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Abliva — Interim / Quarterly Report 2016
Nov 22, 2016
3131_10-q_2016-11-22_6f3b6ab9-b875-4863-bab8-e4e29f277007.pdf
Interim / Quarterly Report
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New business model generates opportunities
Business operations
Important events July-September 2016
- NeuroVive completed a 10 percent partial acquisition of its business partner, Isomerase Therapeutics
- NeuroVive received a request to terminate the Company's license agreement with Arbutus Biopharma
- NeuroVive's strategy for the treatment of mitochondrial disease was published in Nature Communications
Important events after the end of the period
- The development of CicloMulsion for acute kidney injury was discontinued and as a consequence the value of the subsidiary NeuroVive Asia has been written-down by 50 percent and all previously capitalized expenditure in connection with CicloMulsion has been recognized as an impaired value in the interim report for the third quarter
- New business model encompassing out-licensing of projects for common indications, as well as proprietary development of orphan indication projects, was communicated
- Positive preclinical results obtained in an experimental model for non-alcoholic steatohepatitis (NASH), a very serious and common disease for which no medication is currently available
- In a termination agreement, all rights for NVP018 were returned to NeuroVive from Arbutus Biopharma. NeuroVive also received material manufactured by Arbutus valued at USD 1.5 million
Financial information
Third quarter (July – September 2016)
- Net revenues were SEK 0 (0) and other operating income was SEK 16,000 (74,000)
- Loss before tax was SEK 34,290,000 (53,948,000), for further information see page 6
- Loss per share* was SEK 0.86 (1.75)
- Diluted loss per share** was SEK 0.86 (1.75)
First nine months of the year (January-September 2016)
- Net revenues were SEK 0 (2,502,000) and other operating income was SEK 90,000 (499,000)
- Loss before tax was SEK 57,265,000 (83,435,000), for further information see page 6
- Loss per share* was SEK 1.42 (2.78)
- Diluted loss per share** was SEK 1.42 (2.78)
* 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.
Comments from our CEO, Erik Kinnman
The CiPRICS Phase II clinical trial, although well conducted, showed that patients treated with CicloMulsion during open heart surgery had no benefit from the treatment in the prevention of acute kidney injury (AKI). The Company will therefore discontinue its development of CicloMulsion. At the same time, after the end of the period, we reported positive results in the NASH project and presented our new business model.
Key lessons from the CiPRICS Phase II trial
CiPRICS was conducted in an exemplary manner by a team led by Associate Professor Henrik Bjursten at Skåne University Hospital and we are very satisfied with this rewarding collaboration. The trial confirmed the effectiveness of how NeuroVive works with partners, using a network model for early-phase clinical research projects, and provides a solid basis for future work. However, the unambiguous results of the trial showed that CicloMulsion does not protect against acute kidney injury (AKI) during heart surgery when a heart-lung machine is used.
Nature – a seal of quality for NVP015
During the period, the NVP015 project in which acute treatment of energy crisis in patients with genetic mitochondrial disease is developed, attracted attention due to a publication in Nature Communications, one of the world's most prestigious interdisciplinary scientific journals. A publication in Nature requires the highest quality research and is proof that we are on the forefront of mitochondrial medicine. The journal reaches many authorities in the field, and the publication enables us to attract and link up with other experienced and knowledgeable people in the field.
NVP018 - rights regained and valuable materials
After the end of the period, we could announce that we have regained all rights to the compound in the NVP018 project from our previous business partner Arbutus Biopharma, which is very pleasing. Our interactions with Arbutus were positive, and we have learnt useful lessons from the various preclinical development activities. The manufactured product itself is very valuable and saves us time in our projects as we see several possible development options for NVP018.
Isomerase a strong partner
In partnership with Isomerase, we have been able to advance our prioritized NVP018 and NVP015 development programs efficiently and to generate new compounds that are currently being evaluated in experimental models. In mid-August, we completed the second stage of the previously communicated partial acquisition of Isomerase Therapeutics Ltd, a UK-based research and development company. NeuroVive now owns about 10% of the shares in Isomerase.
Positive results from preclinical NASH trial
NVP018 has demonstrated positive effects on fibrosis development in an experimental model for NASH (non-alcoholic steatohepatitis). This indication holds huge potential commercial value, and if further preclinical development confirms these findings, we will be able to initiate out-licensing discussions by the second half of 2017.
New business model creates opportunities
The NASH project is in line with the Company's new business model, involving a broader and accelerated focus on discovery projects with high commercial potential, where the goal is to out-license at the preclinical phase. At the same time, the Company will focus on proprietary orphan drug projects all the way to marketing approval. Overall, this means that we have several projects in our portfolio that can both create value and provide future revenue streams and at the same time we are spreading risks. Recent events, including the termination of a clinical project and the regaining of our rights to another, are enabling NeuroVive to strengthen its focus and build value in these early-phase projects. We are happy to announce the recruitment of Dr Michele Tavecchio, who has joined our research team this autumn. His expertise in the field of cyclophilin D and related metabolic effects will suit NeuroVive's project portfolio perfectly.
Erik Kinnman CEO, NeuroVive Pharmaceutical AB 22 November 2016
Operations
NeuroVive is focused on the research and development of targeted drug candidates that maintain mitochondrial integrity and function for indications with a high unmet medical need. NeuroVive creates value in projects by working in partnerships and by networking with leading research institutions in mitochondrial medicine as well as experts with resources in drug development and manufacturing. The drug development process is comprehensive and carefully regulated, and NeuroVive strives to make this process as cost-effective as possible by collaborating with various partners.
Business model focused on orphan drugs and the out-licensing of early-phase projects
After the end of the reporting period, the Company announced its implementation of a business model that will comprise two components. The first component consists of projects for large indications with high commercial potential, such as NASH, for out-licensing in the preclinical phase. The other component comprises proprietary drug development for rare diseases with a major unmet medical need where the company intends to develop the projects through clinical development up until marketing authorization. NeuroVive maintains its research and development focus in mitochondrial medicine with the aim of helping patients for whom there are few or no treatment options currently available.
Project portfolio
Kidney protection during major surgery (AKI)
The outcome of the CiPRICS exploratory Phase II clinical trial was presented after the end of the reporting period. The results demonstrated that patients treated with CicloMulsion before open heart surgery did not benefit from the treatment, compared with a placebo, to prevent acute kidney injury (AKI). The CiPRICS trial did not, therefore, reach its primary endpoint. Patients in the active dosage group exhibited a transient, but statistically significant increase of the cystatin C and P-creatinine biomarkers compared with placebo. Due to the unambiguous results, the Company decided to discontinue further development of CicloMulsion.
Moderate to severe traumatic brain injury (TBI)
In collaboration with the University of Pennsylvania (PENN), NeuroVive is evaluating the preventative effect of NeuroSTAT in an experimental TBI model. The first two of three sub-studies have been successfully carried out and completed. Positive results from the second sub-study demonstrate that NeuroSTAT crosses the blood-brain barrier and concentration levels in blood and the brain. The third and final sub-study where the effect of NeuroSTAT is evaluated in a TBI model, will be conducted at the end of the year and in early 2017.
In combination, these preclinical studies will show how NeuroSTAT works in the treatment of TBI. These results will form the basis for decisions regarding the continuation of the clinical development. Positive results will be used to supplement the ongoing CHIC (Copenhagen Head Injury Ciclosporin) Phase II clinical trial, in which NeuroSTAT is being assessed in conjunction with the clinical treatment of patients. Project costs for the continued clinical development of
A leader in mitochondrial medicine 3
NeuroVive Pharmaceutical AB (publ) – Interim Report January – September 2016. Corp. Reg. No. 556595-6538.
NeuroSTAT will only be financed by applying for grants from major international institutions or, alternatively, via commercial partners.
At the end of the second quarter, CHIC had recruited 16 patients. Based on the current rate of recruitment, the trial is expected to be fully enrolled by the first quarter of 2017 and the results are estimated to be available in the second quarter of 2017. The primary goal of the CHIC trial is to assess the safety and pharmacokinetics of NeuroSTAT in the blood and cerebrospinal fluid of patients with severe traumatic brain injury (TBI) based on two different dosage levels. Secondarily, exploratory measurements will be carried out to study both the efficacy of NeuroSTAT at the mitochondrial level, and how NeuroSTAT affects various biochemical processes following a brain injury. More information about the trial is available in the public database ClinicalTrials.gov.
Traumatic brain injury (TBI) is caused by external violence to the head resulting in immediate damage to nerve cells. The damage continues to worsen for several days following the injury, which often contributes substantially to the damage from the initial injury. At present, there are no approved treatments for the prevention of these secondary injuries. In the US, some 2.2 million people are affected annually, causing more than 50,000 deaths and 280,000 hospitalizations. The direct and indirect costs associated with TBI are an estimated USD 60 billion, and a large number of patients suffer moderate to severe functional disabilities requiring intensive care and various forms of support (www.nih.gov). The hope is that better preventive therapies for secondary brain damage, such as NeuroSTAT, will lead to higher survival rates, and significantly improve quality of life and neurological function of patients post-TBI.
Mitochondrial respiratory chain disorders (MRCD)
The results of the NVP015 research program into the new pharmacological strategy for the treatment of mitochondrial disease were published in August 2016 in Nature Communications, the third highest-ranked multidisciplinary science journal in the world. The project was conducted by NeuroVive in partnership with Lund University, Newcastle University, Selcia/Mitopharm Ltd and Isomerase Therapeutics Ltd. In the article published in Nature Communications, the research team presents the results of the new treatment strategy, in which succinic acid (succinate) is delivered to cells with complex I dysfunction, a potentially new method for treating patients suffering from diseases caused by mitochondrial complex I dysfunction.
Previous compounds, as described in the Nature Communications journal, are not suitable for studies in more complex experimental models or in vivo, since they lack sufficient plasma stability. To circumnavigate this situation, researchers at NeuroVive and Isomerase have worked within the framework of the NVP015 research program to develop a new series of succinate prodrugs with improved stability in the bloodstream. The most promising compounds from this series are currently being tested in various experimental models. This optimization process has been expanded to include a higher number of interesting compounds than originally planned, and a drug candidate is planned to be selected in the second half of 2017.
The NVP015 project is based on a concept instigated by NeuroVive's CSO Dr Eskil Elmér and his colleagues by which the body's own energy substrate, succinate, is made available in the cell via a prodrug technology. A prodrug is an inactive drug that is activated first when it enters the body by the transformation of its chemical structure. A successful drug candidate from this research program in mitochondrial medicine may potentially be classified as an orphan drug, enabling a faster and less costly market route, as well as a higher price. One of the most common causes of mitochondrial diseases relates to complex I dysfunction, i.e. abnormal functioning of energy conversion in the first of the five protein complexes in the mitochondrion that are involved in effective energy conversion.
Non-alcoholic steatohepatitis (NASH)
After the end of the reporting period, it was announced that positive preclinical results had been obtained for NVP018 in an experimental model for NASH (non-alcoholic steatohepatitis), a serious, chronic and common liver disease. In addition to NVP018, NeuroVive is developing a new class of compounds with a different mechanism of action, that may be supplemental to the treatment of NASH. The project is based on NeuroVive's core expertise in mitochondrial energy regulation, combined with the expertise of its partner company, Isomerase, in innovative chemistry. Efforts are currently underway to confirm the collected data, and to compile a package for the commencement of out-licensing discussions in 2017.
NASH – non-alcoholic steatohepatitis – is a progressive disease that can lead to cirrhosis and liver cancer. Liver damage in NASH is caused by fat accumulation and inflammatory changes in the liver. NASH is a form of NAFLD (non-alcoholic fatty liver disease), which is one of the most common disorders in the world. An estimated 20% of the world population suffers from NAFLD, and about one-third of the US population. There is a strong link between NASH and various metabolic disorders, such as diabetes and obesity. About 3-5% of Americans (about 15 million people) suffer from NASH and there are no FDA-approved treatments at present.1)
1) Vernon G. et al. Aliment Pharmacol Ther. 2011;34(3): 274-85
Organ protection
Within the framework of NeuroVive's new business model, with a new focus on early-phase projects, both NVP019 and the Company's other cyclophilin inhibitors are currently being assessed in a range of indications, in relation to organ protection in acute and chronic conditions.
Ischemic stroke
In line with the increased focus on early-phase projects for out-licensing, the Company has reviewed its portfolio and selected a number of projects with high commercial potential and relatively low risk for further development. The Company has subsequently decided to discontinue development of the NVP014 project for the treatment of stroke.
License agreement with Arbutus
In July 2016, NeuroVive received a purported notice of termination from Arbutus Biopharma (previously OnCore Biopharma, Inc.) regarding the license agreement from 2014. The agreement pertained to the development and commercialization of NeuroVive's NV556 compound, developed for per oral treatment of hepatitis B infection (NVP018). The termination was based on a prior decision by Arbutus to discontinue development of the compound, which was announced in October 2015.
After the end of the reporting period, it was announced that the license agreement with Arbutus Biopharma (previously OnCore Biopharma, Inc.), pertaining to the development and commercialization of NeuroVive's NV556 compound for per oral treatment of hepatitis B infection (NVP018), had been formally terminated. Under the termination agreement, NeuroVive is to receive, free of charge, the NVP018 drug substance and materials manufactured by Arbutus Biopharma, valued at approximately USD 1.5 million. Data from preclinical development and chemistry, manufacturing, and control (CMC) has been transferred to NeuroVive. In addition, all license rights to the NV556 compound have been returned to NeuroVive for further development in all potential indications.
NeuroVive Pharmaceutical Asia, Inc. subsidiary
Based on the decision to discontinue development of CicloMulsion, the NeuroVive Pharmaceutical Asia, Inc. subsidiary is currently evaluating opportunities for its future operations. Because of the decision to discontinue the development of CicloMulsion, the parent company has written-down the shares of NeuroVive Asia by approximately 50%, which corresponds to the estimated value of CicloMulsion in the relevant Asian territories.
NeuroVive France SARL subsidiary closed
After the end of the reporting period, it was announced that closure of the dormant subsidiary in Lyon, France would be completed in order to save resources and costs. Closure of the NeuroVive France SARL subsidiary was a natural course of events due to the negative outcome of the CIRCUS trial. As part of this process, all agreements related to research collaboration with the Hospices Civils de Lyon (HCL) hospital and professor Michel Ovize, were also terminated, including OPeRa (Organ Protection & Replacement).
Financial information
Revenues
The consolidated turnover during the third quarter of 2016 was SEK 0 (0). Other operating revenues for the third quarter of 2016 were SEK 16,000 (74,000). The consolidated turnover for the first nine months was SEK 0 (2,502,000) and the operating revenues amounted SEK 90,000 (499,000).
Results of operations
The operating loss for the third quarter was SEK 34,190,000 (54,056,000). The operating loss for the first nine months was SEK 57,247,000 (84,099,000). The net loss before tax for the third quarter amounted to SEK 34,290,000 (53,948,000). The net loss before tax for the first nine months was SEK 57,265,000 (83,435,000).
The operating loss was affected by external expenses, which for the first nine months were SEK 24,308,000 (44,672,000). Expenses related to development projects have affected the result with SEK 8,204,000 (9,928,000). These expenses relate to development projects that have not reached phase I. Personnel expenses during the first nine months amounts to SEK 11,332,000 (12,689,000). Other operating expenses amount to, SEK 20,888,000 (29,174,000) whereof 20,618,000 (28,135,000) relates to former capitalized costs for the CicloMulsion. Since the results of treatment with CicloMulsion showed no benefits in the prevention of acute kidney injury (AKI) during open heart surgery, the Company decided to discontinue the development of CicloMulsion. Thus, all previously capitalized expenditure in connection with CicloMulsion has been recognized as an impaired value. The remaining portion of other operating expenses pertains to exchange-rate losses.
Financial position
The equity/assets ratio was 95 (85) % as of 30 September 2016, and equity was SEK 182,385,000 (154,779,000) compared to beginning of the year. Cash and cash equivalents amounted to SEK 112,889,000 (116,966,000) as of 30 September 2016, an increase of SEK 16,227,000 from the beginning of the year. Total assets as of 30 September 2016 were SEK 192,978,000 (191,109,000).
Cash flow and investments
Operating cash flow for the third quarter was SEK -10,137,000 (-13,487,000). Operating cash flow from the first nine months was SEK -45,592,000 (-50,437,000). The cash flow effect related to investments in intangibles equals SEK -3,690,000 (-6,310,000) for the third quarter. The cash flow effect related to investments in intangibles equals SEK -9,828,000 (-19,424,000) for the first nine months. Cash flow for the third quarter equals SEK -20,127,000 (-19,871,000). Cash flow for the first nine months equals SEK 14,960,000 (68,411,000).
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. 2016 | 1 Jan. 2015 |
|---|---|---|
| (SEK 000) | 30 Sept 2016 | 30 Sept 2015 |
| Stanbridge bvba (owned by Gregory Batcheller, Executive Chairman) | 722 | 1 100 |
| Ankor Consultants bvba (owned by Arne Ferstad, Board member) | 96 | 377 |
| Bernsten Consulting | 54 | |
| Total transactions with related parties | 872 | 1 477 |
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
NeuroVive does not hold any financial instruments measured at fair value. The reported value of financial instruments essentially corresponds to fair value. The new holding in unlisted securities classified as "financial assets available for sale" would normally be measured at fair value through other comprehensive income. The holding is, in the absence of a reliable fair value valuation, recognized to its acquisition value, SEK 13,100,000.
Human resources
The average number of employees of the group for the period January to September was 17 (10), of which 8 (7) are women.
Parental company
Due to the decision to discontinue development of CicloMulsion, the value of shares in the NeuroVive Pharmaceutical Asia, Inc. subsidiary decreased approximately 50%, corresponding to SEK 20,870,000, which is the estimated value of CicloMulsion in relevant Asian territories. This had a negative impact of SEK 20,870,000 (0) on the parent company's earnings after financial items. The parent company's loss after tax for the period was therefore SEK 74,037 (82,685). 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. The Board of Directors works continuously to secure the business operation's need for financing. A way to spread risks is to out-license projects directed towards larger indications already in the pre-clinical phase, while orphan indication projects are developed by the company up until market registration. With exception for the decision to terminate the continued development of CicloMulsion, no significant changes in relation to risk or uncertainties occurred during the current period.
In March 2013, CicloMulsion AG commenced arbitration seeking declaratory relief with regard to royalties allegedly to be paid by the Company under a 2004 License Agreement as well as certain other claims relating to the Company's obligations under the License Agreement. As previously reported, on May 25, 2016, the Tribunal rendered a partial award. The partial award was appealed by each party to the competent Swedish court (Hovrätten över Skåne Blekinge). A decision on the appeals is expected by the end of 2017. The arbitration proceeding is continuing regarding the applicable royalty rate in certain countries and an award is expected by the end of 2016 or the beginning of 2017 which will also include a decision on the overall costs of the arbitration proceeding. It cannot be excluded, however, that the Tribunal will decide to stay the arbitration proceeding due to the pending appeals.
For more detail of risks and uncertainty factors, refer to the Statutory Administration Report in the Annual Report 2015 and the prospectus published 14 April 2016 for the share issue in April/May 2016.
Incentive programs/share warrants
Currently there is no incentive program.
Audit review
This Interim Report has been subject to review by the company's auditors in accordance with the Standard on Review Engagements (ISRE) 2410, Review of Interim Financial Information Performed by the Independent Auditor of the Entity.
Upcoming financial statements
Year-End Report 2016 21 February 2017 Interim Report January-March 18 May 2017 Interim Report January-June 17 August 2017 Interim Report January-September 21 November 2017 Year-End Report 2017 20 February 2018
The interim reports and the Annual Year Report are available at www.neurovive.com.
Annual General Meeting 2017
NeuroVives Annual General Meeting will be held at Medicon Village, Scheelevägen 2, in Lund on 27 April at 4 pm.
The Nomination Committee for the 2017 AGM comprises:
- Anders Ermén, Chairman nominated by Baulos Capital Belgium SA / Fredrik Olsson
- Michael Vickers nominated by Maas Biolab LLC / Marcus Keep
- Andreas Inghammar nominated by Eskil Elmer
Shareholders wishing to make proposals on the above matters can contact the Committee by email at: [email protected], or by post at: NeuroVive Pharmaceutical AB, FAO: Nomination Committee, Medicon Village, 223 81 Lund, Sweden. In order for the Nomination Committee to consider the proposals received with due care, proposals should be received by the Nomination Committee by no later than 1 February 2017.
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 2015 on pages 54-58. New and revised standards and interpretation statements applicable from 1 January 2016 onwards did not have any effect on the group or parent company's results of operations or financial position.
Consolidated Statement of Comprehensive Income
| (SEK 000) | Note | 1 July. 2016 | 1 July. 2015 | 1 Jan. 2016 | 1 Jan. 2016 | 1 Jan. 2015 |
|---|---|---|---|---|---|---|
| 30 Sept. 2016 | 30 Sept. 2015 | 30 Sept. 2016 | 30 Sept. 2016 | 31 Dec. 2015 | ||
| Net sales | - | - | - | 2 502 | 2 502 | |
| Other operating income | 16 | 74 | 90 | 499 | 522 | |
| 16 | 74 | 90 | 3 001 | 3 024 | ||
| Operating expenses | ||||||
| Other external expenses | -9 172 | -19 687 | -24 308 | -44 672 | -48 514 | |
| Personnel cost | -4 050 | -5 876 | -11 332 | -12 689 | -15 556 | |
| Depreciation and write-down of tangible | -278 | -220 | -808 | -565 | -1 200 | |
| and intangible assets | ||||||
| Other operating expenses | -20 705 | -28 346 | -20 888 | -29 174 | -29 220 | |
| -34 206 | -54 129 | -57 337 | -87 100 | -94 490 | ||
| Operating income | -34 190 | -54 056 | -57 247 | -84 099 | -91 466 | |
| Profit/loss from financial items | ||||||
| Financial income | 21 | 419 | 176 | 1 065 | 1 100 | |
| Financial costs | -121 | -311 | -194 | -401 | -435 | |
| -99 | 108 | -17 | 664 | 665 | ||
| Profit/loss before tax | -34 290 | -53 948 | -57 265 | -83 435 | -90 801 | |
| Income tax | 2 | - | - | - | - | - |
| Profit/loss for the period | -34 290 | -53 948 | -57 265 | -83 435 | -90 801 | |
| -57 265 | ||||||
| Other comprehensive income | 5 | |||||
| Items that may be reclassified to profit or | ||||||
| loss | ||||||
| Translation differences on foreign | 745 | |||||
| subsidiaries | -1 228 | 1 282 | -977 | -667 | ||
| Total comprehensive income for the period | -33 545 | -55 176 | -55 983 | -84 412 | -91 468 | |
| -33 545 | ||||||
| 8 | ||||||
| Loss for the period attributable to: | ||||||
| Parent company shareholders | -33 919 | -53 668 | -56 090 | -83 302 | -90 119 | |
| Non-controlling interests | -371 | -279 | -1 175 | -133 | -682 | |
| -34 290 | -53 948 | -57 265 | -83 435 | -90 801 | ||
| Total comprehensive income for the period | ||||||
| Parent company shareholders | -33 528 | -54 800 | -55 548 | -83 801 | -90 207 | |
| Non-controlling interests | -17 | -376 | -435 | -611 | -1 261 | |
| -33 545 | -55 176 | -55 983 | -84 412 | -91 468 | ||
| Earnings per share before and after | ||||||
| dilution(SEK) based on average number of | -0,86 | -1,75 | -1,42 | -2,78 | -3,01 | |
| shares |
Consolidated Statement of Financial Position
| (SEK 000) | Note | 30 Sept. 2016 | 30 Sept. 2015 | 31 Dec. 2015 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 1 | |||
| Development costs | 47 681 | 57 659 | 59 803 | |
| Patents | 14 703 | 14 817 | 13 023 | |
| Other Intangible assets | 1 956 | 87 | 2 078 | |
| 64 339 | 72 563 | 74 904 | ||
| Tangible assets | ||||
| Equipment | 290 | 347 | 316 | |
| 290 | 347 | 316 | ||
| Financial assets | ||||
| Other long-term securities | 13 101 | - | 1 | |
| Other long-term receivables | 119 | 161 | 148 | |
| 13 220 | 161 | 149 | ||
| Total non-current assets | 77 849 | 73 071 | 75 369 | |
| Current assets | ||||
| Other receivables | 1 574 | 796 | 2 368 528 |
|
| Prepaid expenses and accrued income Cash and cash equivalents |
665 | 277 116 966 |
||
| 112 889 | 118 039 | 96 662 | ||
| 115 128 | 99 558 | |||
| TOTAL ASSETS | 192 978 | 191 109 | 174 927 | |
| (SEK 000) | Note | 30 Sept. 2016 | 30 Sept. 2015 | 31 Dec. 2015 |
| EQUITY AND LIABILITIES | ||||
| Equity attributable to the shareholders of the parent company Share capital |
2 473 | 1 537 | 1 537 | |
| Additional paid in capital | 418 339 | 335 798 | 335 687 | |
| Translation reserve | 352 | -601 | -190 | |
| Retained earnings | -251 995 | -189 090 | -195 906 | |
| Total equity attributable to the shareholders of the parent | 169 169 | 147 644 | 141 128 | |
| company | ||||
| Non-controlling interests | 13 216 | 14 321 | 13 651 | |
| Total equity | 182 385 | 161 965 | 154 779 | |
| Short-term liabilities | ||||
| Accounts payable | 3 642 | 6 312 | 5 207 | |
| Other liabilities | 734 | 431 | 5 000 601 | |
| Accrued expenses and deferred income | 6 217 | 22 402 | 14 340 | |
| 10 593 | 29 145 | 20 148 | ||
| Total liabilities | 10 593 | 29 145 | 20 148 | |
| TOTAL EQUITY AND LIABILITIES | 192 978 | 191 109 | 174 927 |
Consolidated Statement of Changes in Equity
Total number of shares at end of period: 49,458,645 (30,735,152).
| (SEK 000) | Equity attributable to |
|---|---|
| the shareholders of the |
the shareholders of the parent company
| Total equity | |||||||
|---|---|---|---|---|---|---|---|
| Additiona | Transla | attributable to the | Non | ||||
| Share | l paid in | tion | Retained | shareholders of the | controlling | Total | |
| capital | capital | reserve | earnings | parent company | interests | equity* | |
| Opening balance, 1 January 2016 | 1 537 | 335 687 | -190 | -195 906 | 141 128 | 13 651 | 154 779 |
| Comprehensive profit/loss for the | |||||||
| period Profit/loss for the period | - | - | - | -56 090 | -56 090 | -1 175 | -57 265 |
| Other comprehensive income | |||||||
| Translation differences | - | - | 542 | - | 542 | 740 | 1 282 |
| Other comprehensive profit/loss for the | - | - | 542 | - | 542 | 740 | 1 282 |
| period, net after tax | |||||||
| Total comprehensive profit/loss | - | - | 542 | -56 090 | -55 548 | -435 | -55 983 |
| Transactions with shareholders | |||||||
| New share issue | 936 | 82 652 | - | - | 83 588 | - | 83 588 |
| Total transactions with shareholders | 936 | 82 652 | - | - | 83 588 | - - |
83 588 |
| Closing balance, 30 September 2016 | 2 473 | 418 339 | 352 | -251 995 | 169 169 | 13 216 | 182 384 |
| 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 | - | - | - | -83 302 | -83 302 | -133 | -83 435 |
| Other comprehensive income | |||||||
| Translation differences | - | - | -499 | - | -499 | -478 | -977 |
| Other comprehensive profit/loss for the | - | - | -499 | - | -499 | -478 | -977 |
| period, net after tax | |||||||
| Total comprehensive profit/loss | - | - | -499 | -83 302 | -83 801 | -611 | -84 412 |
| Transactions with shareholders | |||||||
| New share issue | 148 | 119 427 | - | - | 119 575 | - | 119 575 |
| Issue through non-controlling interest | - | 8 559 | - | - | 8 559 | 10 403 - |
18 963 |
| Total transactions with shareholders | 148 | 127 986 | - | - | 128 134 | 10 403 | 138 573 |
| aktieägare Closing balance, 30 September 2015 |
1 537 | 335 798 | -601 | -189 089 | 147 645 | 14 321 | 161 966 |
| 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 | - | - | - | -90 119 | -90 119 | -682 | -90 801 |
| Other comprehensive income | |||||||
| Translation differences | - | - | -88 | - | -88 | -579 | -667 |
| Other comprehensive profit/loss for the | - | - | -88 | - | -88 | -579 | -667 |
| period, net after tax Total comprehensive profit/loss |
- | - | -88 | -90 119 | -90 207 | -1 261 | -91 468 |
| Transactions with shareholders | |||||||
| New share issue | 148 | 119 427 | - | - | 119 575 | - | 119 575 |
| Change of ownership in new share issue | - | 8 448 | - | - | 8 448 | - 10 383 |
18 831 |
| - Total transactions with shareholders |
148 | 127 875 | - | - | 128 023 | 10 383 | 138 406 |
| Closing balance, 31 December. 2015 | 1 537 | 335 687 | -190 | -195 906 | 141 128 | 13 651 | 154 779 |
* Total equity includes funds from the in January completed non cash consideration with SEK 6,809,000 less expenses SEK 553,000 and funds from the in May completed rights issue with SEK 94,421,000 less expenses SEK 17,089,000.
Consolidated Statement of Cash Flows
| (SEK 000)) | 1 July. 2016 | 1 July. 2015 | 1 Jan. 2016 | 1 Jan. 2015 | 1 Jan. 2015 |
|---|---|---|---|---|---|
| 30 Sep. 2016 | 30 Sep. 2015 | 30 Sep.2016 | 30 Sep. 2015 | 31 Dec. 2015 | |
| 2016 | |||||
| Cash flow from operating activities | |||||
| Operating income | -34 190 | -54 056 | -57 247 | -84 099 | -91 466 |
| Adjustments for non-cash items: | |||||
| Depreciation | 278 | 220 | 808 | 565 | 1 200 |
| Currency differences on intercompany items | 12 | -39 | 25 | 179 | 153 |
| Impaired Value | 20 618 | 28 135 | 20 618 | 28 135 | 28 135 |
| Disposal of Business | 7 | - | 7 | - | - |
| Interest received | 21 | 419 | 176 | 1 065 | 1 100 |
| Interest paid | -121 | -311 135 |
-194 | -401 | -435 |
| Net cash from operating activities | |||||
| before changes in working capital | -13 375 | -25 632 | -35 807 | -54 556 | -61 313 |
| Changes in working capital | |||||
| Increase/decrease of other current assets | 2 101 | 1 260 | 524 | 387 | -1 255 |
| Increase/decrease of other short-term liabilities | 1 137 | 10 885 | -10 309 | 3 732 | -4 652 |
| Changes in working capital | 3 238 | 12 145 | -9 785 | 4 119 | -5 907 |
| Cash flow from operating activities | -10 137 | -13 487 | -45 592 | -50 437 | --67 220 |
| Investing activities | |||||
| Acquisition of intangible assets | -3 690 | -6 310 | -9 828 | -19 424 | -23 200 |
| Acquisition of tangible assets | -10 | -39 | -108 | -266 | -245 |
| Increase in other financial assets | -6 291 | - | -6 844 | - | - |
| Cash flow from investing activities | -9 991 | -6 349 | -16 780 | -19 690 | -23 445 |
| Financing activities | |||||
| Share issue minority | - | -35 | - | 18 963 | 18 831 |
| New share issue | - | - | 77 332 | 119 576 | 119 575 |
| Cash flow from financing activities | - | -35 | 77 332 | 138 539 | 138 406 |
| Cash flow for the period | -20 127 | -19 871 | 14 960 | 68 411 | 47 741 |
| Cash and cash equivalents at the beginning of the | 132 280 | 138 049 | 96 662 | 49 698 | 49 698 |
| Effect of exchange rate changes on cash | 736 | -1 212 | 1 267 | -1 143 | -777 |
| Cash and cash equivalents at end of period | 112 889 | 116 966 | 112 889 | 116 966 | 96 662 |
Parent Company Income Statement
| (SEK 000) | Note | 1 July. 2016 | 1 July. 2015 | 1 Jan. 2016 | 1 Jan. 2015 | 1 Jan. 2015 |
|---|---|---|---|---|---|---|
| 30 Sept. 2016 | 30 Sept. 2015 | 30 Sept. 2016 | 30 Sept. 2015 | 31 Dec. 2015 | ||
| Net sales | - | - | 9 | - | 327 | |
| Other operating income | 16 | 56 | 90 | 481 | 509 | |
| 16 | 56 | 99 | 481 | 836 | ||
| Operating expenses | ||||||
| Other external expenses | -8 782 | -19 318 | -22 501 | -42 903 | -45 774 | |
| Personnel cost | -3 250 | -5 144 | -9 160 | -11 124 | -13 376 | |
| Depreciation and write-down of tangible and | -250 | -191 | -724 | -500 | -1 106 | |
| intangible assets | ||||||
| Other operating expenses | -20 711 | -28 346 | -20 895 | -29 174 | -29 221 | |
| -32 994 | -52 999 | -53 280 | -83 701 | -89 477 | ||
| Operating income | -32 978 | -52 944 | -53 180 | -83 220 | -88 641 | |
| Profit/loss from financial items | ||||||
| Result from shares in group company | -20 870 | - | -20 870 | - | - | |
| Interest income and other similar profit items | 33 | 85 | 116 | 651 | 654 | |
| Interest expenses and other similar loss items | -94 | -99 | -102 | -116 | -152 | |
| -20 931 | -13 | -20 856 | 535 | 502 | ||
| Profit/loss before tax | -53 908 | -52 957 | -74 037 | -82 685 | -88 139 | |
| Income tax 2 |
- | - | - | - | - | |
| Profit/loss for the period | -53 908 | -52 957 | -74 037 | -82 685 | -88 139 |
Statement of Comprehensive Income, Parent Company
| (SEK 000) Note |
1 July. 2016 | 1 July. 2015 | 1 Jan. 2016 | 1 Jan. 2015 | 1 Jan. 2015 |
|---|---|---|---|---|---|
| 30 Sept. 2016 | 30 Sept. 2015 | 30 Sept. 2016 | 30 Sept. 2015 | 31 Dec. 2015 | |
| Profit/loss for the period Other comprehensive income |
-53 908 - |
-52 957 - |
-74 037 - |
-82 685 - |
-88 139 - |
| Total comprehensive profit/loss for the period | -53 908 | -52 957 | -74 037 | -82 685 | -88 139 |
Parent Company Balance Sheet
| (SEK 000) | Note | 30 Sept. 2016 | 30 Sept. 2015 | 31 Dec. 2015 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 1 | 59 568 | ||
| Development costs | 47 446 | 57 425 | 13 023 | |
| Patents Other intangible assets |
14 704 1 915 |
14 817 27 |
2 023 | |
| 64 065 | 72 268 | 74 614 | ||
| Tangible assets | ||||
| Equipment | 229 | 254 | 232 | |
| 229 | 254 | 232 | ||
| Financial assets | ||||
| Other long-term placement | 13 102 | 1 | 1 | |
| Shares in subsidiaries | 3 | 20 870 | 41 750 | 41 750 |
| 33 972 | 41 751 | 41 751 | ||
| Total non-current assets | 98 265 | 114 273 | 116 597 | |
| Current assets | ||||
| Short term receivables | ||||
| Receivables from group companies | - | 6 | 334 | |
| Other receivables | 1 567 | 772 | 1 323 | |
| Prepaid expenses and accrued income | 246 | 275 | 492 | |
| 1 813 | 1 052 | 2 149 | ||
| Cash and bank balances | 95 010 | 94 264 | 75 936 | |
| Total current assets | 96 823 | 95 317 | 78 085 | |
| TOTAL ASSETS | 195 088 | 209 590 | 194 682 | |
| (SEK 000) | Note | 30 Sept. 2016 | 30 Sept. 2015 | 31 Dec. 2015 |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | ||||
| Share capital | 2 473 | 1 537 | 1 537 1 856 |
|
| Statutory reserve | 1 856 | 1 856 - |
- | |
| Development expenditure reserve | 5 611 9 940 |
3 393 | 3 393 | |
| Unrestricted equity | ||||
| Share premium reserve | 393 648 | 195 720 | 195 720 | |
| Retained earnings | -144 249 | 64 777 | 64 777 | |
| Profit/loss for the period | -74 037 | -82 685 | -88 139 172 358 |
|
| 175 362 | 177 812 | |||
| Total equity | 185 302 | 181 205 | 175 751 | |
| Short-term liabilities | 4 192 | |||
| Accounts payable Liabilities to group companies |
3 110 - |
5 556 - |
- | |
| Other liabilities | 729 | 428 | 398 | |
| Accrued expenses and deferred income | 5 947 | 22 401 | 14 341 | |
| 9 786 | 28 385 | 18 931 | ||
| TOTAL EQUITY AND LIABILITIES | 195 088 | 209 590 | 194 682 |
Note 1 — Intangible assets
| (SEK 000)) | Development costs | Patents* | Other | Total |
|---|---|---|---|---|
| ACCUMULATED COST | ||||
| Opening balance 1 Jan. 2016 | 59 803 | 18 193 | 2 899 | 80 895 |
| Additions | 8 375 | 2 600 | - | 10 975 |
| Impaired value | -20 497 | - | - | -20 497 |
| Closing balance 30 Sept. 2016 | 47 681 | 20 793 | 2 899 | 71 373 |
| ACCUMULATED DEPRECIATION | ||||
| Opening balance 1 Jan. 2016 | - | -5 170 | -821 | -5 991 |
| Depreciation for the period | - | -920 | -122 | -1 042 |
| Closing balance 30 Sept. 2016 | - | -6 090 | -943 | -7 033 |
| 47 681 | 14 703 | 1 956 | 64 340 | |
| Residual value 30 Sept. 2016 |
| (SEK 000) | Development costs | Patents* | Other | Total |
|---|---|---|---|---|
| ACCUMULATED COST | ||||
| Opening balance 1 Jan. 2016 | 68 368 | 15 111 | 400 | 83 879 |
| Additions | 19 570 | 5 502 | 79 | 25 151 |
| Impaired Value | -28 135 | - | - | -28 135 |
| Reclassification | - | -2 420 | 2 420 | - |
| Closing balance 31 Dec. 2015 | 59 803 | 18 193 | 2 899 | 80 995 |
| ACCUMULATED DEPRECIATION | ||||
| Opening balance 1 Jan. 2015 | - | -1 395 | -31 | -4 278 |
| Depreciation for the period | - | -1 205 | -508 | -1 713 |
| Closing balance 31 Dec. 2015 | - | -5 170 | -821 | -5 991 |
| Residual value 31 Dec. 2015 | 59 803 | 13 023 | 2 078 | 74 904 |
* Amortization of patents related to capitalized development costs 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, 99 % is for NeuroSTAT, 1 % is for NVP014.
Note 2 — Tax
The group's total loss carry-forwards amount to SEK 284,764,000 as of 30 September 2016 (224,171,000). The parent company's total loss carry-forwards amount to SEK 260,946,000 as of 30 September 2016 (185,497,000). 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 Hong Kong and NeuroVive Pharmaceutical Taiwan, Inc. domiciled in Taiwan.
This Interim Report gives a true and fair view of the parent company 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
David Laskow-Pooley Board member
Erik Kinnman Chief Executive Officer
Lund, Sweden, 22 November 2016
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 Erik Kinnman, telephone: +46 (0)46-275 62 20
About NeuroVive
NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine. The company is committed to the discovery and development of medicines that preserve mitochondrial integrity and function in areas of unmet medical need. The company's strategy is to take drugs for rare diseases through clinical development and into the market. The strategy for projects within larger indications outside the core focus area is out-licensing in the preclinical phase. NeuroVive enhances the value of its projects in an organization that includes strong international partnerships and a network of mitochondrial research institutions, as well as expertise with capacities within drug development and production.
NeuroVive has a project in early clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®). NeuroSTAT has orphan drug designation in Europe and in the US. The R&D portfolio consists of several late stage research programs in areas ranging from genetic mitochondrial disorders to neurological and metabolic diseases such as NASH.
NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF).
NeuroVive Pharmaceutical AB (publ) Medicon Village, SE-223 81 Lund Tel: +46-46 275 62 20 (switchboard), [email protected] www.neurovive.com
This information is information that NeuroVive Pharmaceuticals (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CET on 22 November 2016.
Auditor's review report
To the Board of Directors of NeuroVive Pharmaceutical AB (publ) Corp.Id.No 556595-6538
Introduction
We have performed a review of the condensed interim financial statements (the interim report) for NeuroVive Pharmaceutical AB (publ) at September 30th, 2016 and the nine months' period then ended. The Board of Directors and the President are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Swedish 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 ISRE 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 the International Standards on Auditing and other generally accepted auditing practices.
The procedures performed in a review do not enable us to obtain a level of assurance that would make us 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, in all material aspects, is not prepared for the Group in accordance with IAS 34 and the Swedish Annual Accounts Act and for the Parent company in accordance with the Swedish Annual Accounts Act.
Helsingborg, November 22nd 2016
Mazars SET Revisionsbyrå AB
Bengt Ekenberg Authorized Public Accountant