Filing scope and business context
Important identification note: The supplied filing is BiondVax Pharmaceuticals Ltd.’s Form 20-F for the fiscal year ended December 31, 2019—not a filing by Scinai Immunotherapeutics Ltd. and not a standalone Q4 filing. The report was signed June 12, 2020 and says COVID-19 disruptions delayed its preparation. Financial statements are audited and prepared under IFRS, with NIS as the reporting currency; USD figures are convenience translations.
BiondVax was a clinical-stage biopharmaceutical company with no product revenue. Its lead and only product candidate was M-001, a proposed broad-protection influenza vaccine. At year-end, a pivotal Phase 3 trial was underway in Europe. The company reported that the trial enrolled 12,463 participants across two cohorts; results were expected by the end of 2020, subject to influenza case rates and other factors.
Financial performance and position
| Metric | 2019 | 2018 |
|---|---|---|
| Revenue | None | None |
| Research and development expense, net | NIS 68.645m; USD 19.863m | NIS 71.913m |
| Marketing, general and administrative expense | NIS 9.706m; USD 2.808m | NIS 5.154m |
| Operating loss | NIS 78.351m; USD 22.671m | NIS 77.067m |
| Net loss | NIS 109.194m; USD 31.596m | NIS 87.727m |
| Net loss per share | NIS 0.33; USD 0.09 | NIS 0.34 |
| Cash and cash equivalents at year-end | NIS 72.467m; USD 20.968m | NIS 75.883m |
| Total assets at year-end | NIS 115.750m; USD 33.493m | NIS 105.837m |
| Total liabilities at year-end | NIS 180.803m; USD 52.316m | NIS 137.052m |
| Shareholders’ equity at year-end | Deficit of NIS 65.053m; USD 18.823m | Deficit of NIS 31.215m |
Cash used in operating activities was NIS 77.058m (USD 22.297m), versus NIS 57.193m in 2018. Investing activities used NIS 7.199m (USD 2.083m), mainly reflecting fixed-asset purchases. Financing activities provided NIS 85.214m (USD 24.656m), including NIS 70.270m from share and option issuances and NIS 15.337m from EIB borrowing. Working capital was reported as approximately USD 15.6m.
The company reported an EIB financing facility drawn in full at €24m. The year-end balance-sheet line “loan from others” was NIS 123.780m (USD 35.816m); the carrying value included valuation effects. The EIB financing is interest-free under stated terms, but repayment provisions include a 3% share of M-001 sales for 12 years or a 2.8-times cash-on-cash return, and certain events may trigger prepayment terms. EIB also holds a first-ranking floating charge over company assets, excluding specified Yeda-licensed assets and intellectual property.
Changes, outlook and risks
- Net loss increased by about 24% from 2018, primarily because financial expenses rose to NIS 30.847m (USD 8.926m) from NIS 13.596m and G&A expense increased. Financial expense included EIB liability valuation, warrant revaluation and foreign-exchange effects. R&D expense declined modestly.
- The 2019 rights offering raised gross proceeds of USD 20m. The controlling shareholder, Angels Investments in High Tech Ltd., subscribed for a substantial portion; the filing reports approximately 37.6% ownership as of May 2020.
- Management stated that available resources were expected to fund operations for at least 12 months from year-end; elsewhere the report says existing cash resources were expected to cover at least 15 months. The company expected continued losses, negative operating cash flow and a need for additional financing. Additional funding was not committed, and failure to raise it could delay, reduce or end development.
- The European Phase 3 trial’s timing and success were uncertain; enrollment could be extended for another influenza season if case numbers were insufficient. The company had no U.S. Phase 3 IND application and might need further U.S. trials. COVID-19 could disrupt trials, facilities, workforce, regulatory timelines and financing.
- Manufacturing scale-up and completion of the Jerusalem production line remained important execution risks. The company also depended on a CRO and contract manufacturer. Its core technology was licensed from Yeda; loss or breach of that license could materially harm the business.
- Israeli IIA grants carry royalty and technology/manufacturing restrictions. The company reported NIS 14.812m (USD 4.286m) of grant liability on the balance sheet and estimated maximum IIA repayment of approximately USD 6.380m including accrued interest.
- No cash dividends had been paid or were anticipated in the foreseeable future. The auditor gave an unqualified opinion on the IFRS financial statements. Management concluded internal control over financial reporting was effective; the auditor did not provide an internal-controls opinion.
Q4 2019 information and items to verify
The annual report includes an unaudited quarterly table. It indicates Q4 2019 R&D expense of NIS 31.608m, G&A expense of NIS 0.965m, and operating loss of NIS 32.573m. The table appears to report Q4 net loss of NIS 33.262m, but its signs and financial-expense presentation are not fully consistent with the annual totals; verify the original quarterly disclosure before relying on that figure.
- Confirm the issuer and period: this is BiondVax’s FY2019 Form 20-F, not a Scinai filing or a standalone Q4 report.
- Reconcile the Q4 figures against the original filed statements and quarterly reports; the extracted table’s signs and net-loss presentation are unclear.
- Verify year-end share counts: the filing gives 402,351,657 shares in the audited balance sheet at December 31, 2019, while the cover states 454,145,376 shares “as of close of the period.” The cover figure may reflect a later date and should be checked.
- Check the EIB loan’s contractual repayment and prepayment exposure, security package, and the financial-statement valuation of the liability.
- Track cash runway, subsequent financing, Phase 3 results and any COVID-related trial or manufacturing delays.
- Reconcile the reported shareholders’ deficit: the balance sheet and selected data show NIS 65.053m, while one equity roll-forward passage gives a different amount.