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Genmab, de Deense parel

3.121 Posts
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  1. Smoker 9 april 2017 01:05
    quote:

    Smoker schreef op 1 april 2017 13:19:


    [...]

    Nu het personeel het cadeau heeft verzilverd kunnen we weer verder kijken
    Zolang we boven de 1312 blijven zie ik geen verdere uitverkoop.


    Ik ook altijd. Goed we testen nu de steunzone pas boven de 1245 kunnen we voorzichtig weer omhoog kijken. Anders 1179 en gaat de uitverkoop gewoon nog ff door. We gaan het zien komende week.
  2. sheriff Grover 9 april 2017 08:24
    quote:

    @GlobalMacro schreef op 8 april 2017 16:57:


    [...]


    Totaal 267 Mio.

    En dan zit er geen off label sales bij.
    De internationale groei geloof ik wel, de 78 mio in de US in maart vind ik lastig.
    Rond de 265 zou wat mij betreft erg goed zijn. Alles er boven zou significant zijn.


    Morguh GlobalMacro , ja ik denk dat je wel redelijk goed zit met je schatting ergens tussen de 250-270 zal het wel worden ....
  3. Fortune21 18 april 2017 16:21
    quote:

    @GlobalMacro schreef op 8 april 2017 16:57:


    [...]

    Novod van Nordea verwacht 78 Mio voor maart ivm het aantal business days.
    Als de Int. Sales dan net zo hard groeit als de US sales kom je uit op 65 Mio.


    En dan zit er geen off label sales bij.
    De internationale groei geloof ik wel, de 78 mio in de US in maart vind ik lastig.
    Rond de 265 zou wat mij betreft erg goed zijn. Alles er boven zou significant zijn.


    $255mln is prima. Bloomberg consensus was $232mln. Split US 201/ROW 54

    De ROW groei is beperkt mede doordat Genmab nog geen goedkeuring heeft voor de second line in Europa. Maart sales US 77 mln.
  4. @GlobalMacro 18 april 2017 18:05
    quote:

    sheriff Grover schreef op 18 april 2017 16:08:


    [...]

    Dank U FredK , maar dit was natuurlijk nooit gelukt zonder het voorbereidend en gedegen rekenwerk van ons gewaardeerd mede forumlid @ Globalmacro ! ;o)


    Haha dank :)

    Mooie cijfers idd, fundamenteel zit het goed, nu de koers nog.
    Zoals altijd met Genmab volgt de koers op een gegeven moment vanzelf.

    Nog even mbt de cijfers, de US groei zat redelijk op wat ik verwacht had. Helaas vallen de RoW cijfers wat mij betreft wel tegen, aangezien Dara in de EU pas per het 2de half jaar 2016 op gang aan het komen is verwachtte ik hier minimaal ook een groei van +/- +25% vs Q4 2016, dat zou betekenen dat we op +/- 60 mio hadden moeten uitkomen en daarmee in totaal rond de 260. Afijn, de blockbuster status obv FY is binnen.

    Via bepaalde kanalen hoor ik geluiden dat er achter de schermen verwacht wordt dat we dit jaar de 2 miljard gaan aantikken, dat zou betekenen dat we ergens dit jaar een grote versnelling moeten maken. Wellicht komt deze zodra de Alcyone studie resultaten bekend worden gemaakt, in de US vergoeden veel verzekeraars zodra significante data bekend is / gepubliceerd is in een vooraanstaand wetenschappelijk tijdschrift. Tevens begreep ik dat in 2nd lijn patiënten eerst hun oude combinatie therapy afmaken voordat ze aan een nieuwe beginnen, dat zou ook nog kunnen betekenen dat er een versnelling aan zit te komen. Laten we het hopen!
  5. sheriff Grover 24 april 2017 08:47
    Biotechnologie is terug

    door Rob Goossens

    Na een mager 2016 staan investeerders weer in de rij voor biotechbedrijven. Met name medicijnen tegen kanker zijn in trek onder Europese en Amerikaanse investeerders.
    De biotechnologische sector wordt als riskant beschouwd en heeft er om die reden meteen last van als de markten onzeker worden. Het afgelopen jaar waren het onder meer de Amerikaanse presidentsverkiezingen waardoor investeerders niet thuis gaven.

    Voor 2017 verwacht echter 73% van de investeerders meer fusies en overnames in deze sector, dus neemt ook de investeringsbereidheid toe. Dat blijkt uit onderzoek van zakenbank Kempen & Co. Van alle ziektes krijgt kanker de meeste aandacht. 60% van de investeerders zegt daar het meest geïnteresseerd in te zijn.
    Volgens managing director corporate finance Oscar Izeboud van Kempen & Co heeft dat niet alleen te maken met de rendementen. „Natuurlijk helpen de succesverhalen, zoals het Nederlandse Genmab dat in twee jaar tijd €8 miljard meer waard is geworden. Maar daarnaast is het ook eenvoudiger om investeringen te trekken voor bekendere ziektes. Dat zie je naast kanker bijvoorbeeld ook met reuma.”

    Zelf zag Izeboud ook al tekenen dat het goed gaat met ‘biotech’. Zo werd zijn eigen team door concurrenten uitgedund, en werden er alles verpletterende ‘knock-out’-biedingen gedaan. Het Zwitsers-Franse Symetis werd in maart op de dag dat de prijs bij een beursgang bekend zou worden gemaakt, overgenomen door Boston Scientific.
    Izeboud: „Dat was bereid om tweeënhalf keer zoveel te betalen als wat een beursgang maximaal zou hebben opgeleverd. Dan sta je als ceo van het bedrijf op zijn zachtst gezegd voor een dilemma.”

    Kempen heeft volgens de managing director in een vergelijkbare situatie gezeten. „Voor ons is het als begeleidende bank aantrekkelijker het bedrijf naar de beurs te brengen. Maar het is natuurlijk te begrijpen als een bedrijf voor een volledige overname kiest als die kans zich voordoet.”

    Vooral medicijnen die al op veiligheid zijn getest, blijken in trek. Deze ‘Fase 2’-medicijnen zagen de interesse in twee jaar tijd met 67% toenemen, terwijl moleculen die pas in de vroegste ontwikkeling zijn juist 58% wegzakten. Ook blijken investeerders het liefst in beursgenoteerde bedrijven te stappen.
    Izeboud: „We zien een voorkeur voor bedrijven die over een langere tijd gevolgd kunnen worden, en een beursnotering helpt daarbij. Ook eisen de meeste ondervraagden dat een bedrijf nog minstens een jaar vooruit kan met de beschikbare middelen.”

    Bang dat deze risico-aversie ervoor zorgt dat bedrijven in de vroegste ontwikkelingsfases geen geld meer krijgen en daardoor de hele ontwikkelingsketen stopt, is Izeboud echter niet. „In Nederland hebben we met onder meer Forbion en Life Sciences Partners gerenommeerde durfkapitalisten. Juist de latere fases waren onderbezet. Het is goed dat de keten zich nu uitbreidt.”

    De Telegraaf van hedenmorgen .
  6. Irenesebregts 25 april 2017 15:21

    Johnson & Johnson's large size suits some investors, but there's no denying growth in the pharmaceuticals is slow: 9 of 15 drugs saw sales declines in 1st quarter 2017.

    Sales of myeloma drug Darzalex grew 99% compared to same quarter a year ago which made it JNJ's best performer in relative terms.

    Darzalex was designed by $11b Danish mAb powerhouse Genmab A/S which sells for high multiples of sales and earnings, but alas earnings are positive for the 4th straight year.

    An $11b market cap will look cheap in retrospect if Darzalex sales peak at $9b, and Genmab may be one of the best pure plays on a future blockbuster.

    Darzalex daratumumab was Johnson & Johnson's (NYSE:JNJ) fastest growing drug during the first quarter of 2017 with US sales of $201 million, up 99% over 1st quarter of 2016. Global sales of the myeloma drug were $255 million compared to $101 million in the same quarter a year ago.

    JNJ total sales growth was an anemic 1.6%. Total consumer growth was 1.0%. Total pharmaceutical sales in 2017Q1 were $67 million more than in 2016Q1, representing growth of 0.8%. Global sales declined across much of the portfolio, notably -6% for best-seller Remicade and by -9% for 3rd best selling drug Xarelto.

    All of JNJ's pharmaceutical growth came from 6 drugs (not counting those categorized as 'other'). The largest growth in sales was for Darzalex which grew by $154 million.

    Here is the $ growth for the quarter vs same quarter a year ago for those 6 drugs:

    growth in quarterly sales ($million)

    DARZALEX.....................$154

    IMBRUVICA....................$148

    INVEGA SUSTENNA..........$ 91

    STELARA........................$ 88

    SIMPONI /SIMPONI ARIA..$ 38

    EDURANT /RILPIVIRINE....$ 30

    The rest of the drugs named in the JNJ portfolio lost ground in Q1 of 2017. So investors are paying a premium to get JNJ's diversified pharmaceutical portfolio that includes 9 drugs with declining sales.

    Growth oriented investors might put their funds to better use in JNJ partner Genmab A/S (OTC:GNMSF), (OTCPK:GMXAY).

    Scientists at Genmab published their discovery of daratumumab 10 years ago (de Weers, 2007). Daratumumab alias HuMax-CD38 is an anti-CD38 human mAb (monoclonal antibody). It was selected from a panel of 42 novel mAb generated in transgenic mice because it was the most effective at killing myeloma cells in a test tube via multiple mechanisms. CD38 is a receptor and enzyme that is found on the surface of cells in the bone marrow at low levels, but is enriched on the surface of myeloma cells. It thus seemed an excellent target.

    One of de Weers' co-authors published results from a phase 1-2 trial involving patients with relapsed myeloma or myeloma that was refractory to two or more prior lines of therapy. In that trial daratumumab as monotherapy was safe and appeared effective (Lokhorst, 2015).

    Myeloma experts Vincent Rajkumar and Robert Kyle of Mayo Clinic Rochester call daratumumab a monoclonal breatkthrough in their October 6, 2016 NEJM editorial comments on the bortezomib-based CASTOR trial and on the lenalidomide-based POLLUX trial published in the same issue.

    In the POLLUX trial (Dimopoulos, 2016) of previously treated patients, daratumumab provided an overall 12-month survival advantage (92.1% vs 86.8%) to patients treated with Revlimid and dexamethasone. The absolute PFS achieved that trial appeared superior to that achieved in CASTOR.

    Daratumumab was granted accelerated approval in November 2015 as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy (see NCT02477891 submitted June 2015). On November 21, 2016, the U.S. Food and Drug Administration approved daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Darzalex is the first monoclonal antibody to receive FDA approval to treat multiple myeloma.

    Although not yet approved as frontline therapy - that will take several years as it did for Celgene's (NASDAQ:CELG) Revlimid - almost all patients with myeloma will eventually be candidates for Darzalex. Genmab CEO Jan van de Winkel has estimated that sales will peak at $9 billion or more. Sales of JNJ top-selling drug Remicade may have peaked at $7b in 2016, just to provide a comparison. $9 billion in sales of Darzalex would mean nearly $1.8 billion yearly for Genmab given the 20% royalty figure that has been reported for sales exceeding $3b.

    Genmab has other important drugs in its pipeline, but a brief discussion of ofatumumab and pipeline candidates is relegated to Footnotes.

    More important to investors who might be trying to decide between the impeccable, bond-like quality that JNJ offers and the growth potential of one of its much smaller partners, is whether the particular partner being considered is, and will remain, financially independent. And Genmab is showing signs that it will.

    Genmab's net earnings were last negative in 2012 (-DKK 487 million) and have grown each year since to DKK 1,187 million in 2016. Genmab has been cash flow positive for the past 3 years, increasing cash on the balance sheet to DKK 3,922 million in 2016. Share count grew by only 6% from year end 2014 to year end 2016. See figure 1 below.

    The quality of Genmab's revenue is also increasing, derived more from recurring royalties than sporadic milestone payments. Total royalties comprised 29% of the revenue in 2016, compared to just 8% in 2015, and covered 68% of total operating expenses in 2016 versus 16% in 2015. See figures 2 & 3 below.

    Guidance for 2017 is revenue at circa DKK 2,050 million representing a modest 13% growth but the quality of that growth will again improve with anticipated doubling of the income stream from royalties.

    Genmab's growth is not labor or capital intensive. It sold its manufacturing facility in 2013. Headcount has increased from 179 in 2012 to only 205 in '16 such that revenue per employee is a healthy $1.27 million. Compare that to $0.31 million per employee for mAb manufacturer Regeneron (NASDAQ:REGN), and $0.27 million for Seattle Genetics (NASDAQ:SGEN) which does not have manufacturing capacity on a commercial scale.

    Seattle Genetics is probably Genmab's closest mAb peer, having a market cap of $9b vs $11b for GNMSF.

    SGEN total revenue grew less (up 25%) in 2016 than did GNMSF's (up 60%) but, of course, the quality of that revenue was superior in that nearly 2/3 came from SGEN's own sales of Adcetris. But SGEN's expenses are growing faster than its revenue so that losses continue to accumulate. Balance sheet cash has nearly doubled in the past 2 FY, but share count has increased by 14%. The mid-range total revenue forecast for 2017 of $425 million is 1.5% higher than the $418 million in 2016.
  7. Irenesebregts 25 april 2017 15:21

    Given that its earnings and cash flows are further into the red each year, and given that revenue growth is slowing, the market has awarded SGEN a P/S ratio of about half that of GNMSF.

    GNMSF multiples of trailing revenue and earnings may seem rich, but those multiples will in retrospect appear cheap if Darzalex peak sales even come close to the $9 billion projected by the Genmab CEO. And while that projection might seem optimistic, expert opinions about the importance of Darzalex can be reasonably interpreted by investors as 'blockbuster.'

    A recent buying opportunity was created by the March 30 announcement that the phase II CARINA study in NHL will not proceed. This should not come as a terrible shock given that there are more frequently expressed targets on the surface of NHL cells than CD38 (see e.g. Li, 2015).

    That March 30 announcement puts at risk two other non-myeloma studies of interest to Janssen and Genmab, both in phase II: NCT03067571 entitled "Relapsed/Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplastic Syndrome" and NCT02927925, Janssen's phase II "Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma." Although the company insists those trials will proceed, it is reasonable to speculate that Darzalex may just not work well in malignancies other than myeloma which gets back to the original concept that because CD38 is highly expressed in myeloma but not in other tissues, a well-designed anti-CD38 antibody (and design is crucial as that 2007 paper showed) should kill myeloma cells without harming other tissues or, in this context, other tumors.

    Investors looking for a bond-like stock may want to watch for JNJ to fall again into the $110-115 range. Those looking for exposure to one of the next blockbusters in cancer therapy that is less diluted than it is by JNJ's lard may want to watch for a pullback in GNMSF (or its ADR GMXAY). Later in 2017 when realized revenue growth moderates due to loss of milestone payments the stock price is likely to drop again. In the more distant future, losses of milestone payments will be more than offset by gains in royalties.

    Footnotes - pipeline and figures.

    ARZERRA ofatumumab, which Genmab initially developed for Novartis (NYSE:NVS), has been approved for CLL (chronic lymphocytic leukemia), but is losing market share to JNJ's Imbruvica ibrutinib which was found superior in the RESONATE trial published in NEJM (Byrd, 2014). A phase III trial for a follicular lymphoma indication is ongoing. Trials to treat relapsing multiple sclerosis were started by Novartis in 2016. There are numerous investigator-initiated trials of ofatumumab against B cells for various indications - a search at clinicaltrials.gov turned up 115 trials in all.

    Genmab and Seattle Genetics are jointly developing tisotumab vedotin, an ADC (antibody-drug conjugate) that targets tissue factor. TF is enriched in various solid tumors. Results from a Genmab-sponsored phase I/II trial (NCT02001623) could be available late in 2017.

    Humax-AXL-ADC is another ADC licensed from SGEN and was designed against another novel target. AXL is a tyrosine kinase receptor that may have an important role in normal tissues such as immune cells, but is overexpressed in many aggressively growing solid tumors, and its overexpression is one mechanism for resistance of tumors to EGFR inhibitors (see Choueiri, 2017; Zhang, 2012; Qu, 2016). Genmab is the sponsor of a phase I/II trial (NCT02988817) of Humax-AXL-ADC for solid tumors.

    Teprotumumab was designed by Genmab for Roche (OTCQX:RHHBY) who then licensed it to River Vision Development Corporation for clinical trial, now in phase II (NCT01868997). Teprotumumab is a fully human monoclonal antibody against a well-validated target for Graves' orbitopathy: Insulin-like Growth Factor-1 Receptor. Teprotumumab has FDA Fast Track, Orphan Drug and Breakthrough status.

    Humax-TAC-ADC is in one phase 1 trial for lymphoma (NCT02432235) and one for CD25 positive ALL and AML (NCT02588092). Both trials are sponsored by ADC Therapeutics which co-designed Genmab's antibody with its warhead and linker, and named it 'ADCT-301.'

    IO candidate Humax-IL8 is in phase I for metastatic or unresectable, locally advanced malignant solid tumors under sponsorship of Bristol-Myers Squibb (NCT02536469). The rationale is provided by evidence that tumors secrete IL8 which recruits immune suppressor cells to the site, and also gives tumor cells greater metastatic potential.

    JNJ-61186372 is a bispecific antibody (a Genmab Duobody) that targets EGFR and cMet in patients with NSCLC and is in phase I (NCT02609776).

    JNJ-63709178 is a Duobody that targets CD3 and CD123 and is in phase I (NCT02715011) for relapsed or refractory acute myeloid leukemia.

    AMG 714 is a human mAb that binds IL-15 an inflammatory cytokine that is being trialed for rheumatoid arthritis, psoriasis and celiac disease by Amgen (NASDAQ:AMGN) and Celimmune.

    Figure 1. Genmab income in both USD and DKK (Danish krone):

    Figure 2. Growth of Genmab revenue quantity in millions DKK:

    Figure 3. Genmab revenue quality (royalties vs milestones) also in millions DKK:
  8. @GlobalMacro 25 april 2017 18:59
    @irenesebrechts mooi stuk!
    Door wie geschreven?

    Laatste stuk mbt een pullback later in 2017 obv een teruglopende omzetversnelling lijkt me gezien het financiele reporting trackrecord + de conservatieve darzalex omzetverwachting niet heel realistisch.
    Een pullback beneden het 200 day MA (+/- 1220 DKK) gaat denk sowieso niet snel meer gebeuren tenzij er een recessie / financiele crisis komt.
    Nu instappen dus! :)
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