I-Mab Reports Full Year 2023 Financial Results and Business Update
- Recently announced agreement to divest assets and business operations in
China marks an important milestone for the Company; the transaction is expected to close by the end ofMarch 2024 - Uliledlimab (CD73 antibody) on track to file an IND in combination with chemotherapy and checkpoint inhibitors for patients with newly diagnosed NSCLC in 1H 2024
- First patient dosed in an ongoing, triplet combination, dose escalation study of givastomig (CLDN18.2x4-1BB bispecific antibody) in 1Q 2024
RMB2.3 billion (US$321.8 million ) in cash and cash equivalents, and short-term investments as ofDecember 31, 2023
"2023 was a transitional year for
Pipeline Overview and Upcoming Milestones:
Uliledlimab: Phase 2, with a focus on non-small cell lung cancer (NSCLC)
Uliledlimab is designed to target CD73 and promote stronger activation of the patient's immune system against cancer cells. Uliledlimab is potentially differentiated from other products in development due to its non-competitive binding with adenosine monophosphate and the potential for complete inhibition of CD73's immune dampening function. Encouraging results from a Phase 2 study of uliledlimab in combination with toripalimab, presented at the
- Upon the receipt of the investigational new drug (IND) approval, the Company plans to initiate the triplet study for uliledlimab in combination with chemotherapy and checkpoint inhibitors in newly diagnosed patients with advanced NSCLC in the second half of 2024.
Givastomig (Claudin 18.2 x 4-1BB bispecific antibody): Phase 1b, with a focus on gastric cancer and esophageal adenocarcinoma
Givastomig was designed as a bispecific antibody to target Claudin 18.2-positive tumor cells, with conditional activation of pro-immune 4-1BB in the tumor microenvironment. Phase 1 monotherapy data presented at the
- The enrollment of patients from the
U.S. andChina with newly diagnosed (frontline treatment) gastric and esophageal cancer in combination with chemotherapy and a checkpoint inhibitor began in the first quarter of 2024.
Ragistomig (PD-L1 x 4-1BB bispecific antibody): Phase 1 dose escalation, with a focus on solid tumors
Ragistomig was designed as a bispecific antibody to address PD-L1 resistant tumors, differentiated by the conditional activation of 4-1BB's pro-immune stimulation when it binds to its PD-L1 target. Early observations reported by our development partner, ABL Bio, showed promising objective responses in patients with various solid tumors whose tumors progressed or recurred after prior standard treatments, including in patients with relapsed or refractory cancer after prior PD-L1 inhibitors. These early signs of efficacy are encouraging, and enrollment in the Phase 1 study continues. This program is being jointly developed with ABL Bio.
- Top-line Phase 1 dose escalation and dose expansion results are expected to be presented at a major medical conference in the first half of 2024.
Impact of Strategic Transaction on Pipeline
The agreement to divest assets and business operations in
As a result of the closing of the transaction, the Company will cease consolidation of the divested entities, assets, and businesses as well as their corresponding financial results. The Company's financial condition and results of operations will be materially affected and the Company's historical results will not be indicative of future financial condition or results of operations.
Full-Year 2023 Financial Results
Cash Position
As of
Share Buyback
In
Net Revenues
Total net revenues for the full year of 2023 were
Research & Development Expenses
Research and development expenses for the full year of 2023 were
Administrative Expenses
Administrative expenses for the full year of 2023 were
Other Expenses, Net
Net other expenses for the full year of 2023 were
Equity in Loss of Affiliates
Equity in loss of affiliates for the full year of 2023 was
Impairment of
For the full year of 2023, the Company recognized an impairment of goodwill of
Net Loss
Net loss for the full year of 2023 was
Non-GAAP Net Loss
Non-GAAP adjusted net loss, which excludes share-based compensation expenses and impairment of goodwill, for the full year of 2023 was
Use of Non-GAAP Financial Measures
To supplement its consolidated financial statements, which are presented in accordance with U.S. GAAP, the Company uses adjusted net income (loss) as a non-GAAP financial measure. Adjusted net income (loss) represents net income (loss) before share-based compensation and impairment of goodwill. The Company's management believes that adjusted net income (loss) facilitates understanding of operating results and provides management with a better capability to plan and forecast future periods. For more information on the non-GAAP financial measures, please see the table captioned "Reconciliation of GAAP and Non-GAAP Results" set forth at the end of this press release.
Non-GAAP information is not prepared in accordance with GAAP and may be different from non-GAAP methods of accounting and reporting used by other companies. The presentation of this additional information should not be considered a substitute for GAAP results. A limitation of using adjusted net income (loss) is that adjusted net income (loss) excludes share-based compensation expense and impairment of goodwill that has been and may continue to be incurred in the future.
Exchange Rate Information
This announcement contains translations of certain Renminbi amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars of the financial results for the year of 2023 are made at a rate of RMB7.0999 to US$1.00, the rate in effect as of December 29, 2023, published by the Federal Reserve Board. All translations from Renminbi to U.S. dollars of the financial results for the year of 2022 are made at a rate of RMB6.8972 to US$1.00, the rate in effect as of December 30, 2022 published by the Federal Reserve Board.
|
||||||
Consolidated Balance Sheets |
||||||
(All amounts in thousands, except for share and per share data, unless otherwise noted) |
||||||
As of |
As of |
|||||
2022 |
2023 |
|||||
RMB |
US$ |
RMB |
US$ |
|||
(Unaudited) |
(Unaudited) |
|||||
Assets |
||||||
Current assets |
||||||
Cash and cash equivalents |
3,214,005 |
465,987 |
2,141,445 |
301,616 |
||
Short-term restricted cash |
96,764 |
14,029 |
- |
- |
||
Short-term investments |
235,429 |
34,134 |
143,221 |
20,172 |
||
Prepayments and other receivables |
80,278 |
11,639 |
52,003 |
7,325 |
||
Total current assets |
3,626,476 |
525,789 |
2,336,669 |
329,113 |
||
Long-term restricted cash |
- |
- |
58,913 |
8,298 |
||
Property, equipment and software |
60,841 |
8,821 |
36,511 |
5,142 |
||
Operating lease right-of-use assets |
63,125 |
9,152 |
46,400 |
6,535 |
||
Intangible assets |
118,888 |
17,237 |
118,110 |
16,635 |
||
|
162,574 |
23,571 |
- |
- |
||
Investments accounted for using the equity method |
30,850 |
4,473 |
12,082 |
1,702 |
||
Other non-current assets |
10,911 |
1,582 |
4,282 |
603 |
||
Total assets |
4,073,665 |
590,625 |
2,612,967 |
368,028 |
||
Liabilities and shareholders' equity |
||||||
Current liabilities |
||||||
Short-term bank borrowings |
18,956 |
2,748 |
29,970 |
4,221 |
||
Accruals and other payables |
706,572 |
102,443 |
357,754 |
50,389 |
||
Operating lease liabilities, current |
23,961 |
3,474 |
21,890 |
3,083 |
||
Contract liabilities, current |
8,677 |
1,258 |
2,200 |
310 |
||
Total current liabilities |
758,166 |
109,923 |
411,814 |
58,003 |
||
Put right liabilities |
88,687 |
12,858 |
98,110 |
13,819 |
||
Contract liabilities, non-current |
267,878 |
38,839 |
292,124 |
41,145 |
||
Operating lease liabilities, non- current |
32,069 |
4,650 |
23,099 |
3,253 |
||
Other non-current liabilities |
16,963 |
2,459 |
69,664 |
9,811 |
||
Total liabilities |
1,163,763 |
168,729 |
894,811 |
126,031 |
||
Shareholders' equity |
||||||
Ordinary shares ( |
132 |
19 |
136 |
19 |
||
|
(21,249) |
(3,081) |
(82,509) |
(11,621) |
||
Additional paid-in capital |
9,579,375 |
1,388,879 |
9,830,082 |
1,384,538 |
||
Accumulated other comprehensive income |
213,794 |
30,997 |
298,291 |
42,013 |
||
Accumulated deficit |
(6,862,150) |
(994,918) |
(8,327,844) |
(1,172,952) |
||
Total shareholders' equity |
2,909,902 |
421,896 |
1,718,156 |
241,997 |
||
Total liabilities and shareholders' equity |
4,073,665 |
590,625 |
2,612,967 |
368,028 |
||
|
||||||||
Consolidated Statements of Comprehensive Loss |
||||||||
(All amounts in thousands, except for share and per share data, unless otherwise noted) |
||||||||
Year Ended |
||||||||
2022 |
2023 |
|||||||
RMB |
US$ |
RMB |
US$ |
|||||
(Unaudited) |
(Unaudited) |
|||||||
Revenues |
||||||||
Licensing and collaboration revenue |
(249,665) |
(36,198) |
16,814 |
2,368 |
||||
Supply of investigational products |
28,102 |
4,074 |
10,830 |
1,525 |
||||
Total revenues |
(221,563) |
(32,124) |
27,644 |
3,893 |
||||
Cost of revenues |
(27,237) |
(3,949) |
- |
- |
||||
Expenses |
||||||||
Research and development expenses (Note 1) |
(904,901) |
(131,198) |
(810,646) |
(114,177) |
||||
Administrative expenses (Note 2) |
(815,766) |
(118,275) |
(453,017) |
(63,806) |
||||
Loss from operations |
(1,969,467) |
(285,546) |
(1,236,019) |
(174,090) |
||||
Interest income |
26,908 |
3,901 |
51,749 |
7,289 |
||||
Interest expense |
(9) |
(1) |
(722) |
(102) |
||||
Other expenses, net |
(126,587) |
(18,353) |
(38,109) |
(5,368) |
||||
Equity in loss of affiliates (Note 3) |
(437,465) |
(63,426) |
(80,019) |
(11,270) |
||||
Impairment of goodwill |
- |
- |
(162,574) |
(22,898) |
||||
Loss before income tax expense |
(2,506,620) |
(363,425) |
(1,465,694) |
(206,439) |
||||
Income tax expense |
(697) |
(101) |
- |
- |
||||
Net loss attributable to |
(2,507,317) |
(363,526) |
(1,465,694) |
(206,439) |
||||
Net loss attributable to ordinary shareholders |
(2,507,317) |
(363,526) |
(1,465,694) |
(206,439) |
||||
Net loss attributable to |
(2,507,317) |
(363,526) |
(1,465,694) |
(206,439) |
||||
Foreign currency translation adjustments, net |
400,304 |
58,039 |
84,497 |
11,901 |
||||
Total comprehensive loss attributable to |
(2,107,013) |
(305,487) |
(1,381,197) |
(194,538) |
||||
Net loss attributable to ordinary shareholders |
(2,507,317) |
(363,526) |
(1,465,694) |
(206,439) |
||||
Weighted-average number of ordinary shares |
189,787,292 |
189,787,292 |
203,904,346 |
203,904,346 |
||||
Net loss per share attributable to ordinary |
||||||||
—Basic and diluted |
(13.21) |
(1.92) |
(7.19) |
(1.01) |
||||
Net loss per ADS attributable to ordinary |
||||||||
—Basic and diluted |
(30.38) |
(4.41) |
(16.54) |
(2.33) |
Notes:
(1) Includes share-based compensation expense of
(2) Includes share-based compensation expense of
(3) Includes share-based compensation expense of
(4) Each ten ADSs represents twenty-three ordinary shares.
|
||||||||
Reconciliation of GAAP and Non-GAAP Results |
||||||||
(All amounts in thousands, except for share and per share data, unless otherwise noted) |
||||||||
Year ended |
||||||||
2022 |
2023 |
|||||||
RMB |
US$ |
RMB |
US$ |
|||||
(Unaudited) |
(Unaudited) |
|||||||
GAAP net loss attributable to |
(2,507,317) |
(363,526) |
(1,465,694) |
(206,439) |
||||
Add back: |
||||||||
Share-based compensation |
371,000 |
53,789 |
197,817 |
27,862 |
||||
Impairment of goodwill |
- |
- |
162,574 |
22,898 |
||||
Non-GAAP adjusted net loss |
(2,136,317) |
(309,737) |
(1,105,303) |
(155,679) |
||||
Non-GAAP adjusted loss |
(2,136,317) |
(309,737) |
(1,105,303) |
(155,679) |
||||
Weighted-average number of |
189,787,292 |
189,787,292 |
203,904,346 |
203,904,346 |
||||
Non-GAAP adjusted loss per |
||||||||
—Basic and diluted |
(11.26) |
(1.63) |
(5.42) |
(0.76) |
||||
Non-GAAP adjusted loss per |
||||||||
—Basic and diluted |
(25.90) |
(3.75) |
(12.47) |
(1.76) |
About I-Mab
I-Mab Forward Looking Statements
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the
For more information, please contact:
I-Mab Contacts
Senior Director, Investor Relations |
Chief Communications Officer |
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