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Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

Laatste koers (eur) Verschil Volume
0,893   +0,020   (+2,23%) Dagrange 0,884 - 0,901 3.728.995   Gem. (3M) 6,5M

Pharming december 2024

3.378 Posts
Pagina: «« 1 ... 163 164 165 166 167 ... 169 »» | Laatste | Omlaag ↓
  1. BRIARC 24 december 2024 10:20
    quote:

    Voorheen_bekend_als_Test schreef op 24 december 2024 10:16:

    [...]

    Nee, ik zit niet short, nooit gezeten ook. Wel een week of twee geleden mijn Pharmingbelang verkocht. Hoewel ik niet beweer dat Pharming niet mogelijk een kip met gouden eieren zal verwerven, zal het nog minstens 24 maanden duren voor dit enigszins zichtbaar is. Hoogst onzeker dus, temeer SDV zelf de kans dat dit een flop wordt, schat op 55%. Tel daarbij op dat Ruconest over the hill is en dat het inmiddels zeer te betwijfelen valt of leniolisib voor enorme geldstromen (inkomende, wel te verstaan) zal zorgen, en u snapt mogelijk mijn besluit mijn kruit nog even droog te houden.
    Ruconest omzet groeit jaar op jaar. Daarnaast zijn reeds positieve resultaten met Joenja in de leeftijd 4 tm 11.

    Naar mijn inziens groeit de huidige positieve cashflow.
  2. forum rang 6 pakman 24 december 2024 10:24
    With regards to partnering strategy for KL1333 and NV354, Abliva’s management has indicated that
    both options are on the table. The company could bring the assets all the way to the market itself or
    sign a deal if the right partner comes on board. In our model we assume that Abliva will
    commercialise both products itself. The assumptions for our rNPV model are summarised in
    Exhibit 10. Key inputs include:
    ? Target patient populations. Abliva is focusing on specific PMDs for both assets in order to
    evaluate the drug candidates in as homogenous patient population as possible, which improves
    the likelihood of quality data and statistical analysis. PMD epidemiology data are scarce, but
    using available sources we calculate respective target patient populations for KL1333 and
    NV354 of 40k and 18k in the United States and the top 15 wealthy European countries (top
    five, the Nordics, Benelux, Austria, Switzerland and Ireland).
    ? Success probabilities. For KL1333 we use a 25% probability to reach the market, which is in
    line with recent analysis published by Wong and Siah (2019), who found drug candidates in
    neurology in Phase II have probability within the range 20–24%; drug candidates for all
    indications excluding oncology had probabilities within the range 27–29%. For NV354 we use
    5% while this asset is in the preclinical stage. As described above, it could move into Phase I
    as soon as next year.
    ? Pricing and market penetration. We assume a price tag of $110,000 for KL1333 and
    $130,000 for NV354 (50% discount in Europe applied) per patient per year. EvaluatePharma’s
    2019 report calculates that the average price per patient for an orphan drug (top 100 products)
    was $151k in 2018, while the median was $110k. For KL1333 we use the price equal to the
    median (2018 data available only), while for NV354 we assume a price closer to the average
    orphan drug pricing, as it is a smaller indication than that targeted by KL1333. The range is
    wide, however, and higher pricing could be secured depending on cost effectiveness. We
    assume 20% market penetration for KL1333 and 30% for NV354, as it targets a smaller
    indication. As there are no effective treatments available, there is no precedent for how to
    model the uptake of new drugs in PMDs. It could be argued that once an effective treatment is
    introduced, most patients would be willing to receive it, so market penetration could be well
    above 50%. For the time being we use a conservative approach, but in Exhibit 9 we have
    provided a sensitivity analysis of peak sales to price and market penetration.
    ? R&D development costs. We estimate the cost of Abliva’s pivotal Phase II/III study of KL1333
    at c $30m and assume a similar development pathway for NV354. Assumed launch dates are
    2025 for KL1333 and 2028 for NV354, with peak sales reached in six years ($670m for KL1333
    and $320m for NV354).

    uit het report, ze schatten maar 25% kans op goedkeuring....en blijkbaar Geen partner vh product gevonden...tricky
  3. BRIARC 24 december 2024 10:27
    quote:

    pakman schreef op 24 december 2024 10:24:

    With regards to partnering strategy for KL1333 and NV354, Abliva’s management has indicated that
    both options are on the table. The company could bring the assets all the way to the market itself or
    sign a deal if the right partner comes on board. In our model we assume that Abliva will
    commercialise both products itself. The assumptions for our rNPV model are summarised in
    Exhibit 10. Key inputs include:
    ? Target patient populations. Abliva is focusing on specific PMDs for both assets in order to
    evaluate the drug candidates in as homogenous patient population as possible, which improves
    the likelihood of quality data and statistical analysis. PMD epidemiology data are scarce, but
    using available sources we calculate respective target patient populations for KL1333 and
    NV354 of 40k and 18k in the United States and the top 15 wealthy European countries (top
    five, the Nordics, Benelux, Austria, Switzerland and Ireland).
    ? Success probabilities. For KL1333 we use a 25% probability to reach the market, which is in
    line with recent analysis published by Wong and Siah (2019), who found drug candidates in
    neurology in Phase II have probability within the range 20–24%; drug candidates for all
    indications excluding oncology had probabilities within the range 27–29%. For NV354 we use
    5% while this asset is in the preclinical stage. As described above, it could move into Phase I
    as soon as next year.
    ? Pricing and market penetration. We assume a price tag of $110,000 for KL1333 and
    $130,000 for NV354 (50% discount in Europe applied) per patient per year. EvaluatePharma’s
    2019 report calculates that the average price per patient for an orphan drug (top 100 products)
    was $151k in 2018, while the median was $110k. For KL1333 we use the price equal to the
    median (2018 data available only), while for NV354 we assume a price closer to the average
    orphan drug pricing, as it is a smaller indication than that targeted by KL1333. The range is
    wide, however, and higher pricing could be secured depending on cost effectiveness. We
    assume 20% market penetration for KL1333 and 30% for NV354, as it targets a smaller
    indication. As there are no effective treatments available, there is no precedent for how to
    model the uptake of new drugs in PMDs. It could be argued that once an effective treatment is
    introduced, most patients would be willing to receive it, so market penetration could be well
    above 50%. For the time being we use a conservative approach, but in Exhibit 9 we have
    provided a sensitivity analysis of peak sales to price and market penetration.
    ? R&D development costs. We estimate the cost of Abliva’s pivotal Phase II/III study of KL1333
    at c $30m and assume a similar development pathway for NV354. Assumed launch dates are
    2025 for KL1333 and 2028 for NV354, with peak sales reached in six years ($670m for KL1333
    and $320m for NV354).

    uit het report, ze schatten maar 25% kans op goedkeuring....en blijkbaar Geen partner vh product gevonden...tricky
    Welk rapport? Dit is rapport waarschijnlijk gepubliceerd VOOR de positieve interim resultaten van de Fase II studie.
  4. forum rang 6 Voorheen_bekend_als_Test 24 december 2024 10:27
    quote:

    BRIARC schreef op 24 december 2024 10:20:

    [...]

    Ruconest omzet groeit jaar op jaar. Daarnaast zijn reeds positieve resultaten met Joenja in de leeftijd 4 tm 11.

    Naar mijn inziens groeit de huidige positieve cashflow.
    Dat kan. Ik bezie de zaken evenwel liever van wat grotere hoogte, en dat ligt ten grondslag aan mijn scepsis over de toekomst van Pharming.
  5. forum rang 4 putdeksel 24 december 2024 10:30
    De term blockbuster komt idd van Abliva zelf. Zie video 8m45

    youtu.be/6FjwP6vsk5c

    Op minuut 6 zegt Donnely dat KL 1333 aanspraak gaat maken op ODD (orphan drug disease) regeling, waarmee je versneld toegang kunt krijgen. Alleen, als je criteria opzoekt voor ODD dan vind je:

    - Drugs (includes biologics) for the prevention, diagnosis, or treatment of diseases or conditions affecting fewer than 200,000 persons in the US.
    - Drugs that will not be profitable within 7 years following approval by the FDA.

    Volgens mij betekent dit dat als ze goedkeuring krijgen (in de US), de prijsonderhandeling dusdanig gaat zijn dat ze geen enorme winst mogen maken. Op 7m45 zegt ze dat ze 160k per patient wil vragen, de US sales over de eerste 7 jaren zijn ingeschat op grofweg 2 bln totaal, reken met 100m kosten per jaar plus sunk costs van hoeveel (?) 200m tot nu toe (incl neurovive periode)? Dan zouden de sales hier een factor 1.5/2 te hoog worden gerepresenteerd. Een maximale opportunity voor Pharming van old-raised-capital minus 66m, in de US. De meeste sales zijn verwacht in EU ondanks halve prijs.

    Wat ze aan het eind zegt in de Q&A: in de US gaan we zelf marketen want daar is het simpel, maar in de EU moeten we een partner hebben want daar is het regulatoire landschap te ingewikkeld. Dit is Pharming ook tegengekomen, en nog niet opgelost.
  6. forum rang 6 Gadus morhua 24 december 2024 10:36
    quote:

    Voorheen_bekend_als_Test schreef op 24 december 2024 10:27:

    [...]

    Dat kan. Ik bezie de zaken evenwel liever van wat grotere hoogte, en dat ligt ten grondslag aan mijn scepsis over de toekomst van Pharming.
    Dat klopt wel.
    Als je het van grote hoogte bekijkt, dan lijkt alles kleiner.
    Sta je er dichterbij, dan is het groter.
  7. BRIARC 24 december 2024 10:39
    quote:

    putdeksel schreef op 24 december 2024 10:36:

    > Pricing and market penetration. We assume a price tag of $110,000 for KL1333

    In de presentatie uit 2023 hadden ze nog 160k en dat leek me al te hoog, dus met 1/3 minder sales wordt de 1bln sales-wortel ook meteen een stukje lager
    Uitgaande van $110k, met een doelgroep van 30.000 patiënten met het grootste deel in Europa wordt de barrière van 1 miljard overschreden hoor.
3.378 Posts
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