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Abliva Interim / Quarterly Report 2014

Feb 18, 2015

3131_10-k_2015-02-18_80dda36e-21bb-4c65-925f-e2a3aaf45b96.pdf

Interim / Quarterly Report

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YEAR END REPORT

This Interim Report is published in Swedish and English. In the event of any difference between the English version and the Swedish original, the Swedish version shall prevail.

Year End Report 2014

Fourth Quarter (1 Oct. 2014 – 31 Dec. 2014)

  • Net revenues were SEK 0 (0) and other operating income was SEK 8,000 (12,000).
  • Loss before tax was SEK -17,346,000 (9,169,000).
  • Earnings per share* were SEK -0.59 (-0.45).
  • Diluted earnings per share** were SEK -0.59 (-0.45).

Twelve Months (1 Jan. 2014 – 31 Dec. 2014)

  • Net revenues were SEK 7,152,000 (5,335,000) and other operating income was SEK 1,181,000 (1,598,000).
  • Loss before tax was SEK -44,673 (-22,126,000).
  • Earnings per share* were SEK -1.53 (-1,17).
  • Diluted earnings per share** were SEK -1.53 (-1,17).

* Profit/loss for the period divided by the average number of shares before dilution at the end of the period. **Profit/loss for the period divided by the average number of shares after dilution at the end of the period.

Business highlights in the fourth quarter of 2014

NeuroVive and Skåne University Hospital has initiated a collaboration to complete a clinical phase II study on the evaluation of the company's product CicloMulsion® regarding its ability to prevent acute kidney injury in 150 patients undergoing heart surgery. Enrolment to the study will begin in the first half of 2015 and is expected to continue until the end of 2016.

Post balance sheet events

NeuroVive has established a subsidiary in Taiwan, NeuroVive Pharmaceutical Asia, Inc., which has secured initial funding totaling USD 3,255 m. The funding is sourced from Taiwanese investors, collaboration partner Foundation Asia Pacific Ltd. and the parent company ahead of its potential IPO in Taiwan. The subsidiary strengthens the group's presence in Asia and will be the driver behind existing project in the region, while conducting its own research and development operations under license from the parent company.

Comments from our CEO, Mikael Brönnegård

Meeting with FDA with respect to NeuroVive's regulatory strategy

In October, NeuroVive met with the FDA in Washington to discuss CicloMulsion®'s clinical development plan and the ongoing European Phase III study on the treatment of reperfusion injury after myocardial infarct (CIRCUS study). In line with other regulatory authorities, the FDA is awaiting the results from the CIRCUS study regarding CicloMulsion®'s efficacy on the progression of the disease before evaluating the study and potentially granting approval. NeuroVive has scheduled further meetings with regulatory authorities in locations including Germany and the UK during spring 2015, as well as a follow-up meeting with the FDA in summer 2015, with the aim of receiving advice on the regulatory standards for CicloMulsion® and preparing the market ahead of potential regulatory approval.

Following the outlicensing of NVP018 for the treatment of Hepatitis B to OnCore, NeuroVive has accelerated its work to develop the next generation cyclophilin inhibitors (NVP019) with the aim of extending its product portfolio in pharmaceuticals that protect vital organs, primarily for acute medical conditions. As part of our strategy to evaluate new indications for CicloMulsion®, and ultimately NVP019, NeuroVive and Skåne University Hospital began a collaboration in clinical Phase II studies on kidney protection in cardiac surgery towards the end of last year. In addition to this study, NeuroVive is also planning Phase II studies on CicloMulsion®, focusing on additional cardiac indications within the framework of the collaboration with HCL in Lyon and professor Ovize.

Towards the end of the fourth quarter, NeuroVive held a number of shareholders' meetings that indicated significant interest in NeuroVive. The presentation of NeuroVive at the meetings highlighted the importance of focusing on the CIRCUS study in Europe during the first half of 2015 in order to begin to compile and analyze clinical data after the completion of the one-year follow-up of the final patient in 2015. The objective remains to present the results of the study during the third quarter 2015. This milestone will be of major significance to NeuroVive's positioning as the leading mitochondrial medicine company.

Finally, it's very pleasing to conclude that the results of the shareholders' survey completed earlier this year by far exceeded our expectations.

Mikael Brönnegård

CEO, NeuroVive Pharmaceutical AB (publ)

Operations

NeuroVive conducts research and development of pharmaceuticals that protect the mitochondria, and pharmaceuticals that enhance mitochondrial function. Its development technology platform primarily consists of cyclosporine A, as well as molecules with a different chemical structure that serve to protect the mitochondria by inhibiting enzymes of the cyclophilin type. The collective term for this type of candidate drug (CD) is cyclophilin inhibitors. NeuroVive's product portfolio also includes CDs for cellular energy regulation. Cyclosporin A, the active compound of CicloMulsion® and NeuroStat®, has been on the market as an active pharmaceutical compound for nearly 30 years. This means that extensive safety data for this active compound is already extant.

The clinical trial on the company's product that has developed furthest, CicloMulsion®, is continuing as planned, and the final patient in this European phase III trial was treated in February. Work relating to regulation and preparing the market has also intensified, with the objective, assuming positive results, of being able to launch CicloMulsion® as soon as the regulatory authorities have granted approval. The clinical phase II trial in Denmark on NeuroSTAT® for TBI is also going forward as planned.

The potent molecules NeuroVive acquired from Biotica are derivatives of the naturally occurring cyclophilin inhibitor Sanglifehrin as its active compound. This new technology platform has several favorable characteristics that will be important to NeuroVive's future progress. Thanks to extensive preclinical work already completed, only limited further development work is necessary before the lead CD cyclophilin inhibitor can enter the clinical phase. In September the drug candidate NVP 018 for hepatitis B and C was out-licensed to OnCore BioPharma, in US.

Within NeuroVive's core business, the new cyclophilin inhibitors are expected to be more potent (superior clinical efficacy) and more direct acting (less risk of adverse events) than NeuroVive's current products. The conditions for stronger patent protection (to around 2031-2035) are in place. Accordingly, NeuroVive anticipates the cyclophilin inhibitors complementing or completely replacing CicloMulsion®/NeuroSTAT® eventually, thus contributing to NeuroVive extending its leadership in mitochondrial medicine.

Business model

Revenues and results of operations

Revenues

Consolidated revenues for twelve months of 2014 amounts SEK 7,152,000 (5,335,000) and consists the initial upfront payment from OnCore BioPharma. The group's other operating revenues for twelve months of 2014 of SEK 1,181,000 (1,598,000) comprise the EU contribution received from Vinnova, the Swedish Governmental Agency for Innovation Systems.

Results of operations

The operating loss for the fourth quarter was -17,453,000 (-9,286,000) and for twelve months of 2014 - 45,254,000 (-22,346,000). The operating loss for the full year was positively impacted from the revenues from OnCore BioPharma. The operating loss is however higher than corresponding periods of the previous year due to increased operating expenses. The net profit/loss before tax for the fourth quarter amounted to SEK -17,346,000 (-9,169,000), and for twelve months, SEK -44,673,000 (-22,126,000).

The operating loss was affected by increased external expenses, which for the fourth quarter were SEK -13,738,000 (-6,845,000). For twelve months external expenses amounted to SEK -41,962,000 (-22,629,000). For twelve months, expenses related to development projects have affected the result with SEK -13,203,000 (-4,334,000). These expenses relates to development projects that have not reached phase I. The consulting expenses of the Company have increased compared to the corresponding period of the previous year, and expenses for legal consulting in connection to the ongoing arbitration with CicloMulsion AG. Personnel expenses also rose to SEK -10,346,000 (-6,265,000) because of a higher number of employees than the corresponding period of the previous year, due to intensified development work. The majority of the financial cost, SEK -544,000 (-203,000), relates to unrealized foreign exchange losses.

Financial position

The equity/assets ratio was 82 (84) % as of 31 December 2014, and equity was SEK 107,841,000 (74,643,000). Cash and cash equivalents amounted to SEK 49,698,000 (39,992,000) as of 31 December 2014, an increase of SEK 9,706,000 from the beginning of the year. Total assets as of 31 December 2014 were SEK 131,268,000 (89,177,000). The parent company is actively working with different financing possibilities to raise working capital for the company.

Cash flow and investments

Operating cash flow for the fourth quarter was SEK -17,443,000 (-9,286,000). Operating cash flow from twelve months was SEK 44,552,000 (-21,966,000). Consolidated cash flow for twelve months was SEK 9,537,000 (2,821,000), where the positive cash flow is explained by the share issue of SEK 76,599,000 (0). The cash flow effect due to investments has increased to SEK 23,251,000 (11,616,000) for twelve months in 2014.

Transactions with related parties

Transactions between the company and its subsidiaries, which are related parties to the company, have been eliminated on consolidation, and accordingly, no disclosures are made regarding these transactions. Disclosures regarding transactions between the group and other related parties are stated below.

Apart from remuneration to senior managers including remuneration for consulting services and loan commitment, no purchases or sales between the group and related parties occurred. Transactions with related parties affecting profit/loss for the period are stated below.

Transactions with related parties 1 Jan. 2014 1 Jan. 2013
(SEK 000) 31 Dec. 2014 31 Dec 2013
Stanbridge bvba (owned by Gregory Batcheller, Executive Chairman) 1 812 1 440
Jan Nilsson Konsult (owned by Jan Nilsson, COO, former Board member) - 451
Ankor Consultants bvba (owned by Arne Ferstad, Board member) 399 361
Verum Consulting AB (owned by Christian Svensson, former CFO) - 536
Baulos Capital (owned by Fredrik Olsson, shareholder) 48 -
Total transactions with related parties 2 259 2 918

Segment information

Financial information reported to the chief operating decision maker (CEO) as the basis for allocating resources and judging the group's profit or loss is not divided into different operating segments. Accordingly, the group consists of a single operating segment.

Financial instruments

NeuvoVive does not hold any financial instruments measured at fair value. The reported value of financial instruments essentially corresponds to fair value.

Human resources

The average number of employees of the group for the period January to December was 8 (6), of which 4 (3) are women.

Parent company

In preparation for initiating a process with the objective of an IPO in Taiwan further territorial rights in Asia for CicloMulsion® and NeuroSTAT® and rights to ToxPhos in Asia have been transferred within the group. This results in revenues of SEK 27,948,000 in the parent company income statement but has no impact on Group profit and loss. Most of the Group operations are conducted within the parent company. Accordingly, no further specific information regarding the parent company is presented.

Risks and uncertainty factors

A research company such as NeuroVive Pharmaceutical AB (publ) is subject to high operational and financial risks because the projects the company conducts are in different developmental phases, where a number of parameters influence the likelihood of commercial success. Briefly, operations are

associated with risks relating to factors including drug development, competition, technological progress, patents, regulatory requirements, capital requirements, currencies and interest rates. In the current period, there have been no significant changes regarding risks or uncertainty factors.

The arbitration proceeding with CicloMulsion AG is ongoing. In March 2013, CicloMulsion AG invoked an arbitration by which it seeks to determine the contractual right of CicloMulsion AG to receive royalty. If the arbitration is settled in favor of CicloMulsion AG, NeuroVive may be liable to pay future royalties for 15 years after product launch. If the arbitration is settled in favor of the Company, it may be possible for NeuroVive to make no royalty payments. CicloMulsion AG has also claimed payment of 10% royalty from NVP AB on the 5m RMB payment already received by NVP Asia from Sihuan Pharma and made further claims for compensation. NeuroVive's position is that there is no legal basis for such a claim. There is a possibility that CicloMulsion AG may raise further issues relating to the license during the arbitration proceedings. To date, the Tribunal has made a non-binding preliminary consideration of some questions of interpretation of the License Agreement under applicable contract law, while there has yet been no final decision. The Tribunal has recently begun assessing further key questions of the case, inter alia, the licensing and transfer of any know-how to NeuroVive and questions of anti-trust-law. As yet we have no definite timeline for a final award.

For more detail of risks and uncertainty factors, refer to the Statutory Administration Report in the Annual Report 2013 and the prospectus published 8 th January 2014 for the rights issue in January 2014.

Incentive programs/share warrants

The AGM on 10 June 2011 approved an equity-related incentive program for senior managers and/or other employees in the form of an issue of a maximum of 164,000 share warrants, which was fully subscribed. For more information, see note 29 in the Annual Report for 2013. Rights to exercise the incentive program expired on 10 June 2014, and had not been exercised by any option-holders by that time, and accordingly, this program was deregistered effective 17 June 2014.

Audit review

.

This Interim Report has not been subject to review by the company's auditor.

Upcoming financial statements

The Annual Report is published Week 10 2015
Interim Report January-March 2015 20 May 2015
Interim Report April-June 2015 19 August 2015
Interim Report July-September 2015 18 November 2015
Year-End Report 19 February 2016

The interim reports and the Annual Year Report are available at www.neurovive.com

Annual General Meeting 2014

NeuroVives Annual General Meeting will be held at Medicon Village, Scheelevägen 2, in Lund on 30th March, 2015 at 16 pm.

Principles of preparation of the Interim Report

NeuroVive prepares its consolidated accounts in accordance with International Financial Reporting Standards (IFRS) issued by the International Accounting Standards Board (IASB) and interpretation statements from the IFRS Interpretations Committee, as endorsed by the EU for application within the EU. This Interim Report has been prepared in accordance with IAS 34 Interim Financial Reporting.

The parent company applies the Swedish Annual Accounts Act and RFR's (the Swedish Financial Reporting Board) recommendation RFR 2 Accounting for Legal Entities. Application of RFR 2 implies that, as far as possible, the parent company applies all IFRS endorsed by the EU within the limits of the Swedish Annual Accounts Act and the Swedish Pension Obligations Vesting Act, and considering the relationship between accounting and taxation.

The group and parent company have applied the same accounting principles as described in the Annual Report for 2013 on pages 56-61.

New and revised standards and interpretation statements applicable from 1 January 2014 onwards did not have any effect on the group's or parent company's results of operations or financial position.

Consolidated Statement of Comprehensive Income

(SEK 000) Note 1 Oct. 2014 1 Oct. 2013 1 Jan. 2014 1 Jan. 2013
31 Dec. 2014 31 Dec. 2013 31 Dec. 2014 31 Dec. 2013
Net sales - - 7 152 5 335
Other operating income 8 12 1 181 1 598
8 12 8 333 6 933
Operating expenses
Other external expenses -13 738 -6 845 -41 962 -22 629
Personnel cost -3 284 -2 263 -10 346 -6 265
Depreciation and write-down of tangible -129 -38 -441 -147
and intangible assets
Other operating expenses -310 -152 -838 -238
-17 461 -9 298 -53 587 -29 279
Operating income -17 453 -9 286 -45 254 -22 346
Profit/loss from financial items
Financial income 461 156 1 124 423
Financial costs -354 -39 -544 -203
107 117 580 220
Profit/loss before tax -17 346 -9 169 -44 673 -22 126
Income tax 1 - - - -
Profit/loss for the period -17 346 -9 169 -44 673 -22 126
Other comprehensive income
Items that may be reclassified to profit or
loss
Translation differences on foreign
subsidiaries -205 127 -269 131
Total comprehensive income for the period -17 551 -9 042 -44 942 -21 995
Loss for the period attributable to:
Parent company shareholders -16 309 -8 538 -42 549 -22 331
Non-controlling interests -1 037 -631 -2 124 205
-17 346 -9 169 -44 673 -22 126
Total comprehensive income for the period
attributable to: -16 484 -8 450 -42 770 -22 240
Parent company shareholders
Non-controlling interests -1 066 -592 -2 173 245
-17 551 -9 042 -44 942 -21 995
Earnings per share before and after
dilution(SEK) based on average number of
shares
-0.59 -0.45 -1.53 -1.17

Consolidated Statement of Financial Position

(SEK 000) Note 31 Dec. 2014 31 Dec 2013
ASSETS
Non-current assets
Intangible assets 2
Development costs 68 368 39 182
Patents 11 146 7 770
Software 87 167
79 601 47 119
Tangible assets
Equipment 344 457
344 457
Total non-current assets 79 945 47 576
Current assets
Other receivables 1 123 1 096
Prepaid expenses and accrued income 502 513
Cash and cash equivalents 49 698 39 992
51 323 41 601
TOTAL ASSETS 131 268 89 177
(SEK 000) Note 30 Sep. 2014 31 Dec 2013
EQUITY AND LIABILITIES
Equity attributable to the shareholders of the parent company
Share capital 1 389 1 083
Additional paid in capital 207 812 131 519
Translation reserve -102 118
Retained earnings -105 787 -57 264
Total equity attributable to the shareholders of the parent
company
103 312 75 456
Non-controlling interests
Total equity 4 529 -813
107 841 74 643
Short-term liabilities
Accounts payable
14 216 4 759
Other liabilities 5 000
1 801
5 614
Accrued expenses and deferred income 7 410 4 161
23 427 14 534
Total liabilities 23 427 14 534

Consolidated Statement of Changes in Equity

Total number of shares at end of period: 27,788,093 (21,659,046).

(SEK 000) Equity attributable to the shareholders of the parent company
Total equity
Additional attributable to the Non
Share paid-in Translation Retained shareholders of the controlling Total
capital capital reserve earnings parent company interests equity*
Opening balance, 1 January 2014 1 083 131 519 118 -57 264 75 456 -813 74 643
Comprehensive profit/loss for the period
Profit/loss for the period - - - -42 549 -42 549 -2 124 -44 673
Other comprehensive income
Change of ownership in new share issue -5 974 -5 974 7 515 1 541
Translation differences - - -220 - -220 -49 -269
Other comprehensive profit/loss for the
period, net after tax
- - -220 - -220 -49 -269
Total comprehensive profit/loss - - -220 -48 523 -48 743 5 342 -43 401
Transactions with shareholders
New share issue 306 76 293 - - 76 599 0 76 599
Total transactions with shareholders 306 76 293 - - 76 599 0 76 599
Closing balance, 30 Sep 2014 1 389 207 812 -102 -105 787 103 312 4 529 107 841
Opening balance, 1 January 2013 958 98 049 27 -34 933 64 101 -1 058 63 043
Comprehensive profit/loss for the period
Profit/loss for the period - - - -22 331 -22 331 205 -22 126
Other comprehensive income
Translation differences - - 91 - 91 40 131
Other comprehensive profit/loss for the
period, net after tax
- - 91 - 91 40 131
Total comprehensive profit/loss - - 91 -22 331 -22 240 245 -21 995
Transactions with shareholders
New share issue 125 33 470 - - 33 595 - 33 595
Total transactions with shareholders 125 33 470 - - 33 595 - 33 595
Closing balance, 31 December 2013 1 083 131 519 118 -57 264 75 456 -813 74 643

*Total equity includes funds from the in January completed private placement with 85,806,000 SEK less expenses 9,207,000 SEK.

Consolidated Statement of Cash Flows

(SEK 000) 1 Oct. 2014 1 Oct. 2013 1 Jan. 2014 1 Jan. 2013
31 Dec. 2014 31 Dec. 2013 31 Dec. 2014 31 Dec. 2013
Cash flow from operating activities
Operating income -17 453 -9 286 -45 254 -22 346
Adjustments for non-cash items:
Depreciation 129 38 441 147
Currency differences on intercompany items -278 1 -278 1
Interest received 188 126 758 423
Interest paid -29 -147 -219 -191
Net cash from operating activities
before changes in working capital -17 443 -9 268 -44 552 -21 966
Changes in working capital
Increase/decrease of other current assets 7 544 -793 -16 -650
Increase/decrease of other short-term liabilities 8 593 5 428 936 3 527
Changes in working capital 16 137 4 635 920 2 877
Cash flow from operating activities -1 307 -4 633 -43 633 -19 089
Investing activities
Acquisition of tangible assets -149 -41 -178 -69
Acquisition of intangible assets -7 868 -3 874 -23 251 -11 616
Cash flow from investing activities -8 017 -3 915 -23 429 -11 685
Financing activities
New share issue - 33 595 76 599 33 595
Cash flow from financing activities - 33 595 76 599 33 595
Cash flow for the period -9 324 25 047 9 537 2 821
Cash and cash equivalents at the beginning of the 58 944 14 995 39 992 37 177
period
Effect of exchange rate changes on cash
78 -50 169 -6
Cash and cash equivalents at end of period 49 698 39 992 49 698 39 992

Parent Company Income Statement

(SEK 000) Note 1 Oct. 2014 1 Oct. 2013 1 Jan. 2014 1 Jan. 2013
31 Dec. 2014 31 Dec. 2013 31 Dec. 2014 31 Dec. 2013
Net sales - 819 7 546 819
Other operating income 27 953 11 29 125 1 598
27 953 830 36 671 2 417
Operating expenses
Other external expenses -9 989 -5 628 -35 383 -18 996
Personnel cost -3 519 -2 263 -10 346 -6 265
Depreciation and write-down of tangible and
intangible assets
-129 -38 -441 -147
Other operating expenses -298 -148 -816 -234
-13 935 -8 077 -46 986 -25 642
Operating income 14 018 -7 247 -10 315 -23 225
Profit/loss from financial items
Interest income and other similar profit items 276 191 1 047 553
Interest expenses and other similar loss items -232 -13 -376 -138
44 178 671 415
Profit/loss before tax 14 062 -7 069 -9 644 -22 810
Income tax 2 - - - -
Profit/loss for the period 14 062 -7 069 -9 644 -22 810

Statement of Comprehensive Income, Parent Company

(SEK 000) Note 1 Oct. 2014 1 Oct. 2013 1 Jan. 2014 1 Jan. 2013
31 Dec. 2014 31 Dec. 2013 31 Dec. 2014 31 Dec. 2013
Profit/loss for the period
Other comprehensive income
14 062
-
-7 069
-
-9 644
-
-22 810
-
Total comprehensive profit/loss for the period 14 062 -7 069 -9 644 -22 810

Parent Company Balance Sheet

(SEK 000) Note 31 Dec. 2014 31 Dec 2013
ASSETS
Non-current assets
Intangible assets 1
Development costs 68 133 39 182
Patents 11 146 7 770
Software 87 167
79 366 47 119
Tangible assets
Equipment 212 457
212 457
Financial assets
Shares in subsidiaries 3 33 618 6
33 618 6
Total non-current assets 113 196 47 582
Current assets
Short term receivables
Receivables from group companies 2 195 4 625
Other receivables 1 067 1 093
Prepaid expenses and accrued income 498 513
3 760 6 231
Cash and bank balances 48 842 36 769
Total current assets 52 602 43 000
TOTAL ASSETS 165 798 90 582
(SEK 000) Note 31 Dec. 2014 31 Dec 2013
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 1 389 1 083
Statutory reserve 1 856 1 856
3 245 2 939
Unrestricted equity
Share premium reserve 76 293 33 470
Retained earnings 74 422 63 761
Profit/loss for the period -9 644 -22 810
141 071 74 421
Total equity 144 316 77 360
Short-term liabilities
Accounts payable 13 823 4 704
Liabilities to group companies 6 6
Other liabilities 243
7 410
4 351
4 161
Accrued expenses and deferred income 21 482 13 222
TOTAL EQUITY AND LIABILITIES 165 798 90 582
PLEDGE AND CONTINGENT LIABILITIES
Pledge assets
31 Dec. 2014
None
31 Dec 2013
None

Contingent liabilities None None

Note 1 — Intangible assets

(SEK 000) Development costs Patents* Software Total
ACCUMULATED COST
Opening balance 1 Jan. 2014 39 182 11 086 400 50 668
Additions 29 186 4 025 - 33 211
Closing balance 31 Dec. 2014 68 368 15 111 400 83 879
ACCUMULATED DEPRECIATION
Opening balance 1 Jan. 2014 - -3 316 -233 -3 549
Depreciation for the period - -649 -80 -729
Closing balance 31 Dec. 2014 - -3 965 -313 -4 278
Residual value 31 Dec. 2014 68 368 11 146 87 79 601
(SEK 000) Development costs Patents* Software Total
ACCUMULATED COST
Opening balance 1 Jan. 2013
30 042 4 724 400 35 166
Additions 9 140 6 362 - 15 502
Government grants 39 182 11 086 400 50 668
Closing balance 31 Dec. 2013
ACCUMULATED DEPRECIATION
Opening balance 1 Jan. 2013 - -2 308 -153 -2 461
Depreciation for the period - -1 008 -80 -1 088
Closing balance 31 Dec. 2013 - -3 316 -233 -3 549

* Amortization of patents is recognized as a portion of historical cost of capitalized expenditure from product development because patents are used in development work.

Of total capitalized expenditure for product development, 49% is for NeuroSTAT, 50 % is for CicloMulsion, 1 % is for NVP014.

Note 2 – Tax

The group's total loss carry-forwards amount to SEK 116,679,000 as of 31 December 2014 (72,468,000). The parent company's total loss carry-forwards amount to SEK 87,763,000 as of 31 December 2014 (69,573,000). Because the company is loss making, management cannot judge when deductible loss carry-forwards will be utilized.

Note 3 — Shares and participations in group companies

These shares are the holding of 81.95% in the subsidiary NeuroVive Pharmaceutical Asia Inc., domiciled in Taiwan. NeuroVive Pharmaceutical Asia Inc. has two fully owned subsidiaries - NeuroVive Pharmaceutical Asia Ltd. domiciled in Hongkong and NeuroVive Pharmaceutical Taiwan, Inc. domiciled in Taiwan. NeuroVive held 70% of NeuroVive Pharmaceutical Asia Ltd, Hong Kong, until December 2014 when the holding increased to 81.95% by the inclusion of additional territorial rights in Asia for CicloMulsion®, NeuroSTAT® and ToxPhos®. The holding in NeuroVive Pharmaceutical Asia Ltd. has subsequently been converted to the corresponding shares in NeuroVive Pharmaceutical Asia, Inc.

This Interim Report gives a true and fair view of the parent company's and group's operations, financial position and results of operations, and states the significant risks and uncertainty factors facing the parent company and group companies.

Greg Batcheller Arne Ferstad Chairman of the Board Board member

Boel Flodgren Marcus Keep Board member Board member

Board member Board member

Helena Levander Anna Malm Bernsten

Helmuth von Moltke Board member

Mikael Brönnegård Chief Executive Officer

Lund, Sweden, February 18, 2015

This Interim Report is published in Swedish and English. In the event of any difference between the English version and the Swedish original, the Swedish version shall prevail.

For more information concerning this report please contact CEO Mikael Brönnegård, telephone: +46 (0)46-275 62 20.

NeuroVive Pharmaceutical AB (publ) Medicon Village, SE-223 81 Lund Tel: +46-46 275 62 20 (switchboard), Fax: +46-46 888 83 48 www.neurovive.com