / Economics / Economics Profitability / Profitability NPV (US$)
Ruconest HAE - E.U./ Marketed 2011    / 100%              / 15                                     / 18%           / 100%                            / 0.02
Ruconest HAE - U.S./ Phase III 2014     / 95%                / 150                                   / 30%            / 100%                           / 0.14
Ruconest HAE - Prophylaxis Phase II    / 2020                / 0                                       / 30%           / 100%                            / 0.00
                                                                                                                                                                                           Total 0.16
The drug is commercializedin the E.U. under the name Ruconest
in collaboration with Swedish Orphan Biovitrum (SOBI). Pharming is also collaborating with Santarus for the
development and commercialization of Rhucin in the U.S.




Netherlands http://www.aex.nl/products/equities/NL0000377018-XAMS
Germany http://www.boerse-frankfurt.de/de/aktien/pharming+grp+eo+04+NL0000377018
US http://www.otcmarkets.com/stock/PHGUF/company-info

i bought at AEX NL


IN THE NEWS:

November 29, 2012

Ready for the Restart and the FDA; Reiterate Buy; Target to $0.16
 

July 05, 2012
Poster On First Patient Case Study Of HAE Type III Patient Succesfully Treated With Ruconest® Now Online
 

July 04, 2012
Article On Pharming Published In Beleggingsexpres
 

May 29, 2012
Pharming To Present At EPIC Biotechnology Conference
 

May 16, 2012
Pharming Is Attending The HAE Global Conference And Raises Attention For HAE Day
 

April 23, 2012
Interview With CEO Of Pharming Published In 'Medisch Contact'
 

April 18, 2012
Exclusive Video Q&A With CEO Of Pharming On Biomedreports.com
 

April 11, 2012
Pharming To Present At Biocapital Europe
 

March 07, 2012
Pharming Features In Newspaper Supplement On Medical Innovations 
 

March 06, 2012
Pharming Is Attending The AAAAI Annual Meeting
 

February 28, 2012
Pharming Announces Preliminary Results Date
 

February 14, 2012
Pharming Releases Interview With CEO
 

February 13, 2012
New Analyst Research On Pharming Now Available
 

http://www.pharming.com/index.php?act=inv




---------------------------------------




Press Releases:

November 26, 2012
Pharming Announces Receipt Of US$10 Million Milestone Payment 
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that following the announcement by Pharming and Santarus on November 7, 2012 that the pivotal Phase III clinical study of RUCONEST® (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met its primary endpoint, and in accordance with the terms of the license agreement between Pharming and Santarus, a US$10 million milestone has now been paid to Pharming. 
 

November 07, 2012
Pharming Concludes Third Call Of €10 Million Equity Working Capital Facility
 Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the third call under the equity working capital facility is now concluded and that, including an additional 16,056,000 shares that were issued between the last update on this call, as announced on October 26, 2012 and today, a total of 94,464,000 shares were sold to the investors for total cash proceeds of approximately €2,594,000. 
 

November 07, 2012
Santarus And Pharming Announce Positive Top-Line Phase III Results For Ruconest In Acute Hereditary Angioedema
Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief. 
 

November 01, 2012
Pharming Reports On Financial Results Third Quarter 2012 
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today published its financial report for the third quarter ended September 30, 2012. 
 

October 31, 2012
Pharming Announces Publication Of Ruconest HAE Prophylaxis Study
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that the positive results of a clinical trial with recombinant human C1 inhibitor (rhC1INH; RUCONEST®) to prevent attacks of hereditary angioedema (HAE) have been accepted for publication in the international peer-reviewed journal, 'Allergy'. 
 

October 26, 2012
Pharming Provides Update On Ongoing Call Of Third Tranche Of €10 Million Equity Working Capital Facility
 Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the Company's number of outstanding shares has increased following a call by investors under the equity working capital facility.
 

October 22, 2012
Pharming Provides Update On Ongoing Call Of Third Tranche Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the Company's number of outstanding shares has increased following a call by investors under the equity working capital facility.
 

October 19, 2012
Pharming Provides Update On Ongoing Call Of Third Tranche Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the Company's number of outstanding shares has increased following a call by investors under the equity working capital facility.
 

October 18, 2012
Pharming Provides Update On Ongoing Call Of Third Tranche Of €10 Million Equity Working Capital Facility And Exercise Of Warrants
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the Company's number of outstanding shares has increased following a call by investors under the equity working capital facility as well as through the exercise of warrants.
 

October 17, 2012
Pharming Draws Third Tranche Under €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that it has called the third tranche of 16,000,000 shares under the €10 million equity working capital facility. In addition, the Company announces the issuance of 1,795,631 shares in exchange for €41,838 in cash, following the exercise of warrants.
 

October 15, 2012
Pharming Provides Update On Outstanding Shares
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that its number of outstanding shares has increased by 9,483,549 from 899,660,207 on October 10, 2012 to 909,143,756 as of today.
 

October 10, 2012
Pharming Provides Update On Outstanding Shares
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that its number of outstanding shares has increased by 11,107,078 from 888,553,129 on September 26, 2012 to 899,660,207 as of today.
 

September 27, 2012
Pharming Completes Ruconest® US Pivotal Phase III Study
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that it has completed the clinical phase of the US pivotal Phase III clinical study (Study 1310) evaluating the investigational drug RUCONEST® (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). All 75 randomized patients have now reached the final time points according to protocol.
 

September 26, 2012
Pharming Concludes Second Call Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the second call under the Equity Working Capital facility is now concluded and that, including an additional 15,640,000 shares that were issued between the last update on this second call, as announced on September 21, 2012 and today, a total of 80,736,000 shares were sold to the investors for total cash proceeds of approximately €1,121,000. Including the €1,203,000 proceeds following the first call concluded on August 31, 2012, a total of €2,324,000 has now been raised in relation to the €10.0 million equity working capital facility and accordingly this leaves €7,676,000 available for additional financing through this instrument if and when needed.
 

September 21, 2012
Pharming Updates On Ongoing Call Of Second Tranche Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the investors have increased the ongoing call under the facility by 21,824,000 shares from 43,272,000 to 65,096,000. 
 

September 18, 2012
Pharming Updates On Ongoing Call Of Second Tranche Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the investors have increased the ongoing call under the facility by 17,864,000 shares from 25,408,000 to 43,272,000. 
 

September 07, 2012
Pharming Updates On Ongoing Call Of Second Tranche Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the investors have increased the ongoing call under the facility by 9,408,000 shares from 16,000,000 to 25,408,000. 
 

September 05, 2012
Pharming Draws Second Tranche Under €10 Million Equity Working Capital Facility And Provides Update On Pivotal Phase III Study 
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that it has called the second tranche of 16,000,000 shares under the €10 million equity working capital facility previously announced on August 1, 2012. Alongside, Pharming reports that the pivotal Phase III Study (Study 1310) of RUCONEST® is now entering its last weeks prior to completion, with 71 out of 75 patients either treated for a subsequent attack of HAE or reaching the Day 90 endpoint of the study. 
 

August 31, 2012
Pharming Concludes First Call Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the first call under the Equity Working Capital facility is now concluded and that, including an additional 3,000,000 shares that were issued between the last update on this first call, as announced on August 24, 2012 and today, a total of 83,568,453 shares were sold to the investors for total cash proceeds of €1,203,386. 
 

August 24, 2012
Pharming Updates On Ongoing Call Of First Tranche Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the investors have increased the first call under the facility by 18,319,863 shares from 62,248,590 to 80,568,453. 
 

August 23, 2012
Pharming Reports On Financial Results First Half Year 2012
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today published its financial report for the first half year ended June 30, 2012. 
 

August 20, 2012
Pharming Updates On Ongoing Call Of First Tranche Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the investors have increased the first call under the facility by 16,440,148 shares from 45,808,442 to 62,248,590. 
 

August 13, 2012
Pharming Updates On Ongoing Call Of First Tranche Of €10 Million Equity Working Capital Facility And Study 1310
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the investors have increased the first call under the facility by 13,000,000 shares from 32,808,442 to 45,808,442. 
 

August 10, 2012
Pharming Updates On Ongoing Call Of First Tranche Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the investors have increased the first call under the facility by 9,720,074 shares from 23,088,368 to 32,808,442. 
 

August 09, 2012
Pharming Updates On Ongoing Call Of First Tranche Of €10 Million Equity Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that the investors have increased the first call, that was announced yesterday, under the facility, by 8,000,000 shares from 15,088,368 to 23,088,368. 
 

August 08, 2012
Pharming Draws First Tranche Under €10 Million Working Capital Facility
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that it has called the first tranche under the €10 million equity working capital facility previously announced on August 1, 2012. 
 

August 03, 2012
Directorate Change
 Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that Karl Keegan, Chief Financial Officer, is leaving the Company in order to pursue a position based in the UK. Karl will step down from his role as CFO and resign from the Board of Management and the Company as of end of August. In view of the recently announced downsizing of the organization and Karl's upcoming departure, the future size of the Board of Management will also be evaluated. Following Karl's departure, his responsibilities as CFO will be assigned to Sijmen de Vries, Chief Executive Officer.
 

August 02, 2012
Pharming Announces Restructuring Plan 
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced a strategic restructuring plan of its Dutch operations designed to accelerate the Company's path to sustainability and future profitability. The proposed plan, which necessitates a request for "collective redundancies", was filed with the Dutch authorities (UWV Werkbedrijf, in accordance with the "Wet Melding Collectief Ontslag"). The process entails a formal procedure, required when there is a need for downsizing of an organisation by 20 staff or more. The plan continues the restructuring initiated in June by the closure and subsequent sale of Pharming's US facility.
 

August 01, 2012
Pharming Secures €10 Million Working Capital Facility From Existing Investors
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that it has secured an equity working capital facility of up to €10 million for a two year term, with Kingsbrook Opportunities Master Fund LP as lead investor and other institutional investors ("the Investors"). 
 

July 16, 2012
Pharming Confirms Safety Profile Of Recombinant Human Lactoferrin In A Food Safety Study In Healthy Human Volunteers
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that a randomized, cross-over double blind, placebo controlled study in healthy volunteers has shown that Pharming's recombinant human Lactoferrin (rhLF) is safe, based on the assessment of clinical data, gastro-intestinal tolerance and adverse event reporting.
 

July 06, 2012
Pharming Updates On Shares In Issue
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it issued the final amount of shares due to bondholders.
 

July 05, 2012
Pharming Completes Recruitment Of Ruconest® US Pivotal Phase III Study
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that it has reached full recruitment of its ongoing US pivotal Phase III clinical study (Study 1310) evaluating the investigational drug RUCONEST® (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). 75 randomized patients are in the study and no further patients will be entered.

http://www.pharming.com/index.php?act=inv



Pharming develops innovative therapeutics for the treatment of genetic disorders, as well as specialty products for surgical indications, and nutritional products.

 


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