Results of Operation
Comparison of Years Ended December 31, 2024 and 2023
|
|
Year Ended December 31, |
|
|
||
|---|---|---|---|---|---|---|
(in thousands of $ except for shares and EPS) |
|
2024 |
|
2023 |
|
% Change |
Product net sales |
|
2,185,883 |
|
1,190,783 |
|
84% |
Collaboration revenue |
|
4,348 |
|
35,533 |
|
(88%) |
Other operating income |
|
61,808 |
|
42,278 |
|
46% |
Total operating income |
|
2,252,039 |
|
1,268,594 |
|
78% |
Cost of sales |
|
(227,289) |
|
(117,835) |
|
93% |
Research and development expenses |
|
(983,423) |
|
(859,492) |
|
14% |
Selling, general and administrative expenses |
|
(1,055,337) |
|
(711,905) |
|
48% |
Loss from investment in a joint venture |
|
(7,644) |
|
(4,411) |
|
73% |
Total operating expenses |
|
(2,273,693) |
|
(1,693,643) |
|
34% |
Operating loss |
|
(21,654) |
|
(425,049) |
|
(95%) |
Financial income |
|
157,509 |
|
107,386 |
|
47% |
Financial expense |
|
(2,464) |
|
(906) |
|
172% |
Exchange (losses)/gains |
|
(48,211) |
|
14,073 |
|
(443%) |
Profit/(Loss) for the year before taxes |
|
85,180 |
|
(304,496) |
|
(128%) |
Income tax benefit |
|
747,860 |
|
9,443 |
|
7,819% |
Profit/(Loss) for the year |
|
833,040 |
|
(295,053) |
|
382% |
Weighted average number of shares outstanding |
|
59,855,585 |
|
57,169,253 |
|
|
Basic profit/(loss) per share (in $) |
|
13.92 |
|
(5.16) |
|
|
Weighted average number of shares for purpose of diluted profit/(loss) per share |
|
65,177,815 |
|
57,169,253 |
|
|
Diluted profit/(loss) per share (in $) |
|
12.78 |
|
(5.16) |
|
|
Product net sales
|
|
Year Ended December 31, |
||
|---|---|---|---|---|
(in thousands of $) |
|
2024 |
|
2023 |
United States |
|
1,895,919 |
|
1,046,592 |
Japan |
|
89,389 |
|
56,432 |
China |
|
39,177 |
|
14,907 |
Rest of the World |
|
161,398 |
|
72,852 |
Total product net sales |
|
2,185,883 |
|
1,190,783 |
Our product net sales have increased in the U.S. and other countries as the Company continues to execute on the global commercialization of VYVGART and VYVGART SC and obtain further approvals worldwide.
Collaboration Revenue
|
|
Year Ended December 31, |
|
|
||
|---|---|---|---|---|---|---|
(in thousands of $) |
|
2024 |
|
2023 |
|
% Change |
AbbVie |
|
– |
|
30,000 |
|
(100%) |
Zai Lab |
|
4,348 |
|
5,533 |
|
(21%) |
Total collaboration revenue |
|
4,348 |
|
35,533 |
|
(88%) |
Our collaboration revenue decreased by $31 million to $4 million for the year ended December 31, 2024, compared to $36 million for the year ended December 31, 2023. The collaboration revenue recognized in the year ended December 31, 2024 was mainly the result of the clinical supply of product and royalties on product net sales of VYVGART in Greater China through Zai Lab.
Other Operating Income
|
|
Year Ended December 31, |
|
|
||
|---|---|---|---|---|---|---|
(in thousands of $) |
|
2024 |
|
2023 |
|
% Change |
Research and development incentives |
|
46,106 |
|
27,815 |
|
66% |
Payroll tax rebates |
|
11,855 |
|
11,925 |
|
(1%) |
Grants |
|
13 |
|
2,538 |
|
(99%) |
Change in fair value on non-current financial assets |
|
3,834 |
|
– |
|
100% |
Total other operating income |
|
61,808 |
|
42,278 |
|
46% |
Other operating income increased by $20 million to $62 million for the year ended December 31, 2024, compared to $42 million for the year ended December 31, 2023. The $20 million increase was primarily driven by:
- the increase in research and development incentives due to a Belgian research and development tax incentive scheme, as a result of the overall increased research and development costs incurred;
- the increase in payroll tax rebates for the year ended December 31, 2024, as a result of higher research and development personnel expenses eligible for rebates for the year ended December 31, 2024; and
- an increase of $4 million due to the change in fair value on our profit share in AgomAb for the year ended December 31, 2024.
For more information regarding governmental policies that could affect our operations, see “Business Overview” and “Healthcare Law and Regulation”.
Research and Development Expenses
|
|
Year Ended December 31, |
|
|
||
|---|---|---|---|---|---|---|
(in thousands of $) |
|
2024 |
|
2023 |
|
% Change |
External research and development expenses |
|
605,082 |
|
483,192 |
|
25% |
Personnel expenses |
|
310,992 |
|
226,344 |
|
37% |
BIS expenses |
|
34,012 |
|
19,935 |
|
71% |
Materials and consumables |
|
5,863 |
|
4,057 |
|
45% |
Depreciation and amortization |
|
6,204 |
|
105,546 |
|
(94%) |
Other expenses |
|
21,270 |
|
20,418 |
|
4% |
Total Research and development expenses |
|
983,423 |
|
859,492 |
|
14% |
Our research and development expenses totaled $983 million and $859 million for the years ended December 31, 2024 and 2023, respectively. The increase of $124 million in 2024 as compared to 2023 is primarily driven by Personnel expenses and External research and development expenses. This is offset by the decrease in Depreciation and amortization resulting from the use of a Priority Review Voucher (PRV) for priority review by the FDA of its VYVGART HYTRULO for use in CIDP in 2023.
Personnel expenses relate to internal and external R&D personnel. The expenses also include share-based compensation expenses related to the grant of stock options and RSUs to our research and development employees. We employed on average 805 full-time equivalents in our research and development functions in the year ended December 31, 2024, compared to 607 in the year ended December 31, 2023.
Our external research and development expenses for the year ended December 31, 2024 totaled to $605 million, compared to $483 million for the year ended December 31, 2023. The expenses reflect clinical trial costs and manufacturing expenses related to the development of our product candidate portfolio. The table below provides additional detail on our external research and development expenses by program:
|
|
Year Ended December 31, |
|
|
||
|---|---|---|---|---|---|---|
(in thousands of $) |
|
2024 |
|
2023 |
|
% Change |
efgartigimod |
|
405,347 |
|
361,676 |
|
12% |
empasiprubart |
|
86,254 |
|
47,636 |
|
81% |
ARGX-119 |
|
26,098 |
|
13,731 |
|
90% |
cusatuzumab |
|
10,856 |
|
14,298 |
|
(24%) |
Other programs |
|
76,527 |
|
45,851 |
|
67% |
Total |
|
605,082 |
|
483,192 |
|
25% |
External research and development expenses for our lead product efgartigimod totaled $405 million for the year ended December 31, 2024, compared to $362 million for the year ended December 31, 2023 relating to the efforts in evaluating in more than 15 severe autoimmune diseases including MG, CIDP and ITP.
External research and development expenses for empasiprubart totaled $86 million for the year ended December 31, 2024 compared to $48 million for the year ended December 31, 2023. This increase of $39 million was due to the ramp-up of Phase 2 clinical trials in MMN, DGF, DM and CIDP.
External research and development expenses for ARGX-119 increased by $12 million to $26 million for the year ended December 31, 2024 as we continue to invest in proof-of-concept studies ongoing in ALS and CMS.
Our investments in other programs have increased by $31 million with four new pipeline candidate nominations to IIP alongside our continued Discovery programs.
Selling, general and administrative Expenses
|
|
Year Ended December 31, |
|
|
||
|---|---|---|---|---|---|---|
(in thousands of $) |
|
2024 |
|
2023 |
|
% Change |
Personnel expenses |
|
424,916 |
|
303,033 |
|
40% |
Marketing services |
|
306,987 |
|
202,146 |
|
52% |
Professional fees |
|
170,215 |
|
108,820 |
|
56% |
BIS expenses |
|
27,295 |
|
20,408 |
|
34% |
Supervisory board |
|
9,724 |
|
8,362 |
|
16% |
Depreciation and amortization |
|
3,149 |
|
2,366 |
|
33% |
Other expenses |
|
92,163 |
|
55,506 |
|
66% |
Total Selling, general and administrative expenses |
|
1,055,337 |
|
711,905 |
|
48% |
The increase in our Selling, general and administrative expenses for the year ended December 31, 2024 was principally resulting from:
- increased professional and marketing fees, including promotional and marketing costs primarily due to the scaling of our commercial operations relating to VYVGART and VYVGART SC;
- increased costs of personnel expenses is related to planned increase in the headcount of our Selling, general and administrative employees recruited to strengthen our enabling functions and the scaling of our commercial operations relating to VYVGART and VYVGART SC; and
- continued investment in our IT infrastructure.
We employed on average 835 full-time equivalents in our selling, general and administrative functions in the year ended December 31, 2024, compared to 681 in the year ended December 31, 2023.
Financial Income and (Expense)
For the year ended December 31, 2024, financial income amounted to $158 million compared to $107 million for the year ended December 31, 2023. The increase of $50 million in 2024 related primarily to the capital increase of our financial assets.
Exchange Gains (Losses)
Exchange losses totaled $48 million for the year ended December 31, 2024, compared to exchange gains of $14 million for the year ended December 31, 2023. The losses were mainly attributable to unrealized exchange rate losses on the cash and cash equivalents, in addition to current financial assets position in euro during the year ended December 31, 2024.