I-Mab Reports Full Year 2023 Financial Results and Business Update
- Positive clinical results for uliledlimab and givastomig in oncology were highlighted in the PR.
- Strategic divestiture agreement in China to transfer assets and business operations by March 2024.
- Financial results for 2023 show a decrease in net loss, with total net revenues of RMB27.6 million.
- Cash position decreased to RMB2.3 billion by the end of 2023, compared to RMB3.5 billion in 2022.
- Share buyback program authorized, with US$8.6 million repurchased by December 31, 2023.
- Non-GAAP adjusted net loss for 2023 was RMB1,105.3 million, showing improvement from 2022.
- The strategic divestiture may impact the Company's future financial results and operations.
- Net revenues for 2023 were relatively low compared to previous years.
- A significant decrease in cash position from 2022 to 2023 raises concerns about liquidity.
- The share buyback program may not have a substantial impact on improving financial performance.
- Continued net losses and impairment of goodwill reflect ongoing challenges for the Company.
Insights
The divestiture of I-Mab's assets and operations in China is a strategic move that can have significant implications for the company's financial health. By offloading these assets, I-Mab is poised to reduce its future development costs, which is a positive step towards financial streamlining. The potential receipt of up to US$80 million contingent on the Hangzhou Company's performance could provide a non-operational cash influx, enhancing I-Mab's liquidity position.
However, the discontinuation of consolidation of the divested entities may lead to a material change in reported financials. Investors should closely monitor how these changes impact the company's balance sheet and income statement. The extinguishment of the US$183 million repurchase obligations will improve the liabilities side of the balance sheet, potentially leading to a stronger financial position.
From a stock market perspective, the transaction could be received positively if investors believe the move will focus I-Mab's efforts on more promising assets and markets. However, any delays or hiccups in the transaction's completion could create uncertainty that may affect stock performance.
The pipeline updates provided by I-Mab indicate a robust focus on developing treatments for various cancers, with uliledlimab and givastomig leading the way. The progress into Phase 2 and Phase 1b studies respectively suggests that I-Mab is moving forward in the clinical development process, which is critical for eventual FDA approval and commercialization.
The successful dosing of the first patient in the triplet combination study for givastomig and the planned IND filing for uliledlimab in combination therapy are both significant steps in oncology drug development. If these therapies prove to be effective, they could meet significant unmet medical needs and generate substantial revenue for I-Mab in the long term.
However, the actual impact on I-Mab's business will depend on the outcomes of these trials. Positive results could lead to increased investor confidence and potentially higher stock prices, while negative results could have the opposite effect. It is also important to note that the oncology market is highly competitive and the success of these drugs will depend on their efficacy and safety profiles compared to existing treatments.
The financial results show a mixed picture for I-Mab. The decrease in net revenues from RMB-221.6 million in 2022 to RMB27.6 million in 2023 is a significant improvement, although it's important to understand the context of the negative revenues in 2022 due to the non-cash accounting treatment. The reduction in research and development expenses and administrative expenses suggests effective cost management, which could be viewed favorably by the market.
However, the reported net loss of RMB1,465.7 million for 2023, while an improvement from the previous year, still indicates that I-Mab is in a loss-making phase, which is not uncommon for biotech companies in the development stage. The share buyback program indicates management's confidence in the company's value, which could be a positive signal to investors.
It's essential to consider the long-term potential of I-Mab's pipeline against the backdrop of current financial losses. The company's ability to bring its products to market and secure FDA approval will be critical in determining its future financial performance and impact on the stock market.
- 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 of March 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 ) in cash and cash equivalents, and short-term investments as of December 31, 2023$321.8 million
"2023 was a transitional year for I-Mab and we were pleased to report encouraging clinical results in our two lead global assets in oncology, uliledlimab and givastomig. As we prepare for the closing of the strategic divestiture, we look forward to providing investors with a road map to value creation and believe that our differentiated clinical assets, uliledlimab, givastomig, and ragistomig will achieve critical milestones and trial initiations this year," said Raj Kannan, Director and Chief Executive Officer of I-Mab.
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 American Society for Clinical Oncology (ASCO 2023) in patients with advanced NSCLC, provided compelling support for further development of uliledlimab. In particular, the subset of patients with both high CD73 expression and PD-L1 TPS>
- 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 European Society of Medical Oncology (ESMO 2023) showed encouraging objective responses in patients with gastric cancer and esophageal adenocarcinoma whose tumors progressed or recurred after prior standard treatments, including those with low levels of Claudin 18.2 expression. This program is being jointly developed with ABL Bio. I-Mab owns
- 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. I-Mab owns
- 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 December 31, 2023, the Company had cash, cash equivalents, and short-term investments of
Share Buyback
In August 2023, the Board of Directors of the Company authorized a new share repurchase program under which the Company may repurchase up to
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 Goodwill
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
I-Mab | ||||||
Consolidated Balance Sheets | ||||||
(All amounts in thousands, except for share and per share data, unless otherwise noted) | ||||||
As of December 31, | As of December 31, | |||||
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 | ||
Goodwill | 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 | ||
Treasury stock | (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 | ||
I-Mab | ||||||||
Consolidated Statements of Comprehensive Loss | ||||||||
(All amounts in thousands, except for share and per share data, unless otherwise noted) | ||||||||
Year Ended December 31, | ||||||||
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 I-Mab | (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 I-Mab | (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 I-Mab | (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.
I-Mab | ||||||||
Reconciliation of GAAP and Non-GAAP Results | ||||||||
(All amounts in thousands, except for share and per share data, unless otherwise noted) | ||||||||
Year ended December 31, | ||||||||
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 (NASDAQ: IMAB) is a
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
Tyler Ehler Senior Director, Investor Relations | Gigi Feng Chief Communications Officer |
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SOURCE I-Mab
FAQ
What positive clinical results were reported in the PR?
When is the strategic divestiture in China expected to be completed?
What were the total net revenues for I-Mab in 2023?
How much cash did I-Mab have as of December 31, 2023?
What was the total amount of ADSs repurchased by I-Mab by December 31, 2023?
What was the non-GAAP adjusted net loss for I-Mab in 2023?
