CollPlant Reports First Quarter 2018 Financial Results and Provides Business Update

NESS ZIONA, Israel, May 24, 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 first quarter ended March 31, 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 $222,000 (NIS 779,000) for the first quarter of 2018. The Company ended the first quarter of 2018 with $3.9 million (NIS 13.8 million) in cash and cash equivalents, excluding an additional $1.0 million (NIS 3.5 million) that the Company received from Alpha Capital Anstalt ("Alpha") at the end of April 2018, while comprehensive loss for the first quarter of 2018 was $2.1 million (NIS 7.2 million) on a GAAP basis, or adjusted comprehensive loss of $1.2 million (NIS 4.2 million), on a non-GAAP basis.

"During the first quarter of 2018, we made progress advancing our 3D bioprinting business. We continue to move forward with our development activities with various biotechnology and medical device companies that are using CollPlant's rhCollagen based BioInk for the bioprinting of organs and tissues," said Yehiel Tal, CollPlant's Chief Executive Officer.

"CollPlant is also working with foundations and academic institutions, and during the first quarter of 2018, we announced that CollPlant is part of the Regenerative Medicine Development Organization's (ReMDO) advanced biomanufacturing initiative for the development of a universal BioInk with tunable properties for 3D bioprinting of tissues and organs," noted Mr. Tal.

"During the first quarter of 2018, we continued with the development of next generation dermal fillers for the aesthetic field. This month, we filed a provisional patent application with the U.S. Patent and Trademark Office for photocurable dermal fillers comprised of rhCollagen and hyaluronic acid, and are actively pursuing collaborations with key companies in this field," added Mr. Tal.

"During the first quarter of 2018, we established a new rhCollagen production facility in Rehovot, Israel. This cGMP facility will be used for purification of rhCollagen and the formulation of end-products, including BioInks for 3D bioprinting. The facility includes clean rooms and dedicated production equipment to support the company's commercial and R&D demand for the next few years. Furthermore, we expect the new facility to enable operational flexibility, cost reduction and process development. Consequently, we believe our competitiveness and profitability will be enhanced," noted Mr. Tal.

"Additionally, during 2018 we continued to establish our position in the European market, with sales of our advanced wound care product (VergenixFG), and orthopedic product (VergenixSTR). Over time, we have received positive feedback from physicians who have treated patients with both products, and we are aiming to expand sales into new territories across Europe," concluded Mr. Tal.

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

Revenues for the first three months ended March 31, 2018 increased by 309% to $222,000 (NIS 779,000), compared to $72,000 (NIS 252,000) in the first 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 CollPlant's soft tissue repair matrix, VergenixSTR, for treating tendinopathy and its wound care product, VergenixFG.

The Company's gross profit for the three months ended March 31, 2018 increased by 275% to $198,000 (NIS 693,000) compared to $72,000 (NIS 252,000) in the first quarter of 2017.

Total operating costs and expenses were $2.3 million (NIS 7.9 million) compared to $1.5 million (NIS 5.4 million) in the first quarter of 2017. The increase is mainly due to non-cash expenses of the fair market value attributed to services received through the securities purchase agreement with Alpha (the "Alpha Agreement"), which amounted to $435,000 (NIS 1.5 million) and an increase in non-cash share based compensation amounting to $154,000 (NIS 540,000).

Operating loss was $2.1 million (NIS 7.2 million) compared to an operating loss of $1.5 million (NIS 5.1 million) in the first quarter of 2017. Comprehensive loss for the first quarter of 2018 was $2.1 million (NIS 7.2 million), or $0.01 (NIS 0.04) per share, compared to a comprehensive loss of $1.5 million (NIS 5.2 million), or $0.01 (NIS 0.04) per share, for the first quarter of 2017.

Cash used in operating activities during the first quarter was $1.4 million (NIS 4.9 million) compared to $1.7 million (NIS 6.0 million) in the first quarter of 2017. As of March 31, 2018, cash and cash equivalents totaled $3.9 million (NIS 13.8 million). In addition, in April 2018, the Company received $1.0 million (NIS 3.5 million) from Alpha, as part of the third closing of the Alpha Agreement.

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

On a non-GAAP basis, the operating costs and expenses for the first quarter of 2018 were $1.5 million (NIS 5.3 million), compared to $1.4 (NIS 4.8 million) for the first quarter of 2017, while the comprehensive loss for the first quarter of 2018 was $1.2 million (NIS 4.2 million), or $0.01 (NIS 0.03) per share, compared to $1.3 million (NIS 4.6 million), or $0.01 (NIS 0.04) per share, for the first quarter of 2017. Non-GAAP measures exclude certain non-cash expenses. The table on page 8 includes a reconciliation of the Company's GAAP results to non-GAAP results. The reconciliation reflects non-cash expenses in the amount of $853,000 (NIS 3.0 million) with respect to fair market value attributed to services received through the Alpha Agreement, recognition of unrecognized day one loss and share-based compensation to employees, directors and consultants in the first quarter of 2018.

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 Alpha 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 March 31, 2018 (U.S. $1.00 = NIS 3.514).

The Company's consolidated financial results for the three months ended March 31, 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.
Consolidated Statements of Comprehensive Loss
(Unaudited)

                                  Convenience
                                  translation into
                                         USD
                                  ---

                                                                    Three months ended March 31,
                                  -----------------------------

                                              2018                                    2018                            2017
                                              ----                                    ----                            ----

                                  USD in thousands                                           NIS in thousands
                                  ----------------                                           ----------------

    Revenue                                                     222                                               779              252

    Cost of Revenue                                              24                                                86                -
                                                                ---                                               ---              ---

    Gross Profit                                                198                                               693              252
                                                                ---                                               ---              ---


    Operating costs and expenses:

    Research and development
     expenses, net                                            1,272                                             4,467            4,042

    General, administrative and
     marketing expenses                                         980                                             3,445            1,341
                                                                ---                                             -----            -----

    Total operating costs and
     expenses:                                                2,252                                             7,912            5,383
                                                              -----                                             -----            -----

    Operating loss                                            2,054                                             7,219            5,131
                                                              -----                                             -----            -----

    Financial income                                          (110)                                            (387)               -

    Financial expenses                                          116                                               408               61
                                                                ---                                               ---              ---

    Financial expenses, net                                       6                                                21               61
                                                                ---                                               ---              ---

    Comprehensive loss                                        2,060                                             7,240            5,192
                                                              -----                                             -----            -----

    Basic and diluted loss per
     ordinary share (NIS/USD)                                  0.01                                              0.04             0.04
                                                               ----                                              ----             ----

    Weighted average ordinary
     shares outstanding                                 170,551,850                                       170,551,850      118,299,021
                                                        ===========                                       ===========      ===========

 

CollPlant Holdings Ltd.
Consolidated Statements of Financial Position
(Unaudited)

 

                                                         Convenience translation into USD
                                                         --------------------------------

                                                         March 31,                        March 31,                           December 31,
                                                              2018                              2018                                    2017
                                                              ----                              ----                                    ----

                                                         USD In                                    NIS in thousands
                                                         thousands
                                                         ---------

                                                  Assets

    Current assets:

    Cash and cash equivalents                                            3,941                                         13,848                     17,817

    Accounts receivables:

    Trade receivables                                                      264                                            929                        354

    Other                                                                  553                                          1,945                      3,543

    Inventory                                                              295                                          1,038                        700
                                                                           ---                                          -----                        ---

                                                                         5,053                                         17,760                     22,414
                                                                         -----                                         ------                     ------

    Non-current assets:

    Restricted deposit                                                     145                                            510                        503

    Long term-receivables                                                   45                                            157                         92

    Property and equipment, net                                          1,388                                          4,878                      3,582

    Intangible assets, net                                                 401                                          1,408                      1,454
                                                                           ---                                          -----                      -----

                                                                         1,979                                          6,953                      5,631
                                                                         -----                                          -----                      -----

    Total assets                                                         7,032                                         24,713                     28,045
                                                                         =====                                         ======                     ======


                           Liabilities and equity

    Current liabilities:

    Accounts payable:

    Trade payables                                                       1,165                                          4,097                      2,922

    Accrued liabilities and other                                          485                                          1,705                      1,996
                                                                           ---                                          -----                      -----

                                                                         1,650                                          5,802                      4,918
                                                                         -----                                          -----                      -----

    Non-current liabilities:

    Debentures at fair value                                                 -                                             -                    12,639

    Derivatives                                                             48                                            169                        141

    Royalties to the Israel Innovation Authority                           354                                          1,244                      1,203

    Long-term payables                                                       -                                             -                        61
                                                                           ---                                           ---                       ---

                                                                           402                                          1,413                     14,044
                                                                           ---                                          -----                     ------

    Commitments and contingent liabilities

    Total liabilities                                                    2,052                                          7,215                     18,962
                                                                         -----                                          -----                     ------


    Equity:

    Ordinary shares                                                      1,459                                          5,128                      4,998

    Prepaid warrant                                                      3,616                                         12,708                          -

    Additional paid in capital and warrants                             51,270                                        180,160                    178,467

    Accumulated deficit                                               (51,365)                                     (180,498)                 (174,382)
                                                                       -------                                       --------                   --------

    Total equity                                                         4,980                                         17,498                      9,083
                                                                         -----                                         ------                      -----

    Total liabilities and equity                                         7,032                                         24,713                     28,045
                                                                         =====                                         ======                     ======

 

CollPlant Holdings Ltd.
Appendices to the Consolidated Statements of Cash Flows
(Unaudited)

 

                                         Convenience
                                         translation
                                         into USD
                                        ------------

                                                     Three months  ended March  31,
                                                     ------------------------------

                                                2018                                2018                      2017
                                                ----                                ----                      ----

                                         USD In
                                         thousands                                  NIS In thousands
                                        ----------                                  ----------------

    Cash flows used in operating
     activities:

    Comprehensive loss for the period                    (2,060)                                     (7,240)       (5,192)

    Adjustments for:

    Depreciation and amortization                             85                                          298            352

    Share-based compensation to
     employees, directors and
     consultants                                             320                                        1,124            585

    Changes in fair market value of
     services received through the
     Alpha Agreement                                         435                                        1,530              -

    Recognition of unrecognized day one
     loss                                                     98                                          344              -

    Exchange differences on cash and
     cash equivalents                                        (5)                                        (19)            76

    Gain from changes in fair value of
     financial instruments                                  (70)                                       (247)             -

    Exchange differences on restricted
     cash                                                      2                                          (7)            30

                                                         (1,199)                                     (4,217)       (4,149)
                                                          ------                                       ------         ------

    Changes in operating asset and
     liability items:

    Increase in trade receivables                          (164)                                       (575)             -

    Increase in inventory                                   (96)                                       (338)             -

    Decrease in other receivables
     (including long-term receivables)                         -                                           3            304

    Increase (decrease) in trade
     payables (including long-term
     payables)                                               109                                          384        (1,913)

    Decrease in accrued liabilities and
     other payables                                         (83)                                       (291)         (147)

    Increase (decrease) in royalties to
     the IIA                                                  12                                           41           (64)

                                                           (222)                                       (776)       (1,820)
                                                            ----                                         ----         ------

    Net cash used in operating
     activities                                          (1,421)                                     (4,993)       (5,969)
                                                          ------                                       ------         ------


    Cash flows from investing
     activities:

    Purchase of property and equipment                     (214)                                       (755)          (41)
                                                            ----                                         ----            ---

    Net cash used in investing
     activities                                            (214)                                       (755)          (41)
                                                            ----                                         ----            ---

    Cash flows from financing
     activities:

    Proceeds from issuance of shares,
     less issuance expenses                                  519                                        1,823          6,788

    Payments made for equipment on
     financing terms                                        (18)                                        (63)          (63)
                                                             ---                                          ---            ---

    Net cash provided by financing
     activities                                              501                                        1,760          6,725
                                                             ---                                        -----          -----

    Increase (Decrease) in cash and
     cash equivalents                                    (1,134)                                     (3,988)           715

    Cash and cash equivalents at the
     beginning of the period                               5,070                                       17,817          3,797

    Exchange differences on cash and
     cash equivalents                                          5                                           19           (76)
                                                             ---                                          ---            ---

    Cash and cash equivalents at the
     end of the period                                     3,941                                       13,848          4,436
                                                           =====                                       ======          =====

    Appendix to the statement of cash
     flows

    Non-cash investing activities:

    Purchase of property and equipment
     against credit from trade payables                      225                                          791
                                                             ===                                          ===

 

CollPlant Holdings Ltd.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)

 

                                   Convenience
                                    translation
                                    into
                                   USD
                                   ---

                                               Three months ended March  31,
                                               -----------------------------

                                           2018                              2018                   2017
                                           ----                              ----                   ----

                                    USD In
                                    thousands                                NIS in thousands
                                   ----------                                ----------------

    GAAP gross  profit                                   198                                    693        252
                                                         ---                                    ---        ---


    GAAP operating costs and
     expenses:                                         2,252                                  7,912      5,383

    Fair market value attributed
     to services received through
     the Alpha Agreement                                 435                                  1,530

    Share-based compensation to
     employees, directors and
     consultants                                         320                                  1,124        585
                                                         ---                                  -----        ---

    Non-GAAP operating costs and
     expenses:                                         1,497                                  5,258      4,798


    GAAP operating loss                                2,054                                  7,219      5,131


    Non-GAAP operating loss                            1,299                                  4,564      4,546
                                                       -----                                  -----      -----


    GAAP Comprehensive loss                            2,060                                  7,240      5,192

    Fair market value attributed
     to services received through
     the Alpha Agreement                                 435                                  1,530          -

    Recognition of unrecognized
     day one loss                                         98                                    344          -

    Share-based compensation to
     employees, directors and
     consultants                                         320                                  1,124        585
                                                         ---                                  -----        ---

    Non-GAAP Comprehensive loss                        1,207                                  4,242      4,607
                                                       -----                                  -----      -----


    GAAP  Basic and diluted loss
     per ordinary share (NIS/USD)                       0.01                                   0.04       0.04

    Non-GAAP  Basic and diluted
     loss per ordinary share (NIS/
     USD)                                               0.01                                   0.03       0.04

 

Contact at CollPlant:
Eran Rotem
Chief Financial Officer
Tel: +972-73-2325600/612
Email: Eran@collplant.com

IR Contact:
Amato and Partners, LLC
90 Park Avenue, 17th Floor
New York, NY 10016
admin@amatoandpartners.com

 

 

 

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SOURCE CollPlant

     
 
Company Codes: Bloomberg:CLPT@IT, Bloomberg:CQPTY@US, ISIN:IL0004960188, NASDAQ-NMS:CLGN, OTC-BB:CQPTY, RICS:CLPT.TA, TelAviv:CLPT, OTC-QX:CQPTY, OtherOTC:CQPTY, RICS:CQPTY, TelAviv:CLGN
 

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