UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2023
Commission File Number 001-38370
CollPlant Biotechnologies Ltd.
(Exact name of registrant as specified in its charter)
4 Oppenheimer St, Weizmann Science Park
Rehovot 7670104, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F
☒ Form 40-F ☐
This Form 6-K, the text under the headings
“Three and nine-months periods ended September 30, 2023 financial results”, “Balance sheets and cash flows
items” and “Use of Non-US GAAP (“non-GAAP”)” and the accompanying consolidated financial statements
and “Forward Looking Statements” of the press release attached to this Form 6-K as Exhibit 99.1 are hereby incorporated
by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-229163, 333-248479, 333-263842
and 333-271320) and Form
F-3 (File No. 333-228054, 333-238731
and 333-269087), to be
a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently
filed or furnished.
On November 29, 2023, CollPlant Biotechnologies
Ltd. issued a press release entitled “CollPlant Biotechnologies Announces Third Quarter Financial Results for 2023”. A copy
of the letter is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
COLLPLANT BIOTECHNOLOGIES LTD. |
|
|
|
Date: November 29, 2023 |
By: |
/s/ Eran
Rotem |
|
|
Name: |
Eran Rotem |
|
|
Title: |
Deputy CEO and
Chief Financial Officer |
2
Exhibit
99.1
CollPlant
Biotechnologies Announces Third Quarter Financial Results for 2023
| ● | Received
a $10 million milestone payment in the third quarter from partner, AbbVie Inc., for
achieving a major milestone in the second quarter in accordance with the strategic collaboration
agreement related to the clinical-phase dermal filler product candidate |
| ● | Company
is preparing to launch large-animal study with a commercial size breast implant by year-end |
| ● | Cash
and cash equivalents totaled $29 million as of September 30, 2023, representing an estimated
cash runway of at least two years |
| ● | Revenues
of $10.7 million and operating loss of $2.4 million for the first nine months of 2023 |
| ● | Conference
call to be held on November 29, 2023, at 10:00 am U.S. ET; Dial-in information herein |
Rehovot,
Israel, November 29, 2023 – CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetics medicine company developing
innovative technologies and products based on its non-animal-derived collagen for tissue regeneration and organ manufacturing, today
announced financial results for the third quarter ended September 30, 2023, and provided a corporate update on its programs.
“This
quarter, we continued to steadily advance our programs with modest cash use,” said CollPlant’s
Chief Executive Officer, Yehiel Tal. “We are advancing our regenerative breast implants program, and plan to initiate by
the end of this year an animal study with commercial size implants. With AbbVie, we continue to make progress with the dermal filler
candidate, and, in addition, we were pleased to announce earlier this month that a U.S. patent was granted related to our photocurable
dermal filler product candidate. We plan to continue our momentum towards the completion of important upcoming milestones for which we
are entitled to associated payments, that will support our continued robust cash position”.
Third
quarter and recent corporate highlights
Program
developments and collaboration updates
| ● | Dermal
and Soft Tissue Filler – At the end of the second quarter, CollPlant announced the achievement of a milestone with respect
to the dermal and soft tissue filler product candidate, in accordance with its collaboration agreement with AbbVie. Per the agreement,
the achievement of this milestone triggered a $10 million payment from AbbVie to CollPlant that was received in the third quarter. CollPlant
has the potential to receive additional milestone payments as well as future royalties in accordance with its long-term collaboration
with AbbVie for the first-generation dermal filler. |
| ● | Photocurable
Dermal Filler - In November, CollPlant announced that the U.S. Patent and Trademark Office
granted it a patent that covers CollPlant’s photocurable dermal filler product candidate,
being developed for the aesthetics market. U.S. Patent No. 11,801,329 is directed, among
other things, to a method of filling tissue space under the epidermis by introducing a polymerizable
filler solution into the tissue space and applying external light to induce in-situ polymerization.
This issued patent in effect until 2039 provides CollPlant with intellectual property protection
for a regenerative photocurable dermal filler that has contouring capabilities. CollPlant
believes that this patent will strengthen its position in the market for many forthcoming
years. |
| ● | Breast
Implants - CollPlant is planning to initiate the next large-animal study to evaluate
commercial size, 3D bioprinted, regenerative breast implants by year-end. In January of this
year CollPlant announced positive results from its first large-animal study. This study 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. |
In
the U.S. alone, hundreds of thousands of people per year experience adverse events that range from autoimmune symptoms to the very serious
breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). CollPlant’s breast implants, comprised of the Company’s proprietary
plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response and therefore
may provide a revolutionary alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.
| ● | Gut-on-a-Chip
- CollPlant is developing a gut tissue model that will enable a predictive
and personalized treatment for inflammatory bowel diseases (IBD). CollPlant mimics the gut
structure by using high resolution 3D printing in combination with its unique rhCollagen-based
bioink. The first tissue model is to be used for evaluating therapeutic response in
patients suffering from ulcerative colitis. Recently, the CollPlant team managed to
successfully grow epithelial cells on the 3D printed scaffolds that mimic the gut tissue
geometry. In November, CollPlant elected to terminate its collaboration agreement with Tel
Aviv University and Sheba Medical Center and continues to develop this program on its own.
|
| ● | CollPlant
remains engaged in partnering dialogs with several industry leaders and academic institutions
interested in the Company’s rhCollagen technology and expertise in 3D bioprinting,
to develop therapeutics and medical applications. |
Commercial
portfolio of bioink solutions
CollPlant’s
bioink platform is intended to enable its customers to streamline the process of new product development while also accelerating timelines
and reducing overall costs.
During
the last year, CollPlant has released a third BioInk formulation to the market and continues to expand its BioInks portfolio. CollPlant’s
new bioinks enable the end user to address a wide range of 3D bioprinting applications, including drug discovery, drug screening and
tissue testing, as well as the development of transplantable tissues and organs.
Operational
updates
| ● | In
line with CollPlant’s mission to build a company that operates and works towards solutions
that support a sustainable environment, CollPlant recruited a dedicated manager to analyze,
formulate and execute upon the set of standards for its Environmental, Social and Governance
(ESG) program. This initiative is designed to help CollPlant to meet the standards expected
to be instituted by the Securities and Exchange Commission for all publicly listed companies
in the U.S., as well as help socially conscious investors better understand CollPlant’s
alignment with sustainable values – both operationally and as a component of its overall
company mission. |
Related
to this initiative, in September, CollPlant announced that its participation in the United Nations Global Compact, the world’s largest
initiative for sustainable and responsible corporate governance. This alliance unites over 23,000 companies and 4,000 non-business signatories
across over 166 countries and more than 62 Local Networks. By joining this voluntary leadership platform, CollPlant strengthens
its commitment to operate sustainably and also providing further support of its mission to provide sustainable alternatives to existing
regenerative and aesthetics medicine products and technologies.
Three
and nine-months periods ended September 30, 2023 financial results
GAAP
revenues for the third quarter ended September 30, 2023 were $43,000 and included mainly income from sales of the Company’s BioInk
and rhCollagen, a decrease of $66,000 compared to $109,000 in the third quarter ended September 30, 2022.
GAAP
revenues for the nine months ended September 30, 2023, were $10.7 million and included mainly revenues from AbbVie, CollPlant’s
business partner. Revenues increased by $10.5 million, compared to $241,000 in the nine months ended September 30, 2022. The increase
is mainly related to the achievement of a milestone under the AbbVie Agreement and an increase in sales of rhCollagen products.
GAAP
cost of revenues for the third quarter ended September 30, 2023, was $278,000, compared to $264,000 in the third quarter ended September
30, 2022. Cost of revenue mainly includes the cost of the Company’s rhCollagen based products, and royalties to the Israeli Innovative
Authorities for our sales. The increase in cost of revenues in the amount of approximately $14,000 is mainly related to inventory impairments.
GAAP
cost of revenues for the nine months ended September 30, 2023, was $1.2 million, compared to $338,000 in the nine months ended September
30, 2022. The increase in the amount of approximately $880,000 is mainly comprised of: (i) $312,000 in royalty expenses to the IIA mainly
related to the milestone payment received from AbbVie, and (ii) $430,000 relating to the sales of BioInk, VergenixFG, and rhCollagen.
GAAP
gross loss for the third quarter ended September 30, 2023 was $235,000, compared to gross loss of $155,000 in the third quarter ended
September 30, 2022.
GAAP
gross profit for the nine months ended September 30, 2023, was $9.4 million, compared to gross loss of $97,000 in the nine months ended
September 30, 2022.
GAAP
operating expenses for the third quarter ended September 30, 2023 were $4.4 million, compared to $4.3 million in the third quarter ended
September 30, 2022. On a non-GAAP basis, operating expenses for the third quarter ended September 30, 2023 were $3.9 million, compared
to $3.7 million for the third quarter ended September 30, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP
operating expenses for the nine months ended September 30, 2023, were $11.9 million, compared to $12.3 million, in the nine months ended
September 30, 2022. The decrease of approximately $438,000 is mainly attributed to $247,000 in research and product development activities
related to process development in 2022, and approximately $191,000 in general and administrative expenses, mainly comprised of: (i) a
$109,000 increase in professional services expenses offset by (ii) a $320,000 decrease in share-based compensation expenses. On a non-GAAP
basis, the operating expenses for the nine months ended September 30, 2023 were $10.6 million, compared to $11.0 million in the nine
months ended September 30, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP
financial income, net, for the third quarter ended September 30, 2023 totaled $225,000, compared to financial income, net, of $89,000
in the third quarter of 2022. The increase in financial income, net, is due to an increase in interest rates and interest received from
our short-term cash deposits.
GAAP
financial income, net, for the nine months ended September 30, 2023, totaled $114,000, compared to financial expenses, net, of $103,000
in the nine months ended September 30, 2022. The increase in financial income, net, is due to the increase in interest rates and interest
received from the Company’s short-term cash deposits.
GAAP
net loss for the third quarter ended September 30, 2023 was $4.4 million, or $0.38 basic loss per share, compared to a net loss of $4.4
million, or $0.4 basic loss per share, for the third quarter ended September 30, 2022. Non-GAAP net loss for the third quarter ended
September 30, 2023 was $4 million, or $0.35 loss per share, compared to a net loss of $3.7 million, or $0.34 basic loss per share, for
the third quarter ended September 30, 2022.
GAAP
net loss for the nine months ended September 30, 2023 was $2.3 million, or $0.2 basic loss per share, compared to a net loss of $12.5
million, or $1.14 basic loss per share, for the nine months ended September 30, 2022. Non-GAAP net loss for the nine months ended September
30, 2023, was $1.2 million, or $0.11 basic loss per share, compared to $11.2 million loss, or $1.02 basic loss per share, for the nine
months ended September 30, 2022.
Balance
sheets and cash flows items
Cash
and cash equivalents as of September 30, 2023, were $29 million. Based on current estimates, the cash balance represents as
of November 2023, a company cash runway of at least two years of operation.
Cash
provided by operating activities during the three months ended September 30, 2023 was $6.8 million, compared to $3.2 million cash used
in during the three months ended September 30, 2022. Cash used in operating activities during the nine months ended September 30, 2023
was $418,000, compared to $10.4 million during the nine months ended September 30, 2022. Cash provided in the three and nine-months periods
ended September 30, 2023 includes the $10 million milestone payment from AbbVie.
Cash
used in investing activities during the three months ended September 30, 2023 was 243,000, compared to $322,000 cash used in investing
activities during the three months ended September 30, 2022. Cash used in investing activities during the nine months ended September
30, 2023 was $784,000, compared to $29.2 million cash provided by investing activities during the nine months ended September 30, 2022.
The decrease is mainly attributed to repayment and investment in short term cash deposits during the nine months ended September 30,
2022.
Cash
provided by financing activities during the three months ended September 30, 2023 was $216,000. During the three months ended September
30, 2022, there was no cash provided by financing activities. Cash provided by financing activities during the nine months ended September
30, 2023 was $1.1 million, compared to $1.5 million during the nine months ended September 30, 2022. Cash provided by financing activities
is mainly attributed to proceeds from the exercise of options and warrants into shares.
Conference
call information
To
participate in the conference call, please use the dial-in information below:
U.S.
investors: 1-877-407-9716
Investors
outside of the U.S.: 1-201-493-6779
Israel
investors: 1-809-406-247
Conference
ID: 13741767
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.
COLLPLANT
BIOTECHNOLOGIES LTD.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(U.S.
dollars in thousands)
| |
September 30,
2023 | | |
December 31,
2022 | |
| |
(Unaudited) | | |
(Audited) | |
Assets | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 28,981 | | |
$ | 29,653 | |
Restricted deposit | |
| 226 | | |
| 23 | |
Trade receivables | |
| 4 | | |
| 9 | |
Inventories | |
| 1,503 | | |
| 1,430 | |
Other accounts receivable and prepaid expenses | |
| 493 | | |
| 543 | |
Total current assets | |
| 31,207 | | |
| 31,658 | |
Non-current assets: | |
| | | |
| | |
Restricted deposit | |
| 54 | | |
| 188 | |
Operating lease right-of-use assets | |
| 3,179 | | |
| 2,711 | |
Property and equipment, net | |
| 2,916 | | |
| 2,966 | |
Intangible assets, net | |
| 202 | | |
| 245 | |
Total non-current assets | |
| 6,351 | | |
| 6,110 | |
Total assets | |
$ | 37,558 | | |
$ | 37,768 | |
COLLPLANT
BIOTECHNOLOGIES LTD.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(U.S.
dollars in thousands, except share data)
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
(Unaudited) | | |
(Audited) | |
Liabilities and shareholders’ equity | |
| | |
| |
Current liabilities: | |
| | |
| |
Trade payables | |
$ | 744 | | |
$ | 1,133 | |
Operating lease liabilities | |
| 571 | | |
| 529 | |
Accrued liabilities and other | |
| 1,319 | | |
| 1,443 | |
Total current liabilities | |
| 2,634 | | |
| 3,105 | |
Non-current liabilities: | |
| | | |
| | |
Operating lease liabilities | |
| 2,526 | | |
| 2,382 | |
Total non-current liabilities | |
| 2,526 | | |
| 2,382 | |
Total liabilities | |
| 5,160 | | |
| 5,487 | |
Shareholders’ Equity: | |
| | | |
| | |
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares as of September 30, 2023 and December 31, 2022; issued and outstanding: 11,452,672 and 11,186,481 ordinary shares as of September 30, 2023 and December 31, 2022, respectively | |
| 4,982 | | |
| 4,873 | |
Additional paid in capital | |
| 120,437 | | |
| 118,099 | |
Currency translation differences | |
| (969 | ) | |
| (969 | ) |
Accumulated deficit | |
| (92,052 | ) | |
| (89,722 | ) |
Total shareholders’ equity | |
| 32,398 | | |
| 32,281 | |
Total liabilities and shareholders’ equity | |
$ | 37,558 | | |
$ | 37,768 | |
COLLPLANT
BIOTECHNOLOGIES LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S.
dollars in thousands, except share and per share data)
(Unaudited)
| |
Nine months ended September 30, | | |
Three months ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues | |
$ | 10,660 | | |
$ | 241 | | |
$ | 43 | | |
$ | 109 | |
Cost of Revenue | |
| 1,218 | | |
| 338 | | |
| 278 | | |
| 264 | |
Gross Profit (loss) | |
| 9,442 | | |
| (97 | ) | |
| (235 | ) | |
| (155 | ) |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 7,371 | | |
| 7,618 | | |
| 2,695 | | |
| 2,777 | |
General, administrative and marketing | |
| 4,515 | | |
| 4,706 | | |
| 1,672 | | |
| 1,536 | |
Total Operating loss | |
| (2,444 | ) | |
| (12,421 | ) | |
| (4,602 | ) | |
| (4,468 | ) |
Financial income (expenses), net | |
| 114 | | |
| (103 | ) | |
| 225 | | |
| 89 | |
Net loss for the period | |
$ | (2,330 | ) | |
$ | (12,524 | ) | |
$ | (4,377 | ) | |
$ | (4,379 | ) |
Basic and diluted loss per ordinary share | |
$ | (0.20 | ) | |
$ | (1.14 | ) | |
$ | (0.38 | ) | |
$ | (0.40 | ) |
Weighted average ordinary shares outstanding used in computation of basic and diluted loss per share | |
| 11,367,767 | | |
| 10,986,454 | | |
| 11,443,023 | | |
| 11,086,481 | |
COLLPLANT
BIOTECHNOLOGIES LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S.
dollars in thousands)
(Unaudited)
| |
Nine months ended September 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | |
| |
Loss | |
$ | (2,330 | ) | |
$ | (12,524 | ) |
Adjustments for: | |
| | | |
| | |
Depreciation and amortization | |
| 818 | | |
| 782 | |
Interest from Short term cash deposits | |
| - | | |
| (87 | ) |
Interest from restricted deposits | |
| (10 | ) | |
| - | |
Share-based compensation to employees and consultants | |
| 1,373 | | |
| 1,735 | |
Exchange differences on cash and cash equivalents | |
| 578 | | |
| 699 | |
Changes in operating asset and liability items: | |
| | | |
| | |
Decrease in trade receivables | |
| 5 | | |
| 261 | |
Increase in inventories | |
| (107 | ) | |
| (47 | ) |
Decrease (increase) in other receivables | |
| 50 | | |
| (65 | ) |
Decrease in operating right of use assets | |
| 387 | | |
| 345 | |
Decrease in trade payables | |
| (389 | ) | |
| (154 | ) |
Decrease in lease liabilities | |
| (669 | ) | |
| (803 | ) |
Decrease in accrued liabilities and other payables | |
| (124 | ) | |
| (462 | ) |
Decrease in deferred revenues | |
| - | | |
| (32 | ) |
Net cash used in operating activities | |
| (418 | ) | |
| (10,352 | ) |
Cash flows from investing activities: | |
| | | |
| | |
Capitalization of intangible assets | |
| - | | |
| (25 | ) |
Purchase of property and equipment | |
| (725 | ) | |
| (987 | ) |
Repayment of a short term deposits | |
| - | | |
| 50,238 | |
Investment in short term deposits | |
| (59 | ) | |
| (20,000 | ) |
Net cash provided by (used in) investing activities | |
| (784 | ) | |
| 29,226 | |
Cash flows from financing activities: | |
| | | |
| | |
Exercise of options and warrants into shares | |
| 1,108 | | |
| 1,474 | |
Net cash provided by financing activities | |
| 1,108 | | |
| 1,474 | |
Net increase (decrease) in cash and cash equivalents and restricted deposits | |
| (94 | ) | |
| 20,348 | |
Exchange differences on cash and cash equivalents and restricted deposits | |
| (578 | ) | |
| (699 | ) |
Cash and cash equivalents and restricted deposits at the beginning of the period | |
| 29,653 | | |
| 13,374 | |
| |
| | | |
| | |
Cash and cash equivalents and restricted deposits at the end of the period | |
$ | 28,981 | | |
$ | 33,023 | |
COLLPLANT
BIOTECHNOLOGIES LTD.
APPENDICES
TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S.
dollars in thousands)
(Unaudited)
| |
Nine months ended September 30, | |
| |
2023 | | |
2022 | |
Appendix to the statement of cash flows | |
| | |
| |
| |
| | |
| |
A. Supplementary information on investing and financing activities not involving cash flows: | |
| | |
| |
Obtaining right of use assets in exchange for a lease liability | |
| 855 | | |
| 100 | |
Capitalization of Share-based compensation to inventory | |
| 34 | | |
| - | |
| |
| | | |
| | |
B. Reconciliation of Cash, cash equivalents and restricted cash at the end of the period | |
| | | |
| | |
Cash and cash equivalents | |
| 28,981 | | |
| 32,813 | |
Restricted deposits (including long term) | |
| - | | |
| 210 | |
Total cash and cash equivalents and restricted deposits | |
$ | 28,981 | | |
$ | 33,023 | |
CollPlant
Biotechnologies Ltd.
Reconciliation
of GAAP to Non-GAAP Financial Measures
(U.S.
dollars in thousands, except per share data)
(Unaudited)
| |
Nine months ended September 30, | | |
Three months ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
GAAP operating expenses: | |
$ | 11,886 | | |
$ | 12,324 | | |
$ | 4,367 | | |
$ | 4,313 | |
| |
| | | |
| | | |
| | | |
| | |
Change of operating lease accounts | |
| 47 | | |
| 458 | | |
| 14 | | |
| 35 | |
Share-based compensation to employees, directors and consultants | |
| (1,373 | ) | |
| (1,735 | ) | |
| (521 | ) | |
| (680 | ) |
Non-GAAP operating expenses: | |
| 10,560 | | |
| 11,047 | | |
| 3,860 | | |
| 3,668 | |
| |
| | | |
| | | |
| | | |
| | |
GAAP operating loss | |
| (2,444 | ) | |
| (12,421 | ) | |
| (4,602 | ) | |
| (4,468 | ) |
Change of operating lease accounts | |
| (47 | ) | |
| (458 | ) | |
| (14 | ) | |
| (35 | ) |
Share-based compensation to employees, directors and consultants | |
| 1,373 | | |
| 1,735 | | |
| 521 | | |
| 680 | |
Non-GAAP operating loss | |
| (1,118 | ) | |
| (11,144 | ) | |
| (4,095 | ) | |
| (3,823 | ) |
| |
| | | |
| | | |
| | | |
| | |
GAAP Net loss | |
| (2,330 | ) | |
| (12,524 | ) | |
| (4,377 | ) | |
| (4,379 | ) |
Change of operating lease accounts | |
| (282 | ) | |
| (458 | ) | |
| (101 | ) | |
| (35 | ) |
Share-based compensation to employees, directors and consultants | |
| 1,373 | | |
| 1,735 | | |
| 521 | | |
| 680 | |
Non-GAAP Net loss | |
$ | (1,239 | ) | |
$ | (11,247 | ) | |
$ | (3,957 | ) | |
$ | (3,734 | ) |
GAAP basic and diluted loss per ordinary share | |
$ | (0.20 | ) | |
$ | (1.14 | ) | |
$ | (0.38 | ) | |
$ | (0.40 | ) |
NON- GAAP basic and diluted loss per ordinary share | |
$ | (0.11 | ) | |
$ | (1.02 | ) | |
$ | (0.35 | ) | |
$ | (0.34 | ) |
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 2023 and 2022 are presented on both a GAAP and a non-GAAP basis. GAAP results were prepared in accordance with U.S. GAAP
and include all revenue and expenses recognized during the period. The release contains certain non-GAAP financial measures for operating
costs and expenses, operating income (or loss), net income (or loss) and basic and diluted net income (or loss) per share that exclude
the effects of non-cash expense for share-based compensation to employees, directors and consultants, and change in operating lease accounts.
CollPlant’s management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the
Company’s performance that enhances management’s and investors’ ability to evaluate the Company’s operating costs,
net income (or loss) and income (or loss) per share, and to compare them to historical Company results.
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 results for the third quarter ended September 30, 2023, are presented in accordance with generally
accepted accounting principles in the U.S.
A
copy of the Company’s annual report on Form 20-F for the year ended December 31, 2022 has been filed with the U.S. Securities and
Exchange Commission at www.sec.gov and posted on the Company’s investor relations website at http://ir.collplant.com/. The Company
will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its
shareholders upon request to CollPlant Investor Relations at 4 Oppenheimer, Weizmann Science Park, Rehovot 767104, Israel or by phone
at +972-73-232 5600.
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 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 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 Israel- Hamas war, projected capital
expenditures and liquidity, changes in the Company’s strategy, and litigation and regulatory proceedings. More detailed
information about the risks and uncertainties affecting CollPlant are contained under the heading “Risk Factors”
included in CollPlant’s most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has
made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date
of this press release and reflect CollPlant’s current views with respect to future events, and CollPlant does not undertake
and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Contacts
CollPlant:
Eran
Rotem
Deputy
CEO & CFO
Tel:
+ 972-73-2325600
Eran@collplant.com
Investors:
LifeSci
Advisors
John Mullaly
jmullaly@lifesciadvisors.com
14
CollPlant Biotechnologies (NASDAQ:CLGN)
Historical Stock Chart
From May 2024 to Jun 2024
CollPlant Biotechnologies (NASDAQ:CLGN)
Historical Stock Chart
From Jun 2023 to Jun 2024