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Legend Biotech Reports First Quarter 2023 Results and Recent Highlights

  • New and updated data from the CARTITUDE Clinical Development Program and LEGEND-2 study evaluating ciltacabtagene autoleucel (cilta-cel) will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association’s (EHA) 2023 Hybrid Congress
  • $350 million in gross proceeds raised in a registered direct offering
  • $212 million in gross proceeds raised from private placements
  • Gross proceeds of $200 million received from the exercise of warrant issued in May 2021
  • Strategic advisory board established with the appointments of John Maraganore, Ph.D., former CEO of Alnylam Pharmaceuticals and Michel Vounatsos, former CEO of Biogen Inc. as advisors
  • Mythili Koneru, M.D., Ph.D. appointed as Company’s Chief Medical Officer

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 first quarter 2023 unaudited financial results.

"We are extremely pleased to announce that we have recently raised $762 million in funding. With this substantial capital infusion, we are poised to embark on a critical chapter in our company’s growth to advance CARVYKTI® toward its full potential, and we look forward to presenting the latest data from our CARTITUDE clinical development programs at ASCO and EHA this June," said Ying Huang, Chief Executive Officer of Legend Biotech. Dr. Huang continued, “We would like to extend our deepest gratitude to our investors for their overwhelming support and confidence in our company’s mission and remain committed to creating long-term value for all of our stakeholders.”

Financial Results for Quarter Ended March 31, 2023

Cash and Cash Equivalents, Time Deposits, and Short-Term Investments

As of March 31, 2023, prior to giving effect to the registered direct offering, private placements or warrant exercise noted above, Legend Biotech had approximately $854 million of cash and cash equivalents, time deposits, and short-term investments.

Revenue

Total revenue for the three months ended March 31, 2023 was $36.3 million compared to $50.0 million for the three months ended March 31, 2022. Collaboration revenue recognized in the first quarter of 2023 was from CARVYKTI® sales primarily in the U.S. License revenue recognized in first quarter of 2022 was due to the achievement of commercial milestone for FDA approval in the U.S. in connection with the license and collaboration agreement (the “Janssen Agreement”) with Janssen Biotech, Inc. (“Janssen”).

Collaboration Cost of Revenue

Collaboration cost of revenue for the three months ended March 31, 2023 was $35.6 million. Legend Biotech did not have any collaboration cost of revenue in the three months ended March 31, 2022. The $35.6 million is a combination of Legend’s portion of collaboration cost of sales in connection with collaboration revenue under the Janssen Agreement along with expenditures to support the manufacturing capacity expansion which cannot be capitalized.

Research and Development Expenses

Research and development expenses for the three months ended March 31, 2023 were $84.9 million compared to $81.5 million for the three months ended March 31, 2022. This increase of $3.4 million was primarily due to higher patient enrollment for Phase 3 clinical trials for cilta-cel in the first quarter of 2023.

Administrative Expenses

Administrative expenses for the three months ended March 31, 2023 were $22.2 million compared to $12.7 million for the three months ended March 31, 2022. The increase of $9.5 million was primarily due to continued investment in building global information technology infrastructure along with non-recurring financial and legal fees related to Legend Biotech’s restatement of its historical financial statements as reported by Legend Biotech in February 2023.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended March 31, 2023 were $18.0 million compared to $21.3 million for the year three months ended March 31, 2022. This decrease of $3.3 million was primarily due to non-recurring launch expenses incurred in the first quarter of 2022 to support the commercialization in the U.S market.

Other Income and Gains

Other income and gains for the three months ended March 31, 2023 were $8.2 million compared to $1.0 million for the three months ended March 31, 2022. The increase of $7.2 million was primarily due to increase in interest income and gain on investments.

Other Expenses

Other expenses for the three months ended March 31, 2023 were $10.7 million compared to $1.5 million for the three months ended March 31, 2022. The increase was primarily due to unrealized foreign currency exchange loss in the quarter.

Finance Costs

Finance costs for the three months ended March 31, 2023 were $5.1 million compared to $1.0 million for the three months ended March 31, 2022. 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.

Fair Value Gain of Warrant Liability

Fair value gain of warrant liability for the three months ended March 31, 2023 was $20.0 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 $47.0 million as of March 31, 2023. On May 12, 2023, Legend Biotech announced that the warrant had been exercised in full.

Loss for the Period

For the three months ended March 31, 2023, net loss was $112.1 million, or $0.34 per share, compared to a net loss of $32.3 million, or $0.10 per share, for the three months ended March 31, 2022.

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®, including Legend Biotech’s expectations for CARVYKTI®, such as Legend Biotech’s manufacturing and commercialization expectations for CARVYKTI® and the potential effect of treatment with CARVYKTI®; 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; the ability to generate, analyze and present data from clinical trials; expected results of clinical trials; and the potential benefits of Legend Biotech’s product candidates. 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 29, 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

 

 

 

Three months

ended March 31,

2023

 

Three months

ended March 31,

2022

 

 

US$’000, except

per share data

 

US$’000, except

per share data

 

 

(Unaudited)

 

(Unaudited)

REVENUE

 

 

 

 

License revenue

 

 

50,000

Collaboration revenue

 

36,280

 

Other revenue

 

56

 

40

Total revenue

 

36,336

 

50,040

Collaboration cost of revenue

 

(35,613)

 

Other income and gains

 

8,199

 

1,012

Research and development expenses

 

(84,889)

 

(81,548)

Administrative expenses

 

(22,205)

 

(12,657)

Selling and distribution expenses

 

(17,954)

 

(21,302)

Other expenses

 

(10,734)

 

(1,527)

Fair value gain/(loss) of warrant liability

 

20,000

 

34,900

Finance costs

 

(5,113)

 

(1,044)

LOSS BEFORE TAX

 

(111,973)

 

(32,126)

Income tax (expense)/credit

 

(128)

 

(163)

LOSS FOR THE PERIOD

 

(112,101)

 

(32,289)

Attributable to:

 

 

 

 

Ordinary equity holders of the parent

 

(112,101)

 

(32,289)

LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT

 

 

 

 

Basic

 

(0.34)

 

(0.10)

Diluted

 

(0.34)

 

(0.10)

ORDINARY SHARES USED IN LOSS PER SHARE COMPUTATION

 

 

 

 

Basic

 

330,497,072

 

308,699,034

Diluted

 

330,497,072

 

308,699,034

LEGEND BIOTECH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

 

 

 

March 31,

2023

 

December 31,

2022

 

 

 

US$’000

 

US$’000

 

 

 

(Unaudited)

 

Audited

 

NON-CURRENT ASSETS

 

 

 

 

 

Property, plant and equipment

 

110,045

 

105,168

 

Advance payments for property, plant and equipment

 

2,193

 

914

 

Right-of-use assets

 

80,459

 

55,590

 

Time deposits

 

4,366

 

 

Intangible assets

 

2,289

 

3,409

 

Collaboration prepaid leases

 

93,548

 

65,276

 

Other non-current assets

 

1,062

 

1,487

 

Total non-current assets

 

293,962

 

231,844

 

CURRENT ASSETS

 

 

 

 

 

Collaboration inventories

 

12,176

 

10,354

 

Trade receivables

 

56

 

90

 

Prepayments, other receivables and other assets

 

51,761

 

61,755

 

Financial assets at fair value through profit or loss

 

185,705

 

185,603

 

Pledged deposits

 

1,283

 

1,270

 

Time deposits

 

4,366

 

54,016

 

Cash and cash equivalents

 

660,050

 

786,031

 

Total current assets

 

915,397

 

1,099,119

 

Total assets

 

1,209,359

 

1,330,963

 

CURRENT LIABILITIES

 

 

 

 

 

Trade payables

 

29,811

 

32,893

 

Other payables and accruals

 

146,378

 

184,109

 

Government grants

 

457

 

451

 

Lease liabilities

 

4,595

 

3,563

 

Tax payable

 

9,940

 

9,772

 

Warrant liability

 

47,000

 

67,000

 

Total current liabilities

 

238,181

 

297,788

 

NON-CURRENT LIABILITIES

 

 

 

 

 

Collaboration interest-bearing advanced funding

 

265,864

 

260,932

 

Lease liabilities long term

 

44,302

 

20,039

 

Government grants

 

7,631

 

7,659

 

Other non-current liabilities

 

224

 

233

 

Total non-current liabilities

 

318,021

 

288,863

 

Total liabilities

 

556,202

 

586,651

 

EQUITY

 

 

 

 

 

Share capital

 

33

 

33

 

Reserves

 

653,124

 

744,279

 

Total ordinary shareholders’ equity

 

653,157

 

744,312

 

Total equity

 

653,157

 

744,312

 

Total liabilities and equity

 

1,209,359

 

1,330,963

 

LEGEND BIOTECH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

 

 

 

Three months ended

March 31, 2023

 

Three months ended

March 31, 2022

 

 

US$’000

 

US$’000

 

 

(Unaudited)

 

(Unaudited)

LOSS BEFORE TAX

 

(111,973)

 

(32,126)

CASH FLOWS USED IN OPERATING ACTIVITIES

 

(141,053)

 

(78,687)

CASH FLOWS USED IN INVESTING ACTIVITIES

 

17,930

 

(232,500)

CASH FLOWS FROM FINANCING ACTIVITIES

 

(286)

 

25

NET DECREASE IN CASH AND CASH EQUIVALENTS

 

(123,409)

 

(311,162)

Effect of foreign exchange rate changes, net

 

(2,572)

 

10

Cash and cash equivalents at beginning of the period

 

786,031

 

688,938

CASH AND CASH EQUIVALENTS AT END OF THE PERIOD

 

660,050

 

377,786

ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS

 

 

 

 

Cash and bank balances

 

670,065

 

667,465

Less: Pledged deposits

 

1,283

 

1,448

Time deposits

 

8,732

 

288,231

Cash and cash equivalents as stated in the statement of financial position

 

660,050

 

378

Cash and cash equivalents as stated in the statement of cash flows

 

660,050

 

377,786

 

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