On August 15, 2023 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported its unaudited financial results for the three and six months ended June 30, 2023 (Press release, Legend Biotech, AUG 15, 2023, View Source [SID1234634440]).
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In addition to financial performance, Legend Biotech reported on the success of its portfolio and pipeline, including the CARTITUDE clinical development program for CARVYKTI, in collaboration with the Janssen Biotech, Inc. (Janssen).
Initial data from the CARTITUDE-4 study presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) supported recent submissions to U.S. and E.U. regulatory agencies by Janssen to expand the indication of CARVYKTI into earlier treatment of patients (1-3 prior lines of therapy) with relapsed or refractory multiple myeloma.
"We remain committed to exploring the full potential of CARVYKTI and are pleased with the continued growth of our development program, including two regulatory submissions made during the second quarter," said Ying Huang, Chief Executive Officer of Legend Biotech. "Following our most recent fundraising, we are well positioned to advance our pipeline and portfolio. We remain grateful to the investors who support our endeavors."
Financial Results for Quarter Ended June 30, 2023
Cash and Cash Equivalents, Time Deposits, and Short-Term Investments
As of June 30, 2023, after giving effect to the registered direct offering, private placements or warrant exercise noted above, Legend Biotech had approximately $1.5 billion of cash and cash equivalents, time deposits, and short-term investments.
Revenue
License Revenue
License revenue for the three months ended June 30, 2023 was $15.1 million due to the achievement of a milestone during the quarter, compared to no milestones achieved during the three months ended June 30, 2022. License revenue for the six months ended June 30, 2023 was $15.1 million, compared to $50 million for the six months ended June 30, 2022. This decrease of $34.9 million was primarily driven by the nature and timing of milestones achieved as outlined in the Global Development Plan under the Janssen Agreement for cilta-cel six months ended June 30, 2023.
Collaboration Revenue
Collaboration revenue for the three and six months ended June 30, 2023 was $58.2 million and $94.4 million, respectively, compared to $11.9 million for the three and six months ended June 30, 2022. The increases of $46.3 million and $82.5 million for the three and six-month periods, respectively, were due to an increase in revenue generated from sales of CARVYKTI in connection with the Janssen Agreement.
Operating Expenses
Collaboration cost of revenue
Collaboration cost of revenue for the three and six months ended June 30, 2023 was $32.7 million and $68.3 million, respectively, compared to $16.9 million for the three and six months ended June 30, 2022. The increases of $15.7 million and $51.3 million for the three and six months ended, respectively were 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 and six months ended June 30, 2023 were $95.8 million and $180.7 million, respectively, compared to $68.8 million and $150.4 million for the three and six months ended June 30, 2022, respectively. The increases of $27.0 million and $30.3 million for the three and six-month periods, respectively, were primarily due to continuous research and development activities in cilta-cel, including higher patient enrollment for Phase 3 clinical trials for cilta-cel, and an increase in research and development activities for other pipeline items. The other pipeline expenses include continued investment in our solid tumor programs, which include two IND approvals that advanced into phase 1 development.
Administrative Expenses
Administrative expenses for the three and six months ended June 30, 2023 were $27.8 million and $50 million, respectively, compared to $18.1 million and $30.7 million for the three and six months ended June 30, 2022, respectively. The increases of $9.7 million and $19.3 million for the three and six-month periods, respectively, were primarily due to the expansion of supporting administrative functions to facilitate continuous business growth and continued investment in building global information technology infrastructure.
Selling and Distribution Expenses
Selling and distribution expenses for the three and six months ended June 30, 2023 were $21.4 million and $39.4 million, respectively, compared to $27.4 million and $48.7 million for the three and six months ended June 30, 2022. The decrease of $6 million and $9.4 million were primarily due to non-recurring launch expenses incurred in the first half of 2022 to support the commercialization in the U.S market.
Other Income and Gains
Other income and gains for the three and six months ended June 30, 2023 were $16.4 million and $21 million, respectively, compared to $1.9 million and $2.9 million for the three and six months ended June 30, 2022, respectively. The increase of $14.5 million in the three months ended June 30, 2023 compared to the three months ended June 30, 2022 was primarily attributable to approximately a $10.9 million increase in interest income and gain on investment, as well an increase of approximately $3.6 million in foreign currency exchange gain. The increase of $18.1 million for the six month period ended June 30, 2023 compared to the six months ended June 30, 2022 was primarily due to an increase in interest income and gain on investments.
Other Expenses
Other expenses for the three and six months ended June 30, 2023 were $0.02 million and $7.1 million, respectively, compared to $8.1 million and $9.6 million for the three and six months ended June 30, 2022. The decrease in both comparative periods was primarily due to a decrease in foreign currency exchange loss.
Finance Costs
Finance costs for the three and six months ended June 30, 2023 were $5.2 million and $10.3 million, respectively, compared to $1.6 million and $2.7 million for the three and six months ended June 30, 2022. The increase in both comparative periods was primarily due to interest on advance funding, which is interest-bearing borrowings funded by Janssen under the Janssen Agreement and constituted of principal and applicable interests upon such principal.
Fair Value Loss of Warrant Liability
Fair value loss of warrant liability for the six months ended June 30, 2023 was $85.8 million, compared to a fair value loss of $31 million for the six months ended June 30, 2022. The increase was due to the fair value loss recorded on the full exercise of the warrant, which took place on May 11, 2023.
Loss for the Period
For the three months ended June 30, 2023, net loss was $199.1 million, or $0.57 per share, compared to net loss of $193.2 million, or $0.62 per share, for the three months ended June 30, 2022. For the six months ended June 30, 2023, net loss was $311.2 million, or $0.91 per share, compared to a net loss of $225.5 million, or $0.73 per share, for the six months ended June 30, 2022.
Webcast/Conference Call Details:
Legend Biotech will host its quarterly earnings call and webcast today at 8:00am ET. To access the webcast, please visit this weblink.
A replay of the webcast will be available on Legend Biotech’s website at View Source