Argenx,. MAIN EVENTS IN THE SIX MONTHS OF 2022.

Alleen voor leden beschikbaar, wordt daarom gratis lid!

Algemeen advies 28/07/2022 11:08
FIRST QUARTER OF 2022
We refer to our Q1 2022 press release.
SECOND QUARTER OF 2022 AND RECENT BUSINESS UPDATE
“We had a strong second quarter of our global VYVGART launch reflecting the significant need for effective, safe treatment
options for people living with generalized myasthenia gravis and the unwavering commitment of our team to deliver our
innovation to patients around the world. We are still in the early stages of our first commercial launch, but are encouraged by
the initial clinical interest in our first-in-class FcRn blocker and the feedback we are hearing from patients and their supporters,”
said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “Based on our two positive Phase 3 data readouts already in
2022 and our plan to be active in 12 autoimmune indications by the end of the year across both efgartigimod and ARGX-117,
we are confident that we are only at the beginning of our quest to transform the treatment of autoimmune disease.”
VYVGART Launch Progress
VYVGART is the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S. and Japan. VYVGART is approved in
the U.S. for the treatment of adult generalized myasthenia gravis (gMG) patients who are anti-acetylcholine receptor (AChR)
antibody positive and in Japan for adult gMG patients. The global launch strategy is on track to make VYVGART available in
Europe, China and Canada, as well as select additional regions.
- Generated global net product revenues of $75 million for second quarter of VYVGART commercial launch in U.S. and
Japan
- European Commission (EC) approval expected in third quarter 2022 following positive recommendation from Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
- Zai Lab and Medison filed for approval in China and Israel, respectively
- Entered into VYVGART commercial and distribution agreement with Medison in Central and Eastern Europe
Efgartigimod Research and Development
argenx is positioned to expand its leadership position in FcRn blockade to include ten total autoimmune indications by the end of
2022, including registrational trials in six indications and proof-of-concept trials in four indications across multiple therapeutic
franchises.
- Neuromuscular franchise
o BLA for SC efgartigimod for gMG on track to be filed by end of 2022
o Topline data from registrational ADHERE trial of SC efgartigimod for chronic inflammatory demyelinating
polyneuropathy (CIDP) expected in first quarter of 2023
o Registrational ALKIVIA trial of SC efgartigimod on track to start in third quarter of 2022 for three subtypes of
idiopathic inflammatory myopathies (myositis), including immune-mediated necrotizing myopathy, antisynthetase syndrome and dermatomyositis; interim analysis planned of first 30 patients of each subtype
- Hematology franchise
o Enrollment expanded in second registrational ADVANCE-SC trial of SC efgartigimod for primary immune thrombocytopenia (ITP) based on key learnings from positive ADVANCE-IV trial; topline data now expected
in second half of 2023
- Dermatology franchise

o Topline data from registrational ADDRESS trial of SC efgartigimod for pemphigus vulgaris and foliaceus
expected in second half of 2023
o Registrational BALLAD trial ongoing of SC efgartigimod for bullous pemphigoid with interim analysis planned
of first 40 patients
- Proof-of-concept trials to launch in 2022 in collaboration with Zai Lab and IQVIA
o Zai Lab to launch Phase 2 trials in lupus nephritis and membranous nephropathy with argenx to lead global
registrational programs for each potential indication
o IQVIA to launch Phase 2 trials in primary Sjogren’s syndrome and COVID-19-mediated postural orthostatic
tachycardia syndrome (POTS)
Pipeline Progress
argenx is developing ARGX-117 and ARGX-119, which both have pipeline-in-a-product potential for multiple autoimmune
indications.
- ARGX-117 (C2 inhibitor)
o Proof-of-concept ARDA trial ongoing to evaluate safety, tolerability, and potential dosing regimen in multifocal
motor neuropathy (MMN)
o Phase 2 proof-of-concept trial expected to start in 2022 for prevention of delayed graft function and/or allograft
failure after kidney transplantation
- ARGX-119 (muscle-specific kinase (MuSK) agonist)
o Phase 1 dose-escalation trial in healthy volunteers expected to start after Clinical Trial Application filing in
fourth quarter of 2022 with subsequent Phase 1b trial to assess early signal detection in patients
Creation of OncoVerity
argenx, the University of Colorado Anschutz Medical Campus and UCHealth created an asset-centric spin-off, OncoVerity, Inc.,
focused on optimizing and advancing the development of cusatuzumab, a novel anti-CD70 antibody, in acute myeloid leukemia
(AML). OncoVerity will be an entity of co-creation, combining the extensive translational biology insights from Dr. Clayton
Smith, M.D. from the University of Colorado with the experience from argenx on the CD70/CD27 pathway. OncoVerity is the
fourth spin-off company from argenx’s Immunology Innovation Program.
Nomination of Camilla Sylvest as non-executive director to Board of Directors
Ms. Sylvest’s appointment is pending approval, which is expected to occur at an extraordinary general meeting of shareholders
to be held in September 2022. She is the Executive Vice President of Commercial Strategy and Corporate Affairs at Novo
Nordisk, where she has worked for 26 years.
2. FINANCIAL HIGHLIGHTS
Total operating income year-to-date in 2022 was $116.7 million, compared to $498.6 million for the same period in 2021, and
consists of:
? Product net sales from the sales of VYVGART for the six months ended June 30, 2022 was $96 million, following the
approval of VYVGART by the U.S. Food and Drug Administration (FDA) on December 17, 2021 and Pharmaceuticals
and Medical Devices Agency (PMDA) in Japan on January 20, 2022. No product net sales were recognized during the
same period in 2021.
? Collaboration revenue year-to-date in 2022 was $2.6 million, compared to $470.4 million for the same period in 2021.
The collaboration revenue for the six months ended June 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 in collaboration revenue and closing of the strategic collaboration for efgartigimod with
Zai Lab, resulting in the recognition of $151.9 million in collaboration revenue.

? Other operating income year-to-date in 2022 was $18.1 million, compared to $28.2 million for the same period in 2021.
During the three months ended June 30, 2022, the fair value of the argenx profit share in AgomAb Therapeutics NV
increased by $4.3 million. The increase is a result of the extension of a Series B financing round by AgomAb for which
the Company 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 year-to-date in 2022 were and $513.9 million, compared to $403.5 million for the same period in 2021,
and consists of:
? Cost of sales year-to-date in 2022 was $6.4 million. The cost of sales were recognized with respect to the sale of
VYVGART during the first half of 2022. There were no cost of sales recognized in the comparable prior year periods.
? Research and development expenses year-to-date in 2022 were $278.9 million, compared to $273.9 million for the same
period 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 our
other clinical and preclinical pipeline candidates.
? Selling, general and administrative expenses year-to-date in 2022 were $228.7 million, compared to $129.6 million for
the same period 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. and Japan and personnel expenses.
Exchange losses year-to-date in 2022 were $53.4 million, compared to $18.4 million for the same period in 2021. Exchange losses
are mainly attributable to unrealized exchange rate losses on our cash, cash equivalents and current financial assets position in
Euro.
Income tax year-to-date in 2022 was $11.1 of tax income, compared to $12.8 million of tax expense for the same period in 2021.
Tax income for the six months ended June 30, 2022 consists of $7.8 million of income tax expense and $18.9 million of deferred
tax income, compared to $9.3 million of income tax expense and $3.5 million of deferred tax expense for the same period in 2021.
Net loss year-to-date in 2022 was $435.9 million, compared to net profit of $63.2 million for the same periods in 2021.
Cash, cash equivalents and current financial assets totaled $2,597.4 million as of June 30, 2022, compared to $2,336.7 million
as of December 31, 2021. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing
of a global offering of shares, including a U.S. offering and a European private placement, which resulted in the receipt of $761.0
million in net proceeds in March 2022, partially offset by net cash flows used in operating activities.
3. 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.
4. RISK FACTORS
We refer to the description of risk factors in the 2021 annual report, pp. 98-141 as supplemented by the description of risk
factors in our annual report on Form 20-F filed with the U.S. Securities and Exchange Commission, pp. 2-48. In summary,
the principal risks and uncertainties faced by us relate to: our financial position and need for additional capital, development
and clinical testing of our product candidates, commercialization of our product candidates, our business and industry, our
dependence on third parties, intellectual property, our organization and operations, and the ADSs.

We also refer to the description of our financial risk management given in the 2021 annual report, pp. 287-290, which
remains valid.
5. EXTERNAL IMPACTS
Impact of COVID-19 on our business
The current unprecedented challenges as a result of the COVID-19 outbreak have impacted how we operate. We have been
taking, and continue to take, the necessary steps in terms of safety, risk mitigation, and financial measures to best manage
through these challenging times. We have currently experienced limited impact on our financial performance and financial
position, although we continue to face additional risks and challenges associated with the impact of the outbreak.
Impacts of Global economic uncertainty on our business
Global conflicts, including the conflict between Russia and Ukraine, as well as economic sanctions implemented by the
U.S., the European Union and other countries against Russia in response thereto, may negatively impact markets, increase
energy and transportation costs and cause weaker macro-economic conditions. Political developments impacting
government spending and international trade may also negatively impact markets and cause weaker macro-economic
conditions. As a result, enrollment expanded in our registrational ADDRESS trial of SC efgartigimod for pemphigus
vulgaris and foliaceus in order to manage ongoing impact of war in Ukraine, topline data is now expected in second half of
2023. We have currently experienced limited impact on our financial position, although we continue to face additional risks
and challenges associated with the impact of the conflict.
6. FORWARD-LOOKING STATEMENTS
The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.”
These forward-looking statements can be identified by the use of forward-looking terminology, including the terms
“believes,” “hope,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements
argenx makes regarding the VYVGART launch strategy to make VYVGART available in Europe, China, Canada and select
other regions, the expected European Commission (EC) approval in the third quarter of 2022, Zai Lab and Medison’s
respective pending approvals in China and Israel; its position to expand its leadership position in FcRn blockade to include
ten autoimmune indications by the end of 2022; its expectations about its pipeline progress; its collaboration with the
University of Colorado Anschutz Medical Campus and UCHealth to create OncoVerity, Inc.; the therapeutic potential of its
product candidates; the intended results of its strategy and its collaboration partners’, advancement of, and anticipated
clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and
expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory
approvals; its expectation that its 2022 cash burn will be up to $1 billion and the 2022 business and financial outlook and
related plans. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any
such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially
from those predicted by the forward-looking statements as a result of various important factors, including the effects of the
COVID-19 pandemic, inflation and deflation and the corresponding fluctuations in interest rate; regional instability and
conflicts, such as the conflict between Russia and Ukraine, argenx’s expectations regarding the inherent uncertainties
associated with competitive developments, preclinical and clinical trial and product development activities and regulatory
approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of
argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies
and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to
complete the development and commercialization of its product candidates. A further list and description of these risks,
uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports,
including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports
filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such
forward-looking statements. These forward-looking statements speak only as of the date of publication of this document.
argenx undertakes no obligation to publicly update or revise the information in this press release, including any forwardlooking statements, except as may be required by law.

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
ARGENX SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL POSITION
As of
June 30, December 31,
(in thousands of $) Note 2022 2021
ASSETS
Non?current assets
Property, plant and equipment 14,244 15,844
Intangible assets 171,294 171,684
Deferred tax asset 54,267 32,191
Other non-current assets 7 43,100 54,876
Research and development incentive receivables 37,041 32,707
Total non?current assets $ 319,946 $ 307,303
Current assets
Cash and cash equivalents 4, 15 $ 1,367,288 $ 1,334,676
Financial assets 5, 15 1,230,105 1,002,052
Research and development incentive receivables 1,537 —
Trade and other receivables 112,392 38,221
Prepaid expenses 82,310 58,946
Inventories 6 135,711 109,076
Total current assets $ 2,929,343 $ 2,542,971

TOTAL ASSETS $ 3,249,289 $ 2,850,274
The notes are an integral part of these unaudited condensed consolidated interim financial statements

see & read more on
https://www.argenx.com/sites/default/files/media-documents/HY_IAS_34_Report_2022.pdf

tijd 11.13
de Bel 20 3.769.01 +16.97 +0.45% Argenx EUR 378,00 +19,80 vol. 41.000



Beperkte weergave !
Leden hebben toegang tot meer informatie! Omdat u nog geen lid bent of niet staat ingelogd, ziet u nu een beperktere pagina. Wordt daarom GRATIS Lid of login met uw wachtwoord


Copyrights © 2000 by XEA.nl all rights reserved
Niets mag zonder toestemming van de redactie worden gekopieerd, linken naar deze pagina is wel toegestaan.


Copyrights © DEBELEGGERSADVISEUR.NL