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: March 14, 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): ⃞
EXHIBIT INDEX
Exhibit |
Title |
|
99.1 |
Press release, dated March 14, 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) | ||
March 14, 2016 |
By: |
/s/ André Choulika |
André Choulika |
||
|
Chief Executive Officer |
3
Exhibit 99.1
Cellectis Reports Fourth Quarter and Full Year 2015 Financial Results
- On track with submission of UCART19 Clinical Trial Application; Application Filed with MHRA (UK)
- Encouraging data from the First-in-Human compassionate use of UCART19
- Early opt-in by Servier into UCART19; amendment with improved economics
- Successful production of UCART19 batches in GMP conditions; the first
off-the-shelf UCART product candidate
- On track with GMP UCART123 production; IND filing expected later in 2016
- FY2015 Revenues and other income of $61.4 million (€56.4 million), with an adjusted net income of $10.3 million (€9.5 million)
- Strong 2015 year-end cash position of $350 million (€314 million)
NEW YORK--(BUSINESS WIRE)--March 14, 2016--Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), today reported business highlights and financial results for the fourth quarter and year ended December 31, 2015.
“In 2015, Cellectis has reached a key inflection point by applying the first in-human off-the-shelf UCART product candidate. The production of UCART19 in GMP conditions was the gating factor to the filing of the Clinical Trial Application. We believe that our UCART product candidates have the potential to turn an individualized CAR T therapy into universal off-the-shelf products, bringing hope to patients with unmet medical needs. Our U.S. IPO in March 2015 strengthened our financial position to fund our operations over the next years. Our collaborations with Servier and Pfizer are on a strong momentum, and we are forward looking to generating clinical data.” said André Choulika, Chairman and Chief Executive Officer of Cellectis.
Recent Corporate Highlights
Cellectis
Manufacturing:
Clinical:
Corporate:
Medical and R&D:
Calyxt, Inc. (“Calyxt”)
Financial Results
Since Cellectis did not have consolidated financial statements for individual quarters during fiscal year 2014, no comparative quarterly 2014 figures will be presented during 2015. Cellectis will publish quarter-over-quarter comparative figures starting with the first quarter of 2016. The audited report for Cellectis’ consolidated financial statements will be included in the Company’s annual report.
Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).
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. Personnel and other costs related to information technology, human resources, business development, legal, intellectual property and general management that were initially reported during the first three quarters of 2015 in SG&A have been reclassified as R&D costs based on the time that employees spent contributing to R&D activities versus general and administrative activities. This allocation change 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. We approved the reallocation in the fourth quarter of 2015 and assess the performance of the Group based on this new classification.
Three-month period ended | ||||||||||||
Unaudited (€ in thousands) |
March 31, 2015 |
June 30, 2015 |
September 30, 2015 |
|||||||||
Expenses reclassified from SG&A to R&D | (1 836) | (2 216) | (2 681) | |||||||||
R&D expenses as reported | (5 600) | (10 565) | (13 476) | |||||||||
R&D expenses as reclassified | (7 436) | (12 781) | (16 157) | |||||||||
SG&A expenses as reported | (7 195) | (9 082) | (9 602) | |||||||||
SG&A expenses as reclassified | (5 359) | (6 866) | (6 921) | |||||||||
Except for information related to the year ended December 31, 2014, which is based on reported figures, all 2015 information below is based on these reclassified figures.
Fourth Quarter 2015 Financial Results
Cash Position: As of December 31, 2015 Cellectis had €314.2 million in cash and cash equivalents compared to €112.3 million as of December 31, 2014. This increase is primarily attributable to the $228 million of proceeds from Cellectis’ U.S. initial public offering in March 2015 and €42.8 million proceeds in the fourth quarter of 2015 received from Servier in connection with the early exercise of its option to acquire the exclusive worldwide rights to further develop and commercialize UCART19 (including €7.2 million of Value Added Taxes which were repaid in January 2016), partly offset by €39.5 million of net cash flows used in operating activities (excluding the €42.8 million of proceeds from Servier mentioned above), €3.9 million of acquisitions of tangible assets, and the repurchase for €3.5 million of 25% of the minority shares of Cellectis Bioresearch S.A.S, in each case during 2015.
Revenues and Other Income: Total revenues and other income were €29.2 million for the fourth quarter of 2015 and were primarily comprised of €26.8 million of collaboration revenues (including €18.8 million in revenue recorded in relation to the early option exercise by Servier in November 2015), €0.2 million of license revenues (which include Calyxt’s negative adjustments on license revenues related to prior years for €0.7 million) and €2.2 million of research tax credit revenues.
Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the fourth quarter of 2015 were €28.0 million, which includes non-cash stock-based compensation expenses of €12.6 million.
R&D Expenses: Research and development expenses for the fourth quarter of 2015 were €16.0 million which includes personnel expenses of €11.1 million as well as external purchases and other expenses of €4.9 million. Research and development expenses for the fourth quarter notably reflected the impact of non-cash stock-based compensation expense of €8.2 million.
SG&A Expenses: Selling, general and administrative expenses for the fourth quarter of 2015 were €8.1 million, which includes personnel expenses of €5.6 million as well as external purchases and other expenses of €2.5 million. SG&A expenses for the fourth quarter reflected the impacts of non-cash stock-based compensation expense of €4.4 million.
Financial Gain: Financial gain was €7.0 million for the fourth quarter of 2015, which is primarily attributable to an overall net favorable Euro-Dollar exchange rate applied to U.S. dollar-denominated cash and cash equivalents during this period.
Net income Attributable to Shareholders of Cellectis: Net income attributable to shareholders of Cellectis was €8.2 million (€0.23 per share on both a basic and a diluted basis), for the fourth quarter of 2015. This reflects €18.8 million of revenue recorded in relation to the early option exercise on UCART19 by Servier in November 2015, partly offset by the impact of non-cash stock-based compensation of €12.6 million. Adjusted net income attributable to shareholders of Cellectis for the fourth quarter of 2015, which excludes the non-cash stock-based compensation expense of €12.6 million, was €20.9 million, (€0.59 per share on both a basic and a diluted basis). Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliations of GAAP net income to adjusted net income.
Full Year 2015 Financial Results
Revenues: Revenues for the years ended December 31, 2015 and 2014, were €50.3 million and €21.6 million, respectively. The increase of €28.7 million primarily reflects an increase of €36.4 million in revenues under our collaboration agreements with Servier and Pfizer which was partially offset by a decrease in in-license revenue of €5.3 million, a decrease in R&D services revenue of €1.3 million and a decrease in Product and Services revenue of €1.1 million. Revenues related to collaboration non-cash upfront amortization revenue amounted to €21.3 million in 2015 compared to €13.3 million in 2014.
Other Income: Other income was €6.0 million in 2015 and €4.8 million in 2014. The increase of €1.2 million primarily reflects an increase of €1.7 million in research tax credit, offset by a decrease of €0.5 million in research subsidies.
Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income were €84.3 million in 2015 and €31.7 million in 2014), which includes (i) non-cash stock-based compensation expenses of €30.1 million and €0.5 million, respectively and (ii) social charges related to free shares and stock-options granted of €12.2 million and €0.2 million, respectively.
R&D Expenses: Research and development expenses were €52.4 million in 2015 and €14.4 million in 2014. These amounts include personnel expenses of €35.5 million and €6.4 million in 2015 and in 2014, respectively, as well as purchases and external expenses and other expenses of €17.0 million and €8.0 million, respectively. The increase of €38.0 million in research and development expenses reflects (i) increased expenditures in 2015 for the development of UCART programs toward their entry into Phase 1 clinical trials, (ii) expenses in 2015 related to the opening of our facility in New York, (iii) non-cash stock-based compensation expense of €18.5 million in 2015 and €0.2 million in 2014 and (iv) social charges on stock-options and free share grants of €7.7 million in 2015 and €0.1 million in 2014.
SG&A Expenses: SG&A expenses were €27.2 million in 2015 and €13.1 million in 2014. SG&A expenses included personnel expenses of €19.6 million in 2015 compared to €5.5 million in 2014, as well as purchases and external expenses and other expenses of €7.7 million in 2015 compared to €7.6 million in 2014. The increase of €14.1 million primarily reflects an increase of €14.1 million in personnel expenses attributable, among other things, to (i) €11.6 million of non-cash stock-based compensation expense in 2015 from €0.3 million in 2014, (ii) €4.5 million of social charges on stock-options and free share grants in 2015 from €0.1 million in 2014, and an increase in professional costs, in each case in connection with our U.S. IPO in March 2015.
Financial gain: Financial gain was €7.6 million in 2015 compared to €7.1 million in 2014. The increase was primarily attributable to a favorable Euro-Dollar exchange rate applied to increased U.S. dollar-denominated cash and cash equivalents during 2015.
Net Income (Loss) Attributable to Shareholders of Cellectis: Net loss attributable to shareholders of Cellectis was of €20.5 million, or €0.60 per share, in 2015, compared to net income attributable to shareholders of Cellectis of €20,000, or €0.11 per share, in 2014. Adjusted net income attributable to shareholders of Cellectis in 2015 was €9.6 million (€0.28 per share on both a basic and a diluted basis) compared to adjusted net income attributable to shareholders of Cellectis of €0.6 million (€0.02 per share on both a basic and a diluted basis), in 2014. Adjusted net income attributable to shareholders of Cellectis in 2015 and 2014 excludes a non-cash stock-based compensation expense of €30.1 million and €0.5 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income to adjusted net income.
CELLECTIS S.A. STATEMENT OF CONSOLIDATED FINANCIAL POSITION (€ in thousands) |
||||||||
Year Ended December 31, | ||||||||
2014 | 2015 | |||||||
ASSETS | ||||||||
Non-current assets | ||||||||
Goodwill | - | 0 | ||||||
Intangible assets | 1 026 | 956 | ||||||
Property, plant, and equipment | 2 610 | 5 043 | ||||||
Other non-current financial assets | 1 977 | 845 | ||||||
Total non-current assets | 5 613 | 6 844 | ||||||
Current assets | ||||||||
Inventories and accumulated costs on orders in process | 135 | 158 | ||||||
Trade receivables | 5 881 | 6 035 | ||||||
Subsidies receivables | 8 170 | 9 102 | ||||||
Other current assets | 5 468 | 4 685 | ||||||
Cash and cash equivalents | 112 347 | 314 238 | ||||||
Total current assets | 132 001 | 334 218 | ||||||
TOTAL ASSETS | 137 614 | 341 062 | ||||||
LIABILITIES | ||||||||
Shareholders’ equity | ||||||||
Share capital | 1 472 | 1 759 | ||||||
Premiums related to the share capital | 192 842 | 420 682 | ||||||
Treasury share reserve | (251) | (184) | ||||||
Currency translation adjustment | (762) | (1 631) | ||||||
Retained earnings | (132 536) | (137 188) | ||||||
Net income (loss) | 20 | (20 544) | ||||||
Total shareholders’ equity - Group Share | 60 786 | 262 894 | ||||||
Non-controlling interests | (1 259) | 725 | ||||||
Total shareholders’ equity | 59 527 | 263 619 | ||||||
Non-current liabilities | ||||||||
Non-current financial debt | 2 824 | 66 | ||||||
Non-current provisions | 398 | 437 | ||||||
Total non-current liabilities | 3 222 | 503 | ||||||
Current liabilities | ||||||||
Current financial debt | 862 | 1 921 | ||||||
Trade payables | 9 802 | 6 611 | ||||||
Deferred revenues and deferred income | 59 492 | 54 758 | ||||||
Redundancy plan | 715 | 32 | ||||||
Current provisions | 700 | 921 | ||||||
Other current liabilities | 3 294 | 12 697 | ||||||
Total current liabilities | 74 865 | 76 940 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 137 614 | 341 062 | ||||||
CELLECTIS S.A. STATEMENT OF CASH FLOWS (€ in thousands) |
|||||||
Year Ended December 31, | |||||||
2014 | 2015 | ||||||
Net (loss) income for the period of continuing operations | 1 850 | (20 373) | |||||
Adjustments for | |||||||
Expenses related to share-based payments | 548 | 30 103 | |||||
Net finance expenses / revenue | (7 095) | (7 550) | |||||
Amortization and depreciation | 1 372 | 1 745 | |||||
Other items | (981) | 703 | |||||
Operating cash flows before change in working capital | (4 306) | 4 628 | |||||
Decrease (increase) in current assets | (6 873) | 1 120 | |||||
Increase in subsidies receivables | (2 317) | (612) | |||||
(Decrease) increase in current liabilities | 55 969 | (1 900) | |||||
Change in the working capital | 46 779 | (1 392) | |||||
Net cash flows provided by (used in) operating activities of continuing operations | 42 473 | 3 236 | |||||
Proceeds from sale of subsidiaries net of cash disposed of | 505 | (2 850) | |||||
Acquisition of property, plant and equipment | (347) | (3 890) | |||||
Net change in non-current financial assets | (1 542) | (238) | |||||
Other | 31 | 13 | |||||
Net cash flows provided by (used in) investing activities of continuing operations | (1 353) | (6 965) | |||||
Increase in share capital | 59 682 | 216 143 | |||||
Transaction costs | (908) | (16 845) | |||||
Decrease in borrowings | (1 032) | (564) | |||||
Treasury shares | 161 | 67 | |||||
Net cash flows provided by financing activities of continuing operations | 57 904 | 198 802 | |||||
Cash and cash equivalents at the beginning of the year | 7 559 | 112 347 | |||||
(Decrease) increase in cash of continuing operations | 99 024 | 195 073 | |||||
(Decrease) increase in cash of discontinued operations | (748) | - | |||||
Effect of exchange rate changes on cash | 6 511 | 6 818 | |||||
Cash and cash equivalents at the end of the year | 112 347 | 314 238 | |||||
CELLECTIS S.A. STATEMENT OF CONSOLIDATED OPERATIONS Fourth quarter of 2015 (unaudited) and Full Year 2015 (€ in thousands, except per share data) |
|||||||
For the three- |
For the year ended |
||||||
Revenues and other income | |||||||
Revenues | 26 991 | 50 346 | |||||
Other income | 2 194 | 6 039 | |||||
Total revenues and other income | 29 184 | 56 385 | |||||
Operating expenses and other operating income (expenses) | |||||||
Royalty expenses | (1 322) | (2 475) | |||||
Research and development expenses | (16 036) | (52 410) | |||||
Selling, general and administrative expenses | (8 093) | (27 238) | |||||
Other operating income | 297 | 812 | |||||
Redundancy plan | (10) | 249 | |||||
Other operating expenses | (2 814) | (3 246) | |||||
Total operating expenses and other operating income (expenses) | (27 978) | (84 309) | |||||
Operating income (loss) | 1 207 | (27 924) | |||||
Financial gain (loss) | 7 036 | 7 550 | |||||
Income tax | (0) | (0) | |||||
Income (loss) from continuing operations | 8 242 | (20 373) | |||||
Loss from discontinued operations | (0) | 0 | |||||
Net income (loss) | 8 242 | (20 373) | |||||
Attributable to shareholders of Cellectis | 8 242 | (20 544) | |||||
Attributable to non-controlling interests | 0 | 171 | |||||
Basic earnings attributable to shareholders of Cellectis per share (€/share) | 0,23 | (0,60) | |||||
Diluted earnings attributable to shareholders of Cellectis per share (€/share) | 0,23 | (0,60) | |||||
Number of shares used for computing | |||||||
Basic | 35 129 315 | 34 149 908 | |||||
Diluted | 35 535 182 | 34 522 910 | |||||
CELLECTIS S.A. STATEMENT OF CONSOLIDATED OPERATIONS FULL YEARS 2014 and 2015 (€ in thousands, except per share data) |
|||||
Year Ended December 31, | |||||
2014 | 2015 | ||||
Revenues and other income | |||||
Revenues | 21 627 | 50 346 | |||
Other income | 4 826 | 6 039 | |||
Total revenues and other income | 26 453 | 56 385 | |||
Operating expenses and other operating income (expenses) | |||||
Royalty expenses | (3 035) | (2 475) | |||
Research and development expenses | (14 407) | (52 410) | |||
Selling, general and administrative expenses | (13 114) | (27 238) | |||
Other operating income | - | 812 | |||
Redundancy plan | (491) | 249 | |||
Other operating expenses | (651) | (3 246) | |||
Total operating expenses and other operating income (expenses) | (31 698) | (84 309) | |||
Operating income (loss) | (5 245) | (27 924) | |||
Financial gain (loss) | 7 095 | 7 550 | |||
Loss from discontinued operations | (2 822) | 0 | |||
Net income (loss) | (972) | (20 373) | |||
Attributable to shareholders of Cellectis | 20 | (20 544) | |||
Attributable to non-controlling interests | (992) | 171 | |||
Basic / Diluted earnings per share attributable to shareholders of Cellectis | |||||
Basic earnings from continuing operations per share ( € /share) | 0,11 | (0,60) | |||
Basic earnings from discontinued operations per share ( € /share) | (0,11) | - | |||
Diluted earnings from continuing operations per share ( € /share) | 0,11 | (0,60) | |||
Diluted earnings from discontinued operations per share ( € /share) | (0,11) | - | |||
Number of shares used for computing | |||||
Basic | 26 071 709 | 34 149 908 | |||
Diluted | 26 192 652 | 34 522 910 | |||
Note Regarding Use of Non-GAAP Financial Measures
Cellectis S.A. provides non-GAAP net income and non-GAAP net income per share measures that include adjustments to figures presented in accordance with GAAP. In presenting non-GAAP net income, GAAP net income is adjusted to exclude non-cash stock-based compensation expense. Since our management views the Company’s operation and manages its business based, in part, on these non-GAAP financial measures, we believe that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Cellectis' financial performance. The non-GAAP financial measures used by Cellectis may be calculated differently, and therefore may not be comparable to similarly titled non-GAAP financial measures used by other companies. Please refer below for a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME Fourth Quarter (unaudited) and Full Year 2015 (€ in thousands, except per share data) |
||||
For the three- |
For the year |
|||
Net Income (Loss) attributable to shareholders of Cellectis | 8 242 | (20 544) | ||
Adjustment: Non-cash stock-based compensation expense |
12 622 | 30 103 | ||
Adjusted Net Income (Loss) attributable to shareholders of Cellectis | 20 864 | 9 559 | ||
Basic Adjusted Net Income (Loss) attributable to shareholders of Cellectis (€/share) | 0,59 | 0,28 | ||
Weighted average number of outstanding shares, basic (units) | 35 129 315 | 34 149 908 | ||
Diluted Adjusted Net Income (Loss) attributable to shareholders of Cellectis (€/share) | 0,59 | 0,28 | ||
Weighted average number of outstanding shares, diluted (units) | 35 535 182 | 34 522 910 | ||
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME Full Years 2014 and 2015 (€ in thousands, except per share data) |
||||
Year Ended December 31, | ||||
2014 | 2015 | |||
Net Income (Loss) attributable to shareholders of Cellectis | 20 | (20 544) | ||
Adjustment: Non-cash stock-based compensation expense |
548 | 30 103 | ||
Adjusted Net Income (Loss) attributable to shareholders of Cellectis | 568 | 9 559 | ||
Basic Adjusted Net Income (Loss) attributable to shareholders of Cellectis (€/share) | 0,02 | 0,28 | ||
Weighted average number of outstanding shares, basic (units) | 26 071 709 | 34 149 908 | ||
Diluted Adjusted Net Income (Loss) attributable to shareholders of Cellectis (€/share) | 0,02 | 0,28 | ||
Weighted average number of outstanding shares, diluted (units) | 26 192 652 | 34 522 910 | ||
About Cellectis
Cellectis is a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART). The company’s mission is to develop a new generation of cancer therapies based on engineered T-cells. Cellectis capitalizes on its 15 years of expertise in genome engineering - based on its flagship TALEN® products and meganucleases and pioneering electroporation PulseAgile technology - to create a new generation of immunotherapies. CAR technologies are designed to target surface antigens expressed on cells. Using its life-science-focused, pioneering genome-engineering technologies, Cellectis’ goal is to create innovative products in multiple fields and with various target markets. Cellectis is listed on the Nasdaq market (ticker: CLLS) and on the NYSE Alternext market (ticker: ALCLS). To find out more about us, visit our website: www.cellectis.com
Talking about gene editing? We do it.
TALEN® is a
registered trademark owned by the Cellectis Group.
Earnings Call Details
Cellectis will host an earnings call on March 15, 2016 at 8:30am Eastern Time to discuss its financial results and provide a general business update.
Dial-In Numbers:
Live PARTICIPANT Dial-In (Toll-Free US & Canada): 877-407-3104
Live
PARTICIPANT Dial-In (International): +1 201-493-6792
Replay Information:
Conference ID #: 13625168
Replay Dial-In (Toll Free US & Canada):
877-660-6853
Replay Dial-In (International): +1 201-612-7415
Expiration Date: 3/22/16
Webcast URL (Archived for 12 months): http://cellectis.equisolvewebcast.com/q4-2015
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “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 and include, but are not limited to, statements regarding the outlook for Cellectis’ future business and financial performance. Forward-looking statements are based on management’s current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances, many of which are beyond Cellectis’ control. Actual outcomes and results may differ materially due to global political, economic, business, competitive, market, regulatory and other factors and risks. Cellectis expressly disclaims any obligation to update or revise any of these forward-looking statements, whether because of future events, new information, a change in its views or expectations, or otherwise.
CONTACT:
Media
Jennifer Moore, +1 917-580-1088
VP
Communications
media@cellectis.com
or
Caitlin Kasunich,
+1 212-896-1241
KCSA Strategic Communications
ckasunich@kcsa.com
or
Investor
relations
Simon Harnest, +1 646-385-9008
VP Finance and
Investor Relations
simon.harnest@cellectis.com