On July 29, 2021 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported its half year 2021 financial results and provided a second quarter business update and outlook for the remainder of the year (Press release, argenx, JUL 29, 2021, View Source [SID1234585377]).
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"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 Tim Van Hauwermeiren, Chief Executive Officer of argenx.
"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 Mr. Van Hauwermeiren.
SECOND QUARTER 2021 AND RECENT BUSINESS UPDATE
During its July 20th R&D Day, argenx introduced its long-term vision to becoming a global, integrated immunology organization. The ‘argenx 2025’ vision includes the following goals:
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 of December 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 in China
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 in Japan 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, MyRealWorldMG
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
DETAILS OF THE FINANCIAL RESULTS
As of January 1, 2021, the Company changed its functional and presentation currency from euro to U.S. dollars, which results in reporting financial highlights in U.S. dollar as compared to euro in prior periods. Historical financials have been converted at the average exchange rate of the related period.
Cash, cash equivalents and current financial assets totaled $2,731.0 million as of June 30, 2021, compared to $1,996.5 million on December 31, 2020. The increase in cash and cash equivalents and current financial assets resulted primarily from (i) the closing of a global offering, which resulted in the receipt of $1,092.1 million in net proceeds in February 2021, (ii) the net receipt of a $73.1 million non-creditable, non-refundable development cost-sharing payment received from Zai Lab as part of the strategic collaboration for efgartigimod in Greater China, (iii) the payment of $98.0 million related to the purchase of the priority review voucher from Bayer HealthCare Pharmaceuticals, and other net cash flows used in operating activities.
Total operating income increased by $453.2 million for the six months ended June 30, 2021 to $487.5 million, compared to $34.3 million for the six months ended June 30, 2020. The increase was primarily due 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.
Research and development expenses increased by $84.7 million for the six months ended June 30, 2021 to $273.9 million, compared to $189.3 million for the six months ended June 30, 2020. The increase in the first six months of 2021 resulted primarily from higher external research and development expenses, mainly related to the efgartigimod program in various indications and other clinical and preclinical programs. Furthermore, the research and development personnel expenses increased due to a planned increase in headcount and the increased costs of the share-based payment compensation plans related to the grant of stock options.
Selling, general and administrative expenses totaled $129.6 million for the six months ended June 30, 2021, compared to $67.9 million for the six months ended June 30, 2020. The increase resulted primarily from higher personnel expenses, including the costs of the share-based payment compensation plans related to the grant of stock options, and consulting fees linked to the preparation of a possible future commercialization of argenx’s lead product candidate efgartigimod.
The change in fair value on non-current financial assets amounted to $11.2 million for the six months ended June 30, 2021, which is the result of the closing of a Series B financing round of AgomAb Therapeutics, for which argenx maintains a profit share in exchange for granting the license for the use of HGF-mimetic antibodies from the SIMPLE AntibodyTM platform.
Exchange losses totaled $18.4 million for the six months ended June 30, 2021, compared to an exchange gain of $0.2 million for the six months ended June 30, 2020. As a result of the change in the Company’s functional and presentation currency, the exchange losses for the six months ended June 30, 2021 are reflecting the unfavorable change in euro/U.S. dollar exchange rate, mainly attributable to unrealized exchange rate losses on cash, cash equivalents and current financial asset position in euro.
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 U.S, the advancement of its clinical-stage pipeline, including expected global trials of efgartigimod in six indications, and the continued investment in its Immunology Innovation Program.
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 2:30 pm CEST/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.