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Oxurion NV — Interim / Quarterly Report 2016
Aug 25, 2016
3987_ir_2016-08-25_1a168731-9859-4701-8039-e1fbff737e43.pdf
Interim / Quarterly Report
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ThromboGenics NV Interim Financial Report
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Half-year results as of June 30, 2016
This report was prepared in order to comply with the Belgian Royal Decree of November 14, 2007. You can also find this information on the website of ThromboGenics (www.thrombogenics.com) in the Investor Information section.
ThromboGenics published its Interim Financial Report in Dutch. ThromboGenics has also an English translation of this Interim Financial Report. In the case of differences of interpretation between the English and the Dutch versions of the Report, the original Dutch version prevails
A full analysis of the interim financial statement, prepared in accordance to IAS 34, as declared applicable by the European Union, is included under the section "Condensed consolidated interim financial statements".
These statements were submitted to a review by the statutory auditor.
Consolidated key figures as of June 30, 2016
Unaudited Consolidated statement of financial position
| In '000 | 30 June 2016 | 31 December 2015 |
|
|---|---|---|---|
| Property, plant and equipment | 2,062 | 2,088 | |
| Intangible assets | 53,298 | 55,699 | |
| Goodwill | 2,586 | 2,586 | |
| Other non-current assets | 197 | 235 | |
| Non-current tax receivable | 2,038 | 1,645 | |
| Inventories | 6,265 | 6,498 | |
| Trade and other receivables | 7,603 | 7,019 | |
| Current tax receivable | 877 | 1,791 | |
| Investments | 24,507 | 8,044 | |
| Cash and cash equivalents | 66,982 | 93,341 | |
| Employee benefits | 0 | 0 | |
| Total assets | 166,415 | 178,946 | |
| Total equity | 155,051 | 170,015 | |
| Current liabilities | 11,364 | 8,931 | |
| Total equity and liabilities | 166,415 | 178,946 |
Unaudited Consolidated statement of comprehensive income
| In '000 (half-year) | 2016 | 2015 |
|---|---|---|
| Income | 3,980 | 5,982 |
| Operating result | -14,988 | -19,789 |
| Finance income | 141 | 1,044 |
| Finance expense | -155 | -433 |
| Result before income tax | -15,002 | -19,178 |
| Income tax expense | -10 | -1 |
| Loss of the half-year | -15,012 | -19,179 |
| Result per share | ||
| Basic earnings per share (euro) | -0.42 | -0.53 |
| Diluted earnings per share (euro) | -0.42 | -0.53 |
Business Highlights
Research & Development Activities
Diabetes, Diabetic Retinopathy and Diabetic Macular Edema
Diabetes is a major global healthcare problem with 9% of adults (18 years and older) suffering from this disease1 .
Diabetic retinopathy (DR) is the leading cause of visual disability and blindness among professionally active adults2 . More than one in three living with diabetes (35.4%) will develop some form of DR in their lifetime. One in five patients with DR presents with DME.
DR progresses from mild, non-proliferative to more severe or even proliferative stages. As DR progresses, there is a gradual closure of retinal blood vessels leading to impaired perfusion and ischemia of the retina. When this progresses beyond certain thresholds, severe non-proliferative diabetic retinopathy (NPDR) is diagnosed.
The more advanced stage of DR, Proliferative DR (PDR), is characterized by the development of new blood vessels at the inner surface of the retina as a result of retinal ischemia. These new vessels are prone to bleed, resulting in vitreous hemorrhage. These new vessels may also undergo fibrosis and contraction, which may lead to epiretinal membrane formation, vitreoretinal traction bands, retinal tears and traction or retinal detachments.
PDR is considered high risk when the new vessels are accompanied by vitreous hemorrhage, or when they cover a significant area of the optic disc.
Patients who progress to PDR are at high risk of severe vision loss.
1 World Health Organization (WHO). (2015). Diabetes. Fact sheet N°312. http://www.who.int/mediacentre/factsheets/fs312/en/ 21 May 2015. 2 (Cunha-Vaz, 1998; Fong et al., 1999)
Innovative Pipeline of Novel Medicines Targeting Diabetic Eye Disease such as Diabetic Retinopathy and Diabetic Macular Edema
ThromboGenics development pipeline is comprised of:
- THR-409 (ocriplasmin) is in a Phase IIa (CIRCLE) clinical study evaluating the efficacy and safety of multiple doses and/or half-doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR). The Phase IIa study was initiated in early 2016.
- THR-317 a PlGF inhibitor being developed for DME and potentially as a combination therapy for current anti-VEGF treatments. THR-317 is expected to enter the clinic by end of 2016.
- THR-149 a selective plasma kallikrein inhibitor being developed to treat the edema associated with DR. This compound is the result of the Company's research collaboration with Bicycle Therapeutics. THR-149 is expected to enter the clinic by late 2017.
- THR-687 an integrin antagonist being developed to treat a broad range of patients with DR, with or without DME. THR-687 was in-licensed from Galapagos NV in March.
On March 18, 2016, ThromboGenics hosted a R&D investor meeting in London presenting more detailed information on its new development pipeline in diabetic eye disease.
The webcast replay of the event is available on the ThromboGenics' website.
THR-409 for Non Proliferative Diabetic Retinopathy
In January 2016, the Company announced the initiation of its Phase IIa (CIRCLE) study.
The CIRCLE study is evaluating the efficacy and safety of multiple doses of THR-409 (ocriplasmin) in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR).
Research has suggested that total PVD, a complete separation of vitreous and retina, prevents the progression of NPDR to PDR. This could be explained by total PVD leading to elimination of the scaffold needed for the development of new blood vessels and/or the improvement of oxygen supply to the retina, thereby reducing retinal ischemia, production of VEGF, vascular outgrowth and neovascularization.
ThromboGenics believes that by using multiple doses of THR-409 it can reduce the risk of patients' disease progressing from NPDR to PDR by inducing a total PVD. Patients who progress to PDR are at high risk of experiencing severe vision loss or complete blindness.
The primary endpoint of the CIRCLE study is the percentage of patients with total PVD at the time of their visit one month after the 3rd injection, as confirmed by both B-scan ultrasound and SD-OCT.
The study has a number of secondary endpoints that are designed to provide further insights into ocriplasmin's potential in reducing the risk of progression of NPDR to PDR.
THR-317 – anti PIGF antibody to treat Diabetic Macular Edema
THR-317 is a disease modifying, anti PlGF antibody that has the potential to treat a broad range of patients with late stage diabetic eye disease either alone or in combination with anti-VEGF treatments. ThromboGenics is currently developing THR-317 for the treatment of diabetic macular edema and expects to start the clinical development of this novel antibody towards the end of 2016.
The planned Phase I/II study expects to recruit 50 patients, either anti-VEGF naïve patients or anti-VEGF poor responders. The trial will have two arms comparing a low dose of THR-317 with a high dose of THR-317. The trial will assess the safety of THR-317 and will look at best corrected visual acuity and retinal thickness to evaluate the product's efficacy.
Oncurious NV – Developing TB-403 for Pediatric Brain Cancers
Oncurious is developing TB-403 for the treatment of pediatric tumors.
TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF). PlGF is expressed in several types of cancer, including medulloblastoma. High expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall survival. Medulloblastoma is the most common pediatric malignant brain tumor, accounting for 20% of all brain tumors in children.
Treatment with TB-403 in relevant animal models for medulloblastoma has demonstrated beneficial effects on tumor growth and survival. The favorable safety profile of TB-403 has already been demonstrated in clinical trials in patients with other diseases.
In March 2016, Oncurious and its development partner BioInvent International signed a partnership agreement with the Neuroblastoma and Medulloblastoma Translational Research Center (NMTRC) to accelerate the clinical development of TB-403 for the treatment of medulloblastoma in the US. The NMTRC is a non-profit organization with the mission to bring forward new effective therapies against neuroblastoma and medulloblastoma. Headquartered at Helen DeVos Children's Hospital in Grand Rapids, MI, NMTRC is a network of 18 leading university hospitals and pediatric clinics in the US.
In May, Oncurious and BioInvent announced that they had initiated a Phase I/IIa study with TB-403. The study, which is being conducted by NMTRC, aims to recruit 27 patients with Relapsed or Refractory Medulloblastoma.
JETREA Update
JETREA® Regulatory & Markets Access
ThromboGenics' first commercial drug JETREA® is now approved in 54 countries and reimbursed in over 20 countries.
Globally, around 25,000 patients have received a treatment with JETREA® .
The successful development of JETREA® demonstrates ThromboGenics pioneering role in developing pharmacological vitreolysis as a new drug class and treatment option for symptomatic vitreomacular adhesion or vitreomacular traction.
Further JETREA® submissions, approvals and country launches are anticipated in the remainder of 2016.
US FDA Approval for New 'Already-Diluted' Formulation of JETREA®
In June, ThromboGenics announced that the Office of Biotechnology Products of the U.S. Food and Drug Administration (FDA) had approved a new already-diluted formulation of JETREA® (ocriplasmin). The new formulation of JETREA® offers the additional benefit of eliminating the current preparatory dilution steps prior to injection.
ThromboGenics Inc., which is commercializing JETREA® in the US, plans to launch the alreadydiluted formulation of JETREA® in the first half of 2017.
Ocriplasmin Research Findings Presented at ARVO
New JETREA® research findings were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2016 annual meeting in Seattle at the beginning of May.
15 ocriplasmin-related presentations, abstracts and posters were delivered at ARVO. These covered preclinical research findings, real-world clinical data, and further characterization of results from different studies, including OASIS, ORBIT, and OVIID conducted in the US and Europe.
The data update confirmed the product's safety profile as described in the approved product label, with no new safety signals. Moreover, these new clinical studies and real-world data continued to confirm that appropriate patient selection leads to improved treatment outcomes.
Ocriplasmin ORBIT and OASIS Data Presented at ASRS, San Francisco
Ocriplasmin clinical data were presented during the 34th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) which took place from August 9 to 14 in San Francisco.
During this premier educational retina meeting, Dr Mathew MacCumber presented "ORBIT, A Phase IV Clinical Study: Lessons Learned From Patient Selection Criteria for Ocriplasmin Intravitreal Injection".
In addition, Dr Joseph Coney presented "data from the OASIS Trial: Natural History of Symptomatic Vitreomacular Adhesion". Dr Michael Tolentino presented "Efficacy and Safety Outcomes in Subjects with Full-Thickness Macular Hole", also from the OASIS trial.
Ocriplasmin OASIS Phase III b 2 Year Follow- Up Study Published in Ophthalmology, AAO Journal
OASIS is a 2-Year Phase IIIb Study Evaluating Ocriplasmin for the Treatment of Symptomatic VMA/VMT Including Macular Hole.
The full report of the 2 year follow up of the OASIS study with JETREA® (ocriplasmin) for the treatment of Symptomatic VMA/VMT and Macular Hole (n=220) has been published in Ophthalmology, Journal of the American Academy of Ophthalmology.
The OASIS data, and its positive conclusions, will be shared further through presentations and publications which may be expected prior to and during the upcoming AAO meeting in Chicago, (Oct 15 -18, 2016).
7
Condensed consolidated interim financial statements
Unaudited consolidated statement of comprehensive income
| In '000 euro (half-year) | 2016 | 2015 |
|---|---|---|
| Income | 3,980 | 5,982 |
| Sales | 2,570 | 4,241 |
| License income | 0 | 0 |
| Income from royalties | 1,410 | 1,741 |
| Cost of sales | -1,429 | -1,172 |
| Gross profit | 2,551 | 4,810 |
| Research and development expenses | -12,012 | -10,289 |
| General and administrative expenses | -3,381 | -4,208 |
| Selling expenses | -2,201 | -10,184 |
| Other operating income | 55 | 82 |
| Other operating expense | 0 | 0 |
| Operating result | -14,988 | -19,789 |
| Finance income | 141 | 1,044 |
| Finance expense | -155 | -433 |
| Result before income tax | -15,002 | -19,178 |
| Income tax expense | -10 | -1 |
| Loss of the half-year | -15,012 | -19,179 |
| Attributable to: | ||
| Equity holders of the company | -15,016 | -19,179 |
| Non-controlling interest | 4 | 0 |
| Result per Share | ||
| Basic earnings per share (euro) | -0.42 | -0.53 |
| Diluted earnings per share (euro) | -0.42 | -0.53 |
Unaudited consolidated statements of other comprehensive income
| In '000 euro (half-year) | 2016 | 2015 |
|---|---|---|
| Loss of the half-year | -15,012 | -19,179 |
| Net change in fair value of available-for-sale financial assets | 0 | 0 |
| Exchange differences on translation of foreign operations | -30 | 60 |
| Actuarial losses on defined benefit plans | 0 | 0 |
| Other comprehensive income, net of income tax | -30 | 60 |
| Other comprehensive income that may be reclassified to profit or loss | 0 | 0 |
| Other comprehensive income that will not be reclassified to profit or loss | -30 | 60 |
| Total comprehensive income for the period | -15,042 | -19,119 |
| Attributable to: | ||
| Equity holders of the company | -15,046 | -19,119 |
| Non-controlling interest | 4 | 0 |
ThromboGenics NV
Unaudited consolidated statement of financial position
| In '000 euro | 30 June 2016 | 31 December 2015 |
|---|---|---|
| ASSETS | ||
| Property, plant and equipment | 2,062 | 2,088 |
| Intangible assets | 53,298 | 55,699 |
| Goodwill | 2,586 | 2,586 |
| Other non-current assets | 197 | 235 |
| Non-current tax receivable | 2,038 | 1,645 |
| Non-current assets | 60,181 | 62,253 |
| Inventories | 6,265 | 6,498 |
| Trade and other receivables | 7,603 | 7,019 |
| Current tax receivable | 877 | 1,791 |
| Investments | 24,507 | 8,044 |
| Cash and cash equivalents | 66,982 | 93,341 |
| Current assets | 106,234 | 116,693 |
| Total assets | 166,415 | 178,946 |
| EQUITY AND LIABILITIES | ||
| Share capital | 151,991 | 151,991 |
| Share premium | 157,661 | 157,661 |
| Accumulated translation differences | -251 | -221 |
| Other reserves | -13,395 | -13,473 |
| Retained earnings | -141,036 | -126,020 |
| Equity attributable to equity holders of the company | 154,970 | 169,938 |
| Non-controlling interest | 81 | 77 |
| Total equity | 155,051 | 170,015 |
| Trade payables | 5,558 | 4,128 |
| Other short-term liabilities | 5,806 | 4,803 |
| Current liabilities | 11,364 | 8,931 |
| Total equity and liabilities | 166,415 | 178,946 |
Unaudited consolidated statement of cash flows
| In '000 euro (half-year) | 2016 | 2015 |
|---|---|---|
| Cash flows from operating activities | ||
| (Loss) profit for the period | -15,012 | -19,179 |
| Finance expense | 155 | 433 |
| Finance income | -141 | -1,044 |
| Depreciation on property, plant and equipment | 453 | 627 |
| Amortization of intangible assets | 3,401 | 3,410 |
| Increase in accruals and employee benefits | 0 | 0 |
| Equity settled share-based payment transactions | 78 | -357 |
| Change in trade and other receivables including tax receivables and stock | 170 | 5,436 |
| Change in short-term liabilities | 2,433 | -4,967 |
| Net cash (used) from operating activities | -8,463 | -15,641 |
| Cash flows from investing activities | ||
| Disposal of property, plant and equipment (following a sale) | 45 | 1 |
| Change in investments | -16,463 | 2,962 |
| Interest received and similar income | 45 | 217 |
| Acquisition of intangible assets | -1,000 | 0 |
| Acquisition of property, plant and equipment | -473 | -211 |
| Acquisition (divestments) of other non-current assets | 38 | 1,397 |
| Net cash (used in) generated by investing activities | -17,808 | 4,366 |
| Cash flows from financing activities | ||
| Proceeds from issue of share capital | 0 | 0 |
| Paid interests | -2 | -4 |
| Net cash (used in) generated by financing activities | -2 | -4 |
| Net change in cash and cash equivalents | -26,273 | -11,279 |
| Cash and cash equivalents at the start of the period | 93,341 | 123,223 |
| Effect of exchange rate fluctuations | -86 | 459 |
| Cash and cash equivalents at the end of the period | 66,982 | 112,403 |
Unaudited consolidated statement of changes in equity
| Share capital |
Share premium |
Cumulative translation differences |
Other reserves |
Retained earnings |
Attributable to equity holders of the company |
Non controlling interest |
Total | |
|---|---|---|---|---|---|---|---|---|
| Balance as at 1 January 2015 |
151,991 | 157,661 | -276 | -13,228 | -88,136 | 208,012 | 0 | 208,012 |
| Loss of the half-year 2015 |
0 | 0 | 0 | 0 | -19,179 | -19,179 | 0 | -19,179 |
| Change to foreign currency translation difference and revaluation reserve |
0 | 0 | 60 | 0 | 0 | 60 | 0 | 60 |
| Net change in fair value of investments |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Issue of ordinary shares | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Share-based payment transactions |
0 | 0 | 0 | -357 | 0 | -357 | 0 | -357 |
| Balance as at 30 June 2015 |
151,991 | 157,661 | -216 | -13,585 | -107,315 | 188,536 | 0 | 188,536 |
| Balance as at 1 January 2016 |
151,991 | 157,661 | -221 | -13,473 | -126,020 | 169,938 | 77 | 170,015 |
| Loss of the half-year 2016 |
0 | 0 | 0 | 0 | -15,016 | -15,016 | 4 | -15,012 |
| Change to foreign currency translation difference and revaluation reserve |
0 | 0 | -30 | 0 | 0 | -30 | 0 | -30 |
| Net change in fair value of investments |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Issue of ordinary shares | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Share-based payment transactions |
0 | 0 | 0 | 78 | 0 | 78 | 0 | 78 |
| Balance as at 30 June |
ThromboGenics NV
2016 151,991 157,661 -251 -13,395 -141,036 154,970 81 155,051
Gaston Geenslaan 1 | B-3001 Leuven | Belgium | Tel +32 (16) 75 13 10 | Fax +32 (16) 75 13 11 | www.thrombogenics.com
Notes to the condensed consolidated interim financial statements
1. General information
ThromboGenics NV ("the Company") was incorporated on May 30, 2006, and is a limited liability company (in Dutch: naamloze vennootschap). The registered office is established at:
Gaston Geenslaan 1 3001 Leuven Belgium Tel: +32 (0)16 751 310 Fax: +32 (0)16 751 311
The company is registered in the Crossroads Databank for Enterprises under single business number 0881.620.924.
ThromboGenics is a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines for the treatment of eye diseases.
ThromboGenics is developing an attractive portfolio of novel medicines for the treatment of diabetic eye disease. Today ThromboGenics pipeline consists of 4 compounds, targeting novel treatments for diabetic retinopathy (DR) - nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR), in the presence or absence of diabetic macular edema (DME):
- THR-409 (ocriplasmin) is in Phase IIa clinical study (CIRCLE) with the target to induce a complete posterior vitreous detachment (PVD), to prevent patients with NPDR from progressing to PDR, a serious sight threatening condition
- THR-317 (a PlGF inhibitor) being developed for DME and potentially as a combination therapy for current anti-VEGF treatments. THR-317 is expected to enter the clinic by end of 2016.
- THR-149 (a selective plasma kallikrein inhibitor) being developed to treat the edema associated with DR. This compound is the result of the Company's research collaboration with Bicycle Therapeutics. THR-149 is expected to enter the clinic in late 2017.
- THR-687 (an integrin antagonist) being developed to treat a broad range of patients with DR, with or without DME. THR-687 was in-licensed from Galapagos NV in March.
Beyond the eye diseases, on April 3, 2015, ThromboGenics founded a subsidiary, Oncurious NV, which has the rights to TB-403 and together with VIB ("Vlaams Instituut voor Biotechnologie"), and will develop this potential oncology therapy.
Oncurious has started a Phase I/IIa study evaluating TB-403 (a PlGF inhibitor) in children with medulloblastoma in May
The Company is the owner of JETREA® (ocriplasmin) a drug indicated for the treatment of symptomatic vitreomacular adhesion (VMA), otherwise indicated as vitreomacular traction (VMT).
JETREA® was granted approval by the US Food and Drugs Administration (FDA) on October 18, 2012 and received approval of the European Commission on March 15, 2013.
The company commercialises JETREA® in the US by its own team through its subsidiary ThromboGenics, Inc. and outside the US through a strategic partnership with Alcon (Novartis).
These condensed interim consolidated financial statements of ThromboGenics for the six months ended June 30, 2016 (the 'interim period') include ThromboGenics NV and its subsidiaries ThromboGenics, Inc. and Oncurious NV, who constitute the ThromboGenics Group. These statements were approved by the Board of Directors on August 25, 2016. These statements were submitted to a review by the statutory auditor.
The consolidated financial statements of the Group for the year 2015 are available on request at the above-mentioned address or on the Company's website (http://thrombogenics.com/investors/reports-presentations).
2. Summary of significant accounting policies
2.1. Basis of preparation of half-year report
This condensed consolidated interim financial information has been prepared in accordance with IAS 34, (Interim Financial Reporting) as adopted by the European Union.
The condensed consolidated interim financial information does not include all the necessary information for preparing financial statements for a full accounting year and therefore should be read in conjunction with the annual financial statements of the group for the year ended December 31, 2015.
Preparing condensed consolidated interim financial statements in accordance with IFRS obliges the management to make estimates and assumptions that affect the reported amounts of assets, liabilities and the notes on the latent assets and liabilities on the date of the condensed consolidated interim financial statements, and the reported amounts of income and costs during the reporting period. If in the future such estimates and assumptions, which are based on management's best estimates and judgment at the time of drawing up the financial statements, deviate from the actual circumstances, the original estimates and assumptions will be modified and the effects of the revisions will be reflected in the period in which the circumstances change. The principal risks during the interim period have not materially changed from those mentioned in the financial report as of December 31, 2015.
All statements and information relate to the interim period unless otherwise stated.
The consolidated financial statements are presented in euro and all values are rounded to the nearest thousand except when otherwise indicated.
2.2. Accounting policies
The same accounting policies, presentation and methods of computation have been followed in these condensed financial statements as were applied in the preparation of the Group's financial statements for the year ended December 31, 2015, except for the potential impact of the adoption of the Standards and Interpretations described below.
New Standards, Interpretations and Amendments adopted by the Group
During the current financial year, the Group has adopted all the new and revised Standards and Interpretations issued by the International Accounting Standards Board (IASB) and the International Financial Reporting Interpretations Committee (IFRIC) of the IASB, that are relevant to its operations and effective for the accounting year starting on January 1, 2016. The Group has not applied any new IFRS requirements that are not yet effective as per June 30, 2016.
The following new Standards, Interpretations and Amendments issued by the IASB and the IFRIC are effective for the current period:
Annual Improvements to IFRSs 2010-2012 Cycle (issued by the IASB in December 2013) Annual Improvements to IFRSs 2012-2014 Cycle (issued by the IASB in September 2014) IFRS 11 Joint Arrangements — Amendments regarding the accounting for acquisitions of an interest in a joint operation (May 2014)
IAS 1 Presentation of Financial Statements — Amendments resulting from the disclosure initiative (December 2014)
IAS 16 Property, Plant and Equipment — Amendments regarding the clarification of acceptable methods of depreciation and amortization (May 2014)
IAS 16 Property, Plant and Equipment — Amendments bringing bearer plants into the scope of IAS 16 (June 2014)
IAS 19 Employee Benefits — Amendments relating to Defined Benefit Plans: Employee Contributions (November 2013)
IAS 27 Consolidated and Separate Financial Statements — Amendments reinstating the equity method as an accounting option for investments in subsidiaries, joint ventures and associates in an entity's separate financial statements (August 2014)
IAS 38 Intangible Assets — Amendments regarding the clarification of acceptable methods of depreciation and amortization (May 2014)
The adoption of these new standards and amendments has not led to major changes in the Group's accounting policies.
Standards and Interpretations issued but not yet effective in the current period
The Group elected not to early adopt the following new Standards, Interpretations and Amendments, which have been issued but are not yet effective as per June 30, 2016.
IFRS 2 Share-based Payment — Amendments to clarify the classification and measurement of share-based payment transactions (June 2016)*
IFRS 7 Financial Instruments: Disclosures (Amendments December 2011) — Deferral of mandatory effective date of IFRS 9 and amendments to transition disclosures*
IFRS 7 Financial Instruments: Disclosures (Amendment November 2013) — Additional hedge accounting disclosures (and consequential amendments) resulting from the introduction of the hedge accounting chapter in IFRS 9*
IFRS 9 Financial Instruments — Classification and Measurement (Original issue July 2014, and subsequent amendments)*
IFRS 10 Consolidated Financial Statements — Amendments regarding the sale or contribution of assets between an investor and its associate or joint venture (September 2014)*
IFRS 10 Consolidated Financial Statements — Amendments regarding the application of the consolidation exception (December 2014)*
IFRS 12 Disclosure of Interests in Other Entities — Amendments regarding the application of the consolidation exception (December 2014)*
IFRS 14 Regulatory Deferral Accounts (Original issue January 2014)*
IFRS 15 Revenue from Contracts with Customers (Original issue May 2014)*
IFRS 16 Leases (Original issue January 2016)*
IAS 7 Cash flow statement — Amendments as result of the Disclosure initiative (January 2016)*
IAS 12 Income taxes — Amendments regarding the recognition of deferred tax assets for unrealized losses (January 2016)*
IAS 28 Investments in Associates and Joint Ventures — Amendments regarding the sale or contribution of assets between an investor and its associate or joint venture (September 2014)* IAS 28 Investments in Associates and Joint Ventures — Amendments regarding the application of the consolidation exception (December 2014)*
IAS 39 Financial Instruments: Recognition and Measurement — Amendments for continuation of hedge accounting (fair value hedge of interest rate exposure) when IFRS 9 is applied (November 2013)*
* Not yet endorsed by the EU as of June 30, 2016
2.3. Exchange rates
During the interim period, the Group mainly dealt with transactions in euro, USD and GBP. The exchange rate between euro and USD was on average €1.1159 and at period-end €1.1102. The exchange rate between euro and GBP was on average €0.7788 and at periodend €0.8265.
3. Segment information
In this interim financial report, no segment information was reported as the Group does not have report per segment. The decisions of the management are based on the figures of the Group as a whole.
4. Seasonality of operations
The activities of research and development within ThromboGenics are not in any way seasonal.
5. Group structure and important events and transactions
The consolidated interim financial statements include ThromboGenics NV and its subsidiaries ThromboGenics, Inc. (US) and Oncurious NV (Belgium).
6. Result of the period
During the first six months of 2016, the income of ThromboGenics amounted to €4.0 million, this includes €2.4 million of product sales in the US, €1.4 million of income from royalties and the remaining being miscellaneous product sales. This compares to a total income of €6.0 million in the first six months of 2015.
During the first six months of 2016, the Group had a gross profit of €2.6 million.
ThromboGenics' R&D expenses were €12.0 million during the first half year, including a amortization on the intangible assets with regards to JETREA® 's Phase III program (in the VMA/VMT indication) of €3.4 million. In the same period of 2015, the R&D expenses were €10.3 million also including €3.4 million amortization.
The general and administrative expenses have decreased from €4.2 million to €3.4 million.
In the first half of 2016, selling and marketing expenses amounted to €2.2 million compared to €10.2 million in the corresponding period of 2015. This cost reduction is due to the full effect of the reduction in size of its US organization that happened in 2015 to reflect the market demand for JETREA®. ThromboGenics Inc. is now a lean customer-centric organization that is continuing to support JETREA® via a well-established distribution network.
ThromboGenics reported a net loss of €15.0 million for the first half of 2016 (€-0.42 per share) compared to €19.2 million net loss in the same period of 2015 (€-0.53 per share).
7. Financial position and cash flow
The capitalized intangible assets related to JETREA® 's Phase III program amount to €52.2 million. In the first half of 2016, ThromboGenics capitalized the payment for the exclusive inlicensing with Galapagos NV of €1.0 million. The change compared to the end of 2015 is due to this acquisition and the inclusion of an amortization of €3.4 million for the first half-year.
As of June 30, 2016, ThromboGenics had €91.5 million in cash and cash equivalents (including €24.5 million investments). This compares to €113.3 million on June 30, 2015 (including €0.9 million investments) and €101.4 million on December 31, 2015 (including €8.0 million investments). The increase of investments in the first half year, corresponds to fixed interest deposits longer than 3 months.
Inventories amounted to €6.3 million euro on June 30, 2016.
ThromboGenics' current cash resources will allow the Company to execute its operational projects.
The other reserves amount to €-13.4 million on June 30, 2016, which compares with €-13.5 million on December 31, 2015.
At the end of the first half-year of 2016, the total equity of ThromboGenics was €155.1 million versus €170.0 million at the end of 2015. This includes retained earnings of €-141.0 million.
8. Capital structure and evolution of the equity
On June 30, 2016, there were 36,094,349 ordinary shares. This number remained unchanged compared with December 31, 2015.
The share capital and the issue premium did not evolve compared to previous close.
| In '000 euro | Capital | Issue premium |
|---|---|---|
| 31 December 2015 | 151,991 | 157,661 |
| 30 June 2016 | 151,991 | 157,661 |
The loss of the period was carried forward and brings the equity at €155.1 million on June 30, 2016.
The results were approved by the Board of Directors on August 25, 2016. The Board of Directors is responsible for the preparation and presentation of the condensed consolidated financial information.
In April 2016, warrants from the Warrant Plan 2014 have been granted to employees and consultants of the Group. The fair value of each warrant has been assessed on the basis of the Black-Scholes model on the date it is granted.
9. Key agreements, commitments and contingent liabilities
Interest-bearing loans and financial instruments
The Group has neither concluded any new credit agreements during the interim period, nor any new financial instruments.
Litigation
The Group has no material pending litigation.
Disputes
As per the Annual Report of 2015, ThromboGenics is involved in a pending dispute with Alcon. The situation is unchanged as of today.
Other items
ThromboGenics is subject to an inquiry by FSMA with respect to timely disclosure of information. The outcome is unknown at this moment.
Other Commitments
The Company has not concluded any new commitments that could influence substantially the financial position of the Company beside those mentioned in our latest annual report.
For the risks and the uncertainties for the rest of the year, we refer to the analysis included in the latest available Annual Report for 2015. No new elements of risk have been identified in the first six months of 2016 which require a modification of the list of risks and uncertainties.
10. Transactions with Related Parties
In the first 6 months of 2016, an amount of €382.7 thousand was paid to the executive directors.
No other transactions with related parties were made during the first 6 months of 2016 which have a material impact on the financial position and results of the Group. There were also no changes to related party transactions disclosed in the Annual Report 2015 that potentially had a material impact to the financial figures of the first 6 months of 2016.
11. Events occurring after the reporting period
No significant events occurred after the balance sheet date which may have an impact on the presentation of the submitted interim financial statement.
12. Impairment
At the end of each reporting period, management assesses the possible presence of indications of events which could require booking of impairments. As per today, referring to IAS 36 the amount of net assets is higher than market capitalization.
As there is an indicator for impairment (lower sales), the Company performed the impairment test.
The Company adopted a value in use approach when performing the annual impairment test. As such a recoverable amount analysis happened on the basis of a DCF model which foresees cash flows for the next eight years (i.e. the patent life for JETREA®) on the basis of the actual evolution of business, the amortization of intangibles in place and with a residual value of five years after 2024 (patent life). A discount rate (WACC) of 8 % is applied. Based on this model which is in accordance with IAS 36, there is no indication of impairment loss, even if a sensitivity analysis is performed.
The situation will be re-evaluated at year-end.
Declaration of responsible persons
Dr Patrik De Haes, CEO and Executive Board member and Dominique Vanfleteren, Chief Financial Officer of ThromboGenics declare that, as far as they are aware:
- The condensed consolidated interim financial statements, made up according to the applicable standards for financial statements, give a true and fair view of the equity, financial position and the results of the Company and its consolidated companies.
- This interim report represents a true and fair view of the development and the results of the company for the first 6 months of 2016, and of the principal risks and uncertainties for the second half year and of the transactions with related parties.
Statutory auditor's report to the Board of Directors of ThromboGenics NV on the review of consolidated interim financial information for the six-month period ended 30 June 2016
Introduction
We have reviewed the accompanying interim consolidated statement of financial position of ThromboGenics NV as of 30 June 2016 and the related interim consolidated statements of comprehensive income, cash flows and changes in equity for the six-month period then ended, as well as the explanatory notes. The Board of Directors is responsible for the preparation and presentation of this consolidated interim financial information in accordance with IAS 34 "Interim Financial Reporting", as adopted by the European Union. Our responsibility is to express a conclusion on this consolidated interim financial information based on our review.
Scope of review
We conducted our review in accordance with International Standard on Review Engagements 2410, "Review of Interim Financial Information Performed by the Independent Auditor of the Entity". A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the accompanying consolidated interim financial information is not prepared, in all material respects, in accordance with IAS 34 "Interim Financial Reporting", as adopted by the European Union.
Zaventem, 25 August 2016
BDO Bedrijfsrevisoren Burg. Ven. CBVA / BDO Réviseurs d'Entreprises Soc. Civ. SCRL Statutory auditor Represented by Gert Claes