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Gentian Diagnostics ASA

Quarterly Report Nov 15, 2017

3604_rns_2017-11-15_8ce4284b-15a2-409e-9310-672a362d99a7.pdf

Quarterly Report

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Third quarter 2017 results

Third Quarter 2017 results

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.

Gentian designs, develops and markets in vitro diagnostic reagents (IVD) based on its proprietary NanosenseTM technology. The goal is to offer efficient and accurate reagents within the areas of kidney disease, cardiac disease, inflammation and veterinary medicine. The NanosenseTM 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

  • 66% growth in sales revenue compared to 3Q16, 16 % y/y
  • New patent protection received after end of period

FINANCIAL PERFORMANCE

Comparative numbers for Gentian 2016 in ()

Sales and Geographic Split

Total operating revenue ended at MNOK 8.0 (MNOK 6.0) for 3Q17, and MNOK 24.6 (MNOK 21.8) year to date.

Sales revenue in 3Q17 ended at MNOK 6.7 (MNOK 4.0), a 66 % increase compared to 3Q16. Sales revenue year to date ended at MNOK 20.1 (MNOK 17.3).

Geographic split:

MNOK 3Q17 3Q16 1Q-3Q17 1Q-3Q16
US 0,4 0,2 1,0 0,7
Europe 3,5 1,8 12,3 6,8
Asia 2,7 2,0 6,8 9,8
Total 6,7 4,0 20,1 17,3

Other operating revenue ended at MNOK 0.6 (MNOK 1.1) for 3Q17. SkatteFUNN funding ended at MNOK 0.7 (MNOK 0.9) for 3Q17.

Cost of Goods Sold

COGS ended at MNOK 1.5 (MNOK 1.4) in 3Q17, which represents 23 % (34 %) of sales revenue. Total COGS year to date ended at MNOK 3.8 (MNOK 5.6), which represents 19 % (32 %) of sales revenue. The lower COGS % is due to improved production processes and more sales of products with higher margins.

Total Operating Expenses

Total operating expenses before capitalization of R&D expenses ended at MNOK 11.3 (MNOK 9.2) in 3Q17, and MNOK 33.6 (MNOK 22.3) year to date.

Operating costs include total salary and social expenses of MNOK 7,5 (MNOK 5.5) and other expenses of MNOK 3.7 (MNOK 3.7) for 3Q17. Total salary and social expenses year to date ended at MNOK 20.7 (MNOK 13.1) and other expenses ended at MNOK 12.9 (MNOK 9.3). The increase is according to the planned acceleration of activities.

Total operating expenses after capitalization of R&D expenses ended at MNOK 10.8 (MNOK 8.9) in 3Q17, and MNOK 29.1 (MNOK 21.3) year to date.

R&D Expenses

R&D expenses amounted to 35 % (33 %) of total operating expenses before capitalization for 3Q17, and 35 % (34 %) year to date.

Earnings

Operating profit before depreciation and amortization (EBITDA) ended at MNOK -4.3 (MNOK -4.2) for 3Q17, and MNOK -8.2 (MNOK - 5.1) year to date.

Net financial income/expense ended at MNOK 0.1 (MNOK 0.1) for 3Q17, and MNOK 0.6 (MNOK 0.6) year to date.

Net profit ended at MNOK -5.0 (MNOK -4.7) for 3Q17, and MNOK -9.9 (MNOK -6.2) year to date.

Balance Sheet

Cash and cash equivalents as of 30.09.2017 were MNOK 148.9 (MNOK 56.1). Of this, MNOK 1.6 is placed in a collateral account for currency trading, and MNOK 0.3 is currently held in a deposit account. The remaining cash balance, a total of MNOK 147.0, is placed in both savings accounts and current accounts.

Accounts receivables as of 30.09.2017 were MNOK 5.8 (MNOK 1.1). The increase in accounts receivables is due to some delayed payments, which were received in October, some high sales late in September and a general increase in sales.

Inventory as of 30.09.2017 were MNOK 11.9 (MNOK 6.5). The increase in inventory is due to more products, increased demand and building of security inventory.

Cash Flow

Cash flow from operating activities ended at MNOK -17.8 (MNOK -7.0) year to date and MNOK -6.0 (MNOK -5.1) for 3Q17.

Cash flow from investment activities ended at MNOK -5.3 (MNOK -5.2) year to date and MNOK -1.0 (MNOK -0.8) for 3Q17. Included in investment activities are capitalization of R&D expenses, which in 3Q17 amounted to MNOK 0.5 (MNOK 0.3). This gives a total capitalization of MNOK 4.5 (MNOK 1.0) year to date.

Cash flow from financial activities ended at MNOK 96.1 (MNOK 0.4) year to date and MNOK 0.0 (MNOK 0.0) for 3Q17.

OPERATIONAL STATUS

Product Sales

Sales in 3Q17 showed an increase of 66 % compared to 3Q16, ending the quarter with a sales revenue of MNOK 6.7. The increase is, amongst other things, driven by increased sales of fCAL turbo. The decrease from 2Q17 to 3Q17 of 23 % is due to the 2MNOK one-off order in 2Q17 for Cystatin C from our previous distributor in China.

Year to date, sales revenue ended at 20.1 MNOK, which is 16 % up from the same period in 2016.

R&D

The GCAL test (calprotectin in blood samples) was launched in July, resulting in an increase of available R&D resources to focus on other key projects, such as:

  • Building clinical documentation supporting the use of GCAL
  • Optimizing the G-1001, the new automated assay for heart failure

OUTLOOK 2017

Due to current sales status (YTD) and estimated sales until end of the year, Gentian expects total revenues for 2017 to end moderately higher than in 2016. This is slightly better than communicated at the beginning of the year.

Within R&D, Gentian expects to deliver a proof-of-concept on a new diagnostic test during 4Q17.

EVENTS AFTER THE BALANCE SHEET DATE

On October 3, 2017, the Critical Care and Resuscitation Journal published an article demonstrating the advantage of Gentians new assay product GCAL, testing calprotectin in blood plasma for the prediction and diagnosis of bacterial infections in critically ill patients.

On November 6, 2017, Gentian announced that the PCT (The Patent Cooperation Treaty) authority had decided that our international patent application; PCT/EP2016/067639 entitled "Method for assessing cell surface receptors of blood cells", is patentable in its entire set of claims.

There are no additional events to report after the balance sheet date.

SHAREHOLDER INFORMATION

20 largest shareholders in Gentian Diagnostics AS as of 30.09.2017 according to VPS:

Shareholder Number of Shares %
Holta Life Sciences AS 2 028 502 14,49 %
Salix AS 1 368 630 9,78 %
Safrino AS 1 350 000 9,65 %
Storebrand Vekst 1 240 611 8,86 %
Silvercoin Industries AS 543 986 3,89 %
Vingulmork Predictor AS 535 710 3,83 %
Verdipapirfondet DNB SMB 484 900 3,46 %
Statoil Pensjon 400 131 2,86 %
Vatne Equity AS 394 051 2,82 %
Portia AS 375 000 2,68 %
Arctic Funds PLC 361 945 2,59 %
Bård Sundrehagen 357 010 2,55 %
Strawberry Capital AS 300 300 2,15 %
Kiristianro AS 300 000 2,14 %
Cressida AS 235 000 1,68 %
Spar Kapital Investor AS 234 000 1,67 %
OM Holding AS 209 000 1,49 %
Marstal AS 202 000 1,44 %
DNB NOR Markets 200 000 1,43 %
Mutus AS 187 210 1,34 %
Employee Shareholders 204 266 1,46 %
Other Shareholders 2 484 041 17,75 %
Total Shares 13 996 293 100,00 %
Statement of Comprehensive Income Gentian Group
-- ------------------------------------------------- -- -- --
2017 2017 2016 2016
(figures in NOK thousands) Q3 01.01-30.09 Q3 01.01-30.09
Operating Revenue
Sales revenue 6 666 20 051 4 016 17 343
Royalties - 96 - -
Other operating revenue 608 1 999 1 146 2 247
SkatteFUNN - tax deduction 687 2 451 876 2 203
Total Operating Revenue 7 961 24 597 6 038 21 792
Operating Expenses/Costs
Cost of goods sold -1 510 -3 761 -1 364 -5 584
Operating costs -11 278 -33 555 -9 224 -22 332
Capitalization 493 4 501 317 1 042
Total Operating Expenses/Costs -12 295 -32 815 -10 271 -26 873
EBITDA -4 334 -8 219 -4 233 -5 081
Depreciation -748 -2 239 -591 -1 667
EBIT -5 081 -10 458 -4 824 -6 748
Financial income/expense 106 566 82 566
Net Profit -4 975 -9 892 -4 742 -6 182

3. Quarter Statement of Comprehensive Income in 2017 is not audited

Statement of Financial Position Gentian Group

2017 2016 2016
(figures in NOK thousands) 30.09 31.12 30.09
Assets
Non-Current Assets
Property, plants and equipment 4 777 4 743 3 950
Capitalized development costs 15 701 12 333 10 245
Other intangible assets 13 762 14 126 9 161
Loan to other companies - - -
Financial assets 1 944 1 870 2 389
Total Non-Current Assets 36 184 33 071 25 744
Current Assets
Inventory 11 883 7 546 6 502
Accounts receivables 5 813 2 855 1 126
Other receivables 7 624 5 399 7 656
Cash and cah equivalents 146 961 74 088 53 742
Derivatives - - 78
Total Currents Assets 172 280 89 889 69 104
Total Assets 208 464 122 960 94 848
Equity and Liabilities
Equity
Net profit (Loss) 9 892 8 927 6 182
Other equity -211 600 -124 468 -95 455
Equity -201 708 -115 541 -89 273
Non-Current Liabilities
Interest-bearing loans and dept - - -
Total Non-Current Liabilities - - -
Current liabilities
Accounts payable -3 361 -3 519 -3 484
Public dept -1 000 -1 610 -753
Accrued expenses -2 396 -2 289 -1 338
Derivatives - - -
Bank overdraft - - -
Total Current Liabilities -6 756 -7 419 -5 574
Total Equity and Liabilities -208 464 -122 960 -94 848

3. Quarter Statement of Financial Position is not audited

Cash Flow Statement

2017 2017 2017 2016 2016
(figures in NOK thousands) Q3 Q2 Q1 31.12 30.06
Cash Flow from Operating Activities
Net profit (loss) -4 975 412 -5 329 -8 927 -1 440
- - - - -
Depreciation 748 708 784 2 304 1 076
Change Inventory -832 -1 841 -1 663 -3 671 -1 851
Change Accounts Receivables -1 063 -1 464 -430 1 137 1 732
Change Accounts Payables 177 -503 167 1 234 987
Change in other short-term receivables/ liabilities -90 -1 236 -1 406 21 -2 396
Net Cash Flow from Operating Activities -6 036 -3 924 -7 877 -7 902 -1 893
Cash Flows from Investment Activities
Acquisition of Property, plant and equipment -529 -30 -224 -3 684 -2 942
Investment in intangible assets -493 -1 727 -2 281 -3 422 -725
Investment in other companies - - - 3 329 -
Loan to other companies - 725 -725 - -
Other changes in financial items - - - -702 -729
Net Cash Flow from Investment Activities -1 022 -1 032 -3 230 -4 479 -4 396
Cash Flow from Financial Activities
New debt - - - - -
Downpayment of loans - - - - -
Change in Bankoverdraft - - - - -
Cash flows from share issues - - 96 069 20 400 400
Dividend payment - - - - -
Net Cash Flow from Financial Activities - - 96 069 20 400 400
Net Change in Cash and Cash Equivalents -7 058 -4 955 84 961 8 019 -5 890
Cash flow from last period 155 991 160 947 75 958 67 934 67 934
Currency adjustment -29 - 28 5 -
7
Net Cash and Cash Equivalents 148 905 155 991 160 947 75 958 62 036

3. Quarter Cash Flow Statement is not audited

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

Note: 30.06.2016 and 31.12.2016 uses 31.12.2015 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 2015 957 883 99 115 443 1 467 131 -6 478 973 95 061 484
Net profit (loss) -1 440 373 -1 440 373
Proceeds from share issue 3 400 396 440 399 840
Share Issue Cost -
Other changes in equity -207 -207
As of 30th June 2016 961 283 99 511 883 1 467 131 -7 919 553 94 020 744
Net profit (loss) -7 486 614 -7 486 614
Proceeds from share issue 152 632 28 847 448 29 000 080
Share Issue Cost -
Other changes in equity 7 126 7 126
As of 31st December 2016 1 113 915 128 359 331 1 467 131 -15 399 041 115 541 336
Net profit (loss) -9 892 446 -9 892 446
Proceeds from share issue 285 714 99 714 291 100 000 005
Share Issue Cost -3 931 089 -3 931 089
Other changes in equity -9 783 -9 783
As of 30th September 2017 1 685 343 319 925 735 1 467 131 -34 906 964 201 708 023

3. Quarter Statement of Changes in Equity is not audited

NOTES

Accounting Principles

The interim report for Q3 2017 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 2016.

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. As of 2017 Pretect will recognize SkatteFUNN funding continuously in the same manner as Gentian. 2Q17 is the first quarter where Pretect AS has recognized SkatteFUNN funding and includes funding that should have been recognized during 1Q17. Going forward, Pretect AS will recognize this funding on a quarterly basis.

COGS

The Group had an immaterial correction in COGS of less than 1% in 2Q16 after the 2. quarterly report of 2016 was released.

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