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VBI Vaccines Inc/BC (VBIV)·Q3 2023 Earnings Summary

Executive Summary

  • Q3 2023 revenue accelerated to $6.6M, driven by U.S. PreHevbrio net sales ($1.1M) and licensing/R&D services tied to the expanded HBV partnership with Brii Biosciences; GAAP EPS was -$1.01 and non-GAAP EPS (ex-impairment and FX) improved to -$0.38 .
  • PreHevbrio net sales grew 52% QoQ (Q3: $1.1M vs. Q2: $0.7M), with continued channel and customer expansion; Q3 discounts/chargebacks/rebates totaled $0.6M (gross $1.7M to net $1.1M) .
  • OpEx efficiency continued: SG&A fell to $9.0M (vs. $10.9M in Q2 and $14.2M in Q3’22), consistent with workforce reductions and tighter commercial spend; R&D declined to $1.5M (offset by grants) .
  • Non-GAAP adjustments were significant (impairment $3.6M; FX loss $8.8M), with FX headwinds from USD/CAD strength vs. NIS on intercompany loans; cash ended Q3 at $35.5M, up from $20.8M in Q2, aided by July financing and partnership proceeds .
  • Near-term catalysts: Q4 EU launches via Valneva, VBI-1901 Phase 2b enrollment underway, and additional VBI-2901 data expected in Q1 2024; new mRNA-launched eVLP (MLE) platform announced in October .

What Went Well and What Went Wrong

What Went Well

  • PreHevbrio commercial ramp: “Global net product sales increased 52% from Q2 2023 with $1.1 million earned in Q3 2023” and customer base grew >10% QoQ, with expanding contracts across retail, IDNs, hospital systems, federal/military, prisons, and clinics .
  • Strategic partnership momentum: Expanded HBV collaboration with Brii (global rights to VBI-2601; APAC rights to PreHevbri) with $15M upfront (incl. ~$3M equity) and up to $422M in potential milestones plus double-digit royalties .
  • Pipeline execution: First patients dosed in VBI-1901 Phase 2b GBM study; initial Phase 1 data for pan-coronavirus VBI-2901; novel MLE platform launched blending eVLP and mRNA benefits .

Quote: “We were focused on pipeline execution with continued revenue growth for PreHevbrio… and the announcement of a next-generation proprietary technology that blends the benefits of our eVLP technology with those of mRNA platforms.” – Jeff Baxter, President & CEO .

What Went Wrong

  • FX and impairment headwinds: Q3 impairment charges of $3.6M and foreign exchange loss of $8.8M drove GAAP net loss; FX losses primarily from USD/CAD strengthening vs. NIS on intercompany loans .
  • Continued GAAP losses: Net loss was $20.4M (EPS -$1.01), though improved vs. Q2 and Q3’22; non-GAAP net loss still -$8.0M (EPS -$0.38) .
  • Cost of revenue remains elevated relative to small product base: While Q3 cost of revenue decreased to $2.5M YoY, gross scale remains limited; management cited lower direct labor from organizational changes as a driver .

Financial Results

Core P&L and Cash (USD Millions unless noted)

MetricQ1 2023Q2 2023Q3 2023
Revenues, net ($M)$0.485 $0.720 $6.624
Cost of revenue ($M)$3.559 $3.483 $2.525
Research & Development ($M)$3.151 $3.292 $1.532
SG&A ($M)$13.284 $10.917 $9.036
Impairment charges ($M)$20.000 $3.600
Loss from operations ($M)$(19.509) $(36.972) $(10.069)
Interest expense, net ($M)$(1.429) $(1.708) $(1.543)
Foreign exchange loss ($M)$(6.813) $(5.948) $(8.832)
Net Loss ($M)$(27.751) $(44.628) $(20.444)
GAAP EPS ($)$(3.22) $(5.05) $(1.01)
Non-GAAP Net Loss ($M) (ex-FX, ex-impairment)$(20.938) $(18.680) $(8.012)
Non-GAAP EPS ($) (ex-FX, ex-impairment)$(2.43) $(2.17) $(0.38)
Cash and equivalents ($M)$40.392 $20.840 $35.454

KPIs and Commercial Detail

KPIQ1 2023Q2 2023Q3 2023
PreHevbrio net product sales ($M)$0.5 $0.7 $1.1
Gross→Net discounts on PreHevbrio ($M)$0.3 (gross $0.8 to net $0.5) $0.5 (gross $1.2 to net $0.7) $0.6 (gross $1.7 to net $1.1)
Customer base QoQ change>10% increase vs. Q2

Note on revenue composition: Q3 revenue included product sales in U.S. and Europe (via Valneva) plus license and R&D services tied to the July Brii Bio HBV agreement .

Estimates vs. Actual

  • S&P Global consensus estimates for VBIV were unavailable due to missing mapping; attempts to retrieve Q3 2023 EPS and revenue consensus via S&P Global were unsuccessful. As a result, a beat/miss assessment versus S&P consensus is not provided. Values retrieved from S&P Global were unavailable.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating expenses (normal business)H2 2023 vs. H2 2022Reduce OpEx by 30–35% (announced April 4 and reiterated in Q1/Q2) Reduce OpEx by 30–35% (confirmed in Q3) Maintained
EU launches (PreHevbri via Valneva)Q4 2023Additional EU market launches expected Additional EU market launches expected Maintained
VBI-1901 Phase 2b (recurrent GBM)H2 2023–H2 2024First patients expected Q3 2023; interim analyses H2 2024 (subject to enrollment) First patients dosed Sept 2023; interim analyses H2 2024 (subject to enrollment) Progressed (execution on timeline)
INSIGhT study arm (primary GBM, combo with balstilimab)Around YE 2023Expected initiation Q4 2023 Expected initiation around YE 2023 Maintained
VBI-2901 Phase 1 durability/breadth dataQ1 2024Interim data expected Q3 2023 Additional durability & breadth data expected Q1 2024 Updated timing (next readout Q1 2024)

Earnings Call Themes & Trends

(No Q3 2023 earnings call transcript located; themes synthesized from Q1/Q2/Q3 press releases.)

TopicPrevious Mentions (Q1 & Q2 2023)Current Period (Q3 2023)Trend
Product performance (PreHevbrio)Q1: Net sales $0.5M; retail/pharmacy and VA/DoJ access expanding; CPT coverage strong . Q2: Net sales $0.7M; 48% QoQ; +46% avg order size among switch accounts; CDC adult vaccine contract up to $25.4M .Q3: Net sales $1.1M; +52% QoQ; >10% customer base increase; contracting expansion across segments .Accelerating commercial traction
R&D execution (HBV immunotherapy VBI-2601)Phase 2 combo (with siRNA) interim data at APASL; expanded Brii license to global rights .Positive interim combo data; late-breaking AASLD posters reinforce functional antibody response and HBsAg loss insights .Advancing towards functional cure strategies
Oncology (VBI-1901 GBM)Next phase initiation expected mid-year/Q3 .Phase 2b first patients dosed; INSIGhT arm initiation expected around YE 2023 .On track/initiated
COVID-19 & Pan-coronaviruses (VBI-2901)Phase 1 interim data expected Q3 2023 .Initial Phase 1 data reported; broad neutralizing responses and durability; additional data in Q1 2024 .Positive data; further readouts pending
Technology platformseVLP platform emphasized .Novel mRNA-launched eVLP (MLE) platform announced; potential cross-indication applicability .Platform expansion
Macro/capital disciplineWorkforce reduction; 30–35% OpEx reduction targeted H2 2023 vs. H2 2022 .Continued focus on OpEx management; SG&A decline YoY/QoQ .Cost discipline sustained

Management Commentary

  • Strategic focus: “We are intensely focused on managing our operating expenses and capital to fuel sustainable growth and value for key stakeholders.” – Jeff Baxter, President & CEO .
  • Commercial and channel progress: Management highlighted customer base growth and contracting network expansion across retail, IDNs/hospitals, federal/military, prisons, and clinics for PreHevbrio .
  • Platform innovation: The novel MLE platform enables particulate vaccines with polyfunctional immune activation on accelerated timelines, potentially spanning infectious disease and oncology .
  • Financial mix shift: Q3 revenue included EU product sales via Valneva and license/R&D services from the Brii agreement expanded in July 2023 .

Q&A Highlights

  • No Q3 2023 earnings call transcript available; commentary summarized from the Q3 press release. If a call was held, a transcript was not found via document search.

Estimates Context

  • S&P Global consensus estimates for VBIV Q3 2023 were unavailable (attempt returned a mapping error); therefore, comparison to Wall Street consensus is not provided. Values retrieved from S&P Global were unavailable.

Key Takeaways for Investors

  • Commercial inflection: PreHevbrio net sales ramped from $0.5M (Q1) to $0.7M (Q2) to $1.1M (Q3), with broader access and contracting footprint supporting sustainable growth .
  • Revenue mix diversification: Q3 revenue benefited from EU sales (Valneva) and license/R&D services tied to Brii’s expanded HBV partnership, de-risking near-term top line .
  • Operating leverage emerging: SG&A down QoQ/YoY and R&D lower (offset by grants), consistent with workforce/channel restructuring; non-GAAP EPS improved to -$0.38 .
  • FX and impairment are key noise factors: GAAP loss reflects $3.6M impairment and $8.8M FX loss from currency translation of intercompany loans; monitor FX sensitivity given NIS exposure .
  • Cash runway improved vs. Q2: Cash ended Q3 at $35.5M, aided by July financing and upfront partnership proceeds; watch covenant/secured liens tied to K2 HealthVentures and Brii agreements .
  • Pipeline catalysts: Near-term EU launches (Q4), GBM execution (VBI-1901), pan-coronavirus durability data (Q1 2024), and MLE platform expansion offer multiple announcement points .
  • Trading implications: Positive commercial trajectory and milestone cadence are supportive, but FX/impairment volatility and limited product scale warrant caution on near-term GAAP profitability; focus on non-GAAP trends and contract wins .

Supporting Press Releases (External)

  • VBI Vaccines Reports Third Quarter 2023 Financial Results (company site; mirrors 8-K EX-99.1):
  • VBI Vaccines Reports Second Quarter 2023 Financial Results:

Document Citations

  • Q3 2023 8-K press release and exhibits:
  • Q2 2023 8-K press release and exhibits:
  • Q1 2023 8-K press release and exhibits:
  • July 5, 2023 expanded Brii partnership press release and agreements: (press release) and related agreement details