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Abliva — Interim / Quarterly Report 2015
Aug 19, 2015
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Interim / Quarterly Report
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1 Jan 2015 to 30 June 2015
INTER IM REPORT
NeuroVive Pharmaceutical AB (publ) I 556595-6538 I www.neurovive.se I [email protected]
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.
Negative top-line result of phase III study and continued progress in other clinical projects
Second Quarter (1 Apr. 2015 – 30 Jun. 2015)
- Net revenues were SEK 2,502,000 (0) and other operating income was SEK 377,000 (1,128,000).
- Loss before tax was SEK -15,216,000 (-13,690,000).
- Earnings per share* were SEK -0.54 (-0.69).
- Diluted earnings per share** were SEK -0.54 (-0.69).
Six Months (1 Jan. 2015 – 30 Jun. 2015)
- Net revenues were SEK 2,502,000 (0) and other operating income was SEK 426,000 (1,171,000).
- Loss before tax was SEK -29,487,000 (-23,567,000).
- Earnings per share* were SEK -1.02 (-0.50).
- Diluted earnings per share** were SEK -1.02 (-0.50).
* 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 second quarter of 2015
- A directed share issue was completed, and contributed SEK 59 million to the Company after transaction costs. The share issue was directed to a limited group of institutional US investors in order to strengthen the company's ownership base in the US.
- The phase III CIRCUS study of CicloMulsion® in patients with a specific type of heart attack known as ST-segment elevation acute myocardial infarction (STEMI) did not meet its primary clinical endpoint in a topline analysis. This result does not contain specific data concerning the level of significance for either the composite endpoint or each individual element of the composite endpoint. It is anticipated that the full results of the 12-month data from the CIRCUS study will be made available in the third quarter.
- The development project NVP014 for the treatment of ischemic stroke is entering a new phase in collaboration with UK partner Isomerase Therapeutics.
- The independent safety committee has endorsed moving on to the next dose level, following the treatment of 10 of 20 patients in the ongoing clinical Phase IIa study for traumatic brain injury with the company's drug candidate NeuroSTAT®. The study will continue as planned and move on to the next dose level for the final 10 patients.
-
The first patient has been enrolled in a clinical phase II study for acute kidney injury using the company's product CicloMulsion®.
-
NeuroVive Pharmaceutical Asia group has signed a collaboration agreement with Sanofi's local affiliate for the development and commercialization of CicloMulsion® in South Korea. Under the agreement NeuroVive Asia will get an upfront payment, a conditional milestone payment and royalty on potential future sales in South Korea.
- NeuroVive share upgraded on OTC Market in US.
Events post balance sheet
No events post balance sheet completion to report.
Comments from our CEO, Mikael Brönnegård
The second quarter of the year was characterized by the result from the European phase III study with CicloMulsion® for the treatment of reperfusion injury after myocardial infarction ( CIRCUS study), which did not meet its primary endpoint as previously communicated on 1 June. This was despite convincing results from pre-clinical and phase II trials. The extensive study data is now being analyzed to determine why the primary endpoint—a combination of heart function, heart failure and mortality—wasn't met, and to evaluate the remaining comprehensive data from the clinical trial, including the numerous secondary endpoints.
The collaboration with Isomerase in the UK was extended in the period, and now includes all NeuroVive's pre-clinical projects. The extended collaboration has generated a new chemistry platform for the stroke project (NVP014) and the mitochondrial energy-regulation project (NVP015).
The SEK 70 m directed share issue completed in May enabled us to continue our focus on phase II studies with CicloMulsion® for renal protection in connection with heart surgery (CiPRICS) and
NeuroSTAT® in traumatic brain injury (CHIC). The first patient in the CiPRICS study in Lund was enrolled in April, and enrolment has proceeded as planned. A NeuroSTAT® safety evaluation that was planned to take place after 10 patients were enrolled demonstrated that the treatment is safe. The study will
continue as planned with a higher dose administered to the next 10 patients included in the study.
The NeuroVive share was upgraded on the OTC market in the US in the second quarter. Alongside the share issue completed in May, which was aimed at limited circle of high-profile US institutional investors, this is set to strengthen NeuroVive's presence in the US and increase interest from key capital markets operators. NeuroVive also strengthened its position in Asia through an agreement with Sanofi-Aventis Korea.
Overall, the company has followed its development plans for the portfolio's other projects despite not meeting the primary endpoint for the European phase III study with CicloMulsion®, and NeuroVive remains strong with a broad development portfolio in mitochondrial medicine. Looking ahead, our assessment is that mitochondrial medicine will progress to encompass a number of different drugs that affect various parts of the mitochondria, similar to how hypertension is treated with a number of different pharmaceuticals. Our focus on addressing acute conditions with a combination of mitochondria-protecting and energy-regulating drugs means that we're well positioned for the future.
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 in place.
The new technology platform is based on the naturally occurring cyclophilin inhibitor Sanglifehrin which has several favorable characteristics that will become important to NeuroVive's future progress. The new cyclophilin inhibitors are more potent (more effective) and more specific (potentially lower risk of adverse events) than NeuroVive's existing drug candidates. Accordingly, NeuroVive anticipates these drugs to complement or completely replace CicloMulsion®/NeuroSTAT® eventually, contributing to NeuroVive extending its leadership in mitochondrial medicine.
The clinical trial with the company's drug candidate, CicloMulsion®, did not meet its primary endpoint in a topline analysis, This will delay the commercialization of CicloMulsion®. The 12-month follow-up of the CIRCUS study is currently being carefully analyzed, and the full results of the study are expected to be available and published in the third quarter.
The by NeuroVive initiated clinical phase II study in Denmark investigating NeuroSTAT® for traumatic brain injury has passed the first safety evaluation, which means that it is moving on to the next higher dosage group according to plan. The planning for an international phase III study with NeuroSTAT® will takeplace in parallel with the ongoing phase II study. NeuroVive intends to seek one or several cofinanciers for the study.
Enrolment for the investor initiated clinical phase II CiPRICS study at Skåne University Hospital in Sweden has begun and is proceeding as planned. Patients are being treated with CicloMulsion® or placebo before undergoing coronary bypass surgery with the aim of evaluating whether prior treatment with mitochondria-protecting drugs protects the kidneys against injury and compromised renal function, which result from altered blood supply during cardiac surgery.
NeuroVive's Asian operations are focusing on establishing a research and development platform in Asia and Asia-Pacific based on the company's international strategy. The operations include collaboration with Sihuan in China and Sanofi-Aventis Korea. The ToxPhos® technology platform will be marketed to the pharmaceutical industry and will be operated by the subsidiary in Taiwan.
Project overview
Business model
Revenues and results of operations
Revenues
The consolidated revenues during the second quarter of 2015 were SEK 2,502,000 (0). And other operating revenues for the second quarter of 2015 were SEK 377,000 (1,128,000). The revenues for the half year amounted to SEK 2,502,000 (0) includes the upfront payment in connection with signing NeuroVive Asia's collaboration agreement with Sanofi and the other operating revenues amounted to SEK 426,000 (1,171,000).
Results of operations
The operating loss for the second quarter was SEK -15,325,000 (-14,095,000) and for the half year SEK - 30,043,000 (-23,955,000). The net loss before tax in the second quarter was SEK -15,216,000 (- 13,690,000), and for the half year SEK -29,487,000 (-23,567,000).
The operating loss was affected by increased external expenses, which for the first six months were SEK - 32,971,000 (-25,126,000). Expenses related to development projects have affected the result with SEK - 8,022,000 (-4,830,000). These expenses relates to development projects that have not reached phase I. Personnel expenses rose to SEK -6,813,000 (-4,718,000) because of a higher number of employees than the corresponding period of the previous year, due to increased development work. The financial costs, SEK -90,000 (-138,000), relates to unrealized foreign exchange losses.
Financial position
The equity/assets ratio was 91 (93) % as of 30 June 2015, and equity was SEK 217,177 (127,571,000). Cash and cash equivalents amounted to SEK 138,049,000 (74,512,000) as of 30 June 2015, an increase of SEK 88,351,000 from the beginning of the year. The increase is due on the capital from the new share issues in NeuroVive AB and the external financing of the subsidiary in Asia. Total assets as of 30 June 2015 were SEK 238,470,000 (136,586,000).
Cash flow and investments
Operating cash flow for the second quarter was SEK -36,950,000 (-30,140,000). Operating cash flow from the second quarter was SEK -13,816,000 (-12,787,000) Consolidated cash flow was SEK 88,282,000 (34,457,000), where the positive cash flow is explained by the share issues of SEK 119,575,000 (76,599,000) and the external financing of the subsidiary in Asia. The cash flow effect due to investments in intangible assets was SEK -13,114,000 (12,039,000) for first half year of 2015.
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. 2015 | 1 Jan. 2014 |
|---|---|---|
| (SEK 000) | 30 Jun.2015 | 30 Jun.2014 |
| Stanbridge bvba (owned by Gregory Batcheller, Executive Chairman) | 802 | 916 |
| Ankor Consultants bvba (owned by Arne Ferstad, Board member) | 182 | 210 |
| Baulos Capital (owned by Fredrik Olsson, Board member) | - | 48 |
| Total transactions with related parties | 984 | 1 174 |
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 was 11 (8), of which 7 (4) are women.
Parent company
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. New share issues in the first quarter of 2015 secured the company's capital requirement for its next development activities. Except for the negative Top-line result of CIRCUS (study investigating CicloMulsion®), there have been no significant changes regarding risks or uncertainty factors during the current period.
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 2014 and the prospectus published 18th May 2015 for the rights issue in May 2015.
Incentive programs/share warrants Currently there is no incentive program.
Audit review
This Interim Report has not been subject to review by the company's auditor.
Upcoming financial statements
| 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
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 2014 on pages 52-56.
New and revised standards and interpretation statements applicable from 1 January 2015 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 Apr. 2015 | 1 Apr. 2014 | 1 Jan. 2015 | 1 Jan. 2014 | 1 Jan. 2014 |
|---|---|---|---|---|---|---|
| 30 Jun. 2015 | 30 Jun. 2014 | 30 Jun. 2015 | 30 Jun. 2014 | 31 Dec. 2014 | ||
| Net sales | 2 502 | - | 2 502 | 7 152 | ||
| Other operating income | 377 | 1 128 | 426 | 1 171 | 1 181 | |
| 2 879 | 1 128 | 2 928 | 8 333 | |||
| Operating expenses | ||||||
| Other external expenses | -14 235 | -12 354 | -24 985 | -20 071 | -41 962 | |
| Personnel cost | -3 510 | -2 592 | -6 813 | --- -4 718 |
-10 346 | |
| Depreciation and write-down of tangible | -195 | -345 | -441 | |||
| and intangible assets | -40 | -80 ---258 |
||||
| Other operating expenses | -263 | -238 | -828 | -258 | -838 | |
| -18 204 | -15 223 | -32 971 | -25 126 | -53 587 | ||
| -15 325 | -30 043 | -23 955 | -45 254 | |||
| Operating income | -14 095 | |||||
| Profit/loss from financial items | ||||||
| Financial income | 135 | 458 | 646 | 526 | 1 124 | |
| Financial costs | -26 | -53 | -90 | -1 -138 |
-544 | |
| 109 | 406 | 556 | 389 | 580 | ||
| Profit/loss before tax | -15 216 | -13 690 | -29 487 | -23 567 | -44 673 | |
| Income tax | 2 | - | - | - | - | |
| Profit/loss for the period | -15 216 | -13 690 | -29 487 | -23 567 | -44 673 | |
| Other comprehensive income | ||||||
| Items that may be reclassified to profit or | ||||||
| loss Translation differences on foreign |
||||||
| subsidiaries | 890 | -97 | 251 | -105 | -269 | |
| Total comprehensive income for the period | -14 326 | -13 786 | -29 236 | -23 671 | -44 942 | |
| Loss for the period attributable to: | ||||||
| Parent company shareholders | -15 623 | -13 225 | -29 634 | -22 790 | -42 549 | |
| Non-controlling interests | 407 | -465 | 147 | -777 | -2 124 | |
| -15 216 | -13 690 | -29 487 | -23 567 | -44 673 | ||
| Total comprehensive income for the period attributable to: |
||||||
| Parent company shareholders | -15 414 | -13 292 | -29 001 | -22 863 | -42 770 | |
| Non-controlling interests | 1 088 | -494 | -235 | -808 | -2 173 | |
| -14 326 | -13 786 | -29 236 | -23 671 | -44 942 | ||
| Earnings per share before and after dilution(SEK) based on average number of |
-0.54 | -0.69 | -1.02 | -0.93 | -1.53 | |
| shares |
Consolidated Statement of Financial Position
| (SEK 000) | Note | 30 Jun. 2015 | 30 Jun. 2014 | 31 Dec. 2014 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 1 | |||
| Development costs | 83 056 | 50 736 | 68 368 | |
| Patents | 14 336 | 9 689 | 11 146 | |
| Software | 116 | 127 | 87 | |
| 97 508 | 60 552 | 79 601 | ||
| Tangible assets | ||||
| Equipment | 410 | 328 | 344 | |
| 410 | 328 | 344 | ||
| Financial assets | ||||
| Other long-term receivables | 181 181 |
- | - | |
| - | - | |||
| Total non-current assets | 98 099 | 60 880 | 79 945 | |
| Current assets | ||||
| Other receivables | 1 619 | 716 | 1 123 | |
| Prepaid expenses and accrued income | 703 | 477 | 502 | |
| Cash and cash equivalents | 138 049 | 74 512 | 49 698 | |
| 140 371 | 75 706 | 51 323 | ||
| TOTAL ASSETS | 238 470 | 136 586 | 131 268 | |
| (SEK 000) | Note | 30 Jun. 2015 | 30 Jun. 2014 | 31 Dec. 2014 |
| EQUITY AND LIABILITIES | ||||
| Equity attributable to the shareholders of the parent company | ||||
| Share capital | 1 537 | 1 389 | 1 389 | |
| Additional paid in capital Translation reserve |
335 672 531 |
207 812 46 |
207 812 -102 |
|
| Retained earnings | -135 421 | -80 054 | -105 787 | |
| Total equity attributable to the shareholders of the parent | 202 317 | 129 193 | 103 312 | |
| company | ||||
| Non-controlling interests | 14 859 | -1 622 | 4 529 | |
| Total equity | 217 177 | 127 571 | 107 841 | |
| Short-term liabilities Accounts payable |
9 717 | 4 352 | 14 216 | |
| Other liabilities | 499 | 1 711 | 5 000 1 801 |
|
| Accrued expenses and deferred income | 11 077 | 2 952 | 7 410 | |
| 21 293 | 9 015 | 23 427 | ||
| Total liabilities | 21 293 | 9 015 | 23 427 | |
| TOTAL EQUITY AND LIABILITIES | 238 470 | 136 586 | 131 268 |
Consolidated Statement of Changes in Equity
Total number of shares at end of period: 30,735,152 (27,788,093).
| (SEK 000) | Equity attributable to the shareholders of the parent company | ||||||
|---|---|---|---|---|---|---|---|
| Additional | Total equity 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 2015 | 1 389 | 207 812 | -102 | -105 787 | 103 312 | 4 529 | 107 841 |
| Comprehensive profit/loss for the period | |||||||
| Profit/loss for the period | - | - | - | -29 634 | -29 634 | 147 | -29 487 |
| Other comprehensive income | |||||||
| Translation differences | - | - | 633 | - | 633 | -382 | 251 |
| Other comprehensive profit/loss for the period, net after tax |
- | - | 633 | - | 633 | -382 | 251 |
| Total comprehensive profit/loss | - | - | 633 | -29 634 | -29 001 | -235 | -29 236 |
| Transactions with shareholders | |||||||
| New share issue | 148 | 119 427 | - | - | 119 575 | - | 119 575 |
| Share issue with non-controlling interests | - | 8 433 | - | - | 8 433 | - 10 565 |
18 998 |
| in new share issue Total transactions with shareholders |
148 | 127 860 | - | - | 128 008 | 10 565 | 138 573 |
| Closing balance, 30 June 2015 | 1 537 | 335 672 | 531 | -135 421 | 202 319 | 14 859 | 217 178 |
| 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 | - | - | - | -22 790 | -22 790 | -777 | -23 567 |
| Other comprehensive income | |||||||
| Translation differences | - | - | -73 | - | -73 | -23 | -105 |
| Other comprehensive profit/loss for the | - | - | -73 | - | -73 | -23 | -105 |
| period, net after tax | |||||||
| Total comprehensive profit/loss | - | - | -73 | -22 790 | -22 862 | -809 | -23 671 |
| Transactions with shareholders | |||||||
| New share issue | 306 | 76 293 | - | - | 76 599 | - | 76 599 |
| Total transactions with shareholders | 306 | 76 293 | - | - | 76 599 | - | 76 599 |
| Closing balance, 30 June 2014 | 1 389 | 207 812 | 46 | -80 054 | 129 193 | -1 622 | 127 571 |
| Opening balance, 1 January 2014 | 1 083 | 131 519 | 118 | -80 054 | 129 193 | -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 | |||||||
| 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 | -42 549 | -42 769 | -2 173 | -44 942 |
| Transactions with shareholders | |||||||
| New share issue | 306 | 76 293 | - | - | 76 599 | - | 76 599 |
| Change of ownership in new share issue | - | - | - | -5 974 | -5 974 | 7 515 | 1 541 |
| Total transactions with shareholders | 306 | 76 293 | - | -5 974 | 70 625 | 7 515 | 78 140 |
| Closing balance, 31 Dec. 2014 | 1 389 | 207 812 | -102 | -105 787 | 103 312 | 4 529 | 107 841 |
*Total equity includes funds from the in January completed private placement with 65,000,000 SEK less expenses 4,787,000 SEK and the in May completed private placement with 70,000,000 less expenses 10,639,000.
Consolidated Statement of Cash Flows
| (SEK 000) | 1 Apr. 2015 | 1 Apr. 2014 | 1 Jan. 2015 | 1 Jan. 2014 | 1 Jan. 2014 |
|---|---|---|---|---|---|
| 30 Jun. 2015 | 30 Jun. 2014 | 30 Jun. 2015 | 30 Jun. 2014 | 31 Dec. 2014 | |
| Cash flow from operating activities | |||||
| Operating income | -15 325 | -14 095 | -30 043 | -23 955 | -45 254 |
| Adjustments for non-cash items: | |||||
| Depreciation | 195 | 40 | 345 | 80 | 441 |
| Currency differences on intercompany items | -305 | - | 218 | -278 | |
| 433 | |||||
| Interest received | 135 | 383 | 646 | -138 | 758 |
| Interest paid | -26 | -53 | -90 | -219 | |
| Net cash from operating activities | |||||
| before changes in working capital | -15 326 | -13 725 | -28 924 | -23 580 | -44 552 |
| Changes in working capital | |||||
| Increase/decrease of other current assets | -376 | -1 034 | -873 | 508 | -16 |
| Increase/decrease of other short-term liabilities | 1 886 | -96 | -7 153 | -7 068 | 936 |
| Changes in working capital | 1 510 | -938 | -8 026 | -6 560 | 920 |
| Cash flow from operating activities | -13 816 | -12 787 | -36 950 | -30 140 | -43 633 |
| Investing activities | |||||
| Acquisition of tangible assets | 13 | 37 | -227 | 37 | -178 |
| Acquisition of intangible assets | -12 906 | -9 906 | -13 114 | -12 039 | -23 251 |
| Cash flow from investing activities | -12 894 | -9 869 | -13 342 | -12 002 | -23 429 |
| Financing activities | |||||
| Share issue minority | -571 | - | 18 998 | - | |
| New share issue | 59 363 | 119 576 | 76 599 | 76 599 | |
| Cash flow from financing activities | 58 792 | 138 574 | 76 599 | 76 599 | |
| Cash flow for the period | 32 082 | -22 656 | 88 282 | 34 457 | 9 537 |
| Cash and cash equivalents at the beginning of the period |
104 735 | 97 097 | 49 698 | 39 992 + |
39 992 |
| Effect of exchange rate changes on cash | 1 232 | 71 | 69 | 63 | 169 |
| Cash and cash equivalents at end of period | 138 049 | 74 512 | 138 049 | 74 512 | 49 698 |
Parent Company Income Statement
| (SEK 000) | Note | 1 Apr. 2015 | 1 Apr. 2014 | 1 Jan. 2015 | 1 Jan. 2014 | 1 Jan. 2014 |
|---|---|---|---|---|---|---|
| 30 Jun. 2015 | 30 Jun. 2014 | 30 Jun. 2015 | 30 Jun. 2014 | 31 Dec. 2014 | ||
| Net sales | - | 372 | - | 372 | 7 546 | |
| Other operating income | 377 | 1 128 | 426 | 1 171 | 29 125 | |
| 377 | 1 500 | 426 | 1 543 | 36 671 | ||
| Operating expenses | ||||||
| Other external expenses | -13 709 | -11 206 | -23 585 | -17 953 | -35 383 | |
| Personnel cost | -3 150 | -2 592 | -5 980 | -4 718 | -10 346 | |
| Depreciation and write-down of tangible and | -172 | -40 | -308 | -441 | ||
| intangible assets | -80 | |||||
| Other operating expenses | -363 | -239 | -828 | - -259 |
-816 | |
| -17 394 | -14 077 | -30 702 | -259 -23 010 |
-46 986 | ||
| Operating income | -17 018 | -12 577 | -30 276 | -21 467 | -10 315 | |
| Profit/loss from financial items | ||||||
| Interest income and other similar profit items | 235 | 495 | 566 | 598 | 1 047 | |
| Interest expenses and other similar loss items | 35 | -57 | -17 | -108 | -376 | |
| 270 | 438 | 548 | 490 | 671 | ||
| Profit/loss before tax | -16 748 | -12 139 | -29 727 | -20 977 | -9 644 | |
| Income tax | 2 | - | - | - | - | - |
| Profit/loss for the period | -16 748 | -12 139 | -29 727 | -20 977 | -9 644 |
Statement of Comprehensive Income, Parent Company
| (SEK 000) Note |
1 Jan. 2015 30 Jun. 2015 |
1 Jan. 2014 30 Jun. |
1 Jan. 2015 30 Jun. 2015 |
1 Jan. 2014 30 Jun. 2014 |
1 Jan. 2014 31 Dec. 2014 |
|---|---|---|---|---|---|
| Profit/loss for the period Other comprehensive income |
-16 748 - |
2014 -12 139 - |
-29 727 - |
-20 977 - |
-9 644 - |
| Total comprehensive profit/loss for the | -16 748 | -12 139 | -29 727 | -20 977 | -9 644 |
Parent Company Balance Sheet
| (SEK 000) | Note | 30 Jun. 2015 | 30 Jun. 2014 | 31 Dec 2014 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 1 | |||
| Development costs | 82 821 | 50 736 | 68 133 | |
| Patents | 14 336 | 9 689 | 11 146 | |
| Software | 47 | 127 | 87 | |
| 97 204 | 60 552 | 79 366 | ||
| Tangible assets | ||||
| Equipment | 302 | 328 | 212 | |
| 302 | 328 | 212 | ||
| Financial assets | ||||
| Other lpng-term placement | 1 | - | - | |
| Shares in subsidiaries | 3 | 41 750 | 6 | 33 618 |
| 41 751 | 6 | 33 618 | ||
| Total non-current assets | 139 257 | 60 886 | 113 196 | |
| Current assets | ||||
| Short term receivables | ||||
| Receivables from group companies | 2 157 | 5 201 | 2 195 | |
| Other receivables | 1 592 | 714 | 1 067 | |
| Prepaid expenses and accrued income | 702 | 294 | 498 | |
| 4 473 | 6 209 | 3 760 | ||
| Cash and bank balances | 111 113 | 73 580 | 48 842 | |
| Total current assets | 115 586 | 79 789 | 52 602 | |
| TOTAL ASSETS | 254 844 | 140 675 | 165 798 | |
| (SEK 000) | Note | 30 Jun. 2015 | 30 Jun. 2014 | 31 Dec 2014 |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | ||||
| Share capital | 1 537 | 1 389 | 1 389 | |
| Statutory reserve | 1 856 | 1 856 | 1 856 | |
| 3 393 | 3 245 | 3 245 | ||
| Unrestricted equity | ||||
| Share premium reserve | 195 720 | 76 293 | 76 293 | |
| Retained earnings | 64 777 | 74 423 | 74 422 | |
| Profit/loss for the period | -29 727 | -20 977 | -9 644 | |
| 230 769 | 129 739 | 141 071 | ||
| Total equity | 234 162 | 132 984 | 144 316 | |
| Short-term liabilities | ||||
| Accounts payable | 9 100 | 4 352 | 13 823 | |
| Liabilities to group companies | 6 | 6 | 6 | |
| Other liabilities | 498 | 381 | 243 | |
| Accrued expenses and deferred income | 11 077 | 2 952 | 7 410 | |
| 20 681 | 7 691 | 21 482 | ||
| 254 844 | 140 675 | 165 798 | ||
| TOTAL EQUITY AND LIABILITIES | ||||
| PLEDGE AND CONTINGENT LIABILITIES | 30 Jun. 2015 | 30 Jun. 2014 | 31 Dec 2014 | |
| Pledge assets | None | None | None | |
| Contingent liabilities | None | None | None |
Note 1 — Intangible assets
| (SEK 000) | Development costs | Patents* | Software | Total |
|---|---|---|---|---|
| ACCUMULATED COST | ||||
| Opening balance 1 Jan. 2015 | 68 368 | 15 111 | 400 | 83 879 |
| Additions | 14 688 | 3 443 | 69 | 18 200 |
| Closing balance 30 Jun. 2015 | 83 056 | 18 554 | 469 | 102 079 |
| ACCUMULATED DEPRECIATION | ||||
| Opening balance 1 Jan. 2015 | - | -3 965 | -313 | -4 278 |
| Depreciation for the period | - | -253 | -40 | -293 |
| Closing balance 31 Mar. 2015 | - | -4 218 | -353 | -4 571 |
| Residual value 31 Mar. 2015 | 83 056 | 14 336 | 116 | 97 508 |
| (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 |
| Government grants | 68 368 | 15 111 | 400 | 83 879 |
| Closing balance 31 Dec. 2014 | ||||
| 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 |
* 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, 45% is for NeuroSTAT, 52 % is for CicloMulsion, 1 % is for NVP014.
Note 2 – Tax
The group's total loss carry-forwards amount to SEK 169,990,000 as of 30 June 2015 (91,032,000). The parent company's total loss carry-forwards amount to SEK 132,558,000 as of 30 June 2015 (87,413,000). 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 71,37% 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. In April the subsidiary NeuroVive Pharamceutical SARL, domiciled in France was included and is owned 100% by NeuroVive Pharmaceutical AB.
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
Helena Levander Anna Malm Bernsten Board member Board member
Helmuth von Moltke Fredrik Olsson Board member Board member
Mikael Brönnegård Chief Executive Officer
Lund, Sweden, August 19, 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