• Partnership with AbbVie to co-develop rhCollagen-based dermal and soft tissue fillers continues to advance according to plan
  • Co-developing 3D bioprinted human intestine model ("Gut-on-a-Chip") for drug discovery and personalized treatment of ulcerative colitis with Tel-Aviv University and SHEBA Hospital
  • 3D bioprinted regenerative breast implant program on track for Q1 2023 readout of large animal study
  • Bioink platform expanded with recent launch of Collink.3D™ 90 to offer additional functionality and performance benefits of biofabricated constructs
  • Strong balance sheet with cash and cash equivalents of $33M as of September 30, 2022

REHOVOT, Israel, Dec. 1, 2022 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetic medicine company developing innovative human collagen-based technologies and products for tissue regeneration and organ manufacturing, today announced financial results for the third quarter ended September 30, 2022 and provided an update on the Company's business developments.

CollPlant's 3D bioprinted regenerative breast implant - program on track for Q1 2023 readout of large animal study (PRNewsfoto/CollPlant Ltd)

"CollPlant made significant progress this quarter with our development partners to advance and diversify our product portfolio, which is targeting large commercial opportunities in both existing and new markets, including medical aesthetics and personalized medicine," said Yehiel Tal, CollPlant's CEO. "Our long-term collaboration with AbbVie to develop what has the potential to be a paradigm-shifting dermal and soft tissue filler, which utilizes rhCollagen to deliver better tissue regeneration performance, continues to move forward according to plan. We also recently announced a partnership with Tel Aviv University and SHEBA Hospital to develop a 3D bioprinted model of the human intestine. We believe this product will be of great interest to biopharma companies to support drug discovery, helping to identify new drug candidates, as well as personalized therapeutic treatments for ulcerative colitis."

"We are also enthusiastic with the progress and potential of our internal pipeline, including the development of a next generation photocurable dermal filler technology for use in soft tissue indications such as facial contouring. We also recently launched our second bioink, Collink.3D™ 90, which is designed to address a wider range of 3D bioprinting applications, such as soft and hard tissues. Our bioink platform is an essential part of our 3D bioprinting strategy to leverage the enhanced safety and performance of our collagen technology with the goal of entering high value partnerships with leading medical companies and other institutions. While advancing our product platform, we've also continued to strengthen our sustainability activities. We believe it is our duty to support a positive eco-system for our society, environment and stakeholders as we work to create a financially sound and profitable company," added Mr. Tal.     

Third Quarter 2022 Financial Results

Cash, cash equivalents and short-term deposits as of September 30, 2022, were $33 million.

GAAP revenues for the third quarter of 2022 were $109,000 and included mainly income from sales of our BioInk and rhCollagen. Revenues decreased by $31,000 compared to $140,000 in the third quarter of 2021.

GAAP cost of revenue for the third quarter of 2022, was $264,000 compared to $142,000 in the third quarter of 2021. Cost of revenue includes mainly the cost of our rhCollagen based products, and royalties to the IIA for our sales. The increase in cost of revenue in the amount of approximately $122,000 is mainly comprised of inventory impairment.

GAAP gross loss for the third quarter of 2022 was $155,000, compared to gross loss of $2,000 in the third quarter of 2021.

GAAP operating expenses for the third quarter of 2022 were $4.3 million compared to $3.1 million in the third quarter of 2021. The net increase of $1.2 million in operating expenses is mainly comprised of: (i) $236,000 in research and product development activities including process development, (ii) $397,000 in employees' salaries and share base compensation, including recruitment of new employees for development of new products in 3D bioprinting and medical aesthetics, and (iii) $356,000 in employees and director's salaries and insurance policy expenses.

On a non-GAAP basis, the operating expenses for the third quarter of 2022 were $3.7 million compared to $2.7 million in the third quarter of 2021. Non-GAAP measures exclude certain non-cash expenses.

GAAP financial income, net for the third quarter of 2022 totaled $89,000 compared to financial income net, of $17,000 in the third quarter of 2021. Financial income, net is mainly attributed to exchange rate and income interest received from our short term cash deposit.

GAAP net loss for the third quarter of 2022 was $4.4 million or $0.40 basic loss per share, compared to a net loss of $3.1 million, or $0.29 basic loss per share, for the third quarter of 2021. Non-GAAP net loss for the third quarter of 2022 was $3.7 million or $0.34 loss per share, compared to a net loss of $2.7 million, or $0.26 basic loss per share, for the third quarter of 2021.

Nine months period ended September 30, 2022, compared to nine months period ended September 30, 2021

GAAP revenues for the nine months ended September 30, 2022 were $241,000 and included mainly income from sales of our BioInk and rhCollagen. Revenues decreased by $15.1 million compared to $15.3 million in the nine months ended September 30, 2021 which mainly derived from the $14 million consideration for the license granted to AbbVie and to a decrease in sales of BioInk and Vergenix products.

GAAP gross loss for the nine months ended September 30, 2022, was $97,000, compared to gross profit of $13.9 million in the nine months ended September 30, 2021.

GAAP operating expenses for the nine months ended September 30, 2022 were $12.3 million, compared to $10 million in the nine months ended September 30, 2021. The net increase of $2.3 million in operating expenses is mainly comprised of: (i) an increase of $1.0 million  in research and product development activities including process development, (ii) an increase of $909,000 in employees' salaries and share base compensation, including recruitment of new employees for development of new products in 3D bioprinting and medical aesthetics, (iii) an increase of $542,000 in general and administrative employees and directors salaries and insurance policy expenses, offset by (iv) a decrease of  $410,000 in one-time expenses relating to the end of the Company's ADS program, and the registration of the ordinary shares for listing on Nasdaq Global Market in 2021. On a non-GAAP basis, the operating expenses for the nine months ended September 30, 2022 were $11.1 million compared to $8.7 million in the nine months ended September 30, 2021. Non-GAAP measures exclude certain non-cash expenses.

GAAP financial expenses, net for the nine months ended September 30, 2022, totaled $103,000 compared to financial income net, of $140,000 in the nine months ended September 30, 2021. Financial expenses, net is mainly attributed to exchange rate and income interest received from the Company's short term cash deposit.

GAAP net loss for the nine months ended September 30, 2022 was $12.5 million, or $1.14 basic loss per share, compared to a net income of $4 million, or $0.41 basic income per share, for the nine months ended September 30, 2021. Non-GAAP net loss for the nine months ended September 30, 2022 was $11.2 million, or $1.02 basic loss per share, compared to $5.2 million income, or $0.54 basic income per share, for the nine months ended September 30, 2021.

Cash used in operating activities during the nine months ended September 30, 2022, was $10.4 million compared to $4.9 million cash provided from operating activities in the nine months ended September 30, 2021. The change is mainly attributed to the $14 million consideration for the license granted to AbbVie in 2021.

Cash provided by investing activities during the nine months ended September 30, 2022, was $29.2 million compared to $21.1 cash used in the nine months ended September 30, 2021. The change is mainly attributed to repayment and investment in short term cash deposits.

Cash provided by financing activities during the nine months ended September 30, 2022, was $1.5 million compared to cash provided by financing activities of $38.6 million in the nine months ended September 30, 2021. The difference between the periods  is mainly attributed to the Company's registered direct offering in February 2021, which resulted in net proceeds of $32 million and decrease of $4.3 million proceeds in exercise of options and warrants.

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 2022 and 2021 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, net income and basic and diluted net income per share that exclude the effects of non-cash expense for fair market value attributed to change in fair value of financial instruments, 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, comprehensive income and income 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 as of, and for the nine months ended September 30, 2022, are presented in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP").

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 ability to continue as a going concern, and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the impact of the COVID-19 pandemic; the Company's expectations regarding the timing and cost of commencing clinical trials with respect to tissues and organs which are based on its rhCollagen based BioInk and products for medical aesthetics; the Company's ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based BioInk and medical aesthetics products including but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products in 3D Bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; 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; the overall global economic environment; 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. 

Contact at CollPlant:

Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Email: Eran@collplant.com  

 

 

COLLPLANT BIOTECHNOLOGIES LTD.

CONDENSED CONSOLIDATED BALANCE SHEETS

(U.S. dollars in thousands, except share data) 

 

 









September 30,

2022



December 31,

2021

Assets

 







Current assets:







  Cash and cash equivalents



$

32,813



$

13,148

  Short term cash deposits




-




30,151

  Restricted deposit




23




13

  Trade receivables




9




270

  Other accounts receivable and prepaid expenses




489




424

  Inventories




1,128




1,081

Total current assets




34,462




45,087

Non-current assets:









  Restricted deposit




187




213

  Operating lease right-of-use assets




2,708




2,953

  Property and equipment, net




2,963




2,728

  Intangible assets, net




238




243

Total non-current assets




6,096




6,137

Total assets



$

40,558



$

51,224

 

 

COLLPLANT BIOTECHNOLOGIES LTD.


CONDENSED CONSOLIDATED BALANCE SHEETS


(U.S. dollars in thousands, except share data) 

 
















September 30,
2022



December 31,
2021



Liabilities and shareholders' equity









Current liabilities:









  Trade payables



$

880



$

1,034




  Operating lease liabilities




487




519




  Deferred revenues




-




32




  Accrued liabilities and other




967




1,429




Total current liabilities




2,334




3,014




Non-current liabilities:












Operating lease liabilities




2,418




3,089




Total non-current liabilities




2,418




3,089




Total liabilities




4,752




6,103




Shareholders' Equity:












Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares
 as of September 30, 2022 and December 31, 2021; issued and outstanding:
 11,086,481 and 10,772,024 ordinary shares as of September 30, 2022 and
 December 31, 2021, respectively




4,831




4,664




    Additional paid in capital




117,265




114,223




    Currency translation differences




(969)




(969)




    Accumulated deficit




(85,321)




(72,797)




Total shareholders' equity




35,806




45,121




Total liabilities and shareholders' equity



$

40,558



$

51,224




















 

 

COLLPLANT BIOTECHNOLOGIES LTD.


CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS


(U.S. dollars in thousands, except share and per share data)

 

 






Nine months ended
September 30


Three months ended
September 30




2022



2021



2022



2021




U.S. dollars in thousands, except per share data

Revenues


$

241



$

15,331



$

109



$

140


Cost of Revenue



338




1,457




264




142


Gross Profit (loss)



(97)




13,874




(155)




(2)



















Operating expenses:

















Research and development



7,618




5,442




2,777




1,908


General, administrative and marketing



4,706




4,563




1,536




1,184


Total Operating income (loss)



(12,421)




3,869




(4,468)




(3,094)


Financial income (expenses), net



(103)




140




89




17


Net income (loss) for the period


$

(12,524)



$

4,009



$

(4,379)



$

(3,077)


Basic net income (loss) per ordinary share


$

(1.14)



$

0.41



$

(0.40)



$

(0.29)


Diluted net income (loss) per ordinary share


$

(1.14)



$

0.32



$

(0.40)



$

(0.29)


Weighted average ordinary shares outstanding used
 in computation of basic net income (loss) per share



10,986,454




9,716,166




11,086,481




10,502,109


Weighted average ordinary shares outstanding used
 in computation of diluted net income (loss) per share



10,986,454




12,348,934




11,086,481




10,502,109
























 

 

COLLPLANT BIOTECHNOLOGIES LTD.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(U.S. dollars in thousands)




Nine months ended
September 30,




2022



2021



Cash flows from operating activities:










  Income (loss)


$

(12,524)



$

4,009



  Adjustments for:










  Depreciation and amortization



782




549



  Gains from Short term cash deposits 



(87)




(98)



  Share-based compensation to employees and consultants



1,735




1,322



  Exchange differences on cash and cash equivalents



699




10



  Financial Income related to financial instruments



-




(28)













  Changes in operating asset and liability items:










  Decrease in trade receivables



261




695



  Decrease (increase) in inventories



(47)




109



  Increase in other receivables



(65)




(504)



  Decrease in operating right of use assets



345




288



  Increase (decrease) in trade payables



(154)




67



  Decrease in lease liabilities



(803)




(355)



  Decrease in accrued liabilities and other payables



(462)




(936)



  Decrease in deferred revenues



(32)




(207)



  Net cash provided by (used in) operating activities



(10,352)




4,921



Cash flows from investing activities:










  Capitalization of intangible assets



(25)




(112)



  Purchase of property and equipment



(987)




(970)



  Repayment of a short term deposits



50,238




10,000



  Investment in short term deposits



(20,000)




(30,000)



  Net cash provided by (used in) investing activities



29,226




(21,082)



Cash flows from financing activities:










  Proceeds from issuance of shares and warrants less issuance expenses



-




32,743



  Exercise of options and warrants into shares



1,474




5,875



  Net cash provided by financing activities



1,474




38,618



Net increase in cash and cash equivalents and restricted deposits 



20,348




22,457



Exchange differences on cash and cash equivalents and restricted deposits 



(699)




(10)



Cash and cash equivalents and restricted deposits at the beginning of the period



13,374




3,526













Cash and cash equivalents and restricted deposits at the end of the period


$

33,023



$

25,973



 

 

COLLPLANT BIOTECHNOLOGIES LTD.


APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS


(U.S. dollars in thousands)






Nine months ended
September 30,




2022



2021


Appendix to the statement of cash flows







A. Supplementary information on investing and financing activities not involving cash flows:














Obtaining right of use assets in exchange for a lease liability



100




299


Classification of issuance costs liability to equity



-




50











B. Reconciliation of Cash, cash equivalents and restricted cash at the end of the period


















Cash and cash equivalents



32,813




25,755


Restricted deposits (including long term) 



210




218


Total cash and cash equivalents and restricted deposits


$

33,023



$

25,973


 

 

CollPlant Biotechnologies Ltd. 


Reconciliation of GAAP to Non-GAAP Financial Measures


(U.S. dollars in thousands, except per share data)


(Unaudited)

 






Nine months ended
September 30



Three months ended
September 30





2022



2021



2022



2021




USD in thousands















GAAP gross profit (loss)


$

(97)



$

13,874



$

(155)



$

(2)



















GAAP operating expenses:



12,324




10,005




4,313




3,092



















     Change of operating lease accounts



458




67




35




(17)


     Share-based compensation to employees, directors and consultants



(1,735)




(1,322)




(680)




(368)





11,047




8,750




3,668




2,707



















Non-GAAP operating expenses:

















   GAAP operating income (loss)



(12,421)




3,869




(4,468)




(3,094)


   Non-GAAP operating income (loss)



(11,144)




5,124




(3,823)




(2,709)


   GAAP Net Income (loss)



(12,524)




4,009




(4,379)




(3,077)


   Change in fair value of financial instruments



-




(28)








-


   Change of operating lease accounts



(458)




(67)




(35)




17


   Share-based compensation to employees, directors and consultants



1,735




1,322




680




368


   Non-GAAP Net Income (loss)


$

(11,247)



$

5,236



$

(3,734)



$

(2,692)


   GAAP Basic income (loss) per ordinary share


$

(1.14)



$

0.41



$

(0.40)



$

(0.29)


   NON- GAAP Basic income (loss) per ordinary share


$

(1.02)



$

0.54



$

(0.34)



$

(0.26)


   GAAP Diluted income (loss) per ordinary share


$

(1.14)



$

0.32



$

(0.40)



$

(0.29)


   Non-GAAP Diluted income (loss) per ordinary share


$

(1.02)



$

0.42



$

(0.34)



$

(0.26)




















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