- Completion of enrollment expected by year-end for ADAPT-SC and ADVANCE (IV) trials of efgartigimod; topline data for both trials expected in first half of 2022
- Introduced “argenx 2025” vision during R&D Day to highlight commitment to patients and science and outline path to becoming global, integrated immunology leader
- Management to host conference call today at
July 29, 2021
“The first half of 2021 has been marked by clinical, financial and regulatory achievements for argenx. As we look toward 2022, we believe we are well-positioned to build on the impressive progress we have made with our first-in-class FcRn antagonist, efgartigimod. We are expanding our commercial organization to reach patients living with generalized myasthenia gravis this year and expect that these investments will benefit us in the future and support our growing, differentiated pipeline,” said
“Beyond myasthenia gravis, we are expanding the breadth of efgartigimod into our fifth and sixth indications, myositis and bullous pemphigoid, and simultaneously investing in potential scientific breakthroughs through our Immunology Innovation Program (IIP). Our first-in-class C2 inhibitor, ARGX-117, emerged from the IIP and has the potential to be our next pipeline-in-a-product opportunity. Collectively, the demonstrated execution this year supports our ‘argenx 2025’ vision and brings us closer than ever to becoming a global, integrated, immunology company,” concluded
SECOND QUARTER 2021 AND RECENT BUSINESS UPDATE
During its
- Efgartigimod being globally available to patients across its three expanding commercial franchises in neuromuscular diseases, hematology and dermatology
- Efgartigimod either being commercially available or in clinical development in 15 active indications
- Progress across broader immunology pipeline with ARGX-117 in multiple late-stage trials and ARGX-119 demonstrating proof-of-concept
- Investment in continued expansion of differentiated pipeline through its Immunology Innovation Program (IIP), generating one new asset into pipeline each year
On track with buildout of global commercial organization in anticipation of potential approval of efgartigimod for treatment of generalized myasthenia gravis (gMG)
- Biologics License Application (BLA) under review with
U.S. Food and Drug Administration (FDA) with target action date ofDecember 17, 2021 under Prescription Drug User Fee Act (PDUFA) - Marketing Authorization Application (J-MAA) under review with Japan’s
Pharmaceuticals and Medical Devices Agency (PMDA) with anticipated approval in first half of 2022 - MAA on track and expected to be filed with
European Medicines Agency (EMA) in second half of 2021 - Zai Lab on track with expected regulatory discussions with
National Medical Products Administration (NMPA) for approval inChina - ADAPT Phase 3 trial results of efgartigimod for treatment of gMG published in The Lancet Neurology
- Hiring of salesforce expected to be completed in
U.S. in third quarter of 2021 and inJapan in fourth quarter of 2021 - Ongoing engagement with gMG patient community through awareness and advocacy efforts, including award-winning docuseries “A Mystery to Me”, and continued enrollment into real-world evidence study, MyRealWorld®MG
Efgartigimod is currently being evaluated in five ongoing registrational trials across four indications, including ADAPT-SC (gMG), ADHERE (chronic inflammatory demyelinating polyneuropathy or CIDP), ADVANCE (IV) and ADVANCE-SC (primary immune thrombocytopenia or ITP), and ADDRESS (pemphigus)
- Completion of enrollment expected by end of 2021 in ADAPT-SC and ADVANCE (IV); topline data for both trials expected in first half of 2022
- Broadened efgartigimod opportunity with announcement of new indications, idiopathic inflammatory myopathies (myositis) within neuromuscular franchise and bullous pemphigoid within dermatology franchise
- Phase 2/3 trial of efgartigimod for treatment of myositis to start by end of 2021, pending interactions with FDA
- Phase 3 registrational trial of efgartigimod for treatment of bullous pemphigoid to start by end of 2021
- Phase 2 proof-of-concept trials of efgartigimod in additional indications to be evaluated as part of collaboration with Zai Lab
Phase 1 healthy volunteer data of C2-inhibitor, ARGX-117, support path forward into multifocal motor neuropathy (MMN)
- Favorable safety profile demonstrated across single and multiple ascending doses and both IV and SC formulations
- Pharmacokinetic/pharmacodynamic profiles demonstrate potential for infrequent dosing schedules
- Phase 2 trial of MMN patients on track to start by end of 2021
Immunology Innovation Program (IIP) continues to bring value to argenx through internal pipeline programs, partnerships and licensing agreements
- ARGX-119, a SIMPLE Antibody aimed at boosting the neuromuscular junction in disease, emerging from IIP to be next pipeline candidate within neuromuscular franchise
- Regained worldwide rights to anti-CD70 antibody cusatuzumab from Janssen; argenx to evaluate potential alternatives to advance cusatuzumab through partnership
- 15-20 discovery programs under evaluation at any point in time that have emerged from IIP
HALF YEAR 2021 FINANCIAL RESULTS (CONSOLIDATED)
Six Months Ended | |||||||||
(in thousands of $ except for shares and EPS) | 2021 | 2020 | Variance | ||||||
Revenue | $ | 470.398 | $ | 24.683 | $ | 445.715 | |||
Other operating income | 17.079 | 9.619 | 7.460 | ||||||
Total operating income | 487.477 | 34.302 | 453.175 | ||||||
Research and development expenses | -273.907 | -189.251 | -84.656 | ||||||
Selling, general and administrative expenses | -129.599 | -67.926 | -61.673 | ||||||
Total operating expenses | -403.506 | -257.177 | -146.329 | ||||||
Change in fair value on non-current financial assets | 11.152 | 934 | 10.218 | ||||||
Operating income / (loss) | $ | 95.123 | $ | -221.941 | $ | 317.064 | |||
Financial income/(expenses) | -745 | -2.403 | 1.658 | ||||||
Exchange gain/(losses) | -18.375 | 245 | -18.620 | ||||||
Profit / (Loss) before taxes | $ | 76.003 | $ | -224.099 | $ | 300.102 | |||
Income taxes | -12.835 | -2.491 | -10.345 | ||||||
Profit / (Loss) for the period | $ | 63.167 | $ | -226.590 | $ | 289.757 | |||
Weighted average number of shares outstanding | 50.638.702 | 43.476.103 | |||||||
Basic profit / (loss) per share (in $) | 1,25 | -5,21 | |||||||
Diluted profit / (loss) per share (in $) | 1,17 | -5,21 | |||||||
Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2020 and 2019 | 734.545 | 663.686 | |||||||
Cash, cash equivalents and current financial assets at the end of the period | 2.730.997 | 2.164.347 |
DETAILS OF THE FINANCIAL RESULTS
As of
Cash, cash equivalents and current financial assets totaled
Total operating income increased by
Research and development expenses increased by
Selling, general and administrative expenses totaled
The change in fair value on non-current financial assets amounted to
Exchange losses totaled
FINANCIAL GUIDANCE
Based on current plans to fund anticipated operating expenses and capital expenditures, argenx continues to expect its 2021 cash burn to approximately double from 2020. The increased spend will support the Company’s transition to an integrated immunology company, including the build-out of global commercial infrastructure and drug product inventory ahead of the expected launch of efgartigimod in gMG in the
EXPECTED 2021 FINANCIAL CALENDAR
October 28, 2021 : Q3 2021 financial results and business update
CONFERENCE CALL DETAILS
The half year 2021 financial results and second quarter business update will be discussed during a conference call and webcast presentation today at
Dial-in numbers:
Please dial in 15 minutes prior to the live call.
International 1 412 902 0128
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in
For further information, please contact:
Media:
KKirk@argenx.com
Joke Comijn (EU)
jcomijn@argenx.com
Investors:
bdelgiacco@argenx.com
mgreenblatt@argenx.com
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 concerning the argenx 2025 vision; its statement that the submissions in
Attachment
- 2021 HY report_ISA_FINAL
Source: argenx SE
2021 GlobeNewswire, Inc., source