VBI Vaccines Inc. (Nasdaq: VBIV) Announces Q1 2024 Business Update and Financial Results
VBI Vaccines Inc. (Nasdaq: VBIV), a biopharmaceutical company focused on immunology to develop potent disease prevention and treatment solutions, today released a business update and financial results for Q1 2024. Jeff Baxter, President and CEO of VBI, emphasized the company’s dedication to advancing its pipeline, increasing the reach and adoption of PreHevbrio in targeted markets, and forming strategic partnerships to enhance shareholder value and financial stability. Baxter stated, “We remain committed to creating opportunities for our vaccines, candidates, and technologies to significantly impact public health and the lives of patients, providers, and families.”
Recent Key Program Achievements and Upcoming Milestones
PreHevbrio® [Hepatitis B Vaccine (Recombinant)]
- Revenue Growth: Q1 2024 saw a 105% increase in net product revenue from Q1 2023, totaling $1.0 million.
- US Market: H1 2024 sales in the U.S. have already reached over 80% of the total 2023 sales volume within the first five months.
- Commercial Success: Q1 2024 saw new demand within large Integrated Delivery Networks (IDNs) and hospital systems, along with continued national and regional pharmacy uptake.
- Public Sector Expansion: PreHevbrio is now available under the CDC Adult Vaccine Contract.
- European Market: In partnership with Valneva SE, PreHevbri launched in the UK, Sweden, Netherlands, and Belgium in 2023, with Denmark and Norway added in early 2024.
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate – Glioblastoma (GBM)
- Phase 2b Study: VBI-1901 is being evaluated against standard chemotherapy in recurrent GBM patients.
- Early Results: As of April 2024, the VBI-1901 arm showed a 40% disease control rate at week 12, while the control arm showed no tumor response.
- Upcoming Data: Additional tumor response data is expected mid-year 2024, with initial survival data anticipated by year-end 2024.
Novel mRNA-Launched eVLP (MLE) Technology Platform
- Partnership Expansion: In April 2024, VBI expanded its strategic partnership with the Canadian Government to further develop the MLE technology platform, supported by CAD$28 million in funding.
- Ongoing Evaluations: The MLE platform is under active review by potential partners throughout 2024.
Other Achievements and Upcoming Milestones
- Brii Biosciences Agreements: In February 2024, VBI announced agreements with Brii Biosciences, potentially yielding up to $33 million for manufacturing capabilities, intellectual property for VBI-2601, and a license for VBI-1901 in the Asia Pacific region (excluding Japan). Completion of this transaction is expected by mid-year 2024, which will significantly reduce VBI’s total debt principal to $17 million.
- VBI-2901 Data: Additional data from the Phase 1 study of VBI-2901, a multivalent pan-coronavirus vaccine candidate, is expected in 2024.
Recent Peer-Reviewed Publications
- Cytomegalovirus Vaccine Study: “An enveloped virus-like particle alum-adjuvanted cytomegalovirus vaccine is safe and immunogenic: A first-in-humans Canadian Immunization Research Network (CIRN) study” published in Vaccine by Langley, Gantt, et al.
Financial Results for Q1 2024
- Cash Position: As of March 31, 2024, VBI had $12.6 million in cash, down from $23.7 million at the end of 2023. This does not include $2.8 million from subsequent offerings and sales.
- Revenues: Q1 2024 net revenues were $1.2 million, up from $0.5 million in Q1 2023, driven by increased U.S. sales of PreHevbrio.
- Cost of Revenues: Decreased to $2.7 million in Q1 2024 from $3.6 million in Q1 2023 due to organizational changes and reduced inventory costs.
- R&D Expenses: Decreased to $2.6 million in Q1 2024 from $3.2 million in Q1 2023, offset by government grants.
- SG&A Expenses: Reduced to $7.7 million in Q1 2024 from $13.3 million in Q1 2023 due to organizational changes.
- Net Cash Used in Operating Activities: Reduced to $11.8 million in Q1 2024 from $21.7 million in Q1 2023, reflecting decreased net loss and working capital changes.
- Net Loss and Net Loss Per Share: Q1 2024 net loss was $17.9 million ($0.73 per share) compared to $27.8 million ($3.22 per share) in Q1 2023. Excluding foreign exchange loss, net loss was $13.6 million ($0.55 per share) versus $20.9 million ($2.43 per share) in Q1 2023.
Use of Non-GAAP Financial Measures
VBI uses non-GAAP financial measures to evaluate performance, excluding foreign exchange losses primarily driven by exchange rate changes related to intercompany loans. These measures are supplemental and not a substitute for GAAP financial results.
GAAP to Non-GAAP Reconciliations
The following reconciles GAAP net loss to non-GAAP net loss excluding foreign exchange loss:
- Net Loss: Q1 2024 – $17.9 million, Q1 2023 – $27.8 million
- Foreign Exchange Loss: Q1 2024 – $4.3 million, Q1 2023 – $6.8 million
- Net Loss Excluding Foreign Exchange Loss: Q1 2024 – $13.6 million, Q1 2023 – $20.9 million
- Net Loss Per Share Excluding Foreign Exchange Loss: Q1 2024 – $0.55, Q1 2023 – $2.43
