Legend Biotech Reports Full-Year 2022 Results and Recent Highlights
- CARTITUDE-4, a Phase 3 study of CARVYKTI® (ciltacabtagene autoleucel) meets primary endpoint at the study’s first pre-specified interim analysis
-
FDA clearance of IND application for LB2102 in Extensive Stage Small Cell
Lung Cancer (SCLC) -
CARVYKTI® (ciltacabtagene autoleucel) receives approval from Japan’s
Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with relapsed or refractory multiple myeloma -
China’s
National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel)
"2022 was a year of significant milestones for
"Our teams across the entire business delivered exceptionally during an incredibly busy year. Looking forward, we remain focused on the continued expansion of our manufacturing footprint and advancing our clinical program in order to bring CARVYKTI® to more eligible patients."
Second Half 2022 Highlights and Recent Events
-
On
January 27, 2023 ,Legend Biotech announced that CARTITUDE-4, the Phase 3 study evaluating CARVYKTI® (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma, met its primary endpoint of showing a statistically significant improvement in progression-free survival (PFS) compared to standard therapy at the study’s first pre-specified interim analysis
-
On
January 2, 2023 ,Legend Biotech announced that China’sNational Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel)
-
On
November 21, 2022 ,Legend Biotech announced that theU.S. Food and Drug Administration (FDA) cleared Legend Biotech’s Investigational New Drug (IND) application to proceed with the clinical development of LB2102, an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adult patients with extensive stage small cell lung cancer (SCLC)
-
On
September 27, 2022 ,Legend Biotech announced that Japan’sMinistry of Health, Labour and Welfare (MHLW) approved CARVYKTI® (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting both of the following conditions: patients have no history of CAR-positive T cell infusion therapy targeting BCMA; and patients have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy
Financial Results for Year Ended
Cash and Cash Equivalents, Time Deposits, and Short-Term Investments
As of
Revenue
Revenue for the year ended
Research and Development Expenses
Research and development expenses for the year ended
Administrative Expenses
Administrative expenses for the year ended
Selling and Distribution Expenses
Selling and distribution expenses for the year ended
Other Income and Gains
Other income and gains for the year ended
Other Expenses
Other expenses for the year ended
Finance Costs
Finance costs for the year ended
Fair Value Gain of Warrant Liability
Fair value gain of warrant liability for the year ended
Loss for the Period
For the year ended
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Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; statements relating to CARVYKTI® and other product candidates, including Legend Biotech’s expectations for CARVYKTI® and other product candidates, such as Legend Biotech’s manufacturing and commercialization expectations for CARVYKTI® and the potential effect of treatment with CARVYKTI® and other product candidates; statements about submissions for CARVYKTI® and other product candidates to, and the progress of such submissions with, the
|
|
|||||||||
| Twelve months ended |
|||||||||
| (in thousands, US$, except share and per share data) |
2022 |
2021 |
2020 |
||||||
| REVENUE | |||||||||
| License revenue |
50,000 |
|
65,402 |
|
75,000 |
|
|||
| Collaboration revenue |
66,677 |
|
- |
|
- |
|
|||
| Other revenue |
328 |
|
3,424 |
|
0 |
|
|||
| Total revenue |
117,005 |
|
68,826 |
|
75,000 |
|
|||
| Collaboration cost of revenue |
(65,363 |
) |
- |
|
- |
|
|||
| Other income and gains |
12,049 |
|
3,059 |
|
6,119 |
|
|||
| Research and development expenses |
(335,648 |
) |
(313,346 |
) |
(232,160 |
) |
|||
| Administrative expenses |
(80,631 |
) |
(46,961 |
) |
(23,134 |
) |
|||
| Selling and distribution expenses |
(93,417 |
) |
(102,542 |
) |
(49,571 |
) |
|||
| Other expenses |
(9,823 |
) |
(9,132 |
) |
(346 |
) |
|||
| Fair value gain/(loss) of warrant liability |
20,900 |
|
(6,200 |
) |
- |
|
|||
| Fair value loss of convertible redeemable preferred shares |
- |
|
- |
|
(79,984 |
) |
|||
| Finance costs |
(10,796 |
) |
(900 |
) |
(4,209 |
) |
|||
| LOSS BEFORE TAX |
(445,724 |
) |
(407,196 |
) |
(308,285 |
) |
|||
| Income tax (expense)/credit |
(625 |
) |
3,614 |
|
41,912 |
|
|||
| LOSS FOR THE YEAR |
(446,349 |
) |
(403,582 |
) |
(266,373 |
) |
|||
| Attributable to: | |||||||||
| Ordinary equity holders of the parent |
(446,349 |
) |
(403,582 |
) |
(266,373 |
) |
|||
| Loss per share attributable to ordinary equity holders of the parent: | |||||||||
| Ordinary shares - basic |
(1.40 |
) |
(1.43 |
) |
(1.13 |
) |
|||
| Ordinary shares - diluted |
(1.40 |
) |
(1.43 |
) |
(1.13 |
) |
|||
| Shares used in loss per share computation: | |||||||||
| Weighted average number of ordinary shares |
318,083,913 |
|
281,703,291 |
|
236,305,234 |
|
|||
|
|
||||
| (in thousands, US$) |
|
|
||
| NON-CURRENT ASSETS | ||||
| Property, plant and equipment |
105,168 |
102,506 |
||
| Advance payments for property, plant and equipment |
914 |
2,168 |
||
| Right-of-use assets |
55,590 |
38,283 |
||
| Time deposits |
- |
4,705 |
||
| Intangible assets |
3,409 |
4,684 |
||
| Collaboration prepaid leases |
65,276 |
12,121 |
||
| Other non-current assets |
1,487 |
5,148 |
||
| Total non-current assets |
231,844 |
169,615 |
||
| CURRENT ASSETS | ||||
| Collaboration inventories |
10,354 |
1,749 |
||
| Trade receivables |
90 |
50,410 |
||
| Prepayments, other receivables and other assets |
61,755 |
13,852 |
||
| Financial assets at fair value through profit or loss |
185,603 |
- |
||
| Financial assets measured at amortized cost |
- |
29,937 |
||
| Pledged deposits |
1,270 |
1,444 |
||
| Time deposits |
54,016 |
163,520 |
||
| Cash and cash equivalents |
786,031 |
688,938 |
||
| Total current assets |
1,099,119 |
949,850 |
||
| Total assets |
1,330,963 |
1,119,465 |
||
| CURRENT LIABILITIES | ||||
| Trade payables |
32,893 |
7,043 |
||
| Other payables and accruals |
184,109 |
123,558 |
||
| Government grants |
451 |
304 |
||
| Lease liabilities |
3,563 |
911 |
||
| Tax payable |
9,772 |
9,488 |
||
| Warrant liability |
67,000 |
87,900 |
||
| Total current liabilities |
297,788 |
229,204 |
||
| NON-CURRENT LIABILITIES | ||||
| Collaboration interest-bearing advanced funding |
260,932 |
120,462 |
||
| Lease liabilities long term |
20,039 |
1,593 |
||
| Government grants |
7,659 |
1,866 |
||
| Other non-current liabilities |
233 |
396 |
||
| Total non-current liabilities |
288,863 |
124,317 |
||
| Total liabilities |
586,651 |
353,521 |
||
| EQUITY | ||||
| Share capital |
33 |
31 |
||
| Reserves |
744,279 |
765,913 |
||
| Total ordinary shareholders’ equity |
744,312 |
765,944 |
||
| Total equity |
744,312 |
765,944 |
||
| Total liabilities and equity |
1,330,963 |
1,119,465 |
||
|
|
|||||||||
| (in thousands, US$) |
2022 |
2021 |
2020 |
||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||
| Loss before tax |
(445,724 |
) |
(407,196 |
) |
(308,285 |
) |
|||
| Adjustments for: | |||||||||
| Finance income |
(8,182 |
) |
(971 |
) |
(2,930 |
) |
|||
| Finance costs |
10,796 |
|
900 |
|
4,209 |
|
|||
| Depreciation of property, plant and equipment |
10,173 |
|
8,139 |
|
6,234 |
|
|||
| Loss on disposal of property, plant and equipment |
481 |
|
974 |
|
55 |
|
|||
| Amortization of intangible assets |
2,476 |
|
1,379 |
|
192 |
|
|||
| Depreciation of right-of-use assets |
5,743 |
|
4,399 |
|
3,507 |
|
|||
| Fair value (gain)/ loss of warrant liability |
(20,900 |
) |
6,200 |
|
- |
|
|||
| Fair value loss of convertible redeemable preferred shares |
- |
|
- |
|
79,984 |
|
|||
| Fair value gains on financial assets measured at fair value change through profit or loss |
(593 |
) |
- |
|
(47 |
) |
|||
| Foreign currency exchange loss/(gain), net |
9,159 |
|
4,867 |
|
(66 |
) |
|||
| Equity-settled share-based compensation expense |
34,338 |
|
20,158 |
|
4,760 |
|
|||
| Deferred government grant |
(307 |
) |
(295 |
) |
(114 |
) |
|||
|
(402,540 |
) |
(361,446 |
) |
(212,501 |
) |
||||
| Decrease/(increase) in trade receivables |
50,320 |
|
24,590 |
|
(45,000 |
) |
|||
| (Increase)/decrease in prepayments, other receivables and other assets |
(50,614 |
) |
(2,966 |
) |
3,366 |
|
|||
| Decrease/(increase) in other non-current assets |
3,661 |
|
(1,175 |
) |
(3,973 |
) |
|||
| (Increase)/decrease in collaboration inventories |
(8,605 |
) |
51 |
|
(643 |
) |
|||
| Government grant received |
6,180 |
|
80 |
|
2,452 |
|
|||
| Increase/(decrease) in trade payables |
25,850 |
|
1,805 |
|
(4,348 |
) |
|||
| Increase in other payables and accruals |
165,883 |
|
140,747 |
|
26,932 |
|
|||
| Increase/(decrease) in other non-current liabilities |
(163 |
) |
(158 |
) |
554 |
|
|||
| Increase in pledged deposits, net |
(15 |
) |
(1,060 |
) |
(128 |
) |
|||
| Cash used in operations |
(210,043 |
) |
(199,532 |
) |
(233,289 |
) |
|||
| Income tax paid |
- |
|
- |
|
(278 |
) |
|||
| Finance income received |
6,832 |
|
652 |
|
3,366 |
|
|||
| Income tax received |
3,709 |
|
557 |
|
7,391 |
|
|||
| Interest on lease payments |
(527 |
) |
(142 |
) |
(195 |
) |
|||
| Net cash used in operating activities |
(200,029 |
) |
(198,465 |
) |
(223,005 |
) |
|||
|
2022 |
2021 |
2020 |
|||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||
| Purchase of property, plant and equipment |
(20,927 |
) |
(42,197 |
) |
(26,254 |
) |
|||
| Purchase of intangible assets |
(1,348 |
) |
(3,207 |
) |
(4,029 |
) |
|||
| Prepayment to collaborator for collaboration assets |
(14,810 |
) |
(1,708 |
) |
(19,493 |
) |
|||
| Purchase of financial assets measured at fair value through profit or loss |
(285,000 |
) |
(50,000 |
) |
(22,682 |
) |
|||
| Cash received from withdrawal of financial assets measured at fair value through profit or loss |
99,990 |
|
50,081 |
|
22,682 |
|
|||
| Cash received from withdrawal of financial assets measured at amortized cost |
30,000 |
|
- |
|
- |
|
|||
| Cash receipts of investment income |
- |
|
- |
|
47 |
|
|||
| Proceeds from disposal of property, plant and equipment |
- |
|
4 |
|
1 |
|
|||
| Addition in time deposits |
(369,971 |
) |
(298,107 |
) |
(50,000 |
) |
|||
| Decrease in time deposits |
483,617 |
|
180,000 |
|
75,559 |
|
|||
| Decrease in pledged deposits |
105 |
|
- |
|
- |
|
|||
| Purchase of financial assets measured at amortized cost |
- |
|
(29,849 |
) |
- |
|
|||
| Net cash used in investing activities |
(78,344 |
) |
(194,983 |
) |
(24,169 |
) |
|||
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||
| Repayment of cash advances from related parties |
- |
|
- |
|
(4 |
) |
|||
| Proceeds from convertible redeemable preferred shares |
- |
|
- |
|
160,450 |
|
|||
| Proceeds from issuance of ordinary shares for initial public offering, net of issuance costs |
- |
|
- |
|
450,085 |
|
|||
| Proceeds from issuance of ordinary shares relating to private placement by |
- |
|
- |
|
12,000 |
|
|||
| Proceeds from issuance of ordinary shares for follow on public offering, net of issuance costs |
377,643 |
|
323,440 |
|
- |
|
|||
| Proceeds from issuance of ordinary shares and warrant relating to private placement for an institutional investor |
- |
|
300,000 |
|
- |
|
|||
| Proceeds from exercise of share options |
2,929 |
|
4,642 |
|
1,464 |
|
|||
| Payments of expenses for issuance of convertible redeemable preferred shares |
- |
|
- |
|
(2,514 |
) |
|||
| Principal portion of lease payments |
(2,596 |
) |
(1,419 |
) |
(2,602 |
) |
|||
| Net cash provided by financing activities |
377,976 |
|
626,663 |
|
618,879 |
|
|||
|
2022 |
2021 |
2020 |
|||||||
| NET INCREASE IN CASH AND CASH EQUIVALENTS |
99,603 |
|
233,215 |
|
371,705 |
|
|||
| Effect of foreign exchange rate changes, net |
(2,510 |
) |
34 |
|
620 |
|
|||
| Cash and cash equivalents at beginning of year |
688,938 |
|
455,689 |
|
83,364 |
|
|||
| CASH AND CASH EQUIVALENTS AT END OF YEAR |
786,031 |
|
688,938 |
|
455,689 |
|
|||
View source version on businesswire.com: https://www.businesswire.com/news/home/20230330005616/en/
Investor Contacts:
Joanne.choi@legendbiotech.com
crystal.chen@legendbiotech.com
Press Contact:
tina.carter@legendbiotech.com
(908) 331-5025
Source:
