CollPlant Biotechnologies Ltd. — FY2022 Form 20-F
Reporting period: Fiscal year ended December 31, 2022. This is an annual report, not a standalone Q4 filing; quarterly results are not provided in the supplied filing text. Financial statements are prepared under U.S. GAAP and reported in U.S. dollars.
Business context
CollPlant develops plant-produced recombinant human collagen (rhCollagen) for regenerative medicine, 3D bioprinting, wound care and medical aesthetics. Commercial products include Collink.3D bioinks and Vergenix products sold in Europe. Much of the pipeline—including regenerative breast implants and aesthetic fillers—remains preclinical or dependent on partners and regulatory progress.
Key financial metrics
| Metric (USD, except per-share data) | FY2022 | FY2021 |
|---|---|---|
| Revenue | $0.299 million | $15.641 million |
| Gross profit (loss) | $(0.101) million | $13.636 million |
| Gross margin | -33.8% | 87.2% |
| Research and development expense | $10.255 million | $7.631 million |
| General, administrative and marketing expense | $6.741 million | $5.940 million |
| Operating loss | $(17.097) million | Operating income of $0.065 million |
| Net income (loss) | $(16.925) million | $0.237 million |
| Basic and diluted earnings (loss) per share | $(1.53) | $0.02 |
| Net cash from (used in) operating activities | $(13.698) million | $2.501 million |
| Cash and cash equivalents at year-end | $29.653 million | $13.148 million |
| Total assets | $37.768 million | $51.224 million |
| Total liabilities | $5.487 million | $6.103 million |
| Operating lease liabilities | $2.911 million | $3.608 million |
Cash plus short-term deposits were $29.7 million at year-end 2022; there were no short-term deposits remaining on the balance sheet at that date. Current assets were $31.658 million and current liabilities $3.105 million. The filing reports no borrowings in the presented balance sheet; lease liabilities are the principal disclosed financing-like obligation. The company reported an accumulated deficit of $89.722 million.
Changes versus prior year
- Revenue fell 98% from 2021, primarily because 2021 included the $14 million AbbVie upfront license payment; 2022 revenue was mainly product sales.
- Gross result moved from $13.636 million profit to a $0.101 million loss. Cost of revenue declined to $0.400 million from $2.005 million, but was greater than 2022 revenue.
- R&D expense rose approximately 34% to $10.255 million, reflecting increased process and product development and staffing. General, administrative and marketing costs rose approximately 13%.
- Net result swung from $0.237 million income to a $16.925 million loss. Operating cash flow also shifted from $2.501 million provided to $13.698 million used.
- Year-end cash and cash equivalents increased to $29.653 million from $13.148 million, principally reflecting the conversion and repayment of short-term deposits, not operating cash generation. Financing cash flow was $1.874 million in 2022, primarily from warrant and option exercises; 2021 included net offering proceeds.
Outlook, commentary and risks
- Management stated that cash and cash equivalents and short-term deposits available at the report date—approximately $29.6 million—were expected to fund operations and capital expenditures for at least 12 months. This estimate depends on assumptions; the company expects to need additional capital in the future.
- Management expects significant expenses and operating losses to continue as it advances R&D, preclinical work, manufacturing scale-up and commercialization. No quantified revenue or earnings guidance is provided.
- Key development updates: Collink.3D 90 launched in November 2022; a powder-form bioink, Collink.3D 50L, launched in January 2023. A November 2022 agreement with Tel Aviv University and Sheba Medical Center covers development of a Gut-on-a-Chip model.
- In January 2023, the company reported successful completion of a large-animal study of its 3D bioprinted breast implant and planned a follow-up study using commercial-size implants in the second half of 2023. These are company-reported preclinical results, not proof of human clinical efficacy.
- The AbbVie collaboration provides up to $36 million in additional milestones for exclusive filler products, plus potential royalties and supply fees; separate option products could provide up to $53 million, subject to definitive agreements and milestones. AbbVie may terminate specified rights on 60 days’ notice.
- Material risks include recurring losses and future financing needs; uncertain clinical and regulatory paths; limited commercial-scale manufacturing experience; reliance on third parties and tobacco-plant supply; competition, reimbursement and market acceptance; intellectual-property exposure; Israeli geopolitical and operational risk; foreign-exchange exposure; and obligations and restrictions associated with Israeli Innovation Authority (IIA) grants. Gross IIA grants received totaled approximately $10.1 million; royalties paid totaled $2.8 million, with maximum remaining royalties disclosed as approximately $7.314 million before interest.
- The company reported no material pending or threatened legal proceedings. Its auditor issued an unqualified opinion on the financial statements. Management concluded internal control over financial reporting was effective; the auditor did not provide an ICFR attestation because of the company’s emerging-growth-company exemption.
Important facts for investors to verify
- Whether product revenue grows beyond the low FY2022 base and whether further AbbVie milestones, options or commercial royalties are achieved.
- Cash burn, investment needs and the actual duration of the stated cash runway, including potential dilution from future financing.
- Progress and results of planned animal studies, subsequent human studies, and regulatory pathways for breast implants, fillers and other pipeline products.
- Commercial-scale rhCollagen capacity, quality consistency, supply resilience and the cost and timing of facility upgrades.
- IIA royalty balance and approval requirements for any manufacturing or transfer of funded know-how outside Israel.
- Clarification of cash-flow comparative-year labeling: one narrative table in the filing appears to label the third comparative year as 2019, while the audited cash-flow statements present 2020.