SHANGHAI, China and GAITHERSBURG, Md., March 29, 2021 (GLOBE NEWSWIRE) — I-Mab (the “Company”) (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced financial results for the full year ended December 31, 2020 and provided key business updates.
“In an unprecedented year marked by the global pandemic, I-Mab outperformed in delivering outstanding results to accelerate our progress towards becoming a fully-integrated global biopharma company,” said Dr. Jingwu Zang, Founder, Chairman and Director of I-Mab. “We have accomplished 18 significant clinical milestones since our IPO last year and our pipeline today has advanced to include three registrational trials with the first NDA planned later this year for a total 19 clinical trials either on-going or to be initiated in both the United States and China.”
I-Mab’s globally competitive pipeline has now progressed to include 16 novel or highly differentiated assets with 11 in clinical development stages and five in the pre-clinical stage. The Company’s pre-NDA and core clinical assets of near-term value realization, including felzartamab (TJ202) and eftansomatropin alfa (TJ101), are progressing towards NDA. In addition, two highly differentiated investigational drugs, lemzoparlimab (TJC4) and uliledlimab (TJD5), have achieved critical progress as global front-runners. I-Mab’s next wave of innovative assets, epitomized by the novel bispecific antibodies TJ-L14B and TJ-CD4B, are now moving into clinical trials in the U.S.
In the near-term, I-Mab will continue creating corporate value by delivering on a series of critical milestones including the planned NDA submission for felzartamab in 2021 as well as forging potential strategic global out-licensing partnerships for uliledlimab and other innovative assets and selected in-licensing partnerships to enrich its pipeline. The focused R&D effort is further complemented by the Company’s new discovery initiative to create the next generation of innovative assets through transformative platform technologies.
“We are confident in our innovative R&D strength in immuno-oncology to continue advancing and upgrading our globally competitive pipeline.” Dr. Zang concluded.
In addition to creating the near-term value, the Company has also made notable strides in its journey to become a global biopharmaceutical company, which include building a state-of-the-art GMP manufacturing facility in China with a pilot plant and commercial scale production lines.
In parallel, I-Mab has begun to execute a commercialization plan that focuses on building a leading position in hematologic oncology in China, leveraging I-Mab’s core assets (i.e., felzartamab and lemzoparlimab) and additional key product(s) to be in-licensed. As both assets are progressing towards NDA, preparations are being made for product launch and commercialization. Our revenue stream generated from out-licensing deals grew tremendously in 2020 to make I-Mab profitable for the first time and is expected to converge with product sales revenues to be generated in a near term, projecting a promising financial outlook for the Company and its shareholders.
Overview of Operations
I-Mab currently has three registrational trials underway, 16 phase 1 and 2 clinical studies – either ongoing or to be initiated soon in both the U.S. and China – and five on-going pre-clinical programs in 2021. Four additional new discovery programs are set to advance to the pre-clinical development stage by the end of 2021 as a result of the new discovery initiative.
I-Mab has achieved critical advancements in core clinical assets in early 2021. These achievements include the full patient enrollment for felzartamab in the third-line multiple myeloma trial, a key step for the NDA submission that is on track for late 2021, and the initiation to enroll patients for the registrational clinical trial of eftansomatropin alfa. The Company has also set forth with its accelerated clinical development plan for lemzoparlimab, aiming for NDA approval as the first CD47 antibody drug for the treatment of hematologic malignancies (such as MDS, AML and NHL) in China while continuing to advance clinical trials in solid tumors in combination with PD-1 therapy.
These clinical trials are on-going in the U.S. and China with preliminary data readouts planned in Q4 2021 for the non-Hodgkin’s lymphoma (NHL) study and the solid tumor study in the U.S. The Company also plans to initiate a combination clinical trial of lemzoparlimab with felzartamab as a possible novel treatment option for relapsed and refractory and newly diagnosed MM with a potential to become first-line treatment if proven in addition to felzartamab currently being evaluated as a second-line and third-line treatment for MM.
For uliledlimab, a globally competitive and differentiated CD73 antibody, the Company recently completed a phase 1 clinical study in the U.S., which demonstrated favorable safety, PK/PD and receptor occupancy profile, together with observed clinical activity of the investigational drug in cancer patients. The detailed clinical data have been submitted for presentation at ASCO 2021. In addition, a combined phase 1/2 clinical trial has been ongoing and the dose expansion part of the trial will be initiated in combination with PD-1 therapy in patients with cancers in China in 2H 2021.
Already operating globally with five hubs in China and the U.S., I-Mab has plans to open a new R&D center in San Diego, CA, focusing on translational medicine and formulation research. In preparation for the market launch of its initial series of products in China, the Company is in construction of a comprehensive biologics manufacturing facility in Hangzhou, China, and is building up its commercialization capabilities.
To support its long-term growth, I-Mab is actively monitoring market conditions and considering potential options for further equity listings on Greater China stock exchanges such as the STAR Market in Shanghai and the Main Board of the Hong Kong Stock Exchange under Chapter 18A of the Hong Kong Listing Rules.
Recent Pipeline Highlights and Upcoming Milestones
Core Clinical Assets – Global Frontrunners
(2) The Company continues to enroll more patients with NHL in a combination clinical trial with rituximab (Rituxan®) in the U.S. This clinical trial includes clinical sites in China through an IMCT (international multi-center trial) mechanism in order to potentially bridge – pending approval by the NMPA – to a registrational clinical trial in NHL in China. The preliminary data readout of the NHL trial is set in Q4 2021.
(3) The Company will participate in a global clinical trial to be led by AbbVie in patients with AML for registrational purposes globally by AbbVie and in China by I-Mab.
Core Clinical Assets – Pre-NDA Products
Other Clinical Assets
Two new bi-specific antibodies have entered the clinical development stage in 2021
Pre-Clinical Assets
Commercialization Capability
Manufacturing Facility
Corporate Achievements
Full Year 2020 Financial Results
Cash Position
As of December 31, 2020, the Company had cash, cash equivalents, restricted cash and short-term investments of RMB 4.8 billion (US $734.1 million), compared with RMB 1.2 billion as of December 31, 2019. The current cash on hand is sufficient to fund operations through 2023, including data readouts on core clinical assets such as lemzoparlimab and uliledlimab and commercialization in China of pre-NDA assets felzartamab and efineptakin alfa.
Net Revenues
Total net revenues for the full year of 2020 were RMB 1,542.7 million (US $236.4 million), compared with RMB 30.0 million for the full year of 2019. The revenues generated for the full year of 2020 solely consisted of the revenues recognized in connection with the strategic collaboration with AbbVie.
Research & Development Expenses
Research and development expenses for the full year of 2020 were RMB 984.7 million (US $150.9 million), compared with RMB 840.4 million for the full year of 2019. The increase was primarily due to the increase in employee benefit expenses, which consist of share-based compensation and payroll expenses, to support expansion of research and development programs.
Administrative Expenses
Administrative expenses for the full year of 2020 were RMB 402.4 million (US $61.7 million), compared with RMB 654.6 million for the full year of 2019. The decrease was primarily due to reduced share-based compensation expenses of RMB 305.7 million (US $46.9 million).
Other Income (Expenses), net
Net other income for the full year of 2020 was RMB 412.9 million (US $63.3 million), compared with net other expenses of RMB 20.2 million for the full year of 2019. The change was primarily attributable to the RMB 407.6 million gain recognized as a result of the transfer of equity of I-Mab Hangzhou from I-Mab Hong Kong to a group of domestic investors in China. The equity transfer realized the fair value appreciation in the pipeline assets as well as the employment of a team of designated management and workforce.
Net Income
Net income for the full year of 2020 was RMB 470.9 million (US $72.2 million), compared with a loss of RMB 1,452.0 million for the full year of 2019. Net income per share attributable to ordinary shareholders for the full year of 2020 was RMB 3.51 (US $0.54), compared with net loss per share attributable to ordinary shareholders of RMB 201.19 for the full year of 2019. Net income per ADS attributable to ordinary shareholders for the full year of 2020 was RMB 8.07 (US $1.24), compared with net loss per ADS attributable to ordinary shareholders of RMB 462.74 for the full year of 2019.
Non-GAAP Net Income
Non-GAAP adjusted net income, which excludes share-based compensation expenses, for the full year of 2020 was RMB 997.1 million (US $152.8 million), compared with non-GAAP adjusted net loss of RMB 936.7 million for the full year of 2019. Non-GAAP adjusted net income per share attributable to ordinary shareholders for 2020 was RMB 7.43 (US $1.14), compared with non-GAAP adjusted net loss per share attributable to ordinary shareholders of RMB 131.39 for the full year of 2019. Non-GAAP adjusted net income per ADS attributable to ordinary shareholders for the full year of 2020 was RMB 17.09 (US $2.62), compared with non-GAAP adjusted net loss per ADS attributable to ordinary shareholders of RMB 302.20 for the full year of 2019.
Conference Call and Webcast Information
The Company will host a live conference call and webcast on March 29, 2020 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows:
Registration Link: | http://apac.directeventreg.com/registration/event/4848159 |
Conference ID: | 4848159 |
Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.
A webcast replay will be archived on the Company’s website for one year after the conclusion of the call at http://ir.i-mabbiopharma.com.
A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 4848159.
About I-Mab
I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and near-term commercialization of novel or highly differentiated biologics in in immuno-oncology therapeutic area. The Company’s mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab’s globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company’s unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capabilities. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.
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. The Company’s management believes that adjusted net income (loss) facilitates better understanding of operating results and provide 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 that has been and may continue to be incurred in the future.
Exchange Rate Information
This announcement contains translations of certain RMB 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 are made at a rate of RMB6.5250 to US$1.00, the rate in effect as of December 31, 2020 published by the Federal Reserve Board.
Safe Harbor Statement
This press release contains statements that may constitute “forward-looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to” and similar statements. Statements that are not historical facts, including statements about I-Mab’s beliefs, plans and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. Further information regarding these and other risks is included in I-Mab’s filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
For more information, please contact:
I-Mab
Jielun Zhu, Chief Financial Officer
E-mail: jielun.zhu@i-mabbiopharma.com
Office line: +86 21 6057 8000
Gigi Feng, Chief Communications Officer
E-mail: Gigi.Feng@i-mabbiopharma.com
Office line: +86 21 6057 5785
Investor Inquiries:
The Piacente Group, Inc.
Emilie Wu
E-mail: emilie@thepiacentegroup.com
Office line: + 86 21 6039 8363
I-MAB
Consolidated Balance Sheets
(All amounts in thousands, except for share and per share data, unless otherwise noted)
As of December 31, | |||||
2019 | 2020 | ||||
RMB | RMB | US$ | |||
Assets | |||||
Current assets | |||||
Cash and cash equivalents | 1,137,473 | 4,758,778 | 729,315 | ||
Restricted cash | 55,810 | – | – | ||
Accounts receivable | – | 130,498 | 20,000 | ||
Contract assets | – | 227,391 | 34,849 | ||
Short-term investments | 32,000 | 31,530 | 4,832 | ||
Prepayments and other receivables | 136,036 | 195,467 | 29,957 | ||
Total current assets | 1,361,319 | 5,343,664 | 818,953 | ||
Property, equipment and software | 30,069 | 25,272 | 3,873 | ||
Operating lease right-of-use assets | 16,435 | 14,997 | 2,298 | ||
Intangible assets | 148,844 | 120,444 | 18,459 | ||
Goodwill | 162,574 | 162,574 | 24,916 | ||
Investment accounted for using the equity method | – | 664,832 | 101,890 | ||
Other non-current assets | 18,331 | 2,010 | 308 | ||
Total assets | 1,737,572 | 6,333,793 | 970,697 | ||
Liabilities, mezzanine equity and shareholders’ equity (deficit) | |||||
Current liabilities | |||||
Short-term borrowings | 50,000 | – | – | ||
Accruals and other payables | 273,553 | 560,558 | 85,909 | ||
Operating lease liabilities, current | 6,807 | 8,058 | 1,235 | ||
Ordinary shares to be issued to Everest | 258,119 | – | – | ||
Deferred subsidy income | – | 7,509 | 1,151 | ||
Total current liabilities | 588,479 | 576,125 | 88,295 | ||
Convertible promissory notes | 68,199 | – | – | ||
Put right liabilities | – | 116,006 | 17,779 | ||
Operating lease liabilities, non-current | 7,492 | 5,542 | 849 | ||
Deferred subsidy income | 3,920 | – | – | ||
Other non-current liabilities | – | 8,975 | 1,375 | ||
Total liabilities | 668,090 | 706,648 | 108,298 | ||
Mezzanine equity | |||||
Series A convertible preferred shares (US$0.0001 par value, 30,227,056 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020) | 687,482 | – | – | ||
Series B convertible preferred shares (US$0.0001 par value, 30,305,212 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020) | 921,243 | – | – | ||
Series C convertible preferred shares (US$0.0001 par value, 31,046,360 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020) | 1,306,633 | – | – | ||
Series C-1 convertible preferred shares (US$0.0001 par value, 3,857,143 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020) | 188,819 | – | – | ||
Total mezzanine equity | 3,104,177 | – | – | ||
I-MAB
Consolidated Balance Sheets (Continued)
(All amounts in thousands, except for share and per share data, unless otherwise noted)
As of December 31, |
||||||
2019 | 2020 | |||||
RMB | RMB | US$ | ||||
Shareholders’ equity (deficit) | ||||||
Ordinary shares (US$0.0001 par value, 500,000,000 and 800,000,000 shares authorized as of December 31, 2019 and December 31, 2020, respectively; 8,363,719 and 164,888,519 shares issued and outstanding as of December 31, 2019 and December 31, 2020, respectively) | 6 | 114 | 17 | |||
Additional paid-in capital | 389,379 | 7,701,116 | 1,180,249 | |||
Accumulated other comprehensive income (loss) | 70,127 | (50,793 | ) | (7,784 | ) | |
Accumulated deficit | (2,494,207 | ) | (2,023,292 | ) | (310,083 | ) |
Total shareholders’ equity (deficit) | (2,034,695 | ) | 5,627,145 | 862,399 | ||
Total liabilities, mezzanine equity and shareholders’ equity (deficit) | 1,737,572 | 6,333,793 | 970,697 | |||
I-MAB
Consolidated Statements of Comprehensive Income (Loss)
(All amounts in thousands, except for share and per share data, unless otherwise noted)
Year Ended December 31, | |||||||||||
2018 | 2019 | 2020 | |||||||||
RMB | RMB | RMB | US$ | ||||||||
Revenues | |||||||||||
Licensing and collaboration revenue | 53,781 | 30,000 | 1,542,668 | 236,424 | |||||||
Expenses | |||||||||||
Research and development expenses (Note 1) | (426,028 | ) | (840,415 | ) | (984,689 | ) | (150,910 | ) | |||
Administrative expenses (Note 2) | (66,391 | ) | (654,553 | ) | (402,409 | ) | (61,672 | ) | |||
Income (loss) from operations | (438,638 | ) | (1,464,968 | ) | 155,570 | 23,842 | |||||
Interest income | 4,597 | 30,570 | 24,228 | 3,713 | |||||||
Interest expense | (11,695 | ) | (2,991 | ) | (957 | ) | (147 | ) | |||
Other income (expenses), net | (16,780 | ) | (20,205 | ) | 412,892 | 63,278 | |||||
Equity in loss of an affiliate (Note 3) | – | – | (108,587 | ) | (16,642 | ) | |||||
Fair value change of warrants | 61,405 | 5,644 | – | – | |||||||
Income (loss) before income tax expense | (401,111 | ) | (1,451,950 | ) | 483,146 | 74,044 | |||||
Income tax expense | (1,722 | ) | – | (12,231 | ) | (1,874 | ) | ||||
Net income (loss) attributable to I-MAB | (402,833 | ) | (1,451,950 | ) | 470,915 | 72,170 | |||||
Deemed dividend to Series C-1 preferred shareholders at extinguishment of Series C-1 Preferred Shares | – | (5,283 | ) | – | – | ||||||
Deemed dividend to Series B-1, B-2 and C preferred shareholders at modification of Series B-1, B-2 and C Preferred Shares | – | (27,768 | ) | – | – | ||||||
Net income (loss) attributable to ordinary shareholders | (402,833 | ) | (1,485,001 | ) | 470,915 | 72,170 | |||||
Net income (loss) attributable to I-MAB | (402,833 | ) | (1,451,950 | ) | 470,915 | 72,170 | |||||
Other comprehensive income (loss): | |||||||||||
Foreign currency translation adjustments, net of nil tax | 53,689 | 10,747 | (120,920 | ) | (18,531 | ) | |||||
Total comprehensive income (loss) attributable to I-MAB | (349,144 | ) | (1,441,203 | ) | 349,995 | 53,639 | |||||
I-MAB
Consolidated Statements of Comprehensive Income (Loss) (Continued)
(All amounts in thousands, except for share and per share data, unless otherwise noted)
Year Ended December 31, | |||||||||
2018 | 2019 | 2020 | |||||||
RMB | RMB | RMB | US$ | ||||||
Net income (loss) attributable to ordinary shareholders | (402,833 | ) | (1,485,001 | ) | 470,915 | 72,170 | |||
Weighted-average number of ordinary shares used in calculating net income (loss) per share – basic | 6,529,092 | 7,381,230 | 134,158,824 | 134,158,824 | |||||
Weighted-average number of ordinary shares used in calculating net income (loss) per share – diluted | 6,529,092 | 7,381,230 | 157,231,652 | 157,231,652 | |||||
Net income (loss) per share attributable to ordinary shareholders | |||||||||
—Basic | (61.70 | ) | (201.19 | ) | 3.51 | 0.54 | |||
—Diluted | (61.70 | ) | (201.19 | ) | 3.00 | 0.46 | |||
Net income (loss) per ADS attributable to ordinary shareholders (Note 4) | |||||||||
—Basic | (141.91 | ) | (462.74 | ) | 8.07 | 1.24 | |||
—Diluted | (141.91 | ) | (462.74 | ) | 6.90 | 1.06 |
Note:
(1) Includes share-based compensation expense of RMB470 thousand and RMB284,431 thousand (US$43,591 thousand) for the year ended December 31, 2019 and 2020, respectively.
(2) Includes share-based compensation expense of RMB514,733 thousand and RMB209,033 thousand (US$32,036 thousand) for the year ended December 31, 2019 and 2020, respectively.
(3) Includes share-based compensation expense of nil and RMB32,707 thousand (US$5,013 thousand) for the year ended December 31, 2019 and 2020, respectively.
(4) Each ten ADSs represents twenty-three ordinary shares.
I-MAB
Reconciliation of GAAP and Non-GAAP Results
(All amounts in thousands, except for share and per share data, unless otherwise noted)
Year ended December 31, | |||||||||
2018 | 2019 | 2020 | |||||||
RMB | RMB | RMB | US$ | ||||||
GAAP net income (loss) attributable to I-MAB | (402,833 | ) | (1,451,950 | ) | 470,915 | 72,170 | |||
Add back: | |||||||||
Share-based compensation expense | 3,520 | 515,203 | 526,171 | 80,640 | |||||
Non-GAAP adjusted net income (loss) attributable to I-MAB | (399,313 | ) | (936,747 | ) | 997,086 | 152,810 | |||
Non-GAAP adjusted income (loss) attributable to ordinary shareholders | (399,313 | ) | (969,798 | ) | 997,086 | 152,810 | |||
Weighted-average number of ordinary shares used in calculating net income (loss) per share – basic | 6,529,092 | 7,381,230 | 134,158,824 | 134,158,824 | |||||
Weighted-average number of ordinary shares used in calculating net income (loss) per share – diluted | 6,529,092 | 7,381,230 | 157,231,652 | 157,231,652 | |||||
Non-GAAP adjusted income (loss) per share attributable to ordinary shareholders | |||||||||
—Basic | (61.16 | ) | (131.39 | ) | 7.43 | 1.14 | |||
—Diluted | (61.16 | ) | (131.39 | ) | 6.34 | 0.97 | |||
Non-GAAP adjusted income (loss) per ADS attributable to ordinary shareholders | |||||||||
—Basic | (140.67 | ) | (302.20 | ) | 17.09 | 2.62 | |||
—Diluted | (140.67 | ) | (302.20 | ) | 14.58 | 2.23 |
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