Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

quote:

jandekkers schreef op 18 oktober 2017 04:47:

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Sustained sales momentum... Since reacquiring US rights to Ruconest in December
2016, Pharming’s modestly larger but significantly ‘smarter’ sales force (in terms of patient outreach and engagement) has had a dramatic impact on sales of Ruconest, used to treat acute attacks in patients with hereditary angioedema (HAE). According to IMS sales data, average monthly Ruconest revenues in 1H17 were $5m vs just $2.2m in 1H16. Similarly, 2Q17 sales at $16.8m were +25% higher than $13.4m in 1Q17. Sales in July and August have maintained recent momentum, averaging $5.3m (see overleaf).

...with potential further benefit from competitor issues... In mid-September, Shire announced yet another supply issue for prophylaxis treatment Cinryze. Recall production at Sanquin’s facility was suspended in 2016 following an FDA warning letter, which has since been resolved, but had an impact on product availability during 2H16. The current supply issue was confirmed by Shire at the recent HAEA National Patient Summit (15-17 September). While the extent and duration of the shortage is unknown, we would logically expect Ruconest, unencumbered so far by supply constraints, to be a beneficiary. Similarly, we also understand that CSL’s recently launched SC prophylaxis product Haegarda is experiencing manufacturing up-scaling issues (also discussed at the HAEA conference). With the potential upside from these issues likely to impact 4Q,
we have slightly increased our 3Q17 sales estimate to $16.8m (vs $16.1m) but boosted our 4Q17 forecast to $18.5m (vs $17.3m). The pull-through effect of this is an increase to FY17 Ruconest US sales to $66m (vs $64m) and FY18 sales to $93m (vs $80m). Longer term, our peak sales estimate for 2022, for combined sales of Ruconest in both acute and prophylaxis settings, has also increased, c.10% to $313m vs $280m previously.

...as pipeline makes good progress. Pharming recently announced it was invited by the FDA to file for accelerated FDA approval (expected in 4Q17) for Ruconest in the prophylaxis setting. This follows compelling Phase II data with twice-weekly Ruconest which compares more than favourably to current standard Cinryze. While we expect current growth in the acute setting (using the existing label) to continue with greater awareness, acceptance and demand from patients/physicians/payers for an ‘on demand’ product like Ruconest, there will clearly be additional use in the prophylaxis setting.

Ruconest could become the only product available for both uses, with a compelling efficacy, safety and economic profile compared to competitors in the HAE field. Stars are rapidly aligning; increase TP to €1.05; Reiterate Buy. We raise our rNPVbased TP to €1.05 on the back of increased Ruconest forecasts, and greater operational leverage from additional sales in prophylaxis use, having already made the step-up in required investment into the US commercial infrastructure in 1H17. We would also note that fresh pipeline opportunities in Fabry and Pompe diseases are not specifically included in our model, offering further potential upside. The shifting dynamics in the HAE market increasingly appear to favour a recombinant, ‘on demand’ product like Ruconest, over expensive, blood-based products (with continual manufacturing constraints) with
questionable suitability for prophylaxis use.

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jandekkers schreef op 18 oktober 2017 05:05:

Hereditary Angioedema Market to be Worth US$3.81 Billion by 2025: Initiatives to Generate Awareness by Physicians and Patient Bodies Drive Growth

SOURCE Transparency Market Research

ALBANY, New York, August 23, 2017 /PRNewswire/ --

Some of the prominent names operating in the global hereditary angioedema market are Pharming Group NV, Shire plc, CSL Limited, Ionis Pharmaceuticals, Inc., iBio Inc., and BioCryst Pharmaceuticals, Inc. As per a report by Transparency Market Research, the global hereditary angioedema market will likely rise at a healthy 9.1% CAGR between 2017 and 2025 to become worth US$3.81 bn by 2025 from US$ 1.73 bn in 2016.

Depending upon the class of drugs, the global hereditary angioedema market can be segmented into C1 Esterase Inhibitor, Selective Bradykinin B2 Receptor Antagonist, and Kallikrein Inhibitor, among others including conventional and pipeline. The C1 esterase inhibitor can be further divided into drugs such as Cinryze, Berinert, and Ruconest. Among them, C1 esterase inhibitor, accounted for more than half the share in the market in 2016 and going forward too, the segment is slated to dominate the market on account of its use in treatment of prophylactic and severe HAE attack. The emergence of novel products will aid the segment to hold on to its leading share in the future.

Geography-wise, North America, Europe, and Rest of the World are the key regions in the global hereditary angioedema market. At present, North America accounts for a leading position and in the upcoming years too is expected to retain its dominant share by rising at a healthy 8.3% CAGR between 2017 and 2025. This is because of the superior healthcare infrastructure and strong support from public and private sector in terms of reimbursements. Increasing knowledge about HAE among patients has resulted better methods of diagnosis of HAE and adoption of specialty drugs for treatment of HAE - this is also expected to catalyze growth in the market.

Hereditary angioedema is a rare disease that is estimated to affect 1 in 30,000 to 1 in 50,000 people worldwide. Hereditary angioedema is often mistaken for common allergic reactions and abdominal pain due to lack of awareness both among physicians and patients. It is estimated that around 40% of the affected patient are diagnosed correctly for HAE in the U.S. and Europe. With progress in diagnostic field and different initiatives undertaken by patient bodies and industry players to spread awareness, the market for hereditary angioedema is projected to grow.

"Specialty hereditary angioedema drugs are offered orphan drug designation across the markets which offers them market exclusivity and several incentives in the regional markets. The frequency and severity of HAE attacks is found to be increased with triggers such as stress, anxiety, minor surgeries, hormone replacement therapies and ACE inhibitors used for treatment of hypertension. According to World Allergy Organization, an estimated 40 million people are receiving ACE inhibitor treatment annually. The projected rise in incidences of HAE attacks is estimated to drive growth for global hereditary angioedema market during the forecast period from 2017 to 2025," explains the lead analyst of the TMR report.

Acting as a hindrance to the market, on the other hand, is a few approved specialty hereditary angioedema drugs which makes them highly expensive.

This review is based on the findings of a TMR report, titled, "Hereditary Angioedema Market (Drug Class - C1 Esterase Inhibitor (Cinryze, Berinert, and Ruconest), Selective Bradykinin B2 Receptor Antagonist (Firazyr), and Kallikrein Inhibitor (Kalbitor); Route of Administration - Intravenous, Subcutaneous Injection, and Oral; Distribution Channel - Hospital Pharmacies and Retail Pharmacies) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2017 - 2025."

C1 Esterase Inhibitor
Cinryze
Berinert
Ruconest
Selective Bradykinin B2 Receptor Antagonist
Firazyr
Kallikrein Inhibitor
Kalbitor
Others
Conventional Drugs (attenuated androgens, antifibrinolytic agents
Pipeline Products (DX-2930, BCX-7353)
Global Hereditary Angioedema Market, by Route of Administration

Intravenous
Subcutaneous Injection
Oral
Global Hereditary angioedema Market, by Distribution Channel

Hospital Pharmacies
Retail Pharmacies
Others
Global Hereditary Angioedema Market, by Geography

North America
Europe
Rest of the World

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Patience schreef op 18 oktober 2017 15:47:

[...]That wish is dom.;-)

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dader schreef op 18 oktober 2017 16:07:

AEX in no time 2 punten ingeleverd en dat zie je heel snel het RODE kleurtje wat jammer.

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tKanVriezenEnDooien schreef op 18 oktober 2017 11:39:

2 nieuwe websites van Pharming. Ze moeten nog wel vertaald worden en er is nog wel wat werk voor het online marketing team om deze websites goed vindbaar te maken, maar de opzet ziet er goed uit in mijn ogen.

www.haevitae.eu/
www.rucovitae.com/nl/

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red see diver schreef op 18 oktober 2017 16:15:

veel terechte twijfelaars zie ik nu, MACD is onder de signaallijn en vertrokken naar beneden

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red see diver schreef op 18 oktober 2017 16:15:

veel terechte twijfelaars zie ik nu, MACD is onder de signaallijn en vertrokken naar beneden

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H.invest schreef op 18 oktober 2017 16:09:

Blijf volhouden, volgende week gaat het gebeuren!

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C200 schreef op 18 oktober 2017 16:11:

[...]

ASML had supercijfers. 4 €uro eraf.