Novabridge Biosciences annual report, Q4 FY2019

I-Mab Annual Report Summary

Entity and period: The supplied filing is I-Mab’s Form 20-F for the fiscal year ended December 31, 2019, not a filing for “Novabridge Biosciences” or a standalone 2019 fourth quarter. It reports annual results; separate Q4 figures are not provided. Financial statements use U.S. GAAP and RMB, with U.S. dollar translations where stated.

Business context

I-Mab is a clinical-stage biopharmaceutical company developing biologics, principally for cancer and autoimmune diseases. It had no approved products and no product-sales revenue; reported revenue came from licensing and collaboration arrangements. Its ADSs began trading on Nasdaq in January 2020, after the reporting period.

Financial performance and liquidity

MetricFY 2019FY 2018
Licensing and collaboration revenueRMB 30.0 million (US$4.3 million)RMB 53.8 million
Research and development expenseRMB 840.4 million (US$120.7 million)RMB 426.0 million
Administrative expenseRMB 654.6 million (US$94.0 million)RMB 66.4 million
Operating lossRMB 1,465.0 million (US$210.4 million)RMB 438.6 million
Net loss attributable to I-MabRMB 1,452.0 million (US$208.6 million)RMB 402.8 million
Net cash used in operating activitiesRMB 868.0 million (US$124.7 million)RMB 280.7 million
Cash, cash equivalents and restricted cash at year-endRMB 1,193.3 million (US$171.4 million)RMB 1,680.9 million

Gross and operating margins are not meaningful measures for this pre-commercial company. At year-end 2019, current assets were RMB 1,361.3 million and current liabilities were RMB 588.5 million; current assets included RMB 1,137.5 million in cash and cash equivalents, RMB 55.8 million in restricted cash and RMB 32.0 million in short-term investments. Total liabilities were RMB 668.1 million, including RMB 50.0 million in short-term borrowings and RMB 68.2 million in convertible notes. Actual reported shareholders’ deficit was RMB 2,034.7 million, alongside RMB 3,104.2 million of mezzanine equity. The filing’s pro forma balance sheet, assuming preferred-share conversion, instead shows shareholders’ equity of RMB 1,327.6 million.

Changes and unusual items

  • Revenue fell 44.2% year over year, as 2019 revenue consisted of CSPC upfront and milestone payments, compared with HDYM milestone and ABL Bio upfront payments in 2018.
  • R&D expense rose 97.3%, mainly from higher CRO costs as programs advanced and expanded, higher licensing fees, and increased R&D staffing.
  • Administrative expense rose sharply, chiefly due to share-based compensation and a director share-award repurchase: RMB 365.3 million for immediately vested options and RMB 148.3 million for repurchased awards. Total 2019 share-based compensation was RMB 366.9 million in the cash-flow reconciliation.
  • Net loss attributable to ordinary shareholders was RMB 1,485.0 million, including RMB 33.1 million in deemed dividends related to preferred-share modification and extinguishment. Operating cash outflow was partly offset in the reconciliation by non-cash share-based compensation and increased accruals.
  • Cash, cash equivalents and restricted cash decreased RMB 487.6 million during 2019. Investing activities generated RMB 212.5 million, while financing activities generated RMB 152.7 million.

Outlook, risks and contingencies

  • Management expects losses and R&D spending to continue increasing. It stated that available cash was expected to cover working-capital needs and capital expenditures for at least 12 months from the filing’s operating-plan assessment, while also noting the need for substantial additional funding over time.
  • Planned development included TJ202 multiple-myeloma registrational submissions targeted for 2021; 2020 clinical or regulatory steps for TJ107, TJ101 and enoblituzumab; and continued trials for TJ301, TJM2, TJC4 and TJD5. These are plans, not assured outcomes.
  • COVID-19 was identified as a source of uncertainty, with possible disruption to clinical enrollment, trial operations, regulatory interactions and financing. The company reported mitigation measures and did not expect a material long-term impact, but could not reliably estimate the financial effect.
  • The company disclosed two material weaknesses in financial reporting controls: insufficient U.S. GAAP/SEC-reporting expertise and insufficient documented close procedures, particularly for licensing arrangements and expense cut-off/accruals. Management said disclosure controls were ineffective at December 31, 2019 and described remediation plans.
  • Key business risks include clinical failure or delay, regulatory approval and commercialization uncertainty, reliance on CROs/CMOs and licensors, competitive and intellectual-property risks, PRC regulatory and currency restrictions, and potential dilution or financing constraints. The filing also notes that the PCAOB could not inspect the auditor’s China-based audit work at that time.
  • The Everest TJ202 collaboration ended in November 2019. I-Mab retained the Greater China rights and issued Everest shares valued at US$37.0 million in connection with the settlement. The filing reports no material pending legal proceedings.

Important facts for investors to verify

  • Confirm the issuer identity: this filing is for I-Mab (Nasdaq: IMAB), not Novabridge Biosciences, and covers the full fiscal year rather than Q4 alone.
  • Review the audited statements and notes for the 2019 share-based compensation, director award repurchase, preferred-share deemed dividends, Everest settlement and actual-versus-pro-forma equity presentation.
  • Reconcile IPO proceeds: the filing describes different proceeds figures in different sections, including US$105.3 million, US$103.7 million and US$96.4 million, while also reporting total gross proceeds of US$114.5 million after the over-allotment. The precise net proceeds are unclear from the supplied text.
  • Track cash runway against the stated operating plan, the rising annual operating burn, restricted cash, the RMB 50 million borrowing due in June 2020, and access to IPO proceeds through PRC rules.
  • Monitor remediation of the material weaknesses and obtain subsequent updates on audit oversight, clinical milestones, COVID-related trial effects and any changes to management’s liquidity outlook.