Legend Biotech Reports Full-Year 2022 Results and Recent Highlights

Mar 30, 2023

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.— 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 very 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