May 13, 2024
First Quarter 2024
Financial Results & Corporate Update
This presentation is for investor relations purposes only - Not for product promotional purposes
Forward-looking Statements
This presentation has been prepared by Legend Biotech Corporation ("Legend Biotech" or the "Company") solely for information purpose and does not contain all relevant information relating to the Company.
The safety and efficacy of the agents and/or uses under investigation discussed in this presentation have not been established, except to the extent specifically provided by marketing authorizations previously received from relevant health authorities. Further, for investigational agents and/or uses, the Company cannot guarantee health authority approval or that such agents and/or uses will become commercially available in any country.
Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and Legend Biotech's own internal estimates and research. While Legend Biotech believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. While Legend Biotech believes its internal research is reliable, such research has not been verified by any independent source.
Statements in this presentation 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® (ciltacabtagene autoleucel; cilta- cel), including patient population of CARVYKTI®, Legend Biotech's expectations for
CARVYKTI®, including manufacturing expectations for CARVYKTI®; and statements about regulatory submissions for CARVYKTI®, and the progress of such submissions with the FDA, the EMA and other regulatory authorities; and expected results and timing of clinical trials; Legend Biotech's expectations for LB2102 and its potential benefits; the potential benefits of
the licensing transaction; Legend Biotech's expectations on advancing their pipeline and product portfolio; 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 for the year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on March 19, 2024 and Legend Biotech's other filings with the SEC.
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 presentation as anticipated, believed, estimated or expected. Any forward-looking statements contained in this presentation speak only as of the date of this presentation. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
2 This presentation is for investor relations purposes only - Not for product promotional purposes
Agenda
- Opening Remarks
- Q1 2024 Performance Overview
- Our Pipeline
- Financial Performance
- Upcoming Milestones
- Q&A
3 This presentation is for investor relations purposes only - Not for product promotional purposes
Forward-looking Statements
Ying Huang, PhD | Lori Macomber |
Chief Executive Officer | Chief Financial Officer |
4 This presentation is for investor relations purposes only - Not for product promotional purposes
Business Highlights
C O N T I N U E D P R O G R E S S A G A I N S T O U R S T R AT E G I C P R I O R I T I E S
Establishing a strong
foundation for CARVYKTI®
market penetration
- Achieved net trade sales of $157 million for Q1 2024
-
Received FDA approval for label expansion to treat 2L+
MM - Received EC approval for label expansion to treat 2L+ MM
- Received approval in Brazil for 2L+ treatment of RRMM
Strengthening our | Unlocking value across |
manufacturing capabilities | our broader pipeline |
• Entered into Master | • Continued to advance early- |
Manufacturing and Supply | stage pipeline candidates |
Services Agreement with | across hematologic and solid |
Novartis Pharmaceuticals | tumor indications |
Corporation |
- Continued industry leading launch performance for
CARVYKTI® - Wider release specification approved by the FDA following earlier lines approval
- On track for annualized capacity of 10,000 slots by end of 2025
Maintaining a solid financial position to fund sustainable growth
- Cash position of $1.3 billion and growing revenues expected to fund operating and capital expenditures into 2026, when we expect to begin to achieve an operating profit
- Achieved a $45 million milestone payment on April 5 for FDA's approval
of CARVYKTI® label expansion to treat 2L+ MM - Published inaugural ESG report
Published inaugural ESG report aligned to SASB sector standards
5 | This presentation is for investor relations purposes only - Not for product promotional purposes |
CARVYKTI® Regulatory Approval Progress
- Approved for patients with RRMM in:
-
U.S. (2L+)* - first and only BCMA-targeted therapy approved by
FDA for treatment of 2L+ MM - E.U. (2L+)*
- Brazil (2L+)*
- Japan (4L+)
-
U.S. (2L+)* - first and only BCMA-targeted therapy approved by
- Supported by extensive, long-term clinical data available across multiple lines of therapy for MM
Commercially available in US, Germany, Austria and Brazil
Well-positioned to build upon existing commercial footprint to continue growing market share
*Based on CARTITUDE-4 data demonstrating statistically significant and clinically meaningful improvement in progression free survival with CARVYKTI over SOC
6 | This presentation is for investor relations purposes only - Not for product promotional purposes |
Unleashing the Strength of CARVYKTI®
is a potential Best-in-Class CAR T approved in MM
• Entered into a Master Manufacturing and Supply Services Agreement with Novartis1 to | |
On track to reach 10,000 | supplement existing manufacturing capabilities, increase commercial supply, and |
meet global demand of CARVYKTI® | |
annual dose capacity of | |
• Plan to double YE2023 CARVYKTI® capacity by the end of 2024 | |
CARVYKTI® by end of 2025 | |
• Wider release specification approved by the FDA following earlier lines approval |
Reliable manufacturing and economic advantages
Increased our capacity | Industry leading early | Expanded CMO | Significant improvement in | Over 140K square feet of |
100% since beginning | launch performance | relationship with Novartis1 | manufacturing success | manufacturing space |
of 2023 | to include commercial | rate | across facilities in | |
supply through 2029 | strategic geographies |
Treated 2,700+ patients across 90+ ATCs2 globally
1. Novartis Pharmaceuticals Corporation | |
8 | 2. ATC - Authorized treatment center |
This presentation is for investor relations purposes only - Not for product promotional purposes
US and EU CARVYKTI® Supply Overview
GLOBAL CAPACITY ROADMAP
G L O B A L C A P A C I T Y R A M P U P
- Increase Current Raritan Output
- Add Supply Nodes
- Ramp Plants to Full Capacity
- Additional Facility Expansion
Launch
→ Process Optimization
Raritan Slot
Ramp Up
Tech Lane
Online
Obelisc
Online
Raritan Physical
Expansion
CMO Online
Facilities
Expansion/Process
Optimization
Facilities Driving
To Full Capacity
1H22 | 2H22 | 1H23 | 2H23 | 1H24 | 2H24 | 1H25 | 2H25 | 1H26 | 2H26 | 1H27 | 2H27 | 2028 | 2029 | 2030 |
9This presentation is for investor relations purposes only - Not for product promotional purposes
CARVYKTI® Uptake Continues
Continued market penetration, population in earlier lines of treatment represents significant opportunity for continued growth
180
160
140
120
100
80
60
40
20
0
CARVYKTI® Net Trade Sales ($MM)
+118% growth vs Q1'23
12 | 13 | ||
3 | |||
146 | |||
140 | |||
2 | |||
0 | 0 | 114 | |
70
0 55 55
24
YoY Growth | QoQ Growth | |
U.S. | 100% | -4% |
EU | 700% | 23% |
Global | 118% | -1% |
16
140
- U.S. QoQ decline of 4% primarily driven by phasing and timing of delivery and billing of orders
- Number of activated U.S. treatment sites increased to 72
- EU QoQ growth of 23% primarily due to ongoing launch in Germany and Austria
Q2 2022 Q3 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 Q4 2023 Q1 2024
U.S. EU
10This presentation is for investor relations purposes only - Not for product promotional purposes
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Legend Biotech Corporation published this content on 13 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 May 2024 11:11:03 UTC.