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Abliva — Interim / Quarterly Report 2013
Nov 20, 2013
3131_10-q_2013-11-20_93071206-792f-4e0e-aa29-cd5e4949e930.pdf
Interim / Quarterly Report
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INTERIM 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.
Increased interest in NeuroVives product portfolio with cyclophilin inhibitors and energy regulators
Nine months (1 Jan. 2013 – 30 Sep. 2013)
- Net revenues were SEK 5,335,000 (0) and other operating income was SEK 1,586,000 (520,000).
- Loss before tax was SEK -12,957,000 (-10,755,000).
- Earnings per share* were SEK -0.72 (-0.60).
- Diluted earnings per share** were SEK -0.72 (-0.60).
Third quarter (1 Jul. 2013 – 30 Sep. 2013)
- Net revenues were SEK 0 (0) and other operating income was SEK 723,000 (201,000).
- Loss before tax was SEK -6,751,000 (-3,884,000).
- Earnings per share* were SEK -0.33 (-0.19).
- Diluted earnings per share** were SEK-0.33 (-0.19).
* 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 third quarter of 2013
- Over 800 of the 972 patients have been enrolled in the multinational phase III trial on the company's pharmaceuticals CicloMulsion® (CIRCUS trial) to treat reperfusion injury coincident with myocardial infarction.
- With its collaboration partner Sihuan, NeuroVive participated in the 18th Army Neurosurgery Annual Conference in Beijing, China.
Post balance sheet events
- NeuroVive has appointed Catharina Jz Johansson as its new CFO. She will take up her position on 1 December 2013.
- NeuroVive proposes resolution on private placement and rights issue totaling approximately SEK 111 m.
- NeuroVive has announced that an extraordinary General Meeting will be held on Friday 13th December at 10 am in Lund.
Comments from our CEO, Mikael Brönnegård
STRONG DEVELOPMENTAL PERIOD, WITH CICLOMULSION® THE LEADER
The company's previous reports this year have emphasized how NeuroVive has secured its prominent international status in mitochondrial medicine. Successful clinical work, and the acquisition of new, potent candidate drugs (CDs) combined with active participation in international conferences, mean that I can now detect far greater interest in the company's product portfolio than just a year or so ago. Obviously, this is pleasing, and an inspiration.
I'd also like to point out that as many as 30% of NeuroVive's registered shareholders responded to its previously advertised shareholder survey. This demonstrates great commitment to the company, which we really appreciate. We'll be compiling and considering all the views expressed.
Cyclophilin inhibitors like cyclosporine A and NeuroVive's new CDs have gained increasing attention, and are now regarded as representing a new drug class with potential for treating a large number of diseases. The potential applications have proven wider than only treating conditions relating to mitochondrial dysfunction, and currently also include other anti-viral indications like hepatitis B and C. Treating viral diseases with cyclophilin inhibitors has attracted very substantial interest from large pharmaceutical companies, and have shifted the focus onto NeuroVive's new CDs for potential out-licensing deals, with discussions currently ongoing with possible counterparties.
NeuroVive's clinical trial program on CicloMulsion® is continuing as planned, and we are now approaching the treatment of the final patient in the European phase III trial. Additionally, work relating to regulations and preparing the market has also intensified, with the objective of being able to launch CicloMulsion® in 2016, assuming positive results from its phase III trial. In addition to actual marketing work, the first production volumes for commercial use are scheduled to leave the new production facility of our production partner in Graz, Austria, next year.
Clinical work on NeuroSTAT® in traumatic brain injury (TBI) is also continuing. Discussions with European and American pharmaceutical regulators are scheduled for 2014, with the objective of initiating a multinational phase III trial based on the current phase II trial in Denmark, plus preclinical trials. The ambition is to be seeking a co-financier for this trial.
NeuroVive's products are attracting increasing interest in China and in the rest of Asia as work for the planned phase III trial on CicloMulsion® in reperfusion injury after myocardial infarction progresses. Opinion-formers in the cardiovascular segment have also shown interest in this trial and the plan is to include also other Asian countries. The treatment of TBI with NeuroSTAT® has also been the subject of discussion at two important neurosurgery conferences in China. Professor Carl-Henrik Nordström was guest lecturer at these conferences in his capacity as a member of NeuroVive's Advisory Board.
To summarize, all the company's products in preclinical and clinical development phases have taken more steps forward. Preclinical projects on CDs in energy regulation, new cyclophilin inhibitors for cardio and neuroprotection and anti-viral CDs are now entering various preparatory phases with the target of achieving the first dose in humans.
Finally, I'd like to take this opportunity to thank our CFO, Christian Svensson, for making a significant contribution to NeuroVive's great progress over many years, while simultaneously extending a warm welcome to our new CFO, Catharina Jz Johansson.
Mikael Brönnegård
CEO, NeuroVive Pharmaceutical AB (publ)
NeuroVive
OPERATIONS
NeuroVive conducts research and development into 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 CD is cyclophilin inhibitors. NeuroVive's product portfolio also includes CDs for cellular energy regulation.
A LEADING MITOCHONDRIAL MEDICINE COMPANY | NeuroVive Pharmaceutical AB (publ) | VAT number: SE556595653801
Cyclosporine 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 we are now approaching treatment of the final patient in this European phase III trial. 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 continuing. In parallel with the current phase II trial, the planning for an international phase III trial on NeuroSTAT® is ongoing. The ambition is to find partnership for co-financing this trial.
The new, 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 cyclophilin inhibitors can enter the clinical phase. The company are also evaluating out-licensing opportunities, primarily for the CD NVP018 for hepatitis B and C.
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 new cyclophilin inhibitors complementing or completely replacing CicloMulsion®/NeuroSTAT® eventually, thus contributing to NeuroVive extending its leadership in mitochondrial medicine.
Project overview
Business model
NeuroVive is evaluating various types of innovative collaboration with large pharmaceutical companies and/or CRO (contract research organizations) partners with the intention of creating a reduced-risk and cost-efficient business model. This will enable NeuroVive to exploit established promotion channels with selected partners to build future business segments such as the marketing and sale of future pharmaceuticals. The business model based on strategic alliances with trade partners also enables various types of direct investment in NeuroVive as part-funding of phase III trials, and future straight marketing and sales activities. NeuroVive also intends to outlicense drugs to large pharmaceutical companies for registration, marketing and sale. The company's remuneration may consist of up-front and milestone payments on out-licensing and the route to launch, as well as ongoing royalty revenues based on the sale of out-licensed pharmaceuticals.
NeuroVive is working systematically on accumulating critical mass in the company's current research segments through acquisitions of technologies and projects in the nerve cell and mitochondrial protection research segments and partnerships in technology and product development. Eventually, this acquisition and partnership strategy will promote NeuroVive's prospects of bringing new drugs in traumatic brain damage, and the company's other priority indications, to market. In this way, NeuroVive is mitigating the risk of long development cycles for new pharmaceuticals.
Revenues and results of operations
Revenues
Consolidated revenues in the first half-year of SEK 5,335,000 (0) consist of remuneration to the 70%-owned subsidiary in China, NeuroVive Pharmaceutical Asia Ltd, for milestones achieved pursuant to a collaboration agreement. The majority of the group's other operating revenues for the first half-year of SEK 1,586,000 (520,000) comprise the EU contribution received from Vinnova, the Swedish Governmental Agency for Innovation Systems.
Results of operations
The operating profit/loss for the first nine months of, SEK -13,060,000 (-11,146,000), and for the third quarter of SEK -6,671,000 (-4,160,000) was positively affected by the revenues of the subsidiary. 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 first nine months was SEK -12,957,000 (-10,755,000), and for the third quarter, SEK -6,751,000
(-3,884,000).
The operating loss was affected by increased external expenses, which were SEK -15,784,000 (-8,229,000). For the first nine months, expenses related to development projects has affected the result with SEK -2,562,000 (0). These expenses relates to development projects that have not reached phase I which since the fourth quarter 2012, are being expensed. The company also incurred expenses coincident with its IPO on Nasdaq OMX, consulting expenses 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 -4,002,000
(-3,227,000) 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 -164,000 (-1,000), relates to a loan commitment of SEK 4,000,000.
Financial position
The equity/assets ratio was 85 (88) % as of 30 September 2013, and equity was SEK 50,090,000 (63,043,000). Cash and cash equivalents amounted to SEK 14,995,000 (37,177,000) as of 30 September 2013, a decrease of SEK 22,182,000 since the beginning of the year. Total assets as of 30 September 2013 were SEK 58,914,000 (71,506,000). The company has a loan commitment of SEK 4,000,000 from Private Placement SPRL (under name change to Baulos Capital Belgium SA), one of the major shareholders.
NeuroVive proposes a resolution on private placement and rights issue totaling approximately SEK 111 m and has announced that and extraordinary General Meeting will be held on Friday 13th December at 10 am in Lund.
Cash flow and investments
Consolidated cash flow for the first nine months was SEK -22,227,000 (30,770,000), where previous years cash flow is explained by the share issue of SEK 46 m. The change in working capital has affected the cash flow negatively with -4,064,000 compared to last year, SEK -1,758,000 (2,308,000). The cash flow has also been affected negatively by the increase in operating loss, SEK -13,060,000 (-11,146,000). The cash flow effect due to investments has also affected the cash flow with SEK -7,770 (-7,220,000) in 2013. Cash flow was positively affected by the milestone payment received.
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, 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. 2013 | 1 Jan. 2012 |
|---|---|---|
| (SEK 000) | 30 Sep. 2013 | Sep. 2012 |
| Stanbridge bvba (owned by Gregory Batcheller, Executive Chairman) | 1 030 | 831 |
| Jan Nilsson Konsult (owned by Jan Nilsson, COO, former Board member) | 46 | 179 |
| Ankor Consultants bvba (owned by Arne Ferstad, Board member) | 298 | 258 |
| Verum Consulting AB (owned by Christian Svensson, CFO) | 120 | 456 |
| Total transactions with related bodies | 1 494 | 1 723 |
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.
Human resources
The average number of employees of the group for the period January to September was 6 (4), of which 3 (2) are women.
Parent company
Most of the group's operations are conducted within the parent company except for the milestone-payment that the subsidiary NeuroVive Pharmaceutical Asia Ltd received. 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 second quarter 2012, the capital requirement was assured for the company's upcoming development activities. 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 implications of NeuroVive's capacity to cancel the licensing agreement after 2013 and how CicloMulsion AG's rights to receive royalties would be affected by such cancellation. If the arbitration is settled in favor of CicloMulsion AG, NeuroVive may be liable to pay future royalties without being able to cancel the agreement. Thereby, NeuroVive may be compelled to pay royalties for 15 years after the products are launched. If the arbitration is settled in favor of the Company, it may be possible for NeuroVive to terminate the agreement and thus avoid royalty payments after 2013. There is a possibility that CicloMulsion AG may raise further issues relating to the license during the arbitration proceedings.
For more detail of risks and uncertainty factors, refer to the Statutory Administration Report in the Annual Report 2012 and the prospectus published 3rd April 2013, prior to the listing on Nasdaq OMX Stockholm.
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 30 in the Annual Report for 2012.
This Interim Report has been subject to review by the company's auditors in accordance with the Standard on Review Engagements (SÖG) 2410, Review of Interim Financial Information Performed by the Independent Auditor of the Entity.
A LEADING MITOCHONDRIAL MEDICINE COMPANY | NeuroVive Pharmaceutical AB (publ) | VAT number: SE556595653801
Upcoming financial statements
• Year-end Report for 2013 19 February 2014
Annual General Meeting 2014
NeuroVives Annual General Meeting will be held at Medicon Village, Scheelevägen 2, in Lund on 9th May, 2014 at 10 am.
Shareholders have the right to have a matter addressed at the Annual General Meeting, if the request has been notified to the Board of Directors no later than 21st March 2014. The Board of Directors can be contacted by email: [email protected] or through regular mail to: NeuroVive Pharmaceutical AB, Att: Greg Batcheller, Medicon Village, 223 81 Lund.
The Nomination Committee consists of the following persons:
Michael Vickers, chairman in the Nomination Committee and appointed by Maas Biolab LLC; Anders Ermén, appointed by Private Placement SPRL (under name change to Baulos Capital Belgium SA), and Tomas Hagström, appointed by Eskil Elmér.
Shareholders who wish to submit proposals to the Nomination Committee can contact the Nomination Committee by e-mail: [email protected] or through regular mail to: NeuroVive Pharmaceutical AB, Att: Valberedningen, Medicon Village, 223 81 Lund. Proposals to the Nomination Committee should be submitted no later than 28th February 2014.
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 2012 on pages 22-28.
New and revised standards and interpretation statements applicable from 1 January 2013 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 Jul. 2013 | 1 Jul. 2012 | 1 Jan. 2013 | 1 Jan. 2012 |
|---|---|---|---|---|---|
| 30 Sep. 2013 | 30 Sep. 2012 | 30 Sep. 2013 | 30 Sep. 2012 | ||
| Net sales | - | - | 5 335 | - | |
| Other operating income | 723 | 201 | 1 586 | 520 | |
| 723 | 201 | 6 921 | 520 | ||
| Operating expenses | |||||
| Other external expenses | -5 979 | -2 913 | -15 784 | -8 229 | |
| Personnel cost | -1 334 | -1 330 | -4 002 | -3 227 | |
| Depreciation and write-down of tangible | -35 | -27 | -109 | -79 | |
| and intangible assets | |||||
| Other operating expenses | -46 | -91 | -86 | -131 | |
| -7 394 | -4 361 | -19 981 | -11 666 | ||
| Operating income | -6 671 | -4 160 | -13 060 | -11 146 | |
| Profit/loss from financial items | |||||
| Financial income | 53 | 276 | 267 | 392 | |
| Financial costs | -133 | - | -164 | -1 | |
| -80 | 276 | 103 | 391 | ||
| Profit/loss before tax | -6 751 | -3 884 | -12 957 | -10 755 | |
| Income tax | 1 | 55 | - | - | - |
| Profit/loss for the period | -6 696 | -3 884 | -12 957 | -10 755 | |
| Other comprehensive income | |||||
| Items that may be reclassified to profit or | |||||
| loss | |||||
| Translation differences on foreign | -39 | 55 | 4 | 75 | |
| subsidiaries | |||||
| Total comprehensive income for the period | -6 735 | -3 829 | -12 953 | -10 680 | |
| Loss for the period attributable to: | |||||
| Parent company shareholders | -6 399 | -3 679 | -13 793 | -10 145 | |
| Non-controlling interests | -297 | -205 | 836 | -610 | |
| -6 696 | -3 884 | -12 957 | -10 755 | ||
| Total comprehensive income for the period attributable to: |
|||||
| Parent company shareholders | -6 426 -309 |
-3 624 -205 |
-13 790 837 |
-10 070 -610 |
|
| Non-controlling interests | -6 735 | -3 829 | -12 953 | -10 680 | |
| Earnings per share before and after | |||||
| dilution(SEK) based on average number of shares |
-0,33 | -0,19 | -0,72 | -0,60 |
Consolidated Statement of Financial Position
| (SEK 000) | Note | 30 Sep. 2013 | 30 Sep. 2012 | 31 Dec 2012 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 2 | |||
| Development costs | 36 119 | 25 346 | 30 042 | |
| Patents | 6 340 | 2 350 | 2 416 | |
| Software | 187 | 267 | 247 | |
| 42 646 | 27 963 | 32 705 | ||
| Tangible assets Equipment |
487 | 736 | 665 | |
| 487 | 736 | 665 | ||
| Total non-current assets | 43 133 | 28 699 | 33 370 | |
| Current assets | ||||
| Other receivables | 414 | 497 | 734 | |
| Prepaid expenses and accrued income | 372 | 191 | 225 | |
| Cash and cash equivalents | 14 995 | 43 565 | 37 177 | |
| 15 781 | 44 253 | 38 136 | ||
| TOTAL ASSETS | 58 914 | 72 952 | 71 506 | |
| (SEK 000) | Note | 30 Sep. 2013 | 30 Sep. 2012 | 31 Dec 2012 |
| EQUITY AND LIABILITIES | ||||
| Equity attributable to the shareholders of the parent company | ||||
| Share capital | 958 | 958 | 958 | |
| Additional paid in capital | 98 049 | 98 049 | 98 049 | |
| Translation reserve | 4 | 75 | 27 | |
| Retained earnings | -48 700 | -30 205 | -34 933 | |
| Total equity attributable to the shareholders of the parent | 50 311 | 68 877 | 64 101 | |
| company Non-controlling interests |
-221 | -650 | -1 058 | |
| Total equity | 50 090 | 68 227 | 63 043 | |
| Short-term liabilities | ||||
| Accounts payable | 3 862 | 1 274 | 4 724 | |
| Other liabilities | 1 805 | 718 | 1 103 | |
| Accrued expenses and deferred income | 3 157 | 2 733 | 2 636 | |
| 8 824 | 4 725 | 8 463 | ||
| Total liabilities | 8 824 | 4 725 | 8 463 |
Consolidated Statement of Changes in Equity
Total number of shares at end of period: 19,159,046.
| (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 2013 | 958 | 98 049 | 27 | -34 933 | 64 101 | -1 058 | 63 043 |
| Comprehensive profit/loss for the period | |||||||
| Profit/loss for the period | - | - | - | -13 793 | -13 793 | 836 | -12 957 |
| Other comprehensive income | |||||||
| Translation differences | - | - | -23 | 26 | 3 | 1 | 4 |
| Other comprehensive profit/loss for the period, net after tax |
- | - | -23 | 26 | 3 | 1 | 4 |
| Total comprehensive profit/loss | - | - | -23 | -13 767 | -13 790 | 837 | -12 953 |
| Transactions with shareholders | |||||||
| New share issue | - | - | - | - | - | - | - |
| Total transactions with shareholders | - | - | - | - | - | - | - |
| Closing balance, 30 September 2013 | 958 | 98 049 | 4 | -48 700 | 50 311 | -221 | 50 090 |
| Opening balance, 1 January 2012 | 747 | 51 938 | - | -20 060 | 32 625 | -40 | 32 585 |
| Comprehensive profit/loss for the period | |||||||
| Profit/loss for the period | - | - | - | -10 145 | -10 145 | -610 | -10 755 |
| Other comprehensive income | |||||||
| Translation differences | - | - | 75 | - | 75 | - | 75 |
| Other comprehensive profit/loss for the | - | - | 75 | - | 75 | - | 75 |
| period, net after tax | |||||||
| Total comprehensive profit/loss | - | - | 75 | -10 145 | -10 070 | -610 | -10 680 |
| Transactions with shareholders | |||||||
| New share issue | 211 | 46 111 | - | - | 46 322 | - | 46 322 |
| Total transactions with shareholders | 211 | 46 111 | - | - | 46 322 | - | 46 322 |
| Closing balance, 30 September 2012 | 958 | 98 049 | 75 | -30 205 | 68 877 | -650 | 68 227 |
| Opening balance, 1 October 2012 | 958 | 98 049 | 75 | -30 205 | 68 877 | -650 | 68 227 |
| Comprehensive profit/loss for the period | |||||||
| Profit/loss for the period | - | - | - | -4 728 | -4 728 | -420 | -5 148 |
| Other comprehensive income | |||||||
| Translation differences | - | - | -48 | - | -48 | 12 | -36 |
| Other comprehensive profit/loss for the | |||||||
| period, net after tax | - | - | -48 | - | -48 | 12 | -36 |
| Total comprehensive profit/loss | - | - | -48 | -4 728 | -4 776 | -408 | -5 184 |
| Transactions with shareholders | |||||||
| New share issue | - | - | - | - | - | - | - |
| Total transactions with shareholders | - | - | - | - | - | - | - |
| Closing balance, 31 December 2012 | 958 | 98 049 | 27 | -34 933 | 64 101 | -1 058 | 63 043 |
Consolidated Statement of Cash Flows
| (SEK 000) | 1 Jul. 2013 | 1 Jul. 2012 | 1 Jan. 2013 | 1 Jan. 2012 |
|---|---|---|---|---|
| 30 Sep. 2013 | 30 Sep. 2012 | 30 Sep. 2013 | 30 Sep. 2012 | |
| Cash flow from operating activities | ||||
| Operating income | -6 671 | -4 160 | -13 060 | -11 146 |
| Adjustments for non-cash items: | ||||
| Depreciation | 35 | 27 | 109 | 79 |
| Currency differences on intercompany items | -45 | 55 | - | 75 |
| Interest received | 59 | 273 | 297 | 353 |
| Interest paid | -13 | - | -44 | -1 |
| Net cash from operating activities | ||||
| before changes in working capital | -6 635 | -3 805 | -12 698 | -10 640 |
| Changes in working capital | ||||
| Increase/decrease of other current assets | 276 | 1 496 | 143 | -148 |
| Increase/decrease of other short-term liabilities | 207 | 371 | -1 901 | 2 456 |
| Changes in working capital | 483 | 1 867 | -1 758 | 2 308 |
| Cash flow from operating activities | -6 153 | -1 938 | -14 457 | -8 332 |
| Investing activities | ||||
| Acquisition of tangible assets | -28 | -307 | -28 | -333 |
| Acquisition of intangible assets | -1 841 | -3 612 | -7 742 | -6 887 |
| Cash flow from investing activities | -1 869 | -3 919 | -7 770 | -7 220 |
| Financing activities | ||||
| New share issue | - | - | - | 46 322 |
| Cash flow from financing activities | - | - | - | 46 322 |
| Cash flow for the period | -8 022 | -5 857 | -22 227 | 30 770 |
| Cash and cash equivalents at the beginning of the | 22 972 | 49 422 | 37 177 | 12 795 |
| period Effect of exchange rate changes on cash |
45 | - | 45 | - |
| Cash and cash equivalents at end of period | 14 995 | 43 565 | 14 995 | 43 565 |
Parent Company Income Statement
| (SEK 000) | Note | 1 Jul. 2013 | 1 Jul. 2012 | 1 Jan. 2013 | 1 Jan. 2012 |
|---|---|---|---|---|---|
| 30 Sep. 2013 | 30 Sep. 2012 | 30 Sep. 2013 | 30 Sep. 2012 | ||
| Net sales | - | - | - | - | |
| Other operating income | 724 | 201 | 1 587 | 520 | |
| 724 | 201 | 1 587 | 520 | ||
| Operating expenses | |||||
| Other external expenses | -4 984 | -2 231 | -13 368 | -6 196 | |
| Personnel cost | -1 334 | -1 330 | -4 002 | -3 227 | |
| Depreciation and write-down of tangible and intangible assets |
-35 | -27 | -109 | -79 | |
| Other operating expenses | -46 | -91 | -86 | -131 | |
| -6 399 | -3 679 | -17 565 | -9 633 | ||
| Operating income | -5 675 | -3 478 | -15 978 | -9 113 | |
| Profit/loss from financial items | |||||
| Interest income and other similar profit items | 89 | 276 | 362 | 392 | |
| Interest expenses and other similar loss items | -119 | - | -125 | -1 | |
| -30 | 276 | 237 | 391 | ||
| Profit/loss before tax | -5 705 | -3 202 | -15 741 | -8 722 | |
| Income tax | 1 | - | - | - | - |
| Profit/loss for the period | -5 705 | -3 202 | -15 741 | -8 722 |
Statement of Comprehensive Income, Parent Company
| (SEK 000) | Note | 1 Jul. 2013 | 1 Jul. 2012 | 1 Jan. 2013 | 1 Jan. 2012 |
|---|---|---|---|---|---|
| 30 Sep. 2013 | 30 Sep. 2012 | 30 Sep. 2013 | 30 Sep. 2012 | ||
| Profit/loss for the period | -5 705 | -3 202 | -15 741 | -8 722 | |
| Other comprehensive income | - | - | - | - | |
| Total comprehensive profit/loss for the period | -5 705 | -3 202 | -15 741 | -8 722 |
Parent Company Balance Sheet
| (SEK 000) | Note | 30 Sep. 2013 | 30 Sep. 2012 | 31 Dec 2012 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 2 | |||
| Development costs | 36 119 | 25 346 | 30 042 | |
| Patents | 6 340 | 2 350 | 2 416 | |
| Software | 187 | 267 | 247 | |
| 42 646 | 27 963 | 32 705 | ||
| Tangible assets | ||||
| Equipment | 487 | 736 | 665 | |
| 487 | 736 | 665 | ||
| Financial assets | ||||
| Shares in subsidiaries | 3 | 6 | 6 | 6 |
| 6 | 6 | 6 | ||
| Total non-current assets | 43 139 | 28 705 | 33 376 | |
| Current assets | ||||
| Short term receivables | ||||
| Receivables from group companies | 3 659 | 1 307 | 2 716 | |
| Other receivables | 411 | 495 | 732 | |
| Prepaid expenses and accrued income | 372 | 191 | 225 | |
| 4 442 | 1 993 | 3 673 | ||
| Cash and bank balances | 10 870 | 43 564 | 37 177 | |
| Total current assets | 15 312 | 45 557 | 40 850 | |
| 58 451 | 74 262 | 74 226 | ||
| TOTAL ASSETS | ||||
| (SEK 000) | Note | 30 Sep. 2013 | 30 Sep. 2012 | 31 Dec 2012 |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | ||||
| Share capital | 958 | 958 | 958 | |
| Statutory reserve | 1 856 | 1 856 | 1 856 | |
| 2 814 | 2 814 | 2 814 | ||
| Unrestricted equity | ||||
| Share premium reserve | - | 46 111 | 46 111 | |
| Retained earnings | 63 761 | 30 122 | 30 122 | |
| Profit/loss for the period | -15 743 | -8 722 | -12 471 | |
| 48 018 | 67 511 | 63 762 | ||
| Total equity | 50 832 | 70 325 | 66 576 | |
| Short-term liabilities | ||||
| Accounts payable | 3 862 | 1 274 | 4 724 | |
| Liabilities to group companies | 6 | 6 | 6 | |
| Other liabilities | 594 | 158 | 284 | |
| Accrued expenses and deferred income | 3 157 | 2 499 | 2 636 | |
| 7 619 | 3 937 | 7 650 | ||
| TOTAL EQUITY AND LIABILITIES | 58 451 | 74 262 | 74 226 |
Note 1 – Tax
The group's total loss carry-forwards amount to SEK 62,198,000 as of 30 September 2013 (49,559,000 31 December 2012). The parent company's total loss carry-forwards amount to SEK 61,552,000 as of 30 September 2013 (46,127,000 31 December 2012). Because the company is loss making, management cannot judge when deductible loss carry-forwards will be utilized.
| (SEK 000) | Development costs | Patents* | Software | Total |
|---|---|---|---|---|
| ACCUMULATED COST | ||||
| Opening balance 1 Jan. 2013 | 30 042 | 4 724 | 400 | 35 166 |
| Additions | 6 077 | 4 640 | - | 10 717 |
| Closing balance 30 Sep. 2013 | 36 119 | 9 364 | 400 | 45 883 |
| ACCUMULATED DEPRECIATION | ||||
| Opening balance 1 Jan. 2013 | - | -2 308 | -153 | -2461 |
| Depreciation for the period | - | -716 | -60 | -776 |
| Closing balance 30 Sep. 2013 | - | -3 024 | -213 | -3237 |
| Residual value 30 Sep. 2013 | 36 119 | 6 340 | 187 | 42 646 |
| (SEK 000) | Development costs | Patents* | Software | Total |
| ACCUMULATED COST | ||||
| Opening balance 1 Jan. 2012 | 17 840 | 4 083 | 400 | 22 323 |
| Additions | 12 434 | 641 | - | 13 075 |
| Government grants | -232 | - | - | -232 |
| Closing balance 31 Dec. 2012 | 30 042 | 4 724 | 400 | 35 166 |
| ACCUMULATED DEPRECIATION | ||||
| Opening balance 1 Jan. 2012 | - | -1 452 | -73 | -1 525 |
| Depreciation for the period | - | -856 | -80 | -936 |
| Closing balance 31 Dec. 2012 | - | -2 308 | -153 | -2 461 |
Note 2 — Intangible assets
* 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, 60% is for NeuroSTAT, 38% is for CicloMulsion, 2% is for NVP014.
Note 3 — Shares and participations in group companies
These shares are the holding of 70% in Hong Kong-registered subsidiary NeuroVive Pharmaceutical Asia Ltd., which was incorporated in December 2011.
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.
Chairman of the Board Board member
Greg Batcheller Arne Ferstad
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, 20th November 2013
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: 046-275 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
AUDITORS' REVIEW REPORT
Introduction
We have reviewed the summarized interim financial information NeuroVive Pharmaceutical AB (publ) on September 30th 2013 and for the nine month period then ended. The board of directors and the CEO are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
Scope of review
We conducted our review in accordance with the Standard on Review Engagements (SÖG) 2410, Review of Interim Financial Information Performed by the Independent Auditor of the Entity. A review 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 Standard of Auditing (ISA), and other generally accepted auditing standards in Sweden. The procedures performed in a review do not enable us to obtain a level of assurance that we would become aware of all significant matters that might be identified in an audit. Therefore, the conclusion expressed based on a review does not give the same level of assurance as a conclusion expressed based on an audit.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, for the group´s part according to IAS 34 and the Annual Accounts Act and for the parent company´s part according to the Annual Accounts Act.
Helsingborg November 20th 2013
Mazars SET Revisionsbyrå AB
Bengt Ekenberg Authorized Public Accountant