TMCnet News
Cellectis Reports 4th Quarter and Full Year 2016 Financial ResultsRegulatory News: Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced its results for the three-month period ended December 31, 2016 and for the year ended December 31, 2016. Earnings Call Details Cellectis will host an earnings call on March 7, 2017 at 8:00am Eastern Time to discuss its financial results and provide a general business update.
Dial-In Numbers:
Replay Information: Webcast URL (Archived for 12 months): http://cellectis.equisolvewebcast.com/q4-2016 RECENT CORPORATE HIGHLIGHTS Cellectis - Therapeutics UCART123 - Cellectis' most advanced, wholly owned TALEN® gene-edited product candidate
UCART19, exclusively licensed to Servier
Scientific Publications
Clinical Advisory Board
Calyxt - Cellectis' plant science subsidiary
Financial Results Cellectis' consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board ("IASB"). The audit procedures have been carried out by the independent auditors and their audit report relating to the certification of the financials is in the process of being issued. The audited report for Cellectis' consolidated financial statements will be included in the Company's annual report. Fourth quarter 2016 Financial Results Cash: As of December 31, 2016 Cellectis had €276.2 million in total cash, cash equivalents and current financial assets compared to €264.0 million as of September 30, 2016. This increase of €12.2 million notably reflects (i) the receipt of R&D tax credits of €9.2 million, (ii) proceeds of €7.0 million related to the supply agreement with Servier, (iii) the unrealized positive translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €12.1 million, partially offset by (iv) other net cash flows used by operating activities of €15.0 million and (v) fixed assets expenditures of €1.1 million. Revenues and Other Income: During the quarters ended December 31, 2015 and 2016, we recorded €29.2 million and €12.1 million, respectively, in revenues and other income. This decrease is mainly due to the decrease of €20.0 million in collaboration revenues, notably due to the €18.8 million revenue recorded in 2015 in relation to early exercise by Servier of its option to acquire the exclusive worldwide rights to further develop and commercialize UCART19, partially offset by increases of €1.0 million in research tax credit and €1.3 million in subsidies. Total Operating Expenses: Total operating expenses for the fourth quarter of 2016 were €30.9 million, compared to €28.0 million for the fourth quarter of 2015. The non-cash stock-based compensation expenses included in these amounts were €13.1 million and €12.6 million, respectively. R&D Expenses: For the quarters ended December 31, 2015 and 2016, research and development expenses increased by €2.6 million from €16.0 million in 2015 to €18.7 million in 2016. Personnel expenses increased by €0.5 million from €11.2 million in 2015 to €11.6 million in 2016, due to a €1.8 million increase in social charges on stock options, partially offset by a €1.1 million decrease in non-cash stock based compensation expense and a €0.2 million decrease in wages and salaries. Purchases, external expenses and other expenses increased by €2.2 million from €4.3 million in 2015 to €6.5 million in 2016. SG&A Expenses: During the quarters ended December 31, 2015 and 2016, we recorded €8.1 million and €11.4 million, respectively, of selling, general and administrative expenses. The increase of €3.3 million primarily reflects the increase in personnel expenses from €5.6 million to €8.9 million, attributable to the increase of €1.5 million in non-cash stock-based compensation expense, €1.4 million in social charges on stock options, and €0.4 million in wages and salaries. No material variance has been identified on purchases, external expenses and other expenses. Financial Gain (Loss): The financial gain was €7.0 million for the fourth quarter of 2015 compared with a financial gain of €6.4 million for the fourth quarter of 2016. The change in financial result was primarily attributable to the increase of €1.3 million in fair value adjustment expense on our foreign exchange derivatives and current financial assets, partially offset by the gain of €0.8 million due to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts. Net Income (Loss) Attributable to Shareholders of Cellectis: During the quarters ended December 31, 2015 and 2016, we recorded a net gain of €8.2 million (or €0.23 per share on both a basic and a diluted basis) and net loss of €12.5 million (or €0.35 per share on both a basic and a diluted basis), respectively. Adjusted income attributable to shareholders of Cellectis for the fourth quarter of 2016 was €0.6 million (€0.02 per share on both a basic and a diluted basis) compared to adjusted income attributable to shareholders of Cellectis of €20.9 million (€0.59 per share on both a basic and a diluted basis), for the fourth quarter of 2015. Adjusted income (loss) attributable to shareholders of Cellectis for the fourth quarter of 2016 and 2015 excludes non-cash stock-based compensation expense of €13.1 million and €12.6 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis. Full year 2016 Financial Results Cash: As of December 31, 2016 Cellectis had €276.2 million in total cash, cash equivalents and current financial assets compared to € 314.2 million as of December 31, 2015. This decrease of €38.0 million was primarily driven by (i) €29.6 million of cash used in operating activities, related to our research and development and manufacturing efforts, including the advancement of UCART123, for which an IND was filed in the United States in early 2017, partially offset by payments received from Servier and Pfizer pursuant to our collaboration agreements and R&D tax credit, and (ii) €12.5 million of cash used in investment activities, primarily through Calyxt's land acquisition and greenhouse construction in an aggregate amount of €9.5 million. The decrease was also partially offset by the positive unrealized translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €4.4 million. Cellectis expects that its cash, cash equivalents and Current financial assets of €276.2 million as of December 31, 2016 will be sufficient to fund its current operations to 2019. Revenues and Other Income: During the year ended December 31, 2015 and 2016, we recorded €56.4 million and €51.0 million, respectively, in revenues and other income. This decrease is mainly due (i) to the decrease of €10.4 million in collaboration revenues notably due to revenue recorded in 2015 in relation to early exercise by Servier of its option to acquire the exclusive worldwide rights to further develop and commercialize UCART19 (€18.8 million) partially offset by the revenue from an agreement to provide Servier with raw materials and additional batches of UCART19 products and the achievement of two milestones in 2016 (totaling €11.9 million), (ii) increases of €4.0 million in research tax credit, €0.5 million in licenses fees and €0.4 million in research subsidies. Total Operating Expenses: Total operating expenses for the year ended December 31, 2016 were €111.8 million, compared to €84.3 million for the year ended December 31, 2015. The non-cash stock-based compensation expenses included in these amounts were €53.0 million and €30.1 million, respectively. R&D Expenses: For the year ended December 31, 2015 and 2016, research and development expenses increased by €18.5 million from €52.4 million in 2015 to €70.9 million in 2016. Personnel expenses increased by €8.8 million from €35.5 million in 2015 to €44.3 million in 2016, notably due to a €1.6 million increase in wages and salaries, and a €11.5 million increase in non-cash stock based compensation expense, partially offset by a €4.3 million decrease in social charges on stock options and free share grants. Purchases and external expenses increased by €9.8 million from €15.2 million in 2015 to €25.0 million in 2016, due to increased expenses related to UCART123 and other product candidates' development, including payments to third parties and costs related to preparation of UCART123 clinical trials, purchases of biological materials and expenses associated with the use of laboratories and other facilities. SG&A Expenses: During the year ended December 31, 2015 and 2016, we recorded €27.2 million and €39.2 million, respectively, of selling, general and administrative expenses. The increase of €12.0 million primarily reflects (i) an increase of €10.7 million in personnel expenses from €19.6 million to €30.3 million attributable to a €0.9 million increase in wages and salaries, an increase of €11.4 million of non-cash stock-based compensation expense, partially offset by a decrease of €1.6 million of social charges on stock options and free share grants, (ii) an increase of €1.9 million in purchases and external expenses and (iii) a decrease of €0.6 in other expenses due to lower business taxes and lower provisions. Financial Gain (Loss): The financial gain was €7.6 million for the year ended December 31, 2015 and the financial gain was null for the year ended December 31, 2016. The decrease in financial income and expenses between 2016 and 2015 was mainly attributable to the decrease of €5.9 million in net foreign exchange gain, €1.6 million foreign exchange derivatives fair value expense, and €0.9 million current financial assets fair value expenses, partially offset by an increase of €0.5 million in interest income. Net Income (Loss) Attributable to Shareholders of Cellectis: During the year ended December 31, 2015 and 2016, we recorded a net loss of €20.5 million (or € 0.60 per share on both a basic and a diluted basis) and a net loss of €60.8 million (or €1.72 per share on both a basic and diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the year ended December 31, 2016 was €7.8 million (€0.22 per share on both a basic and a diluted basis) compared to Adjusted income attributable to shareholders of Cellectis of € 9.6 million (€0.28 per share on both a basic and a diluted basis), for the year ended December 31, 2015. Adjusted income (loss) attributable to shareholders of Cellectis for the year ended December 31, 2016 and 2015 excludes non-cash stock-based compensation expense of €53.0 million and €30.1 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis. CELLECTIS S.A.
STATEMENT OF CONSOLIDATED FINANCIAL POSITION
CELLECTIS S.A.
STATEMENT OF CONSOLIDATED OPERATIONS - Fourth quarter
CELLECTIS S.A.
STATEMENT OF CONSOLIDATED OPERATIONS - Full years
Note Regarding Use of Non-GAAP Financial Measures Cellectis S.A. presents Adjusted Income (Loss) attributable to shareholders of Cellectis in this press release. Adjusted Income (Loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We have included in this press release a reconciliation of this figure to Net Income (Loss) attributable to shareholders of Cellectis, the most directly comparable financial measure calculated in accordance with IFRS. Because Adjusted Income (Loss) attributable to shareholders of Cellectis excludes Non-cash stock-based compensation expense-a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis' financial performance. Moreover, our management views the Company's operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of Non-cash stock-based expenses from Net Income (Loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of Adjusted Income (Loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of Non-cash stock-based compensation expense differently; and (b) other companies may report Adjusted Income (Loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider Adjusted Income (Loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net Income (Loss) attributable to shareholders of Cellectis.
RECONCILIATION OF GAAP TO NON-GAAP NET (News - Alert) INCOME - Fourth quarter
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME - Full years
As a foreign private issuer, we are not required under the Exchange Act to file periodic reports and financial statements with the SEC (News - Alert) as frequently or as promptly as United States companies whose securities are registered under the Exchange Act. Notwithstanding the foregoing, we currently provide quarterly interim consolidated financial data to the SEC, and commencing with our first quarter interim report for the 2017 fiscal year, we intend to file our periodic reports within the deadlines applicable to domestic reporting companies. 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 17 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. 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.
1 Cellectis granted Servier an exclusive license to UCART19
product candidate, and Pfizer has been exclusively licensed by Servier
for the development and commercialization of UCART19 in U.S.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170306006263/en/ |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
