Q&A Genmab 2019-08-20
Aktiesnakken
Bavarian Nordic
Ennogie
TESLA
Genmab
Shipping
Biotek-snakken
NOVO
AMBU
Grønne Aktier
OLIE OG GAS
Smallcap og First North aktier
Amerikanske aktier
Hansa Biopharma
Pharma
Vestas
Medico
EL-BILER
ExpreS2ion
Laks
Zealand Pharma
GN Store Nord
Gubra
Banker og Finans
Chemometec
Embla Medical
Krypto
20/8 15:45 af Jan Van de Winkel |
We continue to be highly excited about the therapeutic profile of DuoBody CD3xCD20 and very much look forward to sharing data from the first clinical study in this year.
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20/8 15:44 af Sukkeralf |
It seems like your confidence in the CD20/CD3 BsAb is growing - could we conclude the same about the way you silenced this BsAb or is it to early to say anything about that?
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20/8 15:44 af Jan Van de Winkel |
The mointoring for a few hours is only applicable to the first injection of SC Dara, unless the patient has an IRR during the first injection.
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20/8 15:43 af Bulder |
How long time is to be expected for post-monitoring after sc dara injection? Will it be all injections or only the first?
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20/8 15:43 af Jan Van de Winkel |
The GMXAY was transfered into the new GMAB ADS's. The old ADRs are incremental to the newly listed ADS's.
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20/8 15:41 af Helge Larsen/PI-redaktør |
Bikube: With the establishment of ADS GMAB, ADR GMXAY disappeared from the list. Have they entered as part of the 28.5 million or have they been added so that there are actually over 28.5 million ADS. OTCMKTS:GNMSF still exists. Why is it so?
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20/8 15:41 af Jan Van de Winkel |
Since the US listing the daily volume of GMAB equity trading has nearly doubled.
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20/8 15:40 af Jan Van de Winkel |
It is uncertain at this stage how the balance between ADS's and shares will develop over the coming period. What we can already see, is there is strong support from US shareholders reflected in increased trading of ADS's over the last month...
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20/8 15:39 af Solsen |
Mr Eatwell. Is the portion of adrs and danish shares stabil or could we se more adrs in the future and less danish shares if US investors are interested in more GMAB
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20/8 15:39 af Jan Van de Winkel |
We believe major shareholder statements refer to listed shares.
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20/8 15:37 af peter12 |
The major shareholder statement from Blackrock, mention financial instruments as a part of the holdings. Does shorted shares count here ?
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20/8 15:37 af Jan Van de Winkel |
Directors, executives and senior management are falling under this lockup agreement - standard practice for listings.
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20/8 15:36 af peter12 |
There is a lockup period in the new IPO of 180 days. Does it make sense in this IPO and in case it does, who are restricted ?
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20/8 15:36 af Jan Van de Winkel |
FX gain in the first 6 months was about 90 mio kroner on the Darzalex royalties. We increased the guidance for the full year by 200 mio kr.
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20/8 15:35 af SP-1 |
For the Q&A perhaps a short economic question. Is the renewed guidance for 2019 bases on the already realized exchange gain until now (where we are sure about the dollar value) or is this also estimated for the possible value of the dollar for the upcoming months?
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20/8 15:34 af Jan Van de Winkel |
No further price adjustments anticipated at this stage in 2019.
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20/8 15:33 af Helge Larsen/PI-redaktør |
Bikube : At Q3 in -2017 and -2018 a discount was deducted in ROW, is that something we can expect again at Q3 this year, after getting an extra 16% at Q2?
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20/8 15:33 af Jan Van de Winkel |
Other:
Registration statement filed w/ SEC for proposed public offering of ADSs in U.S. (May). Process completed in July with total new shares issued of 3,277,500 with gross proceeds of $582M (3,873M DKK) and underwriting commissions paid of $32M (213M DKK).
Agreement signed with Janssen for next-gen. CD38 antibody, HexaBody-CD38 (June).
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20/8 15:32 af Jan Van de Winkel |
Partnered programs:
Teprotumumab topline Ph III data reported by Horizon. (Feb.) BLA submission occurred Q3 (July). In partnership w/ U.S. FDA, Horizon developed expanded access program to make teprotumumab available for people with active TED who meet protocol criteria. Program will be available for limited time while the U.S. FDA reviews the BLA…
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20/8 15:32 af Jan Van de Winkel |
Proprietary Pipeline:
TV FPD Ph I/II innovaTV 205 study in comb with bevacizumab, pembrolizumab or carboplatin for recurrent cervical cancer (Feb.)
TV FPD Ph I/II innovaTV 206 study in Japan in cervical cancer (March)
TV patient enrollment completed Ph II innovaTV 204 study in recurrent and/or metastatic cervical cancer (April)
CTA filed for DuoBody-CD40x4-1BB (March)
CTA filed for DuoBody-PD-L1x4-1BB (Jan.)
FPD in DuoBody-PD-L1x4-1BB Ph I/II in solid tumors (May)…
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20/8 15:32 af Jan Van de Winkel |
MAIA (March)
New Ph III D+ R as maintenance for NDMM (April); FPD in June.
Priority Review from U.S. FDA for sBLA based on CASSIOPEIA, Sept 26, 2019 PDUFA data (May)
Approval in U.S. based on MAIA for D+Rd in NDMM, ineligible for ASCT (June)
Data from Ph II GRIFFIN (D+VRd in NDMM eligible for high-dose chemo & ASCT meets primary endpoint of sCR (July)
Submission of BLA in U.S. for SC formulation of dara (July)
Submission of label expansion in EU for SC formulation of dara (July)...
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20/8 15:31 af Jan Van de Winkel |
Daratumumab:
Continued strong DARZALEX sales uptake
MorphoSys patent case ended (Jan.)
US approval split dose regimen (Feb.)
Positive topline Phase III COLUMBA data SC vs IV – met primary endpoints (Feb.)
US & EU regulatory submissions based on CASSIOPEIA (March)
US & EU regulatory submissions based on MAIA (March)
New Ph III D+ R as maintenance for NDMM (April); FPD in June.
Priority Review from U.S. FDA for sBLA based on CASSIOPEIA, Sept 26, 2019 PDUFA data (May)
Approval in U.S. based on MA
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20/8 15:31 af Jan Van de Winkel |
Key H1 achievements:…
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20/8 15:30 af Jan Van de Winkel |
DARZALEX H1 net sales were USD 1,403 million vs USD 943 million in H1 18, driven by the continued strong uptake in the US, EU and Japan – resulting in royalties of DKK 1,169M – we firmly expect to reach net sales USD 3 billion in 2019…
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20/8 15:30 af Jan Van de Winkel |
We are updating our 2019 financial guidance, from what was initially published on Feb. 20, due to increased royalty income related to the sales of DARZALEX (positive impact of USD/DKK exchange rates movements) and increased operating expenses as a result of the advancement of our product pipeline…
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20/8 15:30 af Jan Van de Winkel |
During Q2, we experienced solid business progress as we continue to invest in achieving our 2025 vision and accelerating our world-class product pipeline…
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20/8 15:30 af Jan Van de Winkel |
Financial highlights from H1:
We are pleased to be well on track with the company’s financial results for the first half of 2019 and with the excellent progress with DARZALEX and our proprietary pipeline…
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20/8 15:29 af Helge Larsen/PI-redaktør |
Q2 was very eventfull. Can you give us a short-term update on key figures and important events.
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20/8 15:29 af Helge Larsen/PI-redaktør |
Jan van de Winkel, David Eatwell, Andrew Carlsen and Marisol
- Welcome to Q&A here on ProInvestor.com. We are very happy to have you here and ready to answer questions from our investors.
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20/8 15:28 af Jan Van de Winkel |
Fire away.
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20/8 15:28 af Jan Van de Winkel |
I am here with David, Andrew and Marisol...
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20/8 15:28 af Helge Larsen/PI-redaktør |
Jan, David and Andrew. Are you online?
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20/8 15:28 af Jan Van de Winkel |
Hello, we are ready to go...
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20/8 12:55 af Helge Larsen/PI-redaktør |
Denne session vil starte kl. 16,30.
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