CollPlant Reports Second Quarter 2018 Financial Results and Provides Business Update

NESS ZIONA, Israel, Sept. 21, 2018 /PRNewswire/ -- CollPlant (NASDAQ: CLGN) (TASE: CLGN), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products (recombinant human, "rhCollagen"), today announced financial results for the second quarter ended June 30, 2018 and provided an update on the Company's business developments. Certain metrics, including those expressed on an adjusted basis, are non-GAAP measures. See "Use of Non-IFRS (non-GAAP) Measures" below.

CollPlant reported revenues of $170,000 (NIS 653,000) for the second quarter of 2018. The Company ended the second quarter of 2018 with $2.6 million (NIS 9.4 million) in cash and cash equivalents, and received an additional $1.25 million in July through a private placement, while comprehensive loss for the second quarter of 2018 was $1.5 million (NIS 5.6 million) on a GAAP basis, or adjusted comprehensive loss of $1.2 million (NIS 4.5 million), on a non-GAAP basis.

"We are very pleased to report that during the second quarter of 2018, we have successfully produced high yield batches of rhCollagen, as well as scaled-up the BioInk production in our new cGMP production facility. This constitutes an important milestone in our plan to become a market leader in the field of regenerative medicine, and as a leading supplier of BioInks for 3D bioprinting of tissues and organs. The production facility bolsters our competitiveness by yielding higher margins on our products and by serving as a process development center where we continue to develop our groundbreaking BioInk formulations," stated Yehiel Tal, CollPlant's Chief Executive Officer.

"During the second quarter, CollPlant received grant approval from the Israel Innovation Authority (IIA) supporting the continued development of BioInk formulations. Additionally, we recently received funding from investors, when in May, we completed the third investment round from an investor of $1 million, and, in July, we raised another $1.25 million through a private placement with another investor, bringing the total amount raised in the last year to $9.2 million," Mr. Tal added.

"In addition to the progress we made with our BioInks, we are continuing the development of next-generation dermal fillers for the aesthetic medicine market. Based on our work with major market players in the fields of 3D bioprinting of tissues and organs, and medical aesthetics, we believe that CollPlant's rhCollagen is the ideal building block for regenerative medicine scaffolds," concluded Mr. Tal.

Second Quarter 2018 Financial Results on IFRS basis ("GAAP")

Revenues for the three months ended June 30, 2018 increased 209% to $170,000 (NIS 653,000), compared to $55,000 (NIS 201,000) in the second quarter of 2017. Revenues were derived from sales in the U.S. of CollPlant's BioInk for development of 3D bioprinting of organs, as well as sales in Europe of mainly, CollPlant's soft tissue repair matrix, VergenixSTR, for treating tendinopathy.

The Company's gross profit for the three months ended June 30, 2018 increased 91% to $105,000 (NIS 415,000) compared to $55,000 (NIS 201,000) in the second quarter of 2017.

Total operating costs and expenses were $1.4 million (NIS 5.4 million) compared to $1.6 million (NIS 5.9 million) in the second quarter of 2017. The net decrease in the amount of $200,000 is attributed to a 2018 grant from the Israel Innovation Authorities, supporting the Company's development program of rhCollagen based BioInk, for 3D bioprinting of tissues and organs.

Operating loss was $1.3 million (NIS 5.0 million) compared to an operating loss of $1.6 million (NIS 5.7 million) in the second quarter of 2017. Comprehensive loss for the second quarter of 2018 was $1.5 million (NIS 5.6 million), or $0.01 (NIS 0.03) per share, compared to a comprehensive loss of $1.6 million (NIS 5.8 million), or $0.01 (NIS 0.04) per share, for the second quarter of 2017.

Second Quarter 2018 Financial Results on Non-IFRS Basis ("non-GAAP")

On a non-GAAP basis, the operating costs and expenses for the second quarter of 2018 were $1.2 million (NIS 4.4 million), compared to $1.5 (NIS 5.4 million) for the second quarter of 2017. The comprehensive loss for the second quarter of 2018 was $1.2 million (NIS 4.5 million), or $0.01 (NIS 0.03) per share, compared to $1.5 million (NIS 5.4 million), or $0.01 (NIS 0.04) per share, for the second quarter of 2017. Non-GAAP measures exclude certain non-cash expenses. The table at the end of this press release titled "Reconciliation of GAAP to Non-GAAP Financial Measures" includes a reconciliation of the Company's GAAP results to non-GAAP results. The reconciliation reflects non-cash expenses in the amount of $273,000 (NIS 1.1 million) in the second quarter of 2018, with respect to fair market value attributed to services received through a securities purchase agreement with an investor (the "Share Purchase Agreement"), recognition of unrecognized day one loss and share-based compensation to employees, directors and consultants.

Use of Non-IFRS ("non-GAAP") Measures

This press release contains certain non-GAAP financial measures for operating costs and expenses, operating loss, comprehensive loss and basic and diluted comprehensive loss per share that exclude the effects of non-cash expense for fair market value attributed to services received through the Share Purchase Agreement, recognition of unrecognized day one loss, and share-based compensation to employees, directors and consultants. 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 loss and 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" table on page 8 in this press release. This accompanying table on page 8 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.

For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange as of June 30, 2018 (U.S. $1.00 = NIS 3.650).

The Company's consolidated financial results for the six months ended June 30, 2018 are presented in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board.

About CollPlant

CollPlant is a regenerative medicine company focused on 3D bioprinting of tissues and organs, and on developing and commercializing tissue repair products for orthobiologics, and advanced wound care markets. Our products are based on our rhCollagen (recombinant human collagen) that is produced with CollPlant's proprietary plant based genetic engineering technology.

Our products address indications for diverse fields of organ and tissue repair, and are ushering in a new era in regenerative medicine. Our flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs, and our unique Vergenix line of rhCollagen products includes a soft tissue repair matrix for treating tendinopathy and a wound repair matrix to promote a rapid optimal healing of acute and chronic wounds.

For more information about CollPlant, visit http://www.collplant.com

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 and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company's expectations regarding the timing and cost of commencing clinical trials with respect to tissues and organs which are based on its rhCollagen based Bioink, VergenixSTR, and VergenixFG; the Company's ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based BioInk, VergenixSTR, and VergenixFG 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 BioInk, VergenixSTR, and VergenixFG; 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 we are 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.

 

COLLPLANT HOLDINGS LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)














Convenience
translation into
USD










Six months ended
June 30



Three months ended
June 30



Six months ended
June 30



Three months ended
June 30




2018



2018



2017



2018



2017



2018




USD in thousands



NIS in thousands


Revenue



392




170




453




1,432




201




653


Cost of Revenue



89




65




-




324




-




238


Gross Profit



303




105




453




1,108




201




415



























Operating costs and 
    expenses:

























Research and development
    expenses, net:



1,863




591




8,340




6,802




4,298




2,335


General, administrative and 
    marketing expenses



1,792




812




2,930




6,539




1,589




3,094


Total operating costs and
    expenses:



3,655




1,403




11,270




13,341




5,887




5,429


Operating loss



3,352




1,298




10,817




12,233




5,686




5,014


Financial income



(128)




(18)




-




(469)




-




(82)


Financial expenses



289




173




220




1,054




159




646


Financial expenses, net



161




155




220




585




159




564


Comprehensive loss



3,513




1,453




11,037




12,818




5,845




5,578


Basic and diluted loss per
    ordinary share (NIS/USD)



0.02




0.01




0.09




0.06




0.04




0.03


Weighted average ordinary
    shares outstanding



206,884,141




217,428,969




124,504,278




206,884,141




130,598,626




217,428,969


 

 

COLLPLANT HOLDINGS LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)













Convenience translation into USD










June 30



June 30



December 31




2018



2018



2017




USD in
thousands



NIS in thousands


Assets










Current assets:










Cash and cash equivalents



2,565




9,363




17,817


Accounts receivables:













Trade receivables



423




1,544




354


Other



587




2,144




3,543


Inventory



642




2,345




700





4,217




15,396




22,414


Non-current assets:













Restricted deposit



145




530




503


Long-term receivables



43




157




92


Property and equipment, net



1,480




5,402




3,582


Intangible assets, net



373




1,363




1,454





2,041




7,452




5,631


TOTAL ASSETS



6,258




22,848




28,045















Liabilities and equity













Current liabilities -













Accounts payable:













Trade payables



643




2,350




2,922


Accrued liabilities and other



425




1,550




1,996





1,068




3,900




4,918


Non-current liabilities













Debentures at fair value



-




-




12,639


Warrants at fair value



1,267




4,625




-


Derivatives



23




84




141


Royalties to the Israel Innovation Authority



299




1,092




1,203


Loan



58




210




-


Long-term payables



-




-




61





1,647




6,011




14,044


Total liabilities



2,715




9,911




18,962















Equity:













Ordinary shares



1,405




5,128




4,998


Additional paid in capital and warrants



52,839




192,868




178,467


Accumulated deficit



(50,701)




(185,059)




(174,382)


TOTAL EQUITY



3,543




12,937




9,083


TOTAL LIABILITIES AND EQUITY



6,258




22,848




28,045


 

 

 

COLLPLANT HOLDINGS LTD.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

(UNAUDITED)













Convenience translation into USD










 

Six months ended June 30




2018



2017



2018




USD in thousands



NIS in thousands


Cash flows used in operating activities:










Comprehensive loss for the period



(3,513)




(11,037)




(12,818)


Adjustments for:













Depreciation and amortization



164




601




600


Share-based compensation to employees and consultants



588




1,056




2,141


Changes in fair market value of services received through the Alpha Agreement



419




-




1,530


Recognition of unrecognized day one loss



119




-




433


Exchange differences on cash and cash equivalents



(16)




75




(59)


Loss from changes in fair value of financial instruments



161




-




589


Exchange differences on restricted cash



(7)




50




(27)





(2,085)




(9,255)




(7,611)


Changes in operating asset and liability items:













Increase in trade receivables



(326)




-




(1,190)


Increase in inventory



(451)




(63)




(1,645)


Decrease (increase) in other receivables (including long-term receivables)



(54)




2,757




(196)


Decrease) in trade payables (including long-term payables)



(139)




(2,998)




(507)


Decrease (increase) in accrued liabilities and other payables



(122)




169




(446)


Increase (decrease) in royalties to the IIA



(30)




(26)




(111)





(1,122)




(161)




(4,095)


Net cash used in operating activities



(3,207)




(9,416)




(11,706)


Cash flows from investing activities:













Purchase of property and equipment



(638)




(45)




(2,329)


Net cash used in investing activities



(638)




(45)




(2,329)


Cash flows from financing activities:













Proceeds from issue of shares and warrants, net of issue expenses



1,490




6,788




5,438


Exercise of warrants into shares



-




3,618




-


Loan received



58




-




210


Payments made for equipment on financing terms



(35)




(127)




(126)


Net cash provided by financing activities



1,513




10,279




5,522


Increase (Decrease) in cash and cash equivalents



(2,332)




818




(8,513)


Cash and cash equivalents at the beginning of the period



4,881




3,797




17,817


Exchange differences on cash and cash equivalents



16




(75)




59


Cash and cash equivalents at the end of the period



2,565




4,540




9,363


Non-cash investing activities:













Conversion of Debentures to pre-paid warrant



3,482








12,708


 

 




COLLPLANT HOLDINGS LTD.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES

(UNAUDITED)


Convenience translation into USD











 

Six months ended June 30


 

Three months ended June 30



 

Six months ended June 30


 

        Three months ended

June 30


2018


2018



2017


2018


2017


2018



USD in thousands


                           NIS in thousands














GAAP gross  profit           

303


105



453


1,108


201


415














GAAP operating costs and expenses:

3,655


1,403



11,270


13,341


5,887


5,429

Fair market value attributed to services received through the Alpha Agreement

419


(16)



-


1,530


-


-

Share-based compensation to employees, directors and consultants

588


268



1,056


2,141


471


1,017

Non-GAAP operating costs and expenses:

2,648


1,151



10,214


9,670


5,416


4,412

GAAP operating loss

3,352


1,298



10,817


12,233


5,686


5,014

Non-GAAP operating loss

2,345


1,046



9,761


8,562


5,215


3,997

GAAP Comprehensive loss

3,513


1,453



11,037


12,818


5,845


5,578

Fair market value attributed to services received through the Alpha Agreement

419


(16)



-


1,530


-


-

Recognition of unrecognized day one loss

119


21



-


433


-


89

Share-based compensation to employees, directors and consultants

588


268



1,056


2,141


471


1,017

Non-GAAP Comprehensive loss

2,387


1,180



9,984


8,714


5,374


4,472

GAAP Basic and diluted loss per ordinary share (NIS/USD)

0.02


0.01



0.09


0.06


0.04


0.03

Non-GAAP    Basic and diluted loss per ordinary share (NIS/USD)

0.01


0.01



0.08


0.04


0.04


0.02














 

 

Contact at CollPlant
Eran Rotem
Deputy CEO & CFO
Tel: +972-2325600/612
Email: Eran@collplant.com

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SOURCE CollPlant