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 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of September 2016
Commission File Number: 001-36826
ADVANCED ACCELERATOR APPLICATIONS S.A.
(Exact name of registrant as specified in its charter)
20 rue Diesel
01630 Saint Genis Pouilly, France
(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 | X |
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):
Yes | No | X |
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):
Yes | No | X |
SIGNATURE
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.
ADVANCED ACCELERATOR APPLICATIONS S.A. | |||||
By: | /s/ Heinz Mäusli | ||||
Name: | Heinz Mäusli | ||||
Title: | Chief Financial Officer |
Date: September 12, 2016
ADVANCED ACCELERATOR APPLICATIONS S.A.
EXHIBIT INDEX
Exhibit No. |
Description |
99.1 | IFRS Condensed Consolidated Interim Financial Statements for the Six Months and Three Months ended June 30, 2016 and 2015 |
Advanced Accelerator Applications SA
Advanced Accelerator Applications S.A.
20 rue Rudolf Diesel
01630 Saint Genis Pouilly
____________________________
IFRS CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS Six months and three months ended
|
1
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
Six Months and three Months ended June 30, 2016 and 2015
Three months | Six months | |||||||||
In € thousands | Notes | June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | |||||
Sales | 4.1 | 27,640 | 22,210 | 54,559 | 42,974 | |||||
Raw materials and consumables used | (5,572) | (4,839) | (11,196) | (9,091) | ||||||
Personnel costs | 4.2 | (9,248) | (6,812) | (18,927) | (12,970) | |||||
Other operating expenses | 4.4 | (11,980) | (11,065) | (22,827) | (21,678) | |||||
Other operating income | 4.5 | 1,425 | 1,317 | 2,735 | 2,677 | |||||
Depreciation and amortization | (3,228) | (2,778) | (6,427) | (5,460) | ||||||
Operating loss | (963) | (1,967) | (2,083) | (3,548) | ||||||
Finance income (including changes in fair value of contingent consideration) | 4.7 | 1,035 | 129 | 445 | 85 | |||||
Finance costs (including changes in fair value of contingent consideration) | 4.7 | (1,629) | (568) | (3,217) | (4,311) | |||||
Net finance loss | (594) | (439) | (2,772) | (4,226) | ||||||
Loss before income taxes | (1,557) | (2,406) | (4,855) | (7,774) | ||||||
Income taxes | 4.8 | 125 | (154) | 447 | (689) | |||||
Loss for the period | (1,432) | (2,560) | (4,408) | (8,463) | ||||||
Attributable to: | ||||||||||
Owners of the Company | (1,432) | (2,560) | (4,408) | (8,463) | ||||||
Loss per share | ||||||||||
Basic (€ per share) | 5.7 | (0.02) | (0.04) | (0.06) | (0.13) | |||||
Diluted (€ per share) | 5.7 | (0.02) | (0.04) | (0.06) | (0.13) | |||||
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Condensed Consolidated statements of comprehensive income
Six Months and three Months ended June 30, 2016 and 2015
Three months | Six months | |||||||
In € thousands | June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||
Loss for the period | (1,432) | (2,560) | (4,408) | (8,463) | ||||
Other comprehensive income / (expense): | ||||||||
Items that may be reclassified subsequently to profit or loss | ||||||||
Exchange differences on translating foreign operations | 362 | 27 | (399) | 3,887 | ||||
Items that will never be reclassified subsequently to profit or loss | ||||||||
Remeasurement of defined benefit liability | (6) | 56 | (43) | 37 | ||||
Other comprehensive income / (expense) net of tax (1) | 356 | 83 | (442) | 3,924 | ||||
Total comprehensive loss for the period | (1,076) | (2,477) | (4,850) | (4,539) | ||||
Total comprehensive loss attributable to: | ||||||||
Owners of the Company | (1,076) | (2,477) | (4,850) | (4,539) |
(1) | Positive tax effect of €3 thousand at Q2 2016 and negative tax effect of €28 thousand at Q2 2015 |
Positive tax effect of €22 thousand at first half 2016 and negative tax effect of €18 thousand at first half 2015
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Condensed Consolidated statements of financial position
at June 30, 2016
ASSETS (In € thousands) | Notes | June 30, 2016 | December 31, 2015 | |||
Non-current assets | 151,096 | 116,872 | ||||
Goodwill | 5.2 | 33,369 | 22,662 | |||
Other intangible assets | 5.2 | 46,371 | 31,884 | |||
Property, plant and equipment | 5.3 | 63,369 | 56,332 | |||
Financial assets | 1,338 | 1,512 | ||||
Other non-current assets | 5.4 | 6,021 | 4,185 | |||
Deferred tax assets | 628 | 297 | ||||
Current assets | 122,285 | 157,231 | ||||
Inventories | 5,988 | 4,105 | ||||
Trade and other receivables | 5.5 | 29,556 | 23,625 | |||
Other current assets | 5.6 | 11,002 | 10,615 | |||
Cash and cash equivalents | 75,739 | 118,886 | ||||
TOTAL ASSETS | 273,381 | 274,103 | ||||
EQUITY AND LIABILITIES (In € thousands) | Notes | June 30, 2016 | December 31, 2015 | |||
Equity attributable to owners of the Company | 167,449 | 169,754 | ||||
Share capital | 7,856 | 7,856 | ||||
Share premium | 213,982 | 213,982 | ||||
Reserves and retained earnings | (49,981) | (35,083) | ||||
Net loss for the period / year | (4,408) | (17,001) | ||||
Total equity | 5.7 | 167,449 | 169,754 | |||
Non-current liabilities | 70,913 | 68,341 | ||||
Non-current provisions | 10,950 | 9,968 | ||||
Non-current financial liabilities | 5.10 | 14,319 | 16,205 | |||
Deferred tax liabilities | 5.9 | 5,319 | 2,804 | |||
Other non-current liabilities | 5.11 | 40,325 | 39,364 | |||
Current liabilities | 35,019 | 36,008 | ||||
Current provisions | 5.11 | 250 | - | |||
Current financial liabilities | 5.10 | 4,221 | 5,560 | |||
Trade and other payables | 15,770 | 14,710 | ||||
Other current liabilities | 5.11 | 14,778 | 15,738 | |||
Total liabilities | 105,932 | 104,349 | ||||
TOTAL EQUITY AND LIABILITIES | 273,381 | 274,103 |
4
Condensed Consolidated statement of changes in equity
Six Months ended June 30, 2016
In € thousands | Share capital | Share premium | Translation reserve | Net Income / (loss) for the period | Group reserves | Total | ||||||
At January 1, 2016 | 7,856 | 213,982 | 4,859 | (17,001) | (39,942) | 169,754 | ||||||
Comprehensive loss for the period | ||||||||||||
Loss for the period | - | - | - | (4,408) | - | (4,408) | ||||||
Other comprehensive income / (loss) for the period | - | - | (399) | - | (43) | (442) | ||||||
Total comprehensive income | - | - | (399) | (4,408) | (43) | (4,850) | ||||||
Transactions with owners of the company | ||||||||||||
Appropriation of 2015 net loss | - | - | - | 17,001 | (17,001) | - | ||||||
Equity-settled share-based payments | - | - | - | - | 2,545 | 2,545 | ||||||
Total transactions with owners of the Company | - | - | - | 17,001 | (14,456) | 2,545 | ||||||
At June 30, 2016 | 7,856 | 213,982 | 4,460 | (4,408) | (54,441) | 167,449 |
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Condensed Consolidated statement of changes in equity
Six Months ended June 30, 2015
In € thousands | Share capital | Share premium | Translation reserve | Net Income / (loss) for the period | Group reserves | Total | ||||||
At January 1, 2015 | 6,323 | 118,421 | 1,620 | (9,499) | (31,678) | 85,187 | ||||||
Comprehensive income for the period | ||||||||||||
Loss for the period | - | - | - | (8,463) | - | (8,463) | ||||||
Other comprehensive income / (loss) for the period | - | - | 3,887 | - | 37 | 3,924 | ||||||
Total comprehensive income | - | - | 3,887 | (8,463) | 37 | (4,539) | ||||||
Transactions with owners of the company | ||||||||||||
Issue of ordinary shares | 379 | 22,738 | 23,117 | |||||||||
Appropriation of 2014 net loss | - | - | - | 9,499 | (9,499) | - | ||||||
Equity-settled share-based payments | - | - | - | - | 835 | 835 | ||||||
Total transactions with owners of the company | 379 | 22,738 | - | 9,499 | (8,664) | 23,952 | ||||||
At June 30, 2015 | 6,702 | 141,159 | 5,507 | (8,463) | (40,305) | 104,600 |
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Condensed Consolidated statements of cash flows
Six Months ended June 30, 2016 and 2015
Six months ended | ||||||
Notes | June 30, | June 30, | ||||
In € thousands | 2016 | 2015 | ||||
Cash flows from operating activities | ||||||
Net loss for the period | (4,408) | (8,463) | ||||
Adjustments: | ||||||
Depreciation, amortization and impairment of non-current assets | 6,427 | 5,460 | ||||
Share based payment expense | 2,545 | 835 | ||||
Loss / (Gain) on disposal of property, plant and equipment | 85 | 7 | ||||
Financial result | 2,772 | 4,226 | ||||
Income tax expense | (447) | 689 | ||||
Negative goodwill | (127) | - | ||||
Subtotal | 6,847 | 2,754 | ||||
Increase in inventories | (1,242) | (609) | ||||
Increase in trade receivables | (5,026) | (5,253) | ||||
Increase / (decrease) in trade payables | 1,307 | 516 | ||||
Change in other receivables and payables | (7,469) | (1,059) | ||||
Increase / (decrease) in provisions | 415 | 176 | ||||
Change in working capital | (12,015) | (6,229) | ||||
Income tax paid | (1,266) | (538) | ||||
Net cash used in operating activities | (6,434) | (4,013) | ||||
Cash flows from investing activities | ||||||
Acquisition of property, plant and equipment | 5.3 | (7,950) | (3,119) | |||
Acquisition of intangible assets | (984) | (591) | ||||
Acquisition of financial assets | (18) | (45) | ||||
Reimbursement of financial asset | 821 | - | ||||
Interests received | 287 | 176 | ||||
Proceeds from disposal of property, plant and equipment | 7 | 31 | ||||
Acquisition of subsidiaries, net of cash acquired | 5.1.1 | (22,453) | - | |||
Net cash used in investing activities | (30,290) | (3,548) | ||||
Net cash from financing activities | ||||||
Payment of deferred and contingent liabilities to former owners of acquired subsidiaries | 5.11. | (2,870) | - | |||
Issuance of share capital | - | 23,117 | ||||
Repayment of borrowings | (3,156) | (2,464) | ||||
Interests paid | (177) | (388) | ||||
Net cash (used) / generated in financing activities | (6,203) | 20,265 | ||||
Net (decrease) / increase in cash and cash equivalents | (42,927) | 12,704 | ||||
Cash and cash equivalents at the beginning of the period | 118,886 | 45,096 | ||||
Effect of exchange rate changes on cash and cash equivalents | (220) | 661 | ||||
Cash and cash equivalents at the end of the period * | 75,739 | 58,461 |
* Netted of bank overdrafts presented in financial statements
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Table of contents
1 | Description of the group’s business | 9 |
2 | Major events | 10 |
2.1. | Acquisitions | 10 |
2.2. | Other significant events of the first six months of 2016 | 10 |
2.3. | Events after the reporting date | 11 |
3 | Significant accounting policies | 11 |
3.1. | Statement of Compliance | 11 |
3.2. | Basis of preparation | 12 |
3.3. | IFRS standards | 12 |
3.4. | Foreign currency translation | 14 |
3.5. | Changes in scope and method of consolidation | 15 |
4 | Notes to the condensed consolidated statement of income | 15 |
4.1. | Operating segments and entity-wide disclosures | 15 |
4.2. | Personnel costs | 16 |
4.3. | Share-based payments | 17 |
4.4. | Other operating expenses | 18 |
4.5. | Other operating income | 19 |
4.6. | Research and development expenditures | 19 |
4.7. | Finance income and finance costs | 19 |
4.8. | Income taxes | 20 |
5 | Notes to the condensed consolidated statement of financial position | 20 |
5.1. | Acquisition of business | 20 |
5.2. | Goodwill and Other intangible assets | 22 |
5.3. | Property, plants and equipment | 23 |
5.4. | Other non-current assets | 23 |
5.5. | Trade and other receivables | 24 |
5.6. | Other current assets | 24 |
5.7. | Equity | 24 |
5.8. | Retirement benefit schemes | 26 |
5.9. | Deferred taxes | 26 |
5.10. | Financial liabilities | 26 |
5.11. | Other current and non-current liabilities | 27 |
5.12. | Financial assets and liabilities | 29 |
5.13. | Derivative instruments | 31 |
6 | Consolidation scope | 32 |
7 | Related party disclosures | 32 |
8
Advanced Accelerator Applications SA Notes to the Condensed Consolidated Interim Financial Statements Six Months and Three Months ended June 30, 2016 and 2015 |
Advanced Accelerator Applications S.A. (“AAA” or the “Company”) is incorporated in France. Its registered office is at 20 rue Rudolf Diesel, 01630 Saint Genis Pouilly, France. The condensed consolidated financial statements include those of the Company and its subsidiaries (“the Group”). Each company is referred to as a “Group entity”). The condensed consolidated financial statements were authorized for issue by the Board of Directors on August 30, 2016.
1. | Description of the group’s business |
AAA is a radiopharmaceutical company founded in 2002 that develops, produces and commercializes molecular nuclear medicine (“MNM”) diagnostic and therapeutic products. MNM is a medical specialty that uses trace amounts of radioactive compounds to create functional images of organs and lesions and to treat diseases such as cancer. The Company has a portfolio of seven diagnostic positron emission tomography (“PET”) and single-photon emission computed tomography (“SPECT”) products. PET and SPECT are imaging techniques in molecular nuclear diagnostics (“MND”) with applications in clinical oncology, cardiology, neurology and inflammatory/infectious diseases. AAA’s leading diagnostic product is Gluscan, our branded 18-fluorodeoxyglucose (“FDG”) PET imaging agent. Gluscan assists in the diagnosis of serious medical conditions, primarily in oncology, by assessing glucose metabolism. In June 2016, AAA received approval from the U.S. Food and Drug Administration (“FDA”) for NETSPOTTM (formerly known as Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (“NETs”) in adult and pediatric patients using PET. AAA’s primary development focus is on product candidates in the field of molecular nuclear therapy (“MNT”). AAA’s lead therapeutic candidate, Lutathera, is a novel compound that it is currently in development for the treatment of Neuro Endocrine Tumors (“NETs”), a significant unmet medical need. Lutathera is a Lu-177 labeled somatostatin analogue peptide that has received orphan drug designation from the European Medicines Agency (“EMA”) and the US Food and Drug Administration (“FDA”). Lutathera was granted Fast-Track designation by the FDA for the treatment of inoperable progressive midgut NETs. It is also currently administered on a compassionate use and named patient basis for the treatment of NETs in ten European countries and in the US. In April 2016, AAA completed its New Drug Application (“NDA”) and Marketing Authorization Application (“MAA”) submissions to the FDA and European Medicines Agency (“EMA”). The Accelerated Assessment from the EMA was granted on April 26, 2016 and the FDA granted Priority Review in July 2016.
AAA continues to build upon its foundation and expertise in MNM by developing additional diagnostic and therapeutic candidates. Key diagnostic pipeline candidates include Somakit-TOC, a PET diagnostic for NETS and Annexin V-128, a SPECT product candidate for the imaging of apoptotic and necrotic lesions with potential applications in a broad range of indications. Other product candidates being developed as theragnostic pairs (complementary diagnostics and treatments targeting the same receptor) include PSMA-SR6, a selective, second-generation PSMA-targeted ligand and NeoBOMB1 a unique, new generation antagonist bombesin analogue targeting GRPR-expressing malignancies.
In addition to its own portfolio of PET, SPECT and Therapy products and product candidates, AAA manufactures several diagnostic products and product candidates for third parties, including GE Healthcare and Eli Lilly in Europe. AAA also manufactures and distributes IASOflu (bone metastases), IASOdopa (Parkinson’s disease), and IASOcholine (prostate cancer) under a license from IASON.
9
These products and product candidates are for the most part manufactured in one or several of AAA’s 21 production sites.
2. | Major events |
2.1. | Acquisitions |
2.1.1. | Acquisitions for the period 2016 |
Acquisition of the PetNet business in Germany
AAA Germany signed an asset purchase agreement in May 2016 to acquire, out of an insolvency procedure, assets and rights to operate F18 production sites in Munich and in Erlangen (both in Germany). The contract in Munich requires AAA Germany to provide a regular supply of F18 products to the owner of the site, the Klinikum of the University of Munich (KUM), for which AAA will be paid a guaranteed revenue stream until July 2028. The transaction closed in June.
The main objectives of the transaction are to strengthen the Company’s presence in the German market and to potentially gain access to interesting R&D activities of the KUM in radiotherapy with prostate-specific membrane antigen (PSMA) and Lutetium.
Please refer to note 5.1.1 for details on the acquired business.
Acquisition of the IDB Group
AAA acquired 100% of the shares of the IDB Group, incorporated in The Netherlands, in January 2016. The IDB Group consists of six entities in The Netherlands and one in Belgium. Their business activities include the development, production and wholesale of medical products and more specifically radiopharmaceutical products and medical and industrial radioactive substances. This transaction contributes to AAA’s international expansion and strengthens AAA’s global supply chain in preparation for the commercial launch of Lutathera. Acquiring the IDB Group provides AAA with a reliable supply of Lu-177 for the production of Lutathera and a business for other future product candidates.
Please ref to note 5.1.1 for details on the acquired entity.
2.1.2. | Acquisitions for the period 2015 |
There were no acquisitions in 2015.
2.2. | Other significant events of the first six months of 2016 |
Product development
In January 2016, AAA announced the signing of an exclusive license agreement with Johns Hopkins University to develop a PSMA receptor ligand in prostate cancer. This agreement enables AAA to broaden its pipeline with PSMA, which could be used to treat, image, monitor and stage prostate cancer, utilizing a clinical development strategy similar to Lutathera and Somakit.
AAA entered, in January 2016, into a non-exclusive agreement with Zevacor for the preparation and delivery of SomaKit-TATE (now marketed as NETSPOTTM) in the US.
Additional Lutathera NETTER-1 Phase III data were presented on January 22, 2016, at the 2016 Gastrointestinal Cancer Symposium (ASCO GI) in San Francisco, California and on March 11, 2016, at the 13th Annual European Neuroendocrine Tumor Society (ENETS) conference in Barcelona, Spain.
In March 2016, AAA opened an expanded access program (“EAP”) in the U.S. for Lutathera. Through the program, Lutathera is being made available for eligible patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors, and progressive under somatostatin analogue therapy.
10
At the end of April 2016 AAA had completed the rolling Lutathera NDA submission to the FDA and it had also submitted a Lutathera MAA to the EMA.
The Accelerated Assessment from the EMA was granted on April 26, 2016 and the FDA granted Priority Review in July 2016.
On June 1, 2016, the FDA approved NETSPOTTM (formerly known as Somakit-TATE) for the localization of somatostatin receptor positive NETs in adult and pediatric patients using PET. NETSPOTTM received approval following a Priority Review from the FDA. NETSPOTTM is a kit for the preparation of gallium Ga 68 dotatate injection. NETSPOTTM is the first approved drug using gallium Ga 68 as a positron emitter. Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and EMA in March 2014. NETSPOTTM is being commercialized in two forms in the U.S.: As a kit for reconstitution using a gallium Ga 68 generator, and as NETSPOTTM Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas. NETSPOTTM is currently approved for use with the GalliaPharm® Ga 68 generator from Eckert & Ziegler.
In June, AAA also announced the expansion of its pipeline of theragnostic products with the addition of NeoBOMB1, a novel GRPR antagonist. NeoBOMB1 is a unique new generation antagonist bombesin analogue, which binds selectively and with high affinity to the GRP receptors expressed by several types of tumors, including prostate, breast and gastro-intestinal stromal tumors. GRP receptors are considered relevant molecular targets for both therapeutic and diagnostic purposes in those cancers. In vitro and in vivo pre-clinical models have demonstrated that NeoBOMB1 has desirable imaging properties as well as a favorable pharmacokinetic and safety profile. NeoBOMB1 was originally developed by Marion De Jong of Erasmus University Medical Center and Theadosia Maina and Berthold Nock of Demokritos. AAA has acquired the rights to develop NeoBOMB1 and is currently planning three clinical studies in different indications including gastrointestinal stromal tumors, prostate cancer and breast cancer.
Governance
On May 26, Mr. Francois Nader, M.D., MBA was elected by the shareholders to join the Company Board of Directors as an Independent Non-Executive Director. He replaces Mrs. Muriel de Szilbereky.
2.3. | Events after the reporting date |
AAA USA’s first distribution and future production site in Millburn, NJ, has been established in July 2016. The facility is made up of 60% manufacturing space and 40% office space, with a capacity to accommodate fifty employees. Initially as of July, fifteen employees are working in the facility, including manufacturing, quality, sales and marketing, market access, and administrative functions. The Millburn site is being qualified for production of Lutathera and will be submitted for FDA approval immediately following the approval of Lutathera.
In early July, the first patient was treated with Lutathera under the U.S. Expanded Access Program.
In late July, AAA announced a clinical trial agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, whereby NCI will sponsor and conduct a study of Lutathera in patients with inoperable pheochromocytoma and paraganglioma.
3. | Significant accounting policies |
3.1. | Statement of Compliance |
The condensed consolidated interim financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”).
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The condensed consolidated interim financial statements for the three and six months ended June 30, 2016 and 2015 are presented and have been prepared in compliance with IAS 34, Interim Financial Reporting, regarding interim financial reporting information. This standard stipulates that condensed consolidated interim financial statements do not include all the information required under IFRS for the preparation of annual consolidated financial statements. These condensed consolidated interim financial statements must therefore be read in conjunction with the consolidated financial statements for the year ended December 31, 2015. The Group’s activity related to the three and six months period ended June 30, 2016 and 2015 does not show any significant seasonal effect.
3.2. | Basis of preparation |
The condensed consolidated interim financial statements for the three and six months period ended June 30, 2016 and 2015 are presented in Euro, the functional currency of the Company, rounded to the nearest thousand unless otherwise stated.
The condensed consolidated statement of income is presented on the basis of a classification of income and expenses by nature.
The condensed consolidated statement of cash flows has been prepared according to the indirect method.
3.3. | IFRS standards |
New currently effective requirements
The accounting policies are consistent with those of the annual financial statements for the year ended December 31, 2015, as described in the consolidated financial statements for the year ended December 31, 2015, with the exception of the adoption as of January 1, 2016 of the standards and interpretations described below:
a) | Annual Improvements to IFRSs 2012-2014 Cycle |
b) | Amendments to IAS 16 and IAS 38, clarification of acceptable methods of depreciation and amortization |
c) | Amendments to IFRS 11, accounting for acquisitions of interests in joint operations |
d) | Amendment to IAS 1, disclosure initiative |
The adoption of the above standards did not result in any significant impact in these condensed consolidated interim financial statements.
The nature and effects of the changes are explained below.
a) | Annual Improvements to IFRSs 2012-2014 Cycle |
b) | It includes amendments to a number of IFRSs. The application of these amendments has had no material impact on the disclosures or on the amounts recognized in the condensed interim consolidated financial statements. |
c) | Amendments to IAS 16 and IAS 38, clarification of acceptable methods of depreciation and amortization |
d) | The amendments clarify that a revenue-based method is not considered to be an appropriate manifestation of consumption. |
e) | Amendments to IFRS 11, accounting for acquisitions of interests in joint operations |
f) | The amendments clarify that the acquirer of an interest in a joint operation in which the activity constitutes a business, as defined in IFRS 3, is required to apply all of the principles on business combinations accounting in IFRS 3 and other IFRSs with the exception of those principles that conflict with the guidance in IFRS 11. |
g) | Amendment to IAS 1, disclosure initiative |
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h) | The amendment aims at clarifying IAS 1 to address perceived impediments to preparers exercising their judgement in presenting their financial reports. |
Forthcoming requirements
The Group has not applied the following new and revised IFRSs that have been issued but are not yet effective:
Amendment to IAS 7 | Disclosure initiative (1) |
Amendment to IAS 12 | Recognition of Deferred Tax Assets for Unrealized Losses (1) |
IFRS 9 | Financial Instruments (2) |
IFRS 15 | Revenue from contract with customers (2) |
Amendments to IFRS 10 and IAS 28 | Sale or Contribution of Assets between an Investor and its Associate or Joint Venture (3) |
IFRS 16 | Leases (4) |
(1) | Effective for annual period beginning on or after 1 January 2017, with earlier application permitted |
(2) | Effective for annual period beginning on or after 1 January 2018, with earlier application permitted for IFRS 9 and IFRS 15 |
(3) | Effective date of this amendment has been postponed indefinitely, with earlier application permitted |
(4) | Effective for annual period beginning on or after 1 January 2019, with earlier adoption permitted if IFRS 15 Revenue from Contracts with Customers has also been applied |
These standards are further detailed below:
IAS 7 Statement of Cash Flows requires an entity to present a statement of cash flows as an integral part of its primary financial statements. Cash flows are classified and presented into operating activities (either using the 'direct' or 'indirect' method), investing activities or financing activities, with the latter two categories generally presented on a gross basis.
As of 1 January 2017, the entities shall provide disclosures that enable users of financial statements to evaluate changes in liabilities arising from financing activities.
The Amendment to IAS 12 will clarify whether an unrealized loss on a debt instrument measured at fair value gives rise to a deductible temporary difference when the holder expects to recover the carrying amount of the asset by holding it to maturity and collecting all the contractual cash flows.
IFRS 9, published in July 2014, replaces the existing guidance in IAS 39 Financial Instruments: Recognition and Measurement. IFRS 9 includes revised guidance on the classification and measurement of financial instruments, a new expected credit loss model for calculating impairment on financial assets, and new general hedge accounting requirements. It also carries forward the guidance and recognition and derecognition of financial instruments from IAS 39.
IFRS 9 is effective for annual reporting periods beginning on or after 1 January 2018, with early adoption permitted.
IFRS 15 provides a single, principles based five-step model to be applied to all contracts with customers.
The five steps in the model are:
· | Step 1: Identify the contract with the customer; |
· | Step 2: Identify the performance obligations in the contract; |
· | Step 3: Determine the transaction price; |
· | Step 4: Allocate the transaction price to the performance obligations in the contracts; |
· | Step 5: Recognize revenue when (or as) the entity satisfies a performance obligation. |
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Under IFRS 15, an entity recognizes revenue when (or as) a performance obligation is satisfied.
IFRS 15 will supersede the current revenue recognition guidance including IAS 18 Revenue, IAS 11 Construction Contracts and the related Interpretations when it becomes effective.
Guidance is provided on topics such as the point at which revenue is recognized, accounting for variable consideration, costs of fulfilling and obtaining a contract and various related matters. New disclosures about revenue are also introduced.
IFRS 15 will become effective for annual periods beginning on or after January 1, 2018 with early adoption permitted.
Most of the Group’s revenue is derived from the sales of diagnostic products. For such products, the transfer of control occurs when the batch is delivered to the customer, which is also the date on which the sales revenue is recognized in the statement of income. The application of IFRS 15 is not expected to have any significant impact on the revenue recognition for these products.
IFRS 16 establishes principles for the recognition, measurement, presentation and disclosure of leases, with the objective of ensuring that lessees and lessors provide relevant information that faithfully represents those transactions.
IFRS 16 eliminates the classification of leases as either operating lease or finance lease for a lessee. Instead, all leases are treated in a similar way to finance leases applying IAS 17. Leases are capitalized recognizing the present value of the lease payments and showing them either as lease assets (right-of-use assets) or together with property, plant and equipment. If lease payments are made over time, the Company also recognizes a financial liability representing its obligation to make future lease payments.
IFRS changes the nature of expenses related to off-balance sheet leases. It replaces the typical straight line operating lease expense with a depreciation charge for lease assets (included within operating costs) and an interest expense on lease liabilities (included within finance costs).
Accounting exemptions apply to short-term lease and to leases of low-value assets.
The potential impact of the application of these standards is currently under review by the Group, especially IFRS 16 and IFRS 15.
3.4. | Foreign currency translation |
In preparing the financial statements of the Group, the financial statements of subsidiaries, which report in a currency other than the Euro, are translated to Euro as follows:
· | Assets and liabilities, including goodwill and fair value adjustments arising on a business combination, are translated into Euros at the foreign exchange rates at the reporting date. |
· | Income statement items are translated into Euros at the exchange rate, which represents the average exchange rate for the period. |
· | All resulting translation differences are recognized directly in other comprehensive income. |
2016 | USD | CAD | ILS | CHF | GBP | PLN |
Closing Rate | 0.9007 | 0.6952 | 0.2339 | 0.9202 | 1.2099 | 0.2254 |
Average Rate six months ended June 30, | 0.8924 | 0.6784 | 0.2321 | 0.9126 | 1.2776 | 0.2293 |
2015 | USD | CAD | ILS | CHF | GBP | PLN |
Closing Rate | 0.8937 | 0.7226 | 0.2369 | 0.9603 | 1.4057 | 0.2386 |
Average Rate six months ended June 30, | 0.8967 | 0.7255 | 0.2302 | 0.9507 | 1.3687 | 0.2419 |
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3.5. | Changes in scope and method of consolidation |
On January 6, 2016 and May 18, 2016 AAA respectively acquired the IDB Group and the PetNet business in Germany as explained in notes 2.1.1. and 5.1.1. These businesses have been consolidated since their dates of acquisition.
There were no changes in the scope and method of consolidation in 2015.
4. | Notes to the condensed consolidated statement of income |
4.1. | Operating segments and entity-wide disclosures |
Operating segment
In compliance with IFRS 8 Operating Segments, the segment information is based on internal management reports used by the Board of Directors (the chief operating decision maker of the Group) to review the performance of the business. There is only one operating segment in the Group and its performance is shown in the condensed consolidated interim statement of income.
Entity-wide disclosures
Other required entity-wide disclosures in accordance with IFRS 8 are presented below.
Sales by product category
Three months | Six months | |||||||
In € thousands | June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||
PET | 16,811 | 14,879 | 32,723 | 29,236 | ||||
Therapy | 5,581 | 2,357 | 11,173 | 4,396 | ||||
SPECT | 2,380 | 1,948 | 4,627 | 3,995 | ||||
Other products | 2,868 | 3,026 | 6,036 | 5,347 | ||||
Total | 27,640 | 22,210 | 54,559 | 42,974 |
Geographical information
The two tables that follow show the Group’s sales and non-current assets by country. In presenting the following information, sales disclosures are based on the location of customers and asset disclosures on the location of the sites of Group entities.
Sales by country
Three months | Six months | |||||||
In € thousands | June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||
France | 8,773 | 6,997 | 16,939 | 13,333 | ||||
Italy | 5,862 | 5,859 | 11,435 | 11,311 | ||||
United Kingdom | 3,742 | 3,698 | 8,353 | 7,029 | ||||
Spain | 3,219 | 2,418 | 6,014 | 4,753 | ||||
Netherlands | 1,895 | - | 3,951 | - | ||||
Switzerland | 1,510 | 1,304 | 2,910 | 2,385 | ||||
Portugal | 962 | 876 | 1,923 | 1,768 | ||||
Israel | 458 | 450 | 1,091 | 1,293 | ||||
Germany | 1,003 | 503 | 1,545 | 892 | ||||
Poland | 172 | 105 | 319 | 210 | ||||
Belgium | 44 | - | 79 | - | ||||
Total | 27,640 | 22,210 | 54,559 | 42,974 |
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Non-current assets by country
The table of non-current assets by geographical location excludes financial and deferred tax assets.
In € thousands | June 30, 2016 | December 31, 2015 | ||
Netherlands | 27,459 | - | ||
United States | 27,407 | 23,036 | ||
France | 23,409 | 24,836 | ||
Spain | 19,079 | 18,671 | ||
Italy | 14,609 | 15,237 | ||
Israel | 12,483 | 12,899 | ||
Germany | 11,052 | 8,504 | ||
Canada | 5,745 | 5,467 | ||
United Kingdom | 980 | 1,295 | ||
Switzerland | 767 | 785 | ||
Poland | 119 | 146 | ||
Belgium | 1 | 2 | ||
Portugal | - | - | ||
Total | 143,110 | 110,878 |
4.2. | Personnel costs |
Personnel costs are analyzed as follows:
Three months | Six months | |||||||
In € thousands | June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||
Wages and salaries | (6,105) | (4,989) | (12,456) | (9,385) | ||||
Social charges | (1,581) | (1,251) | (3,184) | (2,556) | ||||
Share-based payments | (1,239) | (440) | (2,545) | (835) | ||||
Other personnel expenses | (323) | (132) | (742) | (194) | ||||
Total | (9,248) | (6,812) | (18,927) | (12,970) |
The table below shows AAA personnel by country as of June 30, 2016 and June 30, 2015.
June 30, 2016 | June 30, 2015 | |||
Italy | 128 | 114 | ||
France | 119 | 102 | ||
Spain | 54 | 41 | ||
United States | 38 | 15 | ||
United Kingdom | 31 | 23 | ||
Germany | 28 | 12 | ||
Portugal | 16 | 17 | ||
Switzerland | 16 | 10 | ||
Israel | 15 | 14 | ||
Poland | 14 | 11 | ||
Netherlands | 9 | - | ||
Total | 468 | 359 |
In the second quarter and first half 2016 and 2015, the total remuneration of the Group’s senior executives was as follows:
Three months | Six months | |||||||
In € thousands | June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||
Short-term benefits | 429 | 418 | 875 | 881 | ||||
Share-based payments | 141 | 87 | 285 | 87 | ||||
Post employment benefits | 8 | - | 16 | - | ||||
Total | 578 | 505 | 1,176 | 968 |
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4.3. | Share-based payments |
4.3.1. | Restricted (free) share plans |
Share-based payments include restricted (free) share plans for Group management. The fair value of the share grants was determined by reference to the subscription price of share capital increases carried out closest to the dates of these free share grants.
There are no vesting conditions, except for a service condition.
Grant date | 09/2010 | 11/2011 | 01/2012 | 12/2012 | 08/2013 | 11/2014 | 05/2015 |
Number of shares granted | 370,000 | 370,000 | 15,000 | 562,500 | 477,500 | 155,000 | 160,000 |
Fair value at grant date (€) | 2.5 | 4.0 | 4.0 | 4.0 | 5.0 | 5.0 | 6.1 |
Total fair value (€) | 925,000 | 1,480,000 | 60,000 | 2,250,000 | 2,387,500 | 775,000 | 976,000 |
Vesting period (in years)* | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
*except for Italian employees for whom the vesting period has been extended to 4 or 5 years for tax purposes in accordance with the shareholders meeting decision of December 16, 2014 and the Board of Directors’ decision of February 26, 2015.
4.3.2. | Options |
3,947,625 stock options were granted to employees over ordinary shares in the Company in November 2015. Movements in stock options in the six months ended June 30, 2016, were as follows:
Number of options | Weighted average exercise price | |||
At January 1, 2016 | 3,947,625 | $8.00 | ||
Options granted in the period | - | - | ||
Options exercised in the period | - | - | ||
Options lapsed in the period | - | - | ||
Options forfeited in the period | 87,500 | $8.00 | ||
At June 30, 2016 | 3,860,125 | $8.00 |
The options outstanding at June 30, 2016 had an exercise price of US$8.00 (€7.45 based on an exchange rate at the grant date) and a weighted average remaining contractual life of 9.36 years. No options were exercisable at June 30, 2016.
4.3.3. | Warrants |
The 225,000 warrants granted in 2015 to six Board members for a consideration of €0.80 per warrant are exercisable immediately following the grant date and lapse after a period of 18 months.
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Movements in equity-settled warrants over ordinary shares in the Company in the period were as follows:
Number of warrants | Weighted average exercise price | |||
At January 1, 2016 | 225,000 | €6.10 | ||
Warrants granted in the period | - | - | ||
Warrants lapsed in the year | - | - | ||
Warrants exercised in the year | - | - | ||
At June 30, 2016 | 225,000 | €6.10 |
225,000 warrants are exercisable at reporting date.
AAA shareholders approved on May 26, 2016 a warrant plan for the seven non-executive board members and delegated authorization for its execution to the Board. There are 149’800 warrants available in the plan. The purchase of one warrant entitles to purchase one share. The shareholder resolution states that the Board has 18 months to use the delegation and the beneficiaries of the plan have 3 years to exercise their right to buy shares should they decide to so. The Board made use of the shareholder delegation on May 26 and decided to put in place the warrant plan. The warrant subscription price and the share exercise price were determined with the support of an external valuation specialist.
The fair value of the warrants was estimated to be USD 6.33 (€ 5.66 at the exchange rate at May 26, 2016) per warrant by a third party using the Black-Scholes pricing model with the following significant assumptions:
Term of option (years) | 3 |
Risk-free interest rate | 1.0895% |
Volatility | 57.0% |
As the consideration paid by the grantees represented the fair value of the warrants at the grant date, no related expense has been recognized in the consolidated statement of income (loss) for the quarter ended June 30, 2016.
The subscription period has not been opened on August 30. As of August 30, 2016 no warrants have been subscribed.
4.4. | Other operating expenses |
Other operating expenses principally concern non-inventoried purchases, consumable equipment & supplies, travelling expenses, communication costs, consulting and other external services relating to R&D, and other professional services:
Three months | Six months | |||||||
In € thousands
| June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||
Transport | (2,712) | (2,492) | (5,504) | (5,036) | ||||
External R&D services (1) | (1,879) | (2,698) | (3,798) | (5,761) | ||||
Consulting and other professional services (2) | (1,761) | (1,128) | (3,218) | (2,759) | ||||
Lease and other administrative expenses (3) | (1,153) | (1,115) | (2,369) | (1,809) | ||||
Repairs and maintenance | (1,265) | (791) | (2,198) | (1,458) | ||||
Travel expenses | (752) | (468) | (1,579) | (960) | ||||
Communications (4) | (937) | (301) | (1,365) | (505) | ||||
Royalties and Licensing fees | (418) | (258) | (897) | (652) | ||||
Energy | (324) | (335) | (674) | (655) | ||||
Taxes | (210) | (398) | (474) | (615) | ||||
Allowance for doubtful accounts | (43) | (188) | (43) | (190) | ||||
Other | (526) | (893) | (708) | (1,278) | ||||
Total | (11,980) | (11,065) | (22,827) | (21,678) |
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(1) The decrease for €1,963 thousand in the six months ended June 30, 2016 compared to six months ended June 30, 2015 is mainly due to phasing of R&D services expenses.
(2) The increase for €633 thousand in the six months ended June 30, 2016 compared to the six months ended June 30, 2015 is mainly explained by the registration fees for €510 thousand for Somakit and Lutathera.
(3) The increase for €560 thousand in the six months ended June 30, 2016 compared to six months ended June 30, 2015 is explained by the increase in insurance costs and the costs related to the Millburn facility.
(4) The increase for €860 thousand in the six months ended June 30, 2016 compared to six months ended June 30, 2015 is explained by the increase in Lutathera communication costs.
The IDB acquisition adds operating expenses of €847 thousand and of 389 thousand in the six months and three months periods ended June 30, 2016, respectively.
4.5. | Other operating income |
Three months | Six months | |||||||
In € thousands | June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||
Government subsidies | 867 | 1,165 | 2,014 | 2,239 | ||||
Net gain / (loss) on disposal of non-current assets | (14) | (6) | (86) | (7) | ||||
Other operating income | 572 | 158 | 807 | 445 | ||||
Total | 1,425 | 1,317 | 2,735 | 2,677 |
Government subsidies consist for the most part of the French research tax credit (CIR).
4.6. | Research and development expenditures |
Three months | Six months | |||||||
In € thousands | June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||
Personnel costs (including share-based payments for R&D personnel) | (1,216) | (653) | (2,077) | (1,313) | ||||
Other operating costs (including depreciation and amortization) | (2,460) | (3,113) | (4,824) | (6,276) | ||||
Total | (3,676) | (3,766) | (6,901) | (7,589) |
Total expenditures on R&D projects include external fees, personnel costs, depreciation and amortization on fixed and intangible assets, transport and consumables costs.
4.7. | Finance income and finance costs |
Three months | Six months | |||||||
In € thousands | June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||
Net foreign exchange gain | 681 | 58 | - | - | ||||
Unrealised gain on derivatives at fair value | 12 | - | 25 | - | ||||
Change in fair value of contingent consideration (1) | 224 | - | 204 | - | ||||
Other | 118 | 71 | 216 | 85 | ||||
Total finance income | 1,035 | 129 | 445 | 85 |
Three months | Six months | |||||||
In € thousands | June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||
Net foreign exchange loss (3) | - | - | (1,266) | (181) | ||||
Unrealised loss on derivatives at fair value | (15) | - | (39) | - | ||||
Change in fair value of contingent consideration (2) | (1,317) | (278) | (1,344) | (3,550) | ||||
Interest expenses | (84) | (149) | (177) | (340) | ||||
Other | (213) | (141) | (391) | (240) | ||||
Total finance costs | (1,629) | (568) | (3,217) | (4,311) | ||||
(1) | Includes €219 thousand gain relating to the renegociation of the IDB share purchase agreement |
(2) | The change relates primarily to the estimated fair values of the contingent considerations payable to the former owners of BioSynthema (now Advanced Accelerator Applications USA, Inc.) and Atreus (now Advanced Accelerator Applications Canada Inc.). Refer to note 5.11 for further details |
(3) | The net foreign exchange loss is mainly due to the conversion of the US$ cash position into our reporting currency. The loss is partially compensated by the realized gain of €896 thousand on foreign exchange hedging contracts |
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4.8. | Income taxes |
Income tax expense represents the best estimate of the average annual effective tax rate expected for the full year, applied to the pre-tax income of the six months period ended June 30, 2016.
For the six months ended June 30, 2016 the consolidated income tax profit amounted to €0.45 million compared to an income tax expense for €0.69 million for the same period in 2015. The variation is mainly due the €1.1 million deferred tax income recognized on the tax loss for the period for Advanced Accelerator Applications USA Inc. The deferred tax income was recognized because it can be utilized against the existing available taxable temporary differences.
5. | Notes to the condensed consolidated statement of financial position |
5.1. | Acquisition of business |
5.1.1. | Acquisition of business in the six months ended June 30, 2016 |
Acquisition of the PetNet business in Germany
AAA Germany signed in May 2016 an asset purchase agreement to acquire, out of an insolvency procedure, assets and rights to operate F18 production sites in Munich and in Erlangen (both in Germany). The contract in Munich requires AAA Germany to supply F18 products to the owner of the site, the Klinikum of the University of Munich (KUM). AAA will be paid a guaranteed revenue stream until July 2028 for this supply.
In June 2016, AAA Germany acquired from PetNet Solutions GmbH, a cooling system, which is installed in the Munich site.
The main objectives of these acquisitions are to improve the Company’s competitive position in the German market and to potentially gain access to interesting new product development efforts, which are fully in line with AAA’s own R&D efforts.
The total consideration for the purchase of all assets is €2.22 million. It is an asset deal, in accordance with IFRS 3. AAA also agreed, with the insolvency administrators, to pay the salaries of the persons employed at these two sites as of May 2016.
Recognized amounts of identifiable assets acquired and liabilities assumed at acquisition date (June 1st, 2016) (in thousands) | € | |
Customer relationships | 2,126 | |
Property, plant and equipment | 579 | |
Inventory | 151 | |
Other current assets | 16 | |
Deferred tax assets | 636 | |
Deferred tax liabilities | (698) | |
Non-current provisions | (364) | |
Other current liabilities | (99) | |
Total net assets acquired | 2,347 | |
Negative goodwill * | (127) | |
Total consideration | 2,220 | |
Satisfied by: | ||
Cash | 2,220 | |
Total consideration transferred | 2,220 |
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Net cash outflow due to this acquisition: | ||
Cash consideration | 2,220 | |
2,220 |
* recognized in other income
The amounts of revenue and profit of the PetNet business since the acquisition date included in the consolidated statement of comprehensive income for the six months period ended June 30, 2016 are €0.27 million and €0.11 million respectively.
As of June 30, 2016 the purchase price allocation is considered preliminary. The initial accounting for this acquisition may be revised within one year following the acquisition date should new information on facts and circumstances that already existed at the date of acquisition be obtained.
Acquisition of the IDB Group
AAA acquired 100% of the shares of the IDB Group, incorporated in The Netherlands, in January 2016. The IDB Group consists of six entities in The Netherlands and one in Belgium. Their business activities include the development, production and wholesale of medical products and more specifically radiopharmaceutical products and medical and industrial radioactive substances. This transaction contributes to AAA’s international expansion and strengthens AAA’s global supply chain in preparation for the commercial launch of Lutathera. Acquiring the IDB Group provides AAA with a reliable supply of Lu-177 for the production of Lutathera and a business for other future product candidates.
Recognized amounts of identifiable assets acquired and liabilities assumed at acquisition date (in thousands) | € | |
Intangible assets | 14,292 | |
Property, plant and equipment | 3,406 | |
Inventory | 490 | |
Trade and other receivables | 905 | |
Other current assets | 340 | |
Cash and cash equivalent | 3,467 | |
Deferred tax liabilities | (4,150) | |
Trade and other payable | (800) | |
Other current liabilities | (449) | |
Total net assets acquired | 17,501 | |
Goodwill | 10,814 | |
Total consideration | 28,315 | |
Satisfied by: | ||
Cash | 23,700 | |
Contingent consideration arrangement | 4,615 | |
Total consideration transferred | 28,315 | |
Net cash outflow due to this acquisition: | ||
Cash consideration | 23,700 | |
Less: cash and cash equivalents acquired | (3,467) | |
20,233 |
Intangible assets acquired consist of customer relationships valued at €6 million and trademarks and licenses valued at €8.3 million.
Under the contingent consideration arrangement, AAA is obligated to pay the sellers an additional earn-out. AAA has made a first payment of €1.7 million at the end of April 2016 and a second payment of €1 million in June 2016. A final payment of €1.75 million is due in January 2017.
AAA paid, also in April 2016 €0.3 million based on the net financial position at the acquisition date.
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A Goodwill has been recognized in the acquisition of the IDB Group because the consideration paid included expectations regarding future revenue growth, ease of market development and increased control of distribution channels. These benefits are not recognized separately from Goodwill because they do not meet the recognition criteria for identifiable intangible assets. Goodwill resulting from this acquisition is not expected to be deductible for tax purposes.
The amounts of revenue and profit or loss of the acquiree since the acquisition date included in the consolidated statement of comprehensive income for the six months period ended June 30, 2016 are €4 million and €0.58 million respectively.
As of June 30, 2016 the purchase price allocation is considered preliminary. The initial accounting for this acquisition may be revised within one year following the acquisition date should new information on facts and circumstances that existed at the date of acquisition being obtained.
5.1.2. | Acquisition of business in the six months ended June 30, 2015 |
None.
5.2. | Goodwill and Other intangible assets |
5.2.1. | Change in the period |
The carrying amount of the Goodwill and other intangible assets was €54.5 million at December 31, 2015 and increased to €79.7 million at June 30, 2016, the change is mainly attributable to the acquisition of the IDB Group for €25.1 million and to translation differences.
5.2.2. | Allocation of Goodwill and Other non-amortized intangible assets to Cash-Generating Units (CGUs) |
The Group has allocated Goodwill and other intangible assets to its CGUs. The CGUs correspond to each of the countries in which the Group operates. The carrying amount of goodwill and other non-amortized intangible assets allocated is as follows:
June 30, 2016 | ||||||||
In € thousands | Goodwill | Acquired IPR&D | Accumulated impairment | Total | ||||
Gipharma | 1,947 | - | - | 1,947 | ||||
Italy | 200 | - | - | 200 | ||||
Canada | 579 | 5,165 | - | 5,744 | ||||
United States | 4,073 | 11,889 | - | 15,962 | ||||
Germany | 1,027 | - | - | 1,027 | ||||
Spain | 6,261 | - | - | 6,261 | ||||
Israel | 8,430 | - | - | 8,430 | ||||
Netherlands | 10,814 | - | - | 10,814 | ||||
Portugal | 1,855 | - | (1,855) | - | ||||
Other countries | 38 | - | - | 38 | ||||
Total | 35,224 | 17,054 | (1,855) | 50,423 |
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December 31, 2015 | ||||||||
In € thousands | Goodwill | Acquired IPR&D | Accumulated impairment | Total | ||||
Gipharma | 1,947 | - | - | 1,947 | ||||
Italy | 200 | - | - | 200 | ||||
Canada | 551 | 4,916 | - | 5,467 | ||||
USA | 4,154 | 12,124 | - | 16,278 | ||||
Germany | 1,027 | - | - | 1,027 | ||||
Spain | 6,261 | - | - | 6,261 | ||||
Israel | 8,484 | - | - | 8,484 | ||||
Portugal | 1,855 | - | (1,855) | - | ||||
Other countries | 38 | - | - | 38 | ||||
Total | 24,517 | 17,040 | (1,855) | 39,702 |
Goodwill increased from €22.7 million at December 31, 2015 to €33.4 million at June 30, 2016. The increase is due to the acquisition of the IDB Group for €10.8 million and to translation differences on the goodwill of the CGUs in Israel, Canada and in the USA.
5.2.3. | Impairment review of intangible assets |
The carrying amounts of Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually, at year end, and whenever events or circumstances indicate that assets may be impaired. An impairment charge is recognized when the recoverable value of an intangible becomes lower than its carrying amount.
No trigger event occurred during the period that would indicate the need for impairment.
Please refer to year-end financial statements for details on the latest annual impairment tests that were carried out, including sensitivity analysis and principal assumptions used.
5.3. | Property, plants and equipment |
For the six months period ended June 30, 2016, the Group spent approximately €4.8 million on the new site currently under construction in the USA and approximately €2.6 million on new equipment and replacements investments in its existing sites in Spain, France, Italy and Germany.
5.4. | Other non-current assets |
The other non-current assets include the French R&D tax credit receivable and the French employment incentive tax credit receivable that the Tax Authorities will repay after one year or more. Following the increase in Group activities the Company is not eligible any more to the accelerated repayment of its tax credit receivables. For each given year, the R&D tax credit and French employment incentive tax credit receivable will be paid by the Tax Authorities with a three years delay.
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5.5. | Trade and other receivables |
Trade and other receivables are as follows:
In € thousands | June 30, 2016 | December 31, 2015 | ||
Gross value | 30,370 | 24,397 | ||
Allowance for doubtful accounts | (814) | (772) | ||
Total | 29,556 | 23,625 |
Aging of trade and other receivables
In € thousands | June 30, 2016 | December 31, 2015 | ||
Not overdue | 18,779 | 15,631 | ||
Past due up to 30 days | 3,810 | 3,041 | ||
Past due for 30-60 days | 2,248 | 1,219 | ||
Past due for 60-90 days | 1,067 | 1,108 | ||
Past due for 90-180 days | 2,052 | 1,575 | ||
Past due for more than 180 days | 2,414 | 1,823 | ||
Allowance for doubtful accounts | (814) | (772) | ||
Total | 29,556 | 23,625 |
AAA is not significantly exposed to credit risk. A large portion of the customers are public hospitals which represent a relatively low risk.
5.6. | Other current assets |
Other current assets are as follows:
In € thousands | June 30, 2016 | December 31, 2015 | ||
R&D tax credit receivable | 3,327 | 3,328 | ||
Tax receivables (incl. VAT) and other receivables | 4,834 | 4,994 | ||
Derivative assets (1) | 24 | 897 | ||
Prepaid expenses | 2,817 | 1,396 | ||
Other current assets | 11,002 | 10,615 |
(1) | Derivative assets primarily correspond to the fair value of the foreign exchange contracts concluded by the Group to hedge its exposure to foreign exchange risks arising from the cash received in US Dollars from the Initial Public Offering (IPO). These derivative assets are measured at fair value subsequent to their initial recognition and any change in the fair value is recorded through the income statement |
5.7. | Equity |
The Group’s financing policy is primarily to ensure the going concern. It intends to achieve this with a mix of equity (comprised of issued capital, reserves and retained earnings) and debt that is appropriate given the overall business risk. The Group is not subject to any externally imposed capital requirements.
At June 30, 2016, the share capital consists of 78,556,211 fully paid-up ordinary shares, with a nominal value of €0.10 per share. There were no changes compared to December 31, 2015.
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Increase of share capital
The increases in share capital, which occurred from January 1, 2015 through June 30, 2016, are described below:
Date | Nature of operation | Note | Number of shares | Price per share / warrant | Raised capital (in K€) | Nominal value | Share capital (in K€) |
Dec 31, 2014 | Outstanding shares | 63,229,041 | 0.10 | 6,323 | |||
May 28, 2015 | Issuance of common shares | (1) | 1,459,660 | 6.10 | 8,904 | 0.10 | 146 |
June 17, 2015 | Issuance of common shares | (2) | 2,330,110 | 6.10 | 14,214 | 0.10 | 233 |
Aug 19, 2015 | Issuance of common shares (free shares allocated to employees) | 352,500 | 0.00 | 0 | 0.10 | 35 | |
Sept 6, 2015 | Issuance of common shares (free shares allocated to employees) | 235,000 | 0.00 | 0 | 0.10 | 24 | |
Sept 28, 2015 | Issuance of common shares (free shares allocated to employees) | 167,500 | 0.00 | 0 | 0.10 | 17 | |
Sept 28, 2015 | Issuance of 225,000 warrants at a €0.8 price | 0.80 | 180 | ||||
Nov 11, 2015 | Issuance of common shares | (3) | 10,782,400 | 7.45 | 80,444 | 0.10 | 1,078 |
Share issuance costs | (6,648) | ||||||
Total | 78,556,211 | 97,094 | 0.10 | 7,856 |
(1) | On May 28, 2015, 1,459,660 shares have been issued at a price of €6.10 per share following the extraordinary general meeting held on December 16, 2014 |
(2) | On June 17, 2015, 2,330,110 shares have been issued at a price of €6.10 per share following the extraordinary general meeting held on December 16, 2014 |
(3) | Initial Public Offering (IPO) |
AAA completed an IPO of 4,688,000 American Depositary Shares (“ADS”) representing 9,376,000 ordinary shares at a price of US$16.00 (€14.9) per ADS (each ADS represents 2 ordinary shares). The ADS have been listed on the Nasdaq Global Select Market on and started trading on November 11, 2015 under the ticker “AAAP”. The overallotment option (Greenshoe) of 15% was also used immediately by the Underwriters and an additional 1,406,400 shares or 703,200 ADS were issued at the same price of US$16.00 (€14.9) per ADS.
Basic and diluted loss per share
Three months | Six months | |||||||||||
Net loss (In € thousands) | Average number of shares outstanding | Loss per share (€) | Net loss (In € thousands) | Average number of shares outstanding | Loss per share (€) | |||||||
June 30, 2016 | (1,432) | (4,408) | ||||||||||
Basic loss per share | 78,556,211 | (0.02) | 78,556,211 | (0.06) | ||||||||
Diluted loss per share | 78,556,211 | (0.02) | 78,556,211 | (0.06) | ||||||||
June 30, 2015 | (2,560) | (8,463) | ||||||||||
Basic loss per share | 63,678,494 | (0.04) | 63,678,494 | (0.13) | ||||||||
Diluted loss per share | 63,678,494 | (0.04) | 63,678,494 | (0.13) |
There are no free shares vested but not yet issued included in the average number of shares outstanding.
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5.8. | Retirement benefit schemes |
The defined benefit obligation at June 30, 2016 is estimated, using the latest actuarial valuation at December 31, 2015 except for the discount rate which has been updated at June 30, 2016. There have not been any significant fluctuations or one-time events since that time that would require adjustments to the actuarial assumptions made at December 31, 2015.
5.9. | Deferred taxes |
The increase in deferred tax liabilities is mainly due to deferred tax liabilities recognized on intangible assets in relation with the acquisition of IDB Group (refer to note 5.1.1).
5.10. | Financial liabilities |
Financial liabilities by category
In € thousands | June 30, 2016 | December 31, 2015 | ||
Finance lease obligations | 5,065 | 6,062 | ||
Loans | 13,475 | 15,703 | ||
Total (1) | 18,540 | 21,765 |
(1) | The financial liabilities of €18.6 million at June 30, 2016 (€21.8 million at December 31, 2015) are guaranteed at €7.1 million (€8.9 million at December 31, 2015) by equipment, land and buildings; loans of €3 million (€3.5 million at December 31, 2015) are backed by an OSEO-issued guarantee. OSEO is today part of the French Banque Publique d’Investissement (BPI) |
Financial liabilities by date of maturity
June 30, 2016 | ||||||||
In € thousands | < 1 year | 1-5 years | > 5 years | Total | ||||
Finance lease obligations | 1,260 | 3,233 | 572 | 5,065 | ||||
Loans | 2,961 | 6,466 | 4,048 | 13,475 | ||||
Total | 4,221 | 9,699 | 4,620 | 18,540 |
December 31, 2015 | ||||||||
In € thousands | < 1 year | 1-5 years | > 5 years | Total | ||||
Finance lease obligations | 1,705 | 3,475 | 882 | 6,062 | ||||
Loans | 3,855 | 7,527 | 4,321 | 15,703 | ||||
Total | 5,560 | 11,002 | 5,203 | 21,765 |
Financial liabilities by type of interest rate
June 30, 2016 | December 31, 2015 | |||||||
In € thousands | Average interest rate | € | Average interest rate | € | ||||
Fixed rates | 2.52% | 12,946 | 2.67% | 15,618 | ||||
Floating rates | 1.85% | 5,594 | 1.94% | 6,147 | ||||
Total | 18,540 | 21,765 |
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5.11. | Other current and non-current liabilities |
In € thousands | June 30, 2016 | December 31, 2015 | ||
Due to former owners of acquired companies (1) | 39,386 | 38,155 | ||
Government subsidies | 909 | 1,209 | ||
Derivatives liabilities | 31 | - | ||
Other non-current liabilities | 40,325 | 39,364 | ||
Due to former owners of acquired companies (1) | 5,878 | 4,223 | ||
Tax, personnel and social charges | 6,540 | 8,938 | ||
Other (2) | 2,360 | 2,577 | ||
Other current liabilities | 14,778 | 15,738 |
(1) | The Group is obligated to pay contingent considerations to the former owners of acquired companies, as defined under each acquisition agreement |
(2) | The other current liabilities include mainly deferred income |
Debt due to former owners of acquired companies
To the former BioSynthema Inc.owners:
The principal contingent consideration concerns Advanced Accelerator Applications USA, Inc. The initial contingent consideration comprised four equal cash payments and four payments to be made in shares of the Company (number of shares is subject to market value at respective dates) upon reaching certain milestones as defined in the contract. These milestones are based on different stages of the development of Lutathera.
As of June 30, 2016 the first two milestones have been met and paid.
The contingent consideration also includes a variable tranche based on a percentage of future Lutathera worldwide sales. At June 30, 2016 the main assumptions used in calculating the amount of this fixed and variable contingent consideration are the following:
· | Future sales of Lutathera: determined using the most recent Group business plans; and |
· | Probability of occurrence: 80% at June 30, 2016 (80 % at December 31, 2015) for sales and milestones which have not yet been reached. This percentage was estimated by the Company based on the current stage of the product development; and |
· | Discount rate of 10%: this reflects both the time value of money and the estimated risk of not realizing the future cash flows. |
On this basis, the contingent consideration amounted to €34.5 million and €33.8 million, at June 30, 2016 and December 31, 2015, respectively. The resulting finance loss of €0.7 million over the six months period is mainly due to the exchange rate variation of the US$ to the € and the unwinding of the discounting.
If the probability of occurrence was to be increased to 100%, the contingent consideration would have amounted to €43.1 million at June 30, 2016. An increase or decrease of 1 percentage point in the discount rate would respectively lead to a decrease of €1.8 million or to an increase of €1.9 million in the contingent consideration liability. An increase or decrease of 5 percentage point in exchange rate used in the calculation would respectively lead to a decrease of €1.1 million or to an increase of €1.3 million in the contingent consideration liability. Other items could have an impact on the contingent consideration such as the timing of market authorization in the various jurisdictions or the future selling prices.
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To the former Atreus Pharmaceuticals Corporation owners:
On December 18, 2014, the Group acquired the remaining 49.9% non-controlling interest in Atreus Pharmaceuticals Corporation. As a result of this acquisition, AAA holds 100% of Atreus Pharmaceuticals Corporation. The consideration to be paid for this acquisition is composed of fixed anniversary and milestone payments prior to having obtained marketing authorization for Annexin and of a contingent consideration based on low single-digit percentage royalties on sales of Annexin for duration of 10 years following Marketing Authorization.
At June 30, 2016, the main assumptions used in calculating the amount of this fixed and variable contingent consideration are the following:
· | Regulatory approval obtained in 2019 |
· | Future sales of Annexin based on the most recent business plan; |
· | Probability of occurrence: 100% for 2016 payments of anniversary and milestone payments, 60% for 2017 and 2018 payments of anniversary and milestone payments and then 30% for further payments of anniversary and milestone payments and of 30% for royalty payments; These percentages were estimated by the Company based on the current stage of product development; and |
· | Discount rate of 10% to reflect the time value of money and the estimated risk of not realizing future cash flows. |
On this basis, the contingent consideration amounted to €6.9 million and €6.3 million at June 30, 2016 and December 31, 2015 respectively. The resulting finance loss of €0.6 million over the six months period is mainly due to the exchange rate variation of the CA$ to the € and the unwinding of the discounting.
If the probability of occurrence was to be increased to 100%, the contingent consideration would have amounted to €21.6 million at June 30, 2016.
An increase or decrease of 1 percentage point in the discount rate would respectively lead to a decrease of €0.6 million or to an increase of €0.6 million in the contingent consideration liability.
An increase or decrease of 5 percentage point in the CA$ against the € would lead to a decrease or an increase of €0.3 million in the contingent consideration liability, respectively. Other items could have an impact on the contingent consideration such as the timing of market authorization in the various jurisdictions or the future selling prices.
To owners of other acquired companies:
The remaining debt to former owners of acquired companies of €3.9 million as at June 30, 2016 (€2.3 million as at December 31, 2015) comprises €1.75 million for the acquisition on January 6, 2016 of the IDB Group, €1 million (€1 million as at December 31, 2015) for the acquisition of Cadisa and Barnatron in 2012 and €1.2 million (€1.3 million as at December 31, 2015) for the acquisition of the Steripet business of GE Healthcare S.r.L in Italy in 2014. Payment made during the six months period at June 30, 2016 is €0.2 million for the Steripet business of GE Healthcare S.r.L in Italy, and €2.7 million for the acquisition of the IDB Group. The variation of the remaining debt is due to the addendum to the share purchase agreement signed with the former owners in June 2016 and to the unwinding of discounting.
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5.12. | Financial assets and liabilities |
The fair values and the carrying amounts of financial assets and liabilities are summarized as follows:
June 30, 2016
| ||||||||||||||
In € thousands | Carrying amount | Fair value | ||||||||||||
Level | Designated at fair value | Loans and receivables | Available-for-sale | Other financial liabilities | Total | |||||||||
Measured at fair value | ||||||||||||||
Available-for-sale financial assets | (2) | - | - | 53 | - | 53 | 53 | |||||||
Derivatives assets | (2) | 24 | - | - | - | 24 | 24 | |||||||
Total measured at fair value | 24 | - | 53 | - | 77 | 77 | ||||||||
Not measured at fair value | ||||||||||||||
Trade receivables and other receivables | (2) | - | 29,556 | - | - | 29,556 | 29,556 | |||||||
Guarantee deposits | (2) | - | 1,285 | - | - | 1,285 | 1,285 | |||||||
Cash and cash equivalents | (2) | - | 75,739 | - | - | 75,739 | 75,739 | |||||||
Total not measured at fair value | - | 106,580 | - | - | 106,580 | 106,580 | ||||||||
Total financial assets | 24 | 106,580 | 53 | - | 106,657 | 106,657 | ||||||||
Measured at fair value | ||||||||||||||
Debt due to former owners of acquired companies | (3) | 45,264 | - | - | - | 45,264 | 45,264 | |||||||
Derivatives Liabilities | (3) | 30 | - | - | - | 30 | 30 | |||||||
Total measured at fair value | 45,294 | - | - | - | 45,294 | 45,294 | ||||||||
Not measured at fair value | ||||||||||||||
Financial liabilities | (2) | - | - | - | 18,540 | 18,540 | 18,677 | |||||||
Trade payables | (2) | - | - | - | 15,770 | 15,770 | 15,770 | |||||||
Total not measured at fair value | - | - | - | 34,310 | 34,310 | 34,447 | ||||||||
Total financial liabilities | 45,294 | - | - | 34,310 | 79,604 | 79,741 |
(1) | Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date |
(2) | Level 2 inputs are inputs, other than quoted prices included within level 1, that are observable for the asset or liability, either directly or indirectly |
(3) | Level 3 inputs are unobservable inputs for the asset or liability |
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December 31, 2015 | ||||||||||||||
In € thousands | Carrying amount | Fair value | ||||||||||||
Level | Designated at fair value | Loans and receivables | Available-for-sale | Other financial liabilities | Total | |||||||||
Measured at fair value | ||||||||||||||
Available-for-sale financial assets | (2) | - | - | 53 | - | 53 | 53 | |||||||
Derivatives assets | (2) | 897 | - | - | - | 897 | 897 | |||||||
Total measured at fair value | 897 | - | 53 | - | 950 | 950 | ||||||||
Not measured at fair value | ||||||||||||||
Trade receivables and other Receivables | (2) | - | 23,625 | - | - | 23,625 | 23,625 | |||||||
Guarantee deposits | (2) | - | 1,459 | - | - | 1,459 | 1,459 | |||||||
Cash and cash equivalents | (2) | - | 118,886 | - | - | 118,886 | 118,886 | |||||||
Total not measured at fair value | - | 143,970 | - | - | 143,970 | 143,970 | ||||||||
Total financial assets | 897 | 143,970 | 53 | - | 144,920 | 144,920 | ||||||||
Measured at fair value | ||||||||||||||
Debt due to former owners of acquired companies | (3) | 42,378 | - | - | - | 42,378 | 42,378 | |||||||
Total measured at fair value | 42,378 | - | - | - | 42,378 | 42,378 | ||||||||
Not measured at fair value | ||||||||||||||
Financial liabilities | (2) | - | - | - | 21,765 | 21,765 | 22,321 | |||||||
Trade payables | (2) | - | - | - | 14,710 | 14,710 | 14,710 | |||||||
Total not measured at fair value | - | - | - | 36,475 | 36,475 | 37,031 | ||||||||
Total financial liabilities | 42,378 | - | - | 36,475 | 78,853 | 79,409 |
(1) | Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date |
(2) | Level 2 inputs are inputs, other than quoted prices included within level 1, that are observable for the asset or liability, either directly or indirectly |
(3) | Level 3 inputs are unobservable inputs for the asset or liability |
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5.13. | Derivative instruments |
The Group uses derivative financial instruments to hedge its exposure to foreign exchange and interest rate risks arising from operational, financing and investment activities.
Foreign exchange contracts
June 30, 2016 (In € thousands) | Notional amount in Euros | Book value in Euros | Market value in Euros | |||
Over-the-Counter currency options : | ||||||
British Pound Sterling (GBP) | (615) | 14 | 14 | |||
Total Over-the-Counter currency options | (615) | 14 | 14 | |||
Forward currency : | ||||||
US Dollar (USD) | 126 | 10 | 10 | |||
Total Forward currency | 126 | 10 | 10 | |||
Total derivative financial instruments | (489) | 24 | 24 | |||
December 31, 2015 (In € thousands) | Notional amount in Euros | Book value in Euros | Market value in Euros | |||
Over-the-Counter currency options : | ||||||
British Pound Sterling (GBP) | 640 | 9 | 9 | |||
US Dollar (USD) | 41,967 | 888 | 888 | |||
Total Over-the-Counter currency options | 42,607 | 897 | 897 | |||
Total derivative financial instruments | 42,607 | 897 | 897 |
Interest rate swap
June 30, 2016 (in € thousands) | Notional amount in Euros | Book value in Euros | Market value in Euros | |||
Interest rate swap | ||||||
Euro loan (EUR) | 1,029 | (30) | (30) | |||
Total Interest rate swap | 1,029 | (30) | (30) | |||
Total derivative | 1,029 | (30) | (30) |
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6. | Consolidation scope |
Entity | Registered office in | % Interest 2016 | % Interest 2015 | |||
Advanced Accelerator Applications SA | France | Parent Company | Parent Company | |||
Advanced Accelerator Applications Unipessoal Lda | Portugal | 100% | 100% | |||
Advanced Accelerator Applications Polska sp zoo | Poland | 100% | 100% | |||
Advanced Accelerator Applications (Italy) Srl | Italy | 100% | 100% | |||
G.I. Pharma Srl | Italy | 100% | 100% | |||
Advanced Accelerator Applications International SA | Switzerland | 100% | 100% | |||
Advanced Accelerator Applications (Switzerland) SA | Switzerland | 100% | 100% | |||
Advanced Accelerator Applications GmbH (Ex - Umbra Medical AG) | Germany | 100% | 100% | |||
Advanced Accelerator Applications Ibérica S.L. | Spain | 100% | 100% | |||
Advanced Accelerator Applications USA, Inc (Ex - BioSynthema Inc.) | USA | 100% | 100% | |||
Marshall Isotopes Ltd | Israel | 100% | 100% | |||
Marshel (R.R) Investments Ltd | Israel | 100% | 100% | |||
Catalana De Dispensacion | Spain | 100% | 100% | |||
Barnatron SA | Spain | 100% | 100% | |||
Advanced Accelerator Applications Canada Inc. | Canada | 100% | 100% | |||
IDB Radiopharmacy BV | Netherlands | 100% | N/A | |||
IDB Holding BV | Netherlands | 100% | N/A | |||
IDB Holland | Netherlands | 100% | N/A | |||
Beheermaatschappij Weelde BV | Netherlands | 100% | N/A | |||
Meerdonk Holding BV | Netherlands | 100% | N/A | |||
Renswoude Holding BV | Netherlands | 100% | N/A | |||
IDB België BVBA | Belgium | 100% | N/A | |||
Eifel Property GmbH | Germany | 100% | 100% | |||
Imaging Equipment Ltd | UK | 100% | 100% |
7. | Related party disclosures |
In conformity with IAS 24, the total remuneration of Group senior executives is disclosed in note 4.2.
The Board of Directors decided in April 2016 to increase the Group senior executive salaries as of February 2016 by 1.5%, the same as the average salary increase used throughout the Company. Furthermore, the Shareholders decided in their meeting in May 2016 to increase the non-executive Directors’ remuneration for the year 2016 by 32%.
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