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Abliva Interim / Quarterly Report 2013

May 24, 2013

3131_10-q_2013-05-24_7f945af5-c680-446a-ad30-97568ca15330.pdf

Interim / Quarterly Report

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INTERIM REPORT

1 Jan. 2013 till 31 Mar. 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.

NeuroVive Pharmaceutical AB (publ) I Corporate ID no. 556595-6538 I www.neurovive.se I [email protected]

The listing on Nasdaq OMX creates possibilities for the future

"After NeuroVive's IPO on NASDAQ OMX Stockholm Small Cap in April, the company has secured prospects for its continued work in its priority business segments relating to CicloMulsion® and NeuroSTAT® ." CEO Mikael Brönnegård

First quarter (1 Jan. 2013 - 31 Mar. 2013)

  • Net sales were SEK 0 (0) and other operating income was SEK 704,000 (9,000).
  • The loss before tax was SEK -4,739,000 (-2,815,000).
  • Earnings per share* were SEK -0.24 (-0.18).
  • Diluted earnings per share** were SEK -0.24 (-0.18).

* 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 first quarter of 2013

  • In March, NeuroVive acquired a portfolio of new cyclophilin inhibitors and the associated intellectual property from UK biotech enterprise Biotica Ltd. The purchase of these assets is a significant strategic step because it extends and deepens NeuroVive's proprietary product portfolio of new mitochondrial pharmaceuticals. These new cyclophilin inhibitors are expected to serve as the basis of an upcoming generation of the company's products addressing a broad spectrum of diseases including cardio and neuroprotection.
  • On 22 March, NeuroVive reported that over 600 patients had been enrolled in the clinical phase III multi-center trial (CIRCUS), which is evaluating the effects of CicloMulsion® on treating reperfusion injury after stenting coincident with myocardial infarction.
  • Nasdaq OMX's Listing Committee approved NeuroVive's application for a listing on Nasdaq OMX Stockholm Small Cap on 22 March.

Post balance sheet events

  • On 10 April, NeuroVive was listed on Nasdaq OMX Stockholm Small Cap, with the stock symbol NVP.
  • The previously reported arbitration procedure with CicloMulsion AG has been registered with the designated arbitration tribunal.

Comments from our CEO, Mikael Brönnegård

NeuroVive is continuing its intensive efforts to produce pharmaceuticals for patients in a segment with a growing medicinal need. The development of pharmaceuticals that can protect heart and brain cells after acute conditions such as myocardial infarction, stroke and traumatic brain damage is an increasing priority for the pharmaceutical industry, with a growing focus being put on mitochondrial function in health and disease. Cardiovascular disease and acute brain damage not only affect elderly people, but also those of an active and productive age. The current focus of NeuroVive's operations is to complete the current European phase III trial on CicloMulsion® , which has enrolled over 700 patients to date, and to intensify patient enrollment in the recently commenced phased IIa trial on NeuroSTAT® being conducted at Rigshospitalet (the National Hospital) in Copenhagen.

By producing candidate drugs (CDs) for energy regulation and by acquiring new, potent cyclophilin inhibitors from Biotica Ltd already in the preclinical phase, NeuroVive has created promising prospects to maintain strong positioning in mitochondrial medicine. The energy regulation CDs will serve as a foundation for the future treatment of genetic defects that directly affect mitochondrial function resulting in compromised energy production. These new cyclophilin inhibitors are an all-new class of molecules defined as secondgeneration cyclophilin inhibitors after CsA for treating mitochondrial damage arising after acute heart and brain damage. The benefits of these new cyclophilin inhibitors is their more potent efficacy against mitochondrial dysfunction in preclinical trials, and that they also have very long-term patent protection.

Our collaboration with Sihuan in China is continuing as planned, and we hope to be able to commence a heart trial, complementary to the ongoing European phase III trial on CicloMulsion® . Moreover, the plan in time is to extend the collaboration with Sihuan, and after NeuroVive's and Sihuan's R&D teams met in Jinan, China in mid-March this year, a number of promising partnership projects were identified. Additionally, interest in NeuroVive's products has increased in the Asian region after the agreement with Sihuan became public knowledge.

Our collaboration with Dutch company to-BBB has entered a phase in which various formulations of NVP014 are being trialed in preclinical stroke treatment models. The aim is to obtain the maximum nerve cell protection effect after suffering a stroke. The big challenge when developing CDs for stroke treatment is to ensure the compound penetrates the blood-brain barrier so the desired effect is achieved in the brain. Utilizing to-BBB's technology and optimized formulation, NeuroVive hopes that NVP014 will have the desired effect on brain damage after a stroke.

After NeuroVive's IPO on NASDAQ OMX Stockholm Small Cap in April, the company has secured prospects for its continued work in its priority business segments relating to CicloMulsion® and NeuroSTAT® .

Mikael Brönnegård

CEO, NeuroVive Pharmaceutical AB (publ)

NeuroVive

Operations

NeuroVive conducts research and development into pharmaceuticals that protect the mitochondria. Its drug development technology platform consists of versions of cyclosporine, as well as molecules with similar structures that together constitute a new class of pharmaceuticals called cyclophilin inhibitors. Its product portfolio also includes CDs for cellular energy regulation.

Cyclosporin-A is the active compound in CicloMulsion® /NeuroSTAT® (a CD with different names and application segments) and has been on the market as a pharmaceutical compound for nearly 30 years. There is extensive safety data available on the active compound.

Project overview
Candidate drugs Indication/purpose Status
CicloMulsion® Reperfusion injury in myocardial
infarction
Ongoing clinical external phase III trial in
the EU
Planning phase III trial in China
commenced
NeuroSTAT® Traumatic brain injury Clinical phase I trial complete
Clinical phase II trial approved for
commencement
Planning of international phase III trial (EU,
US and China) commenced
NVP014 Stroke Preclinical phase
NVP015 Energy regulation in mitochondria Preclinical phase
Second and third
generation of
NICAM
NCCIM
*
Preclinical evaluation phase

cyclophilin inhibitors

* Non Immunosuppressive Cyclosporin Analogue Molecules (non-immunosuppressive compounds).

** Non Cyclosporine Cyclophilin Inhibiting Molecules (non-cyclosporine-based compounds).

NeuroVive has been granted orphan drug designation for NeuroSTAT® for moderate and severe cranial injury in the US and EU, which means market exclusivity after marketing authorization, even if patents no longer apply. The special designation grants exclusivity for seven (7) years in the US and ten (10) years in the EU, from the date NeuroVive is granted marketing authorization. In itself, the designation does not mean that the CD has demonstrated the efficacy, safety and quality necessary for pharmaceutical registration in the US or Europe. These criteria must be satisfied in the pharmaceutical and clinical phases that regulatory authorities subsequently approve before granting marketing authorization for the pharmaceutical.

Business model

NeuroVive's management is evaluating various types of innovative collaboration with large pharmaceutical companies and/or contract research organization (CRO) partners with the intention of creating a reduced-risk and cost-efficient business model, where NeuroVive can exploit established promotion channels with selected partners to build future business segments such as the marketing and sale of future pharmaceuticals. The business model of strategic alliances with trade partners also enables various forms of direct investment in NeuroVive as a component of funding phase III trials and future straightforward marketing and sales activities. NeuroVive also intends to outlicense pharmaceuticals to large pharmaceutical companies for registration, marketing and sale. The company's revenue can consist of fixed fees from outlicensing, milestone payments on the way to launch, as well as ongoing royalty income based on the sale of outlicensed 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 CDs for traumatic brain damage, and the company's other priority indications, to market. This mitigates the risk of long development cycles for new pharmaceuticals.

Revenue and results of operations

Revenue

The companys other operating income of SEK 704,000 (9,000) for the first quarter, consists mainly of EU subsidies received from Vinnova. The company has not yet started to generate revenues.

Profit/loss

The company's operating loss for the first quarter was SEK -4,863,000 (-2,856,000).

The operating loss was affected by increased external expenses of SEK -4,115,000 (-2,057,000). The main reason for the increased cost is connected to the listing on Nasdaq OMX Stockholm as well as increased consultancy costs due to intensified activities in the development projects. Personnel expenses also increased, SEK -1,333,000 (-762,000), which relates to the increased number of employees compared to the corresponding period last year.

The loss for the period before tax was SEK -4,739,000 (-2,815,000).

Financial position

The equity/assets ratio 88% (88) as of 31 March 2013 and equity was SEK 58,430,000 (63,043,000) compared to the beginning of the year. Cash and cash equivalents were SEK 27,719,000 (37,177,000) as of 31 March 2013, implying a change of SEK -9,458,000 compared to the beginning of the year. Total assets as of 31 March 2013 were SEK 66,400,000 (71,506,000) compared to the beginning of the year.

Cash flow and investments

Consolidated cash flow for the first quarter was SEK -9,458,000 (-2,834,000) where the cash flow decreased with SEK -6,624,000 which mainly relates to investments in immaterial assets, SEK 4,463,000 (-1,419,000), i.e. product development and clinical trials as well as the extraordinary payment in connection with the acquisition of the new cyclophilin inhibitors from Biotica Ltd. Cash flow was also affected by the increased operating loss SEK -4,863,000 (-2,856,000).

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) 31 Mar. 2013 31 Mar. 2012
Stanbridge bvba (owned by Gregory Batcheller, Executive Chairman) 360 197
Jan Nilsson Konsult (owned by Jan Nilsson, COO, former Board member) 46 25
Ankor Consultants bvba (owned by Arne Ferstad, Board member) 101 42
Total transactions with related bodies 507 264

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 March was 6 (3), of which 2 (1) are women.

Parent company

Most of the group's 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 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. For more detail on these items, 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.

Audit review

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

Upcoming financial statements

  • Semi-annual Report 23 August 2013
  • Interim Report 3 22 November 2013

Year-end Report for 2013 21 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 Jan. 2013 1 Jan. 2012
31 Mar. 2013 31 Mar. 2012
Net sales - -
Other operating income 704 9
704 9
Operating expenses
Other external expenses
-4 115 -2 057
Personnel cost -1 333 -762
Depreciation and write-down of tangible
and intangible assets -38 -26
Other operating expenses -81 -20
-5 567 -2 865
Operating income -4 863 -2 856
Profit/loss from financial items
Financial income 137 41
Financial costs -13 -
124 41
Profit/loss before tax -4 739 -2 815
Income tax 2 - -
Profit/loss for the period -4 739 -2 815
Other comprehensive income
Items that may be reclassified to profit or
loss
Translation differences on foreign
subsidiaries 126 2
Total comprehensive income for the period -4 613 -2 813
Loss for the period attributable to:
Parent company shareholders
Non-controlling interests
-4 526
-213
-2 619
-196
-4 739 -2 815
Total comprehensive income for the period
attributable to:
Parent company shareholders -4 438 -2 617
Non-controlling interests -175 -196
-4 613 -2 813
Earnings per share before and after
dilution(SEK) based on average number of
shares -0,24 -0,18

Consolidated Statement of Financial Position

(SEK 000) Note 31 Mar. 2013 31 Mar. 2012 31 Dec. 2012
ASSETS
Non-current assets
Intangible assets 1
Development costs 32 427 19 224 30 042
Patents 4 867 2 679 2 416
Software 227 307 247
37 521 22 210 32 705
Tangible assets
Equipment 595 157 665
595 157 665
Total non-current assets 38 116 22 367 33 370
Current assets
Other receivables 263 600 734
Prepaid expenses and accrued income 302 135 225
Cash and cash equivalents 27 719 9 961 37 177
28 284 10 696 38 136
TOTAL ASSETS 66 400 33 063 71 506
(SEK 000) Note 31 Mar. 2013 31 Mar. 2012 31 Dec. 2012
EQUITY AND LIABILITIES
Equity attributable to the shareholders of the parent company
Share capital 958 747 958
Additional paid in capital 98 049 51 938 98 049
Translation reserve 89 2 27
Retained earnings -39 433 -22 679 -34 933
Total equity attributable to the shareholders of the parent
company 59 663 30 008 64 101
Non-controlling interests -1 233 -236 -1 058
Total equity 58 430 29 772 63 043
Long-term liabilities
Deferred tax liabilities - - -
- - -
Short-term liabilities
Accounts payable 3 294 1 519 4 724
Other liabilities 1 215 306 1 103
Accrued expenses and deferred income 3 461 1 466 2 636
7 970 3 291 8 463
Total liabilities 7 970 3 291 8 463
TOTAL EQUITY AND LIABILITIES 66 400 33 063 71 506

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
Additional Total equity
attributable to the
Share paid-in Translation Retained shareholders of the Non-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 - - - -4 526 -4 526 -213 -4 739
Other comprehensive income
Translation differences - - 62 26 88 38 126
Other comprehensive profit/loss for the
period, net after tax - - 62 26 88 38 126
Total comprehensive profit/loss - - 62 -4 500 -4 438 -175 -4 613
Transactions with shareholders
New share issue - - - - - - -
Total transactions with shareholders - - - - - - -
Closing balance, 31 March 2013 958 98 049 89 -39 433 59 663 1 233 58 430
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 - - - -2 619 -2 619 -196 -2 815
Other comprehensive income
Translation differences - - 2 - 2 - 2
Other comprehensive profit/loss for the
period, net after tax - - 2 - 2 - 2
Total comprehensive profit/loss - - 2 -2 619 -2 617 -196 -2 813
Transactions with shareholders
New share issue - - - - - - -
Total transactions with shareholders - - - - - - -
Closing balance, 31 March 2012 747 51 938 2 -22 679 30 008 -236 29 772
Opening balance, 1 April 2012 747 51 938 2 -22 679 30 008 -236 29 772
Comprehensive profit/loss for the period
Profit/loss for the period - - - -12 254 -12 254 -834 -13 088
Other comprehensive income
Translation differences - - 25 - 25 12 37
Other comprehensive profit/loss for the
period, net after tax
- - 25 - 25 12 37
Total comprehensive profit/loss - - 25 -12 254 -12 229 -822 -13 051
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, 31 December 2012 958 98 049 27 -34 933 64 101 -1 058 63 043

Consolidated Statement of Cash Flows

(SEK 000) 1 Jan. 1 Jan. 2012
2013
31 Mar.
31 Mar. 2012
Cash flow from operating activities 2013
Operating income -4 863 -2 856
Adjustments for non-cash items:
Depreciation 38 26
Currency differences on intercompany items 98 -
Interest received 148 41
Interest paid -13 -
Net cash from operating activities
before changes in working capital -4 592 -2 789
Changes in working capital
Increase/decrease of other current assets 383 -234
Increase/decrease of other short-term liabilities -786 1634
Changes in working capital -403 1 400
Cash flow from operating activities -4 995 -1 389
Investing activities
Acquisition of tangible assets - -26
Acquisition of intangible assets -4 463 -1 419
Cash flow from investing activities -4 463 -1 445
Financing activities
New share issue - -
Cash flow from financing activities - -
Cash flow for the period -9 458 -2 834
Cash and cash equivalents at the beginning of the period 37 177 12 795
Cash and cash equivalents at end of period 27 719 9 961

Parent Company Income Statement

(SEK 000) Note 1 Jan. 2013 1 Jan. 2012
31 Mar. 2013 31 Mar. 2012
Net sales - -
Other operating income 704 9
704 9
Operating expenses
Other external expenses -3 442 -1 403
Personnel cost -1 333 -762
Depreciation and write-down of tangible and
intangible assets -38 -26
Other operating expenses -81 -20
-4 894 -2 211
Operating income -4 190 -2 202
Profit/loss from financial items
Interest income and other similar profit items 162 41
Interest expenses and other similar loss items -2 -1
160 40
Profit/loss before tax -4 030 -2 162
Income tax 2 - -
Profit/loss for the period -4 030 -2 162

Statement of Comprehensive Income, Parent Company

(SEK 000) Note 1 Jan. 2013 1 Jan. 2012
31 Mar. 2013 31 Mar. 2012
Profit/loss for the period -4 030 -2 162
Other comprehensive income - -
Total comprehensive profit/loss for the period -4 030 -2 162

Parent Company Balance Sheet

(SEK 000) Note 31 Mar. 2013 31 Mar. 2012 31 Dec. 2012
ASSETS
Non-current assets
Intangible assets 1
Development costs 32 427 19 224 30 042
Patents 4 867 2 679 2 416
Software 227 307 247
37 521 22 210 32 705
Tangible assets
Equipment 596 157 665
596 157 665
Financial assets
Shares in subsidiaries 3 6 6 6
6 6 6
Total non-current assets 38 123 22 373 33 376
Current assets
Short term receivables
Receivables from group companies 3 133 556 2 716
Other receivables 260 596 732
Prepaid expenses and accrued income 282 136 225
3 675 1 288 3 673
Cash and bank balances 27 717 9 961 37 177
Total current assets 31 392 11 249 40 850
TOTAL ASSETS 69 515 33 622 74 226
(SEK 000) Note 31 Mar. 2013 31 Mar. 2012 31 Dec. 2012
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 958 747 958
Statutory reserve 1 856 1 856 1 856
2 814 2 603 2 814
Unrestricted equity
Share premium reserve
Retained earnings
-
63 761
-
30 122
46 111
30 122
Profit/loss for the period -4 030 -2 162 -12 471
59 731 27 960 63 762
Total equity 62 545 30 563 66 576
Provision
Deferred tax liabilities -
-
-
-
-
-
Short-term liabilities
Accounts payable 3 294 1 519 4 724
Liabilities to group companies 6 6 6
Other liabilities 209 68 284
Accrued expenses and deferred income 3 461 1 466 2 636
6 970 3 059 7 650

Note 1—Intangible assets

(SEK 000) Development costs Patents* Software Total
ACCUMULATED COST
Opening balance 1 Jan. 2013 30 042 4 724 400 35 166
Additions 2 385 2 661 - 5 046
Closing balance 31 Mar. 2013 32 427 7 385 400 40 212
ACCUMULATED DEPRECIATION
Opening balance 1 Jan. 2013 - -2 308 -153 -2 461
Depreciation for the period - -210 -20 -230
Closing balance 31 Mar. 2013 - -2 518 -173 -2 691
Residual value 31 Mar. 2013 32 427 4 867 227 37 521
(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
Residual value 31 Dec. 2012 30 042 2 416 247 32 705

* 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, 63% is for NeuroSTAT, 35% is for CicloMulsion, 2% is for NVP014.

Note 2—Tax

The group's total loss carry-forwards amount to SEK 53,870,000 as of 31 March 2013 (49,559,000 31 December 2012). The parent company's total loss carry-forwards amount to SEK 49,942,000 as of 31 March 2013 (46,127,000 31 December 2012). 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 70% in Hong Kong-registered subsidiary Neuroive Pharmaceutical Asia Ltd., which was incorporated in December 2011.

MITOCHONDRIAL MEDICINE

NeuroVive Pharmaceutical AB (publ) Corporate identity number: 556595-6538

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

Helmut von Moltke Board member

Mikael Brönnegård Chief Executive Officer

Lund, Sweden, 24 May 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, please contact:

Mikael Brönnegård, CEO

Telephone: +46 (0)46 275 6220 (switchboard) Email: [email protected] Website: www.neurovive.se Address: Medicon Village, Scheelevägen 2, 223 81 Lund, Sweden