- Dermal filler program with AbbVie (NYSE:ABBV) in clinical phase
- Regenerative breast implant program large-animal study underway to evaluate commercial-size implants with topline data expected in Q4
- Ends 2023 with
$26.7 million in cash and cash equivalents - Conference call to be held on
Thursday, April 4, 2024 at 10:00 a.m.U.S. EDT
"During 2023, the end of which became a challenging year for our nation, we excelled in the advancement of our key programs," said CollPlant's Chief Executive Officer,
2023 and Recent Corporate Highlights
Collaboration Updates
During 2023, CollPlant made significant progress with its development partner, AbbVie, to advance the dermal and soft tissue filler program toward commercialization.
In
In
CollPlant remains engaged in partnering discussions with several industry leaders in order to leverage its rhCollagen technology and expertise in 3D bioprinting with the mission to develop novel regenerative medical and aesthetics solutions and related applications.
Regenerative Breast Implants
Our regenerative breast implants are targeting the
Currently, there are no commercial products that allow regeneration of soft tissues such as the breast. In the
In addition, CollPlant's regenerative breast implants can be a novel solution for women in the breast reconstruction and augmentation market, which is sizeable, as it is the second most common plastic surgery procedure that is performed worldwide today.
In
In December of 2023, CollPlant initiated a large-animal study to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. This study will be used to obtain data that will be used to support subsequent human studies and future product commercialization. CollPlant expects to report topline data from this study in the fourth quarter of this year.
Intellectual Property
In
In addition, 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.
Gut-on-a-
Given CollPlant's focus on the medical aesthetics area and its collaboration with AbbVie, it has decided to place its resources on hold directed toward its gut-on-a-chip program for the treatment of ulcerative colitis. The Company highly values this program, and the rationale for this relates to the extensive projected timing to progress the tissue model as it relates to cell collection, as well as other processes that must first be conducted before even beginning testing. Therefore, in line with prioritizing its resources, CollPlant expects to reinitiate this program once its resources are commensurate with the projected timing of this program.
Corporate Governance
In the second quarter of 2023, CollPlant announced that it hired a dedicated expert to lead its Environment, Social and Governance (ESG) effort. CollPlant plans to file its first ESG report in the second quarter which will outline its ESG objectives.
In September 2023, CollPlant announced that it joined the United Nations Global Compact, the world's largest initiative for sustainable and responsible corporate governance. As a new participant of this voluntary leadership platform, CollPlant strengthens its commitment to operate sustainably.
Year-Ended
GAAP revenues for the year ended
GAAP cost of revenues for the year ended
GAAP gross profit for the year ended
GAAP operating expenses for the year ended
GAAP financial income, net, for the year ended
GAAP net loss for the year ended
Balance Sheets and Cash Flow
The Company's cash and cash equivalents balance as of December 31, 2023, was $26.7 million.
Cash used in operating activities was
Net cash used in investing activities was
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: 13744114
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&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
COLLPLANT BIOTECHNOLOGIES LTD. | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
( | ||||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 26,674 | $ | 29,653 | ||||
Restricted deposit | 241 | 23 | ||||||
Trade receivables, net | - | 9 | ||||||
Other accounts receivable and prepaid expenses | 393 | 543 | ||||||
Inventories | 714 | 1,430 | ||||||
Total current assets | 28,022 | 31,658 | ||||||
Non-current assets: | ||||||||
Restricted deposit | 57 | 188 | ||||||
Operating lease right-of-use assets | 3,070 | 2,711 | ||||||
Property and equipment, net | 2,789 | 2,966 | ||||||
Intangible assets, net | 188 | 245 | ||||||
Total non-current assets | 6,104 | 6,110 | ||||||
Total assets | $ | 34,126 | $ | 37,768 |
COLLPLANT BIOTECHNOLOGIES LTD. | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
( | ||||||||
2023 | 2022 | |||||||
Liabilities and shareholders' equity | ||||||||
Current liabilities: | ||||||||
Trade payables | $ | 980 | $ | 1,133 | ||||
Operating lease liabilities | 624 | 529 | ||||||
Accrued liabilities and other payables | 1,647 | 1,443 | ||||||
Total current liabilities | 3,251 | 3,105 | ||||||
Non-current liabilities: | ||||||||
Operating lease liabilities | 2,535 | 2,382 | ||||||
Total non-current liabilities | 2,535 | 2,382 | ||||||
Total liabilities | 5,786 | 5,487 | ||||||
Commitments and contingencies | ||||||||
Shareholders' Equity: | ||||||||
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares | 4,982 | 4,873 | ||||||
Additional paid in capital | 121,068 | 118,099 | ||||||
Accumulated other comprehensive loss | (969) | (969) | ||||||
Accumulated deficit | (96,741) | (89,722) | ||||||
Total shareholders' equity | 28,340 | 32,281 | ||||||
Total liabilities and shareholders' equity | $ | 34,126 | $ | 37,768 |
COLLPLANT BIOTECHNOLOGIES LTD. | ||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
( | ||||||||||||
Year ended | ||||||||||||
2023 | 2022 | 2021 | ||||||||||
Revenues | $ | 10,959 | $ | 299 | $ | 15,641 | ||||||
Cost of revenues | 1,991 | 400 | 2,005 | |||||||||
Gross profit (loss) | 8,968 | (101) | 13,636 | |||||||||
Operating expenses: | ||||||||||||
Research and development | 10,484 | 10,255 | 7,631 | |||||||||
General, administrative and marketing | 5,996 | 6,741 | 5,940 | |||||||||
Total operating income (loss) | (7,512) | (17,097) | 65 | |||||||||
Financial income, net | 493 | 172 | 172 | |||||||||
Net income (loss) | $ | (7,019) | $ | (16,925) | $ | 237 | ||||||
Basic net income (loss) per ordinary share | $ | (0.62) | $ | (1.53) | $ | 0.02 | ||||||
Diluted net income (loss) per ordinary share | $ | (0.62) | $ | (1.53) | $ | 0.02 | ||||||
Weighted average number of ordinary shares used in | 11,389,168 | 11,033,310 | 9,968,972 | |||||||||
Weighted average number of ordinary shares used in | 11,389,168 | 11,033,310 | 11,966,788 |
COLLPLANT BIOTECHNOLOGIES LTD. | ||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||||||
( | ||||||||||||
Year ended | ||||||||||||
2023 | 2022 | 2021 | ||||||||||
Cash flows from operating activities: | ||||||||||||
Net income (loss) | $ | (7,019) | $ | (16,925) | $ | 237 | ||||||
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||||||||||||
Loss on sale of property and equipment | 18 | - | - | |||||||||
Depreciation and amortization | 1,102 | 1,076 | 773 | |||||||||
Accrued interest | (28) | (87) | (151) | |||||||||
Share-based compensation to employees and consultants | 1,937 | 2,174 | 1,597 | |||||||||
Exchange differences on cash and cash equivalents | 379 | 608 | (143) | |||||||||
Remeasurement of Derivatives liability | - | - | (28) | |||||||||
Changes in assets and liabilities: | ||||||||||||
Decrease in trade receivables | 9 | 261 | 560 | |||||||||
Decrease (increase) in inventories | 749 | (312) | 181 | |||||||||
Decrease (increase) in other receivables and prepaid expenses | 150 | (119) | (185) | |||||||||
Decrease in operating lease right-of-use assets | 527 | 461 | 400 | |||||||||
Increase (decrease) in trade payables | (153) | 99 | 236 | |||||||||
Decrease in operating lease liabilities | (638) | (916) | (337) | |||||||||
Increase (decrease) in accrued liabilities and other payables | 204 | 14 | (464) | |||||||||
Decrease in deferred revenues | - | (32) | (175) | |||||||||
Net cash provided by (used in) operating activities | (2,763) | (13,698) | 2,501 | |||||||||
Cash flows from investing activities: | ||||||||||||
Capitalization of intangible assets | - | (42) | (161) | |||||||||
Purchase of property and equipment | (954) | (1,274) | (1,428) | |||||||||
Proceed from short term deposit | - | 50,238 | - | |||||||||
Investment in restricted deposits | (270) | - | - | |||||||||
Investment in deposits | - | (20,000) | (30,000) | |||||||||
Proceeds from sale of property and equipment | 68 | - | 33 | |||||||||
Net cash provided by (used in) investing activities | (1,156) | 28,922 | (31,556) | |||||||||
Cash flows from financing activities: | ||||||||||||
Proceeds from issuance of shares and warrants less issuance expenses | - | - | 32,743 | |||||||||
Exercise of options and warrants into shares | 1,108 | 1,874 | 6,017 | |||||||||
Net cash provided by financing activities | 1,108 | 1,874 | 38,760 | |||||||||
Effect of exchange rate changes on cash and cash equivalents and restricted deposits | (379) | (608) | 143 | |||||||||
Net increase (decrease) in cash and cash equivalents and restricted deposits | (3,190) | 16,490 | 9,848 | |||||||||
Cash and cash equivalents and restricted cash at the beginning of the year | 29,864 | 13,374 | 3,526 | |||||||||
Cash and cash equivalents and restricted deposits at the end of the year | $ | 26,674 | $ | 29,864 | $ | 13,374 |
COLLPLANT BIOTECHNOLOGIES LTD. | ||||||||||||
APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||||||
( | ||||||||||||
Year ended | ||||||||||||
2023 | 2022 | 2021 | ||||||||||
Supplemental discloser of non-cash activities: | ||||||||||||
Right of use assets recognized with corresponding lease liabilities | $ | 886 | $ | 219 | $ | 557 | ||||||
Classification of issuance costs liability to equity | $ | - | $ | - | $ | 50 | ||||||
Capitalization of Share-based compensation to inventory | $ | 33 | $ | 37 | $ | - | ||||||
Supplemental discloser of cash activities: | ||||||||||||
Cash paid during the year for taxes | $ | 8 | $ | 31 | $ | - | ||||||
Reconciliation of cash, cash equivalents and restricted cash at the end of the year | ||||||||||||
Cash and cash equivalents | $ | 26,674 | $ | 29,653 | $ | 13,148 | ||||||
Restricted deposits short term | - | 23 | 13 | |||||||||
Restricted deposits long term | - | 188 | 213 | |||||||||
Total cash and cash equivalents and restricted deposits | $ | 26,674 | $ | 29,864 | $ | 13,374 |
CollPlant Biotechnologies Ltd. | ||||
Reconciliation of GAAP to Non-GAAP Financial Measures | ||||
( | ||||
Year ended | ||||
2023 | 2022 | |||
GAAP operating expenses: | $ | 16,480 | $ | 16,996 |
Change of operating lease accounts | - | 455 | ||
Share-based compensation to employees, directors and consultants | (1,937) | (2,211) | ||
Non-GAAP operating expenses: | 14,543 | 15,240 | ||
GAAP operating loss | (7,512) | (17,097) | ||
Change of operating lease accounts | - | (455) | ||
Share-based compensation to employees, directors and consultants | 1,937 | 2,211 | ||
Non-GAAP operating loss | (5,575) | (15,341) | ||
GAAP Net loss | (7,019) | (16,925) | ||
Change of operating lease accounts | (111) | (455) | ||
Share-based compensation to employees, directors and consultants | 1,937 | 2,211 | ||
Non-GAAP Net loss | $ | (5,193) | $ | (15,169) |
GAAP basic and diluted loss per ordinary share | $ | (0.62) | $ | (1.53) |
NON- GAAP basic and diluted loss per ordinary share | $ | (0.46) | $ | (1.37) |
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 (NYSE:AGN), 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 2023 and 2022 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" later 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 year ended
A copy of the Company's annual report on Form 20-F for the year ended
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 timing and cost of commencing 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:
Deputy CEO & CFO
Tel: + 972-73-2325600
Eran@collplant.com
Investors:
LifeSci Advisors
daniel@lifesciadvisors.com
Photo - https://mma.prnewswire.com/media/2378959/CollPlant.jpg