VBI Vaccines Inc/BC (VBIV)·Q1 2024 Earnings Summary

Executive Summary

• Q1 2024 net revenue was $1.214M, driven by U.S. PreHevbrio sales; net loss improved year-over-year to $17.9M and EPS was -$0.73 .
• PreHevbrio net product revenue reached $1.0M (+105% YoY vs Q1 2023), with strong H1 momentum—over 80% of 2023 full-year volume sold in the first five months of 2024 .
• Operating discipline continued: SG&A fell to $7.7M (from $13.3M YoY) and R&D to $2.6M (from $3.2M YoY), while net cash used in operations fell 46% YoY to $11.8M .
• Balance sheet actions: announced a registered direct offering (~$2.8M gross proceeds post-3/31) and an ATM capacity of up to ~$8.47M; expects debt principal to be reduced to ~$17M following Brii transactions by mid-year 2024 .
• Near-term catalysts: additional tumor-response data for VBI-1901 mid-year 2024; initial survival data by year-end, plus potential strategic MLE partnerships supported by CAD$28M remaining under the Canadian agreement .

What Went Well and What Went Wrong

What Went Well

• PreHevbrio momentum: product revenue net rose 105% YoY to $1.0M; U.S. contracting expanded across IDNs/hospital systems and pharmacy networks, and public sector access via CDC Adult Vaccine Contract was secured .
• Expense reduction: SG&A down to $7.7M (vs $13.3M YoY), R&D down to $2.6M (vs $3.2M YoY), reflecting April 2023 organizational changes and focused development timelines .
• Pipeline progress: randomized Phase 2b VBI-1901 arm showed 40% disease control at week 12 (2/5 SD) vs 0% in control (0/6); additional response and survival data expected mid-year and year-end 2024 .
• Management tone: “focus has centered around pipeline execution, expanding access and increased uptake of PreHevbrio in targeted market segments, and execution of strategic partnerships” (Jeff Baxter) .

What Went Wrong

• Revenue volatility: total net revenue fell versus prior quarter (Q3 2023 $6.624M benefited from license/R&D services), underscoring reliance on non-product revenue streams to smooth topline .
• Persistent FX headwinds: foreign exchange loss of $4.3M (vs $6.8M YoY), driven by currency impacts on intercompany loans (NIS and CAD) .
• Negative equity and liquidity pressure: cash fell to $12.6M; stockholders’ equity negative ($-5.467M), prompting financings (registered direct, ATM) to bolster liquidity .

Financial Results

Segment/KPI breakdown:

Notes:

• Q3 2023 revenue included license/R&D services linked to Brii agreements; Q1 2024 revenue primarily reflects U.S. PreHevbrio product sales .
• Post quarter-end financing: ~$2.8M gross proceeds from offerings and warrant exercises; ATM capacity up to ~$8.468M .

Guidance Changes

No formal revenue/EPS guidance ranges were issued in Q1 2024 materials .

Earnings Call Themes & Trends

No Q1 2024 earnings call transcript was available in the document set.

Management Commentary

• “To date in 2024, our focus has centered around pipeline execution, expanding access and increased uptake of PreHevbrio in targeted market segments, and execution of strategic partnerships to drive opportunity for our portfolio assets, create shareholder value, and strengthen our balance sheet.” — Jeff Baxter, President & CEO .
• On VBI-1901: early randomized data showed 40% disease control (SD 2/5) in the study arm vs 0% in control (0/6), with further data mid-year and survival by year-end, subject to enrollment speed .
• On commercial traction: H1 2024 U.S. sales volume for PreHevbrio reached >80% of 2023 full-year volume within five months; public sector access via CDC Adult Vaccine Contract .

Q&A Highlights

No Q1 2024 earnings call transcript was found; therefore, no Q&A highlights are available in the documents searched.

Estimates Context

Consensus estimates (S&P Global) for Q1 2024 EPS and revenue were not available due to missing CIQ mapping. Values retrieved from S&P Global were unavailable for comparison.

Key Takeaways for Investors

• Product-led growth: U.S. PreHevbrio sales momentum and public sector access underpin product revenue, with $1.0M net product revenue in Q1 (+105% YoY) and strong H1 volume trajectory .
• Topline variability from licensing: Q3 2023 revenue ($6.624M) benefited from license/R&D services; Q1 2024 ($1.214M) reflects primarily product sales—expect variability as licensing/partnering occurs .
• Cost discipline is tangible: SG&A fell to $7.7M and R&D to $2.6M, contributing to lower operating and net losses; operating cash burn down 46% YoY to $11.8M .
• Financing runway actions: ATM facility ($8.47M capacity) and April financing ($2.8M gross) plus expected debt reduction to ~$17M post-Brii transactions mitigate liquidity risk but imply dilution/financing overhang .
• GBM program is a catalyst: randomized Phase 2b early tumor response separation vs control, with mid-year and year-end data readouts that could drive sentiment .
• Strategic platform optionality: MLE platform has CAD$28M government support remaining and is under evaluation by partners—potential non-dilutive funding or collaborations .
• Risk watch: FX losses ($4.3M), negative equity ($-5.467M), and reliance on capital markets create execution risk; management flagged Nasdaq compliance risk in forward-looking statements .

Additional Documents Reviewed

• Q1 2024 10-Q, including amendments/agreements with Brii and K2 forbearance and asset purchase terms (debt reduction mechanics and milestones) .
• FY 2023 press release with prelim 2024 U.S. PreHevbrio sales volume context and full-year financials .
• Q3 2023 press release with quarter metrics and commercial channel expansion .