CollPlant Biotechnologies Ltd. — FY2023 Form 20-F
Reporting period: Fiscal year ended December 31, 2023. This is an annual report, not a standalone Q4 filing; quarterly Q4 results are not separately provided. Financial statements use U.S. GAAP and U.S. dollars.
Business context
CollPlant is an Israeli regenerative-medicine and aesthetics company developing products based on recombinant human collagen (rhCollagen) produced using plant-based technology. Its activities include 3D-bioprinting bioinks, regenerative breast implants, medical-aesthetics fillers developed with AbbVie, and commercial rhCollagen and wound-care/tendinopathy products.
Financial performance and liquidity
| Metric | FY2023 | FY2022 |
|---|---|---|
| Revenue | $10.959 million | $0.299 million |
| Cost of revenue | $1.991 million | $0.400 million |
| Gross profit (loss) | $8.968 million | $(0.101) million |
| Gross margin | Approximately 81.8% | Negative |
| Research and development | $10.484 million | $10.255 million |
| General, administrative and marketing | $5.996 million | $6.741 million |
| Operating loss | $(7.512) million | $(17.097) million |
| Net loss | $(7.019) million | $(16.925) million |
| Operating cash flow | $(2.763) million | $(13.698) million |
- FY2023 revenue included a $10.0 million AbbVie milestone payment received in July and $0.959 million from goods sales. The milestone represented most of annual revenue.
- Cash and cash equivalents were $26.674 million at year-end, down from $29.653 million. Current assets were $28.022 million and current liabilities $3.251 million.
- Total liabilities were $5.786 million, including $3.159 million of operating lease liabilities. The filing reports no borrowings in the balance sheet.
- Capital expenditures were $0.954 million. Management said available cash was expected to fund operations and capital expenditures for at least 12 months from the report date, while also stating the company expects to need additional capital before reaching profitability.
- Accumulated deficit was $96.741 million. No dividends have been paid or are expected in the foreseeable future.
Changes versus the prior period
- Revenue rose from $0.299 million to $10.959 million, principally because of the AbbVie milestone; FY2022 revenue had no licensing milestone.
- Net loss narrowed to $7.019 million from $16.925 million, and operating cash use fell to $2.763 million from $13.698 million.
- R&D expense increased modestly, while general, administrative and marketing expense declined. The 2023 cost of revenue included IIA royalties and inventory write-offs.
- Cash and cash equivalents declined by approximately $3.0 million during 2023. Financing cash inflow was $1.108 million, mainly from option and warrant exercises.
Outlook, developments and risks
- No numerical revenue, earnings or cash-flow guidance is provided. The company expects continued losses and significant R&D spending; profitability depends on product development, approvals, commercialization and partner performance.
- AbbVie’s dermal and soft-tissue filler candidate was in clinical testing, with trials designed and conducted by AbbVie. The agreement provides potential additional milestones and royalties, but AbbVie may terminate rights on notice, including for any or no reason in specified circumstances.
- CollPlant initiated a preclinical study of commercial-size 3D-bioprinted breast implants in December 2023. It reported positive results from an earlier large-animal study, but human studies and commercialization remain prospective.
- Collink.3D 50L powder bioink launched in 2023, and the company entered a joint development and commercialization agreement with Stratasys. The company also put its gut-on-a-chip program on hold in March 2024 to prioritize breast implants and fillers.
- Key risks include recurring losses and future financing needs; clinical, regulatory and market-acceptance uncertainty; limited commercial-scale manufacturing experience; dependence on partners and third parties; intellectual-property risks; and exposure to currency movements and Israeli security conditions.
- The company reported that the Yessod Hama’ala production site remained operational, but permits for certain structures were missing and were being pursued with relevant authorities. Escalation of regional hostilities could affect operations, including at that site.
- Inventory write-downs were $0.866 million in the financial-statement note; management’s discussion separately attributes about $0.570 million of 2023 cost-of-revenue increase to inventory write-offs. Investors should clarify the difference.
- The independent auditor issued unqualified opinions on the financial statements and internal controls. Liquidity and going-concern assessment was identified as a critical audit matter; management and the auditor concluded liquidity was adequate for at least one year after issuance.
Important facts for investors to verify
- How much of future revenue and cash runway depends on additional AbbVie milestones, and what conditions and termination rights apply?
- What are the clinical and regulatory timelines, funding needs and next decision points for the filler and breast-implant programs?
- Can production scale reliably, and will the Yessod Hama’ala site obtain the outstanding permits without interruption?
- What explains the difference between the inventory write-off amounts discussed in management’s review and the financial-statement note?
- How sensitive is the stated 12-month liquidity outlook to operating costs, foreign exchange, delays, and the absence of further milestone or financing proceeds?