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Argenx stoomt richting eerste medicijn op de markt

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abelheira schreef op 24 oktober 2022 18:40:

[...]
Ik verwacht een verdere versnelling van de verkopen van vyvgart : gokje : 150 miljoen € voor het derde kwartaal.
Vraag me af wat de consensus is van de analisten, de vorige keer had men een prognose. die kan ik nu niet vinden.
Polylepis
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Ja klopt, vorige keer waren het analisten van Evercore ISI die 50 specialisten hadden aangeschreven. Toevallig gisteren nog naar gezocht. Maar nu geen prognose kunnen vinden. Wel dat ze 5 dagen geleden de price target hebben verhoogd voor argenx. Laten we hopen op mooi nieuws voor morgen.
DeZwarteRidder
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Financial Results and Provides Business Update
News
October 27, 2022

Amsterdam, the Netherlands

$131 million in third quarter VYVGART® (efgartigimod alfa-fcab) global net product sales
Filed Biologics License Application (BLA) for subcutaneous (SC) efgartigimod for treatment of generalized myasthenia gravis (gMG)
Hans de Haard, Ph.D. to retire as Chief Scientific Officer (CSO) in January 2023
Management to host conference call today at 2:30 pm CET (8:30 am ET)

Downloads
Press Release: argenx Reports Third Quarter 2022 Financial Results and Provides Business Update

argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its third quarter 2022 financial results and provided a business update and outlook for the remainder of the year.

“We had a strong third quarter of our global VYVGART launch now underway in our priority territories of the U.S., Japan and the EU. I am proud of what our teams have achieved, working cross-functionally to set a new treatment standard in gMG and serve as many patients as possible. Looking ahead, we are ready to support a SC efgartigimod launch in the first half of 2023 so that gMG patients can have multiple ways to individualize their treatment,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “gMG is also just the beginning and we are committed to advancing our immunology pipeline of efgartigimod, ARGX-117 and ARGX-119 with eight ongoing clinical trials in severe autoimmune diseases and more to start by the end of the year. We believe we are well on our way to realizing our goal of becoming a leading, multi-product immunology company and that we have the right team, a differentiated pipeline, and a sustainable discovery engine to continue innovating on behalf of patients.”

THIRD QUARTER 2022 AND RECENT BUSINESS UPDATE

VYVGART Launch

VYVGART is the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and the European Union (EU). VYVGART is approved in the United States (U.S.) and the EU for the treatment of adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for adult gMG patients who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).

Generated global net VYVGART revenues of $131 million in the third quarter of 2022
Received European Commission (EC) approval on August 11, 2022; commercial launch in Germany initiated on September 1, 2022
Approval decisions expected in 2023 in Canada, China through Zai Lab, and Israel through Medison
Expanded large-scale manufacturing capabilities and capacity through collaboration with FUJIFILM Diosynth Biotechnologies to provide drug substance manufacturing of efgartigimod

Efgartigimod Research and Development

argenx is positioned to expand its leadership position in FcRn blockade to include ten total autoimmune indications in the pipeline by the end of 2022

Neuromuscular franchise
Submitted BLA to the U.S. Food and Drug Administration (FDA) for SC efgartigimod for gMG; approval decision and commercial launch expected in first half of 2023
Topline data from registrational ADHERE trial of SC efgartigimod for chronic inflammatory demyelinating polyneuropathy (CIDP) on track for first quarter of 2023
Registrational ALKIVIA trial ongoing of SC efgartigimod for three subtypes of idiopathic inflammatory myopathies (myositis), including immune-mediated necrotizing myopathy, anti-synthetase syndrome and dermatomyositis; interim analysis planned of first 30 patients of each subtype
DeZwarteRidder
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DETAILS OF THE FINANCIAL RESULTS

Total operating income for the third quarter and year-to-date in 2022 was $146.5 million and $263.2 million, respectively, compared to $7.1 million and $505.7 million for the same periods in 2021, and consists of:

Product net sales from the sales of VYVGART for the three months ended September 30, 2022 were $131.3 million. The product net sales in the nine months ended September 30, 2022 were $227.3 million. No product net sales were recognized during the same period in 2021.
Collaboration revenue for the third quarter and year-to-date in 2022 was $6.7 million and $9.3 million, respectively, compared to $0.1 million and $471.3 million for the same periods in 2021. The collaboration revenue during the three months ended September 30, 2022 primarily relates to milestone revenue of the €5 million triggered by the option exercised by LEO Pharma to enter into a commercial license for ARGX-112. The collaboration revenue for the three and nine months ended September 30, 2021 was primarily attributable to the recognition of the transaction price as a consequence of the termination of the collaboration agreement with Janssen, resulting in the recognition of $315.1 million and the closing of the strategic collaboration for efgartigimod with Zai Lab, resulting in the recognition of $151.9 million in collaboration revenue.
Other operating income for the third quarter and year-to-date in 2022 was $8.5 million, and $26.6 million, respectively, compared to $6.2 million and $34.5 million for the same periods in 2021. During the nine months ended September 30, 2022, and September 30, 2021, the fair value of the argenx profit share in AgomAb Therapeutics NV increased by $4.3 million and $11.2 million respectively. The increase is a result of the extension of a Series B financing round by AgomAb for which argenx maintains a profit share in exchange for granting the license for the use of HGF-mimetic antibodies from the SIMPLE Antibody™ platform.

Total operating expenses for the third quarter and year-to-date in 2022 were $355.1 million and $869.1 million, respectively, compared to $220.1 million and $623.6 million for the same periods in 2021, and consists of:

Cost of sales for the third quarter and year-to-date in 2022 was $10.3 million and $16.6 million, respectively. The cost of sales were recognized with respect to the sale of VYVGART during 2022. There were no cost of sales recognized in the comparable prior year periods.
Research and development expenses for the third quarter and year-to-date in 2022 were $236.7 million and $515.6 million, respectively, compared to $139.4 million and $413.3 million for the same periods in 2021. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of other clinical and preclinical pipeline candidates. The increase in research and development expense during the third quarter 2022 is mainly driven by the recognition of the priority review voucher submitted with the BLA filing for SC efgartigimod for the treatment of gMG, which resulted in an expense of $99.1 million.
Selling, general and administrative expenses for the third quarter and year-to-date in 2022 were $108.2 million and $336.8 million, respectively, compared to $80.6 million and $210.2 million for the same periods in 2021. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART in the U.S., Japan and the EU and personnel expenses.

Exchange losses for the third quarter and year-to-date in 2022 were $39.6 million and $93.0 million, respectively, compared to $17.6 million and $36.0 million for the same periods in 2021. Exchange losses are mainly attributable to unrealized exchange rate losses on cash, cash equivalents and current financial assets position in Euro.

Income tax for the third quarter and year-to-date in 2022 was $6.0 million and $17.1 of tax income, respectively, compared to $2.7 million and $15.6 million of tax expense for the same periods in 2021. Tax income for the three months ended September 30, 2022 consists of $7.3 million of income tax expense and $13.3 million of deferred tax income, compared to $4.3 million of income tax expense and $1.6 million of deferred tax income for the same period in 2021.

Net loss for the third quarter and year-to-date in 2022 was $235.0 million and $671.0 million, respectively, compared to net loss of $233.6 million and $170.4 million for the same periods in 2021.
DeZwarteRidder
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Cash, cash equivalents and current financial assets totaled $2,385.5 million as of September 30, 2022, compared to $2,336.7 million as of December 31, 2021. Cash and cash equivalents and current financial assets increased primarily as a result of the closing of a global offering of shares, which resulted in the receipt of $761.0 million in net proceeds in March 2022, offset by net cash flows used in operating activities.

FINANCIAL GUIDANCE

Based on current plans to fund anticipated operating expenses and capital expenditures, argenx continues to expect its 2022 cash burn to be up to $1 billion.

This will support the global VYVGART launches, clinical development of efgartigimod in 10 indications and ARGX-117 in two indications, investment in the global supply chain, and continued focus on pipeline expansion through the Immunology Innovation Program.

EXPECTED 2023 FINANCIAL CALENDAR

March 2, 2023: FY 2022 financial results and business update
May 4, 2023: Q1 2023 financial results and business update
July 27, 2023: HY 2023 financial results and business update
October 27, 2023: Q3 2023 financial results and business update
de tuinman
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"FUJIFILM Diosynth Biotechnologies sluit een overeenkomst met Argenx voor de productie van Efgartigimod, een monoklonaal antilichaam (mAb) voor de behandeling van ernstige auto-immuunziekten - Benzinga" www.benzinga.com/amp/content/29429463
Lang
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de tuinman schreef op 27 oktober 2022 12:07:

Niemand??? ATH!!
haha...uiteraard....alleen zit ik te denken, wat moet ik nu doen....wel een luxe probleem
Lang
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de tuinman schreef op 27 oktober 2022 12:07:

Niemand??? ATH!!
ATH was ff snel weg om 1530 uur
de tuinman
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quote:

Lang schreef op 27 oktober 2022 15:37:

[...]
ATH was ff snel weg om 1530 uur
Jemig, wat een uitschieters. :(
Omegaplan
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Komt weer terug. Er moeten nog wat boefjes een graantje meepikken. Trap er niet in. Even naar beneden trappen: stofzuiger aan, en die mooi in de pocket.
Antokri
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Idd winstnemingen van de grote mannen....
Paniek zaaien om ons klein beetje aandelen ook te kunnen kopen.
Lang
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Antokri schreef op 27 oktober 2022 17:20:

Idd winstnemingen van de grote mannen....
Paniek zaaien om ons klein beetje aandelen ook te kunnen kopen.

Van de hoogste naar de laagste koers vandaag kost me een Tesla, nouja, ik vind het toch geen fijne auto :)
Tuut
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Pokerface
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quote:

Lang schreef op 27 oktober 2022 18:13:

[...]
Van de hoogste naar de laagste koers vandaag kost me een Tesla, nouja, ik vind het toch geen fijne auto :)
Dus je hebt iets van 1200 aandelen?
Lang
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Pokerface schreef op 27 oktober 2022 21:02:

[...]

Dus je hebt iets van 1200 aandelen?
Dat klopt ongeveer ja, maar heb ze redelijk goedkoop gekocht. Heb ze al jaren, gekocht na de overname van Ablynx. En tot de dag van vandaag zit ik weer op een overname te wachten.
Tuut
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Mooi terug gezet vandaag vanochtend getwijfeld om bij te kopen. Nog steeds niet achter gekomen waarom die dump was gisteren
simidoc
1
quote:

Tuut schreef op 28 oktober 2022 19:51:

Mooi terug gezet vandaag vanochtend getwijfeld om bij te kopen. Nog steeds niet achter gekomen waarom die dump was gisteren
Het Argenx-management temperde op de analistencall na de publicatie van de kwartaalcijfers de verwachtingen voor de rest van het jaar. Die boodschap zette een verkoopgolf in gang.

Na de publicatie van overtuigende kwartaalcijfers ging Argenx ARGX7,37%
hoger, om even later plots een duik van zo'n 10 procent te maken. Aan de basis van die verkoopgolf lagen waarschijnlijk enkele uitspraken van het management in de telefonische conferentie met analisten, vanaf 14.30 uur (zie grafiek).

Het bedrijf zei dat de verkoop van het stergeneesmiddel Vyvgart voor de behandeling van de spierziekte myasthenia gravis erg afhangt van de promotie-inspanningen van het verkoopteam. Die verkopers moeten het geneesmiddel op de lucratieve maar complexe Amerikaanse markt op de kaart zetten.

De verkoop loopt tot nu erg goed, maar tijdens de klassieke eindejaarsperiode in de Verenigde Staten - van Thanksgiving eind november tot Kerstmis - zijn ook de verkoopteams minder actief. Dat leidt mogelijk tot een seizoensgebonden tijdelijk zwakkere verkoop in het vierde kwartaal van dit jaar.

'Die boodschap deed beleggers schrikken', stelt analiste Emily Field van het beurshuis Barclays in een update. Bovendien tikte het aandeel gisteren de psychologisch belangrijke grens van 400 euro aan, waardoor waarschijnlijk heel wat beleggers besloten wat winst van tafel te nemen, gezien de sterke prestatie van het aandeel in 2022 vergeleken met de rest van de sector. Argenx noteert 20 procent hoger dan begin dit jaar, tegenover een verlies van ruim 11 procent voor de Europese gezondheidssector.
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