6-K
Legend Biotech Corp (LEGN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
Date of Report: March 30, 2023
Commission File Number: 001-39307
Legend Biotech Corporation
(Exact Name of Registrant as Specified in its Charter)
2101 Cottontail Lane
Somerset, New Jersey 08873
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Legend Biotech Reports Full Year 2022 Financial Results and Recent Highlights
On March 30, 2023, Legend Biotech Corporation (“Legend Biotech”) issued a press release regarding its audited financial results for the year ended December 31, 2022 and recent business highlights, which is attached to this Form 6-K as Exhibit 99.1.
This report on Form 6-K, including Exhibit 99.1, is hereby incorporated by reference in the registration statements of Legend Biotech on Form F-3 (Nos. 333-257609 and 333-257625) and Form S-8 (No. 333-239478), to the extent not superseded by documents or reports subsequently filed.
EXHIBIT INDEX
| Exhibit | Title |
|---|---|
| 99.1 | Press Release, dated March 30, 2023 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| LEGEND BIOTECH CORPORATION | ||
|---|---|---|
| Date: March 30, 2023 | By: | /s/ Ying Huang |
| Name: | Ying Huang, Ph.D. | |
| Title: | Chief Executive Officer |
Exhibit 99.1
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)
SOMERSET, N.J.--(BUSINESS WIRE)--March 30, 2023--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today reported its full year 2022 audited financial results.
"2022 was a year of significant milestones for Legend Biotech, marked by the regulatory approvals of CARVYKTI***^®^*** in the U.S., Europe, and Japan. In addition to launching our first commercial product, we advanced our clinical development program for cilta-cel, obtained FDA clearances on two investigational new drug applications targeting solid tumors, and critically, expanded our commercial infrastructure and manufacturing capabilities to support future growth" said Ying Huang, Chief Executive Officer of Legend Biotech.
"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’s National 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 the U.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’s Ministry 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 December 31, 2022
Cash and Cash Equivalents, Time Deposits, and Short-Term Investments
As of December 31, 2022, Legend Biotech had approximately $1.0 billion of cash and cash equivalents, time deposits, and short-term investments.
Revenue
Revenue for the year ended December 31, 2022 was $117.0 million compared to $68.8 million for the year ended December 31, 2021. The increase of $48.2 million was due to product sales for the commercial launch of CARVYKTI**^®^** in the U.S. in connection with Legend Biotech’s collaboration agreement with Janssen Biotech, Inc. (the “Janssen Agreement”).
Research and Development Expenses
Research and development expenses for the year ended December 31, 2022 were $335.6 million compared to $313.3 million for the year ended December 31, 2021. This increase of $22.3 million was primarily due to continued investment in cilta-cel for earlier lines of therapies and increase in Legend Biotech’s pipeline expenditures as it filed two Investigational New Drug applications and began preparation for Phase 1 clinical development in the U.S. in the year ended December 31, 2022.
Administrative Expenses
Administrative expenses for the year ended December 31, 2022 were $80.6 million compared to $47.0 million for the year ended December 31, 2021. The increase of $33.7 million was primarily due to the final phase of separation of certain information technology services from GenScript Biotech Corporation, required enhancements for cybersecurity and privacy, along with the required information technology infrastructure build to support manufacturing facilities.
Selling and Distribution Expenses
Selling and distribution expenses for the year ended December 31, 2022 were $93.4 million compared to $102.5 million for the year ended December 31, 2021. This increase of $9.1 million was primarily due to costs associated with the commercialization of CARVYKTI**^®^**.
Other Income and Gains
Other income and gains for the year ended December 31, 2022 were $12.0 million compared to $3.1 million for the year ended December 31, 2021. The increase of $8.9 million was primarily due to increase in interest income, government grants and fair value gain from financial assets.
Other Expenses
Other expenses for the year ended December 31, 2022 were $9.8 million compared to $9.1 million for the year ended December 31, 2021. The increase was primarily due to foreign currency exchange loss in the year.
Finance Costs
Finance costs for the year ended December 31, 2022 were $10.8 million compared to $0.9 million for the year ended December 31, 2021. The increase was primarily due to interest on advance funding, which is interest-bearing borrowings funded by Janssen under the Janssen Agreement and constituted by principal and applicable interests upon such principal. Legend Biotech elected to borrow an incremental $130.3 million as of December 31, 2022 in accordance with the terms of the Janssen Agreement.
Fair Value Gain of Warrant Liability
Fair value gain of warrant liability for the year ended December 31, 2022 was $20.9 million caused by changes in the fair value of a warrant that Legend Biotech issued to an institutional investor through a private placement transaction in May 2021 with an initial fair value of $81.7 million at the issuance date. The warrant was assessed as a financial liability with a fair value of $67.0 million as of December 31, 2022.
Loss for the Period
For the year ended December 31, 2022, net loss was $446.3 million, or $1.40 per share, compared to a net loss of $403.6 million, or $1.43 per share, for the year ended December 31, 2021.
About Legend Biotech
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogeneic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of cutting-edge therapeutics for patients worldwide.
Learn more at www.legendbiotech.com and follow us on Twitter and LinkedIn.
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 U.S. Food and Drug Administration (FDA) and other regulatory authorities; the anticipated timing of, and ability to progress, clinical trials; and the ability to generate, analyze and present data from clinical trials. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; competition in general; government, industry, and general product pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 30, 2023. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
| LEGEND BIOTECH CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS | ||||||
|---|---|---|---|---|---|---|
| Twelve months ended December 31 | ||||||
| (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 |
| LEGEND BIOTECH CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | ||
|---|---|---|
| (in thousands, US$) | December 31, 2022 | December 31, 2021 |
| NON-CURRENT ASSETS | ||
| Property, plant and equipment | 105,168 | 102,506 |
| Advance payments for property, plant and equipment | 914 | 2,168 |
| Right-of-use assets | 55,590 | 38,283 |
| Time deposits | - | 4,705 |
| Intangible assets | 3,409 | 4,684 |
| Collaboration prepaid leases | 65,276 | 12,121 |
| Other non-current assets | 1,487 | 5,148 |
| Total non-current assets | 231,844 | 169,615 |
| CURRENT ASSETS | ||
| Collaboration inventories | 10,354 | 1,749 |
| Trade receivables | 90 | 50,410 |
| Prepayments, other receivables and other assets | 61,755 | 13,852 |
| Financial assets at fair value through profit or loss | 185,603 | - |
| Financial assets measured at amortized cost | - | 29,937 |
| Pledged deposits | 1,270 | 1,444 |
| Time deposits | 54,016 | 163,520 |
| Cash and cash equivalents | 786,031 | 688,938 |
| Total current assets | 1,099,119 | 949,850 |
| Total assets | 1,330,963 | 1,119,465 |
| CURRENT LIABILITIES | ||
| Trade payables | 32,893 | 7,043 |
| Other payables and accruals | 184,109 | 123,558 |
| Government grants | 451 | 304 |
| Lease liabilities | 3,563 | 911 |
| Tax payable | 9,772 | 9,488 |
| Warrant liability | 67,000 | 87,900 |
| Total current liabilities | 297,788 | 229,204 |
| NON-CURRENT LIABILITIES | ||
| Collaboration interest-bearing advanced funding | 260,932 | 120,462 |
| Lease liabilities long term | 20,039 | 1,593 |
| Government grants | 7,659 | 1,866 |
| Other non-current liabilities | 233 | 396 |
| Total non-current liabilities | 288,863 | 124,317 |
| Total liabilities | 586,651 | 353,521 |
| EQUITY | ||
| Share capital | 33 | 31 |
| Reserves | 744,279 | 765,913 |
| Total ordinary shareholders’ equity | 744,312 | 765,944 |
| Total equity | 744,312 | 765,944 |
| Total liabilities and equity | 1,330,963 | 1,119,465 |
| LEGEND BIOTECH CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||
|---|---|---|---|---|---|---|
| (in thousands, US$) | 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 GenScript | - | - | 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 |
Contacts
Investor Contacts:
Joanne Choi, Senior Manager, Investor Relations, Legend Biotech
Joanne.choi@legendbiotech.com
Crystal Chen, Manager, Investor Relations, Legend Biotech
crystal.chen@legendbiotech.com
Press Contact:
Tina Carter, Corporate Communications Lead, Legend Biotech
tina.carter@legendbiotech.com
\(908\) 331-5025