CollPlant Biotechnologies Announces First Quarter Financial Results For 2024 and Provides Corporate Update
CollPlant Biotechnologies (Nasdaq: CLGN) reported its Q1 2024 financial results and provided a corporate update. The company initiated a new large-animal study for its 3D-bioprinted breast implants in December 2023, expected to conclude in June 2024. Q1 2024 GAAP revenue was $98,000, a decrease from $433,000 in Q1 2023. Costs of revenue increased to $545,000 from $325,000, resulting in a gross loss of $447,000 compared to a gross profit of $108,000 in Q1 2023. Net loss widened to $4.2 million from $3.7 million. The company also highlighted advancements in its Environmental, Social, and Governance (ESG) initiatives and recent patent approvals in the U.S., Brazil, Israel, and Australia. Cash and cash equivalents as of March 31, 2024, stood at $23.2 million.
- Initiated new large-animal study for 3D-bioprinted breast implants in Dec 2023.
- Patent approvals in the U.S., Brazil, Israel, and Australia, valid until 2039.
- Cash and cash equivalents balance stood at $23.2 million as of March 31, 2024.
- Ongoing clinical trials for dermal and soft tissue filler products, costs covered by AbbVie.
- Q1 2024 GAAP revenue fell to $98,000, down from $433,000 in Q1 2023.
- Gross loss of $447,000 compared to a gross profit of $108,000 in Q1 2023.
- Net loss increased to $4.2 million from $3.7 million in Q1 2023.
- Operating expenses rose to $3.9 million from $3.6 million in Q1 2023.
- Increase in cost of revenue from $325,000 to $545,000 in Q1 2024.
Insights
CollPlant's financial results for Q1 2024 present a mixed picture. The GAAP revenues for the quarter were
Despite these setbacks, the company ended the quarter with a cash balance of
In summary, while CollPlant is making significant strides in its product development, the financial performance for Q1 2024 indicates challenges in scaling revenue and managing costs effectively.
CollPlant's initiation of a large-animal study for its 3D-bioprinted breast implants is a noteworthy advancement. The implants are designed to regenerate breast tissue, addressing a significant gap in the current market where existing implants come with numerous safety issues. If successful, this technology could revolutionize breast reconstruction, particularly for postmastectomy cancer patients who face limited options today.
The use of plant-derived rhCollagen to minimize immune response is a unique approach, potentially offering a safer alternative to traditional implants. The company's previous large-animal study showed positive results, including tissue regeneration and no adverse events, which sets a promising precedent for the ongoing study.
However, the timeline for obtaining regulatory approval and commercializing these implants is lengthy and fraught with uncertainties. The completion of the large-animal study by June 2024 and subsequent discussions with the FDA are critical milestones that investors should closely watch.
CollPlant's entry into the breast implant market, estimated at
The ESG initiatives highlighted in the report demonstrate CollPlant's commitment to sustainable practices, which can enhance its reputation and appeal to socially responsible investors. However, the immediate financial impact of these initiatives remains unclear and warrants further observation.
Overall, while CollPlant's innovative products and strategic partnerships offer promising growth prospects, the current financial performance highlights some execution risks that need to be managed carefully.
Additional large-animal study with commercial-size breast implants commenced in December 2023 expected to conclude in June 2024
Cash and cash equivalents balance as of March 31, 2024, was
Conference call and webcast to discuss its financial results and corporate updates on May 29 at 10:00 a.m. Eastern Daylight Time (details herein)
REHOVOT,
"In December 2023 we commenced large-animal trials to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. Currently, there are no commercially-available implants that allow regeneration of breast tissue," commented Yehiel Tal, CollPlant's Chief Executive Officer. "CollPlant's breast implants in development are unique in that they are designed to regenerate breast tissue as well as have inherent safety advantages. A primary goal of the large animal study is to obtain data which would support optimization of the implant design and composition. We plan to then apply this design to a pivotal large-animal study of commercial-size implants that is intended to be the subject of discussions with the FDA."
Mr. Tal continued, "Also, since the beginning of the year, we have worked to finalize our first Environmental, Social and Governance, or ESG, report evaluating designated areas of focus to take measurable steps to improve towards becoming a sustainable organization. This comprehensive report highlights our commitment to sustainable practices, ethical governance, and positive social impact. It outlines our new goals in key ESG areas, reflecting our dedication to transparency and accountability. By setting these targets, we aim to create long-term value for our stakeholders while driving meaningful progress towards a more sustainable future.
Q1 and Recent Program Highlights
In January of 2024, CollPlant announced its initiation of a pre-clinical trial to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. Currently, there are no commercial products that allow regeneration of soft tissues such as the breast and many safety issues exist with current implants. Still, the current annual market for breast implants is estimated at
In the
This study follows CollPlant's first large-animal study with positive results announced in January 2023, which demonstrated progressive stages of tissue regeneration after three months, as highlighted by the formation of maturing connective tissue and neovascular networks within the implants, with no adverse events reported.
The dermal and soft tissue filler product candidate for the medical aesthetics market is currently undergoing testing in clinical trials that are designed, planned, and executed by AbbVie, CollPlant business partner. According to the agreement between both parties, AbbVie is responsible for all the costs of the development, including the costs of the clinical trials.
Patent Updates
In the fourth quarter of 2023, the
In March 2024, the same patent application received allowance in
This newly issued patent is related to CollPlant's photocuring technology within its photocurable dermal filler product candidate and represents an integral part of the Company's strategy to expand the uses for its novel, rhCollagen technology into new, high-value markets.
ESG Updates
During the past year, CollPlant initiated its ESG activities and set new goals in various key ESG areas. CollPlant's main ESG targets are to minimize its carbon footprint, improve the lives of the people that it interacts with, and establish a strong ethical governance mission. CollPlant's first ESG report, which is planned for publication this quarter, will highlight these goals and its current achievements.
First Quarter Financial Results
GAAP revenues for the first quarter ended March 31, 2024 were
GAAP cost of revenue for the first quarter ended March 31, 2024 were
GAAP gross loss for the first quarter ended March 31, 2024 was
GAAP operating expenses for the first quarter ended March 31, 2024 were
GAAP financial income, net, for the first quarter ended March 31, 2024, totaled
GAAP net loss for the first quarter ended March 31, 2024 was
Balance Sheets and Cash Flow
The Company's cash and cash equivalents balance as of March 31, 2024 was
Net cash used in operating activities was
Net cash used in investing activities was
Net cash provided by financing activities was
Conference call information
To participate in the conference call, please use the dial-in information below:
Investors outside of the U.S.: 1-201-493-6779
Conference ID: 13745964
Note, you can avoid long wait times for the operator by using the Call me™ feature and clicking the link below 15 minutes prior to the scheduled call start time:
https://callme.viavid.com/viavid/?callme=true&passcode=13728588&h=true&info=company-email&r=true&B=6
Webcast information
A live webcast will also be available in listen-only mode and can be accessed here or via the link to be posted on the News & Events section of the CollPlant Investor relations website. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company's website for a limited time.
Submit questions to management in advance of the call and webcast
To ask management a question ahead of the call, please email Dan Ferry at LifeSci Advisors LLC up until 24 hours before the event at daniel@lifesciadvisors.com.
COLLPLANT BIOTECHNOLOGIES LTD. | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
( | ||||||||
March 31, | December 31, | |||||||
Unaudited | Audited | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 23,225 | $ | 26,674 | ||||
Restricted deposit | 239 | 241 | ||||||
Trade receivables, net | 90 | - | ||||||
Other accounts receivable and prepaid expenses | 279 | 393 | ||||||
Inventories | 645 | 714 | ||||||
Total current assets | 24,478 | 28,022 | ||||||
Non-current assets: | ||||||||
Restricted deposit | 57 | 57 | ||||||
Operating lease right-of-use assets | 2,979 | 3,070 | ||||||
Property and equipment, net | 2,606 | 2,789 | ||||||
Intangible assets, net | 173 | 188 | ||||||
Total non-current assets | 5,815 | 6,104 | ||||||
Total assets | $ | 30,293 | $ | 34,126 |
COLLPLANT BIOTECHNOLOGIES LTD. | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
( | ||||||||
March 31, | December 31, | |||||||
Unaudited | Audited | |||||||
Liabilities and shareholders' equity | ||||||||
Current liabilities: | ||||||||
Trade payables | $ | 1,119 | $ | 980 | ||||
Operating lease liabilities | 598 | 624 | ||||||
Accrued liabilities and other payables | 1,708 | 1,647 | ||||||
Total current liabilities | 3,425 | 3,251 | ||||||
Non-current liabilities: | ||||||||
Operating lease liabilities | 2,421 | 2,535 | ||||||
Total non-current liabilities | 2,421 | 2,535 | ||||||
Total liabilities | 5,846 | 5,786 | ||||||
Commitments and contingencies | ||||||||
Shareholders' Equity: | ||||||||
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares as of | 4,983 | 4,982 | ||||||
Additional paid in capital | 121,369 | 121,068 | ||||||
Accumulated other comprehensive loss | (969) | (969) | ||||||
Accumulated deficit | (100,936) | (96,741) | ||||||
Total shareholders' equity | 24,447 | 28,340 | ||||||
Total liabilities and shareholders' equity | $ | 30,293 | $ | 34,126 |
COLLPLANT BIOTECHNOLOGIES LTD. | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
( | ||||||||
(Unaudited) | ||||||||
Three months ended | ||||||||
2024 | 2023 | |||||||
Revenues | $ | 98 | $ | 433 | ||||
Cost of revenues | 545 | 325 | ||||||
Gross profit (loss) | (447) | 108 | ||||||
Operating expenses: | ||||||||
Research and development | 2,406 | 2,102 | ||||||
General, administrative and marketing | 1,476 | 1,525 | ||||||
Total operating loss | 4,329 | 3,519 | ||||||
Financial income (expenses), net | 134 | (196) | ||||||
Net loss | $ | 4,195 | $ | 3,715 | ||||
Basic net loss per ordinary share | $ | 0.37 | $ | 0.33 | ||||
Diluted net loss per ordinary share | $ | 0.37 | $ | 0.33 | ||||
Weighted average number of ordinary shares used in computation of | 11,453,177 | 11,270,948 | ||||||
Weighted average number of ordinary shares used in computation of | 11,453,177 | 11,270,948 |
COLLPLANT BIOTECHNOLOGIES LTD. | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
( | ||||||||
(Unaudited) | ||||||||
Three months ended | ||||||||
2024 | 2023 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (4,195) | $ | (3,715) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 280 | 280 | ||||||
Share-based compensation to employees and consultants | 290 | 514 | ||||||
Net loss from financing expenses | 125 | 282 | ||||||
Changes in assets and liabilities: | ||||||||
Increase in trade receivables | (90) | (314) | ||||||
Decrease (increase) in inventories | 72 | (345) | ||||||
Decrease in other accounts receivables and prepaid expenses | 114 | 135 | ||||||
Decrease in operating lease right-of-use assets | 137 | 119 | ||||||
Increase (decrease) in trade payables | 139 | (248) | ||||||
Decrease in operating lease liabilities | (186) | (224) | ||||||
Increase in accrued liabilities and other payables | 61 | 66 | ||||||
Net cash used in operating activities | (3,253) | (3,450) | ||||||
Cash flows from investing activities: | ||||||||
Purchase of property and equipment | (82) | (145) | ||||||
Net cash used in investing activities | (82) | (145) | ||||||
Cash flows from financing activities: | ||||||||
Exercise of options and warrants into shares | 9 | 803 | ||||||
Net cash provided by financing activities | 9 | 803 | ||||||
Effect of exchange rate changes on cash and cash equivalents and restricted deposits | (123) | (282) | ||||||
Decrease in cash and cash equivalents and restricted deposits | (3,326) | (3,074) | ||||||
Cash and cash equivalents and restricted cash at the beginning of the period | 26,674 | 29,864 | ||||||
Cash and cash equivalents and restricted deposits at the end of the period | $ | 23,225 | $ | 26,790 |
COLLPLANT BIOTECHNOLOGIES LTD. | ||||||||
APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
( | ||||||||
(Unaudited) | ||||||||
Three months ended | ||||||||
2024 | 2023 | |||||||
Supplemental discloser of non-cash activities: | ||||||||
Right-of-use assets recognized with corresponding lease liabilities | $ | 46 | $ | 788 | ||||
Capitalization of share-based compensation to inventory | $ | 3 | $ | 47 | ||||
Reconciliation of cash, cash equivalents and restricted cash at the end of the period | ||||||||
Cash and cash equivalents | $ | 23,225 | $ | 26,528 | ||||
Restricted deposits (including long term) | - | 262 | ||||||
Total cash and cash equivalents and restricted deposits | $ | 23,225 | $ | 26,790 |
CollPlant Biotechnologies Ltd. | ||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures | ||||||||
( | ||||||||
Three months ended | ||||||||
2024 | 2023 | |||||||
GAAP operating expenses: | $ | 3,882 | $ | 3,627 | ||||
Change of operating lease accounts | 1 | 21 | ||||||
Share-based compensation to employees, directors and consultants | (290) | (514) | ||||||
Non-GAAP operating expenses: | 3,593 | 3,134 | ||||||
GAAP operating loss | 4,329 | 3,519 | ||||||
Change of operating lease accounts | 1 | 21 | ||||||
Share-based compensation to employees, directors and consultants | (290) | (514) | ||||||
Non-GAAP operating loss | 4,040 | 3,026 | ||||||
GAAP Net loss | 4,195 | 3,715 | ||||||
Change of operating lease accounts | 49 | 105 | ||||||
Share-based compensation to employees, directors and consultants | (290) | (514) | ||||||
Non-GAAP Net loss | $ | 3,954 | $ | 3,306 | ||||
GAAP basic and diluted loss per ordinary share | $ | 0.37 | $ | 0.33 | ||||
NON- GAAP basic and diluted loss per ordinary share | $ | 0.35 | $ | 0.29 |
About CollPlant
CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.
In 2021 CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.
For more information about CollPlant, visit http://www.collplant.com.
Use of Non-US GAAP ("non-GAAP")
Financial results for 2024 and 2023 are presented on both a GAAP and a non-GAAP basis. GAAP results were prepared in accordance with
The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company's business internally and therefore decided to make these non-GAAP adjustments available to investors. The non-GAAP financial measures used by the Company in this press release may be different from the measures used by other companies.
For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" in this release. This accompanying table has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.
The Company's consolidated financial statements for the first quarter ended March 31, 2024, are presented in accordance with generally accepted accounting principles in the
Forward-Looking Statements
This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company's expectations regarding the costs and timing of commencing and/or concluding pre-clinical and clinical trials with respect to breast implants, tissues and organs which are based on its rhCollagen based BioInk and other products for medical aesthetics, and specifically the Company's ability to initiate its next large-animal study for its breast implants in a timely manner, or at all; the Company's or it strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based bioink and medical aesthetics products including but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products, in 3D Bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations, including its partnership with AbbVie and its ability to continue to receive milestone and royalties payments under the AbbVie agreement; the Company's reliance on third parties to conduct some or all aspects of its product development and manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates, including, with respect to the
Contacts
CollPlant:
Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Eran@collplant.com
Investors
LifeSci Advisors
Dan Ferry
daniel@lifesciadvisors.com
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SOURCE CollPlant
FAQ
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