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Gentian Diagnostics ASA

Quarterly Report Feb 15, 2017

3604_rns_2017-02-15_9ec936e6-03e3-4f21-b045-3ecd37ba8cab.pdf

Quarterly Report

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Interim Report

Q4 2016

&

Preliminary Annual Report

4 th Quarter & Preliminary Annual Report 2016

Gentian Diagnostics AS is a medical diagnostics company listed on Merkur Market, Oslo Stock Exchange with the ticker "GENT-ME".

Gentian is headquartered in Moss, Norway, with a representative office in China and distribution subsidiaries in Sweden and USA.

The subsidiary Gentian AS designs, develops and markets in vitro diagnostic reagents (IVD) based on its proprietary Nanosense technology. The goal is to offer efficient and accurate reagents for major clinical chemistry platforms with a focus within the areas of kidney disease, cardiac disease, inflammation and veterinary medicine. The Nanosense technology will enable users to move assays from low volume immunology platforms to fully automated, high throughput instruments with shorter turnaround times, better workflow and improved cost efficiency.

The subsidiary PreTect AS develops and manufactures molecular diagnostic tests to detect oncogenic activity in cervical samples. The products PreTect SEE and PreTect HPV Proofer contribute to earlier detection of cervical cancers.

HIGHLIGHTS

  • Total revenues of MNOK 31.0 for 2016
  • Plasma calprotectin test on track to be launched in the second half of 2017
  • Continued progress in all development projects
  • Gentian Diagnostics was listed on Merkur Market in December 2016
  • Acquisition of PreTect AS completed in October 2016
  • Successful completion of private placement of MNOK 100 after the balance sheet date

FINANCIAL PERFORMANCE

Comparative numbers for Gentian 2015 in ()

Sales and Geographic Split

Total operating revenue ended at MNOK 9.1 (MNOK 6.1) for 4Q16 and MNOK 31.0 (MNOK 25.6) for 2016.

Sales revenue in 4Q16 ended at MNOK 7.1 (MNOK 5.1), of which MNOK 0.9 came from the recently acquired subsidiary. Sales revenue for the year ended at MNOK 24.5 (MNOK 20.3), a 20,4 % increase compared to 2015.

Geographic split:

MNOK 4Q16 4Q15 1-4Q16 1-4Q15
US 0,4 0,1 1,1 0,9
Europe 3,6 1,5 10,4 6,2
Asia 3,1 3,6 12,9 13,2
Total 7,1 5,1 24,5 20,3

Organic growth was 11.4% on a currency neutral basis for the year.

Other operating revenue ended at MNOK 0.2 (MNOK 0.2) for Gentian for 4Q16, and MNOK 2.5 (MNOK 2.5) for 2016. SkatteFUNN funding ended at MNOK 1.8 (MNOK 0.8) for 4Q16 and MNOK 4.0 (MNOK 2.8) for the full year.

Cost of Goods Sold

COGS ended at MNOK 1.9 for 4Q16 (MNOK 1.1), which represents 27 % (22 %) of sales revenue. As stated in the 3Q16 report, our move to in-house production of key components has been a challenge from an efficiency point of view. However, the gross margin improved from 66 % in 3Q16 to 73 % in 4Q16, which demonstrates that we are on the right path.

For the full year, COGS ended at MNOK 7.5 (MNOK 5.7), which represents 31 % (28 %) of sales revenue.

Immaterial correction of less than 1% in 2Q16.

Total operating expenses

Total operating expenses before capitalization of R&D expenses ended at MNOK 12.1 (MNOK 6.6) for 4Q16 and MNOK 34.4 (MNOK 23.7) for 2016.

Operating costs include total salary and social expenses of MNOK 7.1 (MNOK 4.3) and other expenses of MNOK 5.0 (MNOK 2.3) for 4Q16.For the full year, total salary and social expenses were MNOK 20.1 (MNOK 14.2) and other expenses were MNOK 14.3 (MNOK 9.5). The increase in costs is a planned development as the company is ramping up its R&D- and marketing activities.

Total operating expenses after capitalization of R&D expenses ended at MNOK 9.9 (MNOK 5.9) for 4Q16 and MNOK 31.2 (MNOK 20.5) for the full year.

R&D Expenses

R&D expenses amounted to 34 % (48 %) of total operating expenses before capitalization for 4Q16 and 34 % (57 %) for the full year.

The R&D expenses are not comparable y/y due to reallocation between operating expenses and R&D expenses in 2016.

Earnings

Operating profit before depreciation and amortization (EBITDA) ended at MNOK -2.7 (MNOK -0.9) for 4Q16, and at MNOK -7.8 (MNOK -0.7) for the year.

Net financial income/expense ended at MNOK 0.6 (MNOK -0.1) for 4Q16, and MNOK 1.1 (MNOK -1.3) for the year.

Net profit ended at MNOK -2.8 (MNOK -1.3) for 4Q16 and MNOK -9.0 (MNOK -3.2) for 2016.

Balance Sheet

Cash and cash equivalents as of 31.12.2016 was MNOK 76.0 (MNOK 67.9). Of this, MNOK 1.6 is placed in a collateral account for currency contracts and customs credit, and MNOK 1.3 is

currently held in a deposit account and a tax withholding account. The remaining cash balance, a total of MNOK 73.0, is in current financial assets.

Capitalization of R&D expenses in 4Q16 amounted to MNOK 2.2 (MNOK 0.7), which gives a total capitalization of MNOK 3.2 (MNOK 3.2) for the year.

Accounts receivables as of 31.12.2016 was MNOK 2.9 (MNOK 3.7).

The total value of all currency contracts in 2016 (as of 31.12.2016) was zero. No new currency contracts (neither FX Outright nor NDF) have been entered into during 3Q16.

Cash Flow

Cash flow from operating activities ended at MNOK -8.1 (MNOK -4.6) for the year. The cash flow from operating activities in 4Q16 was MNOK -1.1.

Cash flow from investment activities ended at MNOK -4.3 (MNOK -4.6) for the year and includes the cost of renovation of new and old facilities as well as the acquisition of the new subsidiary in 4Q16. The cash flow from investment activities in 4Q16 was MNOK -2.4.

Cash flow from financial activities ended at MNOK 20.4 (MNOK 75.3).

Net cash and cash equivalents ended at MNOK 76.0 (MNOK 67.9).

OPERATIONAL STATUS

The acquisition of PreTect AS on October 10th 2016 allowed Gentian access to a broader technology platform for medical diagnostics. Gentian now owns a molecular diagnostic technology utilizing mRNA for controlling negative samples from cervix cancer screening. In addition to increasing the revenue base, this technology also contributes to ongoing development projects addressing the market for diagnosis of infectious diseases.

There has been continued progress in our ongoing R&D programs during the fourth quarter. Our development of a homogenous test measuring calprotectin in blood was signed off as optimized on December 19th 2016, and verification and validation has commenced. These are the last steps before receiving a CE mark and the European launch in 2017. Moreover, we have had good progress in all of our three proof-of-concept projects, although none has yet been published as complete.

LISTING ON MERKUR MARKET

Gentian Diagnostics AS got listed on Merkur Market at Oslo Stock Exchange on 14th December 14th 2016 under the ticker "GENT-ME".

OUTLOOK

The company expects launch of gCAL, a turbidimetric test for calprotectin in blood samples (serum and plasma), in the second half of 2017. We also expect to publish results from ongoing and new clinical demonstrations, and to start sales, distribution and regulatory activities. The results from these initiatives will be important for the acceptance in 2018.

Furthermore, we expect that Gentian's R&D department will deliver at least two proofs-of concept in 2017. The company will also initiate proof-of-concept work on a new test.

We have previously announced that our largest distributor in the Chinese market is challenged by new Chinese import regulations for human material. The distributor has put an order due for delivery in March 2017 on hold while waiting for the approval

EVENTS AFTER THE BALANCE SHEET DATE

Gentian Diagnostics AS successfully completed a private placement of MNOK 100.0 in January 2017. The net proceeds from the Private Placement will be used to further develop the Company's distribution platform, pursue selected identified M&A opportunities, as well as for general corporate purposes.

SHAREHOLDER INFORMATION

20 largest shareholders in Gentian Diagnostics AS as of 30.12.2016 according to VPS:

Shareholder Number of Shares %
Holta Life Sciences AS 1 928 496 17,31 %
Salix AS 1 368 630 12,29 %
Safrino AS 1 350 000 12,12 %
Storebrand Vekst 1 030 420 9,25 %
Vingulmork Predictor AS 535 710 4,81 %
Cognitio Invest AS 496 430 4,46 %
Kristianro AS 493 910 4,43 %
Cressida AS 385 000 3,46 %
Silvercoin Industries AS 381 695 3,43 %
Portia AS 375 000 3,37 %
Bård Sundrehagen 357 010 3,21 %
Viola AS 319 990 2,87 %
Statoil Pensjon 313 900 2,82 %
Strawberry Capital AS 300 300 2,70 %
Spar Kapital Investor AS 184 000 1,65 %
Mutus AS 147 210 1,32 %
Fougner Invest AS 110 410 0,99 %
Carpe Diem Afseth AS 92 320 0,83 %
Statoil Forsikring A.S 83 900 0,75 %
Fjelljakt AS 75 000 0,67 %
Employee Shareholders 169 654 1,52 %
Other Shareholders 640 165 5,75 %
Total Shares 11 139 150 100,00 %
2016 2016 2015 2015
(figures in NOK thousands) Q4 01.01-31.12 Q4 01.01-31.12
Operating Revenue
Sales revenue 7 105 24 470 5 149 20 332
Royalties 48 48 - -
Other operating revenue 224 2 471 228 2 496
SkatteFUNN - tax deduction 1 767 3 970 754 2 759
Total Operating Revenue 9 144 30 958 6 130 25 587
Operating Expenses/Costs
Cost of goods sold -1 929 -7 529 -1 106 -5 736
Operating costs -12 073 -34 406 -6 611 -23 709
Capitalization 2 155 3 198 735 3 188
Total Operating Expenses/Costs -11 847 -38 738 -6 982 -26 258
EBIDTA -2 703 -7 779 -852 -671
Depreciation -637 -2 304 -369 -1 219
EBIT -3 340 -10 083 -1 221 -1 890
Financial income/expense 563 1 129 -76 -1 332
Net Profit -2 777 -8 955 -1 297 -3 222

Statement of Comprehensive Income Gentian Group

  1. Quarter Statement of Comprehensive Income is not audited
Statement of Financial Position Gentian Group
----------------------------------------------- -- -- -- -- --
2016 2015
(figures in NOK thousands) 31.12 31.12
Assets
Non-Current Assets
Property, plants and equipment 4 743 974
Capitalized development costs 12 108 10 078
Other intangible assets 14 074 9 514
Shares in other companies 2 000
Financial assets 2 914 22 466
Total Non-Current Assets 35 840 43 032
Current Assets
Inventory 7 546 3 147
Accounts receivables 2 855 3 737
Other receivables 5 311 4 574
Cash and cash equivalents 73 044 45 468
Derivatives - -
Total Currents Assets 88 757 56 926
Total Assets 124 597 99 958
Equity and Liabilities
Equity
Net profit (Loss) 8 955 3 222
Other equity -124 413 -98 284
Equity -115 458 -95 061
Non-Current Liabilities
Interest-bearing loans and dept - -
Total Non-Current Liabilities - -
Current liabilities
Accounts payables -3 163 -1 673
Public dept -1 824 -1 310
Accrued expenses -4 151 -1 211
Derivatives - -702
Bank overdraft - -
Total Current Liabilities -9 138 -4 896
Total Equity and Liabilities -124 597 -99 958
  1. Quarter Statement of Financial Position is not audited

Cash Flow Statement

2016 2015
(figures in NOK thousands) 31.12 31.12
Cash Flow from Operating Activities
Net profit (loss) -8 955 -3 222
Depreciation 2 304 1 219
Change Inventory -3 671 264
Change Accounts Receivables 1 137 -3 233
Change Accounts Payables 877 -503
Change in other short-term receivables/ liabilities 235 848
Net Cash Flow from Operating Activities -8 072 -4 626
Cash Flows from Investment Activities
Acquisition of Property, plant and equipment -3 725 -935
Investment in intangible assets -3 198 -3 188
Investment in other companies* 3 329
Other changes in financial items -702 -499
Net Cash Flow from Investment Activities -4 296 -4 621
Cash Flow from Financial Activities
New debt - 2 500
Down payment of loans - -4 500
Change in Bank overdraft - -4 076
Cash flows from share issues 20 400 81 351
Dividend payment - -
Net Cash Flow from Financial Activities 20 400 75 276
Net Change in Cash and Cash Equivalents 8 033 66 029
Cash flow from last period 67 934 1 962
Currency adjustment -9 -56
Net Cash and Cash Equivalents 75 958 67 934
  1. Quarter Cash Flow Statement is not audited

*Investment in other companies relates to the acquisition of PreTect AS.

Note: 31.12.2015 uses 31.12.2014 as a comparison and starting point in the Cash Flow Statement.

Statement of Changes in Equity

Share Capital Share Premium Other Reserves Other Equity Total Equity
As of 31st December 2014 392 122 8 736 175 1 467 131 -3 200 555 7 394 873
Net profit (loss) -
Proceeds from share issue 18 000 2 475 000 2 493 000
Share Issue Cost -
Other changes in equity -
As of 30th June 2015 410 122 11 211 175 1 467 131 -3 200 555 9 887 873
Net profit (loss) -3 222 155 -3 222 155
Proceeds from share issue 547 761 90 945 087 91 492 848
Share Issue Cost -3 040 819 -3 040 819
Other changes in equity -56 263 -56 263
As of 31st December 2015 957 883 99 115 443 1 467 131 -6 478 973 95 061 484
Net profit (loss) -
Proceeds from share issue 3 400 396 440 399 840
Share Issue Cost -
Other changes in equity -6 223 -6 223
As of 30th June 2016 961 283 99 511 883 - -6 485 196 95 455 101
Net profit (loss) -8 954 604 -8 954 604
Proceeds from share issue 152 632 28 847 448 29 000 080
Share Issue Cost -
Other changes in equity -42 291 -42 291
As of 31st December 2016 1 113 915 128 359 331 - -15 482 091 115 458 286
  1. Quarter Statement of Changes in Equity is not audited

NOTES

Accounting Principles

The interim report for Q4 2016 has been prepared in accordance with IAS 34 Interim Reporting. The accounting policies applied in the interim report corresponds to what was used in preparing the annual financial statements for 2015.

Currency

The Company uses currency rates given by DNB ASA.

Capitalized R&D

There are currently two projects where the Gentian Group is capitalizing R&D expenses.

SkatteFUNN

Gentian calculates and recognizes SkatteFUNN funding continuously in the same year as the cost has incurred, while PreTect recognizes the SkatteFUNN funding when the refund has been received.

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