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BassieNL schreef op 11 maart 2019 21:01 :
[...]toch 2 afwaarderingen?
Maar ruim boven de lullige koers die er nu staat. Gewoon. Pharming lekker door laten werken. Doelen worden ook weer bijgesteld.
Wegertje schreef op 11 maart 2019 21:07 :
[quote alias=gurt id=11476498 date=201903112101]
morgen dinsdag meestal slecht daggie voor ph. 0.68 here we come
[/quote
Je vrouw zij 69 tegen mij.
Hopa! :-)
Entropi3 schreef op 11 maart 2019 16:28 :
[...]
Nog steeds geen echt verrassende teksten, maar toch ben ik nu ineens nieuwsgierig waar de analogie met varkens vandaan komt. Konijnen of Koeien snap ik maar Pharming een varkentje noemen begrijp ik niet
Hij heeft nog een varkentje te wassen met Pharming denk ik! :-)
Declan 2.0 schreef op 11 maart 2019 12:04 :
[...]
Ik geef je het gratis advies tot 10mei te wachten.
Ruud..
Wel ff het jaartal er bij zetten Ruud! :-)
Oppenheimer. Pharming Group N.V. March 7, 2019 Stock Rating: OUTPERFORM. 12-18 mo. Price Target €2.50 PHARM - NXT AM €0.88 4Q18 Review: HAE Base Solid, New Ruconest Indications Building[/b] ]SUMMARY Pharming (PHARM NA) reported sales/earnings and provided an investor update on 03/07. While the company reported sales slightly below OPCO and consensus expectations (see exhibits below), the company handily beat earnings expectations as its ability to generate earnings gives it some tax flexibility, the norm for biotech companies going through this phase of sales/earnings growth. PHARM NA continues to execute on its commercial HAE Ruconest objectives, even with heightened competitor intensity, while preparing for new potential Ruconest indications in preeclampsia and acute kidney injury. We update our operating model and stay bullish. KEY POINTS ¦ The main reason the company beat earnings expectations was a positive tax provision arising from the company's ability to utilize its net operating losses (NOLs) from previous years going forward, fairly standard for biotech companies that swing from operating losses to profits over a few years. We model NOLs having a positive effect on earnings until 2021. ¦ While the Street is focused on the short-term volatility that Ruconest market share should experience from heightened competitor intensity (Takhzyro, launched 08/1Cool, we continue to believe PHARM NA's ability to manufacture recombinant Ruconest at scale gives the company pricing and contracting flexibility. PHARM NA guided to Y/Y growth for Ruconest in 2019, but with volatility on patient adds/switches. ¦ As PHARM NA's earnings scale, post-breakeven in 2018, we point to a 2018 analysis we conducted on biotechnology performance post-breakeven for earnings. Off-course PHARM NA has to deliver some mid-stage trial success in additional indications like pre-eclampsia and acute kidney injury (CIN), among the most severe and large indications out there related to C1 esterase inhibition. ¦ For pre-eclampsia, the Ruconest phase 2 trial is expected to start in 1Q19. We have commented previously, following PHARM NA's pipeline update in 06/18, on the urgent medical need for this condition among pregnant women. For acute kidney injury (positive phase 1/2 results in 4Q18), PHARM NA is awaiting regulatory guidance before proceeding with a phase 2 trial. ¦ With PHARM NA shares experiencing volatility recently as some doubt Ruconest's potential in HAE, we continue to point to another drug in the complement cascade (Soliris) that had low expectations at launch (2007) with some analysts forecasting peak sales of $1B (vs. the $3.5B and four potential indications at YE18). We believe Ruconest has similar potential, if other indications are positive.
Stifel. Summary Our investment thesis in Pharming is that Ruconest maintains its share of the US HAE market, despite perceived headwinds and the profits generated can be successfully deployed to develop enhancements to Ruconest and new pipeline opportunities. FY18 results, showing US sales of $149m (vs Stifel $153m) helping to generate adj operating profits of ?40.6m (Stifel ?43.5m) were slightly below expectations but latest sales data supports our 'retain market share' thesis. Pharming also ended the year in a net cash position of ?9m, with ?81.5m in gross cash, even after starting to pay-down the $100m Orbimed loan. Taking the slightly lower 4Q18 exit rate for Ruconest and tempering growth expectations through 2019 reduces our sales forecast by 10% and lowers our NPV-based TP to ?1.45 (also adjusting for Pompe disease development timelines). However, we note that our TP does not currently ascribe any value to the planned expansion of Ruconest into larger indications (pre-eclampsia or acute kidney injury) or other early-stage programmes (Fabry's disease). Hence we continue to see further upside potential on successful pipeline execution, and reiterate our Buy rating. Key Points Results broadly in-line with expectations. Total reported FY18 revenues of ?135.1m increased 51% vs FY17, and just below expectations (Stifel ?137.2m; consensus ?136.3m). 4Q18 US sales declined c. 8% to $38.7m (Stifel estimate) compared to 3Q18, which was the high-water mark for 2018. This relatively modest decline comes despite increased competition from the prophylaxis treatments, with Haegarda supply increasing and Takhzyro being rolled out (launched in September 2018). We continue to expect the overall HAE market will inevitably shift to more convenient and effective prophylaxis treatment options, but the real impact will be on sub-optimal Cinryze, the battle between Takhzyro and Haegarda, and more likely results in market expansion than market rotation. This leaves a significant market opportunity for acute, rational treatment of HAE attacks, and assuming more convenient formulations of Ruconest can be developed, we believe Ruconest offers the best profile in this setting. This applies to use of Ruconest as a standard acute treatment regimen, but also in treating breakthrough attacks which will inevitably occur in patients on the prophylactic options. Tempering growth forecasts but remains a strong platform to build from. Pharming expects 'continued growth' in Ruconest sales in 2019. Given fluid market dynamics (continued switch to prophylaxis, potential US generics to Firazyr by July 2019), we have prudently taken the lower 4Q18 US sales exit rate and added 5% growth to forecast FY19 global sales of ?151.5m (includes +30% sales performance in Europe) vs ?168m previously based on +10% growth (see overleaf). For reference, in FY18 US Ruconest sales achieved +6% annual growth on top of the 4Q17 exit rate. The prospect of Firazyr generics entering the US market this year may appear an obvious potential headwind, but recent real-world data, showing the high acute treatment failure rate with Firazyr and the >90% effectiveness of C1 esterase inhibitors such as Ruconest, is likely to impact patient, physician and payer support for Firazyr. Strong operational performance. Group adjusted operating margin in FY18 increased to 30% compared to 25% in FY17, despite a 35% increase in total opex with adjusted R&D spend +40% to ?26.3m. We expect further increases in R&D in FY19 as Pharming seeks to: 1) develop more convenient formulations of Ruconest (IM, SC, intradermal), 2) expand the use of Ruconest beyond HAE, into pre-eclampsia (Phase II due in 1H19) and acute kidney injury (trial protocol being designed), and 3) leverage its recombinant protein technology platform to develop new product candidates for Pompe and Fabry's diseases. With scale up of manufacturing ongoing and IND-enabling studies yet to start, we have prudently pushed back the potential launch for a Pompe disease candidate by 12 months into 2024. We reiterate our Buy rating with Ruconest still valued at ?1.22 on re-based forecasts.
Ron61 schreef op 11 maart 2019 21:11 :
[...]
Maar ruim boven de lullige koers die er nu staat. Gewoon. Pharming lekker door laten werken. Doelen worden ook weer bijgesteld.
Hopelijk leren ze eens van gemaakte fouten cq gaan ze eens een andere koers varen. Sijmen als uithangbord om investeerders te trekken is kansloos gebleken. De opzet zoals jongstleden tijdens de cijfers, kansloos. Dacht dat men in 2019 met een nieuwe opzet qua PR zou gaan werken.. Cijfers waren niet super maar ook zeker niet slecht. Outlook was summier met als gevolg sterk dalende koersen en zelfs neerwaarts bijgestelde koersdoelen. Dan moet je je als bedrijft toch achter je oren krabben en dit niet willen? Je bent al jaren het lachertje van de beurs, maakt inmiddels winst en bent bezig met het neerzetten van een veelbelovende pipeline. Daar moet je toch meer uit kunnen halen?
H.C. Wainwright. Pharming Group NV PHARM.AS: Price: ?0.92; Market Cap (M): ?569 Rating: Buy; Price Target: ?2.50 Joseph Pantginis, Ph.D. 2018 Results; Blocking and Tackling Continues as Ruconest Traction Increases Financial update. This morning, Pharming announced full year results, posting EPS of ?0.04 compared with our estimate of ?0.02, and consensus of ?0.03. Ruconest revenues for 2018 were ?134.3 million, beating our estimate of ?133.9 million and reflected an increase in the number of patients using the drug both in the U.S. and E.U. The company ended the year with ?81.5 million in cash bolstered by growing Ruconest sales. We expect these revenues to continue to grow over the long-term bolstered by potential expansion into additional indications and in the nearer term by: (1) continued core growth in HAE; and (2) potential growth with new and improved formulations. Highlights of 2018. We believe Ruconest's growing traction speaks to the strong execution of the company?s business strategy. Recall that Ruconest entered a relatively crowded market, characterized by a rapid changing landscape, with increasing competition, especially in the prophylactic space, with higher responses rates and improved profiles. However, Ruconest has had, and continues to have advantages due to: (1) the continuous need for drugs able to treat the acute and breakthrough attacks characteristic of HAE; (2) its reliability and consistency of responses, which continue to provide confidence to patients adopting the drug as preferred treatment; and (3) positive patient experience which boosts the Ruconest profile where other drugs are not delivering. Therefore, Ruconest captures both severely affected patients and those that look for a reliable treatment for their breakthrough attacks (which expands the growth opportunities for Ruconest beyond acute treatment). Results from real-world investigator sponsored study of Ruconest in HAE looks good too. Recently, Pharming also announced positive outcomes for Ruconest in HAE patients in a real-world investigator sponsored study. Specifically, these data demonstrated that patients under Ruconest required less re-dosing as opposed to those treated with competitor drug, Firazyr. In short, Ruconest showed higher efficacy in resolving HAE attacks within the first dose vs. Firazyr. Both plasma-derived C1 esterase inhibitors, Berinert and Cinryze, demonstrated positive resolving activity within the first dose showing 100% and 94% efficacy, respectively. The aim of the study was to compare re-dosing rates inter alia of Ruconest (recombinant) and several human plasma-derived C1 esterase inhibitors (e.g., Berinert, Cinryze) vs. Firazyr in seven patients in danger of HAE attacks. By looking at the data we highlight the main takeaways: (1) high efficacy of Ruconest (100% of the treatment cohort receiving labeled dose) to resolve acute HAE attack in the first line of treatment indicates potential increased adoption in the clinical setting; (2) the optimal dose of Ruconest or 50U/kg is required to achieve clinical efficacy; (3) high failures rates of Firazyr, 44% in the first and 62.5% in the second lines further supports Ruconest's role as a clinically valuable solution to target acute HAE attacks; and (4) Firazyr failure rates are higher than reported in previous studies, which is not so uncommon due to the heterogeneity of the diseased population. Briefly, the study reported 69 attacks in seven patients, who could choose different specific therapeutic C1 esterase inhibitor options during the study from the first to the fourth line of treatments.
2019 Outlook; improvements and expansion. During the call, management also provided clear vision, in our belief, as to the next steps pertaining to Ruconest?s development, within and beyond the HAE space. The company is planning to: 1.Continue to invest in the expansion of Ruconest production as current traction is expected to grow especially in the U.S. and Western Europe. Positive trends in patients number and regular patterns in the distribution of revenues during previous quarters, give the company confidence in the possibility of achieving increasing sales quarterly going forward. 2.Improve marketing activity to open new venues for Ruconest. 3.Continue to improve the convenience profile of the drug; as the efficacy of Ruconest is close to 100%, the company is actively working to improve the route of administration so that it can achieve the maximum convenience for patients. Accordingly, intramuscular, subcutaneous and intradermal formulations are being developed. Recall that oral administration is not contemplated because of the large size of the molecule. 4.Tackle large unmet medical needs. Beyond HAE the company is focusing on other diseases caused by a dysfunction in the complement system, such as acute kidney injury and preclamsia for which, currently, there are no approved therapies. Positive results were obtained with Ruconest from an investigator-initiated study conducted in patients at risk for nephropathy during contrast enhanced examination (explained in detail below). In particular, in patients undergoing PCI and valve replacement, Ruconest significantly reduces kidney damage especially in those patients requiring higher volumes of contrast media. Given the positive results, the company decided to move forward with its own program in the acute kidney injury space in patients undergoing PCI. Discussions on the design of this study and the protocol are currently ongoing and the company is planning to seek guidance from the regulators for the next steps. Similarly, after extensive conversations with KOLs, a study to investigate safety and efficacy of Ruconest in preclamsia has been formulated and submitted to the regulators and ethics committee in the Netherlands and Australia (where the primary investigators are based). All study preparations have been completed and the company is waiting for final approval to initiate the study, which should be received soon. 5.Address spaces with shortage in protein replacement therapies such as Pompe and Fabry disease. The development of alpha glucosidase enzyme replacement therapy for Pompe disease continues and dialogs with KOLs have been initiated to provide guidance for the optimal design of future studies. In this case as well, the company is planning to seek feedback from the regulators as to the best course of action and is working on optimizing manufacturing and obtaining material for IND and clinical trial enabling studies. 6.Address the content of the CRL received by the FDA regarding the submitted sBLA for the use of Ruconest, IV in the prophylaxis setting. The company is planning to explore the prophylactic space with the new more convenient formulations. Recall the sBLA was accepted for review by the FDA in January 2018 based on the additional positive randomized Phase 2 in the prophylaxis setting, supported by the already approved indication in the acute setting for the drug and its sizable database of efficacy and safety. However, in September 2018, the FDA has requested an additional trial to "further evaluate the effectiveness of Ruconest in HAE patients" and the company intends to pursue this goal with the more competitive new formulations. Formulation works continues to improve Ruconest profile. A new version of Ruconest has been designed and the company envisions bringing a vial to market, with a very small volume (3 ml) that can be used for IV and does not need reconstitution. This represents a big step forward because, as proven by several C1 esterase products, reconstitution is very inconvenient for patients as it is time consuming, tedious and requires multiple vials. Furthermore, the new formulation is expected to be very versatile as the same vial is expected to be used: (1) for intramuscular injection for acute attacks (2) for subcutaneous injections (thanks to the low volume) which should also represent a competitive advantage and; (3) for intradermal applications (when efficacy is confirmed) as the same vial can be directly used for filling the devices for injections. The company believes the first study with this new vial could be an intramuscular study for acute attacks. Of note, management believes that the rabbit platform is sufficient to accommodate the needs of the HAE market. For the larger market indications the company plans to develop a bovine platform beginning with the required milk analysis towards the end of 2019 and manufacturing for clinical trial material should follow accordingly.
Upcoming catalysts: •1H19: Initiate Phase 2 in contrast-induced nephropathy •YE19: Initiate Phase 2/3 in pre-eclampsia •1H20: Initiate Phase 2/3 in Pompe Valuation and potential impediments to achieving it. We reiterate our Buy rating and ?2.50 price target. Our valuation is based on our clinical net present value (NPV) model, which allows us to flex multiple assumptions affecting a drug's potential commercial profile. Factors which could impede reaching our price target include, lack of meaningful market penetration, failed or inconclusive clinical trials or inability of the company to secure adequate funding to progress its drugs through the development pathway.
PORTZAMPARC Pharming Group 8 mars 2019 Cours : 0,88€ Objectif : 1,80€ ACHETER (1) Cours au 08/03/2019 Résultats financiers 2018 / Conférence téléphonique Une bonne tendance qui se confirme Pharming Group confirme sa capacité à commercialiser le Ruconest® et à délivrer de la performance. RN positif : Une première. Avec un CA T4 de 36,7M€ (+12%) et un CA 2018 de 135,1M€ (+51%), Pharming affiche une croissance en ligne avec nos estimations (PZP CA 2018 134,4M€). Concernant le mix géographique, la majorité des ventes reste sans surprise réalisée aux USA (94%). Cette bonne performance des ventes aux US déclenche le paiement en 2019 d'un milestone de 20M€ à Bausch Health Companies (ex-Valeant), à qui les droits commerciaux avaient été rachetés. Si la société continue sur cette voie de croissance, Valeant sera éligible à 45M€ de milestones dans les prochaines années. Le management rappelle que le ramp-up est en général plus difficile en Europe bien qu'une bonne dynamique semble s'installer pour le Ruconest®. Nous notons une augmentation des coûts de R&D (35,5M€ vs. 28,9M€ n-1), en accord avec l'intensification des essais cliniques avec le Ruconest® dans la prophylaxie de l'AOE, la néphropathie aiguë induite et la pré-éclampsie. Bien que les coûts globaux aient augmenté, la société délivre un résultat opérationnel en progression de 74% à 38,0M€ (MOP 28,3% +360bp). La société publie également le premier bénéfice net de son histoire à 25,0M€. La position de trésorerie brute fin 2018 était de 81,5M€ (vs. 60M€ fin 2017), renforcée par la meilleure rentabilité opérationnelle, une meilleure gestion du BFR et des CAPEX en diminution, et ce malgré le remboursement d'une dette de 14,5M€ par la société. Pas de guidance pour 2019 Le management ne communique pas de guidances chiffrées pour 2019 mais s'attend à continuer de délivrer de la croissance sur les ventes du Ruconest® et à confirmer son RN positif. Des investissements dans l'outil de production et le marketing sont en revanche à prévoir pour répondre à la demande croissante du marché et aux besoins des essais cliniques avec le Ruconest® et dans le "nouveau" pipeline (Maladie de Fabry et de Maladie de Pompe). Pharming semble bien capitaliser sur sa performance exceptionnelle du T4-2017, où la défaillance des principaux concurrents lui a permis de s'implanter réellement dans le marché. L'année 2018 a été bonne et montre que cette dynamique s'inscrit dans la durée. Sans guidance chiffrée pour 2019, nous maintenons notre scénario et notre recommandation Acheter (1) avec un objectif de 1,80€.
Aliassssss schreef op 11 maart 2019 20:40 :
[...]
Ik ook .....Haha....en als de koers omhoog gaat verdwijnen we gewoon stiekempjes van het toneel .....LOL.....
Dat berichtje van je dat je net op het juist moment 180 graden gedraaid was en op precies het juiste moment toch maar long gegaan was, dat was echt geniaal .....TOPKLASSE......
Ik kan nog veel van jou leren MASTER
Hahaha zal die man/vrouw wel eens willen ontmoeten. Soort Louis van Gaal denk
Roth Capital Partners. Healthcare: BioPharmaceuticals Pharming Group NV (OTC: PHGUF) | PHARM.AS - €0.92 - AEX | Buy Analysis of Sales/Earnings Target Price Changed. PHGUF: 4Q18 Recap – Growth to continue in 2019 Pharming reported 4Q18 results that were within expectations (perhaps low end given lower Ruconest #'s). The key takeaways, in our opinion, include 1) Ruconest revenue trends slightly trailed targets (starting to indicate downward 4Q seasonality), 2) modestly reduced revenue/EPS targets based on 4Q trend, 3) despite modifications, significant growth and profitability remain on track, and 4) the company's pipeline should generate news flow in 2019. Maintain Buy rating with price target of €2.00/share (reduced from €2.25). 4Q18 Recap. Pharming reported revenues of €36.9M versus our target of €39.6M (Ruconest: €36.6M actual versus our estimate of €39.4M). Gross margins were below target (82.7% versus 84.0% target), and gross profit of €30.5M trailed our target of €33.3M. Spending was also higher with some 1X noise. However, all of this was offset by 1X noise in other income/tax expense. Net, EPS of €0.02 was ahead of our €0.01 target. Fundamentally, we viewed the quarter within expectations (perhaps lower end given modestly lower revenues). ¦ Takeaway #1 - Ruconest growth to continue. The company's 2019 outlook remains for "continued growth in sales of Ruconest" and "continued achievement of positive earnings". We tweaked our #'s lower given the 4Q18 trend. Revised 2019-22 total revenue targets of €164M, €214M, €280M, and €365M (from €177M, €229M, €297M, and €384M). ¦ Takeaway #2 - Model changes. We modestly revised revenues lower (bullet above), and also modified expenses based on current trends. Revised 2019-22 EPS of €0.05, €0.11, €0.17 and €0.25 (from €0.09, €0.13, €0.19, and €0.27). ¦ Takeaway #3 - Pipeline update. No major changes versus expectations. Upcoming dates to monitor include 1) potential updates on new delivery vehicles for Ruconest in 2019 (vial could be available in 2H19), 2) clinical start for Ruconest to treat pre-eclampsia "any day", 3) toxicology updates for PGN004 to treat Pompe disease potentially in 2019, and 4) the start of a proof-of-concept acute kidney injury study in 2H19. ¦ Maintain Buy rating, PT to €2.00. Pharming is benefiting from growing Ruconest into a significant product that is driving profitability. Further, the company is turning Ruconest into a platform pipeline drug that could have magnitudes of greater revenue potential. We maintain our Buy rating with a modified price target (to reflect lower near-term revenue targets).
Thanks Dreas, mag ik vragen hoe jij dit vindt?
speechless ! echt iets waar we iets aan hebben : prorapporten ............ even belangrijk als het kempen rapport? dan kunnen we de lucht in (positief of negatief).
De amateur schreef op 11 maart 2019 21:42 :
Thanks Dreas, mag ik vragen hoe jij dit vindt?
Door het zonder bronvermelding over te nemen van de buren.......
Mijn verwachting voor morgen is veel te laag, zie de koers morgen weer stevig omhoog gaan. Waarom? ik heb wat naslag werk gedaan over afgelopen weken, en ben tot de conclusie gekomen dat de koers niet gestegen is voor de cijfers, maar omdat er aan een overname gedacht is. En nu dat uitgebleven is, zijn de aangeschafte aandeeltjes linea recta weer verkocht. Dat zit er na vandaag op, en het logisch gevolg is dat de koers morgen op de cijfers morgen gaat stijgen. Want iedereen heeft kunnen zien dat het volume er wel was. Alleen waren er elke dag net meer verkopers, tot nu. Alvast gefeliciteerd.
Toch mis ik Antop wel. Up naar de € 1,75 en hoger. Vasthouden en trust. Up naar de € 1,75 en hoger. Vasthouden en trust. Up naar de € 1,75 en hoger. Vasthouden en trust.
Waar is Techspech gebleven? , vond dat wel een positivo met kennis van zaken
marcello106 schreef op 11 maart 2019 21:48 :
[...]
Door het zonder bronvermelding over te nemen van de buren.......
Ook daar geen bronvermelding.
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LBC
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Leasinvest
Logica
Lotus Bakeries
Macintosh Retail Group
Majorel
Marel
Mastrad
Materialise NV
McGregor
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Mediq
Melexis
Merus Labs International
Merus NV
Microsoft
Miko
Mithra Pharmaceuticals
Montea
Moolen, van der
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Morefield Group
Mota-Engil Africa
MotorK
Moury Construct
MTY Holdings (voorheen Alanheri)
Nationale Bank van België
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Snowworld
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SNS Small & Midcap Competitie
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Stellantis
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