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Nel ASA — Interim / Quarterly Report 2010
Oct 29, 2010
3670_rns_2010-10-29_337ce9e6-a32c-4b24-a614-3193fb9c8845.pdf
Interim / Quarterly Report
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DiaGenic ASA – Interim Report Q3 2010
for early disease detection
DIAGENIC
HIGHLIGHTS
> Interactions with several leading pharmaceutical and imaging companies on the use of DiaGenic products, technology and IP, clinical studies and biobank within the CNS area are progressing according to plan.
> Publication of two central scientific manuscripts.
> Notice of Allowance on a family 3 Patent covering 30 countries in Europe
POST QUARTER HIGHLIGHTS
> Successful private placement of NOK 70 million, conditional upon resolution in the general assembly October 29
- 2 -
The new Board of Directors initiated significant changes to the commercial strategy with a shift towards partner deals with large international pharma and imaging companies. The strategic and operational repositioning of the Company will generate revenue through co-founded R&D collaborative deals, licensing and subsequent product sales. This strategy requires long term financing of the Company, which is manifested by the conditional private placement of NOK 70 million.
BIOMARKERS FOR DRUG DEVELOPMENT AND COMPANION DIAGNOSTICS
The key focus area of DiaGenic is to provide biomarkers for drug development and companion diagnostics. The Alzheimer's Disease (AD) area reflects a global health burden currently affecting 34 million worldwide and representing more than 4 billion USD in pharmaceutical sales. By inclusion of the earlier preclinical stages of AD, previously mild cognitive impairment (MCI) now called prodromal AD, and with the expected growing elderly population this market is expected to reach 13 billion USD by 2017.
All of the larger pharmaceutical companies are active in this disease area, and a number of new compounds positioned to be used in the prodromal AD stage are in development. To select patients into clinical trials new diagnostic tools and algorithms are needed.
Imaging diagnosis of Alzheimers disease (18F-PET tracers) is expected to reach the market in the middle of 2012 and can increase the diagnostic accuracy, albeit to a high procedural cost (5-10.000 USD).
DiaGenic is currently in talks with several pharma and imaging companies. These discussions explore:
- the use of ADtect® for retrospective analysis of completed phase 3 studies in AD patients
- gene expression analysis in planned prodromal AD studies
- DiaGenic's own clinical studies and biobank to develop new tests for early disease detection (prodromal AD).
- disease monitoring/progression using enlarged DiaGenic gene sets. These gene sets were already identified by DiaGenic in earlier whole genome array studies.
These interactions are progressing according to plan.
Because of the change in strategy, the Company does not expect sales to clinicians
to ramp up significantly in the short term. The ongoing activities are the following:
- Ferrer is preparing for launch of ADtect® in Spain and Germany by trainings of their sales force, establishing advisory boards, contact with KDL's and clinicians and by their presence at national congresses. Ferrer expect to expand into other territories covered by the contract in 2011. The recent publications accepted by The Journal of Alzheimer's Disease (see below) will be an important tool for the Ferrer sales team. To ensure best clinical accuracy by doctors, Ferrer will invest in high end imaging (MR/PET) testing of selected Alzheimer's patients as part of their need for local clinical documentation. Reimbursement in Germany is also being evaluated by Ferrer through the use of a national laboratory for the analytical work performed as a part of the ADtect® test. Reimbursement is instrumental for using ADtect® in countries with a limited private payer segment. Similar evaluation is ongoing in Norway.
- The smaller distributors do not have the marketing power to change local diagnostic practice. The advantages afforded by teaming up with larger pharmaceutical companies with capabilities to change this is reflected in DiaGenic's focus on establishing partnership for companion diagnostics with these industry leading companies.
-
Simplification of sample shipment is ongoing. Only dry ice shipment is currently approved. To support transport of samples at higher temperatures DiaGenic has received funding from Becton Dickinson, the producer of PAXgene blood sampling tubes, to perform shipping studies required for CE regulatory purposes.
-
3 -
RESEARCH AND PRODUCT DEVELOPMENT
Alzheimer's disease
Development of a new biomarker, MCltect, for prodromal AD diagnosis in the predementia Mild Cognitive Impairment stage for pharma use is receiving international attention. To support these activities DiaGenic has conducted clinical studies for the last 3 years, to ensure availability of well characterized blood samples for gene selection. Currently, hospitals in Norway, Sweden, Denmark, The Netherlands, Belgium and the US are monitoring > 650 patients, controls and patients with related diseases. DiaGenic has already a world class biobank of blood samples from these and earlier studies totaling more than 1900. This world leading biobank has become an important asset of DiaGenic in the talks with potential pharma partners. Part of the outcome of this biobank is the two articles accepted for publication in the Journal of Alzheimer's Disease Volume 23, Number 1. With an Impact Factor of 5.1, this journal is ranked as # 18 of the top 100 journals across all fields of medicine. These articles will build confidence in ADtect® among clinicians and pharmaceutical companies and confirm DiaGenic's leading position as a provider of biomarkers in the CNS field.
The first article by Booij et al "A Gene Expression Pattern in Blood for the Early
Detection of Alzheimer's Disease" describes the whole genome study performed on blood samples from 94 AD patients and 94 cognitive healthy subjects. The study identified a number of genes impacted by AD and by using a subset of 1239 probes a gene expression signature with a diagnostic accuracy of 87% was developed and validated. This signature demonstrates that alterations specific for AD can be detected distant from the primary site of the disease. This set of probes was used in the development of ADtect®.
The second article by Rye et al "A Novel Blood Test for the Early Detection of Alzheimer's Disease" describes more in detail the documentation on ADtect®, using blood samples from a cohort of 203 probable AD and 209 cognitively healthy age matched controls, resulting in an apparent accuracy of 71.6%. Diagnosis is based on clinical criteria as well as exclusion of other causes of dementia but a definitive diagnosis can only be made at autopsy. Higher agreement (80%) was observed when comparing ADtect® with cerebrospinal fluid testing. Assuming a clinical accuracy of 80%, calculations indicate that the agreement of ADtect® with underlying true pathology is in the range 85%-90%.
Parkinson's disease
A multicentre study, partly funded by the Norwegian Research Council, supporting the development of a test for early Parkinson's disease is ongoing in Norway, Sweden and Germany. Samples from more than 520 PD patients, controls and from patients with related disorders have been included so far. A subset of samples has been analyzed by whole genome screening to identify PD related probes (genes) and to develop disease specific diagnostic models. The clinical study will continue to support the validation of a biomarker for Parkinson's disease. This biomarker development attracts interest from several Pharma companies developing new drugs for treatment of early stages of Parkinson's disease.
Patents
"Notice of Allowance" in Europe for its family 3 patent application was received. The claims allowed cover a set of gene sequences for diagnosis of breast cancer. The patent when granted will be valid in 30 European countries. DiaGenic has now more than 100 patents (granted/allowed) within the three patent families, reflecting its position as a world leader among molecular diagnostic companies developing blood based gene expression tests.
Patent overview
| Expiry year | Family 1 (WO 98/49342) | Family 2 (WO 2004/046382) | Family 3 (WO 2005/118851) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 2017 | 2023 | 2024 | |||||||
| G | A | P | G | A | P | G | A | P | |
| US | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 1 |
| Europe* | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Europe** | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Norway | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Japan | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Canada | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Hong Kong | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| China | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Australia | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| New Zealand | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| India | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| South Africa | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| ARIPO* | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
G Number of patents granted
A Number of patents accepted by examiner
P Number of patents in progress
Europe*
Designated countries
Austria, Belgium, Switzerland, Cyprus, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, The Netherlands, Portugal and Sweden
Europe**
Designated countries
Austria, Belgium, Switzerland, Cyprus, Germany, Denmark, Spain, Finland, France, United Kingdom Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, Netherlands, Portugal, Romania, Sweden, Slovenia, Slovakia and Turkey
ARIPO® (African Regional Intellectual Property Organization)
Designated countries
Botswana, Gambia, Ghana, Kenya, Lesotho, Malawi, Mozambique, Namibia, Sierra Leone, Sudan, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe
List of granted patents/allowed patent applications
US 6720138; EP 0979308; EP 1323728; NO 317247; NO 20040371; JP 4163758; HK 1026003; HK 03109502.9; AU 2003286262; NZ 540750; IN 2701/DELNP/2005; ZA 2005/03797; ZA 2006/10644; HK 1057217; NO 322084; EP 156557431

FINANCIAL REVIEW
Costs in Q3 2010 down from Q2 2010. NOK 10 million in cash at quarter end.
The company's financial situation with limited funds has imposed cost saving initiatives which consequently leads to restrictions on external activities by DiaGenic. During the quarter main activities have been focused on preparing for a long term funding of the company, progress on pharma agreements and to continue with the ongoing clinical trials within the neurology field (Alzheimer and Parkinson). All other activities and travel have been reduced in the quarter, including support to distributors. When compared with the previous quarter, other operating cost is reduced by more than NOK 2.4 million.
After the end of the quarter DiaGenic carried out a successful conditional private placement of NOK 70 million.
Comparative figures from the corresponding period last year are shown in parentheses.
Comprehensive income
Revenues and research grants
DiaGenic had NOK 8k in operating revenues in the third quarter and NOK 15k in operating revenues for the first nine months of 2010 (NOK 0 and NOK 5k respectively). Research grants are entered net into the accounts (reducing operating costs). Research grants for the third quarter 2010 were NOK 946k (NOK 688k). For the first nine months of 2010 research grants totalled NOK 2,780k (NOK 2,809k).
Operating costs
Total operating costs after deducting research grants were NOK 9,623k (NOK
9.395k) for the third quarter. Salaries and personnel expenses amounted to NDK 5.618k (NDK 5.252k) and all other operating costs were NDK 3.827k (NDK 4.017k) for the third quarter. For second quarter 2010 total operating costs after deducting research grants were NDK 10.525k, of which Salaries and personnel expenses amounted to NDK 4.202k and all other operating costs were NDK 16.253k. Salaries and personnel expenses are up by NDK 1.4 million due to release of vacation accrual in the second quarter. All other operating costs are reduced by more than NDK 2.4 million from second quarter 2010 to third quarter 2010. Cost of Goods Sold for third quarter 2010 totalled NDK 178k (NDK 126k).
For the first nine months of 2010 total operating costs after deducting research grants were NDK 32.081k (NDK 28.597k). Salaries and personnel expenses amounted to NDK 16.194k (NDK 14.588k) and all other operating costs were NDK 15.445k (NDK 13.812k) for the first nine months of 2010. The increase in salaries and personnel expenses in the first nine months of 2010 compared with the corresponding period in 2009 is mainly related to pension expense. The increase in other operating costs in the first nine months of 2010 compared with the corresponding period in 2009 is mainly due to increased patent expenditure and costs related to stepping up the focus towards the pharmaceutical industry. Cost of Goods Sold for first nine months of 2010 totalled NDK 443k (NDK 177k).
Financial position
Total assets at 30 September 2010 were NDK 19.772k (NDK 17.988k) of which current assets amounted to NDK 16.649k (NDK 13.865k). Cash and cash equivalents accounted for the largest share of current assets at the end of September 2010 with a balance of NDK 10.144k (NDK 7.742k). Total value of inventory was NDK 2.405k (NDK 2.314k) at 30 September 2010.
Equity at 30 September 2010 amounted to NDK 5.998k (NDK 9.264k). Current liabilities at the end of September 2010 was NDK 5.223k (NDK 5.421k) and pension liabilities totalled NDK 3.180k (NDK 2.473k). Other long term liabilities at 30 September 2010 totals NDK 5.373k (NDK 760k) and includes lease of laboratory equipment and 4-year loan from Innovation Norway in the amount of NDK 5 million. Current interest rate on the loan is 5.75% p.a.
Cash flows
Net cash flow from operating activities for third quarter 2010 was NDK - 9.547k (NDK 8.594k), and NDK - 33.221k (NDK 27.443k) for the first nine months of 2010. The main drivers for the year over year variance in operating cash flows are changes in short term liabilities. Financing activities for first nine months of 2010 includes a completed share offering for total net proceeds (after deducting issue expenses) in the amount of NDK 8.431k. The company's cash and cash equivalents are held in bank deposits and amounted to NDK 10.144k (NDK 7.742k) on 30 September 2010.
Equity and Financing
In the first nine months of 2010 the Company issued 3.5 million shares for total gross proceeds of NDK 9.6 million and consequently increased share capital by NDK 175k to NDK 3.512k.
After the end of the quarter DiaGenic carried out a conditional private placement of NDK 70 million towards existing and new investors based on a book building process. The Private Placement was subscribed approximately 1.4 times. The subscription price in the Private Placement was set to NDK 0.59 per share. Upon registration of the capital increase the total amount of shares in DiaGenic will increase from 70 236 520 to 210 236 520 shares, each with a nominal value of NDK 0.05 per share. The share capital will increase from NDK 3 511 826 to NDK 10 511 826 at the registration of the capital increase.
To promote equal treatment of the shareholders, the board of directors of DiaGenic has proposed a subsequent repair offering directed at existing shareholders of the Company that did not participate in the Private Placement. It is proposed to issue up to 60 million shares in the subsequent offering at NDK 0.50 per share directed towards shareholders in the Company as of 6 October 2010 who were not allocated shares in the Private Placement. For the Subsequent Offering it will be proposed to issue subscription rights that will be listed and tradable.
The Private Placement and the Subsequent Offering is conditional upon necessary resolutions in the general meeting. The board of directors have called for an extraordinary general meeting on 20 October 2010 with a proposal to resolve the Private placement and the Subsequent Offering.
RISK FACTORS
The information contained in this report includes certain forward-looking statements that address activities, events or developments that the company expects, projects, believes in or anticipates will occur in the future. These statements are based on various assumptions made by the Company which are beyond the Company's control and subject to risk factors and uncertainties. The Company is exposed to a large number of risk factors including, but not limited to, market acceptance of the company's products, necessary approvals from the authorities and the clinical effectiveness of the company's products. Reference is made to the annual report for 2009 and Prospectus dated 21 January 2010 for further information relating to risk factors. As a result of the above-mentioned or other risk factors actual events and the actual result may differ significantly from that indicated in the forward-looking statements. For 2010 key risks are considered to evolve around collaborative agreements with key healthcare players and liquidity risk related to the necessary resolution of the private placement and the subsequent offering by the general meeting to secure sufficient capital for future operations until revenues from operations can cover operating costs.
Future prospects
- Complete the conditional share issue resulting in long term financing of DiaGenic
- Implement and expand the companion diagnostics strategy of biomarkers to the pharmaceutical and imaging industry, leading to partnering agreements
FINANCIAL STATEMENTS- Q3/2010
STATEMENT OF COMPREHENSIVE INCOME
| Note | 2010 | 2009 | 2010 | 2009 | 2009 |
|---|---|---|---|---|---|
| (figures NOK thousands) | Q3 | Q3 | 1 Jan-30 Sept. | 1 Jan-30 Sept. | 1 Jan-30 Dec |
| Operating Income | |||||
| Other income | 8 | 0 | 15 | 5 | 131 |
| Total operating revenue | 8 | 0 | 15 | 5 | 131 |
| Operating expenses | |||||
| Cost of goods sold | 4 | 178 | 126 | 443 | 197 |
| Total cost of goods sold | 178 | 126 | 443 | 197 | 372 |
| Operating costs | |||||
| Wages and social costs | 5 618 | 5 252 | 16 194 | 14 588 | 21 275 |
| Depreciation | 250 | 253 | 719 | 704 | 966 |
| Writedown | 0 | 0 | 0 | 0 | 352 |
| Other operating costs | 3 577 | 3 765 | 14 725 | 13 108 | 17 021 |
| Total other operating costs | 9 445 | 9 269 | 31 638 | 28 400 | 39 614 |
| Total operating costs | 9 623 | 9 395 | 32 081 | 28 597 | 39 986 |
| Operating profit (loss) | -9 615 | -9 395 | -32 066 | -28 591 | -39 856 |
| Financial income | 134 | 156 | 535 | 612 | 738 |
| Financial expenses | 119 | 29 | 419 | 124 | 214 |
| Net financial income/expense | 15 | 128 | 116 | 489 | 524 |
| Pre-tax profit (loss) | -9 600 | -9 268 | -31 950 | -28 103 | -39 332 |
| Income tax costs (benefits) | 0 | 0 | 0 | 0 | 0 |
| NET PROFIT (LOSS) | -9 600 | -9 268 | -31 950 | -28 103 | -39 332 |
| Other comprehensive income | 0 | 0 | 0 | 0 | 0 |
| Comprehensive income | -9 600 | -9 268 | -31 950 | -28 103 | -39 332 |
| Net profit per share (figures in NOK) | 5 | -0.14 | -0.17 | -0.46 | -0.54 |
| Net profit per share after delution (figures in NOK) | 5 | -0.14 | -0.17 | -0.46 | -0.54 |
— 7 —
STATEMENT OF FINANCIAL POSITION
| Note | 2010 | 2009 | 2009 |
|---|---|---|---|
| (figures NOK thousands) | 30 Sept. | 30 Sept. | 31 Dec |
| Assets | |||
| Fixed assets | |||
| Goodwill | 572 | 572 | 572 |
| Software | 1 307 | 1 499 | 1 559 |
| Fixed assets | 1 252 | 1 981 | 1 576 |
| Total non-current assets | 3 131 | 4 053 | 3 707 |
| Current assets | |||
| Inventory | 4 | 2 405 | 2 314 |
| Trade receivables | 15 | 0 | 141 |
| Other receivables | 4 078 | 3 809 | 5 105 |
| Cash and cash equivalents | 10 144 | 7 742 | 35 404 |
| Total current assets | 16 643 | 13 865 | 42 777 |
| Total assets | 19 775 | 17 918 | 46 484 |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Share capital | 2 | 3 512 | 2 712 |
| Paid in equity | 2 | 34 437 | 34 655 |
| Retained earnings | -31 950 | -28 103 | |
| Total equity | 5 998 | 9 264 | |
| Provisions | |||
| Pension liabilities | 3 180 | 2 473 | |
| Total provisions | 3 180 | 2 473 | |
| Other long term liabilities | |||
| Other long term liabilities | 5 373 | 760 | |
| Total other long term liabilities | 5 373 | 760 | |
| Liabilities | |||
| Accounts payable | 1 592 | 1 416 | |
| Social security, VAT etc. payable | 829 | 771 | |
| Other current liabilities | 2 802 | 3 234 | |
| Total current liabilities | 5 223 | 5 421 | |
| Total equity and liabilities | 19 775 | 17 918 |
— 8 —
- 9 -
CASH FLOW STATEMENT
| Note | 2010 | 2009 | 2010 | 2009 | 2009 |
|---|---|---|---|---|---|
| (figures NOK thousands) | Q3 | Q3 | 1 Jan-30 Sept. | 1 Jan-30 Sept. | 1 Jan-30 Dec |
| Cash flow from operating activities | |||||
| Pre-tax profit (loss) | -9 600 | -9 268 | -31 950 | -28 103 | -39 332 |
| Ordinary depreciation | 250 | 253 | 719 | 704 | 966 |
| Impairment of fixed assets | 0 | 0 | 0 | 0 | 352 |
| Fair value granted option rights | 48 | 102 | 144 | 307 | 409 |
| Change in pension scheme liabilities | 203 | 170 | 610 | 511 | 609 |
| Change in inventories, accounts receivable and accounts payable | -1 132 | -1 053 | -1 867 | -2 925 | -988 |
| Change in other short-term receivables and other short-term liabilities | 684 | 1 201 | -878 | 2 063 | 2 296 |
| Net cash flow from operating activities | -9 547 | -8 594 | -33 221 | -27 443 | -35 687 |
| Cash flow from investment activities | |||||
| Acquisitions of fixed assets | -20 | -323 | -144 | -1 127 | -1 394 |
| Net cash flow from investing activities | -20 | -323 | -144 | -1 127 | -1 394 |
| Cash flow from financing activities | |||||
| Contribution of share capital | 2 | 8 648 | 8 431 | 8 648 | 39 883 |
| Proceeds from new loan | 0 | 0 | 0 | 0 | 5 000 |
| Payment of long term liabilities | -101 | -90 | -325 | -294 | -356 |
| Net cash flow from financing activities | -101 | 8 558 | 8 106 | 8 354 | 44 527 |
| Net change in cash and cash equivalents | -9 668 | -359 | -25 260 | -20 216 | 7 446 |
| Cash and cash equivalents | 10 144 | 7 742 | 10 144 | 7 742 | 35 404 |
STATEMENT OF CHANGES IN EQUITY AND NUMBER OF SHARES:
| (figures in NOK/numbers) | Note | Share capital | Share prem. reserve | Other reserves | Other equity | Total equity | Number of shares |
|---|---|---|---|---|---|---|---|
| As at 1st January 2009 | 2 586 826 | 25 825 158 | 0 | 0 | 28 411 984 | 51 736 520 | |
| Fair value granted subscription rights | 0 | 0 | 409 322 | 0 | 409 322 | 0 | |
| Increase of capital - 8th July 2009 | 125 000 | 9 225 000 | 0 | 0 | 9 350 000 | 2 500 000 | |
| Transaction cost | 0 | -702 115 | 0 | 0 | -702 115 | 0 | |
| Increase of capital - 26th November 2009 | 625 000 | 33 750 000 | 0 | 0 | 34 375 000 | 12 500 000 | |
| Transaction cost | 0 | -3 139 705 | 0 | 0 | -3 139 705 | 0 | |
| Comprehensive income 01.01.-31.12.2009 | 0 | 0 | 0 | -39 331 572 | -39 331 572 | 0 | |
| Allocation of comprehensive income | 0 | -38 922 250 | -409 322 | 39 331 572 | 0 | 0 | |
| As at 31st December 2009 | 3 336 826 | 26 036 088 | 0 | 0 | 29 372 916 | 66 736 520 | |
| Fair value granted subscription rights | 0 | 0 | 144 234 | 0 | 144 234 | 0 | |
| Increase of capital - 22nd February 2010 | 2 | 175 000 | 9 450 000 | 0 | 0 | 9 625 000 | 3 500 000 |
| Transaction cost | 0 | -1 193 795 | 0 | 0 | -1 193 795 | 0 | |
| Comprehensive income 01.01.-30.09.2010 | 0 | 0 | 0 | -31 949 897 | -31 949 897 | 0 | |
| As at 30th September 2010 | 3 511 826 | 34 292 293 | 144 234 | -31 949 897 | 5 998 457 | 70 236 520 |
Oslo, 28th of October 2010








Note 1: Presentation
The financial information is prepared in accordance with International Accounting Standard 34 "Interim Financial Reporting" ("IAS 34"). This financial information should be read together with the financial statements for the year ended 31st of December 2009 prepared in accordance with International Financial Reporting Standards ("IFRS").
The accounting policies used and the presentation of the Interim Financial Statements are consistent with those used in the latest Annual Financial Statements.
The preparation of the Interim Financial Statements requires management to make estimates and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities and disclosure of contingent liabilities at the date of the Interim Financial Statements. If in the future such estimates and assumptions, which are based on management's best judgment at the date of the Interim Financial Statements, deviate from the actual circumstances, the original estimates and assumptions will be modified as appropriate in the period in which the circumstances change.
Note 2: Going concern
The financial statement is presented on the going concern assumption under International Financial Reporting Standards. Accordingly, the financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts, the amounts and classification of liabilities, or any other adjustments that might result should the Company be unable to continue as going concern.
After the end of the quarter DiaGenic carried out a conditional private placement of NOK 70 million towards existing and new investors based on a book building process. The conditions are necessary resolutions in the general meeting, registration of the capital increase in the Norwegian Register of Business Enterprises and approved Prospectus. The subscription price in the Private Placement was set to NOK 0.50 per share. Upon registration of the capital increase, the total amount of shares in DiaGenic will increase from 70 236 520 to 210 236 520 shares, each with a nominal value of NOK 0.05 per share. The share capital will increase from NOK 3 511 826 to NOK 10 511 826 at the registration of the capital increase.
The board of directors of DiaGenic has also proposed a subsequent repair offering directed at existing shareholders of the Company that did not participate in the Private Placement. It is proposed to issue up to 60 million shares in the subsequent offering at NOK 0.50 per share directed towards shareholders in the Company as of 6 October 2010 who were not allocated shares in the Private Placement. For the Subsequent Offering it will be proposed to issue subscription rights that will be listed and tradable.
The Private Placement and the Subsequent Offering is conditional upon necessary resolutions in the general meeting. The board of directors have called for an extraordinary general meeting on 29 October 2010 with a proposal to resolve the Private placement and the Subsequent Offering.
Provided that the Private Placement and the Subsequent Offering is approved by the general meeting, the Company will have sufficient working capital for its planned business activities over the next twelve month period.
The Board of Directors confirmed on this basis that the going concern assumption is valid, and that financial statements are prepared in accordance with this assumption.
In February 2010 the Company carried out a share issue with gross proceeds of NOK 9.6 million.
Note 3: Related parties
Transactions with related parties by way of consultancy services took place in the quarter and in the first nine months of 2010. All transactions and agreements are made on commercial terms from the market for goods and services.
Other transactions
Transactions with companies that have connections to related parties are conducted at market terms, based on the principle of arm's length.
figures in NOK
| Supplier | Related party | Q3 | YTD 30 Sep 2010 |
|---|---|---|---|
| Ingmar Kihlstrøm AB | Ingmar Kihlstrøm | 25,757 | 124,647 |
| Investor Corporate AS | Håkon Sæterøy | - | 690,000 |
| Hac Life Sciences | Mina Blair | - | 5,480 |
| Cornucopia AS | Henrik Lund | 90,000 | 255,000 |
| Sum | 1,075,127 |
Note 4: Inventory – figures in thousand NOK
| 30 sept. 2010 | 30 sept. 2009 | |
|---|---|---|
| Inventory | 2,405 | 2,314 |
Inventory is valued at lower of cost and net selling price. Inventory is valued at cost. Inventory obsolescence resulted in a TNOK 268 reduction in inventory value and increased Cost of Goods Sold in the first nine months of 2010.
Note 5: Earnings per share - figures in NOK
The following table shows the changes in number of shares in the first nine months of 2010:
| Ordinary shares | |
|---|---|
| Number of shares as of 1st of January | 66 736 520 |
| Share issue – paid 22.02.2010 | 3 500 000 |
| Number of shares as of 30th of September | 70 236 520 |
| Average number of shares per 30th of September | 69 557 033 |
Note 6: Events after the balance sheet date
At the date of this report, there are no events after the balance sheet date except for the conditional private placement and subsequent offering, which is described in Note 2 above, that will affect the company's position on the balance sheet date which are essential for the company's future financial position.
DiaGenic ASA
Grenseveien 92 • NO - 0663 Oslo • www.diagenic.com • Phone: +47 23 24 89 50 • Fax: +47 23 24 89 59