SOMERSET, N.J.—(BUSINESSWIRE)— November 16, 2020—Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech” or the “Company”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today reported financial results for the quarter ended September 30, 2020.

“Legend Biotech continues to execute on our corporate strategy, advancing the development of our lead product candidate, ciltacabtagene autoleucel (cilta-cel), in collaboration with Janssen Biotech, Inc. as  well as our other pipeline programs,” said Dr. Ying Huang, Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”) of Legend Biotech. “We look forward to initiation of the Biologics License Application (“BLA”) filing for cilta-cel by Janssen Biotech, Inc.”

Third Quarter 2020 & Recent Highlights

• On November 9, 2020, Legend Biotech announced that Ms. Ye (Sally) Wang was appointed, effective November 6, 2020, as Chairwoman of the Board of Directors of Legend Biotech. The Board of Directors also named Dr. Ying Huang as CEO of Legend Biotech, effective November 6, 2020. Dr. Huang had been serving as interim CEO since September 21, 2020. Dr. Huang will continue to hold his position as CFO until such time as a successor CFO is identified.
• On November 5, 2020, Legend Biotech announced that the Company will present new and updated data from its CARTITUDE-1 and LEGEND-2 studies at the 62nd American Society of Hematology(ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.
• On September 21, 2020, Legend Biotech announced that the Customs Anti-Smuggling Department of the People’s Republic of China (“PRC”) had inspected places of business in China of Legend Biotech and GenScript Biotech Corporation, Legend Biotech’s majority shareholder, in connection with what Legend Biotech understands to be an investigation relating to suspected violations of import and export regulations under the laws of the PRC (the “Investigation”) and that Dr. Fangliang Zhang, the Chairman of the Board of Directors and CEO of Legend at that  time, had been placed under “residential surveillance” in the PRC.  No charges have been filed against Legend Biotech, Dr. Zhang, or any of its other officers or directors, and the Company  does not believe that Legend Biotech is a subject of the investigation.
• On August 5, 2020, Legend Biotech announced that the China Center for Drug Evaluation (“CDE”) of National Medical Products Administration (“NMPA”) recommended Breakthrough Therapy Designation(“BTD”) for cilta-cel for the treatment of adults with relapsed/refractory multiple myeloma. The designation was granted on August 13, 2020, making cilta-cel the first investigational product to obtain BTD in China.

Key Upcoming Milestones

• On Saturday, December 5, 2020, during the Myeloma session at ASH entitled: Myeloma/Amyloidosis: Therapy, excluding Transplantation: Novel Therapies Targeting B Cell Maturation Antigen in Relapsed/Refractory Multiple Myeloma, the Phase 1b/2 clinical efficacy and safety data from the CARTITUDE-1 study will be presented.
• During the ASH Annual Meeting and Exposition, LEGEND-2 data in patients with relapsed or refractory multiple myeloma and extramedullary disease will be presented as a poster.
• Legend Biotech’s collaboration partner Janssen Biotech, Inc. anticipates initiating the BLA submission for cilta-cel to the U.S. Food and Drug Administration (“FDA”) by the end of 2020 and submitting a marketing authorization application to the European Medicines Agency (“EMA”) in early 2021.
• Legend Biotech expects to use data from CARTIFAN-1 study to file a regulatory submission in China in 2021.
• Please see Legend Biotech’s comprehensive development pipeline as shown below.

Development Pipeline

Robust Pipeline of the Next Generation Cell Therapies

AML=acute myeloid leukemia, BCMA=B-cell maturation antigen, DLBCL=diffuse large B-cell lymphoma, FL=follicular lymphoma, HIV= human immunodeficiency virus, MCL=mantle cell lymphoma, NHL=non-Hodgkin lymphomas, MM= multiple myeloma, MSLN=mesothelin, RoW =Rest of World, SLL=small lymphocytic lymphoma, TCL=T-cell lymphoma

*In collaboration with Janssen, Pharmaceutical Companies of Johnson & Johnson

The extent to which the COVID-19 pandemic may impact our business and clinical trials is highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak and social distancing regulations, travel restrictions, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

Financial Results for the Three-month and Nine-month Periods Ended September 30, 2020

Cash and Cash Equivalents:

As of September 30, 2020, Legend Biotech had approximately$449.4 million of cash and cash equivalents and approximately$125.6 million in time deposits.

Revenue

Revenue for the three months ended September 30, 2020 was $11.7 million compared to $17.7 million for the three months ended September 30, 2019. The decrease of $6.0 million was primarily due to milestone achieved in July 2019 under the agreement with Janssen Biotech, Inc., which resulted in additional consideration being allocated to the licensing of intellectual property and the steering committee service for the three months ended September 30, 2019, net-off by additional milestone that was achieved in December 2019, which resulted in additional consideration being allocated to the steering committee service for the three months ended September 30, 2020. Revenue for the nine months ended September 30, 2020 was $34.9 million compared to $37.8 million for the nine months ended September 30, 2019. Similarly, the decrease of the nine months period in 2020 was primarily driven by additional milestone payment received from Janssen Biotech, Inc. that was achieved in July 2019, net-off by additional milestone that was achieved in December 2019, which resulted in additional consideration being allocated to the steering committee service for the nine month ended September 30, 2020. Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2020 were $63.7 million compared to $41.9 million for the three months ended September 30, 2019. This increase of $21.8 million was primarily due to a higher number of clinical trials, a higher number of patients enrolled in those trials and a higher number of research and development product candidates in the three  months ended September 30, 2020. Consistently, research and development expenses for the nine months ended September 30, 2020 was $165.2 million compared to $95.8 million for the nine months ended September 30, 2019 with a $69.4 million increase.

Administrative Expenses

Administrative expenses for the three months ended September 30, 2020 were $6.0 million compared  to $2.0 million for the three months ended September 30, 2019. The increase of $4.0 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to aid continued research and development activities. Due to the consistent business expansion, administrative expenses for the nine months ended September 30, 2020 increased by $9.3 million, which was $14.0 million compared to $4.7 million for the nine months ended September 30, 2019.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended September 30, 2020 were $9.3 million compared to $4.5 million for the three months ended September 30, 2019. This increase of $4.8 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel. Driven by the same commercial preparation activities, selling and distribution expenses for the nine months ended September 30, 2020 was $25.4 million compared to $12.2 million for the nine months ended September 30, 2019.

Other Income and Gains

Other income and gains for the three months ended September 30, 2020 was $1.5 million compared to $3.0 million for the three months ended September 30, 2019. The decrease was primarily driven by net foreign exchange loss incurred, net of an increase in government grant received. Other income and gains for the nine months ended September 30, 2020 was $5.3 million compared to $6.6 million for the nine months ended September 30, 2019. The decrease of the nine months period was primarily driven by reduced average interest rate for holding of time deposits that generate interest income.

Other Expenses

Other expenses for the three months ended September 30, 2020 was $1.2 million compared to $0.002 million for the three months ended September 30, 2019.  Other expenses for the nine months ended September 30, 2020 was $1.3 million compared to $0.2 million for the nine months ended September 30, 2019.  The increase was primarily due to foreign exchange loss.

Loss for the Period

For the three months ended September 30, 2020, net loss was $66.5 million, or $0.25 per share, compared to a net loss of $27.8 million, or $0.14 per share, for the three months ended September 30, 2019. Net loss was $245.7 million for the nine months ended September 30, 2020 compared to $69.0 million for the nine months ended September 30, 2019.

Grant of restricted share units and share options

On September 1, 2020, we granted a total number of 777,382 restricted share units (each representing the right to receive one ordinary share) to grantees with a grant date fair market value of $16.335 per share. On September 1, 2020, we granted share options, representing the right to acquire a total number of 569,000 shares to grantees with an exercise price of $16.335 per share.

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.

We are engaged in a strategic collaboration with Janssen Biotech, Inc. to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

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; the anticipated timing of, and ability to progress, clinical trials; the ability to make, and the timing of, regulatory submissions  globally, including the BLA for cilta-cel to the U.S. FDA, the marketing authorization application (MAA) for cilta-cel to the EMA, regulatory submission filing for CARTIFAN-1 in China and the Investigational New Drug Application (IND) of LB1901, a CAR T product under development for the

treatment of relapsed or refractory T-cell lymphoma (TCL), to the U.S. FDA; the ability to generate, analyze and present data from clinical trials; patient enrollment; the potential benefits of our product candidates, the status and outcome of the Investigation and its impact on the Company’s operations.  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, including the factors discussed in the “Risk Factors” section of the prospectus filed with the Securities and Exchange Commission on June 8, 2020. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

UNAUDITED  INTERIM CONDENSED  CONSOLIDATED STATEMENTS  OF PROFIT OR LOSS

FOR THE THREE  AND NINE MONTHS ENDED  SEPTEMBER  30, 2020 AND 2019

Three months ended September 30

Nine months ended September 30

(in thousands, US$, except per share data)     2020   2019     2020   2019   (unaudited)   (unaudited)     (unaudited)   (unaudited)   REVENUE………………………………………………………………..   11,747     17,674       34,893     37,814 Other income and gains…………………………………………… 1,519   2,987     5,315   6,649 Research and development expenses ……………………… (63,656)   (41,917)     (165,226)   (95,846) Administrative    expenses………………………………………….. (6,038)   (1,992)     (13,976)   (4,704) Selling and distribution expenses……………………………… (9,287)   (4,460)     (25,389)   (12,246) Other   expenses ………………………………………………………. (1,249)   (2)     (1,331)   (216) Fair value loss of convertible redeemable preferred                 shares   …………………………………………………………………. —   —     (79,984)   — Finance   costs …………………………………………………………. (90)   (82)     (4,169)   (139)   LOSS BEFORE TAX………………………………………………..   (67,054)     (27,792)       (249,867)     (68,688)   Income taxes credits / (expenses) …………………………….   508     (5)       4,217     (341)   LOSS FOR THE PERIOD………………………………………….   (66,546)     (27,797)       (245,650)     (69,029)

Attributable to:

Equity holders of the parent                                                           (66,546)                                                                                                                     (27,797)                                                                                                                                                  (245,650)                                                                                                                     (69,029)                           

LOSS PER SHARE ATTRIBUTABLE TO ORDINA RY EQUITY  HOLDERS  OF THE PARENT

Ordinary shares—basic                                                                            (0.25)                                                                                                            (0.14)                        (1.08)                                                                                                                        (0.35)

Ordinary shares—diluted                                                                         (0.25)                                                                                                                                       (0.14)                                                                                                                                       (1.08)                                                                                                                                       (0.35) ORDINA RY  SHARES USED IN LOSS PER SHARE

264,328,630         200,000,000         226,764,437          200,000,000      264,328,630   200,000,000   226,764,437   200,000,000

COMPUTATION

Ordinary shares—basic Ordinary shares—diluted

UNAUDITED  INTERIM CONDENSED  CONSOLIDATED STATEMENTS  OF FINANCIAL POSITION

AS AT SEPTEMBER  30, 2020 AND DECEMBER  31, 2019

September

(in thousands, US$)

30, 2020

(Unaudited)

December 31, 2019

NON-CURRENT ASSETS

Property, plant and equipment ………………………………………………………………………                                                                                                                                                          96,125                                                                                                                                                          70,079

Advance payments for property, plant and equipment …………………………………….                                                                                                                                                                675                                                                                                                                                                665

Right-of -use   assets ……………………………………………………………………………………..                                                                                                                                                             8,077                                                                                                                                                             9,348

Intangible     assets …………………………………………………………………………………………                                                                                                                                                                     1,042                                                                                                                                                                519                                                                                                                                                                   

Total   non-current   assets………………………………………………………………………………                                                                                                                                                        105,919                                                                                                                                                          80,611

CURRENT ASSETS

Inventories…………………………………………………………………………………………………..                                                                                                                                                             1,513                                                                                                                                                             1,157

Trade     receivables………………………………………………………………………………………..                                                                                                                                                                   —                                                                                                                           29,991

Prepayments, other receivables and other assets ………………………………………….                                                                                                                                                          24,662                                                                                                                                                          16,777

Financial assets at fair value through profit or loss …………………………………………                                                                                                                                                             1,175                                                                                                                                                                   —

Pledged    short-term  deposits…………………………………………………………………………                                                                                                                                                                430                                                                                                                                                                256

Time    deposits  ……………………………………………………………………………………………..                                                                                                                                                        125,559                                                                                                                                                          75,559

Cash and cash equivalents …………………………………………………………………………..                                                                                                                                                        449,381                                                                                                                                                          83,364

Total   current  assets …………………………………………………………………………………….                                                                                                                                                        602,720                                                                                                                                                        207,104

Total    assets ………………………………………………………………………………………………..                                                                                                                                                                708,639                                                                                                                                                        287,715                                                                                                                                                                   

CURRENT LIABILITIES

Trade and notes payables ……………………………………………………………………………                                                                                                                                                             7,399                                                                                                                                                             9,586

Other payables and accruals………………………………………………………………………..                                                                                                                                                          67,889                                                                                                                                                          70,854

Lease    liabilities …………………………………………………………………………………………….                                                                                                                                                             1,445                                                                                                                                                             1,027

Contract    liabilities …………………………………………………………………………………………                                                                                                                                                          46,789                                                                                                                                                          46,294

Total current liabilities …………………………………………………………………………………..                                                                                                                                                        123,522                                                                                                                                                        127,761

NON-CURRENT LIABILITIES

Contract    liabilities …………………………………………………………………………………………                                                                                                                                                        245,641                                                                                                                                                        277,765

Lease    liabilities …………………………………………………………………………………………….                                                                                                                                                             2,543                                                                                                                                                             5,058

Government    grants  ……………………………………………………………………………………..                                                                                                                                                                    2,033                                                                                                                                  — 

Total non-current liabilities…………………………………………………………………………….                                                                                                                                                        250,217                                                                                                                                                        282,823

Total    liabilities ………………………………………………………………………………………………                                                                                                                                                        373,739                                                                                                                                                        410,584

EQUITY

Share     capital……………………………………………………………………………………………….                                                                                                                                                                  26                                                                                                                                                                  20

Reserves   /  (deficits) …………………………………………………………………………………….                                                                                                                                                        334,874                                                                                                                                                     (122,889)

Total ordinary shareholders’ equity / (deficit) …………………………………………………                                                                                                                                                        334,900                                                                                                                                                     (122,869)

Total equity / (deficit) …………………………………………………………………………………..                                                                                                                                                        334,900                                                                                                                                                     (122,869)

Total liabilities and equity……………………………………………………………………………..                                                                                                                                                        708,639                                                                                                                                                        287,715

UNAUDITED  INTERIM CONDENSED  CONSOLIDATED STATEMENTS  OF CASH FLOWS FOR THE THREE  AND NINE MONTHS ENDED  SEPTEMBER  30, 2020 AND 2019

	Three months ended September 30	Nine months ended September 30
(in thousands, US$)	2020             2019  (Unaudited)   (Unaudited)	2020             2019  (Unaudited)   (Unaudited)
LOSS BEFORE TAX……………………………………………………………..	(67,054)                          (27,792)	(249,867)                             (68,688)
CASH FLOWS (USED IN)/GENERATE D  FROM OPERATI NG
ACTIVITIES……………………………………………………………………….	(64,375)                            19,947	(167,056)                             (23,078)
CASH FLOWS USED IN INVESTING  ACTIVITIES …………………..	(58,623)                          (21,194)	(85,334)                        (172,103)
CASH FLOWS FROM/(USED  IN) FINANCING  ACTIVITIES ……..	9,663                            (154)	618,221                             21,346
NET (DECREASE)/ INCREASE  IN CASH AND CASH
EQUIVALENTS………………………………………………………………….	(113,335)                               (1,401)	365,831                         (173,835)
Ef fect of foreign exchange rate changes, net …………………………..	325                           (44)	186                           (55)
Cash and cash equivalents at beginning of the period ……………..	562,391                             37,721	83,364                        210,166
CASH AND CASH EQUIVALENTS  AT END OF THE PERIOD….	449,381                             36,276	449,381                             36,276

ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS

Cash and bank balances ……………………………………………………….	575,370	147,592	575,370	147,592
Less: Pledged short-term deposits………………………………………….	430	255	430	255
Time deposits ……………………………………………………………….	125,559	111,061	125,559	111,061

Cash and cash equivalents as stated in the statement of

f inancial position………………………………………………………………..           449,381                                                                                                                                36,276                                                                                                                                449,381                                                                                                                                36,276

Cash and cash equivalents as stated in the statement of cash

f low s  ……………………………………………………………………………….        449,381                                                                                                                                36,276                                                                                                                                449,381                                                                                                                                36,276

Media and Investor Relations:

Jessie Yeung, Headof Corporate Finance and Investor Relations, Legend Biotech jessie.yeung@legendbiotech.com or  investor@legendbiotech.com

Surabhi Verma, Manager of Investor

Relations and Corporate Communications, Legend Biotech surabhi.verma@legendbiotech.com or  media@legendbiotech.com

For Medical Affairs inquiries, please contact:

Tonia Nesheiwat, Executive Director, Medical Affairs, Legend Biotech USA Inc. tonia.nesheiwat@legendbiotech.com or medicalinformation@legendbiotech.com

Source: Legend Biotech