CollPlant Biotechnologies Reports Second Quarter (Q2) 2020 Financial Results

REHOVOT, Israel, Aug. 28, 2020 /PRNewswire/ -- CollPlant (NASDAQ: CLGN), a regenerative and aesthetics medicine company, today announced financial results for the second quarter ended June 30, 2020 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-GAAP Measures" below.

CollPlant reported revenues of $823,000 for the second quarter of 2020, a 36% increase from the $606,000 recorded in the second quarter of 2019. The Company ended the second quarter of 2020 with $3.7 million in cash and cash equivalents. Comprehensive loss for the second quarter of 2020 was $2.0 million on a GAAP basis, or adjusted comprehensive loss of $1.4 million, on a non-GAAP basis.

"We continue to make major strides in revolutionizing the fields of regenerative and aesthetic medicine through our first-in-class, recombinant human collagen (rhCollagen) platform technology. First, we are partnering with United Therapeutics Corporation (NASDAQ: UTHR) in efforts to address global organ shortages. We plan to leverage this experience in 3D bioprinting of lung scaffolds to explore other life-saving organs and tissues in the future," stated Yehiel Tal, the Chief Executive Officer of CollPlant. "Second, the combination of hyaluronic acid and rhCollagen in our next-generation, regenerative, photocurable dermal fillers will provide superior skin rejuvenation inclusive of the ability to inject into deep wrinkles, as well as other key attributes. Moreover, we are looking forward to sharing new data on our innovative photocurable dermal fillers and additional updates on our breast implant product pipeline at the exclusive Science of Aging Virtual Symposium 2020, which will be held digitally on September 16, 2020. Third, we continue to abide by Israeli Health Ministry guidelines for optimal protection of our employees. To accommodate heightened social distancing policies amid the ongoing pandemic, we have concentrated efforts on amplifying corporate visibility through a stronger online and social media presence. Finally, we remain committed to bolstering our workforce with brilliant scientists and support staff from prestigious institutions here in Israel. We are opportunistic about establishing relationships with new strategic partners who can support our pipeline development efforts."

Financial Results

Second Quarter 2020 Financial Results on US GAAP basis ("GAAP")

Revenues for the three months ended June 30, 2020 increased by 36% to $823,000, compared to $606,000 in the second quarter of 2019. Revenues were derived mainly from CollPlant's BioInk for the development of 3D bioprinting of human organs, and from sales of rhCollagen for medical aesthetics product development.

Cost of revenue was $748,000 in the three months ended June 30, 2020, an increase of 62% compared to $463,000 in the same period in 2019. The increase is primarily related to differences in the mix of products sold, different profitability and the different capacity of production in the reported periods presented.

The Company's gross profit for the three months ended June 30, 2020 decreased by $68,000 to $75,000 compared to $143,000 in the second quarter of 2019.

Total operating expenses for the three months ended June 30, 2020 were $2.0 million, an increase of 5% compared to $1.9 million in the second quarter of 2019.

Operating loss for the three months ended June 30, 2020 was $1.9 million, an increase of 6% compared to an operating loss of $1.8 million in the second quarter of 2019.

Financial expense, net for the three months ended June 30, 2020 was $58,000 compared to financial income, net of $513,000 in the second quarter of 2019. Financial expense in the three months ended June 30, 2020 derived from non-cash exchange differences of operating lease liabilities under ASC 842, compared to financial income in the three months ended June 30, 2019 which derived from re-evaluation of financial instruments.

Comprehensive loss for the second quarter of 2020 was $2.0 million, or $0.28 per share, compared to a comprehensive loss of $1.2 million, or $0.27 per share, for the second quarter of 2019.

Cash used in operating activities during the six months ended June 30, 2020 was $4.3 million compared to $2.7 million in the six months ended June 30, 2019. As of June 30, 2020, cash and cash equivalents totaled $3.7 million.

Cash used in investing activities during the six months ended June 30, 2020 was $246,000 compared to $1.1 million in the six months ended June 30, 2019. The decrease is mainly attribute to costs incurred in the establishment in 2019 of CollPlant's new HQ and R&D center in Rehovot, Israel.

Cash provided by financing activities during the six months ended June 30, 2020 was $4.5 million compared to cash used in financing activities of $18,000 in the six months ended June 30, 2019. The increase is mainly attribute to proceeds from issuance of shares in a private placement in February 2020.

Second Quarter 2020 Financial Results on Non-US GAAP Basis ("non-GAAP")

On a non-GAAP basis, the operating expenses for the second quarter of 2020 were $1.4 million, compared to $1.5 million for the second quarter of 2019.

Comprehensive loss for the second quarter of 2020 was $1.4 million, or $0.20 per share, compared to $1.5 million, or $0.31 per share, for the second quarter of 2019.

Non-GAAP measures exclude certain non-cash expenses. The table on page 10 includes a reconciliation of the Company's GAAP results to non-GAAP results. The reconciliation reflects non-cash expenses in the amount of $555,000 with respect to (i) change in fair value of financial instruments, (ii) share-based compensation to employees, directors and consultants and (iii) change of operating lease accounts, including related financial expenses.

Use of 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 change in fair value of financial instruments, share-based compensation to employees, directors and consultants, and change in operating lease accounts. 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 10 in this press release. This accompanying table on page 10 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 six months ended, June 30, 2020 are presented in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP").

About CollPlant

CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. 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 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 flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs. Our flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs. In October 2018, we entered into a licensing agreement with United Therapeutics, whereby United Therapeutics is using CollPlant's BioInks in the manufacture of 3D bioprinted lungs for transplant in humans.

In January 2020, we also entered into a Joint Development Agreement with 3D Systems Corporation, or 3D Systems, pursuant to which we and 3D Systems jointly develop tissue and scaffold bioprinting processes for third party collaborators. Our industry collaboration also includes the Advanced Regenerative Manufacturing Institute, or ARMI.

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, 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 outbreak of coronavirus; 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

Sophia Ononye-Onyia, PhD MPH MBA Founder &
CEO, The Sophia Consulting Firm
Tel: +1-347-533-4578
E-mail: sophia@sophiaconsultingfirm.com

                                                                   
            
              COLLPLANT BIOTECHNOLOGIES LTD.
                                                                CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
                                                              (U.S. dollars in thousands, except share and per share data)
                                                                                      (Unaudited)




                                                                          
            
              Six months ended                            
            
              Three months ended
                                                                                         June 30                                                        June 30



                                                                                2020                                       2019                                        2020                 2019



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

                                                                                                                                                                    ---


     Revenue from product sales                                                       $
            1,228                                         $
            1,048                     $
           713    $
           606



     Revenue from service                                                                         204                                                     152                              110




     
              Total Revenue                                                                   1,432                                                   1,200                              823             606



     
              Cost of Revenue                                                                 1,223                                                     883                              748             463




     
              Gross Profit                                                                      209                                                     317                               75             143






     
              Operating expenses:



     Research and development, net                                                              1,812                                                   1,856                            1,002           1,084



     General, administrative and marketing                                                      2,017                                                   1,749                              986             820




     
              Total operating loss                                                            3,620                                                   3,288                            1,913           1,761




     
              Financial income                                                                   26                                                      48                                9             630



     
              Financial expenses                                                                (6)                                                    (6)                             (2)            (6)



     
              Exchange differences                                                               28                                                   (242)                            (65)          (111)




     
              Financial income (expenses), net                                                   48                                                   (200)                            (58)            513




     
              Loss for the period                                                   $
            3,572                                         $
            3,488                   $
           1,971  $
           1,248




     
              Basic and diluted loss per ordinary share                              $
            0.52                                          $
            0.75                    $
           0.28   $
           0.27




     
              Weighted average ordinary shares outstanding                                6,809,666                                               4,660,862                        6,958,109       4,661,506


                                       
       
                COLLPLANT BIOTECHNOLOGIES LTD.
                                         CONDENSED CONSOLIDATED BALANCE SHEETS
                                              (U.S. dollars in thousands)
                                                      (Unaudited)




                                             June 30,                                  December 31,


                                                 2020                                           2019



                   Assets


                   Current assets:


      Cash and cash equivalents                          $
              3,672                            $
      3,791



     Trade receivables                                                321                                   79


      Other accounts receivable and
       prepaid expenses                                                750                                  270



     Restricted deposit                                                12                                   12



     Inventory                                                        730                                  888



      Total current assets                                           5,485                                5,040



                   Non-current assets:



     Restricted deposit                                               167                                  168


      Operating lease right-of-
       use assets                                                    3,048                                3,215


      Property and equipment, net                                    2,248                                2,329



      Total non-current assets                                       5,463                                5,712



                   Total assets                         $
              10,948                           $
      10,752


                                                                                                      
        
                COLLPLANT BIOTECHNOLOGIES LTD.
                                                                                                        CONDENSED CONSOLIDATED BALANCE SHEETS
                                                                                                             (U.S. dollars in thousands)
                                                                                                                     (Unaudited)




                                                                                                                                                       June 30,                December 31,


                                                                                                                                                           2020                         2019




              
                Liabilities and shareholders' equity



              
                Current liabilities:



              Loan                                                                                                                                                $
           12                  $
            24



              Accounts payable:



              Trade payables                                                                                                                                              559                           833



              Accrued liabilities and other                                                                                                                               866                         1,203



              Operating lease liabilities                                                                                                                                 442                           455



              Deferred revenues                                                                                                                                           297                           942




              Total current liabilities                                                                                                                                 2,176                         3,457




              
                Non-current liabilities:



              Derivatives                                                                                                                                                  42                            68



              Operating lease liabilities                                                                                                                               2,953                         3,139




              Total non-current liabilities                                                                                                                             2,995                         3,207




              
                Total liabilities                                                                                                                            5,171                         6,664






              
                Commitments and contingencies





              
                Shareholders' Equity:



              Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares as of June                                                                    2,713                         2,368
    30, 2020 and December 31, 2019; issued and outstanding: 6,467,536 and 5,670,829
    ordinary shares as June 30, 2020 and December 31, 2019, respectively



              Additional paid in capital and warrants                                                                                                                  74,865                        69,949



              Currency translation differences                                                                                                                          (969)                        (969)



              Accumulated deficit                                                                                                                                    (70,832)                     (67,260)




              
                Total shareholders' equity                                                                                                                   5,777                         4,088




              
                Total liabilities and shareholders' equity                                                                                          $
          10,948               $
           10,752


                                                                                                    
            
                COLLPLANT BIOTECHNOLOGIES LTD.
                                                                                                      CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
                                                                                                                (U.S. dollars in thousands)
                                                                                                                        (Unaudited)




                                                                                                                                                                         Six months ended
                                                                                                                                                         June 30,



                                                                                                                                                               2020                       2019




     
                Cash flows from operating activities:



     Net cash used in operations (see Appendix A)                                                                                                                  $
        (4,343)              $
        (2,725)




     Net cash used in operating activities                                                                                                                               (4,343)                    (2,725)




     
                Cash flows from investing activities:



     Purchase of property and equipment                                                                                                                                    (246)                    (1,060)




     Net cash used in investing activities                                                                                                                                 (246)                    (1,060)




     
                Cash flows from financing activities:



     Proceeds from issuance of shares, net                                                                                                                                 4,400



     Exercise of options into shares                                                                                                                                          67                           7



     Loan paid                                                                                                                                                              (12)                        (8)



     Payments made for equipment on financing terms                                                                                                                                                    (17)




     Net cash provided by (used in) financing activities                                                                                                                   4,455                        (18)




     
                Decrease in cash and cash equivalents and restricted deposits                                                                                            (134)                    (3,803)



     
                Cash and cash equivalents and restricted deposits at the beginning of the period                                                                         3,971                       5,663



     
                Exchange differences on cash and cash equivalents and restricted deposits                                                                                   14                          54




     
                Cash and cash equivalents and restricted deposits at the end of the period                                                                         $
        3,851                 $
        1,914


                                                                                                
              
                COLLPLANT BIOTECHNOLOGIES LTD.
                                                                                            APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
                                                                                                             (U.S. dollars in thousands)
                                                                                                                     (Unaudited)




                                                                                                                                                                         Six months ended
                                                                                                                                                                  June 30,



                                                                                                                                                          2020                            2019




     
                Appendix to the statement of cash flows



     
                A. Net cash used in operations:



     Loss                                                                                                                                                     $
             (3,572)              $
     (3,488)



     Adjustments for:



     Depreciation                                                                                                                                                            327                      228



     Share-based compensation to employees and consultants                                                                                                                   794                      629



     Exchange differences on cash and cash equivalents                                                                                                                      (14)                    (54)



     Financial expenses related to financial instruments                                                                                                                    (26)                      60



     Net change of operating lease accounts                                                                                                                                 (32)                     292



                                                                                                                                                                          (2,523)                 (2,333)




     Changes in operating asset and liability items:



     Increase in trade receivables                                                                                                                                         (242)                    (95)



     Decrease (increase) in inventory                                                                                                                                        158                    (144)



     Decrease (increase) in other receivables (including long-term receivables)                                                                                            (480)                      11



     Increase (decrease) in trade payables (including long-term payables)                                                                                                  (274)                     156



     Increase (decrease) in accrued liabilities and other payables                                                                                                         (337)                      91



     Decrease in deferred revenues (including long term deferred revenues)                                                                                                 (645)                   (411)



                                                                                                                                                                          (1,820)                   (392)




     Net cash used in operations                                                                                                                              $
             (4,343)              $
     (2,725)




     
                Supplemental disclosures of non-cash investing and financing activities:



     Conversion of pre-paid warrants to ordinary shares                                                                                                                      137



     Obtaining right of use assets in exchange for a lease liability                                                                                                          23



     Classification of warrants from equity to liabilities, net                                                                                                                                    1,804

                                                                                
              
                CollPlant Biotechnologies Ltd.
                                                                                Reconciliation of GAAP to Non-GAAP Financial Measures
                                                                                  (U.S. dollars in thousands, except per share data)
                                                                                                     (Unaudited)




                                                                                                                   Six months ended                                  Three months ended
                                                                                                           June 30                                           June 30



                                                                                                 2020                                     2019                            2020                    2019



                                                                                                                   
              
            USD in thousands

                                                                                                                                                                ---




              
                GAAP gross profit                                                             $
              209                                 $
         317                       $
          75    $
          143






              
                GAAP operating costs and expenses:                                                      3,829                                      3,605                            1,988          1,904





              Change of operating lease accounts                                                                      32                                      (292)                            (87)          (88)



              Share-based compensation to employees, directors and                                                 (794)                                     (629)                           (477)         (289)
    consultants




              
                Non-GAAP operating costs and expenses:                                                  3,067                                      2,684                            1,424          1,527






              
                GAAP operating loss                                                                     3,620                                      3,288                            1,913          1,761






              
                Non-GAAP operating loss                                                                 2,858                                      2,367                            1,349          1,384






              
                GAAP Comprehensive loss                                                                 3,572                                      3,488                            1,971          1,248






              Change in fair value of financial instruments                                                           26                                       (60)                               9            579



              Change of operating lease accounts                                                                      32                                      (292)                            (87)          (88)



              Share-based compensation to employees, directors and consultants                                     (794)                                     (629)                           (477)         (289)




              
                Non-GAAP Comprehensive loss                                                 $
              2,836                               $
         2,507                    $
          1,416  $
          1,450




              
                GAAP Basic and diluted loss per ordinary share                               $
              0.52                                $
         0.75                     $
          0.28   $
          0.27




              
                Non-GAAP Basic and diluted loss per ordinary share                           $
              0.42                                $
         0.54                     $
          0.20   $
          0.31


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SOURCE CollPlant