Full Press Release Details
I-Mab Reports Full Year 2023 Financial Results
ROCKVILLE, MD, March 14, 2024
- I-Mab (the "Company") (NASDAQ: IMAB), a U.S.-based, global biotech company, exclusively focused on the development
and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, today announced financial results
for the full year ended December 31, 2023, and highlighted recent business updates.
"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
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>1% showed an
impressive 63% overall response rate. Additionally, enrollment of patients with treatment resistant
ovarian cancer has been completed, and ongoing efforts will be streamlined to focus on expediting NSCLC development.
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 50% of the global rights
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 50% of the global rights of ragistomig (TJ-L14B/ABL503).
Impact of Strategic Transaction on Pipeline
The agreement to divest assets and business operations in China, previously
announced in a press release on February 7, 2024, is expected to be completed by the end of March 2024. Upon the closing of
the transaction, the Greater China rights for assets including eftansomatropin alfa, felzartamab, uliledlimab, and givastomig will be
transferred to I-Mab Biopharma (Hangzhou) Co., Ltd., an unconsolidated affiliate (the "Hangzhou Company"). I-Mab
will no longer bear future development costs of these divested assets in China and may receive an aggregate consideration of the RMB equivalent
of up to US$80 million, contingent on the Hangzhou Company group's achievement of certain future regulatory and sales-based milestone
events relating to these divested assets in China. The transaction, if closed, will also extinguish existing repurchase obligations owed
by a wholly-owned subsidiary of the Company in the amount of approximately US$183 million.
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
As of December 31, 2023, the Company had
cash, cash equivalents, and short-term investments of RMB2.3 billion (US$321.8 million), compared with RMB3.5 billion as of December 31,
In August 2023, the Board of Directors
of the Company authorized a new share repurchase program under which the Company may repurchase up to US$40 million of American Depository
Shares ("ADSs"), each ten ADSs representing 23 ordinary shares of the Company, or ordinary shares in aggregate over a 12-month
period. During the period ended December 31, 2023, the Company repurchased US$8.6 million of its ADSs, equating to 4,633,386
ADSs or 10,656,794 ordinary shares. As of December 31, 2023, the Company had issued and outstanding ordinary shares of 185,613,662,
representing the equivalent of 80,701,592 ADSs assuming the conversion of all ordinary shares into ADSs.
Total net revenues for the full year of 2023 were RMB27.6 million (US$3.9
million), compared with RMB-221.6 million (US$-32.1 million) for the full year of 2022. Total net revenues in 2023 consisted of revenues
recognized in connection with the strategic collaboration with AbbVie Inc. (AbbVie) and revenues generated from the supply of investigational
products to AbbVie and Human Immunology Biosciences, Inc. The negative figure for net revenue in 2022 was primarily due to a one-time,
non-cash accounting treatment of US$-48.0 million (equivalent to RMB-314.2 million) recorded in the second half of 2022 following the
amendment to the original license and collaboration agreement with AbbVie in August 2022. This amendment led to a reduced probability
of achieving a key milestone that was included in the consideration of revenue recognition in prior years.
Research & Development Expenses
Research and development expenses for the full year of 2023 were RMB810.6
million (US$114.2 million), compared with RMB904.9 million (US$131.2 million) for the full year of 2022. The decrease was primarily due
to reduced payroll expenses related to headcount optimization as a result of asset prioritization and reduced share-based compensation
expenses. Share-based compensation expense was RMB66.8 million (US$9.4 million) for the full year of 2023, compared with RMB117.9 million
(US$17.1 million) for the full year of 2022.
Administrative Expenses
Administrative expenses for the full year of 2023 were RMB453.0 million
(US$63.8 million), compared with RMB815.8 million (US$118.3 million) for the full year of 2022. The decrease was primarily due to reduced
payroll expenses related to decreased headcount as a result of resource optimization and reduced share-based compensation expenses for
management personnel, reduced expenses for professional services, and reduced legal expenses in relation to the disputes with Tracon Pharmaceuticals, Inc.
of RMB95.5 million (US$13.5 million). Share-based compensation expense was RMB126.2 million (US$17.8 million) for the full year of 2023,
compared with RMB239.3 million (US$34.7 million) for the full year of 2022.
Net other expenses for the full year
of 2023 were RMB38.1 million (US$5.4 million), compared with RMB126.6 million (US$18.4 million) for the full year of 2022. The
change was primarily driven by unrealized exchange rate losses due to the significant fluctuation in the exchange rate of the Renminbi
against the U.S. dollar in 2022.
Equity in Loss of Affiliates
Equity in loss of affiliates for the
full year of 2023 was RMB80.0 million (US$11.3 million), compared with RMB437.5 million (US$63.4 million) for the full year of 2022. The
loss was mainly recognized in relation to the operating loss of the Company's investee, I-Mab Biopharma (Hangzhou) Co., Ltd.
Impairment of Goodwill
For the full year of 2023, the
Company recognized an impairment of goodwill of RMB162.6 million (US$22.9 million). The goodwill impairment resulted from the Company's
annual impairment analysis, and reflects the continued disconnect between I-Mab's anticipated future performance and present uncertainty
reflected in its market valuation.
Net loss for the full year of 2023 was
RMB1,465.7 million (US$206.4 million), compared with RMB2,507.3 million (US$363.5 million) for the year 2022. Net loss per share
attributable to ordinary shareholders for the full year of 2023 was RMB7.19 (US$1.01), compared with RMB13.21 (US$1.92) for the full year
of 2022. Net loss per ADS attributable to ordinary shareholders for the full year of 2023 was RMB16.54 (US$2.33), compared with RMB30.38
(US$4.41) for the full year of 2022.
Non-GAAP adjusted net loss, which excludes
share-based compensation expenses and impairment of goodwill, for the full year of 2023 was RMB1,105.3 million (US$155.7 million),
compared with RMB2,136.3 million (US$309.7 million) for the full year of 2022. Non-GAAP adjusted net loss per share attributable to ordinary
shareholders for the full year of 2023 was RMB5.42 (US$0.76), compared with RMB11.26 (US$1.63) for the full year of 2022. Non-GAAP adjusted
net loss per ADS attributable to ordinary shareholders for the full year of 2023 was RMB12.47 (US$1.76), compared with RMB25.90 (US$3.75)