Cellectis Reports 2nd Quarter and First Half Year 2016 Financial Results

Published on September 09, 2016

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  • First patient dosed in phase 1 clinical trial for UCART19
  • UCART 123 manufacturing ongoing
  • Strong cash position of $300 million1 (€270 million) as of June 30, 2016
  • Revenues and other income of $20 million2 (€18 million) in the 2nd quarter of 2016
  • Adjusted income attributable to shareholders3 of $9 million2 (€8 million) in the 2nd quarter of 2016

 

New York, N.Y. – September 8, 2016 – Cellectis S.A. (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 June 30, 2016 and for the six-month period ended June 30, 2016.

Recent Corporate Highlights

Cellectis

• A Phase I study of UCART19 in pediatric acute B lymphoblastic leukemia (B-ALL) was initiated at the University College of London (UCL), with the first dose administered to a patient in June 2016. This UCART19 clinical trial is sponsored by Servier in close collaboration with Pfizer.

• Cellectis employees presented important scientific presentations: o An intrinsic safeguard Chimeric Antigen Receptor architecture for T-cell immunotherapy, presented by Julien Valton at ASCO, Chicago; o Allogeneic TCRα/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 at EHA, Copenhagen, Denmark.

• The MIT Technology Review has named the Company on its Annual List of 50 Smartest Companies for the second year in a row.

• Cellectis has been selected as a 2016 World Economic Forum Technology Pioneer, a credential that is awarded annually to the most innovative and impactful companies developing new technologies around the world.

Calyxt – Cellectis’ plant science subsidiary

• Appointment of former Monsanto Corporation executive Federico A. Tripodi to the role of Chief Executive Officer, a key hire for the execution of the commercial business plan and market launch of lead programs.

• Completed the expansion of its high-oleic / no-trans-fat (HO) soybean variety in Argentina, as part of its counter-season seed production. Thirty tons of HO soybean seeds have been shipped to production sites in the United States for further expansion, in preparation for an initial commercial launch expected in 2018.

• Calyxt hosted an R&D Day in New York City on May 26. 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.

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 (“GAAP”).

Second Quarter 2016 Financial Results

Cash: As of June 30, 2016 Cellectis had €269.7 million in total cash, cash equivalents and current financial assets compared to €276.5 million as of March 31, 2016. This decrease of €6.8 million notably reflects (i) the net cash flows used in operating activities of €7.6 million and (ii) fixed assets expenditure of €2.4 million. The change was also attributable to the unrealized positive translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €5.8 million.

Revenues and Other Income: During the quarters ended June 30, 2015 and 2016, we recorded €8.0 million and €18.1 million, respectively, in revenues and other income. This is mainly due to the increase of (i) €8.6 million in collaboration revenues, notably due to the achievement of two milestones under our collaboration agreement with Servier and (ii) €1.5 million in research tax credit.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the second quarter of 2016 were €28.2 million, compared to €20.1 million for the second quarter of 2015. The non-cash stock-based compensation expenses included in these amounts were €14.4 million and €7.1 million, respectively.

R&D Expenses: For the quarters ended June 30, 2015 and 2016, research and development expenses increased by €6.7 million from €12.8 million in 2015 to €19.5 million in 2016.Personnel expenses increased by €2.4 million from €9.3 million in 2015 to €11.6 million in 2016, notably due to a €0.5 million increase in wages and salaries, and a €4.5 million increase in non-cash stock based compensation expense, partly offset by a €2.6 million decrease in social charges on stock options and free share grants. Purchases and external expenses increased by €4.3 million from €3.2 million in 2015 to €7.5 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.

SG&A Expenses: During the quarters ended June 30, 2015 and 2016, we recorded €6.9 million and €8.6 million, respectively, of selling, general and administrative expenses. The increase of €1.7 million primarily reflects (i) an increase of €1.9 million in personnel expenses from €4.6 million to €6.5 million, attributable, among other things, to an increase of €2.7 million of non-cash stock-based compensation expense, partly offset by a decrease of €0.9 million of social charges on stock options and free share grants, and (ii) a decrease of €0.3 million in purchases and external expenses.

Financial Gain (Loss): The financial loss was €10.0 million for the second quarter of 2015 compared with a financial gain of €3.8 million for the second quarter of 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.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the three months ended June 30, 2015 and 2016, we recorded a net loss of €22.2 million (or €0.63 per share on both a basic and a diluted basis) and net loss of €6.3 million (or €0.18 per share on both a basic and a diluted basis), respectively. Adjusted income attributable to shareholders of Cellectis for the second quarter of 2016 was €8.1 million (€0.23 per share on both a basic and a diluted basis) compared to Adjusted loss attributable to shareholders of Cellectis of €15.0 million (€0.43 per share on both a basic and a diluted basis), for the second quarter of 2015. Adjusted income (loss) attributable to shareholders of Cellectis for the second quarter of 2016 and 2015 excludes non-cash stock-based compensation expense of €14.4 million and €7.2 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.

First Half Year 2016 Financial Results

Cash: As of June 30, 2016 Cellectis had €269.7 million in total cash, cash equivalents and current financial assets compared to €314.2 million as of December 31, 2015. This decrease of €44.5 million was primarily driven by (i) €27.2 million of cash used in operating activities in connection with the initiation of industrial Good Manufacturing Practice (“GMP”) production of UCART123, increased expenses in materials required of GMP production and a payment of €7.2 million of value added taxes related to proceeds received in the fourth quarter of 2015 from Servier, and (ii) €10.8 million of cash used in investment activities, primarily through Calyxt’s land acquisition and greenhouse construction in an aggregate amount of €8.9 million. The decrease was also partially attributable to the negative unrealized translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets accounts of €5.8 million.

Cellectis expects that its cash, cash equivalents and Current financial assets of €269.7 million as of June 30, 2016 will be sufficient to fund its current operations through the end of 2018.

Revenues and Other Income: During the six months ended June 30, 2015 and 2016, we recorded €17.2 million and €27.6 million, respectively, in revenues and other income. This is mainly due to the increase of (i) €7.1 million in collaboration revenues notably due to the achievement of two milestones under our collaboration agreement with Servier and (ii) €3.4 million in research tax credit.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the first half of 2016 were €58.1 million, compared to €32.9 million for the first half of 2015. The non-cash stock-based compensation expenses included in these amounts were €27.8 million and €8.0 million, respectively.

R&D Expenses: For the six months ended June 30, 2015 and 2016, research and development expenses increased by €18.2 million from €20.2 million in 2015 to €38.4 million in 2016. Personnel expenses increased by €9.5 million from €13.9 million in 2015 to €23.5 million in 2016, notably due to a€1.4 million increase in wages and salaries, and a €11.6 million increase in non-cash stock based compensation expense, partly offset by a €3.5 million decrease in social charges on stock options and free share grants. Purchases and external expenses increased by €8.5 million from €5.7 million in 2015 to €14.2 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.

SG&A Expenses: During the six months ended June 30, 2015 and 2016, we recorded €12.2 million and €19.2 million, respectively, of selling, general and administrative expenses. The increase of €6.9 million primarily reflects (i) an increase of €6.5 million in personnel expenses from €8.3 million to €14.8 million, attributable, among other things, to an increase of €8.2 million of non-cash stock-based compensation expense, partly offset by a decrease of €2.0 million of social charges on stock options and free share grants, and (ii) an increase of €0.4 million in purchases and external expenses.

Financial Gain (Loss): The financial loss was €0.2 million for the first half year of 2015 compared with financial loss of €5.3 million for the first half year of 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.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the six months ended June 30, 2015 and 2016, we recorded a net loss of €16.0 million (or €0.48 per share on both a basic and a diluted basis) and a net loss of €35.7 million (or €1.01 per share on both a basic and diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the first half of 2016 was €7.9 million (€0.22 per share on both a basic and a diluted basis) compared to Adjusted income attributable to shareholders of Cellectis of €8.0 million (€0.24 per share on both a basic and a diluted basis), for the first half of 2015. Adjusted loss attributable to shareholders of Cellectis for the first half of 2016 and 2015 excludes a non-cash stock-based compensation expense of €27.8 million and €8.0 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.

 

1 Euro-US Dollar exchange rate as of June 30, 2016: 1.1102

2 Euro-US Dollar average exchange rate for the 2nd quarter 2016: 1.1293

3 See the section related to the reconciliation of gaap to non-gaap net income. GAAP Net Loss attributable to shareholders amounts to $7 million (€6 million) in the 2nd quarter of 2016

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