0001193125-16-775254.txt : 20161122 0001193125-16-775254.hdr.sgml : 20161122 20161122171332 ACCESSION NUMBER: 0001193125-16-775254 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20161122 FILED AS OF DATE: 20161122 DATE AS OF CHANGE: 20161122 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cellectis S.A. CENTRAL INDEX KEY: 0001627281 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: I0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36891 FILM NUMBER: 162014036 BUSINESS ADDRESS: STREET 1: 8 RUE DE LA CROIX JARRY CITY: PARIS, LLE-DE-FRANCE STATE: I0 ZIP: 75013 BUSINESS PHONE: 33181691600 MAIL ADDRESS: STREET 1: 8 RUE DE LA CROIX JARRY CITY: PARIS, LLE-DE-FRANCE STATE: I0 ZIP: 75013 6-K 1 d285339d6k.htm 6-K 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

of the Securities Exchange Act of 1934

Date of Report: November 22, 2016

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by reference in the registration statement on Form F-3 (No. 333-211202) of Cellectis S.A., to the extent not superseded by documents or reports subsequently filed.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 nine-month periods ended September 30, 2016.


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)

November 22, 2016     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 nine-month periods ended September 30, 2016.
EX-99.1 2 d285339dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

PRELIMINARY NOTE

These unaudited condensed Interim Consolidated Financial Statements for the three-month and nine-month periods ended September 30, 2016 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 euros. All references in this interim report to “$,” “US$,” “U.S.$,” “U.S. dollars,” “dollars,” and “USD” 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 21, 2016 (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.

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.


INDEX

 

PART I – FINANCIAL INFORMATION

     3   

Item 1.

 

Condensed Financial Statements (Unaudited)

     3   

Item 2.

 

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

     29   

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risks

     38   

Item 4.

 

Controls and Procedures

     39   

PART II – OTHER INFORMATION

     39   

Item 1.

 

Legal Proceedings

     39   

Item 1A.

 

Risk Factors

     39   

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

     39   

Item 3.

 

Defaults Upon Senior Securities

     39   

Item 4.

 

Mine Safety Disclosures

     40   

Item 5.

 

Other Information

     40   

Item 6.

 

Exhibits

     40   

 

2


PART I – FINANCIAL INFORMATION

 

Item 1. Condensed Financial Statements (Unaudited)

Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED FINANCIAL POSITION

€ in thousands

 

          As of  
     Notes    December 31, 2015     September 30, 2016  
ASSETS        

Non-current assets

       

Intangible assets

        956        1,180   

Property, plant, and equipment

   6      5,043        15,141   

Other non-current financial assets

        845        612   
     

 

 

   

 

 

 

Total non-current assets

        6,844        16,933   

Current assets

       

Inventories and accumulated costs on orders in process

        158        106   

Trade receivables

        6,035        11,382   

Subsidies receivables

   7      9,102        14,535   

Other current assets

   8      4,685        7,252   

Current financial assets

   9.1      —          77,665   

Cash and cash equivalents

   9.2      314,238        186,303   
     

 

 

   

 

 

 

Total current assets

        334,218        297,243   
     

 

 

   

 

 

 

TOTAL ASSETS

        341,062        314,177   
     

 

 

   

 

 

 
LIABILITIES        

Shareholders’ equity

       

Share capital

   10      1,759        1,767   

Premiums related to the share capital

   10      420,682        460,474   

Treasury share reserve

        (184     (373

Currency translation adjustment

        (1,631     (1,933

Retained earnings

        (137,188     (158,032

Net income (loss)

        (20,544     (48,309
     

 

 

   

 

 

 

Total shareholders’ equity - Group Share

        262,894        253,595   

Non-controlling interests

        725        1,471   
     

 

 

   

 

 

 

Total shareholders’ equity

        263,619        255,066   

Non-current liabilities

       

Non-current financial liabilities

   12.1      66        37   

Non-current provisions

   14      437        581   
     

 

 

   

 

 

 

Total non-current liabilities

        503        619   
     

 

 

   

 

 

 

Current liabilities

       

Current financial liabilities

   12.1      1,921        1,922   

Trade payables

        6,611        9,176   

Deferred revenues and deferred income

   13      54,758        41,893   

Current provisions

   14      953        467   

Other current liabilities

   15      12,697        5,034   
     

 

 

   

 

 

 

Total current liabilities

        76,940        58,492   
     

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

        341,062        314,177   
     

 

 

   

 

 

 

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

 

3


Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED OPERATIONS

For the nine months ended September 30,

€ in thousands, except per share amounts

 

          For the nine-month period
ended September 30,
 
     Notes    2015     2016  

Revenues and other income

       

Revenues

   16.1      23,356        32,892   

Other income

   16.1      3,845        6,053   
     

 

 

   

 

 

 

Total revenues and other income

        27,201        38,945   
     

 

 

   

 

 

 

Operating expenses and other operating income (expenses)

       

Royalty expenses

        (1,153     (1,035

Research and development expenses

   17.1      (36,375     (52,220

Selling, general and administrative expenses

   17.1      (19,145     (27,839

Other operating income

        515        380   

Redundancy plan

   14      259        3   

Other operating expenses

        (432     (216
     

 

 

   

 

 

 

Total operating expenses and other operating income (expenses)

        (56,331     (80,926
     

 

 

   

 

 

 

Operating income (loss)

        (29,130     (41,981
     

 

 

   

 

 

 

Financial gain (loss)

        515        (6,328
     

 

 

   

 

 

 

Net income (loss)

        (28,615     (48,309
     

 

 

   

 

 

 

Attributable to shareholders of Cellectis

        (28,786     (48,309

Attributable to non-controlling interests

        171        —     

Basic / Diluted earnings per share attributable to shareholders of Cellectis

   18.1     

Basic earnings per share (€ /share)

        (0.85     (1.37

Diluted earnings per share (€ /share)

        (0.85     (1.37

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

 

4


UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE INCOME

For the nine months ended September 30,

€ in thousands

 

     For the nine-month period
ended September 30,
 
     2015     2016  

Net income (loss)

     (28,615     (48,309
  

 

 

   

 

 

 

Actuarial gains and losses

     36        (94
  

 

 

   

 

 

 

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

     36        (94
  

 

 

   

 

 

 

Currency translation adjustment

     (1,429     (320
  

 

 

   

 

 

 

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

     (1,429     (320
  

 

 

   

 

 

 

Total Comprehensive income (loss)

     (30,008     (48,723
  

 

 

   

 

 

 

Attributable to shareholders of Cellectis

     (30,114     (48,705

Attributable to non-controlling interests

     106        (18

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

 

5


Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED OPERATIONS

For the three months ended September 30,

€ in thousands, except per share amounts

 

            For the three-month period
ended September 30,
 
     Notes      2015     2016  

Revenues and other income

       

Revenues

     16.2         7,600        10,091   

Other income

     16.2         2,379        1,215   
     

 

 

   

 

 

 

Total revenues and other income

        9,978        11,306   
     

 

 

   

 

 

 

Operating expenses and other operating income (expenses)

       

Royalty expenses

        (334     (311

Research and development expenses

     17.2         (16,156     (13,824

Selling, general and administrative expenses

     17.2         (6,921     (8,712

Other operating income

        —          (6

Redundancy plan

        24        3   

Other operating expenses

        (37     (10
     

 

 

   

 

 

 

Total operating expenses and other operating income (expenses)

        (23,425     (22,860
     

 

 

   

 

 

 

Operating income (loss)

        (13,447     (11,555
     

 

 

   

 

 

 

Financial gain (loss)

        680        (1,035
     

 

 

   

 

 

 

Net income (loss)

        (12,766     (12,590
     

 

 

   

 

 

 

Attributable to shareholders of Cellectis

        (12,766     (12,590

Attributable to non-controlling interests

        —          —     

Basic / Diluted earnings per share attributable to shareholders of Cellectis

     18.2        

Basic earnings per share (€ /share)

        (0.36     (0.36

Diluted earnings per share (€ /share)

        (0.36     (0.36

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

 

6


UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE INCOME

For the three months ended September 30,

€ in thousands

 

     For the three-month period
ended September 30,
 
     2015     2016  

Net income (loss)

     (12,766     (12,590
  

 

 

   

 

 

 

Actuarial gains and losses

     1        —     
  

 

 

   

 

 

 

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

     1        —     
  

 

 

   

 

 

 

Currency translation adjustment

     (635     (429
  

 

 

   

 

 

 

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

     (635     (429
  

 

 

   

 

 

 

Total Comprehensive income (loss)

     (13,399     (13,019
  

 

 

   

 

 

 

Attributable to shareholders of Cellectis

     (13,399     (13,013

Attributable to non-controlling interests

     —          (6

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

 

7


Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED CASH FLOWS

For the nine months ended September 30,

€ in thousands

 

          For the nine-month period
ended September 30,
 
     Notes    2015     2016  

Cash flows from operating activities

       
     

 

 

   

 

 

 

Net loss for the period

        (28,615     (48,309
     

 

 

   

 

 

 

Reconciliation of net loss and of the cash used for operating activities

          —     

Adjustments for

          —     

Amortization and depreciation

        1,228        1,457   

Net loss on disposals

        27        11   

Net finance expenses (revenue)

        (515     6,330   

Expenses related to share-based payments

        17,481        39,911   

Provisions

        (618     (441

Interest (paid) / received

        707        1,540   
     

 

 

   

 

 

 

Operating cash flows before change in working capital

        (10,305     499   
     

 

 

   

 

 

 

Decrease (increase) in inventories

        (43     52   

Decrease (increase) in trade receivables and other current assets

        2,775        (8,076

Decrease (increase) in subsidies receivables

        785        (6,191

(Decrease) increase in trade payables and other current liabilities

        564        (4,244

(Decrease) increase in deferred income

        (15,758     (12,846
     

 

 

   

 

 

 

Change in working capital

        (11,678     (31,305
     

 

 

   

 

 

 

Net cash flows provided by (used in) operating activities

        (21,983     (30,806
     

 

 

   

 

 

 

Cash flows from investment activities

       

Proceeds from disposal of property, plant and equipment

        50        —     

Sale (Acquisition) of subsidiaries net of cash disposed of

        (2,850     —     

Acquisition of intangible assets

        (39     (302

Acquisition of property, plant and equipment

        (3,316     (11,259

Net change in non-current financial assets

        84        192   

Acquisition of current financial assets

   9.1      —          (78,787
     

 

 

   

 

 

 

Net cash flows provided by (used in) investing activities

        (6,070     (90,156
     

 

 

   

 

 

 

Cash flows from financing activities

       

Increase in share capital net of transaction costs

        196,804        648   

Decrease in borrowings

        (1,054     (74

Treasury shares

        (89     (189
     

 

 

   

 

 

 

Net cash flows provided by (used in) financing activities

        195,661        385   
     

 

 

   

 

 

 

(Decrease) increase in cash

        167,608        (120,577
     

 

 

   

 

 

 

Cash and cash equivalents at the beginning of the year

        112,347        314,238   

Effect of exchange rate changes on cash

        (599     (7,358
     

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

   9.2      279,356        186,303   
     

 

 

   

 

 

 

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

 

8


Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CHANGES IN CONSOLIDATED SHAREHOLDERS’ EQUITY

€ in thousands, except share data

 

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

As of January 1, 2015

      29,446,721        1,472        192,842        (251     (762     (132,536     20        60,787        (1,259     59,528   

Net Loss

          —          —          —          —          (28,786     (28,786     171        (28,615

Other comprehensive income (loss)

          —          —          (1,362     34        —          (1,328     (65     (1,393
       

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income (loss)

          —          —          (1,362     34        (28,786     (30,114     106        (30,008

Allocation of prior period loss

      —          —          —          —          —          20        (20     —          —          —     

Capital Increase

    10        5,500,000        275        194,387        —          —          (3     —          194,659        —          194,659   

Purchase of non-controlling interests

      —          —          —          —          —          (4,653     —          (4,653     1,153        (3,500

Treasury shares

      —          —          —          (89     —          —          —          (89     —          (89

Exercise of share warrants and employee warrants

    10        153,997        8        1,496        —          —          (3     —          1,501        —          1,501   

Share based compensation

      —          —          17,218        —          —          —          —          17,218        262        17,480   
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of September 30, 2015

      35,100,718        1,755        405,943        (340     (2,124     (137,140     (28,786     239,307        262        239,570   
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of January 1, 2016

      35,178,614        1,759        420,682        (184     (1,632     (137,188     (20,544     262,894        725        263,619   

Net Loss

        —          —          —          —          —          (48,309     (48,309     —          (48,309

Other comprehensive income (loss)

        —          —          —          (302     (94     —          (395     (18     (413
     

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income (loss)

          —          —          (302     (94     (48,309     (48,705     (18     (48,723

Allocation of prior period loss

      —          —          —          —          —          (20,544     20,544        —          —          —     

Treasury shares

      —          —          —          (189     —          —          —          (189     —          (189

Exercise of share warrants and employee warrants

    10        154,958        8        646        —          —          (5     —          648        —          648   

Share based compensation

      —          —          39,147        —          —          —          —          39,147        764        39,911   

Other movements

      —          —          —          —          —          (201     —          (201     —          (201
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of September 30, 2016

      35,333,572        1,767        460,474        (373     (1,933     (158,032     (48,309     253,594        1,471        255,066   
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

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

 

9


NOTES TO THE UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2016

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 gene-editing company, employing our core proprietary technologies to develop products in the emerging 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 cancers. Our gene-editing technologies allow us to create allogeneic CAR T-cells, meaning they are derived from healthy donors rather than the patients themselves. 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 view our operations and manage our business in two operating and reportable segments that are engaged in the following activities: (1) Therapeutics, which is focused on the development of products in the field of immuno-oncology and of novel therapies outside immuno-oncology to treat other human diseases; (2) Plants, which is focused on the development of new generation plant products in the field of agricultural biotechnology on our own or through alliances with other companies in the agricultural industry.

Note 2. Basis of presentation and statement of compliance

All financial information (unless indicated otherwise) is presented in thousands of euros.

2.1 Compliance with the IFRS accounting framework

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”).

The Interim Consolidated Financial Statements as of and for the three-month and nine-month periods ended September 30, 2016 have been prepared in accordance with IAS 34 Interim Financial Reporting, as endorsed by the International Accounting Standards Board (“IASB”).

The Interim Consolidated Financial Statements as of and for the three-month and nine-month periods ended September 30, 2016 have been prepared using the same accounting policies and methods as those applied for the year ended December 31, 2015.

These Interim Consolidated Financial Statements as of and for the three-month and nine-month periods ended September 30, 2016 were approved by our Board of Directors on November 22, 2016.

 

10


Cellectis reclassified certain expenses related to the year ended December 31, 2015 from SG&A expenses to R&D expenses in the fourth quarter of 2015. This reclassification is effective starting in 2015, and is due to the increased level of efforts towards our R&D activities in order to develop product candidates and work toward clinical phases. Starting in 2015, we classify personnel and other costs related to information technology, human resources, business development, legal, intellectual property and general management in Research and development expenses based on the time that employees spent contributing to research and development activities versus general and administrative activities. We approved the reclassification in Q4 2015 and assess the performance of the consolidated company based on this new classification.

 

     Three-month period ended      Nine-month
period ended
 
     March 31,
2015
     June 30,
2015
     September 30,
2015
     September 30,
2015
 
    

€ in thousands

 

Expenses reclassified from SG&A to R&D

     (1,836      (2,216      (2,681      (6,733

R&D expenses as reported

     (5,600      (10,565      (13,476      (29,641

R&D expenses as amended

     (7,436      (12,782      (16,157      (36,375

SG&A expenses as reported

     (7,195      (9,082      (9,602      (25,879

SG&A expenses as amended

     (5,359      (6,865      (6,921      (19,145

2.2 Application of new or amended standards or new amendments

The following pronouncements and related amendments have been adopted by us from January 1, 2016 but had no significant impact on the Interim Consolidated Financial Statements:

 

    The Annual Improvements to IFRSs for the 2012-2014 Cycle.

 

    Disclosure Initiative (Amendments to IAS1)

 

    IFRS 9 Financial Instruments

2.3 Standards, interpretations and amendments issued but not yet effective

The following pronouncements and related amendments are applicable for first quarter accounting periods beginning after January 1, 2017. 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.

 

    Amendments to IAS 7 “Statement of Cash Flows”

 

    Amendments to IAS 12 “Income Taxes”

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 is effective for annual reporting periods beginning on or after January 1, 2018, with early adoption permitted. We are assessing the potential impact on our consolidated financial statements resulting from the application of IFRS 15.

In January 2016, the IASB issued IFRS 16 “Leases”, which is effective for annual periods beginning on or after January 1, 2019. This new standard aligns the accounting treatment of operating leases with that already applied to finance leases (i.e. recognition in the balance sheet of future lease payments and the associated rights of use).

Note 3. Consolidated entities

As at December 31, 2015 and for the nine months ended September 30, 2016, the consolidated group of companies (sometimes referred to as the “Group”) includes Cellectis S.A., Cellectis, Inc. and Calyxt, Inc. Cellectis, Inc. and Calyxt, Inc. are fully owned by Cellectis S.A.

 

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Our Interim Consolidated Financial Statements for the nine months ended September 30, 2015 include the operations of Cellectis S.A.; our two French subsidiaries, Cellectis Bioresearch and Ectycell; our three U.S. subsidiaries, Calyxt, Inc., Cellectis, Inc. and Cellectis Bioresearch Inc. Non-controlling shareholders held a 24.5% interest in Cellectis Bioresearch, Cellectis Bioresearch Inc. and Ectycell until May 18, 2015.

The following internal reorganization was completed in 2015:

 

    Ectycell was merged into, and absorbed by Cellectis Bioresearch in August 2015 with retroactive effect as at January 1, 2015 for French tax purposes;

 

    Cellectis Bioresearch was merged into, and absorbed by, Cellectis S.A in December 2015 with retroactive effect as at January 1, 2015 for French tax purposes;

 

    Cellectis Bioresearch Inc. was merged into Cellectis Inc. in September 2015.

Note 4. Reportable segments

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.

Cellectis’ CODM is composed of:

 

    The Chairman and Chief Executive Officer;

 

    The Executive Vice President and Chief Operating Officer;

 

    The Executive Vice President Corporate Development;

 

    The Chief Scientific Officer;

 

    The Chief Financial Officer;

 

    The Vice President Business Development;

 

    The General Counsel; and

 

    The Chief Executive Officer of Calyxt, Inc.

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 of products in the field of immuno-oncology and 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. and Cellectis, 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 applying our gene-editing technologies to develop new-generation plant products in the field of agricultural biotechnology through our own efforts or through alliances with other companies in the agricultural market. It corresponds to the activity of our U.S.-based subsidiary, Calyxt, Inc., which is based in New Brighton, Minnesota.

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

These inter-segment transactions are generally priced based on provisions of service agreements signed between our legal entities, according to which services are to be allocated at cost plus a mark-up of between 4% and 10%, depending on the nature of the service. According to a cash pooling agreement with our subsidiaries, interest is allocated/paid to segments at 12-month Euribor plus 5%.

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 Operating income (loss) before tax (which does not include non-cash stock-based expense) are used by the CODM to measure performance. The CODM does not review any asset or liability information by segment or by region. The Operating income or loss before tax includes the impact of the operations between segments while the intra-segment operations are eliminated.

 

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4.1 Reportable segments for the nine-month period ended September 30, 2016 and 2015

 

     For the nine-month period
ended September 30, 2015
    For the nine-month period
ended September 30, 2016
 
     € in thousands  
     Plants     Therapeutics     Total reportable
segments
    Plants     Therapeutics     Total reportable
segments
 

Segment revenues and other income

     581        28,526        29,107        368        39,975        40,343   

Inter-segment revenues

     —          (1,906     (1,906     (75     (1,324     (1,398
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     581        26,620        27,201        293        38,652        38,945   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Research and development expenses

     (1,635     (34,739     (36,375     (2,765     (49,455     (52,220

Selling, general and administrative expenses

     (883     (18,262     (19,145     (3,022     (24,817     (27,839

Royalties and other operating income and expenses

     (37     (775     (811     (340     (527     (868
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (2,555     (53,776     (56,331     (6,127     (74,799     (80,926
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (1,974     (27,156     (29,130     (5,834     (36,147     (41,981
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (92     (723     (1,228     (134     (1,323     (1,457

Expenses related to share-based payments

     (263     (17,218     (17,481     (987     (38,924     (39,911

Additions to tangible and intangible assets

     232        3,285        3,517        9,222        2,639        11,860   

 

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4.2 Reportable segments for the three-month period ended September 30, 2016 and 2015

 

     For the three-month period
ended September 30, 2015
    For the three-month period
ended September 30, 2016
 
     € in thousands  
     Plants     Therapeutics     Total
reportable
segments
    Plants     Therapeutics     Total
reportable
segments
 

Segment revenues and other income

     146        10,901        11,047        122        11,714        11,836   

Inter-segment revenues

     —          (1,069     (1,069     (29     (502     (530
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     146        9,832        9,978        94        11,212        11,306   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Research and development expenses

     (527     (15,630     (16,157     (896     (12,928     (13,824

Selling, general and administrative expenses

     (66     (6,854     (6,920     (1,135     (7,578     (8,712

Royalties and other operating income and expenses

     (43     (304     (347     (41     (283     (325
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (636     (22,787     (23,424     (2,072     (20,788     (22,860
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (490     (12,956     (13,447     (1,978     (9,576     (11,555
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (36     —          (449     (72     (455     (527

Expenses related to share-based payments

     (100     (9,364     (9,464     (371     (11,743     (12,114

Additions to tangible and intangible assets

     48        329        377        81        365        446   

Note 5. Impairment tests

Our cash-generating units (“CGUs”) correspond to the operating/reportable segments: Therapeutics and Plants. No indicator of impairment has been identified for either of the CGUs for the nine months ended September 30, 2016 or 2015.

 

14


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, 2015

     1,166        1,403        41        —          2,610   

Additions to tangible assets

     1,395        1,763        319        —          3,476   

Disposal of tangible assets

     —          (106     —          —          (106

Depreciation expense

     (339     (720     (61     —          (1,120

Reclassification

     —          (18     18        —          —     

Translation adjustments

     (7     31        (1     —          23   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net book value as of September 30, 2015

     2,215        2,354        315        —          4,884   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross value at end of period

     3,769        10,285        732        —          14,786   

Accumulated depreciation and impairment at end of period

     (1,554     (7,931     (417     —          (9,901
     Lands and
Buildings
    Technical
equipment
    Fixtures,
fittings
and other
equipment
    Assets
under
construction
    Total  
     € in thousands  

Net book value as of January 1, 2016

     1,903        2,661        312        168        5,043   

Additions to tangible assets

     9,537        652        354        912        11,455   

Disposal of tangible assets

     —          —          (1     —          (1

Reclassification

     —          —          —          (11     (11

Depreciation expense

     (481     (662     (135     —          (1,277

Translation adjustments

     (28     (31     (5     (4     (68
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net book value as of September 30, 2016

     10,931        2,619        526        1,065        15,141   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross value at end of period

     13,240        11,067        889        1,065        26,261   

Accumulated depreciation and impairment at end of period

     (2,309     (8,448     (363     —          (11,120

For the nine months ended September 30, 2016, additions to tangible assets includes the purchase by Calyxt, Inc. of a 10-acre parcel of land in Roseville, Minnesota for $5.7 million and the construction of a greenhouse on this land for $4.3 million. On-site operations started during the third quarter of 2016. In addition we made investments and R&D equipment in both the United States and France.

 

15


Note 7. Subsidies receivables

 

     As of December 31,      As of September 30,  
     2015      2016  
     € in thousands  

Research tax credit

     8,227         14,171   

Other subsidies

     1,981         1,470   

Valuation allowance for other subsidies

     (1,106      (1,106
  

 

 

    

 

 

 

Total

     9,102         14,535   
  

 

 

    

 

 

 

Research tax credit receivables as of September 30, 2016 include amounts pursuant to French research tax credits related to the 2014 and 2015 fiscal years, as well as the accrual for a French research tax credit for the nine months ended September 30, 2016.

Note 8. Other current assets

 

     As of December 31,      As of September 30,  
     2015      2016  
     € in thousands  

VAT receivables

     461         488   

Prepaid expenses and other prepayments

     3,778         6,104   

Other current assets

     446         660   
  

 

 

    

 

 

 

Total

     4,685         7,252   
  

 

 

    

 

 

 

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.

 

16


Note 9. Current financial assets and Cash and cash equivalents

 

As of December 31, 2015    Carrying
amount
     Unrealized
Gains/(Losses)
     Estimated fair
value
 
            € in thousands         

Current financial assets

     —           —           —     

Cash and cash equivalents

     314,238         —           314,238   
  

 

 

    

 

 

    

 

 

 

Current financial assets and cash and cash equivalents

     314,238         —           314,238   
  

 

 

    

 

 

    

 

 

 
As of September 30, 2016    Carrying
amount
     Unrealized
Gains/(Losses)
     Estimated fair
value
 
            € in thousands         

Current financial assets

     77,665         —           77,665   

Cash and cash equivalents

     186,303         —           186,303   
  

 

 

    

 

 

    

 

 

 

Current financial assets and cash and cash equivalents

     263,968         —           263,968   
  

 

 

    

 

 

    

 

 

 

9.1 Current financial assets

Current financial assets that are measured at fair value through profit or loss in accordance with IAS 39 include the following:

 

    Financial assets including embedded derivatives for which Cellectis elected to designate at fair value through profit or loss;

 

    Financial assets managed on a fair value basis; and

 

    Derivative instruments that are not documented in hedging relationships.

IFRS 13 (Fair Value Measurement) requires counterparty and own credit risk to be taken into account when measuring the fair value of financial instruments. This risk is estimated on the basis of observable, publicly-available statistical data.

Current financial assets are measured at fair value through profit or loss and are classified as follows within the fair value hierarchy:

 

    Instruments classified under level 1 are measured with reference to quoted prices in active markets; they consist of notes with baskets of fixed income and diversified equity funds, and amount to €77.4 million of such current financial assets as of September 30, 2016;

 

    Instrument classified under level 2 are measured with reference to observable valuation inputs; they consist in zero premium collars and accumulators, and amount to €0.3 million of such current financial assets as of September 30, 2016.

 

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9.2 Cash and cash equivalents

 

     As of December 31,
2015
     As of September 30,
2016
 
     € in thousands  

Cash and bank accounts

     283,877         156,162   

Money market funds

     11,361         11,141   

Fixed bank deposits

     19,000         19,000   
  

 

 

    

 

 

 

Total cash and cash equivalents

     314,238         186,303   
  

 

 

    

 

 

 

Cash and cash equivalents are held for the purpose of meeting short-term cash commitments, rather than for investment or other purposes. 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.

Note 10. Capital

 

Nature of the Transactions

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

Balance as of January 1, 2015

     1,472         192,842         29,446,721         0.05   

Capital increase by issuance of common shares (IPO Nasdaq)

     275         194,387         5,500,000         —     

Capital increase by issuance of ordinary shares (BSA & Free shares)

     8         1,496         153,997         —     

Share based compensation

     —           17,218         —           —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance as of September 30, 2015

     1,755         405,943         35,100,718         0.05   
  

 

 

    

 

 

    

 

 

    

 

 

 

Nature of the Transactions

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

Balance as of January 1, 2016

     1,759         420,682         35,178,614         0.05   

Capital increase by issuance of ordinary shares (BSA, BSPCE and free shares)

     8         646         154,958         —     

Share based compensation

     —           39,147         —           —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance as of September 30, 2016

     1,767         460,474         35,333,572         0.05   
  

 

 

    

 

 

    

 

 

    

 

 

 

Capital evolution during the nine-month period ended September 30, 2016

During the nine months ended September 30, 2016, we issued 56,958 ordinary shares related to the conversion of warrants and 98,000 ordinary shares related to the conversion of free shares.

Note 11. Warrants and share-based payments

The new instruments issued during the nine-month period ended September 30, 2016, are the following:

 

    March 14, 2016, 2,060,602 Cellectis stock options were granted to certain of our employees and officers. Non-cash stock-based compensation expense recorded during the nine months ended September 30, 2016 was €8.0 million.

 

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    March 14, 2016, 229,361 Cellectis warrants were granted to members of our board of directors. Non-cash stock-based compensation expense recorded the nine months ended September 30, 2016 was €0.7 million.

 

    April 7, 2016, 6,850 Calyxt stock options were granted to certain of our employees, officers and consultants. Non-cash stock-based compensation expense recorded during the nine months ended September 30, 2016 was €0.5 million.

Share warrants and employee warrants which are referred to as Bon de Souscription d’Action (“BSAs”) are granted to our board members and consultants.

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 of such options and warrants are granted.

The following tables provide the expenses related to share-based compensation instruments during the three-month and the nine-month periods ended September 30, 2015 and 2016:

Non-cash share-based compensation expense for the nine-month period ended September 30, 2016

 

Non-cash share-based compensation expense    Free
shares
2014 and
before
     Free
shares
2015
     Stock
options
2015
     BSA
2015
     Stock
options
Calyxt
2015
     Stock
options
2016
     BSA
2016
     Stock
options
Calyxt
2016
     Total  
For the nine-month period ended                           
     € in thousands  

September 30, 2015

     287         2,612         13,336         984         263         —           —           —           17,481   

September 30, 2016

     92         4,844         22,938         2,613         238         8,009         651         526         39,911   

Non-cash share-based compensation expense for the three-month period ended September 30, 2016

 

Non-cash share-based compensation expense    Free
shares
2014 and
before
     Free
shares
2015
     Stock
options
2015
     BSA
2015
     Stock
options
Calyxt
2015
     Stock
options
2016
     BSA
2016
     Stock
options
Calyxt
2016
     Total  
For the three-month period ended                           
     € in thousands  

September 30, 2015

     81         1,659         7,014         612         99         —           —           —           9,464   

September 30, 2016

     1         1,525         5,699         731         144         3,628         218         526         12,114   

 

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Detail of Cellectis S.A. stock options issued during the nine-month period ended September 30, 2016

 

Date of grant

   03/14/2016  

Vesting period

     Graded   

Plan expiration date

     03/14/2026   

Number of options granted

     2,060,602   

Share entitlement per options

     1   

Exercise price (in euros per share)

     22.44   

Valuation method used

     Black-Scholes   

Grant date share fair value (in euros per share)

     22.48   

Expected volatility

     62.8

Average life of options

     6.11   

Discount rate

     0.03

Expected dividends

     0

Performance conditions

     n.a   

Fair value per options (in euros per share)

     12.65   

Detail of Cellectis S.A. warrants issued during the nine-month period ended September 30, 2016

 

Date of grant

   03/14/2016  

Vesting period (years)

     3   

Plan expiration date

     03/14/2016   

Number of warrants granted

     229,361   

Share entitlement per warrant

     1   

Exercise price (in euros per share)

     27.37   

Valuation method used

     Black-Scholes   

Grant date share fair value (in euros per share)

     22.48   

Expected volatility

     62.8

Average life of warrant

     6.00   

Discount rate

     0.04

Expected dividends

     0

Performance conditions

     n.a   

Fair value per warrant (in euros per share)

     10.51   

 

20


Detail of Calyxt stock options issued during the nine-month period ended September 30, 2016

 

Date of grant

   04/07/2016  

Vesting period

     Graded   

Plan expiration date

     04/07/2026   

Number of options granted

     6,850   

Share entitlement per options

     1   

Exercise price (in $ per share)

     879   

Valuation method used

     Black-Scholes   

Grant date share fair value (in $ per share)

     879   

Expected volatility

     30.0

Average life of options

     5.74   

Discount rate

     1.41

Expected dividends

     0

Performance conditions

     Trigger event

Fair value per options (in $ per share)

     273   

 

* The plans pursuant to which Calyxt stock options are issued require the occurrence of an IPO or a “triggering event” as a condition for the exercise of vested stock options and, in some circumstances, as a condition to vesting. If the condition is expected to occur during the service period, then it is a non-market performance condition. A triggering event is designed as any transaction that would result in Cellectis losing control of Calyxt, Inc.

The Calyxt options issued on April 7, 2016 shall vest as follows:

C-Level; “VP” and Consultants

With respect to awards of stock options granted to executive-level officers, vice presidents and consultants of Calyxt:

 

    20% of the total Number of Shares on April 7, 2016;

 

    10% of the total Number of Shares on April 7, 2017;

 

    5% of the total Number of Shares on the last day of each calendar quarter beginning from the second quarter 2017;

 

    25% of additional vesting in case of triggering event or initial public offering; and

 

    100% in the event of termination without cause or resignation for good reason in the case of a change of control.

Heads of department and Analysts

With respect to awards of stock options granted to employees designated as “head of” a department within Calyxt or as an analyst:

 

    20% of the total Number of Shares on April 7, 2017;

 

    10% of the total Number of Shares on April 7, 2018;

 

    5% of the total Number of Shares on the last day of each calendar quarter beginning from the second quarter 2018; and

 

    25% of additional vesting in case of triggering event or initial public offering.

 

21


Note 12. Financial liabilities

12.1 Non-current / Current financial liabilities

 

     As of  
     December 31, 2015      September 30, 2016  
     € in thousands  

Finance leases

     64         37   

Other

     2         —     
  

 

 

    

 

 

 

Total non-current financial liabilities

     66         37   
  

 

 

    

 

 

 

Conditional advances

     1,839         1,839   

Finance leases

     82         35   

Derivative instruments

     —           48   
  

 

 

    

 

 

 

Total current financial liabilities

     1,921         1,922   
  

 

 

    

 

 

 

Total Financial liabilities

     1,987         1,959   
  

 

 

    

 

 

 

Conditional advances are payments made to Cellectis by Bpifrance (formerly named OSEO Innovation) to co-finance research programs.

Derivative instruments consist of fair value of zero premium collar instruments.

12.2 Due dates of the financial liabilities

 

Balance as of September 30, 2016    Gross
Amount
     Less than
One Year
     One to Five
Years
     More than
Five Years
 
     € in thousands  

Conditional advances

     1,839         1,839         —           —     

Finance leases

     73         35         37         —     

Derivative instruments

     48         48         —           —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

     1,959         1,922         37         —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Note 13. Deferred revenues and deferred income

 

     As of  
     December 31, 2015      September 30, 2016  
     € in thousands  

Deferred revenues

     54,422         41,694   

Lease incentive

     336         198   
  

 

 

    

 

 

 

Total Deferred revenue and deferred income

     54,758         41,893   
  

 

 

    

 

 

 

 

22


Note 14. Provisions

 

     1/1/2015      Additions      Amounts used
during the
period
    Reversals     Reclassification     09/30/2015  
     € in thousands  

Pension

     398         41         —          —          (64     375   

Litigations

     700         279         (391     (41     —          547   

Redundancy plan

     715         8         (24     (239     (409     51   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total

     1,813         328         (415     (280     (473     973   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Non-current provisions

     398         41         —          —          (64     375   

Current provisions

     1,415         287         (415     (280     (409     598   
     1/1/2016      Additions      Amounts used
during the
period
    Reversals     OCI     09/30/2016  
     € in thousands  

Pension

     437         51         —          —          94        581   

Litigations

     922         356         (535     (294     —          448   

Redundancy plan

     32         —           (9     (4     —          19   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total

     1,391         406         (543     (298     94        1,049   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Non-current provisions

     437         51         —          —          94        581   

Current provisions

     953         356         (543     (298     —          467   

During the nine-month period ended September 30, 2016 we recorded (i) provisions for commercial litigations that amounted to €183 thousand and (ii) provisions for employees’ severance expenses for €173 thousand. Amounts used during the nine-month period ended September 30, 2016 mainly consist of personnel related payments. The reversals relate to (i) ordinary course litigation relating to personnel matters and (ii) the settlement of a commercial litigation matter with a former supplier.

Note 15. Other current liabilities

 

     As of  
     December 31, 2015      September 30, 2016  
     € in thousands  

VAT Payables

     6,314         1,283   

Accruals for personnel related expenses

     3,958         3,107   

Other

     2,425         644   
  

 

 

    

 

 

 

Total

     12,697         5,034   
  

 

 

    

 

 

 

 

23


Note 16. Revenues and other income

16.1 For the nine-month period ended September 30, 2016

 

     For the nine-month period
ended September 30,
 
     2015      2016  
     € in thousands  

From France (Cellectis S.A.)

     22,775         32,599   

From USA (Calyxt, Inc.)

     581         293   
  

 

 

    

 

 

 

Revenues

     23,356         32,892   
  

 

 

    

 

 

 

Research tax credit

     2,845         5,923   

Subsidies and other

     1,000         130   
  

 

 

    

 

 

 

Other income

     3,845         6,053   
  

 

 

    

 

 

 

Total revenues and other income

     27,201         38,945   
  

 

 

    

 

 

 

Revenues by nature

 

     For the nine-month period
ended September 30,
 
     2015      2016  
     € in thousands  

Products & services

     22         65   

Licenses

     1,934         1,824   

Collaboration agreements

     21,400         31,003   
  

 

 

    

 

 

 

Total revenues

     23,356         32,892   
  

 

 

    

 

 

 

16.2 For the three-month period ended September 30, 2016

 

     For the three-month period ended September 30,  
     2015      2016  
     € in thousands  

From France (Cellectis S.A.)

     7,454         9,998   

From USA (Calyxt, Inc.)

     146         93   
  

 

 

    

 

 

 

Revenues

     7,600         10,091   
  

 

 

    

 

 

 

Research tax credit

     1,529         1,195   

Subsidies and other

     849         20   
  

 

 

    

 

 

 

Other income

     2,378         1,215   
  

 

 

    

 

 

 

Total revenues and other income

     9,978         11,306   

 

24


Revenues by nature

 

     For the three-month period ended September 30,  
     2015      2016  
     € in thousands  

Products & services

     6         20   

Licenses

     669         682   

Collaboration agreements

     6,924         9,389   
  

 

 

    

 

 

 

Total revenues

     7,600         10,091   
  

 

 

    

 

 

 

 

25


Note 17. Operating expenses

17.1 For the nine-month period ended September 30, 2016

 

    

For the nine-month period

ended September 30,

 
Research and development expenses    2015      2016  
     € in thousands  

Personnel expenses

     (24,305      (32,661

Purchases and external expenses

     (10,989      (18,583

Other

     (1,081      (976
  

 

 

    

 

 

 

Total research and development expenses

     (36,375      (52,220
  

 

 

    

 

 

 
    

For the nine-month period

ended September 30,

 
Selling, general and administrative expenses    2015      2016  
     € in thousands  

Personnel expenses

     (14,018      (21,434

Purchases and external expenses

     (4,750      (5,794

Other

     (377      (611
  

 

 

    

 

 

 

Total selling, general and administrative expenses

     (19,145      (27,839
  

 

 

    

 

 

 
    

For the nine-month period

ended September 30,

 
Personnel expenses    2015      2016  
     € in thousands  

Wages and salaries

     (8,642      (11,026

Social charges on stock option and free shares grants

     (12,200      (3,159

Non cash stock based compensation expense

     (17,481      (39,911
  

 

 

    

 

 

 

Total personnel expenses

     (38,323      (54,096
  

 

 

    

 

 

 

 

26


17.2 For the three-month period ended September 30, 2016

 

     For the three-month period ended
September 30,
 
Research and development expenses    2015      2016  
     € in thousands  

Personnel expenses

     (10,357      (9,192

Purchases and external expenses

     (5,338      (4,394

Other

     (462      (238
  

 

 

    

 

 

 

Total research and development expenses

     (16,156      (13,824
  

 

 

    

 

 

 
     For the three-month period ended
September 30,
 
Selling, general and administrative expenses    2015      2016  
     € in thousands  

Personnel expenses

     (5,719      (6,651

Purchases and external expenses

     (1,186      (1,794

Other

     (16      (267
  

 

 

    

 

 

 

Total selling, general and administrative expenses

     (6,921      (8,712
  

 

 

    

 

 

 
     For the three-month period ended
September 30,
 
Personnel expenses    2015      2016  
     € in thousands  

Wages and salaries

     (3,113      (3,729

Social charges on stock option and free shares grants

     (3,500      —     

Non cash stock based compensation expense

     (9,464      (12,115
  

 

 

    

 

 

 

Total personnel expenses

     (16,076      (15,843
  

 

 

    

 

 

 

Note 18. Earnings per share

18.1 For the nine-month period ended September 30, 2016

 

     For the nine-month period
ended September 30,
 
     2015      2016  

Net profit (loss) attributable to shareholders of Cellectis (€ in thousands)

     (28,786      (48,309

Adjusted weighted average number of outstanding shares

     33,819,191         35,274,890   

Adjusted weighted average number of outstanding shares, net of effects of dilutive potential ordinary shares

     34,152,422         35,695,907   

Basic / Diluted earnings per share (€ / share)

     

Basic earnings per share (€ /share)

     (0.85      (1.37

Diluted earnings per share (€ /share)

     (0.85      (1.37

 

27


18.2 For the three-month period ended September 30, 2016

 

     For the three-month period
ended September 30,
 
     2015      2016  

Net profit (loss) attributable to shareholders of Cellectis (€ in thousands)

     (12,766      (12,590

Adjusted weighted average number of outstanding shares

     35,094,503         35,333,572   

Adjusted weighted average number of outstanding shares, net of effects of dilutive potential ordinary shares

     35,475,034         35,713,432   

Basic / Diluted earnings per share (€ / share)

     

Basic earnings per share (€ /share)

     (0.36      (0.36

Diluted earnings per share (€ /share)

     (0.36      (0.36

Note 19. Contractual obligations

 

     Total      Less than 1 year      1 - 3 years      3 - 5 years      More than
5 years
 
As of September 30, 2016    € in thousands  

Finance lease agreements

     73         35         37         —           —     

Conditional advances and subsidies

     1,839         1,839         —           —           —     

Facility lease agreements

     10,424         2,128         3,002         2,130         3,165   

License agreements

     18,684         1,092         2,216         2,216         13,159   

Manufacturing agreements

     8,795         7,227         1,568         —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total contractual obligations

     39,815         12,322         6,824         4,346         16,324   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty. We 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.

Facility lease agreements and license agreements disclosed in the table above along with the letters of credit provided to the landlords of our facilities in New York and in New Brighton are off balance sheets commitments.

Note 20. Subsequent events

 

    On October 12, 2016, Bpifrance elected to designate €1.3 million of research program conditional advances as subsidies, Cellectis S.A. will reimburse Bpifrance for the remaining balance of €0.5 million.

 

    On October 28, 2016, the board of directors granted 2,773,028 stock options under the 2016 Stock Option Plan with an exercise price of €17.90 per ordinary share, of which 1,358,865 were granted to our directors and executive officers. In addition, on October 28, 2016, 188,000 non-employee warrants exercisable for an aggregate of 188,000 ordinary shares at an exercise price of €18.68 per share, were issued by our board of directors to certain of our directors and consultants.

 

    Cellectis S.A. received the payment of 3.2 million pursuant to the French research tax credit related to the 2014 fiscal year in November 2016.

 

28


Item 2. Management’s Discussion & Analysis of Financial Condition and Results of Operations

 

Overview

We are a pioneering gene-editing company, employing our core proprietary technologies to develop best-in-class products in the emerging 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 cancers. 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 allogeneic production of CAR T-cells will allow us to develop cost-effective, “off-the-shelf” products and are capable of being 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 focused on the development of products in the field of immuno-oncology and of novel products outside immuno-oncology to treat other human diseases. 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 create food products with consumer health benefits, adaptations for climate change or nutritional enhancements that address the needs of a growing population. We do not have any products approved for sale and have not generated any revenues from immunotherapy or agricultural biotechnology product sales.

In February 2014, we entered into an alliance with Servier for the development of UCART19 and other product candidates directed at four additional molecular targets. In November 2015, we entered into an amendment to our initial collaboration agreement with Servier, which allowed for an early exercise of Servier’s option with respect to UCART19 and other product candidates. Pursuant to this amendment, Servier has exercised its option to acquire the exclusive worldwide rights to further develop and commercialize UCART19. In addition, Pfizer and Servier have announced that they have entered into an exclusive global license and collaboration agreement to co-develop and commercialize UCART19. In December 2015, we filed a CTA in the United Kingdom requesting approval to initiate a Phase 1 clinical trial on UCART19 in acute lymphoblastic leukemia (ALL) which has been approved and is being conducted by Servier. In connection with the entry into the amendment to the collaboration agreement, Servier made an upfront payment of €35.6 million ($38.5 million), excluding taxes. As of December 31, 2015, Cellectis was eligible to receive up to €895 million ($974 million) in potential option exercise fees, development, clinical and sales milestones, in addition to royalties on sales and research and development costs reimbursements. During the three months ended June 30, 2016, collaboration revenue was recognized in relation to the achievement of two milestones under our collaboration agreement with Servier with respect of UCART19. The previously recognized milestone payments were received during the three months ended September 30, 2016. In September 2016, Cellectis entered into an agreement with Servier pursuant to which Cellectis will provide Servier with materials and GMP- and R&D-grade UCART19 products.

 

29


Our alliance with Pfizer, which commenced in June 2014, addresses the development of other CAR T-cell immunotherapies in the field of oncology. This strategic alliance is potentially worth up to $2.9 billion in payments by Pfizer to us, including an $80 million upfront payment and $2.8 billion in potential clinical and commercial milestone payments. In addition, we invoice research and development costs assigned to our projects in common with Pfizer. Pfizer also purchased 10% of our then-outstanding equity in connection with this collaboration for €25.8 million. We believe that both of these strategic transactions position us to compete in the promising field of immuno-oncology and add additional clinical and financial resources to our programs.

We have also entered into research and development alliances with each of Weill Cornell Medical College and The University of Texas MD Anderson Cancer Center. Pursuant to these strategic alliances, we will collaborate with these two centers to accelerate the development of our lead product candidates UCART123, UCARTCS1, UCART22 and UCART38 in AML, BPDCN, multiple myeloma, B-cell and T-cell ALL.

In addition, in March 2016, we entered into a research collaboration and license agreement with MabQuest SA pertaining to the development of a new class of monoclonal antibodies targeting PD-1. The agreement included a collaboration phase funded by Cellectis for the joint pursuit of preclinical research on several candidate antibodies. Under the agreement, MabQuest granted an exclusive option to Cellectis to pursue the clinical development and commercialization of the selected antibody, and to obtain a worldwide exclusive rights over the family of PD-1 antagonist antibodies developed under the collaboration for all fields, and further potential derivatives of these antibodies. In October 2016, we decided not to exercise the option and therefore terminated the research collaboration and license agreement with MabQuest SA.

In addition to our cash generated by operations (including payments under our strategic alliances), we have funded our operations primarily through private and public offerings of our equity securities, grant revenues, payments received under intellectual property licenses, and reimbursements of research tax credits. Our ordinary shares have traded on the Alternext market of Euronext in Paris since February 7, 2007. From January 1, 2013 through December 31, 2014, we received €61.0 million through sales of equity and €73.7 million in payments made to us under our collaboration agreements with Pfizer and Servier. In March 2015, we completed our U.S. initial public offering of 5,500,000 American Depositary Shares on the Nasdaq Global Market for gross proceeds of $228.2 million. In 2015, we received €46.9 million in payments pursuant to the Pfizer and Servier collaborations and for the nine-month period ended September 30, 2016, we received €14.8 million of such payments.

Key events of the nine-month period ended September 30, 2016

Since the beginning of 2016, Cellectis has made the following key achievements:

 

    Cellectis announced on January 11, 2016 the publication of a study in Scientific Reports, a Nature Publishing Group journal, describing the design and development of a new CAR architecture with an integrated switch-on system that permits control over CAR T-cell functions. This integrated switch-on system offers the advantages of controllable CAR T-cells for safety while allowing for the possibility of multiple cytotoxicity cycles using a small molecule drug.

 

    On January 19, 2016, Cellectis entered into a new agreement with CELLforCURE for the GMP manufacturing of clinical batches of UCART123 Cellectis’ lead product candidate. Under the agreement, CELLforCURE will implement GMP manufacturing processes designed and developed by Cellectis.

 

    Cellectis gave a presentation at the Cowen and Company 36th Annual Health Care Conference on March 9, 2016 in Boston, MA.

 

    In April 2016, Cellectis employees gave scientific presentations at AACR in New Orleans, LA:

 

    Allogeneic TCR a/CS1 Double Knockout T-Cell Bearing an Anti-CS1 Chimeric Antigen Receptor: An Improved Immunotherapy Approach for the Treatment of Multiple Myeloma, presented by Roman Galetto.

 

    Improved Safety by a Non-Lethal Switch to Control CAR Activity at the T-Cell Surface Membrane, presented by Laurent Poirot.

 

    On March 14, 2016, 2,060,602 stock options were granted under the 2015 Stock Option Plan with an exercise price of €22.44 per ordinary share, 944,121 of which were granted to our directors and executive officers. In addition, 229,361 non-employee warrants exercisable for an aggregate of 229,361 ordinary shares at an exercise price of €27.37 per share, were issued by our board of directors to certain of our directors and consultants.

 

30


    On March 21, 2016, Cellectis announced that it had entered into a supply and license agreement with Takara Bio Inc. for recombinant human fibronectin fragment RetroNectin ®. Access to Takara Bio Inc.’s RetroNectin supports Cellectis’ manufacturing processes and expands the Company’s UCART production capabilities. Under the terms of the agreement, RetroNectin, which is used for cell engineering, may be applied in the production of both R&D- and GMP-grade Cellectis’ UCART product candidates.

 

    Dr. Loan Hoang–Sayag was appointed to the role of Chief Medical Officer, joining Cellectis from Quintiles Transnational, where she was most recently Senior Director of Medical Science.

 

    On June 20, 2016, Cellectis announced that the first dose of UCART 19 had been administered in the Phase 1 Trial of UCART19 in Pediatric Acute B Lymphoblastic Leukemia (B-ALL) at the University College of London (UCL). This UCART19 pediatric phase 1 clinical trial, which is sponsored by Servier in close collaboration with Pfizer, is an open label, non-comparative, monocenter study to evaluate the safety and ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia ahead of planned allogeneic haematopoeitic stem cell transplantation (allo-HSCT). In connection with this initial dosing, Cellectis received a milestone payment from Servier pursuant to its collaboration agreement.

 

    On June 27, 2016, Cellectis was selected as a 2016 World Economic Forum Technology Pioneer, a credential that is awarded annually to companies selected as among the most innovative and impactful in developing new technologies around the world.

 

    On June 27, 2016, the MIT Technology Review named Cellectis to its Annual List of 50 Smartest Companies for the second year in a row.

 

    Cellectis employees presented important scientific presentations:

 

    Scientific presentation at ASCO, Chicago: An intrinsic safeguard Chimeric Antigen Receptor architecture for T-cell immunotherapy, presented by Julien Valton

 

    Scientific presentation at EHA, Copenhagen, Denmark: Allogeneic TCRa/CD38 double knockout T-cells bearing an anti-CD38 Chimeric Antigen Receptor (CAR): an improved immunotherapy for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and multiple myeloma (MM), presented by Mathilde Dusseaux

 

    Cellectis won EuropaBio’s 2016 Most Innovative European Biotech SME Award for the healthcare category on September 27, 2016. The Awards recognize innovative biotech small- and medium-sized enterprises in Europe and the crucial role that they play in answering societal challenges through biotechnology.

Since the beginning of 2016, Calyxt, Inc., Cellectis’ plant science subsidiary, has made the following achievements:

 

    Calyxt, Inc. announced on March 1, 2016 that it closed on the purchase of a 10-acre parcel in the St. Paul suburb of Roseville, Minnesota to build its new headquarters facility. The new facility consists of an office and lab building, with greenhouses and outdoor research plots. On-site operations started during the third quarter of 2016.

 

    On May 23, 2016, Calyxt announced the appointment of former Monsanto Corporation executive Federico A. Tripodi to the role of Chief Executive Officer. Mr. Tripodi is closely working with Calyxt’s executive team and researchers to further the Company’s mission to develop crops and food products with healthier characteristics, as well as maximize partnerships and collaborations.

 

    On May 24, 2016, Calyxt announced the completion of the expansion of its high oleic/no trans-fat soybean variety in Argentina, as part of its counter-season seed production. Thirty tons of high oleic/no trans-fat soybean seeds have been shipped to production sites in the United States for further expansion, in preparation of a soft commercial launch expected in 2018.

 

    Calyxt hosted an R&D Day in New York City on May 26, 2016. Speakers reviewed advancements made in the plant science community with a focus on Calyxt’s plant engineering platform. Additionally, management provided an overview of Calyxt’s crop programs.

 

31


Key events after September 30, 2016

 

    On October 4, 2016, Cellectis announced the issuance of U.S. patent 9,458,439 – which claims gene inactivation by use of chimeric restriction endonucleases. This patent granted by the USPTO to the Institut Pasteur and Boston Children’s Hospital naming Dr. André Choulika and Prof. Richard C. Mulligan as co-inventors, is exclusively licensed to Cellectis.

 

    This issuance of this patent, which encompasses broad uses of technologies such as CRISPR/Cas9, Zinc Finger Nucleases and TAL-effector nucleases for plant gene editing, will expand the patent portfolio of Cellectis’ agricultural biotechnology subsidiary, Calyxt.

 

    On October 28, 2016, the board of directors granted 2,773,028 stock options under the 2016 Stock Option Plan with an exercise price of €17.90 per ordinary share, of which 1,358,865 were granted to our directors and executive officers. In addition, on October 28, 2016, 188,000 non-employee warrants exercisable for an aggregate of 188,000 ordinary shares at an exercise price of €18.68 per share, were issued by our board of directors to certain of our directors and consultants.

 

    On October 31, 2016, Cellectis announced, along with its agricultural biotech subsidiary, Calyxt, that they hosted the world’s first dinner made with gene edited foods in New York.

 

    On November 7, 2016, Cellectis announced that abstracts regarding the Company’s allogeneic, off-the-shelf, CAR T programs have been accepted for presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will be held December 3-6, 2016 in San Diego.

Emerging Growth Company Status

As of June 30, 2016, we had a public float of greater than U.S. $700 million and will therefore no longer be considered an “emerging growth company” under the Jumpstart Our Business Startups Act as of our Annual Report on Form 20-F for the fiscal year ending December 31, 2016. We will become a large accelerated filer as defined in Rule 12b-2 under the Exchange Act at December 31, 2016.

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:

 

    continue the research and development of our immuno-oncology product candidates;

 

    continue the research and development of our agricultural product candidates;

 

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

 

    multiply field trials of our agricultural product candidates;

 

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    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;

 

    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;

 

    secure manufacturing arrangements for clinical and commercial production;

 

    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.

 

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Results of Operations

Comparisons for the nine-month period ended September 30, 2015 and 2016

Revenues: During the nine months ended September 30, 2015 and 2016, we recorded €23.4 million and €32.9 million, respectively, in revenues. The increase of €9.5 million primarily reflects an increase of €9.2 million in revenues under our collaboration agreement with Servier.

Other income: During the nine months ended September 30, 2015 and 2016, we recorded €3.8 million and €6.1 million, respectively, in other income. The increase of €2.2 million reflects an increase of €3.1 million in research tax credit, partly offset by a decrease of €0.9 million in research subsidies, resulting from the termination of related research programs.

Royalty expenses: During the nine months ended September 30, 2015 and 2016, we recorded royalty expenses of €1.2 million and €1.0 million, respectively.

Research and development expenses: For the nine months ended September 30, 2015 and 2016, research and development expenses increased by €15.8 million from €36.4 million in 2015 to €52.2 million in 2016, respectively. Personnel expenses increased by €8.4 million from €24.3 million in 2015 to €32.7 million in 2016, notably due to a €1.9 million increase in wages and salaries, and a €12.6 million increase in non-cash stock based compensation expense, partly offset by a €6.1 million decrease in social charges on stock option and free shares grants. Purchases and external expenses increased by €7.6 million from €11.0 million in 2015 to €18.6 million in 2016, due to increased expenses related to innovation and platform development, including payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities. Other expenses relate to continuing leasing and other commitments and amounted to €1.1 million in 2015 and €1.0 million in 2016.

Selling, general and administrative expenses: During the nine months ended September 30, 2015 and 2016, we recorded €19.1 million and €27.8 million, respectively, of selling, general and administrative expenses. The increase of €8.7 million primarily reflects (i) an increase of €7.4 million in personnel expenses from €14.0 million to €21.4 million, attributable, among other things, to an increase of €9.9 million of non-cash stock-based compensation expense, partly offset by a decrease of €3.0 million of social charges on stock options and free share grants, and (ii) an increase of €1.0 million in purchases and external expenses.

Other operating income: During the nine months ended September 30, 2015 and 2016, our other operating income amounted to €0.5 million and €0.4 million, respectively. Other operating income for the nine months ended September 30, 2016 included (i) a one-off tax reimbursement and (ii) reversals of provisions related to ordinary course personnel litigations and the settlement of a commercial litigation matter with a former supplier.

Redundancy plan: During the nine months ended September 30, 2015 we recorded net income of €0.3 million. This amount was null for the nine months ended September 30, 2016.

Other operating expenses: During the nine months ended September 30, 2015 and 2016, our other operating expenses amounted to €0.4 million and €0.2 million respectively, mainly reflecting changes in provisions for commercial litigation.

Financial gain (loss): Financial gain was €0.5 million for the nine months ended September 30, 2015 compared with financial loss of €6.3 million for the nine months ended September 30, 2016. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts. During the nine-months ended September 30, 2016, we entered into financial derivative agreements (primarily zero premium collar and accumulator instruments) to mitigate the impact of currency exchange rate fluctuations on a portion of our cash and cash equivalent denominated in US dollars that we will need to convert into Euros over a certain period in the future.

Net income (loss): During the nine months ended September 30, 2015 and 2016, we recorded net losses of €28.6 million and €48.3 million, respectively. The change in net loss of €19.7 million was mainly due to (i) the €6.8 million change in financial result, (ii) a €22.4 million increase in non-cash stock-based compensation expense, partially offset by €9.0 decrease in social charges on stock options and free share grants.

Gain/Loss attributable to non-controlling interests: During the nine months ended September 30, 2015, we recognized a gain of €0.2 million attributable to non-controlling interests.

 

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Segment Results

The following table summarizes segment revenues and segment operating profit (loss) for the nine months ended September 30, 2015 and 2016:

 

     For the nine-month period
ended September 30, 2015
    For the nine-month period
ended September 30, 2016
 
     € in thousands  
     Plants     Therapeutics     Total
reportable
segments
    Plants     Therapeutics     Total
reportable
segments
 

Segment revenues and other income

     581        28,526        29,107        368        39,975        40,343   

Inter-segment revenues

     —          (1,906     (1,906     (75     (1,324     (1,398
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     581        26,620        27,201        293        38,652        38,945   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Research and development expenses

     (1,635     (34,739     (36,375     (2,765     (49,455     (52,220

Selling, general and administrative expenses

     (883     (18,262     (19,145     (3,022     (24,817     (27,839

Royalties and other operating income and expenses

     (37     (775     (811     (340     (527     (868
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (2,555     (53,776     (56,331     (6,127     (74,799     (80,926
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (1,974     (27,156     (29,130     (5,834     (36,147     (41,981
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (92     (723     (1,228     (134     (1,323     (1,457

Expenses related to share-based payments

     (263     (17,218     (17,481     (987     (38,924     (39,911

Additions to tangible and intangible assets

     232        3,285        3,517        9,222        2,639        11,860   

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, Royalties and other operating income and expenses, and Operating income/loss are used by the CODM to measure segment performance. Segment operating income includes the impact of the operations between separate segments, while the intra-segment operations are eliminated. The operations of Cellectis S.A. are presented entirely in the Therapeutics segment. We do not focus on any asset or liability information by segment or region to measure performance.

There are inter-segment transactions between the two reportable segments, including allocations of (i) corporate, general and administrative expenses and (ii) research and development expenses allocable to our subsidiaries. These inter-segment expenses are priced at cost, plus a mark-up of 4-10%, depending on the nature of the service.

Therapeutics segment

External revenues in our Therapeutics segment increased by €12.0 million, from €26.6 million for the nine months ended September 30, 2015 to €38.7 million for the nine months ended September 30, 2016. The increase was primarily due to an increase of €9.6 million in collaboration agreement revenues and higher research tax credit, in connection with higher research expenses. The increase in operating expenses of €21.0 million from the nine months ended September 30, 2015 to the nine months ended September 30, 2016 resulted primarily from higher personnel expenses, attributable, among other things, to the increase in non-cash stock-based compensation expenses, as well as the increase in external expenses for product development. Segment operating loss before tax increased by €9.0 million, from €27.2 million for the nine months ended September 30, 2015 to €36.1 million for the nine months ended September 30, 2016.

 

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Plants segment

External revenues in our Plants segment decreased by €0.3 million, from €0.6 million for the nine months ended September 30, 2015 to €0.3 million for the nine months ended September 30, 2016. The increase in operating expenses of €3.6 million from the nine months ended September 30, 2015 to the nine months ended September 30, 2016 resulted primarily from a significant increase in Calyxt, Inc. activities, as well as an increase of €0.7 million in non-cash stock-based compensation expenses. Segment operating loss before tax increased by €3.9 million from €2.0 million for the nine months ended September 30, 2015 to €5.8 million for the nine months ended September 30, 2016.

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 patent licenses, reimbursements of research tax credit claims and payments under our strategic alliances with Pfizer and Servier. Our ordinary shares have been traded on the Alternext market of Euronext in Paris since February 7, 2007 and our ADSs have traded on the Nasdaq Global Market in New York since March 25, 2015.

Liquidity management

As of September 30, 2016, we had cash and cash equivalents of €186.3 million and current financial assets of €77.7 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 and are primarily denominated in U.S. Dollars ($164.8 million as of September 30, 2016). Current financial assets denominated in U.S. Dollars amounted to $88.0 million as of September 30, 2016.

 

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Historical Changes in Cash Flows

The table below summarizes our sources and uses of cash with respect to continuing operations for the nine months ended September 30, 2015 and 2016:

 

     For the nine-month period
ended September 30,
 
     2015      2016  
     € in thousands  

Net cash flows provided by (used in) operating activities

     (21,983      (30,806

Net cash flows provided by (used in) investing activities

     (6,070      (90,156

Net cash flows provided by (used in) financing activities

     195,661         385   
  

 

 

    

 

 

 

Total

     167,608         (120,577
  

 

 

    

 

 

 

For the nine months ended September 30, 2015 and 2016, our net cash flows used in operating activities were €22.0 million and €30.8 million, respectively. The increase in net cash flows used was due to the increase in our net loss from continuing operations and the relevant factors with respect to this net loss, described above, plus several advance payments made for manufacturing activities.

For the nine months ended September 30, 2015 and 2016, our net cash flows used in investing activities were €6.1 million and €90.2 million, respectively. This increase primarily reflects our use of $10.0 million (€8.9 million) for the acquisition of land by Calyxt and the building of its greenhouse, and the acquisition of $88.0 million (€78.8 million) of financial current assets at Cellectis S.A.

For the nine months ended September 30, 2015 and 2016, our net cash flows provided by financing activities were €195.7 million and €0.4 million, respectively. The 2015 figure reflects the effect of our Initial Public Offering on the Nasdaq Global Market in New York.

Operating capital requirements

To date, we have not generated any revenues from therapeutic or agricultural product sales. 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. 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 are subject to all risks incident in the development of new gene therapy products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We are also subject to all risks incident in the development of new agricultural products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. 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.

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.

 

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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 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;

 

    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

During the periods presented, we did not and do not currently have any off-balance sheet arrangements as defined under Securities and Exchange Commission rules.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risks

Interest Rate Risk

We seek to engage in prudent management of our cash and cash equivalents, mainly cash on hand and common financial instruments (typically short- and mid-term deposits). Furthermore, the interest rate risk related to cash, cash equivalents and common financial instruments is not significant based on the quality of the financial institutions with which we work.

Foreign Currency Exchange Risk

We derive a significant portion of our revenues, including payments under our collaboration agreement with Pfizer in U.S. dollars. Since the beginning of fiscal year 2015, we have been significantly expanding our activities in the United States, but there continues to be a currency mismatch in our cash flows since most of our expenses remain denominated primarily in Euros. Our financial condition and results of operations are measured and recorded in the relevant local base currency and then translated each month into Euros for inclusion in our Consolidated Financial Statements. We translate balance sheet amounts at the exchange rates in effect on the date of the balance sheet, while income and cash flow items are translated at the average rate of exchange in effect for the relevant period. Our exposure to currencies other than the U.S. dollar is negligible.

 

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For the nine months ended September 30, 2016, our revenues denominated in U.S. dollars notably related to the Pfizer collaboration agreement and revenues from our Plants segment. Our cash and cash equivalents and marketable securities denominated in U.S dollars amounted to $164.8 million as of September 30, 2016. Current financial assets denominated in U.S. dollars amounted to $88.0 million as of September 30, 2016.

Financial gain was €0.5 million for the nine months ended September 30, 2015 compared with financial loss of €6.3 million for the nine months ended September 30, 2016. During the nine-month period ended September 30, 2016, we subscribed to zero premium collars ($20 million nominal value) and accumulators ($20 million nominal value) and we transferred $70 million to Cellectis Inc. which has transactions mainly denominated in dollars. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollars cash and cash equivalent accounts.

Inflation Risk

We do not believe that inflation has had a material effect on our business, financial condition or results of operations. If our costs were to become subject to significant inflationary pressures, we may not be able to fully offset such higher costs through price increases. Our inability or failure to do so could harm our business, financial condition and results of operations.

 

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 are first required to issue management’s annual report on internal control over financial reporting, pursuant to Section 404 of the Sarbanes-Oxley Act, as of December 31, 2016.

The rules governing the standards that must be met for our management to assess our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act are complex and require significant documentation, testing and possible remediation.

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.

 

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Item 4. Mine Safety Disclosures

Not Applicable.

 

Item 5. Other Information

None.

 

Item 6. Exhibits

None.

 

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