We have determined the existence of three material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, such that there is a reasonable possibility that a material misstatement of our annual consolidated financial statements will not be prevented or detected on a timely basis by our employees. The material weakness identified were a lack of knowledge of:
accounting resources required to fulfill the reporting requirements of International Financial Reporting Standards, or IFRS, and financial reporting requirements;
comprehensive IFRS accounting policies and financial reporting procedures; and segregation of duties given the size of our finance and accounting team.
As described in Note 2.36 of our consolidated financial statements referred to in this prospectus, we have restated our consolidated financial statements as of and for the year ended 31 December 2013 as a result of errors in the accounting treatment of shareholders convertible loans and share-based payments. We believe that the material weaknesses identified contributed to the restatements.
We have not yet undertaken and our independent registered public accounting firm has not yet conducted a comprehensive assessment of our internal control over financial reporting for purposes of identifying and reporting material weaknesses, significant deficiencies and control deficiencies in our internal control over financial reporting. We anticipate being first required to issue management’s annual report on internal control over financial reporting, pursuant to Section 404 of the Sarbanes-Oxley Act, in connection with issuing our consolidated financial statements as of and for the year ending 31 December 2016.
We believe it is possible that, if we had performed a formal assessment of our internal control over financial reporting, or if our independent registered public accounting firm had performed an audit of our internal control over financial reporting, other material weaknesses, significant deficiencies or control deficiencies may have been identified.
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We have taken several remedial actions to address the material weaknesses identified. In particular, we have hired additional staff for the finance department, including a corporate controller, and we are planning to hire a compliance financial officer with experience with external financial reporting, IFRS and establishing appropriate financial reporting policies, controls and procedures.
The process of designing and implementing an effective financial reporting system is a continuous effort that requires us to anticipate and react to changes in our business and the economic and regulatory environments, as well as to expend significant resources to maintain a financial reporting system that is adequate to satisfy our reporting obligations. See “RISK FACTORS – Risks Related to Our Business Failure to build our finance infrastructure and improve our accounting systems and controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies.”
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12
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION
On 21 January 2015, we acquired the outstanding membership interests in Oncyte LLC (“Oncyte”) the oncology division of Celdara Medical, LLC (“Celdara”), a privately-held biotechnology company based in Lebanon, New Hampshire, USA. The acquisition establishes our entry into the field of immuno-oncology with a portfolio of drug product candidates including three autologous CAR T-Cell cell therapy products and an allogeneic T-cell platform, targeting a broad range of cancer indications. Pursuant to the terms of the Stock Purchase Agreement and the Asset Purchase Agreement, we made a cash payment of $6.0 million at closing and issued new shares to Celdara with a value of $4.0 million. Additional contingent payments with an estimated fair value of $42.0 million may be due upon reaching various clinical and sales milestones. We financed the acquisition with existing cash and authorized share capital.
The unaudited pro forma condensed combined financial information gives effect to the acquisition as if it had been completed on 1 January 2014 for purposes of the statement of operations and 31 December 2014 for purposes of the statement of financial position. The historical consolidated financial information of us and Oncyte has been adjusted in the unaudited pro forma condensed combined financial information to give effect to events that are (1) directly attributable to the acquisition, (2) factually supportable, and (3) with respect to the statements of operations, expected to have a continuing impact on the combined results. The unaudited pro forma adjustments are based upon currently available information and assumptions that we believe to be reasonable. The pro forma adjustments and related assumptions are described in the notes accompanying the unaudited pro forma condensed combined financial information.
The pro forma financial information and adjustments are preliminary and have been made solely for purposes of providing these unaudited pro forma condensed combined statements of operations and balance sheet. Differences between these preliminary estimates and the final acquisition accounting may occur and these differences could have a material impact on the pro forma financial information presented and the combined company’s future results of operations and financial position. The actual results reported in future periods may differ significantly from that reflected in these pro forma financial information for a number of reasons, including but not limited to differences between the assumptions used to prepare this pro forma financial statements and actual amounts, as well as cost savings from operating and expense efficiencies and potential income enhancements.
The unaudited pro forma condensed combined statement of operations does not reflect any prospective income enhancements or operating synergies that the combined company may achieve as a result of the acquisition or the costs to integrate the operations or the costs necessary to achieve these income enhancements and operating synergies. In addition, the unaudited pro forma condensed combined statements of operations do not give effect to the consummation of this offering. As a result, the pro forma information does not purport to be indicative of what the financial condition or results of operations would have been had the transactions been completed on the applicable dates of this pro forma financial information. The unaudited pro forma condensed combined statements of operations and balance sheet are for informational purposes only and do not purport to project the future financial condition and results of operations after giving effect to the transactions.
The following unaudited pro forma condensed financial information is derived from our audited historical consolidated financial statements as of and for the year-ended 31 December 2014 prepared in accordance with IFRS as issued by the IASB and the audited financial statements of the OnCyte Clinical Trials Program as of and for the year-ended 31 December 2014 prepared in accordance with accounting principles generally accepted in the United States of America, or US GAAP, each included elsewhere in this prospectus. You should read this unaudited pro forma condensed combined financial information in conjunction with the accompanying notes, the audited financial statements of the Company and Oncyte referred to above, as well as with “MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS”, included elsewhere in this prospectus.
Statement of Financial Position Celyad SA Oncyte combined Proforma (€’000) December 2014 As of 31 December 2014 As of 31 Reclassification (Note 2)
Pro Forma Adjustment
(Note 4) December 2014 As of 31 NON-CURRENT ASSETS ... 11,041 83 — 44,817 55,941 Intangible assets ... 10,266 61 — 44,839(a)(b) 55,166 Property, Plant and Equipment ... 598 22 (22)(b) 598 Investment accounted for using the equity
method ... 68 — — 68
Other non-current assets ... 109 — — 109
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Statement of Financial Position Celyad SA Oncyte combined Proforma (€’000) December 2014 As of 31 December 2014 As of 31 Reclassification (Note 2)
Pro Forma Adjustment
(Note 4) December 2014 As of 31 Trade and Other Receivables ... 830 141 (141)(b) 830
Grant receivables ... 1,009 — 1,009
Other current assets ... 792 4 (4)(b) 792
Short-term investment ... 2,671 — 2,671
Cash and cash equivalents ... 27,633 — (5,181)(c) 22,452 TOTAL ASSETS... 43,976 228 — 39,491 83,695 EQUITY ... 26,684 20 — 3,431 30,135 Share Capital ... 24,615 208 — 117(b)(d) 24,940 Share premium ... 53,302 — 3,126(d) 56,428 Other reserves ... 19,982 (16) 16(b) 19,982 Retained loss ... (71,215) (172) 172(b) (71,215) NON-CURRENT LIABILITIES ... 11,239 24 — 36,244 47,507 Financial leases ... 279 — — 279 Advances repayable ... 10,778 — — 10,778 Other non-current liabilities ... 182 24 (24)(b) 182 Contingent liabilities ... — — 36,268(e) 36,268 CURRENT LIABILITIES ... 6,053 184 — (184) 6,053 Financial leases ... 134 — — 134
Advances repayable ... 777 — — 777
Trade payables ... 4,042 — — 4,042 Other current liabilities ... 1,100 184 (184)(b) 1,100 TOTAL EQUITY AND LIABILITIES ... 43,976 228 — 39,491 83,695
IFRS Statement of operations Celyad SA Oncyte combined Proforma (€’000)
For the year ended 31 December 2014
For the year ended 31
December 2014 Reclassification (Note 2)
Pro Forma Adjustment
(Note 4)
For the year ended 31 December 2014 Revenue ... 146 — — — 146 Grant income ... — 756 (756) — — Cost of sales... (115) (115) Gross profit... 31 31 Costs of Operations ... — (928) 928 — — Research and Development ... (15,865) — (928) (16,793) General and administrative ... (5,016) — — — (5,016) Other operating income ... 4,413 — 756 — 5,169 Operating Loss ... (16,437) (172) — (16,609)
Financial (income) ... 277 — — — 277 Financial expenses ... (41) — — — (41) Share of Loss of investment accounted for
using the equity method ... (252) — — — (252) Loss before taxes ... (16,453) (172) — (16,625)
Income taxes ... — — — —
Loss for the year... (16,453) (172) — (16,625) Basic and diluted loss per share (in €) ... (2.44) (2.43)
Oncyte LLC—Notes to Unaudited Pro Forma Condensed Combined Financial Information Note 1: Basis of preparation
The acquisition is accounted for in accordance with the acquisition method of accounting for business combinations with Celyad SA as the acquiring entity. The unaudited pro forma condensed combined financial information is based on the historical consolidated financial statements of the Celyad SA and Oncyte after giving effect to the consideration paid by Celyad SA to consummate the acquisition, as well as pro forma adjustments as described in Note 4. In accordance with the acquisition method of accounting for business combinations, tangible and intangible assets acquired and liabilities assumed are required to be recorded at their respective fair market values as of the date of the acquisition, with any excess purchase price allocated to goodwill.
The unaudited pro forma condensed combined statement of operations for the twelve months ended 31 December 2014 is presented as if the acquisition had occurred on 1 January 2014. The unaudited pro forma condensed combined statement of financial position is presented as if the acquisition had occurred on 31 December 2014.
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The fair values assigned to the intangible assets acquired from Oncyte are based on management’s estimates and assumptions with the assistance of an independent valuation specialist. The estimated fair values of these assets acquired are considered preliminary. We believe that the information provides a reasonable basis for estimating the fair values of assets acquired; however, the provisional measurements of fair value are subject to change. We expect to finalize the valuation of the intangible assets as soon as practicable, but not later than one-year from the acquisition date.
The Oncyte’ balance sheet positions initially expressed in USD have been translated in EUR by using the closing EUR/USD exchange rate as at 31 December 2014 (1EUR = 1.21548USD); whereas the Oncyte’ statement of operations positions initially expressed in USD have been translated in EUR by using the average EUR/USD exchange rate over the year 2014 (1EUR = 1.32947USD).
Under the acquisition method, acquisition-related transaction costs (e.g. advisory, legal, valuation and other professional fees) are not included as consideration transferred but are accounted for as expenses in the periods in which the costs are incurred. These costs are not presented in the unaudited pro forma combined consolidated statements of operations because they will not have a continuing impact on the combined results. Total acquisition- related transaction costs of the combined company were immaterial.
Note 2. Accounting Policies
The historical financial information extracted from the financial statements of Oncyte is prepared in accordance with U.S. GAAP. For the purpose of presenting the historical information of Oncyte in a reporting format that is consistent with that of the Company, certain components of Oncyte’s statement of operations and comprehensive income have been reclassified. The following reclassifications have been made in the unaudited proforma combined statement of operations for the year ended 31 December 2014:
Amounts historically included in Grant income on Oncyte’s statements of operations and comprehensive income (loss) have been reclassified to Other operating income in order to conform with our financial statement presentation. Amounts historically included in Cost of Operations on Oncyte’s statements of operations and comprehensive income (loss) have been reclassified to Research and Development in order to conform with our financial statement presentation. The unaudited pro forma condensed combined financial information does not assume any differences in accounting policies. We believe there are no differences between US GAAP and IFRS as issued by the IASB that would have a material impact on the unaudited pro forma condensed combined financial information.
Note 3. Calculation of Estimated Consideration Transferred and Preliminary Allocation of Consideration to Net Assets Acquired
The following table summarizes the preliminary reconciliation of upfront payment in accordance to the Share Purchase Agreement and the total purchase price:
Cash consideration according to the Share Purchase Agreement ... $ 6.0 million € 5.2 million Issuance of ordinary shares of the Group according to the Share
Purchase Agreement ... $ 4.0 million € 3.4 million Premiliminary estimate of fair value of contingent consideration ... $42.0 million €36.3 million Total Purchase Price ... $52.0 million €44.9 million ______
[1] Converted using the following exchange rate as of 21 January 2015: 1EUR = 1
The value of the 93,087 ordinary shares issued as part of the consideration paid for Oncyte was based on a share price of €37.08, our share price at the date of the acquisition.
The preliminary fair value estimate of contingent consideration of $42.0 million (€36.3 million) relates to the achievement of certain regulatory and sales milestones and are based on the contractual terms defined in the Share Purchase Agreement. The preliminary fair value estimate of contingent consideration was obtained using several discount rates and probability rates of success over the different products candidates acquired and is subject to change.
Following the terms of the Share Purchase Agreement, assuming successful development of the lead product CAR- NKG2D, Celdara could receive up to $45.0 million in development and regulatory milestones until market approval. Celdara will also be eligible to additional payments on the other products in development upon achievement of development and regulatory milestones totaling up to $21.0 million per product. In addition, the seller will receive per product up to $80.0 million in sales milestones when total net sales will exceed $1 billion and royalties ranging from 5% to 8% on net sales.
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The transaction was accounted for as a business combination under the acquisition method of accounting.
For purposes of these unaudited pro forma condensed financial statements, the above consideration transferred will be assigned to the fair value of acquired assets and is based on preliminary estimates and is subject to change. The following table summarizes the estimated fair values of the assets acquired as if the transaction occurred on 31 December 2014:
In process research and development $52.0 million €44.9 million
Assets acquired $52.0 million €44.9 million
Liabilities assumed —
Net assets acquired $52.0 million €44.9 million
______
[1] Converted using the following exchange rate as of 21 January 2015: 1EUR = 1.15806USD
No deferred tax liability has been recorded on the fair value of the intangible assets acquired. We intend to make an election to treat the share acquisition as the acquisition of assets for U.S. federal income tax purposes resulting in tax deductible amortization of the intangible assets acquired.
The fair value of the acquired assets and liabilities assumed was determined on a provisional basis. The provisional fair value of acquired assets and liabilities assumed can change when the final fair value of the acquired assets and liabilities assumed is established.
Note 4. Pro Forma Adjustments
a) To consider the estimated fair value of the intangible asset of Oncyte. The acquired assets have been recognized at an estimated fair value determined by us with the assistance of an independent valuation specialist in an amount of €44.9 million—$52.0 million translated by using the closing EUR/USD exchange rate as at 21 January 2015 (1EUR = 1.15806USD).
b) The Oncyte business has been acquired through a special purpose vehicle especially created for this transaction which only the intangible assets related to the CAR-T-cell technology have been transferred in. We have not acquired the underlying property, plant and equipment, working capital and long term liabilities of the Oncyte business. The historical figures reflected in the unaudited condensed consolidated statement of financial position is a carve-out of the financial statements of the Sellers’ activities related to CAR T-cell technology as at 31 December 2014 including all the assets and liabilities. Consequently, the elements not related to the intangible assets have been eliminated in the pro forma combined financial information.
c) To record the use of cash and cash equivalents to fund the cash consideration paid according the Share Purchase Agreement amounting to €5.2 million—$6.0 million translated by using historical exchange rate (1 EUR = 1.15806USD) as at the acquisition date (21 January 2015).
d) To record the issuance of our new shares for a total value of €3.4 million—$4.0 million translated by using historical exchange rate (1 EUR = 1.15806USD) as at the acquisition date (21 January 2015), split between the share capital (€0.3 million) and the share premium (€3.1 million).
e) To reflect the preliminary fair value estimate of the contingent consideration: €36.3 million—$42.0 million translated by using the closing EUR/USD exchange rate as at 21 January 2015 (1EUR = 1.15806USD).
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13
BUSINESS
13.1
Overview
We consider we are a leader in engineered cell therapy treatments with clinical programs initially targeting indications in cardiovascular disease and oncology. Our lead drug product candidate in cardiovascular disease is C-Cure, an autologous cell therapy for the treatment of patients with ischemic heart failure, or HF. We completed enrollment in our first Phase 3 clinical trial of C-Cure in Europe and Israel, or CHART-1, in March 2015. On 30 March 2015, we announced that the Data Safety Monitoring Board, or DSMB, reviewed unblinded safety data from CHART-1 and determined that there was no evidence of obvious differences in safety profiles of patients in the two arms of the trial, which means that the data did not support discontinuation of the trial on the basis of safety. The full data readout from this trial is expected in the middle of 2016. We anticipate initiating our second Phase 3 clinical trial of C-Cure in the United States and Europe, or CHART-2, pending U.S. Food and Drug Administration, or FDA, clearance to initiate the trial, which we expect in the second half of 2015. Our lead drug product candidate in oncology is CAR-NKG2D, an autologous chimeric antigen receptor T lymphocyte, or CAR T-cell, therapy. We are currently enrolling patients with refractory or relapsed acute myeloid leukemia, or AML, or multiple myeloma, or MM, in a Phase 1 clinical trial of CAR- NKG2D in the United States. The first patient was treated in this trial in April 2014 and no treatment-related safety concerns were reported during the 30-day follow-up period. Interim data from this trial is expected to be reported at various times during the trial, with the full data readout expected in the middle of 2016.
All of our current drug product candidates are autologous cell therapy treatments. In autologous procedures, a patient’s cells are harvested, selected, reprogrammed and expanded, and then infused back into the same patient. A benefit of autologous therapies is that autologous cells are not recognized as foreign by patients’ immune systems. We believe that we are well situated to effectively advance autologous cell therapy treatments for cancer and other indications as a result of the expertise and know-how that we have acquired through our development of C-Cure. We also believe that there are numerous operational synergies between our product platforms, including that, prior to