Form 6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

Date of Report: August 6, 2019

Commission File Number: 001-36891

 

 

Cellectis S.A.

(Exact Name of registrant as specified in its charter)

 

 

8, rue de la Croix Jarry

75013 Paris, France

+33 1 81 69 16 00

(Address of principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F  ☒             Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

 

 

 


Exhibits

The following document, which is attached as an exhibit hereto, is incorporated by reference herein.

This report on Form 6-K shall be deemed to be incorporated by reference in the registration statements of Cellectis S.A. on Form F-3 (No. 333-217086) and Form S-8 (Nos. 333-204205, 333-214884, 333-222482 and 333-227717), to the extent not superseded by documents or reports subsequently filed.

 

Exhibit

  

Title

99.1    Cellectis S.A.’s interim report for the three-month and six-month periods ended June 30, 2019.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

   

CELLECTIS S.A.

(Registrant)

August 6, 2019     By:  

/s/ André Choulika

      André Choulika
      Chief Executive Officer


EXHIBIT INDEX

 

Exhibit

  

Title

99.1    Cellectis S.A.’s interim report for the three-month and six-month periods ended June 30, 2019.
EX-99.1

Exhibit 99.1

PRELIMINARY NOTE

The unaudited Condensed Consolidated Financial Statements for the three-month and six-month periods ended June 30, 2019, included herein, have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”). The Consolidated Financial Statements are presented in U.S. dollars in order to enhance comparability with Cellectis’ peers, which primarily present their financial statements in U.S. dollars. All references in this interim report to “$,” “U.S. dollars,” and “dollars,” mean U.S. dollars and all references to “€” and “euros” mean euros, unless otherwise noted.

This interim report, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act. All statements other than present and historical facts and conditions contained in this interim report, including statements regarding our future results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this interim report, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those projected in any forward-looking statement. Factors that may cause actual results to differ from those in any forward-looking statement include, without limitation, those described under “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in our Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 13, 2018, as amended on April 25, 2019 (the “Annual Report”). As a result of these factors, we cannot assure you that the forward-looking statements in this interim report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

We own various trademark registrations and applications, and unregistered trademarks and service marks, including Cellectis®, TALEN® and our corporate logos, and all such trademarks and service marks appearing in this interim report are the property of Cellectis. The trademarks Calyxt® and Calyno are owned by Calyxt. All other trade names, trademarks and service marks of other companies appearing in this interim report are the property of their respective holders. Solely for convenience, the trademarks and trade names in this interim report may be referred to without the ® and symbols, but such references, or the failure of such symbols to appear, should not be construed as any indication that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend to use or display other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

As used in this interim report, the terms “Cellectis,” “we,” “our,” “us,” and “the Company” refer to Cellectis S.A. and its subsidiaries, taken as a whole, unless the context otherwise requires. References to “Calyxt” refer to Calyxt, Inc.

 

1


INDEX

 

PART I – FINANCIAL INFORMATION      3  
Item 1.  

Condensed Consolidated Financial Statements (Unaudited)

     3  
Item 2.  

Management’s Discussion & Analysis of Financial Condition and Results of Operations

     47  
Item 3.  

Quantitative and Qualitative Disclosures About Market Risks

     60  
Item 4.  

Controls and Procedures

     60  
PART II – OTHER INFORMATION      61  
Item 1.  

Legal Proceedings

     61  
Item 1A.  

Risk Factors

     61  
Item 2.  

Unregistered Sales of Equity Securities and Use of Proceeds

     61  
Item 3.  

Default Upon Senior Securities

     61  
Item 4.  

Mine Safety Disclosures

     61  
Item 5.  

Other Information

     61  
Item 6.  

Exhibits

     61  

 

2


PART I – FINANCIAL INFORMATION

 

Item 1.

Condensed Consolidated Financial Statements (unaudited)

Cellectis S.A.

INTERIM STATEMENTS OF CONSOLIDATED FINANCIAL POSITION

$ in thousands

 

            As of  
     Notes      December 31, 2018     June 30, 2019*  
ASSETS        

Non-current assets

       

Intangible assets

        1,268       1,209  

Property, plant, and equipment

     6        10,041       12,320  

Right-of-use assets

     5        —         47,876  

Other non-current financial assets

        1,891       4,755  
     

 

 

   

 

 

 

Total non-current assets

        13,199       66,161  

Current assets

       

Inventories

        275       986  

Trade receivables

     7.1        2,971       2,990  

Subsidies receivables

     7.2        17,173       21,335  

Other current assets

     7.3        15,333       16,495  

Current financial assets

     8.1        388       389  

Cash and cash equivalents

     8.2        451,501       396,967  
     

 

 

   

 

 

 

Total current assets

        487,641       439,163  
     

 

 

   

 

 

 

TOTAL ASSETS

        500,840       505,323  
     

 

 

   

 

 

 
LIABILITIES        

Shareholders’ equity

       

Share capital

     12        2,765       2,766  

Premiums related to the share capital

     12        828,525       834,830  

Currency translation adjustment

        (16,668     (18,903

Retained deficit

        (326,628     (406,078

Net income (loss)

        (78,693     (48,791
     

 

 

   

 

 

 

Total shareholders’ equity - Group Share

        409,301       363,824  

Non-controlling interests

        40,970       41,284  
     

 

 

   

 

 

 

Total shareholders’ equity

        450,272       405,108  

Non-current liabilities

       

Non-current lease debts

     9        1,018       45,710  

Non-current provisions

     15        2,681       2,684  
     

 

 

   

 

 

 

Total non-current liabilities

        3,699       48,394  
     

 

 

   

 

 

 

Current liabilities

       

Current lease debts

     9        333       2,104  

Trade payables

     9        15,883       19,760  

Deferred revenues and contract liabilities

     11        20,754       20,385  

Current provisions

     15        1,530       2,928  

Other current liabilities

     10        8,369       6,643  
     

 

 

   

 

 

 

Total current liabilities

        46,869       51,821  
     

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

        500,840       505,323  
     

 

 

   

 

 

 

The accompanying notes form an integral part of these unaudited Interim Condensed Consolidated Financial Statements

 

(*)

The 2019 Interim Condensed Consolidated Financial Statements have been prepared according to the new IFRS 16 “Leases” standard with a new ‘right-of-use assets” category and an implied significant increase of “lease debts” compared to the previous period (see note 2.2 for discussion of the application of IFRS 16 “Lease” at January 1, 2019).

 

3


Cellectis S.A.

UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS

For the six-month period ended June 30,

$ in thousands, except per share amounts

 

            For the six-month period ended
June 30,
 
     Notes      2018     2019*  

Revenues and other income

       

Revenues

     3.1        11,076       2,188  

Other income

     3.1        5,340       4,172  
     

 

 

   

 

 

 

Total revenues and other income

        16,417       6,360  
     

 

 

   

 

 

 

Operating expenses

       

Cost of revenue

     3.2        (1,138     (1,403

Research and development expenses

     3.2        (36,441     (39,987

Selling, general and administrative expenses

     3.2        (25,224     (23,309

Other operating income (expenses)

        (171     29  
     

 

 

   

 

 

 

Total operating expenses

        (62,975     (64,670
     

 

 

   

 

 

 

Operating income (loss)

        (46,558     (58,310
     

 

 

   

 

 

 

Financial gain (loss)

        10,040       3,849  
     

 

 

   

 

 

 

Income tax

        —         —    
     

 

 

   

 

 

 

Net income (loss)

        (36,518     (54,461
     

 

 

   

 

 

 

Attributable to shareholders of Cellectis

        (32,422     (48,791

Attributable to non-controlling interests

        (4,096     (5,670

Basic / Diluted net income (loss) per share attributable to shareholders of Cellectis

     14       

Basic net income (loss) per share ($ /share)

        (0.83     (1.15

Diluted net income (loss) per share ($ /share)

        (0.83     (1.15

The accompanying notes form an integral part of these unaudited Interim Condensed Consolidated Financial Statements

 

(*)

The 2019 Interim Condensed Consolidated Financial Statements have been prepared according to the new IFRS 16 “Leases” standard with a new “right-of-use assets” category and an implied significant increase of “lease debts” compared to the previous period (see note 2.2 for discussion of the application of IFRS 16 “Lease” at January 1, 2019).

 

4


UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE INCOME (LOSS)

For the six-month periods ended June 30,

$ in thousands

 

     For the six-month period ended
June 30,
 
     2018     2019  

Net income (loss)

     (36,518     (54,461
  

 

 

   

 

 

 

Actuarial gains and losses

     —         (271
  

 

 

   

 

 

 

Other comprehensive income (loss) that will not be reclassified subsequently to income or loss

     —         (271
  

 

 

   

 

 

 

Currency translation adjustment

     (14,060     (1,990
  

 

 

   

 

 

 

Other comprehensive income (loss) that will be reclassified subsequently to income or loss

     (14,060     (1,990
  

 

 

   

 

 

 

Total Comprehensive income (loss)

     (50,578     (56,723
  

 

 

   

 

 

 

Attributable to shareholders of Cellectis

     (45,791     (51,298

Attributable to non-controlling interests

     (4,787     (5,425

The accompanying notes form an integral part of these unaudited Interim Condensed Consolidated Financial Statements

 

5


Cellectis S.A.

UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS

For the three-month period ended June 30,

$ in thousands, except per share amounts

 

            For the three-month period
ended June 30,
 
     Notes      2018     2019  

Revenues and other income

       

Revenues

     3.1        5,049       1,152  

Other income

     3.1        3,295       1,780  
     

 

 

   

 

 

 

Total revenues and other income

        8,343       2,932  
     

 

 

   

 

 

 

Operating expenses

       

Cost of revenue

     3.2        (559     (815

Research and development expenses

     3.2        (18,042     (25,421

Selling, general and administrative expenses

     3.2        (11,248     (11,818

Other operating income (expenses)

        (189     (3
     

 

 

   

 

 

 

Total operating expenses

        (30,039     (38,058
     

 

 

   

 

 

 

Operating income (loss)

        (21,696     (35,126
     

 

 

   

 

 

 

Financial gain (loss)

        11,958       (1,512
     

 

 

   

 

 

 

Income tax

        —         —    
     

 

 

   

 

 

 

Net income (loss)

        (9,738     (36,637
     

 

 

   

 

 

 

Attributable to shareholders of Cellectis

        (7,256     (33,447

Attributable to non-controlling interests

        (2,482     (3,190

Basic / Diluted net income (loss) per share attributable to shareholders of Cellectis

     14       

Basic net income (loss) per share ( $ /share)

        (0.17     (0.79

Diluted net income (loss) per share ( $ /share)

        (0.17     (0.79

 

(*)

The 2019 Interim Condensed Consolidated Financial Statements have been prepared according to the new IFRS 16 “Leases” standard with a new “right-of-use assets” category and an implied significant increase of “lease debts” compared to the previous period (see note 2.2 for discussion of the application of IFRS 16 “Lease” at January 1, 2019).

 

6


Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE INCOME (LOSS)

For the three-month periods ended June 30,

$ in thousands

 

     For the three-month period
ended June 30,
 
     2018     2019  

Net income (loss)

     (9,738     (36,637
  

 

 

   

 

 

 

Actuarial gains and losses

     —         (271
  

 

 

   

 

 

 

Other comprehensive income (loss) that will not be reclassified subsequently to income or loss

     —         (271
  

 

 

   

 

 

 

Currency translation adjustment

     (18,186     3,368  
  

 

 

   

 

 

 

Other comprehensive income (loss) that will be reclassified subsequently to income or loss

     (18,186     3,368  
  

 

 

   

 

 

 

Total Comprehensive income (loss)

     (27,924     (33,541
  

 

 

   

 

 

 

Attributable to shareholders of Cellectis

     (24,615     (30,333

Attributable to non-controlling interests

     (3,310     (3,208

 

7


Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED CASH FLOWS

For the six-month period ended June 30,

$ in thousands

 

            For the six-month period ended
June 30,
 
     Notes      2018     2019  

Cash flows from operating activities

       
     

 

 

   

 

 

 

Net loss for the period

        (36,518     (54,461
     

 

 

   

 

 

 

Reconciliation of net loss and of the cash provided by (used in) operating activities

       

Adjustments for

       

Amortization and depreciation

        1,262       3,215  

Net loss (income) on disposals

        67       356  

Net financial loss (gain)

        (10,040     (3,848

Expenses related to share-based payments

        21,023       11,810  

Provisions

        (342     1,155  

Interest (paid) / received

        3,354       4,146  
     

 

 

   

 

 

 

Operating cash flows before change in working capital

        (21,194     (37,627
     

 

 

   

 

 

 

Decrease (increase) in inventories

        12       (709

Decrease (increase) in trade receivables and other current assets

        (2,695     (3,436

Decrease (increase) in subsidies receivables

        (5,086     (4,266

(Decrease) increase in trade payables and other current liabilities

        3,509       2,370  

(Decrease) increase in deferred income

        (7,069     54  
     

 

 

   

 

 

 

Change in working capital

        (11,330     (5,985
     

 

 

   

 

 

 

Net cash flows provided by (used in) operating activities

        (32,523     (43,613
     

 

 

   

 

 

 

Cash flows from investment activities

       

Proceeds from disposal of property, plant and equipment

        20       —    

Acquisition of intangible assets

        1       (29

Acquisition of property, plant and equipment

        (1,186     (4,811

Net change in non-current financial assets

        277       (2,866

Sale (Acquisition) of current financial assets

        20,192       161  
     

 

 

   

 

 

 

Net cash flows provided by (used in) investing activities

        19,304       (7,545
     

 

 

   

 

 

 

Cash flows from financing activities

       

Increase in share capital net of transaction costs

        185,992       —    

Shares of Calyxt issued to third parties

        48,761       (251

Payments on lease debts

        (45     (1,748

Treasury shares

        (291     —    
     

 

 

   

 

 

 

Net cash flows provided by financing activities

        234,417       (1,999
     

 

 

   

 

 

 

(Decrease) increase in cash

        221,198       (53,157
     

 

 

   

 

 

 

Cash and cash equivalents at the beginning of the year

        256,380       451,501  

Effect of exchange rate changes on cash

        (6,364     (1,377
     

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

     8        471,215       396,967  
     

 

 

   

 

 

 

The accompanying notes form an integral part of these unaudited Interim Condensed Consolidated Financial Statements

 

(*)

The 2019 Interim Condensed Consolidated Financial Statements have been prepared according to the new IFRS 16 “Leases” standard with a new “right-of-use assets” category and an implied significant increase of “lease debts” compared to the previous period (see note 2.2 for discussion of the application of IFRS 16 “Lease” at January 1, 2019).

 

8


Cellectis S.A.

UNAUDITED STATEMENTS OF CHANGES IN CONSOLIDATED SHAREHOLDERS’ EQUITY

For the six-month period ended June 30,

$ in thousands, except share data

 

          Share Capital
Ordinary Shares
                                  Equity        
    Notes     Number of
shares
    Amount     Premiums
related to
share
capital
    Treasury
shares
reserve
    Currency
translation
adjustment
    Retained
earnings
(deficit)
    Income
(Loss)
    attributable
to
shareholders
of Cellectis
    Non
controlling
interests
    Total
Shareholders’
Equity
 

As of January 1, 2018, as restated (*)

      35,960,062       2,367       614,037       (297     1,835       (253,702     (99,368     264,873       19,113       283,986  

Net Loss

      —         —         —         —         —         —         (32,422     (32,422     (4,096     (36,518

Other comprehensive income (loss)

      —         —         —         —         (13,369     —         —         (13,369     (691     (14,060
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income (loss)

      —         —         —         —         (13,369     —         (32,422     (45,791     (4,787     (50,578

Allocation of prior period loss

      —         —         —         —         —         (99,368     99,368       —         —         —    

Capital Increase

      6,146,000       379       178,171       —         —         —         —         178,550       —         178,550  

Transaction with subsidiaries (1)

      —         —         —         —         —         26,299       —         26,299       22,463       48,761  

Treasury shares

      —         —         —         (291     —         —         —         (291     —         (291

Exercise of share warrants, employee warrants and stock options

    11       300,306       18       7,424       —         —         —         —         7,442       —         7,442  

Non-cash stock-based compensation expense

    12       —         —         16,730       —         —         —         —         16,730       4,293       21,023  

Other movements

      —         —         —         —         —         (84     —         (84     (36     (120
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of June 30, 2018

      42,406,368       2,764       816,363       (587     (11,534     (326,856     (32,422     447,728       41,046       488,774  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of January 1, 2019

      42,430,069       2,765       828,525       —         (16,668     (326,628     (78,693     409,301       40,970       450,272  

Net Loss

      —         —         —         —         —         —         (48,791     (48,791     (5,670     (54,461

Other comprehensive income (loss)

      —         —         —         —         (2,235     (271     —         (2,507     245       (2,262
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income (loss)

      —         —         —         —         (2,235     (271     (48,791     (51,298     (5,425     (56,723

Allocation of prior period loss

      —         —         —         —         —         (78,693     78,693       —         —         —    

Capital Increase

      15,600       1         —         —         (1     —         —         —         —    

Transaction with subsidiaries (2)

      —         —         —         —         —         (481     —         (481     230       (251

Non-cash stock-based compensation expense

    12       —         —         6,302       —         —         —         —         6,302       5,509       11,810  

Other movements

      —         —         3       —         —         (3     —         —         —         —    
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of June 30, 2019

      42,445,669       2,766       834,830       —         (18,903     (406,078     (48,791     363,824       41,284       405,108  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)

Corresponds to the impact of Calyxt’s follow-on offering and Calyxt stock options exercises during the period.

(2)

Corresponds to the impact of Calyxt stock options exercises during the period.

The accompanying notes form an integral part of these unaudited Interim Condensed Consolidated Financial Statements

 

(*)

Reflects the application of IFRS15 with effect from January 1, 2018 using the full retrospective method. Reconciliation between consolidated financial statements presented in previous periods and 2017 consolidated financial statements is available in Note 2.3.

 

9


NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2019

Note 1. The Company

Cellectis S.A. (hereinafter “Cellectis” or “we”) is a limited liability company (“société anonyme”) registered and domiciled in Paris, France. We are a clinical-stage biotechnological company, employing our core proprietary technologies to develop best-in-class products in the field of immuno-oncology. Our product candidates, based on gene-edited T-cells that express chimeric antigen receptors, or CARs, seek to harness the power of the immune system to target and eradicate cancer cells. Our gene-editing technologies allow us to create allogeneic CAR T-cells, meaning they are derived from healthy donors rather than the patients themselves. Our gene-editing expertise also enables us to develop product candidates that feature additional safety and efficacy attributes, including control properties designed to prevent them from attacking healthy tissues, to enable them to tolerate standard oncology treatments, and to equip them to resist mechanisms that inhibit immune-system activity. In addition to our focus on immuno-oncology, we are exploring the use of our gene-editing technologies in other therapeutic applications, as well as to develop healthier food products for a growing population.

Cellectis S.A., Cellectis, Inc., Cellectis Biologics Inc. (which was incorporated on January 18, 2019) and Calyxt, Inc. are sometimes referred to as a consolidated group of companies as the “Group.”

Note 2. Accounting principles

2.1 Basis for preparation

The Interim Condensed Consolidated Financial Statements of Cellectis as of June 30, 2019 and for the three-month and six-month periods ended June 30, 2019 were approved by our Board of Directors on August 5, 2019.

The Interim Condensed Consolidated Financial Statements are presented in U.S. dollars. See Note 2.4.

The Interim Condensed Consolidated Financial Statements as of June 30, 2019 and for the three-month and six-month periods ended June 30, 2019 have been prepared in accordance with IAS 34 Interim Financial Reporting, as issued by the International Accounting Standards Board (“IASB”).

The Interim Condensed Consolidated Financial Statements as of June 30, 2019 and for the three-month and six-month periods ended June 30, 2019 have been prepared using the same accounting policies and methods as those applied for the year ended December 31, 2018, except as described below related to the new or amended standards applied.

IFRS include International Financial Reporting Standards (“IFRS”), International Accounting Standards (“the IAS”), as well as the interpretations issued by the Standards Interpretation Committee (“the SIC”), and the International Financial Reporting Interpretations Committee (“IFRIC”).

Application of new or amended standards or new amendments

The following pronouncements and related amendments have been adopted by us from January 1, 2019 but had no significant impact on the Interim Condensed Consolidated Financial Statements:

 

   

Amendment to IFRS 9 “Financial Instruments – Prepayment Features with Negative Compensation” (applicable for periods beginning after January 1, 2019)

 

   

IFRIC 23 “Uncertainty over Income Tax Treatments” (applicable for periods beginning after January 1, 2019)

 

10


Standards, interpretations and amendments issued but not yet effective

The following pronouncements and related amendments are applicable for accounting periods beginning after January 1, 2020. We do not anticipate that the adoption of these pronouncements and amendments will have a material impact on our results of operations, financial position or cash flows:

 

   

Amendment to IFRS 3 “Business Combinations” (Effective for the accounting periods as of January 1, 2020)

 

   

Amendments to IAS 1“Presentation of financial statements” and IAS 8 “Accounting policies, changes in accounting estimates and errors” (Effective for the accounting periods as of January 1, 2020)

 

11


2.2 IFRS16 application

Since January 1, 2019, Cellectis has applied the new standard IFRS 16 “Leases”.

Under this standard, a financial asset and a financial liability are recognized for Group leases that meet the standard’s criteria.

The financial statements for the 2018 financial year have not been restated in accordance with the transition options of IFRS 16 elected by the Group since Cellectis has applied the modified retrospective approach.

The Group uses the two capitalization exemptions provided by the standard:

 

   

lease contracts with a duration of less than 12 months (mainly storage area leases); and

 

   

lease contracts for which the underlying asset has a low value, which has been defined by the Group to be below $5,000.

The Group has also applied the following practical expedients at the transition date:

 

   

exclusion of initial direct costs from the measurement of the right-of-use asset at the date of initial application; and

 

   

accounting for leases for which the lease term ends within 12 months of the date of initial application as short-term leases, i.e. accounting for leases expenses in Profit and loss account.

 

   

the carrying amount of the right-of-use asset and the lease liability at the date of initial application is the carrying amount of the lease asset and lease liability immediately before the date measured applying IAS 17.

The following discount rates have been applied:

 

   

building rental in France (discounting rate 2%), building rental in Roseville, Minnesota, USA and Raleigh, North Carolina, USA (discounting rate of 8%), building rental in New York, New York, USA (discounting rate of 4.4%), and equipment rental (discounting rate 1%);

The main changes introduced by IFRS 16 are the following:

Capitalization of the right-of-use assets for real-estate lease contracts:

Identified lease contracts mainly concern Cellectis’ Headquarters and R&D buildings in Paris, New York and Raleigh, North Carolina, USA and Calyxt’s Headquarters and its production and storage areas in Roseville, Minnesota, USA.

For purposes of IFRS 16, the lease term corresponds to the non-terminable period as extended, if applicable, by renewal options whose exercise by the Group are reasonably certain.

The discount rate used to calculate the lease debt has been determined, for each portfolio of assets, according to the incremental borrowing rate at the transition date.

The sale and lease-back agreement entered into by Calyxt in the third quarter of 2017 has a defined lease term and was classified as an operating lease agreement under IAS 17. According to IFRS 16, this lease receives the standard accounting treatment for operating leases existing at the date of initial application and the value of the right-of-use asset is adjusted for the amount of the net deferred losses recognized in the statement of financial position immediately before the date of initial application, which was $1.8 million.

Accounting for the other-assets leases:

The main lease contracts identified correspond to office and laboratory equipment.

 

12


The cumulative effect of initially applying IFRS 16 has been recognized as an adjustment to the opening balance sheet at the date of initial application, January 1, 2019, as presented in the table below:

 

     1st January, 2019
as presented
     IFRS 16
restatement
     1st January, 2019
as restated
 
ASSETS         

Non-current assets

        

Intangible assets

     1,268           1,268  

Property, plant, and equipment

     10,041        (1,309      8,732  

Right-of-use assets

     —          37,569        37,569  

Other non-current financial assets

     1,891           1,891  
  

 

 

    

 

 

    

 

 

 

Total non-current assets

     13,199        36,260        49,460  

Current assets

        

Inventories

     275           275  

Trade receivables

     2,971           2,971  

Subsidies receivables

     17,173           17,173  

Other current assets

     15,333        (2,139      13,194  

Current financial assets

     388           388  

Cash and cash equivalents

     451,501           451,501  
  

 

 

    

 

 

    

 

 

 

Total current assets

     487,641        (2,139      485,502  
  

 

 

    

 

 

    

 

 

 

TOTAL ASSETS

     500,840        34,121        534,961  
  

 

 

    

 

 

    

 

 

 
LIABILITIES         

Shareholders’ equity

        

Share capital

     2,765           2,765  

Premiums related to the share capital

     828,525           828,525  

Treasury share reserve

     —             —    

Currency translation adjustment

     (16,668         (16,668

Retained earnings (deficit)

     (326,628         (326,628

Net income (loss)

     (78,693         (78,693
  

 

 

    

 

 

    

 

 

 

Total shareholders’ equity - Group Share

     409,301           409,301  

Non-controlling interests

     40,970           40,970  
  

 

 

    

 

 

    

 

 

 

Total shareholders’ equity

     450,272           450,272  

Non-current liabilities

        

Non-current lease debts

     1,018        31,720        32,737  

Non-current provisions

     2,681        (639      2,042  
  

 

 

    

 

 

    

 

 

 

Total non-current liabilities

     3,699        31,081        34,779  
  

 

 

    

 

 

    

 

 

 

Current liabilities

        

Current lease debts

     333        3,743        4,076  

Trade payables

     15,883           15,883  

Deferred revenues and contract liabilities

     20,754        (299      20,454  

Current provisions

     1,530        (403      1,127  

Other current liabilities

     8,369           8,369  
  

 

 

    

 

 

    

 

 

 

Total current liabilities

     46,869        3,041        49,910  
  

 

 

    

 

 

    

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

     500,840        34,121        534,961  
  

 

 

    

 

 

    

 

 

 

 

13


The rental charges relating to these leases – i.e. $2.6 million for the first half of 2019 – are replaced with the recognition of an amortization expense of $2.2 million and a financial expense of $1.2 million.

The rental charges relating to short-term and low-value leases remain classified as leases expenses and are considered not significant.

In the statement of cash flows,

 

   

rent paid on leases that meet the criteria of IFRS 16 are classified within financing activities as principal portion and interest payment on the lease debt, which was $1.7 million for the first half of 2019; and

 

   

short-term lease payments, payments for leases of low-value assets and variable lease payments not included in the measurement of the lease liability remain classified within operating activities.

The table below explains the differences between Operating lease commitments disclosed under IAS 17 as of December 31, 2018, discounted using the incremental borrowing rate at the date of initial application, and Lease liabilities recognized in the statement of financial position at the date of initial application.

Operating lease commitments disclosed under IAS 17 as of December 31, 2018 (in thousands):

 

Sale and lease-back agreement

   $ 31,668  

Facility lease agreements

   $ 28,230  
  

 

 

 

Total

   $ 59,898  

-Discounting impact & assumption changes

   $ (18,966

-Facility lease termination

   $ (4,220

-Other

   $ 101  
  

 

 

 

Total lease debt

   $ 36,813  

Use of judgment, estimates and assumptions:

The application of IFRS 16 “Leases” requires the Group to make assumptions and estimates in order to determine the value of the right-of-use assets and the lease debt, which mainly relates to the incremental borrowing rate for real estate and other lease contracts. The Group also exercises its judgement as to whether or not to qualify renewal options as reasonably certain.

2.3 IFRS15 application

IFRS 15 “Revenue from Contracts with Customers” establishes a comprehensive framework for determining whether, how much and when revenue is recognized. It replaces existing revenue recognition guidance, including IAS 18 “Revenue”. IFRS 15 was effective for annual reporting periods beginning on or after January 1, 2018.

The different categories of contracts with customers of Cellectis, which were reviewed are:

 

   

Collaboration agreements; and

 

   

Licensing agreements.

 

14


Cellectis applied IFRS 15 with effect from January 1, 2018 using the full retrospective method. The application of IFRS 15 led to a deferral of collaboration revenue (specifically milestone payments) from fiscal year 2015 with a negative opening equity adjustment of $1.7 million as of January 1, 2018. See the table below for the impact on adoption.

 

     December 31, 2017
as presented
     IFRS 15
restatement
     December 31, 2017
as restated
 

Total non-current assets

     9,661        —          9,661  
  

 

 

    

 

 

    

 

 

 

Total current assets

     323,221        —          323,221  
  

 

 

    

 

 

    

 

 

 

TOTAL ASSETS

     332,882        —          332,882  
  

 

 

    

 

 

    

 

 

 

Shareholders’ equity

           —    

Share capital

     2,367        —          2,367  

Premiums related to the share capital

     614,037        —          614,037  

Treasury share reserve

     (297      —          (297

Currency translation adjustment

     1,978        (143      1,835  

Retained earnings (deficit)

     (251,927      (1,775      (253,702

Net income (loss)

     (99,368      —          (99,368
  

 

 

    

 

 

    

 

 

 

Total shareholders’ equity - Group Share

     266,791        (1,919      264,873  

Non-controlling interests

     19,113        —          19,113  
  

 

 

    

 

 

    

 

 

 

Total shareholders’ equity

     285,904        (1,919      283,986  
  

 

 

    

 

 

    

 

 

 

Total non-current liabilities

     3,443        —          3,443  
  

 

 

    

 

 

    

 

 

 

Current liabilities

           —    

Current financial liabilities

     21        —          21  

Trade payables

     9,460        —          9,460  

Deferred revenues and deferred income

     26,056        1,919        27,975  

Current provisions

     1,427        —          1,427  

Other current liabilities

     6,570        —          6,570  
  

 

 

    

 

 

    

 

 

 

Total current liabilities

     43,534        1,919        45,453  
  

 

 

    

 

 

    

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

     332,882        —          332,882  
  

 

 

    

 

 

    

 

 

 

 

15


    Share Capital
Ordinary Shares
                                  Equity        
    Number of
shares
    Amount     Premiums
related to share
capital
    Treasury
shares
reserve
    Currency
translation
adjustment
    Retained
earnings
(deficit)
    Income
(Loss)
    attributable to
shareholders of
Cellectis
    Non
controlling
interests
    Total
Shareholders’
Equity
 

As of January 1, 2018, as presented

    35,960,062       2,367       614,037       (297     1,978       (251,927     (99,368     266,791       19,113       285,904  

IFRS 15 restatement

    —         —         —         —         (143     (1,775     —         (1,919     —         (1,919

As of January 1, 2018, as restated

    35,960,062       2,367       614,037       (297     1,835       (253,702     (99,368     264,873       19,113       283,986  

 

16


2.4 Currency of the financial statements

The Interim Condensed Consolidated Financial Statements are presented in U.S. dollars, which differs from the functional currency of Cellectis, which is the euro. We believe that this presentation enhances the comparability with peers, which primarily present their financial statements in U.S. dollars.

All financial information (unless indicated otherwise) is presented in thousands of U.S. dollars.

The statements of financial position of consolidated entities having a functional currency different from the U.S. dollar are translated into U.S. dollars at the closing exchange rate (spot exchange rate at the statement of financial position date) and the statements of operations, statements of comprehensive income (loss) and statements of cash flow of such consolidated entities are translated at the average period to date exchange rate. The resulting translation adjustments are included in equity under the caption “Accumulated other comprehensive income (loss)” in the Consolidated Statements of Changes in Shareholders’ Equity.

2.5 Consolidated entities and non-controlling interests

Consolidated entities

For the six-month period ended June 30, 2019, the Group included Cellectis S.A., Cellectis, Inc., Cellectis Biologics Inc., which was incorporated on January 18, 2019, and Calyxt, Inc.

For the year ended December 31, 2018, the Group included Cellectis S.A., Cellectis, Inc. and Calyxt, Inc.

As of December 31, 2018, Cellectis S.A. owned 100% of Cellectis, Inc. and approximately 69.5% of Calyxt’s outstanding shares of common stock. As of June 30, 2019, Cellectis S.A. owns 100% of Cellectis, Inc., which owns 100% of Cellectis Biologics, Inc., and approximately 69.1% of Calyxt’s outstanding shares of common stock.

Calyxt’s shares of common stock are traded on NASDAQ under the symbol “CLXT”.

Non-controlling interests

Non-controlling shareholders held a 30.5% interest in Calyxt, Inc. as of December 31, 2018 and a 30.9% interest in Calyxt, Inc. as of June 30, 2019. These non-controlling interests were generated as a result of Calyxt’s IPO, which closed on July 25, 2017, and subsequent follow-on offering, which closed on May 22, 2018, as well as through vesting and exercises of equity awards.

 

17


Note 3. Information concerning the Group’s Consolidated Operations

3.1 Revenues and other income

3.1.1 For the six-month periods ended June 30

Revenues by country of origin and other income

 

     For the six-month period ended June 30,  
     2018      2019  
     $ in thousands  

From France

     10,869        1,623  

From USA (1)

     207        566  
  

 

 

    

 

 

 

Revenues

     11,076        2,188  
  

 

 

    

 

 

 

Research tax credit

     5,283        4,172  

Subsidies and other

     57        —    
  

 

 

    

 

 

 

Other income

     5,340        4,172  
  

 

 

    

 

 

 

Total revenues and other income

     16,417        6,360  
  

 

 

    

 

 

 

 

(1)

Revenues from USA only relate to Calyxt.

Revenues by nature

 

     For the six-month period ended June 30,  
     2018      2019  
     $ in thousands  

Recognition of previously deferred upfront payments

     7,291        —    

Other revenues

     2,552        724  
  

 

 

    

 

 

 

Collaboration agreements

     9,842        724  
  

 

 

    

 

 

 

Licenses

     1,219        872  

Products & services

     15        592  
  

 

 

    

 

 

 

Total revenues

     11,076        2,188  
  

 

 

    

 

 

 

 

18


3.1.2 For the three-month periods ended June 30

Revenues by country of origin and other income

 

     For the three-month period ended June 30,  
                     2018                                       2019                   
     $ in thousands  

From France

     4,855        745  

From USA (1)

     194        407  
  

 

 

    

 

 

 

Revenues

     5,049        1,152  
  

 

 

    

 

 

 

Research tax credit

     3,270        1,805  

Subsidies and other

     25        (25
  

 

 

    

 

 

 

Other income

     3,295        1,780  
  

 

 

    

 

 

 

Total revenues and other income

     8,343        2,932  
  

 

 

    

 

 

 

 

  (1)

Revenues from USA only relate to Calyxt.

Revenues by nature

 

     For the three-month period ended June 30,  
                     2018                                       2019                   
     $ in thousands  

Recognition of previously deferred upfront payments

     3,509        —    

Other revenues

     858        298  
  

 

 

    

 

 

 

Collaboration agreements

     4,366        298  
  

 

 

    

 

 

 

Licenses

     668        431  

Products & services

     14        423  
  

 

 

    

 

 

 

Total revenues

     5,049        1,152  
  

 

 

    

 

 

 

 

19


3.2 Operating expenses

3.2.1 For the six-month periods ended June 30

 

     For the six-month period ended June 30,  
     2018      2019  

Cost of goods sold

     —          (337

Royalty expenses

     (1,138      (1,066
  

 

 

    

 

 

 

Cost of revenue

     (1,138      (1,403
  

 

 

    

 

 

 

 

     For the six-month period ended June 30,  
                     2018                                       2019                   

Research and development expenses

     

Wages and salaries

     (7,759      (9,566

Social charges on stock option grants

     —          (1,333

Non-cash stock based compensation expense

     (9,316      (4,151
  

 

 

    

 

 

 

Personnel expenses

     (17,075      (15,049
  

 

 

    

 

 

 

Purchases and external expenses

     (18,913      (21,586

Other

     (452      (3,353
  

 

 

    

 

 

 

Total research and development expenses

     (36,441      (39,987
  

 

 

    

 

 

 

 

     For the six-month period ended June 30,  
                     2018                                       2019                   

Selling, general and administrative expenses

     

Wages and salaries

     (5,282      (6,961

Social charges on stock option grants

     —          (490

Non-cash stock based compensation expense

     (11,708      (7,660
  

 

 

    

 

 

 

Personnel expenses

     (16,990      (15,111
  

 

 

    

 

 

 

Purchases and external expenses

     (7,127      (6,554

Other

     (1,107      (1,644
  

 

 

    

 

 

 

Total selling, general and administrative expenses

     (25,224      (23,309
  

 

 

    

 

 

 

 

     For the six-month period ended June 30,  
                     2018                                       2019                   

Personnel expenses

     

Wages and salaries

     (13,042      (16,526

Social charges on stock option grants

     —          (1,823

Non-cash stock based compensation expense

     (21,023      (11,810
  

 

 

    

 

 

 

Total personnel expenses

     (34,065      (30,160
  

 

 

    

 

 

 

The rental charges relating to leases accounted for according to IFRS 16 (see note 2.2 for discussion of the application of IFRS 16 “Lease” at January 1, 2019), which amounted to $2.6 million for the first half of 2019, are replaced with the recognition of an amortization expense of $2.2 million (that continues to be disclosed within operating expenses) and a financial expense of $1.2 million.

 

20


3.2.2 For the three-month periods ended June 30

 

     For the three-month period ended June 30,  
                     2018                                       2019                   

Cost of goods sold

     —          (302

Royalty expenses

     (559      (513
  

 

 

    

 

 

 

Cost of revenue

     (559      (815
  

 

 

    

 

 

 

 

     For the three-month period ended June 30,  
                     2018                                       2019                   

Research and development expenses

     

Wages and salaries

     (3,842      (4,986

Social charges on stock option grants

     —          (1,326

Non-cash stock based compensation expense

     (4,581      (2,992
  

 

 

    

 

 

 

Personnel expenses

     (8,422      (9,304
  

 

 

    

 

 

 

Purchases and external expenses

     (9,991      (13,967

Other

     371        (2,150
  

 

 

    

 

 

 

Total research and development expenses

     (18,042      (25,421
  

 

 

    

 

 

 

 

     For the three-month period ended June 30,  
                     2018                                       2019                   

Selling, general and administrative expenses

     

Wages and salaries

     (2,393      (3,823

Social charges on stock option grants

     (22      (468

Non-cash stock based compensation expense

     (4,466      (3,717
  

 

 

    

 

 

 

Personnel expenses

     (6,881      (8,008
  

 

 

    

 

 

 

Purchases and external expenses

     (3,710      (3,048

Other

     (657      (762
  

 

 

    

 

 

 

Total selling, general and administrative expenses

     (11,248      (11,818
  

 

 

    

 

 

 

 

     For the three-month period ended June 30,  
                     2018                                       2019                   

Personnel expenses

     

Wages and salaries

     (6,234      (8,809

Social charges on stock option grants

     (22      (1,794

Non-cash stock based compensation expense

     (9,046      (6,710
  

 

 

    

 

 

 

Total personnel expenses

     (15,303      (17,313
  

 

 

    

 

 

 

 

21


3.3 Reportable segments

Accounting policies

Reportable segments are identified as components of an enterprise that have discrete financial information available for evaluation by the Chief Operating Decision Maker (“CODM”), for purposes of performance assessment and resource allocation.

For the six-month period ended June 30, 2019, Cellectis’ CODM is composed of:

 

   

The Chairman and Chief Executive Officer;

 

   

The Chief Operating Officer (until July 24, 2019);

 

   

The Executive Vice President Technical Operation;

 

   

The Chief Scientific Officer;

 

   

The Chief Financial Officer;

 

   

The General Counsel; and

 

   

The Chief Regulatory & Compliance Officer.

We view our operations and manage our business in two operating and reportable segments that are engaged in the following activities:

 

   

Therapeutics: This segment is focused on the development (i) of products in the field of immuno-oncology and (ii) of novel therapies outside immuno-oncology to treat other human diseases. This approach is based on our gene editing and Chimeric Antigen Receptors (“CARs”) technologies. All these activities are supported by Cellectis S.A., Cellectis, Inc. and Cellectis Biologics, Inc. The operations of Cellectis S.A., the parent company, are presented entirely in the Therapeutics segment which also comprises research and development, management and support functions.

 

   

Plants: This segment is focused on creating healthier food ingredients through the use of gene editing technology for plants. It corresponds to the activity of our U.S.-based majority-owned subsidiary, Calyxt, Inc., which is currently based in Roseville, Minnesota.

There are inter-segment transactions between the two reportable segments, including allocation of corporate general and administrative expenses by Cellectis S.A. and the allocation of research and development expenses to the reportable segments.

With respect to corporate general and administrative expenses, Cellectis S.A. provides Calyxt, Inc. with general sales and administrative functions, accounting and finance functions, investor relations, intellectual property, legal advice, human resources, communication and information technology under a Management Services Agreement. Under the Management Services Agreement, Cellectis S.A. charges Calyxt, Inc. in euros at cost plus a mark-up ranging between zero to 10%, depending on the nature of the service. Amounts due to Cellectis S.A. pursuant to inter-segment transactions bear interest at a rate of the 12-month Euribor plus 5% per annum.

The intersegment revenues represent the transactions between segments. Intra-segment transactions are eliminated within a segment’s results and intersegment transactions are eliminated in consolidation as well as in key performance indicators by reportable segment.

 

22


Information related to each reportable segment is set out below. Segment revenues and other income, research and development expenses, selling, general and administrative expenses, and royalties and other operating income and expenses, and adjusted net income (loss) attributable to shareholders of Cellectis (which does not include non-cash stock-based compensation expense) are used by the CODM for purposes of making decisions about allocating resources to the segments and assessing their performance. The CODM does not review any asset or liability information by segment or by region.

Adjusted net income (loss) attributable to shareholders of Cellectis S.A. is not a measure calculated in accordance with IFRS. Because adjusted net income (loss) attributable to shareholders of Cellectis excludes non-cash stock-based compensation expense—a non-cash expense, our management believes that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure.

The net income (loss) includes the impact of the operations between segments while the intra-segment operations are eliminated.

 

23


Details of key performance indicators by reportable segment for the six-month periods ended June 30,

 

     For the six-month period ended
June 30, 2018
    For the six-month period ended
June 30, 2019
 
$ in thousands    Plants     Therapeutics     Total
reportable
segments
    Plants     Therapeutics     Total
reportable
segments
 

External revenues

     207       10,869       11,076       566       1,623       2,188  

External other income

     —         5,340       5,340       125       4,047       4,172  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     207       16,209       16,417       691       5,669       6,360  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of revenue

     (1     (1,137     (1,138     (337     (1,066     (1,403

Research and development expenses

     (3,360     (33,081     (36,441     (5,300     (34,688     (39,987

Selling, general and administrative expenses

     (9,382     (15,842     (25,224     (12,542     (10,767     (23,309

Other operating income and expenses

     (21     (150     (171     20       9       29  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (12,764     (50,211     (62,975     (18,158     (46,511     (64,670
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (12,557     (34,002     (46,558     (17,468     (40,842     (58,310
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Financial gain (loss)

     83       9,957       10,040       347       3,502       3,849  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (12,474     (24,044     (36,518     (17,121     (37,340     (54,461
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non controlling interests

     4,096       —         4,096       5,670       —         5,670  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to shareholders of Cellectis

     (8,377     (24,044     (32,422     (11,451     (37,340     (48,791
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

R&D non-cash stock-based expense attributable to shareholder of Cellectis

     535       8,554       9,089       592       3,294       3,886  

SG&A non-cash stock-based expense attributable to shareholder of Cellectis

     2,480       8,177       10,657       3,215       3,008       6,223  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjustment of share-based compensation attributable to shareholders of Cellectis

     3,015       16,730       19,746       3,808       6,302       10,109  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income (loss) attributable to shareholders of Cellectis

     (5,362     (7,314     (12,676     (7,643     (31,039     (38,682
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (371     (900     (1,271     (758     (2,457     (3,215

Additions to tangible and intangible assets

     620       631       1,251       1,172       3,425       4,597  

 

24


Details of key performance indicators by reportable segment for the three-month periods ended June 30,

 

     For the three-month period ended
June 30, 2018
    For the three-month period ended
June 30, 2019
 
$ in thousands    Plants     Therapeutics     Total
reportable
segments
    Plants     Therapeutics     Total
reportable
segments
 

External revenues

     194       4,855       5,049       407       745       1,152  

External other income

     —         3,295       3,295       62       1,717       1,780  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     194       8,150       8,343       469       2,462       2,932  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of revenue

     3       (562     (559     (302     (513     (815

Research and development expenses

     (1,802     (16,241     (18,042     (3,269     (22,151     (25,421

Selling, general and administrative expenses

     (3,757     (7,491     (11,248     (6,480     (5,338     (11,818

Other operating income and expenses

     21       (211     (189     16       (20     (3
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (5,534     (24,504     (30,039     (10,035     (28,023     (38,058
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (5,341     (16,354     (21,696     (9,566     (25,560     (35,126
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Financial gain (loss)

     (64     12,022       11,958       133       (1,645     (1,512
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (5,405     (4,332     (9,738     (9,432     (27,205     (36,637
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non controlling interests

     2,482       —         2,482       3,190       —         3,190  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to shareholders of Cellectis

     (2,923     (4,332     (7,256     (6,242     (27,205     (33,447
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

R&D non-cash stock-based expense attributable to shareholder of Cellectis

     183       4,274       4,457       10       2,934       2,945  

SG&A non-cash stock-based expense attributable to shareholder of Cellectis

     318       3,733       4,051       1,657       1,309       2,966  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjustment of share-based compensation attributable to shareholders of Cellectis

     501       8,007       8,508       1,667       4,243       5,910  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income (loss) attributable to shareholders of Cellectis

     (2,422     3,675       1,252       (4,575     (22,962     (27,537
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (213     (428     (642     (386     (1,300     (1,687

Additions to tangible and intangible assets

     492       83       575       822       2,116       2,938  

Reconciliation of Plants Segment results of operations

The tables below present a reconciliation between the Plants Segment figures, which are prepared in accordance with IFRS for the Group, with Calyxt, Inc. stand alone financial statements, which are prepared in accordance with US GAAP for the domestic registration.

 

25


Reconciliation of Plants Segment results of operations for the six-month period ended June 30, 2019

 

$ in thousands    For the six-month period ended June 30, 2019  
   Cellectis
Consolidated
financial
statements

Reportable
segments
note (IFRS)
    Non-cash
stock-based
compensation
booked in
IFRS (1)
     Non-cash
stock-based
compensation
in US GAAP
(1)
    Intersegment
transactions
(2)
    Reclassifications
(3)
    Other
(4)
    Calyxt
Stand alone
financial
statements

(US
GAAP)
 

External revenues and other income

     691       —          —         162       (287     —         566  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Research and development expenses

     (5,300     857        (779     (6     272       (1     (4,957

Selling, general and administrative expenses

     (12,542     4,652        (3,081     (385     (164     45       (11,475

Cost of revenue and other operating income and expenses

     (317     —          —         (1,011     180       —         (1,149
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (18,158     5,509        (3,861     (1,402     287       44       (17,581
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (17,468     5,509        (3,861     (1,240     —         44       (17,015
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Financial gain (loss)

     347       —          —         —         —         (110     237  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (17,121     5,509        (3,861     (1,240     —         (65     (16,778
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

26


Reconciliation of Plants Segment result of operations for the six-month period ended June 30, 2018

 

$ in thousands    For the six-month period ended June 30, 2018  
   Cellectis
Consolidated
financial
statements

Reportable
segments
note (IFRS)
    Non cash
stock-based
compensation
booked in
IFRS (1)
     Non cash
stock-based
compensation
in US GAAP
(1)
    Intersegment
transactions
(2)
    Reclassifications
(3)
    Other
(4)
    Calyxt
Stand alone
financial
statements

(US
GAAP)
 

External revenues and other income

     207       —          —         —         —         —         207  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Research and development expenses

     (3,360     762        (985     —         (827     —         (4,410

Selling, general and administrative expenses

     (9,382     3,531        (1,443     (1,260     1,447       505       (6,603

Cost of revenue and other operating income and expenses

     (22     —          —         —         (960     —         (982
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (12,764     4,293        (2,428     (1,260     (340     505       (11,995
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (12,557     4,293        (2,428     (1,260     (340     505       (11,788
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Financial gain (loss)

     83       —          —         (29     340       (552     (158
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (12,474     4,293        (2,428     (1,290     —         (48     (11,946
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

27


Reconciliation of Plants Segment result of operations for the three-month period ended June 30, 2019

 

$ in thousands    For the three-month period ended June 30, 2019  
   Cellectis
Consolidated
financial
statements

Reportable
segments
note (IFRS)
    Non-cash
stock-based
compensation
booked in
IFRS (1)
     Non-cash
stock-based
compensation
in US GAAP
(1)
    Intersegment
transactions
(2)
    Reclassifications
(3)
    Other
(4)
    Calyxt
Stand alone
financial
statements

(US
GAAP)
 

External revenues and other income

     469       —          —         162       (223     —         408  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Research and development expenses

     (3,269     762        (536     (6     312       (1     (2,738

Selling, general and administrative expenses

     (6,480     2,408        (1,764     (233     (360     20       (6,408

Cost of revenue and other operating income and expenses

     (286     —          —         (728     260       —         (754
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (10,035     3,170        (2,300     (967     213       20       (9,900
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (9,566     3,170        (2,300     (806     (10     20       (9,492
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Financial gain (loss)

     133       —          —         —         —         (45     89  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (9,432     3,170        (2,300     (806     (10     (25     (9,403
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

28


Reconciliation of Plants Segment result of operations for the three-month period ended June 30, 2018

 

$ in thousands    For the three-month period ended June 30, 2018  
   Cellectis
Consolidated
financial
statements

Reportable
segments
note (IFRS)
    Non cash
stock-based
compensation
booked in
IFRS (1)
     Non cash
stock-based
compensation
in US GAAP
(1)
    Intersegment
transactions
(2)
    Reclassifications
(3)
    Other
(4)
    Calyxt
Stand alone
financial
statements

(US
GAAP)
 

External revenues and other income

     194       —          —         (48     51       (1     196  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Research and development expenses

     (1,802     307        (1,368     —         (378     —         (3,241

Selling, general and administrative expenses

     (3,757     733        (1,020     (646     335       307       (4,048

Cost of revenue and other operating income and expenses

     24       —          —         —         (423     —         (399
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (5,534     1,039        (2,388     (646     (466     307       (7,688
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (5,341     1,039        (2,388     (694     (414     306       (7,492
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Financial gain (loss)

     (64     —          —         (49     415       (386     (84
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (5,405     1,039        (2,388     (742     —         (80     (7,576
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

29


  (1)

In IFRS, non-cash stock-based compensation is recorded for stock options and other equity compensation plan awards issued by all entities of the consolidated Group. The grant-date fair value of share warrants, employee warrants, stock options and free shares granted to employees is recognized as a payroll expense over the vesting period. In U.S. GAAP, the expenses related to the stock options granted in 2014, 2015 and 2016 under the Calyxt, Inc. Equity Incentive Existing Plan and in 2017 and 2018 under the Omnibus Plan are only incurred upon a triggering event or Initial Public Offering of Calyxt, Inc., as defined by the plan. Accordingly, Plants Segment compensation expense was not recognized for Calyxt stock options and other Calyxt equity compensation plan awards in periods prior to the completion of Calyxt’s IPO on July 25, 2017.

Cellectis allocates share-based compensation to the share-related entity (rather than the entity related to the employee that benefited from such compensation), considering that the share-based compensation is an expense linked to such entity’s performance. Consequently, in the segment disclosure, all share-based compensation based on Cellectis shares have been charged in the Therapeutics segment, even if some Calyxt employees are included in a Cellectis stock-option plan. However, the Cellectis equity award plan non-cash stock-based compensation expenses related to Cellectis stock-option plans have been recorded in the Calyxt stand-alone financial statements prepared under U.S. GAAP.

 

  (2)

Intersegment transactions primarily relate to management fees invoiced by Cellectis to Calyxt. Intersegment transactions are eliminated in the consolidated financial statements as well as in Cellectis’ presentation of key performance indicators by reportable segment. However, intersegment transactions are included in Calyxt’s stand-alone financial statements.

 

  (3)

Reclassifications relate to expenses, which are classified differently under IFRS for Cellectis’ consolidated financials and U.S. GAAP for Calyxt’s stand-alone financial statements.

 

  (4)

Other principally includes the restatement of Calyxt’s sale and lease-back transaction with respect to its Roseville, Minnesota property, which is recorded as a finance lease in U.S. GAAP and as an operating lease under IFRS for the six-month period ended June 30, 2018, and as lease under the new standard IFRS 16 for the six-month period ended June 30, 2019.

Note 4. Impairment tests

Our cash-generating units (“CGUs”) correspond to the operating/reportable segments: Therapeutics and Plants.

No indicator of impairment has been identified for any intangible or tangible assets in either of the CGUs at the end of six-month periods ended June 30, 2018 and 2019.

 

30


Note 5. Right-of-use assets

Accounting policy

Lease contracts recognition

Lease contracts, as defined by IFRS 16 “Leases”, are recorded in the statement of consolidated financial position, which leads to the recognition of:

 

   

an asset representing a right of use of the asset leased during the lease term of the contract “right-of-use”; and

 

   

a liability related to the payment obligation “lease debt”.

Measurement of the right-of use asset

At the commencement date, the right-of-use asset is measured at cost and comprises:

 

   

the amount of the initial measurement of the lease liability, to which is added, if applicable, any lease payments made at or before the commencement date, less any lease incentives received;

 

   

where relevant, any initial direct costs incurred by the lessee for the conclusion of the contract. These are incremental costs which would not have been incurred if the contract had not been concluded; and

 

   

estimated costs for restoration of the leased asset according to the terms of the contract.

Following the initial recognition, the right-of-use asset must be depreciated over the useful life of the underlying assets as lease term for the rental component.

Measurement of the lease liability

At the commencement date, the lease liability is recognized for an amount equal to the present value of the lease payments over the lease term.

Amounts involved in the measurement of the lease liability are:

 

   

fixed payments (including in-substance fixed payments; meaning that even if they are variable in form, they are in-substance unavoidable);

 

   

variable lease payments that depend on an index or a rate, initially measured using the index or the rate in force at the lease commencement date; amounts expected to be payable by the lessee under residual value guarantees; and

 

   

payments of penalties for terminating the lease, if the lease term reflects the lessee exercising an option to terminate the lease.

The lease liability is subsequently measured based on a process similar to the amortized cost method using the discount rate:

 

   

the liability is increased by the accrued interests resulting from the discounting of the lease liability, at the beginning of the lease period; and

 

   

payments made are deducted.

The interest cost for the period as well as variable payments, not taken into account in the initial measurement of the lease liability and incurred over the relevant period are recognized as costs.

In addition, the lease liability may be remeasured in the following situations:

 

   

the occurrence of a change in the lease term or a modification related to the assessment of the reasonably certain nature (or not) of the exercise of an option,

 

   

a remeasurement linked to residual value guarantees,

 

31


   

the occurrence of an adjustment to the rates and indices according to which the rents are calculated when rent adjustments occur.

Main contracts applicable

Based on its analysis, the Group has identified lease contracts according to the standard concerning office buildings, laboratories, production facilities and storage facilities.

For purposes of IFRS 16, the lease term corresponds to the non-terminable period as extended, if applicable, by renewal options whose exercise by the Group are reasonably certain.

The discount rate used to calculate the lease debt is determined, for each portfolio of assets, according to the incremental borrowing rate at the contract date.

The incremental borrowing rate is the rate of interest that a lessee would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of a similar value to the right-of-use asset in a similar economic environment.

The rental charges relating to short terms and low value lease remains classified as leases expenses in operating expenses.

Details of finance lease

IFRS 16 “Leases” is applicable for annual periods beginning on or after January 1, 2019. The consequence of the application of this standard is to recognize a right of use and lease liability on the balance sheet.

The Group records right-of-use assets on its balance sheet corresponding to its lease contracts.

For the leaseback on Calyxt Headquarters, according to IFRS 16, the value of the right-of-use asset has been adjusted for the amount of the net deferred losses recognized in the statement of financial position immediately before the date of initial application, which was $1.8 million.

The breakdown of right-of-use assets is as follows:

 

     Building lease      Office and
laboratory
equipment
     Total  
     $ in thousands  

Net book value as of January 1, 2019 as restated

     36,062        1,508        37,569  
  

 

 

    

 

 

    

 

 

 

Additions

     12,323        271        12,593  

Depreciation expense

     (1,978      (220      (2,198

Translation adjustments

     (86      (2      (89
  

 

 

    

 

 

    

Net book value as of June 30, 2019

     46,320        1,556        47,876  
  

 

 

    

 

 

    

 

 

 

Gross value at end of period

     48,303        1,910        50,213  

Accumulated depreciation at end of period

     (1,983      (354      (2,337

 

32


Note 6. Property, plant and equipment

 

     Lands and
Buildings
    Technical
equipment
    Fixtures,
fittings and
other
equipment
    Assets
under
construction
    Total  
     $ in thousands  

Net book value as of January 1, 2018

     3,159       2,505       753       809       7,226  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Additions to tangible assets

     74       738       353       318       1,483  

Disposal of tangible assets

     —         (20     (5     —         (25

Reclassification

     405       113       414       (932     —    

Depreciation expense

     (431     (529     (186     —         (1,147

Translation adjustments

     (43     (39     (14     (4     (101
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net book value as of June 30, 2018

     3,164       2,768       1,315       191       7,437  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross value at end of period

     7,273       12,507       2,167       988       22,936  

Accumulated depreciation and impairment at end of period

     (4,110     (9,739     (853     (798     (15,499

Net book value as of January 1, 2019 as restated

     3,229       2,084       2,172       1,247       8,732  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Additions to tangible assets

     334       195       269       4,079       4,877  

Disposal of tangible assets

     —         (10     —         (346     (356

Reclassification

     7       1       22       (30     —    

Depreciation expense

     (61     (552     (314     —         (927

Translation adjustments

     (13     (5     (4     15       (7
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net book value as of June 30, 2019

     3,496       1,713       2,145       4,965       12,320  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross value at end of period

     7,912       11,927       3,499       5,762       29,100  

Accumulated depreciation and impairment at end of period

     (4,416     (10,214     (1,353     (798     (16,781

As of June 30, 2019, no assets have been pledged as security for financial liabilities. There is no restriction on title of property, plant and equipment.

For the six-month period ended June 30, 2019, we continued our investments in research and development equipment in both the United States of America and France. The addition in tangible assets reflects improvements of Calyxt and Cellectis sites for $0.3 million and other equipment for $0.4 million.

Assets under construction as of June 30, 2019 primarily relates to Cellectis’ new raw materials manufacturing facility in Paris ($1.1 million), a new commercial manufacturing facility in Raleigh, North Carolina ($1.8 million) and the balance relates to capital expenditure in the Plants Segment.

 

33


Note 7. Trade receivables and other current assets

7.1 Trade receivables

 

     As of December 31,      As of June 30,  
     2018      2019  
     $ in thousands  

Trade receivables

     3,353        3,372  

Valuation allowance

     (382      (382
  

 

 

    

 

 

 

Total net value of trade receivables

     2,971        2,990  
  

 

 

    

 

 

 

All trade receivables have payment terms of less than one year.

7.2 Subsidies receivables

 

     As of December 31,      As of June 30,  
     2018      2019  
     $ in thousands  

Research tax credit

     16,842        21,006  

Other subsidies

     1,598        1,588  

Valuation allowance for other subsidies

     (1,266      (1,259
  

 

 

    

 

 

 

Total subsidies receivables

     17,173        21,335  
  

 

 

    

 

 

 

Research tax credit receivables as of June 30, 2019 include the accrual for a French research tax credit related to 2017 for $8.0 million, related to 2018 for $7.8 million and related to the six-month period ended June 30, 2019 for $4.2 million. The remaining amount relates to refundable tax credits in the United States. During December 2018, the French Tax Authority initiated an audit related to the 2014, 2015, 2016 and 2017 French research tax credits. Based on our current evaluation of the status of the audit, we do not believe that a provision should be recorded as of June 30, 2019.

7.3 Other current assets

 

     As of December 31,      As of June 30,  
     2018      2019  
     $ in thousands  

VAT receivables

     1,679        3,275  

Prepaid expenses and other prepayments

     10,985        12,718  

Tax and social receivables

     244        123  

Deferred expenses and other current assets

     2,425        380  
  

 

 

    

 

 

 

Total other current assets

     15,333        16,495  
  

 

 

    

 

 

 

Prepaid expenses and other prepayments primarily include advances to our sub-contractors on research and development activities. They mainly relate to advance payments to suppliers of biological raw materials and to third parties participating in product manufacturing.

During the year ended December 31, 2018, and the six-month period ended June 30, 2019, we prepaid certain manufacturing costs related to our product candidates UCART 123, UCART 22 and UCART CS1 of which the delivery of products or services is expected in the coming months.

 

34


As of December 31, 2018, deferred expenses and other current assets include (i) a deferred expense of $2.1 million related to the sale and lease-back transaction entered into by Calyxt and (ii) other current assets for $0.3 million. As of January 1, 2019, the $2.1 million deferred expense mentioned above has been reclassified in “Right-of-use assets” following the IFRS16 application.

As of December 31, 2018, tax and social receivables include $0.2 million of social charges on personnel expenses. As of June 30, 2019, tax and social receivables relate mainly to tax reimbursement.

 

35


Note 8. Current financial assets and Cash and cash equivalents

 

As of December 31, 2018    Carrying
amount
     Unrealized
Gains/(Losses)
     Estimated fair
value
 
            $ in thousands         

Current financial assets

     388        —          388  

Cash and cash equivalents

     451,501        —          451,501  
  

 

 

    

 

 

    

 

 

 

Current financial assets and cash and cash equivalents

     451,889        —          451,889  
  

 

 

    

 

 

    

 

 

 
As of June 30, 2019    Carrying
amount
     Unrealized
Gains/(Losses)
     Estimated fair
value
 
            $ in thousands         

Current financial assets

     389        —          389  

Cash and cash equivalents

     396,967        —          396,967  
  

 

 

    

 

 

    

 

 

 

Current financial assets and cash and cash equivalents

     397,356        —          397,356  
  

 

 

    

 

 

    

 

 

 

8.1 Current financial assets

Current financial assets include current restricted cash and other current financial assets.

As of June 30, 2019, restricted cash consists of deposits to secure a Calyxt furniture and equipment sale-leaseback for $1.5 million of which $0.4 million are classified as short-term restricted cash.

There were no other current financial assets as of June 30, 2019.

As of December 31, 2018, restricted cash consists of deposits to secure a Calyxt furniture and equipment sale-leaseback for $1.5 million of which $0.4 million are classified as short-term restricted cash.

There were no other current financial assets as of December 31, 2018.

8.2 Cash and cash equivalents

 

     As of December 31,      As of June 30,  
     2018      2019  
     $ in thousands  

Cash and bank accounts

     398,178        326,497  

Money market funds

     13,248        13,570  

Fixed bank deposits

     40,075        56,900  
  

 

 

    

 

 

 

Total cash and cash equivalents

     451,501        396,967  
  

 

 

    

 

 

 

Money market funds earn interest and are refundable overnight. Fixed bank deposits have fixed terms that are less than three months or are readily convertible to a known amount of cash.

 

36


Note 9. Financial liabilities

9.1 Detail of financial liabilities

 

     As of December 31,      As of June 30,  
     2018      2019  
     $ in thousands  

Lease debts

     1,018        45,710  
  

 

 

    

 

 

 

Total non-current financial liabilities

     1,018        45,710  
  

 

 

    

 

 

 

Lease debts

     333        2,104  
  

 

 

    

 

 

 

Total current financial liabilities

     333        2,104  
  

 

 

    

 

 

 

Trade payables

     15,883        19,760  

Other current liabilities

     8,369        6,643  
  

 

 

    

 

 

 

Total Financial liabilities

     25,603        74,218  
  

 

 

    

 

 

 

IFRS 16 “Leases” is applicable for annual periods beginning on or after January 1, 2019. The consequence of the application of this standard is to recognize a right-of-use and lease liability on the balance sheet, which explains the increase in lease debts.

9.2 Due dates of the financial liabilities

 

Balance as of June 30, 2019    Book Value      Less than
One Year
     One to Five
Years
     More than
Five Years
 
     $ in thousands  

Lease debts

     47,815        2,104        15,050        30,660  
  

 

 

    

 

 

    

 

 

    

 

 

 

Financial liabilities

     47,815        2,104        15,050        30,660  
  

 

 

    

 

 

    

 

 

    

 

 

 

Trade payables

     19,760        19,760        —          —    

Other current liabilities

     6,643        6,643        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

     74,218        28,508        15,050        30,660  
  

 

 

    

 

 

    

 

 

    

 

 

 

Note 10. Other current liabilities

 

     As of December 31,      As of June 30,  
     2018      2019  
     $ in thousands  

VAT Payables

     291        155  

Accruals for personnel related expenses

     7,041        5,380  

Other

     1,037        1,107  
  

 

 

    

 

 

 

Total

     8,369        6,643  
  

 

 

    

 

 

 

Accruals for personnel are related to annual bonuses, vacations accruals and social expenses on stock options. The decrease in accruals for personnel related expenses between December 31, 2018 and June 30, 2019, is mainly driven by lower accrual for annual bonuses due to their payments during the period.

 

37


Note 11. Deferred revenues and contract liabilities

 

     As of December 31, 2018      As of June 30, 2019  
     $ in thousands  

Deferred revenues and contract liabilities

     20,454        20,385  

Other

     299        —    
  

 

 

    

 

 

 

Total Deferred revenue and contract liabilities

     20,754        20,385  
  

 

 

    

 

 

 

The deferred revenues and contract liabilities correspond to upfront payments for the License Development and Commercialization Agreement with Les Laboratoires Servier and Institut de Recherche Servier (together “Servier”).

Note 12. Share capital and premium related to the share capitals

 

Nature of the Transactions

   Share
Capital
     Share
premium
     Number of
shares
     Nominal
value
 
     $ in thousands      in $  

Balance as of January 1, 2018

     2,367        614,037        35,960,062        0.05  

Capital Increase

     379        178,171        6,146,000        —    

Exercise of share warrants, employee warrants and stock options

     18        7,424        300,306        —    

Non-cash stock based compensation expense

     —          16,730        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance as of June 30, 2018

     2,764        816,363        42,406,368        0.05  
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance as of January 1, 2019

     2,765        828,525        42,430,069        0.05  

Capital Increase

     1        —          15,600        —    

Non-cash stock based compensation expense

     —          6,302        —          —    

Other movements

     —          3        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance as of June 30, 2019

     2,766        834,830        42,445,669        0.05  
  

 

 

    

 

 

    

 

 

    

 

 

 

Capital evolution during the six-month period ended June 30, 2019.

 

   

During the six-month period ended June 30, 2019, 15,600 free shares were converted to 15,600 ordinary shares.

 

38


Note 13. Non-cash share-based compensation

13.1 Detail of Cellectis equity awards

Holders of vested Cellectis stock options and warrants are entitled to exercise such options and warrants to purchase Cellectis Ordinary shares at a fixed exercise price established at the time such options and warrants are granted during their useful life.

For stock options and warrants, we estimate the fair value of each option on the grant date or other measurement date if applicable using a Black-Scholes option-pricing model, which requires us to make predictive assumptions regarding future stock price volatility, employee exercise behavior, dividend yield, and the forfeiture rate. We estimate our future stock price volatility based on Cellectis historical closing share prices over the expected term period. Our expected term represents the period of time that options granted are expected to be outstanding determined using the simplified method. The risk-free interest rate for periods during the expected term of the options is based on the French government securities with maturities similar to the expected term of the options in effect at the time of grant. We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero. Options may be priced at 100 percent or more of the fair market value on the date of grant, and generally vest over four years after the date of grant. Options generally expire within ten years after the date of grant.

Stock Options

The weighted-average fair values of stock options granted and the assumptions used for the Black-Scholes option pricing model were as follows:

 

     2018   2019

Weighted-Average fair values of stock options granted

   8.89€   10.35€

Assumptions:

    

Risk-free interest rate

   0.13%   0% - 0.21%

Share entitlement per options

   1   1

Exercise price

   24.80€   15.69€ - 18.37€

Grant date share fair value

   17.78€   16€ - 17.80€

Expected volatility

   63.3%   63.4% - 66.64%

Expected term (in years)

   6.25   6.15 - 6.25

Vesting conditions

   Service   Service

Vesting period

   Graded   Graded

 

39


Information on stock option activity follows:

 

     Options
Exercisable
     Weighted-
Average
Exercise
Price Per
Share
    Options
Outstanding
    Weighted-
Average
Exercise
Price Per
Share
    Remaining
Average
Useful Life
 

Balance as of December 31, 2017

     3,822,772        28.02  €      9,332,604       25.17  €      8.3y  

Granted

          100,000       24.80  €   

Exercised

          (319,568     19.72  €   

Forfeited or Expired

          (174,930     23.68  €   

Balance as of December 31, 2018

     5,644,044        27.47  €      8,938,106       25.39  €      7.3y  

Granted

          1,605,800       18.25  €   

Exercised

          0       0.00  €   

Forfeited or Expired

          (750,823     24.74  €   

Balance as of June 30, 2019

     6,259,803        26.90  €      9,793,083       24.27  €      7.3y  

Share-based compensation expense related to stock option awards was respectively for the six-month periods ended June 30, 2019 and 2018, $5.7 million and $15.3 million.

 

40


Warrants

No Warrants (or “Bons de Souscriptions d’Actions” or “BSA”) has been granted during the periods presented.

Information on warrants activity follows:

 

     Warrants
Exercisable
     Weighted-
Average
Exercise
Price Per
Share
    Warrants
Outstanding
    Weighted-
Average
Exercise
Price Per
Share
    Remaining
Average
Useful Life
 

Balance as of December 31, 2017

     469,436        28.80  €      1,100,969       27.23  €      8.2y  

Granted

          0       0.00  €   

Exercised

          (1,867     6.16  €   

Forfeited or Expired

          (180,175     29.95  €   

Balance as of December 31, 2018

     687,252        27.74  €      918,927       26.74  €      7.2y  

Granted

          0       0.00  €   

Exercised

          0       0.00  €   

Forfeited or Expired

          0       0.00  €   

Balance as of June 30, 2019

     736,260        27.71  €      918,927       26.74  €      6.7y  

Share-based compensation expense related to warrants awards was respectively for the six-month periods ended June 30, 2019 and 2018, $0.5 million and $1.3 million.

Free shares

The free shares granted prior to 2018 are subject to a two-year vesting period and two-year holding period for French residents and four years vesting period for foreign residents.

The free shares granted in 2018 and after are subject to a one-year vesting period for French residents and one-year holding period and two-years for foreign residents.

Information on free shares activity follows:

 

     Number of Free shares
Outstanding
     Weighted-Average
Grant Date Fair Value
 

Unvested balance at December 31, 2017

     15,600        28.17  € 

Granted

     43,000        17.78  € 

Vested

     0        0.00  € 

Cancelled

     0        0.00  € 

Unvested balance at December 31, 2018

     58,600        20.55  € 

Granted

     16,500        16.00  € 

Vested

     (15,600      28.17  € 

Cancelled

     0        0.00  € 

Unvested balance at June 30, 2019

     59,500        17.29  € 

The fair value of free shares corresponds to the grant date share fair value.

We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero.

 

41


Share-based compensation expense related to free shares awards was respectively for the six-month periods ended June 30, 2019 and 2018, $0.1 million and $0.1 million.

13.2 Detail of Calyxt equity awards

Stock Options

The estimated fair values of stock options granted and the assumptions used for the Black-Scholes option pricing model were as follows:

 

     2018    2019

Weighted-Average fair values of stock options granted

   $9.09    $10.70

Assumptions:

     

Risk-free interest rate

   2.45% - 2.89%    1.90% - 2.50%

Share entitlement per options

   1    1

Exercise price

   $14.24 - $23.39    $13.01 - $15.39

Grant date share fair value

   $14.24 - $23.39    $13.01 - $15.39

Expected volatility

   40.86% - 57.22%    77.9% - 78.9%

Expected term (in years)

   5.6 - 10.0    6.8 - 10.0

Vesting conditions

   Service    Service

Vesting period

   Graded    Graded

Calyxt estimates the fair value of each option on the grant date or other measurement date if applicable using a Black-Scholes option-pricing model, which requires Calyxt to make predictive assumptions regarding future stock price volatility, employee exercise behavior, dividend yield, and the forfeiture rate. Calyxt estimates its future stock price volatility using the historical volatility of comparable public companies over the expected term of the option.

The expected term represents the period of time that options granted are expected to be outstanding determined using the simplified method.

The risk-free interest rate for periods during the expected term of the options is based on the U.S. Treasury zero-coupon yield curve in effect at the time of grant.

Calyxt has not paid and does not expect to pay dividends for the foreseeable future.

Options may be priced at 100 percent or more of the fair market value on the date of grant, and generally vest over six years after the date of grant. Options generally expire within ten years after the date of grant. Certain awards granted before Calyxt’s IPO contained accelerated vesting provisions if certain events occurred as defined in the option agreement.

 

42


Information on stock option activity follows:

 

     Options
Exercisable
     Weighted-
Average
Exercise Price
Per Share
     Options
Outstanding
    Weighted-
Average
Exercise Price
Per Share
     Remaining
Average
Useful Life
 

Balance as of December 31, 2017

     1,244,968      $ 5.20        3,883,432     $ 9.16        8.8y  

Granted

     —          —          554,243     $ 16.69     

Exercised

     —          —          (592,342   $ 4.43     

Forfeited or Expired

     —          —          (643,446   $ 12.52     

Balance as of December 31, 2018

     1,278,038      $ 7.45        3,201,887     $ 10.67        8.2y  

Granted

     —          —          1,490,000     $ 14.75     

Exercised

     —          —          (85,452   $ 3.61     

Forfeited or Expired

     —          —          (12,085   $ 17.72     

Other activity

     —          —          12,495     $ 13.29     

Balance as of June 30, 2019

     1,585,276      $ 8.34        4,606,845     $ 12.11        8.4y  

Stock-based compensation expense related to stock option awards was respectively for the six-months periods ended 2019 and 2018, $2.7 million and $1.5 million.

Restricted Stock Units

Units settled in stock subject to a restricted period may be granted to key employees under the 2017 Omnibus Plan. Restricted stock units generally vest and become unrestricted over five years after the date of grant.

Information on restricted stock unit activity follows:

 

     Number of Restricted
Stock Units Outstanding
     Weighted-Average Grant
Date Fair Value
 

Unvested balance at December 31, 2017

     1,373,933      $ 13.29  

Granted

     315,825      $ 16.68  

Vested

     (261,507    $ 14.07  

Cancelled

     (376,837    $ 13.30  

Unvested balance at December 31, 2018

     1,051,414      $ 14.11  

Granted

     100,000      $ 12.48  

Vested

     (163,818    $ 8.38  

Cancelled

     (2,000    $ 8.00  

Unvested balance at June 30, 2019

     985,596      $ 9.93  

The fair value of restricted stock units corresponds to the grant date share fair value.

Calyxt has not paid and does not expect to pay dividends for the foreseeable future.

Share-based compensation expense related to restricted stock units awards was respectively for the six-month periods ended June 30, 2019 and 2018, $2.8 million and $2.8 million.

 

43


Performance Stock Unit

In June 2019, Calyxt granted performance stock units, which carry a market condition based on Calyxt share price. These awards contain a continuous service period of three years, the performance period, from the date of grant, followed by a restricted period of two years if the shares are issued following the performance period during which the grantee is required to provide continuous service and the awarded shares must be held by the grantee until the end of the period. The number of shares of common stock delivered following the performance period depends upon the change in Calyxt share price during the performance period. Calyxt granted a targeted amount of 311,667 performance stock units, the performance criteria allow for the actual payout to be between zero and 120 percent of target. The fair value of the performance stock units was determined using a Monte Carlo simulation and will be recognized over the next five years.

 

44


Note 14. Earnings per share

14.1 For the six-month periods ended June 30

 

     For the six-month period ended June 30,  
     2018      2019  

Net income (loss) attributable to shareholders of Cellectis ($ in thousands)

     (32,422      (48,791

Adjusted weighted average number of outstanding shares, used to calculate both basic and diluted net result per share

     39,125,546        42,435,269  

Basic / Diluted net income (loss) per share ($ / share)

     

Basic net income (loss) per share ($ /share)

     (0.83      (1.15

Diluted net income (loss) per share ($ /share)

     (0.83      (1.15

14.2 For the three-month periods ended June 30

 

     For the three-month period ended June 30,  
     2018      2019  

Net income (loss) attributable to shareholders of Cellectis ($ in thousands)

     (7,256      (33,447

Adjusted weighted average number of outstanding shares, used to calculate both basic and diluted net result per share

     42,216,910        42,440,469  

Basic / Diluted net income (loss) per share ($ / share)

     

Basic net income (loss) per share ($ /share)

     (0.17      (0.79

Diluted net income (loss) per share ($ /share)

     (0.17      (0.79

Note 15. Provisions

 

     January 1,
2019 as
restated
     Reclassification      Additions      Amounts
used
during the
period
    Reversals      OCI     6/30/2019  
     $ in thousands  

Pension

     2,278        —          172        —         —          234       2,684  

Loss on contract

     —          1,043        690        —         —          —         1,732  

Employee litigation and severance

     41        —          352        (41     —          2       355  

Commercial litigation

     850        —          531        (535     —          (5     841  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total

     3,169        1,043        1,745        (575     —          231       5,612  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Non-current provisions

     2,278        —          172        —         —          234       2,684  

Current provisions

     891        1,043        1,573        (575     —          (3     2,928  

 

45


During the six-month period ended June 30, 2019, additions mainly relate to (i) $0.7 million relating to the discontinuation of the lease for Calyxt’s Montavle, New Jersey facilities, (ii) operating charges relating to discussions with suppliers for $0.6 million, (iii) employee litigation for $0.4 million and (iv) pension service cost of the period for $0.2 million.

The amounts used during the period and the associated accrual reversals relating to commercial litigation follow the positive conclusion of discussions with a supplier.

As of January, 1, 2019, Montvale facility lease agreement provision for loss on contract was scoped under IFRS 16 and classified as lease debts. During the period, the agreement has been discontinued which changed its treatment placing it outside the scope of IFRS 16 and resulting in the reclassification presented above.

Note 16. Commitments

 

As of June 30, 2019    Total      Less than
1 year
     1 - 3 years      3 - 5 years      More than
5 years
 
     $ in thousands  

Lease agreement

     318        299        17        1        —    

License agreements

     17,473        1,237        2,474        2,474        11,288  

Manufacturing agreements

     8,917        8,917        —          —          —    

Clinical & R&D agreements

     6,258        4,494        1,763        —          —    

Other agreements

     18,991        14,845        4,146        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total contractual obligations

     51,957        29,793        8,400        2,475        11,288  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Obligations under the terms of lease agreement

We have entered into various operating leases for equipment that are not covered by the application of IFRS 16 and result instead in off-balance sheet commitments.

Obligations under the terms of license agreements

We have entered into various license agreements with third parties that subject us to certain fixed license fees, as well as fees based on future events, such as research and sales milestones.

We also have collaboration agreements whereby we are obligated to pay royalties and milestones based on future events that are uncertain and therefore they are not included in the table above.

Obligations under the terms of manufacturing agreements

We have manufacturing agreements whereby we are obligated to pay for services rendered in the next year regarding our products UCART123, UCARTCS1 and UCART22.

Obligations under the terms of Clinical & Research agreements

We have entered into clinical and research agreements where we are obligated to pay for services to be provided in the next years regarding our clinical trials and translational research project.

Obligations under the terms of other agreements

Calyxt has forward purchase commitments with growers to purchase seed and grain at future dates with settlement values based on commodity futures market prices. This amount is not recorded in the financial statements because the company has not taken delivery of the seed and grain.

Note 17. Subsequent events

None

 

46


Item 2.

Management’s Discussion & Analysis of Financial Condition and Results of Operations

Overview

We are a clinical stage biotechnological company, employing our core proprietary technologies to develop best-in-class products in the field of immuno-oncology. Our product candidates, based on gene-edited T-cells that express chimeric antigen receptors, or CARs, seek to harness the power of the immune system to target and eradicate cancer cells. We believe that CAR-based immunotherapy is one of the most promising areas of cancer research, representing a new paradigm for cancer treatment. We are designing next-generation immunotherapies that are based on gene-edited CAR T-cells. Our gene-editing technologies allow us to create allogeneic CAR T-cells, meaning they are derived from healthy donors rather than the patients themselves. We believe that the production of allogeneic CAR T-cells will allow us to develop cost-effective, off-the-shelf products that are capable of being cryopreserved, stored and distributed worldwide. Our gene-editing expertise also enables us to develop product candidates that feature additional safety and efficacy attributes, including control properties designed to prevent them from attacking healthy tissues, to enable them to tolerate standard oncology treatments, and to equip them to resist mechanisms that inhibit immune-system activity. In addition to our focus on immuno-oncology, we are exploring the use of our gene-editing technologies in other therapeutic applications, as well as to develop healthier food products for a growing population.

We currently conduct our operations through two business segments, Therapeutics and Plants. Our Therapeutics segment is mainly focused on the development of products in the field of immuno-oncology. Our Plants segment focuses on applying our gene-editing technologies to develop new generation plant products in the field of agricultural biotechnology through its own efforts or through alliances with other companies in the agricultural market.

Since our inception in early 2000, we have devoted substantially all of our financial resources to research and development efforts. Our current research and development focuses primarily on our CAR T-cell immunotherapy product candidates, including preparing to conduct clinical studies of our product candidates, providing general and administrative support for these operations and protecting our intellectual property. In addition, by leveraging our plant-engineering platform and the transformative potential of gene editing, we aim to address consumer preferences that are evolving to demand healthier, more nutritionally rich foods. We do not have any products approved for sale and have not generated any revenues from immunotherapy. Calyxt completed the first sales of its High Oleic Soybean Oil and High Oleic Soybean Meal in the first quarter of 2019.

As described in our Annual Report, we are party to collaboration agreements with each of Les Laboratories Servier and Institut de Recherche Servier, or Servier, and Allogene Therapeutics, Inc., or Allogene. We believe that our strategic transactions with Allogene and Servier position us to compete in the promising field of immuno-oncology and add additional clinical and financial resources to our programs. For the six-month period ended June 30, 2019, we received $1.7 million pursuant to these collaborations.

We are also party to research and development agreements with each of Cornell University, MD Anderson Cancer Center and King’s College Hospital NHS Foundation pursuant to which we collaborate with these centers to accelerate the pre-clinical and clinical development of our lead product candidates. Under these agreements, we fund the research activities performed at these centers.

We are also party to the following key clinical trial agreements with respect to:

 

   

The Phase 1 dose-escalation clinical trial under the protocol UCART123_01 for UCART123 targeting the AML, which will be conducted at Weill Cornell Medical Center (New York, USA), MD Anderson Cancer Center (Texas, USA), H. Lee Moffitt Cancer Center (Florida, USA) and Dana Farber (Massachussetts, USA).

 

47


   

The Phase 1 dose-escalation clinical trial under the protocol UCART22-01 for UCART22 targeting B-ALL, which will be conducted at MD Anderson Cancer Center (Texas, USA) and The University of Chicago Comprehensive Cancer Center (Illinois, USA).

 

   

The Phase 1 dose-escalation under the protocol UCARTCS1_01 for UCARTCS1 targeting multiple myeloma, which will be conducted at MD Anderson Cancer Center (Texas, USA), and Hackensack University Medical Center (New Jersey, USA).

Our ordinary shares have traded on the Euronext Growth market of Euronext in Paris since February 7, 2007.

Key events of the six-month period ended June 30, 2019

Since the beginning of 2019, Cellectis has made the following key achievements:

 

   

On February 25, 2019, Cellectis published a study in The Journal of Biological Chemistry, identifying Granulocyte Macrophage Colony Stimulating Factor (GMCSF) secreted by Chimeric Antigen Receptor (CAR) T-cells as a key factor promoting cytokine release syndrome (CRS). The report leverages these findings to elaborate an innovative engineering strategy that potentially paves the way for developing safer UCART products.

 

   

On March 7, 2019, Cellectis announced that it entered into a lease agreement to build an 82,000 square foot commercial-scale manufacturing facility named IMPACT (Innovative Manufacturing Plant for Allogeneic Cellular Therapies) in Raleigh, North Carolina, for clinical and commercial production of Cellectis’ leading allogeneic UCART products. In addition, Cellectis started building a 14,000 square foot manufacturing facility in Paris, France named SMART (Starting Material Realization for CAR-T products) to produce Cellectis’ critical starting material supply for UCART clinical studies and commercial products.

 

   

On April 2, 2019, Cellectis announced that the U.S. Food and Drug Administration (FDA) had approved the Company’s Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for UCARTCS1, in patients with multiple myeloma. The IND application for UCARTCS1 was filed on December 28, 2018 and approved by the FDA on January 25, 2019. Cellectis is the sponsor of the UCARTCS1 clinical study and successfully ensured the manufacturing and release of UCARTCS1 GMP batches. Cellectis also obtained IRB approval.

 

   

During the April 29 to May 2, 2019 American Society of Gene and Cell Therapy Annual Meeting, Cellectis employees held an oral presentation which demonstrated the potential of UCARTCS1 as a treatment approach for patients with multiple myeloma and a poster presentation which showcased Cellectis’ allogeneic CAR T-cell manufacturing expertise, focusing on a novel, straightforward and efficient strategy to generate Universal CAR T-Cells.

 

   

On June 25, 2019, Cellectis held its Combined Shareholders Meeting at its Paris Headquarters. At the meeting, during which more than 68% of voting rights were exercised, Resolutions 1 through 18, 23 and 24 were adopted. Resolutions 19 through 22 and Resolution 25 were rejected.

Since the beginning of 2019, Calyxt, Cellectis’ majority-owned plant science subsidiary, has made the following key achievements:

 

   

Effective January 7, 2019, Calyxt hired William F. (Bill) Koschak, as its Chief Financial Officer. Mr. Koschak brings over 25 years of corporate, finance and accounting leadership to Calyxt.

 

   

Effective January 17, 2019, Kimberly Nelson was appointed to Calyxt’s Board of Directors.

 

   

Effective February 11, 2019, Calyxt hired Debra Frimerman as its General Counsel. Debra brings deep industry knowledge and legal expertise to the Calyxt executive team.

 

   

On February 19, 2019, Calyxt and Agtegra Cooperative (Agtegra)—an innovative farmer owned grain and agronomy cooperative serving over 6,300 farmer members across North and South Dakota—announced that Agtegra will offer distribution, storage and transportation services for Calyxt High Oleic Soybean to its customers.

 

   

On February 26, 2019, Calyxt, Inc. announced the successful commercial launch of its highly anticipated Calyno High Oleic Soybean Oil, which is the Company’s first product to be sold on the U.S. market. This first commercial sale of Calyno oil was in the foodservice industry for frying and salad dressing, as well as sauce applications.

 

   

For the 2019 growing season, Calyxt, Inc. contracted over 55,000 acres of its High Oleic Soybean with more than 150 growers, more than tripling Calyxt’s 2018 acreage.

 

48


   

On May 6, 2019, Calyxt announced that its co-founder and Chief Science Officer, Dan Voytas, Ph.D., has been elected to the National Academy of Sciences for his many contributions to the field of plant genomics, one of which is being an inventor of the TALEN® gene-editing technology.

 

   

On May 15, 2019, Calyxt announced the appointment of Dr. Travis Frey as Chief Technology Officer, effective May 20, 2019. Dr. Frey brings his extensive knowledge in plant biology and biotechnology to a newly created position at the Company. As Chief Technology Officer, Dr. Frey will be responsible for the research and development team to propel product development and Calyxt’s pipeline of healthier food ingredients.

 

   

On June 24, 2019, Calyxt announced that it had entered into a commercial crushing agreement with Landus Cooperative, significantly expanding Calyxt’s network of processing partners. With this agreement, Landus Cooperative, with decades of soybean crushing experience, will manufacture, purchase and distribute soybean meal.

Key events post June 30, 2019

 

   

On July 8, 2019, Cellectis announced the publication of a study in BMC Biotechnology, a Springer Nature journal, describing and evaluating the development of the SWIFF-CAR, a CAR construct with an embedded on/off-switch, which enables tight control of the CAR surface presentation and subsequent cytolytic functions using a small molecule drug. The reversible control of these engineered T-cells represents a promising approach to further mitigate the potential toxicities that are associated with CAR T-cell administration in clinical settings and to improve the process of CAR T-cell production for specific target antigens.

 

   

On July 22, 2019, William Monteith, Executive Vice President Global Operations, and Jon Voss, Executive Vice President Global Quality Assurance, joined the Cellectis Executive Committee, which is Cellectis’ CODM. On July 22, 2019. On July 24, 2019, Elsy Boglioli, Chief Operating Officer, left Cellectis to pursue other opportunities.

Financial Operations Overview

We have incurred net losses in nearly each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from selling, general and administrative expenses associated with our operations. As we continue our intensive research and development programs, we expect to continue to incur significant expenses and may again incur operating losses in future periods. We anticipate that such expenses will increase substantially if and as we:

 

   

progress the clinical trial of our wholly-controlled UCART123 product candidate and initiate additional clinical trials for other wholly-controlled product candidates, among which UCARTCS1 and UCART22;

 

   

continue to advance the research and development of our current and future immuno-oncology product candidates;

 

   

continue, through Calyxt, to advance the research and development of our current and future agricultural product candidates;

 

   

initiate additional clinical studies for, or additional pre-clinical development of, our immuno-oncology product candidates;

 

   

conduct and multiply, though Calyxt, additional field trials of our agricultural product candidates;

 

   

further develop and refine the manufacturing process for our immuno-oncology product candidates;

 

   

change or add additional manufacturers or suppliers of biological materials;

 

   

seek regulatory and marketing approvals for our product candidates, if any, that successfully complete development;

 

49


   

establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;

 

   

seek to identify and validate additional product candidates;

 

   

acquire or in-license other product candidates, technologies, germplasm or other biological material;

 

   

make milestone or other payments under any in-license agreements;

 

   

maintain, protect and expand our intellectual property portfolio;

 

   

build manufacturing facilities and secure arrangements for clinical and commercial manufacturing;

 

   

seek to attract and retain new and existing skilled personnel;

 

   

create additional infrastructure to support our operations as a public company; and

 

   

experience any delays or encounter issues with any of the above.

We do not expect to generate material revenues from sales of our product candidates unless and until we successfully complete development of, and obtain marketing approval for, one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. Accordingly, we anticipate that we will need to raise additional capital prior to completing clinical development of any of our product candidates. Until such time that we can generate substantial revenues from sales of our product candidates, if ever, we expect to finance our operating activities through a combination of milestone payments received pursuant to our strategic alliances, equity offerings, debt financings, government or other third-party funding and collaborations, and licensing arrangements. However, we may be unable to raise additional funds or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our development programs or commercialization efforts or grant to others rights to develop or market product candidates that we would otherwise prefer to develop and market ourselves. Failure to receive additional funding could cause us to cease operations, in part or in full.

Our consolidated financial statements for 2018 and 2019 have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.

 

50


Results of Operations

Comparison for the six-month periods ended June 30, 2018 and 2019

Revenues.

 

     For the six-month period
ended June 30,
     % change     % change at U.S.
dollar-euro
constant rate*
 
     2018      2019      2019 vs 2018  

Collaboration agreements

     9,842        724        -92.6     -92.1

Other revenues

     1,234        1,464        18.7     27.2

Revenues

     11,076        2,188        -80.2     -78.8

 

*

the percentage of change at constant rate has been calculated based on the average rate of the six-month period ended June 30, 2019

The decrease in revenues of $8.9 million, or 80.2%, between the six-month periods ended June 30, 2018 and 2019 primarily reflects (i) a decrease of $9.1 million in revenues under our collaboration agreements of which $7.3 million relates to a decrease in recognition of upfront fees already paid to Cellectis, and (ii) a $0.3 million decrease of licensing revenues, partially offset by a $0.6 million increase in Calyxt revenue primarily attributable to the commercialization of Calyxt’s first products, High Oleic Soybean Oil and High Oleic Soybean Meal.

 

     For the six-month period
ended June 30,
     % change     % change at U.S.
dollar-euro
constant rate
 
     2018      2019      2019 vs 2018  

Research tax credit

     5,283        4,172        -21.0     -15.4

Other income

     57        —          -100.0     -100.0

Other income

     5,340        4,172        -21.9     -16.3

The decrease in other income of $1.2 million, or 21.9%, between the six-month periods ended June 30, 2018 and 2019 reflects a decrease of $1.1 million in research tax credits, due to timing in invoicing of research and development purchases and external expenses during the six-month period ended June 30, 2019 that are eligible for the tax credit.

Cost of revenue

 

     For the six-month period
ended June 30,
     % change     % change at U.S.
dollar-euro
constant rate
 
     2018      2019      2019 vs 2018  

Cost of goods sold

     —           (337      n.a       n.a  

Royalty expenses

     (1,138      (1,066      -6.4     0.3

Cost of revenue

     (1,138      (1,403      23.2     32.1

The increase in cost of goods sold of $0.3 million between the six-month periods ended June 30, 2018 and 2019 relating to the commercial launch of Calyxt’s products. Calyxt’s cost of goods sold in the period reflect supply chain costs associated with the processing and transportation of grain that was purchased prior to commercialization as well as certain costs incurred to process and handle grain following commercialization. Calyxt recorded a reserve of $0.1 million for seed returns.

 

51


Research and development expenses.

 

     For the six-month period
ended June 30,
     % change     % change at U.S.
dollar-euro
constant rate
 
     2018      2019      2019 vs 2018  

Personnel expenses

     (17,075      (15,049      -11.9     -5.5

Purchases, external expenses and other

     (19,366      (24,938      28.8     38.0

Research and development expenses

     (36,441      (39,987      9.7     17.6

During the six-month period ended June 30, 2019, research and development expenses increased by $3.5 million, or 9.7%, compared to the six-month period ended June 30, 2018. Purchases and external expenses and other increased by $5.6 million from $19.4 million in 2018 to $24.9 million in 2019 of which $4.5 million relates to Cellectis due to increased spending on research and development and a provision of loss contract of $0.7 million, and $1.1 million relates to Calyxt. Personnel expenses decreased by $2.0 million from $17.1 million in 2018 to $15.0 million in 2019 primarily due to a $5.2 million decrease in non-cash stock based compensation expense partly offset by (i) a $1.8 million increase in wages and salaries explained by an increase in R&D headcount in both therapeutic and plants activities and (ii) a $1.3 million increase in social charges on stock option grants.

Selling, general and administrative expenses.

 

     For the six-month period
ended June 30,
     % change     % change at U.S.
dollar-euro
constant rate
 
     2018      2019      2019 vs 2018  

Personnel expenses

     (16,990      (15,111      -11.1     -4.7

Purchases, external expenses and other

     (8,235      (8,198      -0.4     6.7

Selling, general and administrative expenses

     (25,224      (23,309      -7.6     -1.0

During the six-month period ended June 30, 2019, selling, general and administrative expenses decreased of $1.9 million, or 7.6%, compared to the six-month period ended June 30, 2018. The decrease primarily reflects a decrease of $1.9 million in personnel expenses from $17.0 million in 2018 to $15.1 million in 2019, attributable to a decrease of $4.0 million in non-cash stock based compensation, partially offset by (i) an increase of $1.7 million in wage and salaries and (ii) an increase of $0.5 million in social charges on stock option grants.

Other operating income and expenses.

 

     For the six-month period
ended June 30,
     % change     % change at U.S.
dollar-euro
constant rate
 
     2018      2019      2019 vs 2018  

Other operating income (expenses)

     (171      29        -117.1     -118.3

For the six-month period ended June 30, 2019, no material item included in other operating income and expenses.

For the six-month period ended June 30, 2018, other operating income (expenses) primarily include social charges on compensation paid to a former employee.

 

52


Financial gain (loss).

 

     For the six-month period
ended June 30,
     % change     % change at U.S.
dollar-euro
constant rate
 
     2018      2019      2019 vs 2018  

Financial income

     12,996        5,643        -56.6     -53.5

Financial expenses

     (2,955      (1,795      -39.3     -34.9

Financial gain (loss)

     10,040        3,849        -61.7     -58.9

The decrease in financial income of $7.4 million, or 56.6%, between the six-month periods ended 2018 and 2019 was mainly attributable to $8.9 million in foreign exchange gain (from a $10.1 million gain in 2018 to a $1.2 million gain in 2019), partially offset by the increase of interest received from financial investment for $1.3 million and the increase in fair value adjustment for $0.2 million.

The decrease in financial expenses of $1.2 million, or 39.3%, between the six-month periods ended 2018 and 2019 was mainly attributable to $1.0 million decrease in foreign exchange loss (from a $1.4 million loss in 2018 to a $0.4 million loss in 2019), the decrease in fair value adjustment for $1.3 million and other immaterial variances for $0.1 million, partially offset by $1.2 million increase in financial expenses related to IFRS16 application.

Net income (loss)

 

     For the six-month period
ended June 30,
     % change     % change at U.S.
dollar-euro
constant rate
 
     2018      2019      2019 vs 2018  

Net income (loss)

     (36,518      (54,461      49.1     59.8

The increase in net loss of $17.9 million between the six-month period ended June 30, 2018 and 2019 was mainly due to (i) a $10.1 million decrease in revenues and other income, (ii) a $6.2 million decrease in financial gain, (iii) a $5.5 million increase in purchases and external expenses and others, (iv) a $3.5 million increase in wages and salaries, (v) a $1.8 million increase in social charges on free shares and stock option grants, (vi) a $0.3 million increase in cost of goods sold, partially offset by a $9.2 million decrease in non-cash stock based compensation expense, and other immaterial variances for $0.3 million.

Non-controlling interests

 

     For the six-month period
ended June 30,
     % change     % change at U.S.
dollar-euro
constant rate
 
     2018      2019      2019 vs 2018  

Gain (loss) attributable to non-controlling interests

     (4,096      (5,670      38.4     48.3

During the six-month period ended June 30, 2019, we recorded $5.7 million in loss attributable to non-controlling interests. The increase in net loss attributable to non-controlling interests of $1.6 million is a result of increase in Calyxt’s net loss.

 

53


Segment Results

Information related to each of our reportable segments is set out below. Segment revenues and other income, research and development expenses, selling, general and administrative expenses, and royalties and other operating income and expenses, and adjusted net income (loss) attributable to shareholders of Cellectis (which does not include non-cash stock-based expense) are used by the CODM for purposes of making decisions about allocating resources to the segments and assessing their performance. The CODM does not review any asset or liability information by segment or by region.

Adjusted net income (loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. Because adjusted net income (loss) attributable to shareholders of Cellectis excludes non-cash stock-based compensation expense—a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure.

There are inter-segment transactions between the two reportable segments, including the allocation of corporate general and administrative expenses by Cellectis S.A. and the allocation of research and development expenses among the reportable segments. With respect to corporate general and administrative expenses, Cellectis S.A. provides Calyxt, Inc. with general sales and administrative functions, accounting and finance functions, investor relations, intellectual property, legal advice, human resources, communication and information technology pursuant to a management services agreement. Under the management services agreement, Cellectis S.A. charges Calyxt, Inc. in euros at cost plus a mark-up ranging between zero to 10%, depending on the nature of the service. Amounts due to Cellectis S.A. pursuant to inter-segment transactions bear interest at a rate of 12-month Euribor plus 5% per annum.

The intersegment revenues represent the transactions between segments. Intra-segment transactions are eliminated within a segment’s results and intersegment transactions are eliminated in consolidation as well as in key performance indicators by reportable segment.

 

54


The following table summarizes segment revenues and segment operating profit (loss) for the six-month periods ended June 30, 2018 and 2019:

 

     For the six-month period ended
June 30, 2018
    For the six-month period ended
June 30, 2019
 
$ in thousands    Plants     Therapeutics     Total
reportable
segments
    Plants     Therapeutics     Total
reportable
segments
 

External revenues

     207       10,869       11,076       566       1,623       2,188  

External other income

     —         5,340       5,340       125       4,047       4,172  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     207       16,209       16,417       691       5,669       6,360  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of revenue

     (1     (1,137     (1,138     (337     (1,066     (1,403

Research and development expenses

     (3,360     (33,081     (36,441     (5,300     (34,688     (39,987

Selling, general and administrative expenses

     (9,382     (15,842     (25,224     (12,542     (10,767     (23,309

Other operating income and expenses

     (21     (150     (171     20       9       29  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (12,764     (50,211     (62,975     (18,158     (46,511     (64,670
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (12,557     (34,002     (46,558     (17,468     (40,842     (58,310
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Financial gain (loss)

     83       9,957       10,040       347       3,502       3,849  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (12,474     (24,044     (36,518     (17,121     (37,340     (54,461
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non controlling interests

     4,096       —         4,096       5,670       —         5,670  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to shareholders of Cellectis

     (8,377     (24,044     (32,422     (11,451     (37,340     (48,791
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

R&D non-cash stock-based expense attributable to shareholder of Cellectis

     535       8,554       9,089       592       3,294       3,886  

SG&A non-cash stock-based expense attributable to shareholder of Cellectis

     2,480       8,177       10,657       3,215       3,008       6,223  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjustment of share-based compensation attributable to shareholders of Cellectis

     3,015       16,730       19,746       3,808       6,302       10,109  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income (loss) attributable to shareholders of Cellectis

     (5,362     (7,314     (12,676     (7,643     (31,039     (38,682
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (371     (900     (1,271     (758     (2,457     (3,215

Additions to tangible and intangible assets

     620       631       1,251       1,172       3,425       4,597  

We allocate the share-based compensation to the share-related entity, (rather than the entity related to the employee that benefited from such compensation), considering that the share-based compensation is linked to entity’s performance. Consequently, all share-based compensation based on Cellectis shares is charged in the Therapeutics segment, even if some Calyxt employees are included in a Cellectis stock-option plan.

 

55


Therapeutics segment

External revenues and other income in our Therapeutics segment decreased by $10.5 million, from $16.2 million for the six-month period ended June 30, 2018, to $5.7 million the six-month period ended June 30, 2019. The decrease was primarily due to a decrease of $9.1 million in collaboration agreement revenues, as described in sections “Revenues” and “Other income” under “Results of Operation” for the consolidated Group.

The decrease in total operating expenses of $3.7 million from the six-month period ended June 30, 2018 to the six-month period ended June 30, 2019 resulted primarily from (i) lower personnel expenses, attributable, to a decrease of $10.4 million in non-cash stock-based compensation expenses partially offset by an increase of $0.6 million in personnel wages and salaries and an increase of $1.8 million in social charges on stock option grants and (ii) an increase of $4.5 million in purchases and external purchases and other expenses partially offset by a decrease of $0.2 million on other operating income and expenses and royalty expenses.

Operating loss before tax for our Therapeutics segment increased by $6.8 million from the six-month period ended June 30, 2018 to the six-month period ended June 30, 2019.

Adjusted net loss attributable to shareholders of Cellectis for our Therapeutics segment increased by $23.7 million from the six-month period ended June 30, 2018 to the six-month period ended June 30, 2019.

Plants segment

External revenues and other income in our Plants segment increased by $0.5 million from $0.2 million for the six-month period ended June 30, 2018 to $0.7 million for the six-month period ended June 30, 2019 due to the commercial launch of Calyxt’s initial High Oleic Soybean products.

The increase in total operating expenses of $5.4 million from the six-month period ended June 30, 2018 to the six-month period ended June 30, 2019 resulted primarily from an increase in Calyxt’s commercialization activities, which contributed to (i) an increase of $4.1 million in personnel expenses, that includes an increase of $2.9 million in personnel wages and salaries, (ii) an increase of $1.2 million in non-cash stock based compensation expense, (iii) an increase of $1.0 million in purchase and external expenses and other, and (iv) an increase of $0.3 million in cost of goods sold.

Operating loss before tax for our Plants segment increased by $4.9 million from the six-month period ended June 30, 2018 to the six-month period ended June 30, 2019.

Adjusted net loss attributable to shareholders of Cellectis for our Plants segment increased by $2.3 million from the six-month period ended June 30, 2018 to the six-month period ended June 30, 2019.

 

56


Liquidity and Capital Resources

Introduction

We have incurred losses and cumulative negative cash flows from operations since our inception in 2000, and we anticipate that we will continue to incur losses for at least the next several years. We expect that our research and development and selling, general and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

We have funded our operations since inception primarily through private and public offerings of our equity securities, grant revenues, payments received under intellectual property licenses, reimbursements of research tax credit claims and payments under our strategic collaboration agreements.

Our ordinary shares have been traded on the Euronext Growth market of Euronext in Paris since February 7, 2007 and our ADSs have traded on the Nasdaq Global Market in New York since March 30, 2015.

Liquidity management

As of June 30, 2019, we had current financial assets and cash and cash equivalents of $397.4 million comprising cash and cash equivalents of $397.0 million and current financial assets of $0.4 million exclusively composed by current restricted cash. Long term restricted cash amounts to $3.6 million.

Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts, money market funds, fixed bank deposits primarily in France.

As of June 30, 2019, $266.8 million of our cash and cash equivalents are denominated in U.S. dollars and $0.4 million of our current financial assets are denominated in U.S. dollars.

Commodity Price Risk

Calyxt enters into purchase agreements for grain with settlement values based on commodity futures market prices. These agreements allow Calyxt’s counterparty to fix their sale prices to Calyxt at various times as defined in the contract. Calyxt may hedge these exposures to either fix prices for variable exposures or convert fixed prices to variable prices through the use of commodity derivative contracts. The notional amount of commodity derivative contracts as of June 30, 2019 was $1.8 million and the fair value was $0.2 million.

Calyxt has designated all of its commodity derivative contracts as cash flow hedges. As a result, all gains or losses associated with marking the commodity derivative contracts to market (fair value) are recorded as a component of other comprehensive income (OCI). Calyxt reclassifies amounts from OCI to inventory when grain is delivered to Calyxt. At the point the inventory is sold, the related transfer from OCI will be expensed and will impact earnings. As of June 30, 2019, Calyxt expects the entire OCI balance related to cash flow hedges to be reclassified into earnings within the next 12 months.

 

57


Historical Changes in Cash Flows

The table below summarizes our sources and uses of cash for the six-month periods ended June 30, 2018 and 2019:

 

     For the six-month period ended
June 30,
 
     2018      2019  
     $ in thousands  

Net cash flows provided by (used in) operating activities

     (32,523      (43,613

Net cash flows provided by (used in) investing activities

     19,304        (7,545

Net cash flows provided by (used in) financing activities

     234,417        (1,999
  

 

 

    

 

 

 

Total

     221,198        (53,157
  

 

 

    

 

 

 

Effect of exchange rate changes on cash

     (6,364      (1,377

For the six-month period ended June 30, 2019, our net cash flows used in operating activities are mainly due to Cellectis cash payments of $23.8 million to suppliers, wages and social expenses of $12.6 million, and Calyxt operating payments of $12.8 million, partially offset by $1.7 million of payments received from Servier and Allogene Therapeutics pursuant to our collaboration agreements, $1.0 million of payments received from licenses, $4.1 million of interest received and $0.4 million of VAT and other taxes reimbursement as well as other variances. For the six-month periods ended June 30, 2018, our net cash flows used in operating activities are mainly due to cash payments of $22.4 million to suppliers, wages and social expenses of $10.5 million, rent payments of $2.6 million and $9.8 million of other operating payments and Calyxt’s suppliers, partially offset by $3.3 million of payments received from Servier and Pfizer pursuant to our collaboration agreements, $0.5 million of payments received from licenses and $2.2 million of VAT and other taxes reimbursement as well as other variances.

For the six-month period ended June 30, 2019, our net cash flows used in investing activities primarily reflects (i) our investments in R&D equipment and building fittings in both the United States and France of $4.8 million included $3.7 million of assets under construction relates to Cellectis’ new raw material manufacturing facility in Paris ($1.1 million) and new commercial manufacturing facility in Raleigh, North Carolina ($1.8 million) and the rest relates to the Plants Segment activity, (ii) the reclassification of $2.5 million related to a letter of credit related to our Raleigh facility in non-current financial asset, (iii) a $0.2 million deposit related to a Paris lease extension and equipment lease agreement as well as other variances. For the six-month periods ended June 30, 2018, our net cash used in investing activities primarily reflects our investments in R&D equipment in both the United States and France of $1.2 million, offset by the change in the amount funded under a liquidity contract that we are party to with Natixis Securities for $0.3 million and by the proceeds from current financial assets of $20.2 million.

For the six-month period ended June 30, 2019, our net cash used by financing activities reflects the payments on lease debts for $1.7 million and Calyxt payment of $0.6 million in withholding taxes in connection with the net settlement of RSUs, partially offset by Calyxt stock options exercises during the period for $0.3 million. For the six-month period ended June 30, 2018, our net cash flows provided by financing activities mainly reflects (i) the net proceeds after deducting underwriting discounts and commissions and offering expenses of $178.6 million from the Cellectis follow-on offering and the net proceeds, after deducting underwriting discounts, commissions and offering expenses and the purchase price with respect to 550,000 shares of Calyxt common stock purchased by Cellectis in the offering, of $48.8 million from Calyxt’s follow-on offering, (ii) the exercise of 298,367 Cellectis stock options during the period for $7.2 million, (iii) the exercise of 333,899 Calyxt stock options during the period for $1.2 million and (iv) the subscription of non-employee warrants for $0.2 million, partially offset by (i) Cellectis’ purchase on June 14, 2018 of 63,175 shares of Calyxt common stock from employees and nonemployees of Calyxt and Cellectis at a price of $19,49 per share (the closing price reported on the NASDAQ Global Market on June 14, 2018) for $1.3 million and (ii) the decrease of cash available in our Natixis liquidity contract by $0.3 million.

 

58


Operating capital requirements

To date, we have not generated any revenues from therapeutic. We do not know when, or if, we will generate any revenues from product sales. We do not expect to generate significant revenues from product sales unless and until we obtain regulatory approval of and commercialize one of our current or future product candidates. Calyxt completed their first sales of their High Oleic Soybean Oil and High Oleic Soybean Meal in the first quarter of 2019.

Our cash consumption is driven by our internal operational activities; our outsourced activities, including preclinical activities and manufacturing activities; payments to clinical research centers and contract research organizations involved in our clinical trials; and annual payment and royalty expenses related to our in-licensing agreements. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products.

We also anticipate substantial expenses related to audit, legal, regulatory and tax-related services associated with our public company obligations in the United States and our continued compliance with applicable U.S. exchange listing and SEC requirements. We anticipate that we will need additional funding in connection with our continuing operations, including for the further development of our existing product candidates and to pursue other development activities related to additional product candidates.

We believe our cash and cash equivalents, our cash flow from operations (including payments we expect to receive pursuant to our collaboration agreements) and government funding of research programs will be sufficient to fund our operations through 2021. However, we may require additional capital for the further development of our existing product candidates and may also need to raise additional funds sooner to pursue other development activities related to additional product candidates.

Until we can generate a sufficient amount of revenues from our products, if ever, we expect to finance a portion of future cash needs through public or private equity or debt offerings. Additional capital may not be available on reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and these securities may have rights senior to those of our ordinary shares. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects.

Our assessment of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

 

   

the initiation, progress, timing, costs and results of pre-clinical and clinical studies for our product candidates;

 

   

the initiation, progress, timing, costs and results of field trials for our agricultural product candidates;

 

   

the capacity of manufacturing our products in France and in United States;

 

   

the outcome, timing and cost of regulatory approvals by U.S. and non-U.S. regulatory authorities, including the possibility that regulatory authorities will require that we perform more studies than those that we currently expect;

 

   

the ability of our product candidates to progress through clinical development successfully;

 

   

the ability of our agricultural product candidates to progress through late stage development successfully, including through field trials;

 

   

the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

 

   

our need to expand our research and development activities;

 

59


   

our need and ability to hire additional personnel;

 

   

our need to implement additional infrastructure and internal systems, including manufacturing processes for our product candidates;

 

   

the effect of competing technological and market developments; and

 

   

the cost of establishing sales, marketing and distribution capabilities for any products for which we may receive regulatory approval.

If we cannot expand our operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition and results of operations could be materially adversely affected.

Off-Balance Sheet Arrangements.

Calyxt entered into seed and grain production agreements with settlement value based on commodity market future pricing. Otherwise, we do not have any off-balance sheet arrangements as defined under SEC rules.

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risks

For quantitative and qualitative disclosures about market risk that affect us, see “Quantitative and Qualitative Disclosures About Market Risk in Item 11 of Part I of the Annual Report. Our exposure to market risk has not changes materially since December 31, 2018.

 

Item 4.

Controls and Procedures

We must maintain effective internal control over financial reporting in order to accurately and timely report our results of operations and financial condition. In addition, as a public company, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, requires, among other things, that we assess the effectiveness of our disclosure controls and procedures and the effectiveness of our internal control over financial reporting at the end of each fiscal year. We issued management’s annual report on internal control over financial reporting, pursuant to Section 404 of the Sarbanes-Oxley Act, as of December 31, 2018.

There have been no changes in the Company’s internal control over financial reporting during the six-month period ended June 30, 2019, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

60


PART II – OTHER INFORMATION

 

Item 1.

Legal Proceedings

From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

 

Item 1A.

Risk Factors

There have been no material changes from the risk factors previously disclosed in the Annual Report.

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

None

 

Item 3.

Defaults Upon Senior Securities

None.

 

Item 4.

Mine Safety Disclosures

Not Applicable.

 

Item 5.

Other Information

None.

 

Item 6.

Exhibits

None.

 

61