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 August 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 heading “Second
Quarter 2023 Financial Results”, the accompanying consolidated financial statements and “Forward Looking Statements”
of the press release attached to this Form 6-K as Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3 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333-238731 and 333-269087), to be a part thereof from the date on which this report is submitted, to the extent not superseded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 August 24, 2023, CollPlant Biotechnologies
Ltd. (the “Company”) issued a press release entitled “CollPlant Biotechnologies Provides Business Updates and Second
Quarter 2023 Financial Results”. In addition, on the same day, the Company issued condensed consolidated interim financial statements
(unaudited) as of June 30, 2023 together with the Company’s Operating and Financial Review and Prospects for the same period.
Attached hereto and incorporated by reference herein are the following
exhibits:
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: August 24, 2023 |
By: |
/s/ Eran Rotem |
|
|
Name: |
Eran Rotem |
|
|
Title: |
Deputy CEO and Chief Financial Officer |
Exhibit 99.1
CollPlant Biotechnologies Announces Second Quarter
Financial Results For 2023 with Revenues of $10.2 Million
| ● | Received
in July 2023, $10 million from partner, AbbVie, for achieving a major milestone in the second quarter, for the clinical-phase dermal
filler product in accordance with the strategic collaboration agreement |
| ● | Entered
into collaboration with Stratasys, a world-leading 3D printing company, with initial focus on the development of a bioprinting solution
for the fabrication of CollPlant’s regenerative breast implants |
| ● | Readying
breast implant study in large animals for initiation by year end |
| ● | Continued
positive sales trajectory for 3D bioinks |
| ● | Cash
and cash equivalents totaled $22.3 million as of June 30, 2023; cash runway extended with additional $10 million milestone payment received
in July 2023 from AbbVie |
| ● | Revenues
of $10.6 million and operating income of $5.7 million for the first six months of 2023 |
| ● | Conference
call to be held on August 24, 2023 at 10:00 am U.S. ET; Dial-in information herein |
Rehovot, Israel, August 24, 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 second quarter
ended June 30, 2023, and provided a corporate update on its programs.
“This quarter, we were very pleased to announce
the achievement of an important milestone related to the dermal filler product developed in collaboration with our partner, AbbVie, for
which we received a $10 million payment. We also announced a joint development and commercialization agreement with Stratasys, a world-leader
in additive manufacturing that will initially focus on developing a bioprinting solution for the fabrication of our regenerative breast
implants in development. Both collaborations are expected to allow us to continue our momentum towards reaching important upcoming milestones
related to these programs, with the former providing a vehicle to maintain our strong cash position,” said
CollPlant’s Chief Executive Officer, Yehiel Tal.
Mr. Tal continued, “One of our upcoming
milestones will be initiating by the end of this year a second large-animal study to evaluate our regenerative breast implants. We have
already established the trial infrastructure and look forward to providing an update as soon as we conclude this study.”
Q2 and recent corporate highlights
Program development
| ● | CollPlant is planning to initiate a second large-animal
study to evaluate commercial sized 3D bioprinted regenerative breast implants, by year end. This study follows the completion of the first
large-animal study, the results of which were announced in January of this year. The first 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 that are comprised of CollPlant’s proprietary
plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response, and thus
may provide a revolutionary alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.
Collaboration updates
| ● | In
June, CollPlant announced the achievement of a milestone with respect to the clinical phase dermal
filler product, which is under its collaboration agreement with AbbVie. According to the agreement, the achievement of this milestone
triggered a $10 million payment from AbbVie to CollPlant. 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 dermal filler product. |
| ● | In
April, CollPlant announced a joint development and commercialization agreement with Stratasys to collaborate on the development
of a printing solution to bio-fabrication of human tissues and organs using Stratasys’ P3 technology-based bioprinter and CollPlant’s
rh-Collagen-based bioinks. The bioprinting solution is being designed to enable the production
of scaffolds that will accurately mimic the physical properties of human tissues and organs. These scaffolds are to meet the product
specification including resolution and reproducibility. The combined proprietary technologies are expected to enable the fabrication
of tissues and organs that also possess differentiated regenerative properties. The first project focuses on the development of an industrial-scale
solution for CollPlant’s regenerative breast implants program. Under the agreement, both companies have also agreed to cross-promote
each other’s bioprinting products. |
| ● | CollPlant is
developing, together with Tel Aviv University and Sheba Medical Center, a system that enhances the physiological relevance of the
human gut to provide a predictive personalized platform. CollPlant mimics the gut structure by 3D printing the gut tissue geometry in
high resolution using its unique rhCollagen-based bioink formulation. This tissue model is to be used for evaluating therapy 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. The Company expects to be able to provide an update on next steps for this program
by the end of this year. |
| ● | 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. CollPlant’s new bioink, Collink.3D-50L is the first bioink available in powder form which provides
enhanced operational specificity and flexibility for the end-user because of its mechanical properties to address additional printing
requirements of soft and hard tissues. These features of CollPlant’s new bioink 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 recently 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 meet the evolving standards applicable to publicly listed
companies in the U.S., as well as help business partners and socially conscious investors better understand CollPlant’s alignment
with sustainable values – both operationally and as a component of its overall company mission. |
Second quarter ended June 30, 2023 financial
results
GAAP revenues for the second quarter ended June
30, 2023 were $10.2 million, an increase of $10.1 million compared to $66,000 in the second quarter ended June 30, 2022. The increase
in revenues was mainly related to the achievement of a milestone with respect to the AbbVie agreement, which triggered a $10 million payment.
GAAP cost of revenues for the second quarter ended
June 30, 2023, was $615,000, an increase of $572,000 compared to $43,000 in the second quarter ended June 30, 2022. Cost of revenue mainly
includes the cost of the Company’s rhCollagen based products, and royalties to the Israeli Innovation Authority (IIA) for our sales. The
increase in cost of revenues in the amount of approximately $572,000 is mainly comprised of: (i) $305,000 in royalty expenses to the IIA
mainly related to the milestone payment received from AbbVie, and (ii) $171,000 relating to the BioInk, VergenixFG, and rhCollagen sales.
GAAP gross profit for the second quarter ended
June 30, 2023 was $9.6 million, compared to gross profit of $23,000 in the second quarter ended June 30, 2022.
GAAP operating expenses for the second quarter
ended June 30, 2023 were $3.9 million, compared to $4.2 million in the second quarter ended June 30, 2022. The decrease of $300,000 is
mainly related to general and administrative expenses and comprised of (i) $223,000 in employees’ salaries expense including a decrease
in accrued vacation liability and alterations in employment contractual terms implemented in 2022, and (ii) $194,000 share-based compensation
expenses mainly related to a directors grant in May 2022, offset by an increase of approximately $116,000 in professional services expenses
and patents expenses. On a non-GAAP basis, operating expenses for the second quarter ended June 30, 2023 were $3.6 million, compared to
$3.9 million in the second quarter ended June 30, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP financial income, net, for the second quarter
ended June 30, 2023 totaled $85,000, compared to financial expenses, net, of $100,000 in the second quarter of 2022. The increase in financial
income is due to interest received from our short-term cash deposits and exchange rate differences.
GAAP net income for the second quarter ended June
30, 2023 was $5.8 million, or $0.51 basic income per share, compared to a net loss of $4.3 million, or $0.39 basic loss per share, for
the second quarter ended June 30, 2022. Non-GAAP net income for the second quarter ended June 30, 2023 was $6.0 million, or $0.53 income
per share, compared to a net loss of $4.0 million, or $0.36 basic loss per share, for the second quarter ended June 30, 2022.
Cash and cash equivalents as of June 30,
2023, were $22.3 million.
Cash used in operating activities during the three
months ended June 30, 2023 was $3.8 million, compared to $4.0 million cash used in operating activities during the three months ended
June 30, 2022.
Cash used in investing activities during the three
months ended June 30, 2023 and during the three months ended June 30, 2022 was $337,000.
Cash provided by financing activities during the three months ended
June 30, 2023 was $89,000. During the three months ended June 30, 2022, there was no cash provided by financing activities.
Year-to-date (six-month) period ended June
30, 2023 financial results
GAAP revenues for the six months ended June 30,
2023, were $10.6 million and included mainly revenues from the AbbVie Agreement as well as income from sales of the Company’s BioInk and
rhCollagen. Revenues increased by $10.5 million, compared to $132,000 in the six months ended June 30, 2022. The increase is related almost
entirely to the achievement of a milestone under the AbbVie Agreement and $500,000 increase in sales of rhCollagen.
GAAP cost of revenues for the six months ended
June 30, 2023, was $940,000, an increase of $866,000 compared to $74,000 in the six months ended June 30, 2022. The increase in cost of
revenues in the amount of approximately $866,000 is mainly comprised of: (i) $316,000 in royalty expenses to the IIA mainly related to
the milestone payment received from AbbVie, and (ii) $424,000 relating to the sales of BioInk, VergenixFG, and rhCollagen.
GAAP gross profit for the six months ended June
30, 2023, was $9.7 million, compared to gross profit of $58,000 in the six months ended June 30, 2022.
GAAP operating expenses for the six months ended
June 30, 2023, were $7.5 million, compared to $8.0 million, in the six months ended June 30, 2022. The decrease of $500,000 in expenses
is mainly related to general and administrative expenses and comprised of: (i) $278,000 in employees’ salaries expense including a decrease
in accrued vacation liability and alterations in employment contractual terms implemented in 2022, and (ii) $124,000 share-based compensation
expenses mainly related to options granted in 2022. On a non-GAAP basis, the operating expenses for the six months ended June 30, 2023
were $6.7 million, compared to $7.4 million in the six months ended June 30, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP financial expenses, net for the six months
ended June 30, 2023, totaled $111,000, compared to $192,000 in the six months ended June 30, 2022. The decrease in financial expenses,
net, is due to interest received from the Company’s short-term cash deposits.
GAAP net income for the six months ended June
30, 2023 was $2.0 million, or $0.18 basic income per share, compared to a net loss of $8.1 million, or $0.74 basic loss per share, for
the six months ended June 30, 2022. Non-GAAP net income for the six months ended June 30, 2023, was $2.7 million, or $0.24 basic loss
per share, compared to $7.5 million loss, or $0.69 basic loss per share, for the six months ended June 30, 2022.
Cash used in operating activities during the six
months ended June 30, 2023 and June 30, 2022, remain unchanged at $7.2 million.
Cash used in investing activities during the six
months ended June 30, 2023 was $541,000, compared to $29.5 million cash provided by investing activities during the six months ended June
30, 2022. The decrease is mainly attributed to repayment and investment in short term cash deposits during the six months ended June 30,
2022.
Cash provided by financing activities during the
six months ended June 30, 2023 was $892,000, compared to cash provided by financing activities of $1.5 million during the six months ended
June 30, 2022. Cash provided by financing activities is attributed to proceeds from the exercise of options and warrants into shares.
Conference call information
CollPlant will hold a conference call to discuss
its second quarter 2023 financial results along with corporate updates on August 24, 2023 at 10 am ET.
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: 13739191
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
Submit questions to management in advance of the call
To ask management a question ahead of the call, please email John Mullaly
at LifeSci Advisors LLC up until 24 hours before the event at jmullaly@lifesciadvisors.com.
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Assets | |
(Unaudited) | | |
(Audited) | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 22,283 | | |
$ | 29,653 | |
Restricted cash | |
| 83 | | |
| - | |
Restricted deposit | |
| 22 | | |
| 23 | |
Trade receivables | |
| 10,160 | | |
| 9 | |
Inventories | |
| 1,552 | | |
| 1,430 | |
Other accounts receivable and prepaid expenses | |
| 758 | | |
| 543 | |
Total current assets | |
| 34,858 | | |
| 31,658 | |
Non-current assets: | |
| | | |
| | |
Restricted (deposit | |
| 237 | | |
| 188 | |
Operating lease right-of-use assets | |
| 3,327 | | |
| 2,711 | |
Property and equipment, net | |
| 2,931 | | |
| 2,966 | |
Intangible assets, net | |
| 216 | | |
| 245 | |
Total non-current assets | |
| 6,711 | | |
| 6,110 | |
Total assets | |
$ | 41,569 | | |
$ | 37,768 | |
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Liabilities and shareholders’ equity | |
(Unaudited) | | |
(Audited) | |
Current liabilities: | |
| | | |
| | |
Trade payables | |
$ | 763 | | |
$ | 1,133 | |
Operating lease liabilities | |
| 598 | | |
| 529 | |
Accrued liabilities and other | |
| 1,421 | | |
| 1,443 | |
Total current liabilities | |
| 2,782 | | |
| 3,105 | |
Non-current liabilities: | |
| | | |
| | |
Operating lease liabilities | |
| 2,748 | | |
| 2,382 | |
Total non-current liabilities | |
| 2,748 | | |
| 2,382 | |
Total liabilities | |
| 5,530 | | |
| 5,487 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
| |
| | | |
| | |
Shareholders’ Equity: | |
| | | |
| | |
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares as of June 30, 2023 (unaudited) and December 31, 2022; issued and outstanding: 11,405,394 and 11,186,481 ordinary shares as of June 30, 2023 (unaudited) and December 31, 2022, respectively | |
| 4,963 | | |
| 4,873 | |
Additional paid in capital | |
| 119,720 | | |
| 118,099 | |
Currency translation differences | |
| (969 | ) | |
| (969 | ) |
Accumulated deficit | |
| (87,675 | ) | |
| (89,722 | ) |
Total shareholders’ equity | |
| 36,039 | | |
| 32,281 | |
Total liabilities and shareholders’ equity | |
$ | 41,569 | | |
$ | 37,768 | |
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per
share data)
(Unaudited)
| |
Six months ended June 30 | | |
Three months ended June 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues | |
$ | 10,617 | | |
$ | 132 | | |
$ | 10,184 | | |
$ | 66 | |
Cost of revenues | |
| 940 | | |
| 74 | | |
| 615 | | |
| 43 | |
Gross Profit | |
| 9,677 | | |
| 58 | | |
| 9,569 | | |
| 23 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 4,676 | | |
| 4,841 | | |
| 2,574 | | |
| 2,599 | |
General, administrative and marketing | |
| 2,843 | | |
| 3,170 | | |
| 1,318 | | |
| 1,609 | |
Operating income (loss) | |
| 2,158 | | |
| (7,953 | ) | |
| 5,677 | | |
| (4,185 | ) |
Financial income (expenses), net | |
| (111 | ) | |
| (192 | ) | |
| 85 | | |
| (100 | ) |
Net income (loss) for the period | |
$ | 2,047 | | |
$ | (8,145 | ) | |
$ | 5,762 | | |
$ | (4,285 | ) |
Basic net income (loss) per ordinary share | |
$ | 0.18 | | |
$ | (0.74 | ) | |
$ | 0.51 | | |
$ | (0.39 | ) |
Diluted net income (loss) per ordinary share | |
$ | 0.17 | | |
$ | (0.74 | ) | |
$ | 0.49 | | |
$ | (0.39 | ) |
Weighted average ordinary shares outstanding used in computation of basic net income (loss) per share | |
| 11,329,516 | | |
| 10,935,611 | | |
| 11,369,031 | | |
| 11,086,481 | |
Weighted average ordinary shares outstanding used in computation of diluted net income (loss) per share | |
| 11,738,884 | | |
| 10,935,611 | | |
| 11,777,139 | | |
| 11,086,481 | |
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
(Unaudited)
|
|
Six months ended
June 30, |
|
|
|
2023 |
|
|
2022 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
Income (loss) |
|
$ |
2,047 |
|
|
$ |
(8,145 |
) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
546 |
|
|
|
501 |
|
Interest from Short term deposits |
|
|
- |
|
|
|
(87 |
) |
Interest from restricted deposits |
|
|
11 |
|
|
|
- |
|
Share-based compensation to employees and consultants |
|
|
852 |
|
|
|
1,055 |
|
Exchange differences on cash and cash equivalents |
|
|
444 |
|
|
|
727 |
|
Changes in operating asset and liability items: |
|
|
|
|
|
|
|
|
Decrease (increase) in trade receivables |
|
|
(10,151 |
) |
|
|
261 |
|
Increase in inventories |
|
|
(155 |
) |
|
|
(275 |
) |
Increase in other accounts receivable and prepaid expenses |
|
|
(215 |
) |
|
|
(170 |
) |
Decrease in operating right of use assets |
|
|
254 |
|
|
|
220 |
|
Decrease in trade payables |
|
|
(370 |
) |
|
|
(274 |
) |
Decrease in lease liabilities |
|
|
(435 |
) |
|
|
(643 |
) |
Decrease in accrued liabilities and other payables |
|
|
(22 |
) |
|
|
(305 |
) |
Decrease in deferred revenues |
|
|
- |
|
|
|
(32 |
) |
Net cash used in operating activities |
|
|
(7,194 |
) |
|
|
(7,167 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Capitalization of intangible assets |
|
|
- |
|
|
|
(12 |
) |
Purchase of property and equipment |
|
|
(482 |
) |
|
|
(678 |
) |
Repayment of a short term deposits |
|
|
- |
|
|
|
50,238 |
|
Investment in short term deposits and restricted deposits |
|
|
(59 |
) |
|
|
(20,000 |
) |
Net cash provided by (used in) investing activities |
|
|
(541 |
) |
|
|
29,548 |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Exercise of options and warrants into shares |
|
|
892 |
|
|
|
1,474 |
|
Net cash provided by financing activities |
|
|
892 |
|
|
|
1,474 |
|
Exchange differences on cash and cash equivalents, restricted cash and restricted deposits |
|
|
(444 |
) |
|
|
(727 |
) |
Net increase (decrease) in cash and cash equivalents, restricted cash and restricted deposits |
|
|
(7,287 |
) |
|
|
23,128 |
|
Cash and cash equivalents, restricted cash and restricted deposits at the beginning of the period |
|
|
29,653 |
|
|
|
13,374 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, restricted cash and restricted deposits at the end of the period |
|
$ |
22,366 |
|
|
$ |
36,502 |
|
COLLPLANT BIOTECHNOLOGIES LTD.
APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS
(U.S. dollars in thousands)
(Unaudited)
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | |
Appendix to the statement of cash flows | |
| | |
| |
A. Supplementary information on investing and financing activities not involving cash flows: | |
| | |
| |
| |
| | |
| |
Right of use assets recognized with corresponding lease liabilities | |
| 870 | | |
| 59 | |
Capitalization of Share-based compensation to inventory | |
| 33 | | |
| - | |
| |
| | | |
| | |
B. Reconciliation of Cash, cash equivalents and restricted cash at the end of the period | |
| | | |
| | |
| |
| | | |
| | |
Cash and cash equivalents | |
| 22,283 | | |
| 36,290 | |
Restricted cash | |
| 83 | | |
| - | |
Restricted deposits (including long term) | |
| - | | |
| 212 | |
Total cash and cash equivalents, restricted cash and restricted deposits | |
$ | 22,366 | | |
$ | 36,502 | |
COLLPLANT BIOTECHNOLOGIES LTD.
Reconciliation of GAAP to Non-GAAP Financial
Measures
(U.S. dollars in thousands, except per share data)
(Unaudited)
|
|
Six months ended
June 30 |
|
|
Three months ended
June 30 |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
USD in thousands |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP gross profit |
|
$ |
9,677 |
|
|
$ |
58 |
|
|
$ |
9,569 |
|
|
$ |
23 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP operating costs and expenses: |
|
|
7,519 |
|
|
|
8,011 |
|
|
|
3,892 |
|
|
|
4,208 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change of operating lease accounts |
|
|
33 |
|
|
|
423 |
|
|
|
12 |
|
|
|
329 |
|
Share-based compensation to employees, directors and consultants |
|
|
(852 |
) |
|
|
(1,055 |
) |
|
|
(338) |
|
|
|
(594 |
) |
Non-GAAP operating costs and expenses: |
|
|
6,700 |
|
|
|
7,379 |
|
|
|
3,566 |
|
|
|
3,943 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP operating income (loss) |
|
|
2,158 |
|
|
|
(7,953 |
) |
|
|
5,677 |
|
|
|
(4,185 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP operating income (loss) |
|
|
2,977 |
|
|
|
(7,321 |
) |
|
|
6,003 |
|
|
|
(3,920 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Net Income (loss) |
|
|
2,047 |
|
|
|
(8,145 |
) |
|
|
5,762 |
|
|
|
(4,285 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change of operating lease accounts |
|
|
(181) |
|
|
|
(423 |
) |
|
|
(76) |
|
|
|
(329 |
) |
Share-based compensation to employees, directors and consultants |
|
|
852 |
|
|
|
1,055 |
|
|
|
338 |
|
|
|
594 |
|
Non-GAAP Net income (loss) |
|
$ |
2,718 |
|
|
$ |
(7,513 |
) |
|
$ |
6,024 |
|
|
$ |
(4,020 |
) |
GAAP Basic income (loss) per ordinary share |
|
$ |
0.18 |
|
|
$ |
(0.74 |
) |
|
$ |
0.51 |
|
|
$ |
(0.39 |
) |
NON- GAAP Basic income (loss) per ordinary share |
|
$ |
0.24 |
|
|
$ |
(0.69 |
) |
|
$ |
0.53 |
|
|
$ |
(0.36 |
) |
GAAP Diluted income (loss) per ordinary share |
|
$ |
0.17 |
|
|
$ |
(0.74 |
) |
|
$ |
0.49 |
|
|
$ |
(0.39 |
) |
Non-GAAP Diluted income (loss) per ordinary share |
|
$ |
0.23 |
|
|
$ |
(0.69 |
) |
|
$ |
0.52 |
|
|
$ |
(0.36 |
) |
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 second quarter ended June 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.
Safe Harbor 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
ability to develop a printing solution for its breast implants program, or at all; the Company’s expectations regarding the timing
and cost of commencing pre-clinical and clinical trials, or at all, 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 a second
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 with respect to the foregoing trials; 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 bioprinter
under development with Stratasys and/or future potential collaborative products and/or CollPlant’s regenerative breast implants
and/or dermal filler product under development with AbbVie and/or other medical aesthetics products; 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 received 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; 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 is
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
15
Exhibit 99.2
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
AS OF JUNE 30, 2023
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
AS OF JUNE 30, 2023
TABLE OF CONTENTS
___________________
___________________________
___________________
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
(Audited) | |
Assets | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 22,283 | | |
$ | 29,653 | |
Restricted cash | |
| 83 | | |
| - | |
Restricted deposit | |
| 22 | | |
| 23 | |
Trade receivables | |
| 10,160 | | |
| 9 | |
Inventories | |
| 1,552 | | |
| 1,430 | |
Other accounts receivable and prepaid expenses | |
| 758 | | |
| 543 | |
Total current assets | |
| 34,858 | | |
| 31,658 | |
Non-current assets: | |
| | | |
| | |
Restricted deposit | |
| 237 | | |
| 188 | |
Operating lease right-of-use assets | |
| 3,327 | | |
| 2,711 | |
Property and equipment, net | |
| 2,931 | | |
| 2,966 | |
Intangible assets, net | |
| 216 | | |
| 245 | |
Total non-current assets | |
| 6,711 | | |
| 6,110 | |
Total assets | |
$ | 41,569 | | |
$ | 37,768 | |
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
(Audited) | |
Liabilities and shareholders’ equity | |
| | |
| |
Current liabilities: | |
| | |
| |
Trade payables | |
$ | 763 | | |
$ | 1,133 | |
Operating lease liabilities | |
| 598 | | |
| 529 | |
Accrued liabilities and other | |
| 1,421 | | |
| 1,443 | |
Total current liabilities | |
| 2,782 | | |
| 3,105 | |
Non-current liabilities: | |
| | | |
| | |
Operating lease liabilities | |
| 2,748 | | |
| 2,382 | |
Total non-current liabilities | |
| 2,748 | | |
| 2,382 | |
Total liabilities | |
| 5,530 | | |
| 5,487 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
| |
| | | |
| | |
Shareholders’ Equity: | |
| | | |
| | |
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares as of June 30, 2023 (unaudited) and December 31, 2022; issued and outstanding: 11,405,394 and 11,186,481 ordinary shares as of June 30, 2023 (unaudited) and December 31, 2022, respectively | |
| 4,963 | | |
| 4,873 | |
Additional paid in capital | |
| 119,720 | | |
| 118,099 | |
Currency translation differences | |
| (969 | ) | |
| (969 | ) |
Accumulated deficit | |
| (87,675 | ) | |
| (89,722 | ) |
Total shareholders’ equity | |
| 36,039 | | |
| 32,281 | |
Total liabilities and shareholders’ equity | |
$ | 41,569 | | |
$ | 37,768 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
| |
Six months ended June 30 | | |
Three months ended June 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues | |
$ | 10,617 | | |
$ | 132 | | |
$ | 10,184 | | |
$ | 66 | |
Cost of revenues | |
| 940 | | |
| 74 | | |
| 615 | | |
| 43 | |
Gross Profit | |
| 9,677 | | |
| 58 | | |
| 9,569 | | |
| 23 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 4,676 | | |
| 4,841 | | |
| 2,574 | | |
| 2,599 | |
General, administrative and marketing | |
| 2,843 | | |
| 3,170 | | |
| 1,318 | | |
| 1,609 | |
Operating income (loss) | |
| 2,158 | | |
| (7,953 | ) | |
| 5,677 | | |
| (4,185 | ) |
Financial income (expenses), net | |
| (111 | ) | |
| (192 | ) | |
| 85 | | |
| (100 | ) |
Net income (loss) for the period | |
$ | 2,047 | | |
$ | (8,145 | ) | |
$ | 5,762 | | |
$ | (4,285 | ) |
Basic net income (loss) per ordinary share | |
$ | 0.18 | | |
$ | (0.74 | ) | |
$ | 0.51 | | |
$ | (0.39 | ) |
Diluted net income (loss) per ordinary share | |
$ | 0.17 | | |
$ | (0.74 | ) | |
$ | 0.49 | | |
$ | (0.39 | ) |
Weighted average ordinary shares outstanding used in computation of basic net income (loss) per share | |
| 11,329,516 | | |
| 10,935,611 | | |
| 11,369,031 | | |
| 11,086,481 | |
Weighted average ordinary shares outstanding used in computation of diluted net income (loss) per share | |
| 11,738,884 | | |
| 10,935,611 | | |
| 11,777,139 | | |
| 11,086,481 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS SHAREHOLDERS’ EQUITY
(U.S. dollars in thousands, except share data)
(Unaudited)
| |
Ordinary shares | | |
Additional | | |
Currency | | |
| | |
| |
| |
Number of shares | | |
Amounts | | |
paid-in
capital | | |
translation
differences | | |
Accumulated
deficit | | |
Total | |
BALANCE AT DECEMBER 31, 2021 | |
| 10,722,024 | | |
$ | 4,664 | | |
$ | 114,223 | | |
$ | (969 | ) | |
$ | (72,797 | ) | |
$ | 45,121 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of options | |
| 39,457 | | |
| 18 | | |
| 156 | | |
| - | | |
| - | | |
| 174 | |
Exercise of warrants | |
| 325,000 | | |
| 149 | | |
| 1,151 | | |
| - | | |
| - | | |
| 1,300 | |
Share-based compensation | |
| - | | |
| - | | |
| 1,055 | | |
| - | | |
| - | | |
| 1,055 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8,145 | ) | |
| (8,145 | ) |
BALANCE AT JUNE 30, 2022 | |
| 11,086,481 | | |
$ | 4,831 | | |
$ | 116,585 | | |
$ | (969 | ) | |
$ | (80,942 | ) | |
$ | 39,505 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE AT DECEMBER 31, 2022 | |
| 11,186,481 | | |
$ | 4,873 | | |
$ | 118,099 | | |
$ | (969 | ) | |
$ | (89,722 | ) | |
$ | 32,281 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of options | |
| 32,913 | | |
| 14 | | |
| 134 | | |
| - | | |
| - | | |
| 148 | |
Exercise of warrants | |
| 186,000 | | |
| 76 | | |
| 668 | | |
| - | | |
| - | | |
| 744 | |
Share-based compensation | |
| - | | |
| - | | |
| 819 | | |
| - | | |
| - | | |
| 819 | |
Net income | |
| - | | |
| - | | |
| - | | |
| - | | |
| 2,047 | | |
| 2,047 | |
BALANCE AT JUNE 30, 2023 | |
| 11,405,394 | | |
$ | 4,963 | | |
$ | 119,720 | | |
$ | (969 | ) | |
$ | (87,675 | ) | |
$ | 36,039 | |
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(U.S. dollars in thousands, except share data)
(Unaudited)
| |
Ordinary shares | | |
Additional | | |
Currency | | |
| | |
| |
| |
Number of shares | | |
Amounts | | |
paid-in
capital | | |
translation
differences | | |
Accumulated
deficit | | |
Total | |
BALANCE AT MARCH 31, 2022 | |
| 11,086,481 | | |
$ | 4,831 | | |
$ | 115,991 | | |
$ | (969 | ) | |
$ | (76,657 | ) | |
$ | 43,196 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Share-based compensation | |
| - | | |
| - | | |
| 594 | | |
| - | | |
| - | | |
| 594 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,285 | ) | |
| (4,285 | ) |
BALANCE AT JUNE 30, 2022 | |
| 11,086,481 | | |
$ | 4,831 | | |
$ | 116,585 | | |
$ | (969 | ) | |
$ | (80,942 | ) | |
$ | 39,505 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE AT MARCH 31, 2023 | |
| 11,385,041 | | |
$ | 4,955 | | |
$ | 119,341 | | |
$ | (969 | ) | |
$ | (93,437 | ) | |
$ | 29,890 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of options | |
| 20,353 | | |
| 8 | | |
| 81 | | |
| - | | |
| - | | |
| 89 | |
Share-based compensation | |
| - | | |
| - | | |
| 298 | | |
| - | | |
| - | | |
| 298 | |
Net income | |
| - | | |
| - | | |
| - | | |
| - | | |
| 5,762 | | |
| 5,762 | |
BALANCE AT JUNE 30, 2023 | |
| 11,405,394 | | |
$ | 4,963 | | |
$ | 119,720 | | |
$ | (969 | ) | |
$ | (87,675 | ) | |
$ | 36,039 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
(Unaudited)
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | |
| |
Income (loss) | |
$ | 2,047 | | |
$ | (8,145 | ) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities | |
| | | |
| | |
Depreciation and amortization | |
| 546 | | |
| 501 | |
Interest from Short term deposits | |
| - | | |
| (87 | ) |
Interest from restricted deposits | |
| 11 | | |
| - | |
Share-based compensation to employees and consultants | |
| 852 | | |
| 1,055 | |
Exchange differences on cash and cash equivalents | |
| 444 | | |
| 727 | |
Changes in operating asset and liability items: | |
| | | |
| | |
Decrease (increase) in trade receivables | |
| (10,151 | ) | |
| 261 | |
Increase in inventories | |
| (155 | ) | |
| (275 | ) |
Increase in other accounts receivable and prepaid expenses | |
| (215 | ) | |
| (170 | ) |
Decrease in operating right of use assets | |
| 254 | | |
| 220 | |
Decrease in trade payables | |
| (370 | ) | |
| (274 | ) |
Decrease in lease liabilities | |
| (435 | ) | |
| (643 | ) |
Decrease in accrued liabilities and other payables | |
| (22 | ) | |
| (305 | ) |
Decrease in deferred revenues | |
| - | | |
| (32 | ) |
Net cash used in operating activities | |
| (7,194 | ) | |
| (7,167 | ) |
Cash flows from investing activities: | |
| | | |
| | |
Capitalization of intangible assets | |
| - | | |
| (12 | ) |
Purchase of property and equipment | |
| (482 | ) | |
| (678 | ) |
Repayment of a short-term cash deposits | |
| - | | |
| 50,238 | |
Investment in short term cash deposits and restricted deposits | |
| (59 | ) | |
| (20,000 | ) |
Net cash provided by (used in) investing activities | |
| (541 | ) | |
| 29,548 | |
Cash flows from financing activities: | |
| | | |
| | |
Exercise of options and warrants into shares | |
| 892 | | |
| 1,474 | |
Net cash provided by financing activities | |
| 892 | | |
| 1,474 | |
Exchange differences on cash and cash equivalents, restricted cash and restricted deposits | |
| (444 | ) | |
| (727 | ) |
Net increase (decrease) in cash and cash
equivalents, restricted cash and restricted deposits | |
| (7,287 | ) | |
| 23,128 | |
Cash and cash
equivalents, restricted cash and restricted deposits at the beginning of the period | |
| 29,653 | | |
| 13,374 | |
| |
| | | |
| | |
Cash and cash
equivalents, restricted cash and restricted deposits at the end of the period | |
$ | 22,366 | | |
$ | 36,502 | |
COLLPLANT BIOTECHNOLOGIES LTD.
APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
(Unaudited)
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | |
Appendix to the statement of cash flows | |
| | |
| |
A. Supplementary information on investing and financing activities not involving cash flows: | |
| | |
| |
| |
| | |
| |
Right of use assets recognized with corresponding lease liabilities | |
| 870 | | |
| 59 | |
Capitalization of Share-based compensation to inventory | |
| 33 | | |
| - | |
| |
| | | |
| | |
B. Reconciliation of Cash, cash equivalents and restricted cash at the end of the period | |
| | | |
| | |
| |
| | | |
| | |
Cash and cash equivalents | |
| 22,283 | | |
| 36,290 | |
Restricted cash | |
| 83 | | |
| - | |
Restricted deposits (including long term) | |
| - | | |
| 212 | |
Total cash and cash equivalents, restricted cash and restricted deposits | |
$ | 22,366 | | |
$ | 36,502 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
COLLPLANT BIOTECHNOLOGIES
LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share amounts)
(Unaudited)
Note
1 - NATURE OF OPERATIONS:
CollPlant Biotechnologies Ltd.
(the “Company”) 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 recombinant human collagen (rhCollagen) produced with its proprietary plant
based technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing.
The Company’s revenues include
income from business collaborators and from sales of (i) BioInk products for the development of 3D bioprinting of organs and tissues,
(ii) rhCollagen for the medical aesthetics market, and (iii) rhCollagen-based products for tendinopathy and wound healing.
The Company operates through its wholly-owned
subsidiary, CollPlant Ltd. (“CollPlant”). In November 2021 CollPlant established CollPlant Inc., a wholly owned subsidiary
in the United States. As of June 30, 2023, CollPlant Inc. has not commenced operation.
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES:
The unaudited condensed consolidated
financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States
of America (“US GAAP”) for interim financial information. Accordingly, they do not contain all information and notes required
by US GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements
reflect all adjustments, which include normal recurring adjustments, necessary for a fair presentation of the results for the interim
periods presented.
These unaudited condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s
annual financial statements for the year ended December 31, 2022, as filed in the 20-F on March 29, 2023.
The Company’s interim period results
do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year. The significant
accounting policies applied in the annual consolidated financial statements of the Company as of December 31, 2022, contained in the
Company’s Annual Report have been applied consistently in these unaudited condensed consolidated financial statements.
| b. | Use of estimates in the preparation of financial statements |
The preparation of financial statements
in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities,
the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. The Company’s management believes that the estimates, judgment and assumptions used are reasonable
based upon information available at the time they are made. Actual results may differ from those estimates.
COLLPLANT BIOTECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share amounts)
(Unaudited)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continue):
| c. | Principles of consolidation |
The consolidated financial statements
include the accounts of CollPlant Biotechnologies Ltd. and its wholly-owned subsidiary, CollPlant Ltd. Intercompany balances and transactions
have been eliminated upon consolidation.
The carrying amount of the cash and
cash equivalents, restricted deposits, trade receivable, trade payables, accrued expenses and other liabilities approximates their fair
value.
| e. | Income
(loss) per share |
Basic income (loss) per share is computed
on the basis of the net income (loss), for the period divided by the weighted average number of ordinary shares outstanding during the
period. Diluted income (loss) per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents
outstanding when dilutive. Ordinary share equivalents include outstanding share options and warrants, which are included under the treasury
stock method when dilutive.
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator: | |
| | |
| | |
| | |
| |
Net income (loss) | |
$ | 2,047 | | |
$ | (8,145 | ) | |
$ | 5,762 | | |
$ | (4,285 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Basic weighted-average ordinary shares outstanding | |
| 11,329,516 | | |
| 10,935,611 | | |
| 11,369,031 | | |
| 11,086,481 | |
Effect of share-based compensation | |
| 409,368 | | |
| — | | |
| 408,108 | | |
| — | |
Diluted weighted average ordinary shares outstanding | |
| 11,738,884 | | |
| 10,935,611 | | |
| 11,777,139 | | |
| 11,086,481 | |
| |
| | | |
| | | |
| | | |
| | |
Basic net income (loss) per share | |
$ | 0.18 | | |
$ | (0.74 | ) | |
$ | 0.51 | | |
$ | (0.39 | ) |
Diluted net income (loss) per share | |
$ | 0.17 | | |
$ | (0.74 | ) | |
$ | 0.49 | | |
$ | (0.39 | ) |
1,201,811 options were excluded from
the calculation of diluted net income per share due to their anti-dilutive effect for the six and the three months ended June 30, 2023.
COLLPLANT BIOTECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share amounts)
(Unaudited)
NOTE
3 - INVENTORY:
| a. | Inventories at June 30, 2023 and December 31, 2022 consisted
of the following: |
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
(Audited) | |
Work in progress | |
$ | 682 | | |
$ | 881 | |
Finished goods’ | |
| 870 | | |
| 549 | |
Total inventory | |
$ | 1,552 | | |
$ | 1,430 | |
| b. | During the six and three months period ended June 30, 2023,
the Company recorded approximately $261 and $215 for write-down of inventory under cost of revenues, respectively. |
During the six and three months period
ended June 30, 2022, the Company recorded approximately $23 and $6 for write-down of inventory under cost of revenues, respectively.
NOTE
4 - SHARE CAPITAL:
| a. | Changes in share capital |
| ● | In 2022, three U.S investors exercised 425,000 warrants into 425,000 ordinary shares in return for $1,700. |
| ● | On February 23, 2023, Ami Sagi exercised 186,000 warrants into 186,000 ordinary shares in return for $744. |
| b. | Share- based compensation |
Under the Company’s Share Ownership and Option Plan (2010), or
the 2010 Plan, employees, directors and consultants of the Company may be granted options, each exercisable into one ordinary share of
the Company of NIS 1.50 par value.
COLLPLANT BIOTECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share amounts)
(Unaudited)
NOTE
4 - SHARE CAPITAL (continue):
Options granted
under the 2010 Plan:
In the six months ended June 30, 2023
and 2022, the Company granted options as follows:
| |
Six months ended June 30, 2023 |
| |
Number of options granted | | |
Exercise price range | | |
Vesting period | |
Expiration |
Employees | |
| 104,500 | | |
$ | 7.5 | | |
4 years | |
10 years |
| |
Six months ended June 30, 2022 |
| |
Number of options granted | | |
Exercise price range | | |
Vesting period range | |
Expiration |
Employees | |
| 398,000 | | |
$ | 9.22 | | |
4 years | |
10 years |
Directors | |
| 217,000 | | |
$ | 9.22 | | |
4 years | |
10 years |
The fair value of options granted during
the six months ended June 30, 2023, and 2022 was $505 and $3,511, respectively.
The fair value of options granted on
the date of grant was computed using the Black-Scholes model. The underlying data used for computing the fair value of the options are
as follows:
| |
Six months ended
June 30 | |
| |
2023 | | |
2022 | |
Value of ordinary share | |
$ | 7.5 | | |
$ | 9.07-9.22 | |
Dividend yield | |
| 0 | % | |
| 0 | % |
Expected volatility | |
| 74.1 | % | |
| 67.28%-67.95 | % |
Risk-free interest rate | |
| 0.36 | % | |
| 1.72%-3.03 | % |
Expected term | |
| 6.11 years | | |
| 6.11 years | |
COLLPLANT BIOTECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share amounts)
(Unaudited)
NOTE
4 - SHARE CAPITAL (continue):
| The following table summarizes the number of options granted to employees and directors under the 2010 Plan for the six months period ended June 30, 2023: |
| |
Number of options | | |
Weighted average exercise price | |
Options outstanding at the beginning of the period | |
| 1,868,749 | | |
$ | 7.85 | |
Granted | |
| 104,500 | | |
| 7.5 | |
Exercised | |
| (29,163 | ) | |
| 4.43 | |
Forfeited or expired | |
| (95,559 | ) | |
| 9.43 | |
Options outstanding at the end of the period | |
| 1,848,527 | | |
$ | 7.8 | |
Options exercisable at the end of the period | |
| 1,105,189 | | |
$ | 7.35 | |
The following table summarizes the
number of options granted to consultants under the Option Plan for the six months period ended June 30, 2023:
| |
Number of options | | |
Weighted average exercise price | |
Options outstanding at the beginning of the period | |
| 15,416 | | |
$ | 16.04 | |
Granted | |
| - | | |
| - | |
Exercised | |
| (3,750 | ) | |
| 5.07 | |
Forfeited or expired | |
| - | | |
| - | |
Options outstanding at the end of the period | |
| 11,666 | | |
$ | 16.45 | |
Options exercisable at the end of the period | |
| 6,329 | | |
$ | 9.81 | |
| 3) | The following table illustrates the effect of share-based
compensation on the statements of operations: |
| |
Six months ended June 30 | | |
Three months ended June 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Cost of revenue | |
$ | 19 | | |
$ | 2 | | |
$ | 11 | | |
$ | 2 | |
Research and development | |
| 307 | | |
| 374 | | |
| 121 | | |
| 173 | |
General, administrative and marketing | |
| 526 | | |
| 647 | | |
| 206 | | |
| 400 | |
| |
$ | 852 | | |
$ | 1,023 | | |
$ | 338 | | |
$ | 575 | |
COLLPLANT BIOTECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share amounts)
(Unaudited)
NOTE 5 - Development,
Exclusivity and Option Products Agreement
On February 5, 2021, CollPlant entered
into a Development, Exclusivity and Option Products Agreement (the “Development Agreement”) with AbbVie, pursuant to which
CollPlant and AbbVie will collaborate in the development and commercialization of dermal and soft tissue filler products for the medical
aesthetics market, using CollPlant rhCollagen technology and AbbVie’s technology.
Pursuant to the Development Agreement,
CollPlant agreed to undertake projects for the development of an aseptic process for sterile rhCollagen that meets or exceeds certain
specifications as set forth in the Development Agreement. CollPlant has successfully completed the development of the aseptic process
and is producing and supplying sterile rhCollagen.
Pursuant to the Development Agreement,
CollPlant granted to AbbVie and certain of its affiliates, worldwide exclusive rights to use its rhCollagen in combination with AbbVie
proprietary technologies, for the production and commercialization of dermal and soft tissue filler products, or the Exclusive Products.
The Development Agreement provides that
with respect to the Exclusive Products CollPlant shall be entitled to receive up to $50,000 comprised of an upfront cash payment of $14,000,
which was received in February 2021, and up to $36,000 in proceeds upon the achievement of certain development, clinical trial, regulatory
and commercial sale milestones. In addition, CollPlant shall be entitled to a fixed-fee royalty payment (subject to certain adjustments)
for each product commercially sold during the applicable royalty term as well as a fee for the supply of rhCollagen to AbbVie.
In June 2023, the Company announced the achievement of a milestone
with respect to the clinical phase dermal filler product. According to the Development Agreement, the milestone achievement triggered
a $10,000 payment from AbbVie to CollPlant, which was received in July 2023.
COLLPLANT BIOTECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share amounts)
(Unaudited)
NOTE 6 - SUPPLEMENTARY FINANCIAL STATEMENT
INFORMATION
| a. | Disaggregated
revenues: |
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues from milestones (See note 5) | |
$ | 10,000 | | |
$ | - | | |
$ | 10,000 | | |
$ | - | |
Revenues from the sales of goods | |
| 617 | | |
| 132 | | |
| 184 | | |
| 66 | |
Total revenues | |
$ | 10,617 | | |
$ | 132 | | |
$ | 10,184 | | |
$ | 66 | |
| b. | Revenues
by geographic area were as follows: |
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
United states and Canada | |
$ | 10,592 | | |
$ | 74 | | |
$ | 10,161 | | |
$ | 41 | |
| |
| | | |
| | | |
| | | |
| | |
Europe and others | |
| 25 | | |
| 58 | | |
$ | 23 | | |
| 25 | |
| |
| | | |
| | | |
| | | |
| | |
Total revenues | |
$ | 10,617 | | |
$ | 132 | | |
$ | 10,184 | | |
$ | 66 | |
|
c. | Revenue recognized in the reporting period that was included
in the deferred revenues balance at the beginning of the period is $32 for the six months period ended June 30, 2022. |
COLLPLANT BIOTECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(U.S. dollars in thousands, except share and per share amounts)
(Unaudited)
NOTE 6 - SUPPLEMENTARY FINANCIAL
STATEMENT INFORMATION (continue):
Set forth below is a breakdown of the
Company’s revenue by major customers (major customer –revenues from these customers constitute at least 10% of total revenues
in a certain period):
| |
Six
months ended
June 30, | | |
Three
months ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Customer
A | |
$ | 10,527 | | |
$ | * | ) | |
$ | 10,151 | | |
$ | 9 | |
| |
| | | |
| | | |
| | | |
| | |
Customer
B | |
$ | * | ) | |
$ | 64 | | |
$ | * | ) | |
$ | 32 | |
| |
| | | |
| | | |
| | | |
| | |
Customer
C | |
$ | * | ) | |
$ | 37 | | |
$ | * | ) | |
$ | * | ) |
NOTE 7 - SUBSEQUENT EVENTS
| a. | On August 23, 2023, the board of directors approved the grant of an aggregate of 33,500 options exercisable into 33,500 ordinary shares to the Company’s employees, at an exercise price of $6.5 per share. The options will vest over four years with one quarter vesting one year after the grant date and the remaining balance will vest in equal parts at the end of each subsequent quarter. |
| b. | On August 23, 2023, the board of directors approved repricing of outstanding
options to purchase an aggregate of 999,648 ordinary shares held by the Company’s employees and directors to an exercise price of
$6.39 per share, subject to obtaining regulatory approvals, and with regard to options granted to members of the board (including the
Company’s Chief Executive Officer), subject to shareholders’ approval. |
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Exhibit 99.3
OPERATING
AND FINANCIAL REVIEW AND PROSPECTS
The following discussion
and analysis should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this Form
6-K and our Annual Report on Form 20-F for the year ended December 31, 2022 (the “Annual Report”).
Unless
the context requires otherwise, the terms “CollPlant,” “we,” “us,” “our,” “the
Company,” and similar designations refer to CollPlant Biotechnologies Ltd. and its wholly owned subsidiary CollPlant Ltd.
References to “ordinary shares”, “warrants” and “share capital” refer to the ordinary shares, warrants
and share capital, respectively, of CollPlant Biotechnologies Ltd.
References
to “U.S. dollars” and “$” are to currency of the United States of America. References to “ordinary shares”
are to our ordinary shares, par value NIS 1.50 per share. Our financial statements are prepared and presented in accordance with U.S.
GAAP. Our historical results do not necessarily indicate our expected results for any future periods.
Forward-Looking Statements
Certain information included
in this discussion may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation
Reform Act of 1995 and other securities laws. Forward-looking statements are often characterized by the use of forward-looking terminology
such as “may,” “will,” “expect,” “anticipate,” “estimate,” “continue,”
“believe,” “should,” “intend,” “project” or other similar words, but are not the only
way these statements are identified.
These forward-looking statements
may include, but are not limited to, statements relating to our objectives, plans and strategies, statements that contain projections
of results of operations or of financial condition, expected capital needs and expenses, statements relating to the research, development,
completion and use of our products, and all statements (other than statements of historical facts) that address activities, events or
developments that we intend, expect, project, believe or anticipate will or may occur in the future.
Forward-looking statements
are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on
assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions,
expected future developments, and other factors they believe to be appropriate.
Important
factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking
statements include, among other things:
|
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our history of significant
losses, and our need to raise additional capital and our inability to obtain additional capital on acceptable terms, or at all; |
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● |
our expectations regarding the timing and cost of commencing pre-clinical
and clinical trials with respect to our breast implants, tissues and organs which are based on our rhCollagen based BioInk and other products
for medical aesthetics; |
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our ability to obtain favorable
pre-clinical and clinical trial results; |
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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; |
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commercial success and
market acceptance of rhCollagen based products, in 3D Bioprinting and medical aesthetics; |
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our ability to establish
sales and marketing capabilities or enter into agreements with third parties and our reliance on third party distributors and resellers; |
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our ability to establish
and maintain strategic partnerships and other corporate collaborations; |
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our reliance on third parties
to conduct some or all aspects of our product manufacturing; |
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the scope of protection
we are able to establish and maintain for intellectual property rights and our ability to operate our business without infringing
the intellectual property rights of others; |
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current or future unfavorable
economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; |
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the impact of competition
and new technologies; |
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general market, political,
and economic conditions in the countries in which we operate; |
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projected capital expenditures
and liquidity; |
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changes in our strategy;
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litigation and regulatory
proceedings; and |
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those factors referred
to under the headings “Risk Factors” and “Operating and Financial Review and Prospects” in our Annual Report,
as well as in our Annual Report generally. |
Readers
are urged to carefully review and consider the various disclosures made throughout the following discussion which are designed to advise
interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.
You
should not put undue reliance on any forward-looking statements. Any forward-looking statements in the following discussion are made
as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in the following discussion.
We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise, except as required by law.
Overview
We are a regenerative and
aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. Our products are based on our recombinant
human collagen (rhCollagen) that is produced with our proprietary plant based genetic engineering technology. Our products address indications
for the diverse fields of tissue repair, aesthetics and organ manufacturing, and, we believe, are ushering in a new era in regenerative
and aesthetic medicine. Our collaborations include, among others, AbbVie, STEMCELL, Tel Aviv University, Sheba Medical Center,
the Advanced Regenerative Manufacturing Institute, and the RegenMed Development Organization.
Our flagship rhCollagen BioInk
product line is ideal for 3D bioprinting of tissues and organs. We are developing 3D bioprinted breast implants for regeneration of breast
tissue, aim to provide a revolutionary alternative to the current practices. The implants in development are printed and loaded with
compositions that are based on rhCollagen and ECM components. These implants are intended to promote tissue regeneration and degrade
in synchronization with the development of a natural breast tissue. We plan to initiate a second large-animal study to evaluate commercial
sized 3D bioprinted regenerative breast implants, by the end of 2023.
In February 2021, we entered
into a Development, Exclusivity and Option Products Agreement with AbbVie (“AbbVie Agreement”), pursuant to which we and
AbbVie will collaborate in the development and commercialization of dermal and soft tissue filler products for the medical aesthetics
market, using our rhCollagen technology and AbbVie’s technology.
In June 2023, we announced
the achievement of a milestone with respect to the clinical phase dermal filler product under the AbbVie Agreement, which triggered a
$10 million payment from AbbVie to us.
In November 2022 we launched
Collink.3D-90, a rhCollagen-based bioink solution for use in a variety of 3D bioprinting applications, offering increased mechanical
properties to address additional printing requirements of soft and hard tissues. Collink.3D-90 is complementary to our first commercial
bioink, Collink.3D-50, which was launched in November 2021, for use in 3D bioprinting. Collink.3D-50 was designed to allow the scalable
and reproduceable biofabrication of scaffolds, tissues and organ transplants. Made entirely from human-derived collagen, Collink.3D bioinks
enables the production of scaffolds that accurately mimic the physical properties of human tissues and organs, with improved bio-functionality,
safety and reproducibility.
Also in November 2022, we
entered into a license and research agreement with Tel Aviv University and Sheba Medical Center hospital, to co-develop a ‘Gut-on-a-Chip’
tissue model for drug discovery and high throughput screening of drugs. The model is intended to be used in personal medicine applications
for the treatment of ulcerative colitis, an inflammatory bowel disease affecting millions of individuals worldwide.
In January 2023, we
launched Collink.3D-50L in powder form, which is our first bioink available in powder form and provides enhanced operational flexibility
to support a wide range of 3D bioprinting applications, including drug discovery, drug screening, tissue testing as well as the development
of transplantable tissues and organs.
In April 2023, we announced
a joint development and commercialization agreement with Stratasys Ltd., pursuant to which we agreed to collaborate on the development
of a solution to bio-fabrication human tissues and organs, using Stratasys’ P3 technology-based bioprinter and our rhCollagen-based
bioinks.
We believe our technology
is the only commercially viable technology available for the production of genetically engineered, or recombinant, human collagen. We
believe that our rhCollagen, though laboratory-derived, is identical to the type I collagen produced by the human body, has significant
advantages compared to currently marketed tissue-derived collagens, including improved biological function, high homogeneity, and reduced
risk of immune response. We believe the attributes of our rhCollagen make it suitable for numerous tissue repair applications throughout
the human body. We believe that the annual market size for our BioInk, and our medical aesthetics product candidates including dermal
filler, exceeded $10 billion in 2021, and is estimated to reach $18 billion in 2026.
Financial Operations Overview
Revenue
Our ability to generate significant
revenues will depend on the successful commercialization of our rhCollagen-based BioInks and products, and on our ability to establish
and maintain business collaborations with leading companies for 3D bioprinting of organs and tissues, and for medical aesthetics. In
the six months ended June 30, 2023, we generated revenues of $10.6 million, mainly from the achievement of a milestone with respect to
the AbbVie agreement, which triggered a $10 million payment, and from sales of our BioInk and rhCollagen.
Our revenues are recorded
in the amount of consideration to which we expect to be entitled in exchange for performance obligations upon transfer of control to
the customer and upon entitlement to milestone payment with respect to AbbVie Agreement.
Cost of Revenues
Cost of revenues in our proprietary
products and services includes expenses for the manufacturing of products such as raw materials, payroll, utilities, laboratory costs,
share-based compensation and depreciation. Cost of revenue also includes provisions for the costs associated with manufacturing scraps
and inventory write offs.
Operating Expenses
Research
and Development Expenses
Research and development
expenses consist of costs incurred for the development of our rhCollagen-based products. Those expenses include:
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employee-related expenses,
including salaries and share-based compensation expenses for employees in research and development functions; |
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expenses incurred in operating
our laboratories; |
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expenses incurred under
agreements with CROs and investigative sites that conduct our clinical trials; |
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expenses relating to outsourced
and contracted services, such as external laboratories, consulting, and advisory services; |
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supply, development, and
manufacturing costs relating to clinical trial materials; |
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maintenance of facilities,
depreciation, and other expenses, which include direct and allocated expenses for rent and insurance, net of expenses capitalized
to inventory; and |
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costs associated with preclinical
and clinical activities. |
Research and development
activities are the primary focus of our business. Products in later stages of clinical development generally have higher development
costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical
trials. We expect that our research and development expenses will continue to be significant in absolute dollars in future periods as
we continue to invest in research and development activities related to the development of our products.
Our total research and development
expenses, for the six months ended June 30, 2023 were $4.7 million. To date, we have charged all research and development expenses to
operations as they are incurred.
There are numerous factors
associated with the successful commercialization of any of our products, including future trial design and various regulatory requirements,
many of which cannot be determined with accuracy at this time. Additionally, future commercial and regulatory factors beyond our control
will affect our clinical development programs and plans.
Participation
in Research and Development Expenses
Between 2013 and 2019, we
received grants from the Israeli Innovation Authority (“IIA”), as part of the research and development programs for our rhCollagen
technology and some of our products. The requirements and restrictions for such grants are found in the Encouragement of Research, Development
and Technological Innovation in the Industry Law 5744 1984 (“Innovation Law”), and related regulations. These grants are
subject to repayment through future royalty payments on any products resulting from these research and development programs. Under the
Innovation Law and related regulations, royalties of 3% on the income generated from sales of products and from related services developed
in whole or in part under IIA programs are payable to the IIA, up to the total amount of grants received, linked to the U.S. dollar and
bearing interest at an annual rate of LIBOR applicable to U.S. dollar deposits, as published on the first business day of each calendar
year. The total gross amount of grants actually received by us from the IIA totaled approximately $10.1 million as of June 30, 2023.
For the six months period ending June 30, 2023, we recorded royalty expenses to the IIA in the amount of $318,500. Since inception and
until June 30, 2023 we paid royalties to the IIA in the total amount of $2.8 million.
Information on our liabilities
and the restrictions that we are subject to under the Innovation Law in connection with the IIA grants that we have received is detailed
in the Annual Report on Form 20-F as of and for the year ended December 31, 2022.
General,
Administrative, and Marketing Expenses
Our general and administrative
expenses consist principally of:
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employee-related expenses,
including salaries, benefits, and related expenses, including equity-based compensation expenses; |
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● |
legal and professional
fees for auditors and other consulting expenses not related to research and development activities; |
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cost of offices, communication,
and office expenses; |
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information technology
expenses; |
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business development and
marketing activities; |
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stock exchange fees and
related services; and |
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board members related expenses,
including fees and directors’ and officers’ liability insurance premiums. |
We expect that our general,
administrative, and marketing expenses will increase in the future as our business expands and we incur additional general and administrative
costs associated with being a public company in the United States, including compliance under the Sarbanes-Oxley Act and rules promulgated
by the SEC. These public company-related increases will likely include costs of additional personnel, additional legal fees, audit fees,
directors’ and officers’ liability insurance premiums, and costs related to investor relations.
Financial
Income/Financial Expense, net
Financial income includes
interest income regarding short-term deposits and restricted deposits. Financial expense consists of bank commissions and exchange rate
differences from the strengthening of the U.S. dollar compared to the New Israeli Shekel.
Taxes
on Income
We do not generate taxable
income in Israel, as we have historically incurred operating losses resulting in carry forward tax losses. As of December 31, 2022, we
have incurred operating losses of approximately $21.5 million for CollPlant Biotechnologies Ltd. and $66.3 million for CollPlant Ltd.
We anticipate that we will
be able to carry forward these tax losses indefinitely to future tax years assuming that we utilize them at the first opportunity. Accordingly,
we do not expect to pay taxes in Israel until we have taxable income after the full utilization of our carry forward tax losses.
The standard corporate tax
rate in Israel is 23%. Under the Israeli Law for the Encouragement of Capital Investments, 5719-1959, and other Israeli laws, we may
be entitled to certain additional tax benefits, including reduced tax rates, accelerated depreciation, and amortization rates for tax
purposes on certain assets and amortization of other intangible property rights for tax purposes.
Operating Results
The following table sets forth a summary
of our operating results (unaudited):
| |
Six months ended June 30 | | |
Three months ended June 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
USD in thousands, except per share
data | |
| |
| |
Revenues | |
$ | 10,617 | | |
$ | 132 | | |
$ | 10,184 | | |
$ | 66 | |
Cost of revenues | |
| 940 | | |
| 74 | | |
| 615 | | |
| 43 | |
Gross Profit | |
| 9,677 | | |
| 58 | | |
| 9,569 | | |
| 23 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 4,676 | | |
| 4,841 | | |
| 2,574 | | |
| 2,599 | |
General, administrative and marketing | |
| 2,843 | | |
| 3,170 | | |
| 1,318 | | |
| 1,609 | |
Total operating expenses: | |
| 7,519 | | |
| 8,011 | | |
| 3,892 | | |
| 4,208 | |
Operating income (loss) | |
| 2,158 | | |
| (7,953 | ) | |
| 5,677 | | |
| (4,185 | ) |
Financial income (expenses), net | |
| (111 | ) | |
| (192 | ) | |
| 85 | | |
| (100 | ) |
Net income (loss) for the period | |
$ | 2,047 | | |
| (8,145 | ) | |
$ | 5,762 | | |
$ | (4,285 | ) |
Basic net income (loss) per ordinary share | |
$ | 0.18 | | |
$ | (0.74 | ) | |
$ | 0.51 | | |
$ | (0.39 | ) |
Diluted net income (loss) per ordinary share | |
$ | 0.17 | | |
$ | (0.74 | ) | |
$ | 0.49 | | |
$ | (0.39 | ) |
Three months ended June 30, 2023, compared
to three months ended June 30, 2022
Revenues
We generated revenues of
$10.2 million in the three months ended June 30, 2023, compared to $66,000 for the three months ended June 30, 2022. The increase in
revenues is mainly related to the achievement of a milestone with respect to the AbbVie agreement, which triggered a $10 million payment.
Cost of revenues
We incurred cost of revenue
in the amount of $615,000 in the three months ended June 30, 2023, compared to $43,000 in the three months ended June 30, 2022. The increase
in cost of revenues in the amount of approximately $572,000 is mainly comprised of: (i) $305,000 in royalty expenses to the IIA mainly
related to the milestone payment received from AbbVie, and (ii) $171,000 relating to the BioInk, VergenixFG, and rhCollagen sales.
Research and Development Expenses
We incurred research and
development expenses amounting to $2.6 million in the three months ended June 30, 2023 and $2.6 million in the three months ended June
30, 2022.
General, Administrative and Marketing Expenses
We incurred general, administrative,
and marketing expenses of $1.3 million in the three months ended June 30, 2023, compared to $1.6 million in the three months ended June
30, 2022. The decrease in expenses related mainly to (i) $223,000 in employees’ salaries expense including a decrease in accrued vacation
liability and alterations in employment contractual terms implemented in 2022, and (ii) $194,000 share-based compensation expenses mainly
related to a directors grant in May 2022, offset by an increase of approximately $116,000 in professional services expenses and patents
expenses.
Financial Income (Expenses), Net
Financial income, net, totaled
$85,000 in the three months ended June 30, 2023, compared to financial expenses, net of $100,000, net in the three months ended June
30, 2022. The increase in financial income is due to interest received from our short-term cash deposits and exchange rate differences.
Six months ended June 30, 2023, compared to six months ended
June 30, 2022
Revenues
We generated revenues from
the sale of our BioInk, rhCollagen and VergenixFG, as well as revenues from the AbbVie Agreement, of approximately $10.6 million in the
six months ended June 30, 2023, compared to $132,000 for the six months ended June 30, 2022. The increase of $10.5 million related almost
entirely to the achievement of a milestone under the AbbVie Agreement and a $500,000 increase in sales of rhCollagen.
Cost of revenues
We incurred cost of revenue
in the amount of $940,000 in the six months ended June 30, 2023, compared to $74,000 in the six months ended June 30, 2022. The increase
in cost of revenues in the amount of approximately $866,000 is mainly comprised of: (i) $316,000 in royalty expenses to the IIA mainly
related to the milestone payment received from AbbVie, and (ii) $424,000 relating to the sales of BioInk, VergenixFG, and rhCollagen.
Research and Development Expenses
We incurred research and
development expenses amounting to $4.7 million in the six months ended June 30, 2023, compared to $4.8 million in the six months ended
June 30, 2022.
General, Administrative and Marketing Expenses
We incurred general, administrative,
and marketing expenses of $2.8 million in the six months ended June 30, 2023, compared to $3.2 million in the six months ended June 30,
2022. The decrease in expenses amounting to approximately $400,000 is mainly comprised of: (i) $278,000 in employees’ salaries expense
including a decrease in our accrued vacation liability and alterations in employment contractual terms implemented in 2022, and (ii)
$124,000 share based compensation expenses mainly related to options granted in 2022.
Financial Income (Expenses), Net
Financial expenses, net for
the six months ended on June 30, 2023, totaled $111,000 compared to financial expenses, net of $192,000 in the six months ended on June
30, 2022. The decrease in financial expenses, net is due to interest received from our short term cash deposits.
Significant Accounting Estimates and Judgments
For information with respect
to significant accounting estimates and judgments, see the discussion under the heading “Significant Accounting Estimates and Judgments”
in our Annual Report.
Recent Accounting Pronouncements
For information with respect
to recent accounting pronouncements, see the discussion under the heading “Recent Accounting Pronouncements” in our Annual
Report.
Liquidity and Capital Resources
Our primary uses of cash
are to fund working capital requirements, research and development expenses and capital expenditures. Historically, we have funded our
operations primarily through cash flow from operations (including sales of our proprietary products and distribution products), payments
received in connection with strategic partnerships (including milestone payments from collaboration agreements), issuances of ordinary
shares and warrants (including public offerings on the Nasdaq, Tel Aviv Stock Exchange and private placements) and government grants
from the IIA.
The balance of cash and cash
equivalents, restricted cash and restricted deposits as of June 30, 2023 and December 31, 2022 totaled $22.4 million and $29.7 million,
respectively. In February 2021 we completed a registered direct offering that resulted in gross proceeds of $35 million and in the same
month, we received a $14 million upfront payment from AbbVie under the AbbVie Agreement. In July 2023, we received an additional $10
million payment from AbbVie under the AbbVie Agreement. We plan to fund our future operations through continued sales of our proprietary
products, commercialization and/or out-licensing of our rhCollagen and BioInk technology and raising additional capital through the issuance
of equity or debt.
Cash Flows
Net Cash Provided by
(Used in) Operating Activities
Net cash provided by or used
in operating activities resulted primarily from our net income or losses, adjusted for non-cash charges and measurements and changes
in components of working capital. Adjustments to net income or loss for non-cash items include depreciation and amortization, share-based
compensation, exchange differences on cash and cash equivalents, interest from short term deposits and interest from restricted deposit.
This cash flow mainly reflects the cash needed for funding the products and pipeline products development and our management costs during
the applicable periods.
Net cash used in operating
activities in the six months ended June 30, 2023, totaled $7.2 million and consisted primarily of (i) net income of $2.0 million, adjusted
for non-cash items including depreciation of $546,000, shared-based compensation of $852,000, and interest from restricted deposits of
$11,000 and (ii) a net change in operating assets and liabilities of $11.1 million, which is attributable almost entirely to an increase
of $10.2 million in trade receivables related mainly to a milestone achievement payment from AbbVie.
Net cash provided by operating
activities in the six months ended June 30, 2022 totaled $7.2 million and consisted primarily of (i) net loss of $8.1 million, adjusted
for non-cash items including depreciation of $501,000, shared-based compensation of $1.1 million and interest from short-term cash deposits
of $87,000, and (ii) a net change in operating assets and liabilities of $1.2 million.
Net Cash Provided by
(Used in) Investing Activities
Net cash used in investing
activities was $541,000 during the six months ended June 30, 2023 and net cash provided by investing activities of $29.5 million during
the six months ended June 30, 2022. The decrease is mainly attributed to repayment and investment in short-term cash deposits during
the six months ended June 30, 2022.
Net Cash Provided by
Financing Activities
Net cash provided by financing
activities was $892,000 for the six months ended June 30, 2023 compared to $1.5 million in the six months ended June 30, 2022. Cash provided
by financing activities is attributed to proceeds from the exercise of warrants and options into shares.
Our cash requirements
from known contractual obligations within the next twelve months include:
|
● |
Lease liabilities in the
amount of $598,000; and |
|
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Trade and other payables
in the amount of $2.2 million, which include amounts related to suppliers, salaries and other liabilities with payment term of less
than one year. |
Our long-term cash requirements
under our various contractual obligations include:
|
● |
Lease liabilities in the amount of $2.7 million. |
Cash
and Funding Sources
The table below summarizes
our sources of funding for the six months ended June 30, 2023:
| |
Exercise of
Options
and
Warrants into
shares | | |
Strategic
Collaboration | | |
Total | |
| |
U.S. dollars in thousands | |
Six months ended June 30, 2023 | |
| 892 | | |
| - | (1) | |
| 892 | |
(1) | In June 2023, we announced the achievement
of a milestone with respect to the clinical phase dermal filler product under the AbbVie
Agreement, which triggered a $10 million payment from AbbVie to us. The payment was received
during July 2023. |
Funding Requirements
We believe that our existing
cash and cash equivalents will enable us to fund our operating expenses and capital expenditures for at least the next 12 months. We
have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
Our present and future funding
requirements will depend on many factors, including, among other things:
|
● |
the number of potential
new products we identify and decide to develop; |
|
|
|
|
● |
the progress, timing, and
completion of preclinical testing and clinical trials in the U.S. for tissues and organs which are based on our BioInk, medical aesthetics,
and any future pipeline product; |
|
● |
selling and marketing activities
undertaken in connection with the commercialization of our products; |
|
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|
|
● |
the costs of upscaling
our manufacturing capabilities; |
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|
● |
costs involved in the development
of distribution channels, and for an effective sales and marketing organization, for the commercialization of our products in Europe; |
|
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|
● |
the time and costs involved
in obtaining regulatory approvals and any delays we may encounter as a result of evolving regulatory requirements or adverse results
with respect to any of these products; and |
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|
● |
the costs involved in filing
patent applications and maintaining and enforcing patents or defending against claims or infringements raised by third parties. |
For more information as to
the risks associated with our future funding needs, see “Item 3.D. Risk Factors— in our Annual Report on Form 20-F. We will
need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain additional capital when
needed may force us to delay, limit, or terminate our product development efforts or other operations” in our Annual Report.
Trend Information
We are in a development stage
with regard to different 3D BioInks and medical aesthetics products, and are in early stages of commercialization of our BioInks for
customers that develop technologies for 3D bio-printing of tissues and organs and the medical aesthetics market. It is not possible for
us to predict with any degree of accuracy the outcome of our research, development, or commercialization efforts. As such, it is not
possible for us to predict with any degree of accuracy any known trends, uncertainties, demands, commitments or events that are reasonably
likely to have a material effect on our net sales or revenues, income from continuing operations, profitability, liquidity or capital
resources, or that would cause reported financial information to not necessarily be indicative of future operating results or financial
condition. However, to the extent possible, certain trends, uncertainties, demands, commitments and events are included under the heading
“Operating and Financial Review and Prospects” in our Annual Report and in this discussion.
Off-balance Sheet Arrangements
As of June 30, 2023, we do
not have any, and during the periods presented we did not have any, off-balance sheet arrangements.
Contractual Obligations
There were no material changes
outside of the ordinary course of business in our contractual obligations as of June 30, 2023, from those as of December 31, 2022
as reported in our Annual Report on Form 20-F for the year ended December 31, 2022, as filed with the SEC on March 29, 2023.
Our balance sheet liabilities
do not include all of the obligations regarding royalties that we are obligated to pay to the IIA based on future sales of our products.
The maximum royalty amount plus interest that would be payable by us is approximately $7.0 million (assuming 100% of the royalties are
payable). This liability is contingent upon sales of our rhCollagen-based products.
11
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Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 22,283
|
$ 29,653
|
Restricted cash |
83
|
|
Restricted deposit |
22
|
23
|
Trade receivables |
10,160
|
9
|
Inventories |
1,552
|
1,430
|
Other accounts receivable and prepaid expenses |
758
|
543
|
Total current assets |
34,858
|
31,658
|
Non-current assets: |
|
|
Restricted deposit |
237
|
188
|
Operating lease right-of-use assets |
3,327
|
2,711
|
Property and equipment, net |
2,931
|
2,966
|
Intangible assets, net |
216
|
245
|
Total non-current assets |
6,711
|
6,110
|
Total assets |
41,569
|
37,768
|
Current liabilities: |
|
|
Trade payables |
763
|
1,133
|
Operating lease liabilities |
598
|
529
|
Accrued liabilities and other |
1,421
|
1,443
|
Total current liabilities |
2,782
|
3,105
|
Non-current liabilities: |
|
|
Operating lease liabilities |
2,748
|
2,382
|
Total non-current liabilities |
2,748
|
2,382
|
Total liabilities |
5,530
|
5,487
|
Commitments and contingencies |
|
|
Shareholders’ Equity: |
|
|
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares as of June 30, 2023 (unaudited) and December 31, 2022; issued and outstanding: 11,405,394 and 11,186,481 ordinary shares as of June 30, 2023 (unaudited) and December 31, 2022, respectively |
4,963
|
4,873
|
Additional paid in capital |
119,720
|
118,099
|
Currency translation differences |
(969)
|
(969)
|
Accumulated deficit |
(87,675)
|
(89,722)
|
Total shareholders’ equity |
36,039
|
32,281
|
Total liabilities and shareholders’ equity |
$ 41,569
|
$ 37,768
|
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v3.23.2
Condensed Consolidated Balance Sheets (Parentheticals) - ₪ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Ordinary shares par value (in New Shekels per share) |
₪ 1.5
|
₪ 1.5
|
Ordinary shares, shares authorized |
30,000,000
|
30,000,000
|
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11,405,394
|
11,186,481
|
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11,405,394
|
11,186,481
|
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v3.23.2
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
$ 10,184
|
$ 66
|
$ 10,617
|
$ 132
|
Cost of revenues |
615
|
43
|
940
|
74
|
Gross Profit |
9,569
|
23
|
9,677
|
58
|
Operating expenses: |
|
|
|
|
Research and development |
2,574
|
2,599
|
4,676
|
4,841
|
General, administrative and marketing |
1,318
|
1,609
|
2,843
|
3,170
|
Operating income (loss) |
5,677
|
(4,185)
|
2,158
|
(7,953)
|
Financial income (expenses), net |
85
|
(100)
|
(111)
|
(192)
|
Net income (loss) for the period |
$ 5,762
|
$ (4,285)
|
$ 2,047
|
$ (8,145)
|
Basic net income (loss) per ordinary share (in Dollars per share) |
$ 0.51
|
$ (0.39)
|
$ 0.18
|
$ (0.74)
|
Diluted net income (loss) per ordinary share (in Dollars per share) |
$ 0.49
|
$ (0.39)
|
$ 0.17
|
$ (0.74)
|
Weighted average ordinary shares outstanding used in computation of basic net income (loss) per share (in Shares) |
11,369,031
|
11,086,481
|
11,329,516
|
10,935,611
|
Weighted average ordinary shares outstanding used in computation of diluted net income (loss) per share (in Shares) |
11,777,139
|
11,086,481
|
11,738,884
|
10,935,611
|
X |
- DefinitionThe aggregate cost of goods produced and sold and services rendered during the reporting period.
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v3.23.2
Condensed Consolidated Statements Shareholders’ Equity (Unaudited) - USD ($) $ in Thousands |
Ordinary shares |
Additional paid-in capital |
Currency translation differences |
Accumulated deficit |
Total |
Balance at Dec. 31, 2021 |
$ 4,664
|
$ 114,223
|
$ (969)
|
$ (72,797)
|
$ 45,121
|
Balance (in Shares) at Dec. 31, 2021 |
10,722,024
|
|
|
|
|
Exercise of options |
$ 18
|
156
|
|
|
174
|
Exercise of options (in Shares) |
39,457
|
|
|
|
|
Exercise of warrants |
$ 149
|
1,151
|
|
|
1,300
|
Exercise of warrants (in Shares) |
325,000
|
|
|
|
|
Share-based compensation |
|
1,055
|
|
|
1,055
|
Net income (loss) |
|
|
|
(8,145)
|
(8,145)
|
Balance at Jun. 30, 2022 |
$ 4,831
|
116,585
|
(969)
|
(80,942)
|
39,505
|
Balance (in Shares) at Jun. 30, 2022 |
11,086,481
|
|
|
|
|
Balance at Mar. 31, 2022 |
$ 4,831
|
115,991
|
(969)
|
(76,657)
|
43,196
|
Balance (in Shares) at Mar. 31, 2022 |
11,086,481
|
|
|
|
|
Share-based compensation |
|
594
|
|
|
594
|
Share-based compensation (in Shares) |
|
|
|
|
|
Net income (loss) |
|
|
|
(4,285)
|
(4,285)
|
Balance at Jun. 30, 2022 |
$ 4,831
|
116,585
|
(969)
|
(80,942)
|
39,505
|
Balance (in Shares) at Jun. 30, 2022 |
11,086,481
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 4,873
|
118,099
|
(969)
|
(89,722)
|
32,281
|
Balance (in Shares) at Dec. 31, 2022 |
11,186,481
|
|
|
|
|
Exercise of options |
$ 14
|
134
|
|
|
148
|
Exercise of options (in Shares) |
32,913
|
|
|
|
|
Exercise of warrants |
$ 76
|
668
|
|
|
744
|
Exercise of warrants (in Shares) |
186,000
|
|
|
|
|
Share-based compensation |
|
819
|
|
|
819
|
Net income (loss) |
|
|
|
2,047
|
2,047
|
Balance at Jun. 30, 2023 |
$ 4,963
|
119,720
|
(969)
|
(87,675)
|
36,039
|
Balance (in Shares) at Jun. 30, 2023 |
11,405,394
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 4,955
|
119,341
|
(969)
|
(93,437)
|
29,890
|
Balance (in Shares) at Mar. 31, 2023 |
11,385,041
|
|
|
|
|
Exercise of options |
$ 8
|
81
|
|
|
89
|
Exercise of options (in Shares) |
20,353
|
|
|
|
|
Share-based compensation |
|
298
|
|
|
298
|
Net income (loss) |
|
|
|
5,762
|
5,762
|
Balance at Jun. 30, 2023 |
$ 4,963
|
$ 119,720
|
$ (969)
|
$ (87,675)
|
$ 36,039
|
Balance (in Shares) at Jun. 30, 2023 |
11,405,394
|
|
|
|
|
X |
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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities: |
|
|
Income (loss) |
$ 2,047
|
$ (8,145)
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities |
|
|
Depreciation and amortization |
546
|
501
|
Interest from Short term deposits |
|
(87)
|
Interest from restricted deposits |
11
|
|
Share-based compensation to employees and consultants |
852
|
1,055
|
Exchange differences on cash and cash equivalents |
444
|
727
|
Changes in operating asset and liability items: |
|
|
Decrease (increase) in trade receivables |
(10,151)
|
261
|
Increase in inventories |
(155)
|
(275)
|
Increase in other accounts receivable and prepaid expenses |
(215)
|
(170)
|
Decrease in operating right of use assets |
254
|
220
|
Decrease in trade payables |
(370)
|
(274)
|
Decrease in lease liabilities |
(435)
|
(643)
|
Decrease in accrued liabilities and other payables |
(22)
|
(305)
|
Decrease in deferred revenues |
|
(32)
|
Net cash used in operating activities |
(7,194)
|
(7,167)
|
Cash flows from investing activities: |
|
|
Capitalization of intangible assets |
|
(12)
|
Purchase of property and equipment |
(482)
|
(678)
|
Repayment of a short-term cash deposits |
|
50,238
|
Investment in short term cash deposits and restricted deposits |
(59)
|
(20,000)
|
Net cash provided by (used in) investing activities |
(541)
|
29,548
|
Cash flows from financing activities: |
|
|
Exercise of options and warrants into shares |
892
|
1,474
|
Net cash provided by financing activities |
892
|
1,474
|
Exchange differences on cash and cash equivalents, restricted cash and restricted deposits |
(444)
|
(727)
|
Net increase (decrease) in cash and cash equivalents, restricted cash and restricted deposits |
(7,287)
|
23,128
|
Cash and cash equivalents, restricted cash and restricted deposits at the beginning of the period |
29,653
|
13,374
|
Cash and cash equivalents, restricted cash and restricted deposits at the end of the period |
22,366
|
36,502
|
A. Supplementary information on investing and financing activities not involving cash flows: |
|
|
Right of use assets recognized with corresponding lease liabilities |
870
|
59
|
Capitalization of Share-based compensation to inventory |
33
|
|
B. Reconciliation of Cash, cash equivalents and restricted cash at the end of the period |
|
|
Cash and cash equivalents |
22,283
|
36,290
|
Restricted cash |
83
|
|
Restricted deposits (including long term) |
|
212
|
Total cash and cash equivalents, restricted cash and restricted deposits |
$ 22,366
|
$ 36,502
|
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v3.23.2
Nature of Operations
|
6 Months Ended |
Jun. 30, 2023 |
Nature of Operations [Abstract] |
|
NATURE OF OPERATIONS |
Note
1 - NATURE OF OPERATIONS:
CollPlant Biotechnologies Ltd.
(the “Company”) 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 recombinant human collagen (rhCollagen) produced with its proprietary plant
based technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing.
The Company’s revenues include
income from business collaborators and from sales of (i) BioInk products for the development of 3D bioprinting of organs and tissues,
(ii) rhCollagen for the medical aesthetics market, and (iii) rhCollagen-based products for tendinopathy and wound healing.
The Company operates through its wholly-owned
subsidiary, CollPlant Ltd. (“CollPlant”). In November 2021 CollPlant established CollPlant Inc., a wholly owned subsidiary
in the United States. As of June 30, 2023, CollPlant Inc. has not commenced operation.
|
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v3.23.2
Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Significant Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES:
The unaudited condensed consolidated
financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States
of America (“US GAAP”) for interim financial information. Accordingly, they do not contain all information and notes required
by US GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements
reflect all adjustments, which include normal recurring adjustments, necessary for a fair presentation of the results for the interim
periods presented.
These unaudited condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s
annual financial statements for the year ended December 31, 2022, as filed in the 20-F on March 29, 2023.
The Company’s interim period results
do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year. The significant
accounting policies applied in the annual consolidated financial statements of the Company as of December 31, 2022, contained in the
Company’s Annual Report have been applied consistently in these unaudited condensed consolidated financial statements.
| b. | Use of estimates in the preparation of financial statements |
The preparation of financial statements
in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities,
the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. The Company’s management believes that the estimates, judgment and assumptions used are reasonable
based upon information available at the time they are made. Actual results may differ from those estimates. | c. | Principles of consolidation |
The consolidated financial statements
include the accounts of CollPlant Biotechnologies Ltd. and its wholly-owned subsidiary, CollPlant Ltd. Intercompany balances and transactions
have been eliminated upon consolidation.
The carrying amount of the cash and
cash equivalents, restricted deposits, trade receivable, trade payables, accrued expenses and other liabilities approximates their fair
value.
| e. | Income
(loss) per share |
Basic income (loss) per share is computed
on the basis of the net income (loss), for the period divided by the weighted average number of ordinary shares outstanding during the
period. Diluted income (loss) per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents
outstanding when dilutive. Ordinary share equivalents include outstanding share options and warrants, which are included under the treasury
stock method when dilutive.
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator: | |
| | |
| | |
| | |
| |
Net income (loss) | |
$ | 2,047 | | |
$ | (8,145 | ) | |
$ | 5,762 | | |
$ | (4,285 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Basic weighted-average ordinary shares outstanding | |
| 11,329,516 | | |
| 10,935,611 | | |
| 11,369,031 | | |
| 11,086,481 | |
Effect of share-based compensation | |
| 409,368 | | |
| — | | |
| 408,108 | | |
| — | |
Diluted weighted average ordinary shares outstanding | |
| 11,738,884 | | |
| 10,935,611 | | |
| 11,777,139 | | |
| 11,086,481 | |
| |
| | | |
| | | |
| | | |
| | |
Basic net income (loss) per share | |
$ | 0.18 | | |
$ | (0.74 | ) | |
$ | 0.51 | | |
$ | (0.39 | ) |
Diluted net income (loss) per share | |
$ | 0.17 | | |
$ | (0.74 | ) | |
$ | 0.49 | | |
$ | (0.39 | ) |
1,201,811 options were excluded from
the calculation of diluted net income per share due to their anti-dilutive effect for the six and the three months ended June 30, 2023.
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v3.23.2
Inventory
|
6 Months Ended |
Jun. 30, 2023 |
Inventories [Abstract] |
|
INVENTORY |
NOTE
3 - INVENTORY:
| a. | Inventories at June 30, 2023 and December 31, 2022 consisted
of the following: |
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
(Audited) | |
Work in progress | |
$ | 682 | | |
$ | 881 | |
Finished goods’ | |
| 870 | | |
| 549 | |
Total inventory | |
$ | 1,552 | | |
$ | 1,430 | |
| b. | During the six and three months period ended June 30, 2023,
the Company recorded approximately $261 and $215 for write-down of inventory under cost of revenues, respectively. |
During the six and three months period
ended June 30, 2022, the Company recorded approximately $23 and $6 for write-down of inventory under cost of revenues, respectively.
|
X |
- DefinitionThe entire disclosure for inventory. Includes, but is not limited to, the basis of stating inventory, the method of determining inventory cost, the classes of inventory, and the nature of the cost elements included in inventory.
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v3.23.2
Share Capital
|
6 Months Ended |
Jun. 30, 2023 |
Share Capital [Abstract] |
|
SHARE CAPITAL |
NOTE
4 - SHARE CAPITAL:
| a. | Changes in share capital |
| ● | In 2022, three U.S investors exercised 425,000 warrants into 425,000 ordinary shares in return for $1,700. |
| ● | On February 23, 2023, Ami Sagi exercised 186,000 warrants into 186,000 ordinary shares in return for $744. |
| b. | Share- based compensation |
Under the Company’s Share Ownership and Option Plan (2010), or
the 2010 Plan, employees, directors and consultants of the Company may be granted options, each exercisable into one ordinary share of
the Company of NIS 1.50 par value.
Options granted
under the 2010 Plan:
In the six months ended June 30, 2023
and 2022, the Company granted options as follows:
| |
Six months ended June 30, 2023 |
| |
Number of options granted | | |
Exercise price range | | |
Vesting period | |
Expiration |
Employees | |
| 104,500 | | |
$ | 7.5 | | |
4 years | |
10 years |
| |
Six months ended June 30, 2022 |
| |
Number of options granted | | |
Exercise price range | | |
Vesting period range | |
Expiration |
Employees | |
| 398,000 | | |
$ | 9.22 | | |
4 years | |
10 years |
Directors | |
| 217,000 | | |
$ | 9.22 | | |
4 years | |
10 years |
The fair value of options granted during
the six months ended June 30, 2023, and 2022 was $505 and $3,511, respectively.
The fair value of options granted on
the date of grant was computed using the Black-Scholes model. The underlying data used for computing the fair value of the options are
as follows:
| |
Six months ended
June 30 | |
| |
2023 | | |
2022 | |
Value of ordinary share | |
$ | 7.5 | | |
$ | 9.07-9.22 | |
Dividend yield | |
| 0 | % | |
| 0 | % |
Expected volatility | |
| 74.1 | % | |
| 67.28%-67.95 | % |
Risk-free interest rate | |
| 0.36 | % | |
| 1.72%-3.03 | % |
Expected term | |
| 6.11 years | | |
| 6.11 years | |
| The following table summarizes the number of options granted to employees and directors under the 2010 Plan for the six months period ended June 30, 2023: |
| |
Number of options | | |
Weighted average exercise price | |
Options outstanding at the beginning of the period | |
| 1,868,749 | | |
$ | 7.85 | |
Granted | |
| 104,500 | | |
| 7.5 | |
Exercised | |
| (29,163 | ) | |
| 4.43 | |
Forfeited or expired | |
| (95,559 | ) | |
| 9.43 | |
Options outstanding at the end of the period | |
| 1,848,527 | | |
$ | 7.8 | |
Options exercisable at the end of the period | |
| 1,105,189 | | |
$ | 7.35 | |
The following table summarizes the
number of options granted to consultants under the Option Plan for the six months period ended June 30, 2023:
| |
Number of options | | |
Weighted average exercise price | |
Options outstanding at the beginning of the period | |
| 15,416 | | |
$ | 16.04 | |
Granted | |
| - | | |
| - | |
Exercised | |
| (3,750 | ) | |
| 5.07 | |
Forfeited or expired | |
| - | | |
| - | |
Options outstanding at the end of the period | |
| 11,666 | | |
$ | 16.45 | |
Options exercisable at the end of the period | |
| 6,329 | | |
$ | 9.81 | |
| 3) | The following table illustrates the effect of share-based
compensation on the statements of operations: |
| |
Six months ended June 30 | | |
Three months ended June 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Cost of revenue | |
$ | 19 | | |
$ | 2 | | |
$ | 11 | | |
$ | 2 | |
Research and development | |
| 307 | | |
| 374 | | |
| 121 | | |
| 173 | |
General, administrative and marketing | |
| 526 | | |
| 647 | | |
| 206 | | |
| 400 | |
| |
$ | 852 | | |
$ | 1,023 | | |
$ | 338 | | |
$ | 575 | |
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v3.23.2
Development, Exclusivity and Option Products Agreement
|
6 Months Ended |
Jun. 30, 2023 |
Development , Exclusivity and Option Products Agreements [Abstract] |
|
DEVELOPMENT, EXCLUSIVITY AND OPTION PRODUCTS AGREEMENT |
NOTE 5 - Development,
Exclusivity and Option Products Agreement
On February 5, 2021, CollPlant entered
into a Development, Exclusivity and Option Products Agreement (the “Development Agreement”) with AbbVie, pursuant to which
CollPlant and AbbVie will collaborate in the development and commercialization of dermal and soft tissue filler products for the medical
aesthetics market, using CollPlant rhCollagen technology and AbbVie’s technology.
Pursuant to the Development Agreement,
CollPlant agreed to undertake projects for the development of an aseptic process for sterile rhCollagen that meets or exceeds certain
specifications as set forth in the Development Agreement. CollPlant has successfully completed the development of the aseptic process
and is producing and supplying sterile rhCollagen.
Pursuant to the Development Agreement,
CollPlant granted to AbbVie and certain of its affiliates, worldwide exclusive rights to use its rhCollagen in combination with AbbVie
proprietary technologies, for the production and commercialization of dermal and soft tissue filler products, or the Exclusive Products.
The Development Agreement provides that
with respect to the Exclusive Products CollPlant shall be entitled to receive up to $50,000 comprised of an upfront cash payment of $14,000,
which was received in February 2021, and up to $36,000 in proceeds upon the achievement of certain development, clinical trial, regulatory
and commercial sale milestones. In addition, CollPlant shall be entitled to a fixed-fee royalty payment (subject to certain adjustments)
for each product commercially sold during the applicable royalty term as well as a fee for the supply of rhCollagen to AbbVie.
In June 2023, the Company announced the achievement of a milestone
with respect to the clinical phase dermal filler product. According to the Development Agreement, the milestone achievement triggered
a $10,000 payment from AbbVie to CollPlant, which was received in July 2023.
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v3.23.2
Supplementary Financial Statement Information
|
6 Months Ended |
Jun. 30, 2023 |
Supplementary Financial Statement Information [Abstract] |
|
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION |
NOTE 6 - SUPPLEMENTARY FINANCIAL STATEMENT
INFORMATION
| a. | Disaggregated
revenues: |
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues from milestones (See note 5) | |
$ | 10,000 | | |
$ | - | | |
$ | 10,000 | | |
$ | - | |
Revenues from the sales of goods | |
| 617 | | |
| 132 | | |
| 184 | | |
| 66 | |
Total revenues | |
$ | 10,617 | | |
$ | 132 | | |
$ | 10,184 | | |
$ | 66 | |
| b. | Revenues
by geographic area were as follows: |
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
United states and Canada | |
$ | 10,592 | | |
$ | 74 | | |
$ | 10,161 | | |
$ | 41 | |
| |
| | | |
| | | |
| | | |
| | |
Europe and others | |
| 25 | | |
| 58 | | |
$ | 23 | | |
| 25 | |
| |
| | | |
| | | |
| | | |
| | |
Total revenues | |
$ | 10,617 | | |
$ | 132 | | |
$ | 10,184 | | |
$ | 66 | |
|
c. | Revenue recognized in the reporting period that was included
in the deferred revenues balance at the beginning of the period is $32 for the six months period ended June 30, 2022. |
Set forth below is a breakdown of the
Company’s revenue by major customers (major customer –revenues from these customers constitute at least 10% of total revenues
in a certain period):
| |
Six
months ended
June 30, | | |
Three
months ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Customer
A | |
$ | 10,527 | | |
$ | * | ) | |
$ | 10,151 | | |
$ | 9 | |
| |
| | | |
| | | |
| | | |
| | |
Customer
B | |
$ | * | ) | |
$ | 64 | | |
$ | * | ) | |
$ | 32 | |
| |
| | | |
| | | |
| | | |
| | |
Customer
C | |
$ | * | ) | |
$ | 37 | | |
$ | * | ) | |
$ | * | ) |
|
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v3.23.2
Subsequent Events
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE 7 - SUBSEQUENT EVENTS
| a. | On August 23, 2023, the board of directors approved the grant of an aggregate of 33,500 options exercisable into 33,500 ordinary shares to the Company’s employees, at an exercise price of $6.5 per share. The options will vest over four years with one quarter vesting one year after the grant date and the remaining balance will vest in equal parts at the end of each subsequent quarter. |
| b. | On August 23, 2023, the board of directors approved repricing of outstanding
options to purchase an aggregate of 999,648 ordinary shares held by the Company’s employees and directors to an exercise price of
$6.39 per share, subject to obtaining regulatory approvals, and with regard to options granted to members of the board (including the
Company’s Chief Executive Officer), subject to shareholders’ approval. |
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v3.23.2
Accounting Policies, by Policy (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Significant Accounting Policies [Abstract] |
|
Basis of presentation |
The unaudited condensed consolidated
financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States
of America (“US GAAP”) for interim financial information. Accordingly, they do not contain all information and notes required
by US GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements
reflect all adjustments, which include normal recurring adjustments, necessary for a fair presentation of the results for the interim
periods presented. These unaudited condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s
annual financial statements for the year ended December 31, 2022, as filed in the 20-F on March 29, 2023. The Company’s interim period results
do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year. The significant
accounting policies applied in the annual consolidated financial statements of the Company as of December 31, 2022, contained in the
Company’s Annual Report have been applied consistently in these unaudited condensed consolidated financial statements.
|
Use of estimates in the preparation of financial statements |
| b. | Use of estimates in the preparation of financial statements | The preparation of financial statements
in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities,
the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. The Company’s management believes that the estimates, judgment and assumptions used are reasonable
based upon information available at the time they are made. Actual results may differ from those estimates.
|
Principles of consolidation |
| c. | Principles of consolidation | The consolidated financial statements
include the accounts of CollPlant Biotechnologies Ltd. and its wholly-owned subsidiary, CollPlant Ltd. Intercompany balances and transactions
have been eliminated upon consolidation.
|
Fair value measurement |
The carrying amount of the cash and
cash equivalents, restricted deposits, trade receivable, trade payables, accrued expenses and other liabilities approximates their fair
value.
|
Income (loss) per share |
| e. | Income
(loss) per share |
Basic income (loss) per share is computed
on the basis of the net income (loss), for the period divided by the weighted average number of ordinary shares outstanding during the
period. Diluted income (loss) per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents
outstanding when dilutive. Ordinary share equivalents include outstanding share options and warrants, which are included under the treasury
stock method when dilutive.
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator: | |
| | |
| | |
| | |
| |
Net income (loss) | |
$ | 2,047 | | |
$ | (8,145 | ) | |
$ | 5,762 | | |
$ | (4,285 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Basic weighted-average ordinary shares outstanding | |
| 11,329,516 | | |
| 10,935,611 | | |
| 11,369,031 | | |
| 11,086,481 | |
Effect of share-based compensation | |
| 409,368 | | |
| — | | |
| 408,108 | | |
| — | |
Diluted weighted average ordinary shares outstanding | |
| 11,738,884 | | |
| 10,935,611 | | |
| 11,777,139 | | |
| 11,086,481 | |
| |
| | | |
| | | |
| | | |
| | |
Basic net income (loss) per share | |
$ | 0.18 | | |
$ | (0.74 | ) | |
$ | 0.51 | | |
$ | (0.39 | ) |
Diluted net income (loss) per share | |
$ | 0.17 | | |
$ | (0.74 | ) | |
$ | 0.49 | | |
$ | (0.39 | ) |
1,201,811 options were excluded from
the calculation of diluted net income per share due to their anti-dilutive effect for the six and the three months ended June 30, 2023.
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v3.23.2
Significant Accounting Policies (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Significant Accounting Policies [Abstract] |
|
Schedule of Earnings Per Share Basic and Diluted |
Ordinary share equivalents include outstanding share options and warrants, which are included under the treasury
stock method when dilutive.
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator: | |
| | |
| | |
| | |
| |
Net income (loss) | |
$ | 2,047 | | |
$ | (8,145 | ) | |
$ | 5,762 | | |
$ | (4,285 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Basic weighted-average ordinary shares outstanding | |
| 11,329,516 | | |
| 10,935,611 | | |
| 11,369,031 | | |
| 11,086,481 | |
Effect of share-based compensation | |
| 409,368 | | |
| — | | |
| 408,108 | | |
| — | |
Diluted weighted average ordinary shares outstanding | |
| 11,738,884 | | |
| 10,935,611 | | |
| 11,777,139 | | |
| 11,086,481 | |
| |
| | | |
| | | |
| | | |
| | |
Basic net income (loss) per share | |
$ | 0.18 | | |
$ | (0.74 | ) | |
$ | 0.51 | | |
$ | (0.39 | ) |
Diluted net income (loss) per share | |
$ | 0.17 | | |
$ | (0.74 | ) | |
$ | 0.49 | | |
$ | (0.39 | ) |
|
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v3.23.2
Inventory (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Inventories [Abstract] |
|
Schedule of Inventories |
Inventories at June 30, 2023 and December 31, 2022 consisted
of the following:
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
(Audited) | |
Work in progress | |
$ | 682 | | |
$ | 881 | |
Finished goods’ | |
| 870 | | |
| 549 | |
Total inventory | |
$ | 1,552 | | |
$ | 1,430 | |
|
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v3.23.2
Share Capital (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Share Capital [Abstract] |
|
Schedule of Shares Issued Granted Options |
In the six months ended June 30, 2023
and 2022, the Company granted options as follows:
| |
Six months ended June 30, 2023 |
| |
Number of options granted | | |
Exercise price range | | |
Vesting period | |
Expiration |
Employees | |
| 104,500 | | |
$ | 7.5 | | |
4 years | |
10 years |
| |
Six months ended June 30, 2022 |
| |
Number of options granted | | |
Exercise price range | | |
Vesting period range | |
Expiration |
Employees | |
| 398,000 | | |
$ | 9.22 | | |
4 years | |
10 years |
Directors | |
| 217,000 | | |
$ | 9.22 | | |
4 years | |
10 years |
|
Schedule of Fair Value of Options Granted to Employees on the Date of Grant Was Computed Using athe Black-Scholes Model |
The fair value of options granted on
the date of grant was computed using the Black-Scholes model. The underlying data used for computing the fair value of the options are
as follows:
| |
Six months ended
June 30 | |
| |
2023 | | |
2022 | |
Value of ordinary share | |
$ | 7.5 | | |
$ | 9.07-9.22 | |
Dividend yield | |
| 0 | % | |
| 0 | % |
Expected volatility | |
| 74.1 | % | |
| 67.28%-67.95 | % |
Risk-free interest rate | |
| 0.36 | % | |
| 1.72%-3.03 | % |
Expected term | |
| 6.11 years | | |
| 6.11 years | |
|
Schedule of Summarizes the Number of Options Granted to Employees Under the Option Plan |
The following table summarizes the number of options granted to employees and directors under the 2010 Plan for the six months period ended June 30, 2023:
| |
Number of options | | |
Weighted average exercise price | |
Options outstanding at the beginning of the period | |
| 1,868,749 | | |
$ | 7.85 | |
Granted | |
| 104,500 | | |
| 7.5 | |
Exercised | |
| (29,163 | ) | |
| 4.43 | |
Forfeited or expired | |
| (95,559 | ) | |
| 9.43 | |
Options outstanding at the end of the period | |
| 1,848,527 | | |
$ | 7.8 | |
Options exercisable at the end of the period | |
| 1,105,189 | | |
$ | 7.35 | |
| |
Number of options | | |
Weighted average exercise price | |
Options outstanding at the beginning of the period | |
| 15,416 | | |
$ | 16.04 | |
Granted | |
| - | | |
| - | |
Exercised | |
| (3,750 | ) | |
| 5.07 | |
Forfeited or expired | |
| - | | |
| - | |
Options outstanding at the end of the period | |
| 11,666 | | |
$ | 16.45 | |
Options exercisable at the end of the period | |
| 6,329 | | |
$ | 9.81 | |
|
Schedule of Share-Based Compensation |
The following table illustrates the effect of share-based
compensation on the statements of operations:
| |
Six months ended June 30 | | |
Three months ended June 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Cost of revenue | |
$ | 19 | | |
$ | 2 | | |
$ | 11 | | |
$ | 2 | |
Research and development | |
| 307 | | |
| 374 | | |
| 121 | | |
| 173 | |
General, administrative and marketing | |
| 526 | | |
| 647 | | |
| 206 | | |
| 400 | |
| |
$ | 852 | | |
$ | 1,023 | | |
$ | 338 | | |
$ | 575 | |
|
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v3.23.2
Supplementary Financial Statement Information (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Supplementary Financial Statement Information [Abstract] |
|
Schedule of Disaggregated Revenues |
Disaggregated
revenues:
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues from milestones (See note 5) | |
$ | 10,000 | | |
$ | - | | |
$ | 10,000 | | |
$ | - | |
Revenues from the sales of goods | |
| 617 | | |
| 132 | | |
| 184 | | |
| 66 | |
Total revenues | |
$ | 10,617 | | |
$ | 132 | | |
$ | 10,184 | | |
$ | 66 | |
|
Schedule of Revenues by Geographical Area |
Revenues
by geographic area were as follows:
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
United states and Canada | |
$ | 10,592 | | |
$ | 74 | | |
$ | 10,161 | | |
$ | 41 | |
| |
| | | |
| | | |
| | | |
| | |
Europe and others | |
| 25 | | |
| 58 | | |
$ | 23 | | |
| 25 | |
| |
| | | |
| | | |
| | | |
| | |
Total revenues | |
$ | 10,617 | | |
$ | 132 | | |
$ | 10,184 | | |
$ | 66 | |
|
Schedule of Revenue by Major Customers |
Set forth below is a breakdown of the
Company’s revenue by major customers (major customer –revenues from these customers constitute at least 10% of total revenues
in a certain period):
| |
Six
months ended
June 30, | | |
Three
months ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Customer
A | |
$ | 10,527 | | |
$ | * | ) | |
$ | 10,151 | | |
$ | 9 | |
| |
| | | |
| | | |
| | | |
| | |
Customer
B | |
$ | * | ) | |
$ | 64 | | |
$ | * | ) | |
$ | 32 | |
| |
| | | |
| | | |
| | | |
| | |
Customer
C | |
$ | * | ) | |
$ | 37 | | |
$ | * | ) | |
$ | * | ) |
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v3.23.2
Significant Accounting Policies (Details) - Schedule of Earnings Per Share Basic and Diluted - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Numerator: |
|
|
|
|
Net income (loss) (in Dollars) |
$ 5,762
|
$ (4,285)
|
$ 2,047
|
$ (8,145)
|
Denominator: |
|
|
|
|
Basic weighted-average ordinary shares outstanding |
11,369,031
|
11,086,481
|
11,329,516
|
10,935,611
|
Effect of share-based compensation |
408,108
|
|
409,368
|
|
Diluted weighted average ordinary shares outstanding |
11,777,139
|
11,086,481
|
11,738,884
|
10,935,611
|
Basic net income (loss) per share (in Dollars per share) |
$ 0.51
|
$ (0.39)
|
$ 0.18
|
$ (0.74)
|
Diluted net income (loss) per share (in Dollars per share) |
$ 0.49
|
$ (0.39)
|
$ 0.17
|
$ (0.74)
|
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v3.23.2
Share Capital (Details) $ in Thousands |
1 Months Ended |
6 Months Ended |
12 Months Ended |
|
Feb. 23, 2023
USD ($)
shares
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
shares
|
Jun. 30, 2023
₪ / shares
|
Share Capital (Details) [Line Items] |
|
|
|
|
|
Exercised shares |
186,000
|
|
|
|
|
Shares return value | $ |
$ 744
|
|
|
$ 1,700
|
|
Ordinary share price | ₪ / shares |
|
|
|
|
₪ 1.5
|
Fair value of options granted | $ |
|
$ 505
|
$ 3,511
|
|
|
Warrant [Member] |
|
|
|
|
|
Share Capital (Details) [Line Items] |
|
|
|
|
|
Exercised shares |
186,000
|
|
|
425,000
|
|
Ordinary Shares [Member] |
|
|
|
|
|
Share Capital (Details) [Line Items] |
|
|
|
|
|
Exercised shares |
|
|
|
425,000
|
|
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v3.23.2
Share Capital (Details) - Schedule of Summarizes the Number of Options Granted to Employees Under the Option Plan
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Share Capital (Details) - Schedule of Summarizes the Number of Options Granted to Employees Under the Option Plan [Line Items] |
|
Number of options, Options outstanding at the beginning of the period | shares |
1,868,749
|
Weighted average exercise price, Options outstanding at the beginning of the period | $ / shares |
$ 7.85
|
Number of options, Granted | shares |
104,500
|
Weighted average exercise price, Granted | $ / shares |
$ 7.5
|
Number of options, Number of options, Exercised | shares |
(29,163)
|
Weighted average exercise price, Exercised | $ / shares |
$ 4.43
|
Number of options, Forfeited or expired | shares |
(95,559)
|
Weighted average exercise price, Forfeited or expired | $ / shares |
$ 9.43
|
Number of options, Options outstanding at the end of the period | shares |
1,848,527
|
Weighted average exercise price, Options outstanding at the end of the period | $ / shares |
$ 7.8
|
Number of options, Options exercisable at the end of the period | shares |
1,105,189
|
Weighted average exercise price, Options exercisable at the end of the period | $ / shares |
$ 7.35
|
Non-Employees [Member] |
|
Share Capital (Details) - Schedule of Summarizes the Number of Options Granted to Employees Under the Option Plan [Line Items] |
|
Number of options, Options outstanding at the beginning of the period | shares |
15,416
|
Weighted average exercise price, Options outstanding at the beginning of the period | $ / shares |
$ 16.04
|
Number of options, Granted | shares |
|
Weighted average exercise price, Granted | $ / shares |
|
Number of options, Number of options, Exercised | shares |
(3,750)
|
Weighted average exercise price, Exercised | $ / shares |
$ 5.07
|
Number of options, Forfeited or expired | shares |
|
Weighted average exercise price, Forfeited or expired | $ / shares |
|
Number of options, Options outstanding at the end of the period | shares |
11,666
|
Weighted average exercise price, Options outstanding at the end of the period | $ / shares |
$ 16.45
|
Number of options, Options exercisable at the end of the period | shares |
6,329
|
Weighted average exercise price, Options exercisable at the end of the period | $ / shares |
$ 9.81
|
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v3.23.2
Development, Exclusivity and Option Products Agreement (Details) - USD ($) $ in Thousands |
1 Months Ended |
6 Months Ended |
Feb. 28, 2021 |
Jun. 30, 2023 |
Development, Exclusivity and Option Products Agreement (Details) [Line Items] |
|
|
Received amount |
$ 50,000
|
|
Cash payment |
$ 14,000
|
|
Development Agreement [Member] |
|
|
Development, Exclusivity and Option Products Agreement (Details) [Line Items] |
|
|
Proceeds of payments |
|
$ 36,000
|
Collplant [Member] |
|
|
Development, Exclusivity and Option Products Agreement (Details) [Line Items] |
|
|
Payment received |
|
$ 10,000
|
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- DefinitionPer share decrease in exercise price of option. Excludes change due to standard antidilution provision and option granted under share-based payment arrangement.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Topic 505 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 3 -Publisher FASB -URI https://asc.fasb.org//1943274/2147481112/505-10-50-3
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