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Home  /   Forum   /   Galapagos   /   MorphoSys

Aandeel Galapagos AEX:GLPG.NL, BE0003818359

Laatste koers (eur) Verschil Volume
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MorphoSys

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149 Posts
Pagina: «« 1 2 3 4 5 6 ... 8 »» | Laatste | Omlaag ↓
  1. Ruud Rubbers 24 januari 2018 19:34
    quote:

    nelis h schreef op 24 januari 2018 18:00:

    van het duitse forum:

    poster deadflowers :
    "Haltet ihr 500 Mio$ Tremfya-Umsatz 2018 für realistisch?"

    poster weitblick :
    "Davon gehe ich mittlerweile aus. Wenn erst gegen Mitte/Ende Q4 die Zulassung für die EU und Kanada kam und wir damit jetzt in Q1 erstmals in allen 3 Regionen (USA, CAN, EU) Umsätze sehen, müßten die eigentlich im 3-stelligen Millionenbereich liegen. Diesen Sprung von 3Q17 auf 4Q17 also 16mio$ auf 47mio$ hatte ich nicht erwartet. Da bin ich positiv überrascht. :-) === Wenn Morphosys jetzt noch die Patentklage für sich entscheiden könnte, dann winkt daraus bis jetzt (seit 2Q16 mit Einreichung der Klage) eine Beteiligung an über 1,7mrd$ Umsatz - nur aus der Vergangenheit natürlich. Für 2018 kommen sicherlich nochmal 1,5-2mrd$ dazu.

    Morphosys: Setzen auf marktreife Partnerprojekte und dicke Meilensteine | wallstreet-online.de - Vollständige Diskussion unter:
    www.wallstreet-online.de/diskussion/1...

    ---

    Naast Galapagos, Ablynx en ArgenX is Morphosys een mooie kans in de porto

    disclaimer, long in alle 4

    Ik kan geen duits
  3. forum rang 4 harvester 25 januari 2018 00:04
    quote:

    nelis h schreef op 24 januari 2018 18:00:

    van het duitse forum:

    poster deadflowers :
    "Haltet ihr 500 Mio$ Tremfya-Umsatz 2018 für realistisch?"

    poster weitblick :
    "Davon gehe ich mittlerweile aus. Wenn erst gegen Mitte/Ende Q4 die Zulassung für die EU und Kanada kam und wir damit jetzt in Q1 erstmals in allen 3 Regionen (USA, CAN, EU) Umsätze sehen, müßten die eigentlich im 3-stelligen Millionenbereich liegen. Diesen Sprung von 3Q17 auf 4Q17 also 16mio$ auf 47mio$ hatte ich nicht erwartet. Da bin ich positiv überrascht. :-) === Wenn Morphosys jetzt noch die Patentklage für sich entscheiden könnte, dann winkt daraus bis jetzt (seit 2Q16 mit Einreichung der Klage) eine Beteiligung an über 1,7mrd$ Umsatz - nur aus der Vergangenheit natürlich. Für 2018 kommen sicherlich nochmal 1,5-2mrd$ dazu.

    Morphosys: Setzen auf marktreife Partnerprojekte und dicke Meilensteine | wallstreet-online.de - Vollständige Diskussion unter:
    www.wallstreet-online.de/diskussion/1...

    ---

    Mooi hoor. bedankt voor het plaatsen.
  10. forum rang 4 harvester 17 februari 2018 00:06
    quote:

    de tuinman schreef op 16 februari 2018 19:47:

    [...]

    Lijkt mij toch niet niet de verklaring voor de stijging?
    Bij Morphosys geldt dat het een tijdje erg stil was en de koers was te veel gedaald, dus bij Morphosys was het een gedeeltelijk herstel.

    Ook Galapagos kan iets zijn gestegen doordat Mor106 en daarmee Galapagos weer eens ergens genoemd wordt zonder vraagteken.

    Volgens mij gaan beiden de komende week/weken een stuk omhoog.
    Volgende week nabeurs de jaarcijfers van Galapagos, gevolgd door de:
    Webcast 23 February 2018, 14.00 CET.

    Mogelijk dan afgezien van de cijfers (flinke uitgaven voor studies filgotinib) ook meer inzicht in ontvangen/geboekte milestones.
    Maar ook tijdens de webcast vragen en antwoorden over vorderingen in de pijplijn en wellicht vrijdag ook wat commentaar op het persbericht en wat aangepaste koersdoelen.

    Voor Morphosys zelf verwacht ik in de komende tijd, mogelijk pas op 13 maart bij de jaarcijfers 2017 duidelijkheid over de royalties over guselkumab verkopen door J+J uit het 3e en 4e kwartaal.

    Vroeg of laat komt er ook een kwantificering van de vergoedingen die Morphosys kan vangen voor misbruik van haar patenten in producten die door grote pharma's al op de markt zijn gebracht. Ik vermoed dat dit positief uitpakt. Recente rechterlijke uitspraken zijn positief geweest.
  12. Piddybull 17 februari 2018 11:24
    Galapagos en MorphoSys presenteren de resultaten van een Fase 1 studie met MOR106 in eczeem als late-breaking abstract op de American Academy of Dermatology (AAD) Meeting in San Diego



    MOR106 werd goed verdragen in patiënten met eczeem
    Op de hoogste dosering bereikten 5 van de 6 patiënten (83%) na vier weken een verbetering in symptomen van minstens 50% (EASI-50)
    Gebundelde data van alle doseringen met MOR106 lieten na 12 weken een 72% verbetering zien in symptomen ten opzichte van de start van de studie
    Verwachte start Fase 2 MOR106 gepland in de eerste helft van 2018


    Mechelen, België en Planegg/München, Duitsland; 17 februari 2018; 10.00 CET -Galapagos NV (Euronext & NASDAQ: GLPG) en MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) kondigden de presentatie aan van meer gedetailleerde resultaten van de Fase 1 studie met het IL- 17C antilichaam MOR106 in onderzoek in patiënten met eczeem op de American Academy of Dermatology (AAD) Annual Meeting 2018 in San Diego, CA, VS, gehouden van 16 tot 20 februari. Eerdere studiedata werden gerapporteerd in september 2017. In de studie liet MOR106 eerste signalen van klinische activiteit en duurzame reacties zien, ook werd het antilichaam goed verdragen in patiënten met eczeem.



    Professor Diamant Thaçi MD, Direktor Institut für Entzündungsmedizin Universitätsklinikum Schleswig-Holstein Campus Lübeck en onafhankelijk adviseur voor de studie, presenteerde de resultaten in de late-breaking abstracts sessie op AAD 2018. De studie was gerandomiseerd en geblindeerd voor vrijwilligers en artsen, omvatte een placebogroep, en onderzocht enkelvoudige oplopende doseringen (SAD) in gezonde vrijwilligers en meervoudige oplopende doseringen (MAD) in patiënten met matige tot ernstige eczeem. In het MAD-gedeelte ontvingen 25 patiënten, gediagnosticeerd met matige tot ernstige eczeem, vier wekelijkse infusen in een verhouding van 1:3 van hetzij placebo, hetzij MOR106 in doseringen van 1, 3 en 10 mg/kg lichaamsgewicht. Patiënten werden na het einde van de behandeling nog 10 weken gevolgd.



    "Matige tot ernstige eczeem is een chronische, invaliderende ziekte die wereldwijd miljoenen patiënten treft, met een duidelijke medische behoefte aan veilige en werkzame behandelingen, " zei Professor Diamant Thaçi MD. "Zowel de eerste signalen van klinische activiteit als de langdurig aanhoudende reactie, tot aan twee maanden na beëindiging van de behandeling, ondersteunen de verdere klinische ontwikkeling van MOR106."



    Zoals gerapporteerd op AAD 2018 waren alle ongunstige medicijnreacties in het MAD-deel in patiënten mild tot matig en van voorbijgaande aard. Er zijn geen ernstige ongunstige gebeurtenissen (SAE's) noch infuus-gerelateerde reacties waargenomen. MOR106 laat gunstige medicijneigenschappen zien met een dosis-afhankelijke blootstelling.



    Op de hoogste dosering van MOR106 (10mg/kg lichaamsgewicht) bereikte 83% van de patiënten (5 van de 6) na vier weken minimaal een verbetering van 50% in signalen en symptomen van eczeem, zoals gemeten volgens EASI-50. Afhankelijk van de toegediende dosering, begon MOR106 binnen twee tot vier weken te werken.



    Gebundelde data van alle doseringsgroepen laten zien dat met MOR106 behandelde patiënten een EASI verbetering vertonen vergeleken met het startpunt van 58%, 62%, 72% en 64% na respectievelijk 4, 8, 12 en 14 weken. Bij patiënten op placebo werd een EASI-verbetering waargenomen van respectievelijk 32%, 40%, 38% en 50%.



    MOR106 komt voort uit het Ylanthia antilichaam platform van MorphoSys en is gebaseerd op een door Galapagos ontdekt target. IL-17C is een cytokine dat in verband wordt gebracht met ontstekingen in de huid en onderscheidt zich van de andere leden van de IL-17 cytokine familie. MOR106 is het eerste menselijke monoklonale antilichaam in klinische ontwikkeling dat op IL-17C is gericht. MOR106 is een medicijn in onderzoek waarvan de veiligheid en werkzaamheid nog moet worden vastgesteld.



    De start van Fase 2 ontwikkeling met MOR106 wordt verwacht in de eerste helft van 2018.



    Details van de mondelinge presentatie over MOR106 op AAD 2018:

    Abstract #6753 - MOR106, an Anti-IL-17C mAb, a Potential New Approach for Treatment of Moderate-to-severe Atopic Dermatitis: Phase 1 Study.

    Sessie #F061 - Late-breaking Research: Clinical Trials

    Datum: zaterdag 17 februari van 1:00 PM - 3:00 PM PT (10:00 PM - 0:00 AM CET)

    Locatie: Ballroom 20A

    Presentator: Professor Diamant Thaçi MD, Director of the Institute for Inflammation Medicine at the University Clinic Schleswig-Holstein Campus Luebeck



  13. forum rang 4 harvester 17 februari 2018 14:37
    even wat oude (want van 15 feb 2018) bwschouwingwen over Morphosys van deraktionar website geplukt:

    Stemmer Imaging Billboard
    Morphosys
    15.02.2018 - 13:56 Uhr - Marion Schlegel - Redakteurin
    Morphosys: Negative Analystenstimmen sorgen für Druck – was nun?

    Noch im Januar sah es bei der Aktie von Morphosys danach aus, als könnte sie den Ausbruch nach oben schaffen. Doch im Zuge der Korrektur an den Märkten, dem Handeln von einigen Shortsellern und negativen Analystenkommentaren hat der Wert wieder den Rückzug angetreten. Zunächst haben die Analysten der britischen Großbank HSBC für einen Dämpfer gesorgt. Sie halten die Begeisterung der Anleger über den Wirkstoffkandidaten MOR208 für übertrieben. Demzufolge haben sie die Einstufung für die Aktie von „Halten“ auf „Reduce“ zurückgenommen, das Kursziel allerdings von 59 auf 64 Euro erhöht. „Der Aktienkurs unterstellt, dass MOR208 zugelassen wird und Morphosys die Vermarktung in Europa und den USA ohne ein Partnerunternehmen übernimmt", schrieb die Expertin Julie Mead. Zwar seien die frühen Daten bislang ermutigend, doch der Weg bis zur Vermarktung sei noch weit, unterstrich Mead.

    Nun hat auch das Analysehaus RBC Capital mit einem negativen Kommentar nachgelegt. Analystin Zoe Karamanoli bewertet die Aktie von Morphosys mit „Underperform“ und sieht das Kursziel bei 57 Euro. Zwar seien die in der Entwicklung befindlichen Wirkstoffe des Biotech-Unternehmens langfristig werthaltig, doch seien wichtige Kurstreiber in diesem und im kommenden Jahr bereits im Aktienkurs eingepreist.

    DER AKTIONÄR kann den Pessimismus der Analysten allerdings nicht teilen. Sicherlich hängt der Kursverlauf derzeit stark an der Entwicklung des großen in Eigenregie entwickelten Hoffnungsträgers MOR208. Zuletzt hatte dieser hervorragende Daten geliefert und den Status Therapiedurchbruch (Breakthrough Therapy Designation) erhalten. Gelingt tatsächlich die Einreichung des Zulassungsantrags bereits im kommenden Jahr, wäre dies ein weiterer großer Schritt. Im Zulassungsfall würden Morphosys starke Einnahmen winken. Positiv außerdem: Die Geschäfte mit Tremfya, das im vergangenen Jahr für die erste Zulassung in der Firmengeschichte von Morphosys gesorgt hat, laufen besser als von vielen erwartet.

    Mit dem Bewusstsein, dass Biotech-Aktien grundsätzlich spekulative Investments sind, sieht DER AKTIONÄR auf dem aktuellen Niveau langfristig eine günstige Einstiegschance. Aus charttechnischer Sicht wichtig nach der jüngsten Korrektur: die Verteidigung der 200-Tage-Linie, die im Bereich von 70 Euro verläuft. Vorsichtige Anleger warten einen erfolgreichen Test ab.

  14. nelis h 20 februari 2018 07:59
    Tremfya(R) (Guselkumab) Data Demonstrated Long-Term Skin Clearance In Patients With Moderate-To-Severe Plaque Psoriasis

    February 20, 2018 / 7:30 am, CET

    Planegg/Munich, Germany, February 20, 2018

    MorphoSys Announces That Tremfya(R) (Guselkumab) Data Demonstrated Long-Term Skin Clearance In Patients With Moderate-To-Severe Plaque Psoriasis



    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its licensee Janssen Research & Development, LLC (Janssen) reported data from the Phase 3 VOYAGE 2 study of TREMFYA(R) (guselkumab), which demonstrated long-term skin clearance in patients with moderate to severe plaque psoriasis.

    TREMFYA(R) is a fully human anti-IL-23 monoclonal antibody developed by Janssen and was generated utilizing MorphoSys's proprietary HuCAL technology.

    The data were presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California on Saturday, February 17.

    According to a press release published by Janssen on February 16, 2018, 86% of patients with moderate to severe plaque psoriasis receiving TREMFYA(R) who achieved at least 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28, maintained a PASI 90 response with continuous treatment through week 72. Only 11.5 percent of patients who were withdrawn from treatment maintained PASI 90 response. Furthermore, according to Janssen, 87.6% of patients originally randomized to TREMFYA(R), but withdrawn from treatment at week 28, regained a PASI 90 response within six months of initiating TREMFYA(R) retreatment. Janssen reported further that no new safety signals were observed with continuous treatment or retreatment therapy with TREMFYA(R) through week 100.

    Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG, commented: "We are very pleased about the data presented by Janssen at the AAD 2018. The long-term efficacy and durability data demonstrated by TREMFYA(R) in Janssen's VOYAGE 2 study are encouraging. We expect this drug will continue to provide an important treatment option for patients living with moderate-to-severe plaque psoriasis."

    www.morphosys.com/media-investors/med...
  15. forum rang 4 harvester 21 februari 2018 11:44
    quote:

    nelis h schreef op 20 februari 2018 07:59:

    Tremfya(R) (Guselkumab) Data Demonstrated Long-Term Skin Clearance In Patients With Moderate-To-Severe Plaque Psoriasis

    February 20, 2018 / 7:30 am, CET

    Planegg/Munich, Germany, February 20, 2018

    MorphoSys Announces That Tremfya(R) (Guselkumab) Data Demonstrated Long-Term Skin Clearance In Patients With Moderate-To-Severe Plaque Psoriasis



    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its licensee Janssen Research & Development, LLC (Janssen) reported data from the Phase 3 VOYAGE 2 study of TREMFYA(R) (guselkumab), which demonstrated long-term skin clearance in patients with moderate to severe plaque psoriasis.

    TREMFYA(R) is a fully human anti-IL-23 monoclonal antibody developed by Janssen and was generated utilizing MorphoSys's proprietary HuCAL technology.

    The data were presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California on Saturday, February 17.

    According to a press release published by Janssen on February 16, 2018, 86% of patients with moderate to severe plaque psoriasis receiving TREMFYA(R) who achieved at least 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28, maintained a PASI 90 response with continuous treatment through week 72. Only 11.5 percent of patients who were withdrawn from treatment maintained PASI 90 response. Furthermore, according to Janssen, 87.6% of patients originally randomized to TREMFYA(R), but withdrawn from treatment at week 28, regained a PASI 90 response within six months of initiating TREMFYA(R) retreatment. Janssen reported further that no new safety signals were observed with continuous treatment or retreatment therapy with TREMFYA(R) through week 100.

    Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG, commented: "We are very pleased about the data presented by Janssen at the AAD 2018. The long-term efficacy and durability data demonstrated by TREMFYA(R) in Janssen's VOYAGE 2 study are encouraging. We expect this drug will continue to provide an important treatment option for patients living with moderate-to-severe plaque psoriasis."

    www.morphosys.com/media-investors/med...

    Gek dat hiervan (nog) geen fors positief effect op te zien is op de koers van Morphosys.
    Misschien wordt dat ander bij de cijferpresentatie in maart.

    Dan zal duidelijk worden hoeveel royalties Morphosys krijgt van J+J op dit product uit de verkopen die al hebben plaatsgevonden in het 3e en 4e kwartaal 2017.
    Niemand beseft kennelijk dat de markttoelating er al is voor de US, Europa en Canada. J+J heeft in haar kwartaalbericht al gewag gemaakt van de positieve invloed van Tremfya zonder cijfers te noemen. Als ik het mij goed herinner vond Tremfya sneller haar weg naar de patiënten dan verwacht.

  16. forum rang 6 de tuinman 27 februari 2018 12:59
    quote:

    harvester schreef op 21 februari 2018 11:44:

    [...]

    Gek dat hiervan (nog) geen fors positief effect op te zien is op de koers van Morphosys.
    Misschien wordt dat ander bij de cijferpresentatie in maart.

    Dan zal duidelijk worden hoeveel royalties Morphosys krijgt van J+J op dit product uit de verkopen die al hebben plaatsgevonden in het 3e en 4e kwartaal 2017.
    Niemand beseft kennelijk dat de markttoelating er al is voor de US, Europa en Canada. J+J heeft in haar kwartaalbericht al gewag gemaakt van de positieve invloed van Tremfya zonder cijfers te noemen. Als ik het mij goed herinner vond Tremfya sneller haar weg naar de patiënten dan verwacht.

    Koopkans gemist laag in de 70, blijkbaar verwachten beleggers veel van de jaarcijfers.
  18. nelis h 13 maart 2018 07:32
    MorphoSys Presents Results for Fiscal Year 2017

    March 13, 2018 / 7:00 am, CET

    Planegg/Munich, Germany, March 13, 2018


    MorphoSys Presents Results for Fiscal Year 2017


    Conference call and webcast (in English) at 2:00pm CET (1:00pm GMT/9:00am EDT)

    - Revenues 2017 up 34% to EUR 66.8 million (guidance EUR 63 to 66 million)

    - EBIT loss 2017 as expected at EUR -67.6 million (guidance EUR -66 to -71 million)

    - Proprietary R&D expenses 2017 up 26% to EUR 99.1 million (guidance EUR 96 to 100 million)

    - EUR 312 million cash at end of 2017

    - Market launch of Janssen's Tremfya(R) resulting in first product-based royalty revenue for MorphoSys of EUR 1.9 million in 2017

    - New L-MIND study data reported today with MOR208 plus lenalidomide in aggressive lymphoma (r/r DLBCL) consistent with earlier L-MIND data reported: overall response rate (ORR) of 49% with 29 out of 33 responses ongoing; complete remission (CR) rate of 31%; progression free survival (PFS) rate at 12 months of 50.4%

    - MorphoSys continues to have productive discussions with the FDA under the current breakthrough therapy designation on the path to market for MOR208, including the possibility of an expedited regulatory submission and approval for MOR208 based primarily on the L-MIND study

    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today reported results for the financial year 2017, as well as a financial and operational outlook for 2018.

    "The year 2017 was extremely positive for us, marked by events that highlight our maturing product pipeline. Tremfya(R), developed by our partner Janssen, received regulatory approval in the U.S., Europe, and Canada, and became the first marketed drug based on our technology," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "A major highlight was the Breakthrough Therapy Designation granted by the FDA for our lymphoma antibody MOR208. We are in productive discussions with the FDA regarding the path to regulatory submission and FDA review for MOR208. Overall, we have seen significant progress in our entire development portfolio during 2017, which closed the year at a record-high of 114 programs in R&D. The partnering deal for our cancer antibody MOR202 in China with I-Mab Biopharma and phase 1 results showing first signs of clinical activity in atopic dermatitis on our joint MOR106 antibody program with Galapagos were additional highlights."

    "In the event that MOR208 receives regulatory approval, we intend to pursue a commercialization strategy that focuses on maximizing its value," commented Jens Holstein, Chief Financial Officer of MorphoSys AG. "We expect a growing royalty stream from Tremfya(R), as well as the potential for other partnered products in the years to come. We intend to invest in the further development of our proprietary product candidates in order to continue to build value for shareholders."

  19. nelis h 13 maart 2018 07:33

    + MOR208:

    MorphoSys Reports Updated Data from L-MIND Study of MOR208 plus Lenalidomide in Aggressive Lymphoma (r/r DLBCL)

    March 13, 2018 / 7:15 am, CET

    Planegg/Munich, Germany, March 13, 2018


    MorphoSys Reports Updated Data from L-MIND Study of MOR208 plus Lenalidomide in Aggressive Lymphoma (r/r DLBCL)


    - New data from the ongoing L-MIND trial of MOR208 plus lenalidomide in relapsed/refractory DLBCL patients ineligible for high-dose chemotherapy and autologous stem cell transplantation confirm earlier data reported from this trial

    - 81 patients enrolled, 68 available for efficacy assessment at cut-off date

    - Preliminary median progression-free survival (PFS) not reached, preliminary PFS rate at 12 months of 50.4%

    - Overall response rate (ORR) of 49% with 29 out of 33 responses ongoing, complete response (CR) rate of 31%

    - Data show that MOR208 in combination with lenalidomide has been well tolerated in the study: no unexpected toxicities were observed for the treatment combination and no infusion-related reactions were reported for MOR208

    - MorphoSys continues to have productive discussions with the FDA under the current breakthrough therapy designation on the path to market for MOR208, including the possibility of an expedited regulatory submission and approval for MOR208 based primarily on the L-MIND study.


    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today reported updated data from the ongoing single-arm phase 2 clinical trial known as L-MIND. L-MIND is designed to investigate the antibody MOR208 plus lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). MOR208 is an investigational Fc-engineered monoclonal antibody directed against CD19 and is currently in clinical development in blood cancer indications.

    The L-MIND study enrolled patients with r/r DLBCL, who are ineligible for HDC and ASCT, after up to three prior lines of therapy, with at least one prior therapy including an anti-CD20 targeting therapy (such as rituximab). In November 2017, the trial completed patient enrollment with 81 patients. The updated interim data reported today (cut-off date December 12, 2017) included all 81 patients enrolled in the L-MIND trial, 68 of whom were available for efficacy assessment by the investigators at the time of data cut-off. Patients enrolled had a median age of 72 years and had received a median of two prior treatment lines.

    Data reported today, with a median observation time of 8.3 months, showed a response in 33 out of 68 patients (overall response rate (ORR) 49%) and a complete response (CR) in 31% of the patients. The preliminary progression-free survival (PFS) rate at 12 months was 50.4% (95% confidence interval 40 - 67%) and the preliminary median PFS had not been reached (95% confidence interval: 4.3 months-not reached). 29 out of 33 responses (88%) were ongoing at the time of data-cut off. Median time to response was 1.8 months, median time to complete response was 3.6 months.

    No unexpected toxicities were observed for the treatment combination and no infusion-related reactions (IRRs) were reported for MOR208. The most frequent adverse events with a toxicity grading of 3 or higher were neutropenia, thrombocytopenia, febrile neutropenia and pneumonia, observed in 36%, 12%, 7% and 7% of patients, respectively.

    The results reported today confirm and corroborate earlier interim data reported from this trial (Salles et al, ASH 2017), which had been based on 51 patients enrolled, 44 of whom had been eligible for investigators' efficacy assessment at the June 13, 2017 cut-off date.

    "We are truly excited about this data and our productive discussions with FDA under the current breakthrough therapy designation on the path to market for MOR208, including the possibility of an expedited regulatory submission and approval for MOR208 based primarily on the L-MIND study. We look forward to continuing the analysis of maturing data from the L-MIND trial and to maintaining our interactions with the FDA," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG.

    "There is a very high unmet medical need for patients with r/r DLBCL who, after having failed initial therapies, are ineligible for high-dose chemotherapy and autologous stem cell transplantation," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "We are very encouraged by our most recent clinical data from the ongoing L-MIND trial, which support our plan to develop MOR208 in combination with lenalidomide as a chemo-free treatment option for this patient population."
  20. forum rang 4 harvester 13 maart 2018 10:27
    March 13, 2018 / 7:00 am, CET MorphoSys Results for Fiscal Year 2017

    - Revenues 2017 up 34% to EUR 66.8 million (guidance EUR 63 to 66 million)

    - EBIT loss 2017 as expected at EUR -67.6 million (guidance EUR -66 to -71 million)

    - Proprietary R&D expenses 2017 up 26% to EUR 99.1 million (guidance EUR 96 to 100 million)

    - EUR 312 million cash at end of 2017

    - Market launch of Janssen's Tremfya(R) resulting in first product-based royalty revenue for MorphoSys of EUR 1.9 million in 2017

    - New L-MIND study data reported today with MOR208 plus lenalidomide in aggressive lymphoma (r/r DLBCL) consistent with earlier L-MIND data reported: overall response rate (ORR) of 49% with 29 out of 33 responses ongoing; complete remission (CR) rate of 31%; progression free survival (PFS) rate at 12 months of 50.4%

    - MorphoSys continues to have productive discussions with the FDA under the current breakthrough therapy designation on the path to market for MOR208, including the possibility of an expedited regulatory submission and approval for MOR208 based primarily on the L-MIND study

    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today reported results for the financial year 2017, as well as a financial and operational outlook for 2018.

    "The year 2017 was extremely positive for us, marked by events that highlight our maturing product pipeline. Tremfya(R), developed by our partner Janssen, received regulatory approval in the U.S., Europe, and Canada, and became the first marketed drug based on our technology," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "A major highlight was the Breakthrough Therapy Designation granted by the FDA for our lymphoma antibody MOR208. We are in productive discussions with the FDA regarding the path to regulatory submission and FDA review for MOR208. Overall, we have seen significant progress in our entire development portfolio during 2017, which closed the year at a record-high of 114 programs in R&D. The partnering deal for our cancer antibody MOR202 in China with I-Mab Biopharma and phase 1 results showing first signs of clinical activity in atopic dermatitis on our joint MOR106 antibody program with Galapagos were additional highlights."

    "In the event that MOR208 receives regulatory approval, we intend to pursue a commercialization strategy that focuses on maximizing its value," commented Jens Holstein, Chief Financial Officer of MorphoSys AG. "We expect a growing royalty stream from Tremfya(R), as well as the potential for other partnered products in the years to come. We intend to invest in the further development of our proprietary product candidates in order to continue to build value for shareholders."


    Financial Review for the Fiscal Year 2017 (IFRS)

    In 2017, MorphoSys continued to focus on applying its proprietary technology and expertise to the research and development of innovative drug candidates, both for partners and for its own account.Group revenues for 2017 increased 34% to EUR 66.8 million (2016: EUR 49.7 million) and were thus slightly above the updated guidance from November 2017 (EUR 63-66 million). Revenues include royalties on net sales of Tremfya(R) amounting to EUR 1.9 million for Q3 and Q4 of 2017. Following FDA approval in mid July 2017, Tremfya(R) was launched in the U.S. in Q3 2017. Approval was granted in Europe and Canada in November 2017, followed by launches in the respective territories. Due to currency effects, the Tremfya(R) royalty revenue was lowered by EUR 0.2 million.

    At year-end 2017, the Company had a cash position of EUR 312.2 million compared to EUR 359.5 million on December 31, 2016. On the balance sheet, this cash position is reported under the items: cash and cash equivalents; available-for-sale financial assets; bonds, available-for-sale; and current and non-current financial assets classified as loans & receivables. The number of shares issued totaled 29,420,785 at year-end 2017 (year-end 2016: 29,159,770).


    Financial Guidance and operational outlook for 2018

    For the financial year 2018, MorphoSys intends to significantly increase its expenditures with the goal of driving MOR208 to market and preparing the Company for its commercialization. As the Company continues to transition towards an income statement that depends on products rather than services, in 2018 it expects to generate Group revenues in the range of EUR 20 to 25 million. Revenues are expected to include royalty income from Tremfya(R) ranging from EUR 12 to 17 million at constant exchange rate for the US dollar. Expenses for proprietary R&D are anticipated in a corridor of EUR 95 to 105 million. The Company expects earnings before interest and taxes (EBIT) of EUR -110 to -120 million. This guidance does not include revenues from potential future partnerships or licensing agreements or milestone payments for MOR103 or MOR202 that could occur in the course of 2018. Effects from potential in-licensing or co-development deals for new development candidates are also not included in the guidance.

    "In 2018, our main focus will be on MOR208. We plan to continue the analysis of maturing data from the L-MIND study and to continue the ongoing discussion with the FDA regarding a potential expedited regulatory submission. Building commercial capabilities for MOR208, preferably in the U.S., is also a key part of our activities in 2018. At this stage we are working under the assumption that we will need to be ready to commercialize MOR208 starting in the first half of 2020," said Dr. Simon Moroney. "For MOR202, currently in development to treat multiple myeloma, pre-clinical findings with other CD38 antibodies in solid cancers suggest potential for this program in these cancers, and we therefore intend to start clinical development with MOR202 in non-small-cell lung cancer (NSCLC) in 2018. Following the latest phase 1 data presented at the AAD 2018 conference in February, we plan to start a phase 2 study of MOR106 in patients with atopic dermatitis together with our partner Galapagos in the second quarter of 2018."

    In its Proprietary Development segment, MorphoSys expects the following events and activities in 2018:
    (ingekort)

    - MOR106: Initiate a phase 2 trial in atopic dermatitis together with Galapagos.

    MorphoSys will hold its conference call and webcast today to present the annual financial results 2017 and the outlook 2018.

    Dial-in number for the analyst conference call (in English) at 2:00 pm CET; 1:00 pm GMT; 9:00 am EDT (listen-only):
    Germany: +49 (0) 69 201 744 210

    Participant PIN: 12211431#
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