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Message complété le 15/07/2014 18:47:20 par son auteur.
pas eu les cou...es de renforcer je pense que j'aurais du
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Message complété le 15/07/2014 17:53:03 par son auteur.
ou triple !
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Message complété le 15/07/2014 17:02:32 par son auteur.
bon je ne trouve rien de plus (j'y vais)
message du PDG : Sijmen de Vries, CEO: réponse jeudi matin ( il est possible que SALIX qui a présenté le dossier lui le donne demain )
Bon courage à tous
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Message complété le 15/07/2014 16:28:15 par son auteur.
instant T message de chez pharming
Message complété le 15/07/2014 16:33:58 par son auteur.
Healthcare: Biotechnology
Pharming Group NV (OTC: PHGUF)
| PHARM.AS - €0.52 - AEX |
Buy
Company Update
Stock Data
52-Week Low - High
€0.11 - €0.73
Shares Out. (mil)
405.35
Mkt. Cap.(mil)
€210.0
3-Mo. Avg. Vol.
12,506,930
12-Mo.Price Target
$3.00
Cash (mil)
$18.8
Tot. Debt (mil)
$0.0
Pricing information reflects data from the securities primary listing, in this
case the Amsterdam Exchange.
EPS €
Yr Dec
—2013—
—2014E—
—2015E—
Curr
Curr
1Q
(0.05)A
(0.04)A
-
2Q
(0.01)A
(0.01)E
-
3Q
(0.02)A
0.04E
-
4Q
(0.02)A
0.00E
-
YEAR
(0.07)A
0.00E
0.04E
P/E
NM
0.0x
0.1x
EPS may not add to full year due to rounding and increases in share
count
EPS reflect February 2013 1 for 10 reverse stock split
Revenue (€ millions)
Yr Dec
—2013—
—2014E—
—2015E—
Curr
Curr
1Q
0.5A
1.5A
-
2Q
4.4A
1.5E
-
3Q
1.1A
21.7E
-
4Q
0.9A
3.9E
-
YEAR
7.0A
28.6E
35.8E
0.80
0.70
0.60
0.50
0.40
0.30
0.20
0.10
0.00
Aug-13
Sep-13
Oct-13
Nov-13
Dec-13
Jan-14
Feb-14
Mar-14
Apr-14
May-14
Jun-14
Jul-14
350.0
300.0
250.0
200.0
150.0
100.0
50.0
0.0
Price
Vol (m)
PHARM.AS One-Year Price and Volume History
PHARM: Unwarranted Volatility Ahead of
PDUFA a Good Trade in our Opinion
False rumors led to a temporary sharp stock price decline in E.U. trading today
with ongoing negative pressure. Pharming confirmed there has been no FDA
decision yet ahead of tomorrow's PDUFA. We also believe there could be some
"selling the news" based on strong stock performance as of late. We believe
negative pressure translated to the U.S. market today could represent a good
trading opportunity to own the stock. Reiterate Buy.
Event
False rumors led to a temporary sharp stock price decline in E.U. trading today
with ongoing negative pressure. Pharming confirmed there has been no FDA
decision yet ahead of tomorrow's PDUFA. We also believe there could be some
"selling the news" based on strong stock performance as of late.
We believe
Ruconest will receive full approval based on positive Phase III data, under SPA.
Salix (SLXP-Buy) is Pharming's U.S. commercial partner and will pay a $20
million milestone payments based on the first U.S. sale.
Impact - We expect strong positioning for Ruconest
We believe negative pressure translating to the U.S. market today could
represent a good trading opportunity to own the stock
.
We believe Ruconest is
poised for strong positioning upon anticipated approval. Currently, physicians
can only discuss/recommend what is available to them, namely the plasma
derived products such as Cinryze and Berinert, which are associated with
underlying risks (discussed below). Additionally, Firazyr is associated with
~97% of injection site reactions, and upwards of 30% of breakthrough
highlighted by relapse/worsening of symptoms while on therapy. Therefore,
we believe docs will have something new to talk about in Ruconest, with the
added benefit of talking about the favorable safety profile of the drug, which
is based on its recombinant nature. We believe this differentiation, beyond
the underlying efficacy, will allow Ruconest to be a strong competitive threat
to the current therapies. If approved, Pharming believes that Ruconest could
be launched in the September 2014 timeframe and the economics are quite
favorable, in our belief. For the first $100 million in sales, Pharming is entitled to
30-40% of net sales based on a combination of both royalties and drug supply
to Salix.
Action
We reiterate our Buy rating and our target of $3. 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.
Important Disclosures & Regulation AC Certification(s) are located on page 3 to 4 of this report.
Roth Capital Partners, LLC | 888 San Clemente Drive | Newport Beach CA 92660 | 949 720 5700 | Member FINRA/SIPC
Page 2 of 4
PHARMING GROUP NV (OTC: PHGUF)
Flash Note - July 15, 2014
VALUATION
We reiterate our Buy rating and $3 price target. 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. Factors that could impact the shares of Pharming reaching our price target are
negative data readouts from ongoing clinical studies, any perceived or real delays in the commercial uptake
of Rhucin/Ruconest as well as Pharming's ability to continue to fund its operations.
RISKS
·
Regulatory Risk.
FDA had issued a Refuse to File (RTF) letter to Pharming/Santarus’ BLA submitted in
December 2010, outlining concerns that efficacy data for the proposed Rhucin dose of 50 U/kg relied on a
small number of patients, and that the method used to assess the primary endpoint had not been prospectively
defined. The companies engaged in discussions with the agency and are sponsoring an additional Phase III
trial (conducted under SPA) to address the issues raised by the FDA. In November 2012 this Phase III study
met its primary endpoint. While we believe risk was reduced for the program, there is still no guarantee that
the FDA will approve the product or issue a Complete Response letter.
·
Financial Risk.
Pharming is currently a non-profitable biotechnology company, and funding is continuously
necessary to support operations and ongoing clinical studies. Should Pharming encounter problems in raising
sufficient funds to continue its operations, the company’s valuation may be greatly impacted.
·
Partnering Risk.
Pharming has attracted partnerships from SOBI and Santarus for Rhucin. Should it become
unable to meet its agreement obligations or if clinical data fails to show safety and meaningful efficacy, the
partnerships could be terminated. The company’s progress with the development of its candidate products
may be delayed, and future commercial activity negatively impacted.
·
Demand and reimbursement risk.
Rhucin is currently approved in Europe and developed in the U.S.
for the treatment of HAE, a rare disease for which prevalence estimates vary greatly due to misdiagnosis
and underdiagnosis. Failure to properly estimate market size may negatively impact Pharming’s valuation. In
addition, Rhucin faces competition from 3 other drugs in the acute HAE setting. Pharming and its collaborators
may have to undertake extensive efforts to educate physicians of the advantages of Rhucin over competitor
products. Finally, given increased austerity measures imposed in Europe and pressure to reduce medical
spending, Rhucin may see reimbursement pushback. However, we believe that Pharming is attempting to
mitigate this risk having priced Ruconest in Europe at a competitive level, compared to alternative treatments.
COMPANY DESCRIPTION
Pharming focuses on developing pharmaceutical grade recombinant proteins for therapeutic use, based on its
transgenic animal platform. The company produces high yield human-like recombinant proteins from the milk
of transgenic rabbits, using its scalable platform. Pharming’s pipeline is led by Rhucin, recombinant human
C1 esterase inhibitor (rhC1INH), which was approved by the EMA in 2010 for the treatment of an orphan
disease, hereditary angioedema (HAE). The drug is commercialized in 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.
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Message complété le 15/07/2014 16:49:02 par son auteur.
ça sent l'arnaque ( mais à ce point là la bourse sur les marchés extérieure ça deviens l'ENFER
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Message complété le 15/07/2014 15:54:41 par son auteur.
Dément la nouvelle je tape avec la tablette mes excuses
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Forum de discussion Pharming Group
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