Building a Global
Biopharma Leader
May 2024
Forward-Looking Statements
This presentation contains forward-looking statements relating to our strategy and plans; potential of and expectations for our business and pipeline programs; our goals and expectations under our growth strategy (including our expectations regarding our commercial-stage products, clinical-stageglobal-right products, revenue growth / CAGR, profitability and timeline to profitability, operating margins, and cash flow); the peak sales potential of our programs; capital allocation and investment strategy; clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development, commercialization and outreach; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the expected benefits and potential of investments, collaborations, and business development activities; our future financial and operating results; and financial guidance. All statements, other than statements of historical fact, included in this presentation are forward-looking statements, and can be identified by words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "target," "will," "would," and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance.
Forward-looking statements are based on our expectations and assumptions as of the date of this presentation and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives,
- the results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors discussed in our most recent annual and quarterly reports and other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation.
Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC's website at http://www.sec.gov. This presentation does not constitute an offer to sell or the solicitation of an offer to buy any securities of Zai Lab Limited.
2
1Q 2024 Results
and Corporate Updates
Key Accomplishments in 1Q 2024 - Commercial Excellence
1Q 2024 | Continued growth momentum is expected in 2024… |
Product Revenue ($M) | First Quarter Sales | $ 1 3 . 2 M | ||||
post NRDL Inclusion | (vs. nil in 1Q'23) | |||||
+39% Y/Y | ✓ Expect >$70 million in revenue in 2024 | |||||
(+43% CER*) | ||||||
✓ Strong NRDL landing |
87.1 | |
62.8 | |
1Q'23 | 1Q'24 |
$ 4 5 . 5 M | $ 1 2 . 5 M |
(+7% Y/Y, +9% Q/Q) | (-6% Y/Y, +49% Q/Q) |
• Increased hospital sales in 1L OC and | • Recovery of patient volume vs. 4Q'23 |
increased DoT | |
$ 6 . 1 M | $ 9 . 9 M |
(+367% Y/Y, +30% Q/Q) | (+81% Y/Y, +63% Q/Q) |
• NRDL inclusion for 4L GIST in 1Q'23 | • NRDL inclusion for ABSSSI and CABP - |
IV in 1Q'23 and oral formulation in 1Q'24 |
Abbreviations: Year-over-year (Y/Y), quarter-over-quarter (Q/Q), China's national reimbursement drug list (NRDL), ovarian cancer (OC), duration of treatment (DoT), first-line (1L), fourth-line (4L), gastrointestinal | |
4 | stromal tumors (GIST), acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP), intravenous (IV). |
Notes: *Constant exchange rate, or CER, revenue growth is a non-GAAP measure. The trademarks and registered trademarks within are property of their respective owners. |
Key Accomplishments in 1Q 2024 - Regulatory / Clinical Highlights
Product Approval /
Regulatory Advancement
-
sBLA submission
SC efgartigimod in CIDP -
3 regulatory reviews ongoing
SUL-DUR in ABC1 with priority review
Repotrectinib in ROS1+ NSCLC with priority review
SC efgartigimod in gMG
Late-Stage Pipeline Update
-
Positive data readouts
KarXT (schizophrenia): Positive long-term efficacy, safety and metabolic outcomes
TTFields (1L NSCLC brain-met): Met primary endpoint
TIVDAK (r/m cervical cancer): Full approval granted by FDA based on positive results from global Ph3 study
Global Pipeline Update
-
Global Ph1 studies ongoing
ZL-1310(DLL3 ADC) in 2L+ SCLC ZL-1218(CCR8) in solid tumors - Presentations at medical conferences2
Abbreviations: Sulbactam-durlobactam(SUL-DUR), Tumor Treating Fields (TTFields), acinetobacter baumannii-calcoaceticus complex (ABC), subcutaneous (SC), non-small cell lung cancer (NSCLC), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), antibody-drug conjugate (ADC), small cell lung cancer (SCLC), supplemental Biologics License Application (sBLA), generalized myasthenia gravis (gMG), recurrent or metastatic (r/m).
Notes: The trademarks and registered trademarks within are property of their respective owners. (1) hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex; (2) In April 2024, Zai Lab presented posters highlighting the ongoing global Phase 1 studies of ZL-1310 and ZL-1218 at the American Association for Cancer Research (AACR) Annual Meeting, respectively. In March 2024, Zai Lab presented
5 findings from preclinical studies highlighting the therapeutic potential of ZL-1310 at the European Lung Cancer Congress (ELCC) 2024.
VYVGART - Strong Start in 2024
Setting New Standards in
Efficacy and Safety
45% MSE
QoL comparable to healthy
population
Superior cost/benefit
over IVIg
No clinically meaningful reductions in albumin and no increases in LDL cholesterol
Strong Commercial Execution
Nearly 2,700 est. new
patients treated in Q1'24
~150 dedicated sales
representatives post-NRDL
~1,000 hospitals reached by
salesforce, accounting for >80%
addressable patient population
Abbreviations: Minimal Symptom Expression (MSE), Quality of life (QoL), Low-Density Lipoprotein (LDL).
Sources: ADAPT and ADAPT+ clinical trial data; real world evidence.
Note: The trademarks and registered trademarks within are property of their respective owners.
Efgartigimod - A Pipeline-In-A-Product Opportunity
Efgartigimod Today
- gMG (SC) - Under regulatory review in China
- CIDP - sBLA submitted in China
- TED - To join global Phase 3 study in H2'24
- 5 POC data readouts in
2024 - LN, MN - POC trials ongoing
Potential Launch in | Potential Launch in | Opportunities in |
gMG (SC) - 2024 | CIDP - 2025 | 2025+ |
gMG | 170K | CIDP | 50K | BP | 60K |
TED 760K
LN 280K
Department focus | MN | 150K | ||
Neurology | Derma & | Ophthalmology | Potential New | |
Rheumatology | & Endocrinology | Indications | ||
Abbreviations: Generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), thyroid eye disease (TED), proof of concept (POC), lupus nephritis (LN), membranous nephropathy (MN), bullous pemphigoid (BP), subcutaneous (SC), supplemental Biologics License Application (sBLA).
7 Source: China patient numbers are from Zai Lab market research.
Potential Product Approvals / Launches in 2024
Potential Best-in-Class ROS1/NTRK Inhibitor
Unmet Needs & Market Potential in China
- ROS1 Prevalence: 2~3% of NSCLC patients1
- No approved ROS1 TKI for TKI-pretreatedROS1+ NSCLC
- Opportunity to roughly double the ROS1 market & achieve best-in-classshare based on:
- Higher response rate
- Longer duration of response2
- Clinically differentiated profile in NSCLC (TKI-pretreatedactivity and CNS activity)
- Well-toleratedand manageable
safety profile
First Pathogen-Targeted Therapy Addressing
Deadly Acinetobacter Baumannii
Unmet Needs & Market Potential in China
- ~300,000 Acinetobacter infections3
-
High and rising carbapenem-resistant rate:
54% (CARSS)3 / 75% (CHINET)4 - Limited therapeutic options: Polymyxin-basedpolypharmacy, colistin (drug of last resort, associated with nephrotoxicity)
- Mortality ~43% with best available therapy5
- A novel therapeutic option with:
- Statistically higher clinical cure rate
- Favorable safety profile
Notes: The trademarks and registered trademarks within are property of their respective owners. (1) Clinical and the prognostic characteristics of lung adenocarcinoma patients with ROS1 fusion in comparison with other driver mutations in East Asian
populations, 2014; and Frost & Sullivan; (2) Augtyro Prescribing Information. Augtyro U.S. Product Information. Last updated: November 2023. Princeton, NJ: Bristol Myers Squibb Company; (3) 2022 Annual Report of China Antimicrobial Resistance Surveillance System (CARSS) published in November 2023; (4) Report of China Antimicrobial Surveillance Network (CHINET) in 2023; (5) Mohd 2021Sazlly Lim S,et al. The global prevalence of multidrug-resistance among Acinetobacter baumannii
8 causing hospital-acquired and ventilator-associated pneumonia and its associated mortality: A systematic review and meta-analysis. J Infect. 2019 Dec;79(6):593-600.
Sources: Bristol Myers Squibb presentation, January 2023; Zai Lab analysis.
Key 2024 Priorities, Milestones and Catalysts
Commercial Execution
- VYVGART ramp-up in gMG post-NRDL
- Maintain ZEJULA leadership in ovarian cancer
- Continue to grow supplemental insurance plan coverage support for Optune GIO
Clinical Development
- Bemarituzumab in two Ph3 trials
- KarXT bridging confirmatory study in China
- ZL-1102(IL-17 Humabody®) moving into full global Ph2 development
- Continue to enroll patients in global Ph1 study for ZL- 1310 (DLL3 ADC)
Clinical Data and Regulatory Actions
Potential China approvals
- SUL-DUR(ABC)
- SC efgartigimod (gMG)
- Repotrectinib (ROS1+ NSCLC)
Planned China submissions
- SC efgartigimod (CIDP)
- TTFields (2L+ NSCLC)
Key clinical data
- TTFields (1L NSCLC BM)
- TTFields (1L pancreatic cancer)
9 | Abbreviations: National reimbursement drug list (NRDL), non-small cell lung cancer (NSCLC), brain metastases from NSCLC (NSCLC BM), acinetobacter baumannii-calcoaceticus complex (ABC), chronic inflammatory |
demyelinating polyradiculoneuropathy (CIDP), generalized myasthenia gravis (gMG). |
Zai Lab Corporate Vision
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Zai Lab Ltd. published this content on 09 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 May 2024 04:02:06 UTC.