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Pharming januari 2018

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G20 Xdrive
0
quote:

HiRisk schreef op 7 januari 2018 21:40:

[...]Welke Paddo's gebruik jij?
Moest FF hartelijk lachen...Abtje
alles-niks
0
www.participaties.nl/Forum/Upload/201...

Dit is nog wel oud nieuws van tKanVriezenDooien uit het Pharming het aandeel van 2017, Datum: 14 oktober 2017
Ik hoop dat iemand daar nog wat aan heeft met het idee dat schema wel hoger kunt opschalen....
Loterijtje
2
OP ZOEK NAAR DE KASKRAKER

Nico Inberg

Crucell, Galapagos en Pharming: eigenlijk vertellen deze drie beroemde biotechnologiebedrijven uit de Lage Landen het hele verhaal wat beleggen in biotech onweerstaanbaar en misschien wel verslavend maakt. De gok, de fantasie, de belofte, de hoop en wanhoop, de koersexplosies en –implosies én uiteindelijk soms de hoofdprijs: een blockbuster in de apotheekschappen, of een mooie overname. Zo kocht Johnson & Johnson uiteindelijk in 2011 voor veel geld Crucell op.

Beleggen in biotech is een sport apart. Een correcte waardering voor de bedrijven is moeilijk, of niet, te maken. Het gaat niet om het taxeren van omzet en winst - vaak zijn die er helemaal niet - maar om het inschatten van de kans van slagen van een of meerdere medicijnen in ontwikkeling. Hierdoor bewegen de koersen van biotechaandelen vaak hard op en neer en dat trekt handelaren en speculanten aan.

Tenslotte kan goed- of afkeuring van een kandidaat-geneesmiddel een bedrijf maken of breken. Vaak zien we uitslagen van plus of minus 50% of nog meer op Wall Street in de biotechsector. Niet op cijfers, zoals bij de meeste andere bedrijven, maar op persberichten met goed of slecht nieuws.
[verwijderd]
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quote:

HiRisk schreef op 7 januari 2018 21:40:

[...]Welke Paddo's gebruik jij?
waarschijnlijk buitenlandse en is de schrijver onze taal niet machtig ,de vertaal programma's zijn ook nog niet alles.
Loterijtje
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MEER DAN GOKAANDELEN

Toch zijn biotechs meer dan louter holderdebolder-aandelen. De bedrijven zijn vaak ontstaan in de academische gezondheidszorg, waar professoren en artsen door research op het spoor van een nieuw medicijn komen. Verdere vergrijzing en toename van chronische ziekten vormen een vruchtbare bodem voor de almaar verdergaande ontwikkelingen in de biotechnologie.

VEEL GELD NODIG

Voor verdere ontwikkeling is veel geld nodig en dat is waar de eerste investeerders aan boord komen. De meeste biotech start-ups willen zo snel mogelijk naar de beurs, om verdere toegang tot kapitaal mogelijk te maken. Onderzoek duurt namelijk, mede door de strenge eisen, vaak langer dan verwacht en hierdoor is een grote kaspositie onontbeerlijk.

SCHRALE TROOST

Een schrale troost voor beleggers die vooral pech hebben met biotechaandelen is dat ze uiteindelijk zorgen voor een betere gezondheidszorg. U hebt daar dan, misschien onvrijwillig, toch maar uw steentje aan bijgedragen. Ook al bent u zelf bijna al uw geld kwijt…
Loterijtje
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FASE I

In Fase I van de klinische studies wordt een experimenteel geneesmiddel, ook wel een Investigational New Drug, voor het eerst onderzocht bij menselijke (gezonde) proefpersonen. De dosering van het nieuwe geneesmiddel wordt geleidelijk verhoogd, zodat de onderzoeker de klinische respons op het geneesmiddel kan meten.

FASE II

Focus op effectiviteit, bijwerkingen en mogelijke risico's. Bepaling van de meest effectieve dosering en meest geschikte manier van toedienen (infuus, injectie etcetera).

FASE III

Onderzoek in grotere populatie voor aanvullende informatie. Dit onderzoek is vaak dubbelblind (zowel onderzoeker als patiënt weten niet of ze een placebo of het echte middel krijgen).

REGISTRATIE

Aanvraag registratie bij toezichthouder. In de VS bij FDA, in Europa bij EMA, dat volgend jaar van Londen naar Amsterdam verhuist. Na goedkeuring kan het geneesmiddel op de markt worden gebracht.

FASE IV

Post-marketing studie: bedoeld om aanvullende informatie te krijgen over langetermijneffecten en optimaal gebruik. Gaat vaak om duizenden proefpersonen.

Bron: Pfizer.nl
Loterijtje
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1
PHARMING

€1,21

KERNGEGEVENS (IN €)
Verwachte omzet 2017 0,09 mrd
Verwachte winst 2017 -0,01 p.a.
Beurswaarde 0,57 mrd
Hoogste koers 52 wk 1,34
Laagste koers 52 wk 0,22
Loterijtje
2
FUNDAMENTEEL: BIG PHARMING

Natuurlijk gaan we Pharming opnieuw goed volgen dit jaar. De ontwikkeling vorig jaar was spectaculair. Het terugkopen van de verkooprechten in de VS bleek een briljante zet. Topman Sijmen de Vries kreeg het verkoopteam in de VS goed op stoom en had ook nog eens het geluk dat concurrent Shire in leveringsproblemen kwam. Strikt genomen is Pharming NU geen biotechbedrijf meer, maar een farmaceut, het brengt namelijk al een product op de markt. Dat is meteen ook een groot risico: Pharming is afhankelijk van slechts dat ene product. De omzetcijfers over Q4 worden belangrijk: we weten dat die sterk worden, de vraag is alleen hoe sterk. En een andere koerstrigger is de goedkeuring voor prophylaxe: het gebruik van Ruconest als preventief middel. Ook hierover verwachten we in 2018 meer nieuws. Zo nu en dan zal er nog wel wat verwatering optreden door uitoefening van warrants en converteerbare obligaties.

LEES HIER DE LAATSTE UPDATE VAN DE IEX BELEGGERSDESK
Loterijtje
2
Pharming is binnen de stijgende trend, rond weerstand 1,35 (gevormd op 2 september 2011), het koersdoel genaderd. De stijgende trend krijgt pas een nieuwe impuls indien deze top wordt gebroken. In dat geval mag men verdere koersstijgingen tegemoet zien, richting 1,97 (top van maart 2011). Pas na een uitbraak boven 1,35 kopen we bij. Wie de stukken heeft blijft zitten. Nieuwe kopers wachten een uitbraak af.
DAGEVOS
2
Pigeonman: dhr. De. Vries is slim genoeg om dit zelf te bedenken of zijn adviseurs geven hem wel raad of misschien leest hij ook wel eens dit forum. Geduld is een schone zaak.
Burdie65
0
quote:

leon 55 schreef op 7 januari 2018 21:58:

[...]

Moest FF hartelijk lachen...Abtje
Ik ook..., nog een AB-tje voor Hirisk.
jandekkers
0
Celgene to Acquire Impact Biomedicines, Adding Fedratinib to Its Pipeline of Novel Therapies for Hematologic Malignancies
Fedratinib is a highly selective JAK2 kinase inhibitor that is being evaluated for myelofibrosis and polycythemia vera
Fedratinib demonstrated clinical improvement in a phase III trial with treatment-naïve myelofibrosis patients and in a phase II trial with myelofibrosis patients resistant or intolerant to ruxolitinib
A New Drug Application (NDA) submission for fedratinib in myelofibrosis is planned for mid-2018
SUMMIT, N.J. & SAN DIEGO --(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) and Impact Biomedicines today announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera. Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.

Fedratinib, a highly selective JAK2 kinase inhibitor, was evaluated in 877 patients across 18 clinical trials. In a randomized, placebo-controlled, phase III pivotal trial ( JAKARTA -1) for patients with treatment-naïve myelofibrosis, fedratinib demonstrated statistically significant improvements in the primary and secondary endpoints of splenic response and total symptom score, respectively. In an exploratory subgroup analysis, these improvements were observed regardless of a patient's baseline platelet count.

A multi-center, single-arm phase II trial ( JAKARTA -2) evaluated fedratinib in myelofibrosis patients who were found to be resistant or intolerant to ruxolitinib (Jakafi®), a JAK1/JAK2 inhibitor. In this second-line setting, fedratinib demonstrated clinically meaningful improvements in splenic response and total symptom score.

As previously reported, JAKARTA -2 was stopped prematurely due to a clinical hold placed on the fedratinib program by the U.S. Food and Drug Administration (FDA) after potential cases of Wernicke's encephalopathy (WE) were reported in eight out of 877 patients receiving one or more doses (less than one percent of treated patients). The FDA removed the clinical hold in August 2017 .

Based on the reported benefit risk profile of fedratinib from the JAKARTA -1 and JAKARTA -2 clinical trials, regulatory applications in myelofibrosis are planned beginning in the middle of 2018.

"Myelofibrosis is a disease with high unmet medical need as the number of patients who are ineligible for or become resistant to existing therapy continues to increase," said Nadim Ahmed , President, Hematology and Oncology for Celgene . "We believe fedratinib is uniquely positioned as a potential treatment for myelofibrosis and it provides strategic options for us to build leadership in this disease with luspatercept and other pipeline assets."

"We launched Impact Biomedicines and based on our thorough review of the data, fedratinib presents a compelling risk benefit profile in both treatment-naïve patients and patients who are resistant or intolerant to other JAK2 therapies," said Dr. John Hood , Chief Executive Officer of Impact. "We believe Celgene is the ideal organization to follow through on our mission of maximizing fedratinib's potential for patients with myelofibrosis."

Deal Terms

Under the terms of the agreement, Celgene will make an upfront cash payment of approximately $1.1 billion . In addition, Impact Biomedicines's shareholders are eligible to receive contingent payments based on regulatory approval and sales-based milestones. The maximum aggregate amount payable for regulatory approval milestones is $1.4 billion relating to approvals for myelofibrosis and other indications. Starting from global annual net sales of $1.0 billion , aggregate tiered sales-based milestone payments could total a maximum of $4.5 billion if global annual net sales exceed $5.0 billion .

Credit Suisse acted as financial advisor and Hogan Lovells acted as legal counsel to Celgene on the transaction. PJT Partners acted as exclusive financial advisor and Latham & Watkins acted as exclusive legal counsel to Impact Biomedicines on the transaction. The acquisition is subject to customary closing conditions and applicable waiting period under the Hart Scott Rodino Antitrust Improvements Act. The transaction is expected to close in the first quarter of 2018.

About Celgene

Celgene Corporation , headquartered in Summit, New Jersey , is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

About Impact Biomedicines

Impact Biomedicines is pioneering the development of life changing treatments for patients with complex cancers. The Company's pipeline is centered around fedratinib, a highly selective oral small molecule JAK2 kinase inhibitor that is being developed initially for the treatment of myelofibrosis (MF) and polycythemia vera (PV). Impact was financed by Medicxi and Oberland Capital .

Forward-Looking Statement

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission .

Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites.

jandekkers
1

The Bio/Pharma acquisition hunt is officially opened caused by the huge corporate tax cuts. Get ready for a large biotech run (biotech multiples might increase 50%)
jandekkers
0
Wall Street Journal - Drug Industry Is Ripe for a Wave of Deals

In addition to those discussed in WSJ below, I had heard the new tax deal repatriation terms say that US companies have to segregate foreign cash into the amount to be repatriated and the amount to stay oversees.....and have to pay taxes on the repatriation amount even if still overseas...so it makes sense the money would come back to US quickly.

www.wsj.com/articles/drug-industry-is...

Drug Industry Is Ripe for a Wave of Deals

Big pharma and biotech aren’t benefiting as much from higher drug prices, raising the possibility of large deals

8:10 AM ET 01/05/2018
Nearly a decade ago, a wave of megamergers gripped the pharmaceutical industry. In 2018, conditions are right for a sequel.

Back then, concerns about growth and tougher regulations spurred deals like Pfizer(PFE)'s $68 billion acquisition of Wyeth and Merck(MRK) & Co.'s $41 billion acquisition of Schering-Plough.

Today, growth concerns are rising again, and several other factors, including consolidation in other parts of health care, are setting the stage for another wave of deals.

Drugmakers have relied on price increases for a big portion of their recent growth, but those are getting harder to push through. True, pharmaceutical companies boosted list prices as usual when the calendar turned to the new year, but raising prices doesn't pack the same punch as it did in years past.

Now, consolidation among insurers and pharmacy-benefit managers means drugmakers are seeing a smaller share of those hikes than in recent years, while money paid as rebates to PBMs increases. "Biopharma companies now have a reduced ability to increase net, realized price in the U.S." compared to the status quo since 2010, analysts at Leerink Partners said in a note last month.

Buying up smaller biotech startups has also helped boost growth rates for big pharma companies. But years of brisk acquisitions means that there is now a relative scarcity of targets with drugs that are close to generating revenue and have strong enough sales potential to move the needle for bigger outfits.

Consider in 2016, Pfizer bought Medivation, which had a blockbuster cancer drug already on the market, for $14 billion). Gilead Sciences(GILD) bought Kite Pharma for a similar price last summer, but Gilead doesn't expect that deal to contribute to earnings for several years.

Balance sheets within this group are generally strong enough to absorb larger-scale transactions, while debt capital remains extremely cheap. And company executives finally have clarity on U.S. tax policy after a long period of uncertainty. There is no shortage of opportunities for partnering. More than 20 branded drug companies have projected 2018 revenues above $10 billion, according to FactSet.

The main obstacles to deals are regulatory approval and integration concerns, which are particularly important because the companies in question are so large

For big pharma, a new set of challenges could lead to a familiar solution.

(END) Dow Jones Newswires

jandekkers
0
by Rob Coz from the Ziop message board (I hold a long position in Ziop):

Jefferies Yee - Americas / Biotechnology: 3 thoughts and themes we’re focused on into the madness this week…

I have emailed Yee with the Brad Loncar JPM week bio performance which is usually positive (see twitter link) and Yee told me he expects a sector rally this week. Hope he is right.


twitter.com/bradloncar/status/9493258...

Americas / Biotechnology: 3 thoughts and themes we’re focused on into the madness this week…

Key Takeaway

The start of 2018 has been marked by a minor (early) rally in biotech and although encouraging, obviously far too early to be calling any theme. Indeed we look forward to a ton of information flow this week that should more fully drive our sector thesis and idea generation for 2018. Top ideas in large cap remain VRTX, CELG, AMGN; and smid-cap with key data coming: ASMB, ESPR, FGEN, PRTA.

As healthcare investors brace for a long week, we will be busy with our own agenda of 30+ public/private company meetings in San Francisco...3 Thoughts: We remain positive and believe both large and smid cap biotech can move higher this year based on an improving backdrop and driven by: (1) market view that tax reform is a tailwind for capital deployment which is great for large-biotechs and large-pharma AND good for smid-biotech M&A opportunities, (2) “catch-up bounce” i.e. large-cap laggards in 2017 could bounce in 2018 as we continue to move away from political rhetoric and fear factors around drug pricing - sentiment and buying interest for this “cheap sector” which has lagged the market could pick up; we think 2018 guidance should be relatively fine for most of large biotech (or at least viewed as conservative and achievable) which could be an overhang removed…(3) tons of catalysts in smid-cap biotech will move these stocks (see Top 30 events list here) and risk/reward has been pretty good (we count 14 biotechs over $1B cap that were up more than 200% in 2017 - email us for list) and hence we can see why good news/data can drive stocks higher…

Bear case on the group remains: (1) large biotech still faces top line headwinds (biosimilars or generics against big blockbusters) that make these stocks challenging, it's cheap but valuation isn’t a catalyst and there isn’t a compelling secular growth thesis yet in large biotech, (2) M&A hasn’t happened and isn’t happening much, (3) if nothing has changed, then winners keep working (med tech, tools, etc.) and there’s no reason to rotate out to try and be a hero…(4) mid-term elections…mid-term elections….mid-term elections…

3 themes we will be focused on during the week:

(1) Mgmt commentary and investor perception around M&A for 2018. With over $150B+ in biopharma cash to be repatriated, there is a heightened view on M&A in biotech in 2018. In 2016, the sector was in freefall….in 2017 the sector was getting comfortable in a new political environment. In 2018 we could see “mega-merger” potential from big pharma buying big biotech or big biotech buying Smid-biotech….all of these would be reasons for the group to move higher…(2 sub-$2B M&A deals in biotech in last month and ACOR may now be up for sale, see note here).

(2) Trading action in biotech during the week and a post-week rally or sell-off? The set-up seems relatively positive given the broader market backdrop continues well which should support “laggards” to try to move higher (GILD, BIIB, etc. have moved up early). Some years have seen a “post-conference sell-off” perhaps due to a move up the week before or because there is the potential for lots of capital raising by smid-caps…But we think there have been such low expectations on the group that if we see a post-selloff, we think the dip would get bought… we could just as much see a “post-conference rally” for all the reasons discussed above…if we see either dynamic (rally or buying dips), this is a positive sign that the market wants to get more positive on biotech and is what we believe is happening in the broader market.

(3) Just surviving….the goal of our week and for most investors is just surviving…we will work to get as much information flow as possible while drinking out of a firehose and we’ll have some conclusions. We think a positive is to just get past this week and get to earnings season where 2018 guidance and outlooks should be just fine (particularly on tax reform and relatively low expectations)…and a further reason the group could move up.

Forecast2006
0
Als de uitoefening van warrants en converteerbare obligaties vandaag uitblijft is dit een indicator dat de 43 kwartaalcijfers wel eens boven verwachting kunnen zijn.

We gaan dan verder omhoog naar het koersdoel van Stiffel € 1,60.

Kind regards,

Forecast.
[verwijderd]
0
quote:

Forecast2006 schreef op 8 januari 2018 06:39:

Als de uitoefening van warrants en converteerbare obligaties vandaag uitblijft is dit een indicator dat de 43 kwartaalcijfers wel eens boven verwachting kunnen zijn.

We gaan dan verder omhoog naar het koersdoel van Stiffel € 1,60.

Kind regards,

Forecast.
Waarom specifiek vandaag? Waarom zie je dit als een indicator?
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