Investment Outlook

NEGATIVE outlook with significant downside risk

NEGATIVE Outlook

Avecho Biotechnology presents a challenging investment case with our DCF base case valuation of $0.0006 per share representing an 88% downside from the current price of $0.005. The company faces critical funding constraints with only 7 months of cash runway remaining, requiring approximately $6 million in additional capital by mid-2025 to complete its Phase III CBD insomnia trial.

While the potential first-mover advantage in Australia's CBD pharmaceutical market creates meaningful upside in our bull case scenario ($0.0022 per share), the binary nature of clinical trial outcomes combined with no successful Phase III cannabidiol trials in Australia to date suggests the current market price implies an overly optimistic success probability of 20-25%.

The company's manufacturing segment showed encouraging profitability improvement in 2024, but dangerous customer concentration (87.1% of revenue from Switzerland) creates significant business risk. Immediate equity dilution of 15-25% appears inevitable to fund trial completion, further pressuring per-share values for existing shareholders.

Executive Summary

Clinical-stage biotech with binary Phase III trial outcome

Current Price
$0.005
-88% to target
Target Price
$0.0006
Base Case DCF
Cash Runway
7 months
Critical funding needed
Revenue Growth
139.2%
2024 performance

Avecho Biotechnology delivered strong revenue recovery in 2024, growing 139.2% to $1.13 million primarily through improved Vital ET® manufacturing for Ashland. The company transformed its Production segment from loss-making to profitable, with gross margins expanding dramatically from -9.2% to 59.3%. However, accelerated investment in the Phase III CBD insomnia trial increased R&D expenses by 69.6% to $3.59 million, creating critical funding constraints.

The investment case centers on Avecho's potential to become the first company to secure TGA approval for a CBD product in Australia, targeting the substantial insomnia treatment market. The Phase III trial currently has 58 patients actively receiving medication across multiple sites, with commercial launch possible by early 2027 following successful completion and regulatory approval.

However, the company faces a binary outcome with our scenario analysis showing a 22x valuation difference between bull ($0.0022) and bear ($0.0001) cases. With cash reserves declining 56.9% to $2.37 million and monthly burn rates of $330,727, additional funding of approximately $6 million is required by mid-2025, likely resulting in significant equity dilution for existing shareholders.

Company Overview

Australian biotech developing CBD pharmaceuticals using proprietary TPM® technology

Avecho Biotechnology Limited (ASX: AVE) is an Australian biotechnology company that develops and commercializes innovative human and animal health products using its proprietary drug delivery system called TPM® (Tocopherol Phosphate Mixture). TPM® is derived from Vitamin E using unique, patented processes that enhance the solubility and oral, dermal and transdermal absorption of drugs and nutrients.

The company's primary focus is its Phase III clinical trial testing a proprietary CBD soft-gel capsule for insomnia treatment. If successful, Avecho aims to be the first company to gain regulatory approval for a cannabidiol product in Australia, targeting a significant market opportunity following the TGA's 2020 decision to allow over-the-counter CBD products subject to appropriate approvals.

Business Model

Avecho generates revenue through two primary segments: Production (manufacturing TPM® and Vital ET® products) and Human Health (pharmaceutical product development). The Production segment provides current cash flow through manufacturing relationships, particularly with Ashland LLC, while the Human Health segment represents the primary value creation opportunity through clinical development programs.

The company is led by Chairman Dr. Gregory Collier and CEO Dr. Paul Gavin, with a board that combines scientific expertise with business and investment experience. Avecho operates primarily in Australia with sales to customers in Switzerland and India, benefiting from significant R&D tax incentives that help fund its development pipeline.

Latest Results

Strong revenue recovery offset by increased R&D investment and cash burn

MetricFY2024FY2023Change
Revenue$1,132,672$473,551+139.2%
Gross Profit$671,926$(43,795)+1,634.2%
Gross Margin59.3%-9.2%+68.5pp
R&D Expenses$(3,591,156)$(2,117,263)+69.6%
Net Loss$(3,122,048)$(3,436,561)-9.2%
Cash Position$2,374,534$5,504,396-56.9%
Operating Cash Flow$(3,968,718)$(3,179,955)+24.8%

Avecho delivered a remarkable revenue turnaround in 2024, with customer revenues increasing 139.2% to $1.13 million primarily driven by recovery in Vital ET® manufacturing for Ashland. The company produced 11 tonnes of Vital-ET in 2024, including a major 6.4-tonne manufacturing campaign in Q3-Q4, demonstrating the recovery from first-half weakness when revenue declined 30.1%.

The Production segment transformation was particularly impressive, turning from loss-making to profitable while gross margins expanded from -9.2% to 59.3%. This improvement reflects enhanced manufacturing efficiency and the absence of inventory impairments that affected 2023 results. R&D tax incentives provided crucial support, increasing 62.1% to $1.89 million and covering 45.5% of research expenses.

However, the company's strategic focus on the Phase III CBD trial drove R&D expenses up 69.6% to $3.59 million, contributing to accelerated cash burn. Despite reducing administrative expenses by 16.0% and narrowing the net loss by 9.2%, operating cash outflows increased 24.8% to $3.97 million. The introduction of R&D loans ($978,443) represents the first debt on the previously debt-free balance sheet.

Critical Funding Position

With cash reserves declining 56.9% to $2.37 million and monthly burn rates of approximately $330,727, Avecho has only 7 months of runway remaining. The company has secured R&D tax incentive advances from Endpoints Capital but requires approximately $6 million in additional funding by mid-2025 to complete the Phase III trial.

Financial Forecasts

Projecting continued losses until potential CBD commercialization in 2027

Our financial model projects continued revenue growth driven by stable Vital ET® manufacturing (15-20% annually) with potential inflection beginning in 2H-2027 following successful Phase III trial completion and CBD product commercialization. Revenue is forecast to reach $8.6 million by 2H-2029, representing a compound annual growth rate of 46.5% from the 2024 base.

The company is expected to remain EBITDA negative through 1H-2027, with the inflection to positive EBITDA occurring in 2H-2027 at a modest 4.3% margin. Profitability improves steadily thereafter, reaching a 31.1% EBITDA margin by 2H-2029 as revenue scales against a relatively fixed cost base. R&D expenses are projected to remain elevated at $3.5-4.0 million annually until trial completion.

Key Forecast Assumptions

  • Phase III trial completion in late 2025/early 2026
  • TGA approval and commercial launch in 2H-2027
  • Peak CBD product sales of $10-12 million annually by 2029
  • Continued R&D tax incentive support at 45% of eligible expenses
  • Additional funding of $6 million secured in mid-2025

Free cash flow is projected to remain negative through 1H-2028, turning positive in 2H-2028 and accelerating through 2029. The model incorporates working capital investments required for commercialization and modest capital expenditures averaging 5-6% of revenue, consistent with the company's asset-light manufacturing approach.

Valuation Analysis

DCF methodology yields significant discount to current trading price

MethodologyImplied Price Per Share
DCF - Base Case$0.0006
DCF - Bull Case$0.0022
DCF - Bear Case$0.0001
EV/EBITDA Multiple - NTM$0.0010
Precedent Transactions$0.0009
Current Share Price$0.005
Up/Downside to Base Case-88%

Our DCF analysis yields a base case valuation of $0.0006 per share, representing an 88% downside from the current trading price of $0.005. This significant discount reflects the combination of substantial near-term funding requirements, distant commercialization timeline, high discount rate (23.1% WACC), and exceptionally large share count (3.17 billion shares).

The valuation incorporates a projected capital raise in mid-2025, introducing approximately 20% additional dilution that further impacts per-share values. Our WACC calculation reflects the high-risk clinical-stage biotech profile, including a company-specific risk premium of 5.0% capturing clinical trial execution risk, funding constraints, and customer concentration.

Bull Case: $0.0022

+267% upside
  • Strong trial efficacy data
  • Accelerated approval pathway
  • Reduced funding requirements
  • Peak sales 40% higher

Base Case: $0.0006

-88% downside
  • Successful trial completion
  • TGA approval in late 2026
  • Moderate market penetration
  • $6M additional funding needed

Bear Case: $0.0001

-98% downside
  • Phase III trial failure
  • Strategic pivot required
  • Sustained negative cash flows
  • Minimal terminal value

The 22x spread between bull and bear cases underscores the binary nature of this investment, with clinical trial outcomes representing the definitive value inflection point. The current share price implies approximately 20-25% probability weighting toward the bull case, which appears optimistic given historical Phase III success rates and the fact that no cannabidiol trials have yet succeeded in Australia.

Risk Analysis

Multiple high-impact risks threaten investment thesis

HIGH

Funding/Liquidity Risk

Impact: Critical funding constraints with 7-month runway requiring $6M by mid-2025

Mitigation: R&D advances secured but equity raise inevitable with 15-25% dilution

HIGH

Clinical Trial Failure

Impact: Phase III failure would reduce enterprise value by 50-70%

Mitigation: Trial design incorporates learnings from previous failures; 58 patients active

MEDIUM

Customer Concentration

Impact: 87.1% revenue dependency on Switzerland creates cash flow volatility

Mitigation: Ashland relationship stable with January 2025 order confirmed

MEDIUM

Regulatory Approval

Impact: TGA approval delays could extend funding requirements

Mitigation: Positive TGA engagement with no recommended design changes

The primary risk exposure centers on funding constraints, with the company requiring immediate capital to complete its Phase III trial. Clinical trial failure represents an existential threat given the binary nature of the value proposition. Customer concentration in the manufacturing segment creates additional volatility, though this risk diminishes if the CBD program succeeds.

Key Risk Factors

Management has acknowledged specific challenges including patient compliance and placebo effects in insomnia studies. With no successful Phase III cannabidiol trials in Australia to date, execution risk remains substantial despite design improvements incorporating previous trial learnings.