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Vistin Pharma Interim / Quarterly Report 2017

Oct 27, 2017

3782_rns_2017-10-27_fe87f43c-1ef7-42ef-83ce-59b238215fff.pdf

Interim / Quarterly Report

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VISTIN PHARMA ASA THIRD QUARTER 2017 RESULTS PUBLISHED 27 October 2017

CONTENTS

Vistin Pharma in brief2 Risks and uncertainties 7
Overview 3 Outlook 8
Financial review 5 Share information 8
Operational review6 Condensed Interim Financial Statements 9
Market developments 6

Vistin Pharma in brief

Vistin Pharma is a Norwegian pharmaceutical company producing Active Pharmaceutical Ingredients (APIs) and solid dosage forms for the global pharmaceutical industry.

The Group was established in 2015 when Vistin Pharma AS, a wholly owned subsidiary of Vistin Pharma ASA, acquired the metformin and opioids business and tablet production assets from Weifa AS.

On 2 October 2017, Vistin Pharma sold its opioids and CMO business to TPI Enterprises Limited. Following the sale, Vistin Pharma is a pure play metformin producer, with a strong position in the global metformin market and with significant growth ambitions. Metformin is used as the first line treatment of diabetes 2, a

disease which is expected to grow by 50 per cent towards 2030, and affect more than 500 million people. The global market for metformin is expected to grow by four to five percent per annum and Vistin Pharma is attractively positioned to capture part of this growth.

The Company's head office is located in Oslo, Norway. The shares of Vistin Pharma ASA have been listed on Oslo Axess since August 2015.

Overview

Third quarter highlights

  • Revenue growth of 22% and continued strong demand for metformin
  • Revenue of NOK 46.7 million for the quarter vs. NOK 38.3 million in Q3 2016
  • Sales volumes up 32% when compared to Q3 2016
  • Production running at full capacity
  • Capacity expansion expected on track
  • Expected to be competed in 2019
  • Expansion required to meet growth forecasts from existing and new customers
  • Detailed engineering phase completed and key components to be ordered in Q4
  • Opioids and CMO: Successful completion of sale to TPI Enterprises Limited
  • Preliminary purchase consideration of NOK 159.6 million received on 2 October (including NOK 16.0 million in escrow)
  • Expected net cash effect of NOK 140 150 million (before transaction costs)
  • Financials: Dividend of NOK 7 per share proposed by the Board
  • EGM on 2 November to approve an additional dividend of NOK 7 per share (NOK 119.4m) following the sale of the Opioids and CMO business
  • EBITDA from continuing operations of NOK 4.3 million for Q3
  • Cash balance at 30 September of NOK 33.5 million, and no interest-bearing debt
  • Cash balance at the date of this report is NOK 197.7 million, excluding amount in escrow of NOK 16.0 million

Key figures

Key financial information for continuing operations for Vistin Pharma ASA

(NOK 1 000) Q3 2017 Q3 2016 YTD 2017 YTD2016 FY 2016
Total revenue and income 46 725 39 329 144 225 140 791 173 261
EBITDA 4 265 5 149 21 806 26 726 24 020
Adj. EBITDA* 4 265 5 149 12 996 26 726 25 720
Profit/(loss) from continuing operations 5 616 3 063 12 268 18 652 15 941
Earnings per share for continuing operations (NOK): diluted 0,33 0,18 0,72 1,09 0,93
Total Assets 272 355 271 043 272 355 271 043 279 517
Cash & cash equivalents 33 524 72 709 33 524 72 709 89 440

Historical quarterly performance:

*Adjustments:

  • (1) Q2 2017: EBITDA reduced by NOK 8.8 million for net effect of insurance proceeds of NOK 10.8 million
  • (2) Q4 2016: EBITDA increased by NOK 1.7 million for one-off costs relating to a reactor failure at the metformin plant
  • (3) Q4 2015: EBITDA in Q4 2015 reduced by NOK 8.7 million for settlement received in connection with the acquisition of Weifa AS

Financial review

Vistin Pharma ASA (Group)

Profit and loss

Vistin Pharma had total revenues and other income from continuing operations of NOK 46.7 million in the third quarter 2017, compared to NOK 39.3 million in the third quarter 2016.

EBITDA from continuing operations came to NOK 4.3 million for the third quarter, compared to NOK 5.2 million for the same quarter last year.

Depreciation and amortisation were NOK 0.7 million for the third quarter, compared to NOK 0.5 million for the third quarter of 2016.

Net financial gain was NOK 3.8 million, compared to a net loss of NOK 0.6 million in the same quarter of 2016. The financial gain for the quarter primarily relates to unrealised foreign exchange gains relating to EUR hedging contracts for 2017 and 2018.

Vistin Pharma had an income tax expense of NOK 1.8 million in the third quarter, compared to NOK 1.0 million in the corresponding quarter of 2016.

Net loss from discontinued operations was NOK 2.4 million for the third quarter, compared to a gain of NOK 1.2 million for the third quarter 2016.

Net profit for the quarter was NOK 3.2 million, corresponding to earnings per share of NOK 0.19, compared to net profit of NOK 4.3 million and earnings per share of NOK 0.25, respectively for the same quarter 2016.

Cash Flow

Net cash flow from operating activities in the third quarter was negative NOK 16.9 million, as a result of a net increase in working capital of NOK 17.1 million. Net cash flow from operating activities in the third quarter last year was a positive NOK 18.0 million.

Net decrease in cash and cash equivalents amounted to NOK 26.2 million, after equipment purchases of NOK 9.2 million. In the same quarter last year, there was a net increase in cash and cash equivalents of NOK 17.0 million.

Financial position

Vistin Pharma had total assets of NOK 272.4 million as of 30 September 2017. Cash and cash equivalents amounted to NOK 33.5 million. The figures as of 30 September 2016 were NOK 271.0 million and NOK 72.7 million, respectively.

Total equity as of 30 September 2017 was NOK 182.2 million, compared to NOK 194.4 million as of 30 September 2016. This corresponds to an equity ratio of 66.9 percent (71.7 percent).

Vistin Pharma had no interest-bearing debt as of 30 September 2017.

Following the sale of the opioids and CMO business, the Board has proposed an additional dividend of NOK 7.00 per share (NOK 119.4 million) to be approved by an extraordinary general meeting ("EGM") to be held on 2 November 2017. The dividend will be paid as a repayment of paid-in capital (share premium).

Operational review

Following Vistin Pharma's sale of its opioids and CMO business on 2 October 2017, the Group has only one business segment, which is the sale and production of metformin active pharmaceutical ingredients (API) and the sale of metformin tablets.

Total revenue in the third quarter was NOK 46.7 million, compared to NOK 38.3 million in the same quarter of 2016.

Metformin API volumes sold for the quarter were 31.6 percent higher than in the corresponding quarter 2016. Market prices are stable.

The Company is experiencing a strong underlying demand from key customers. Key drivers for future growth are the number of diabetes patients treated with metformin containing products, and as a result continued volume growth from existing multinational customers, market expansion in Japan, and market penetration in the USA.

Vistin Pharma is producing approximately 3,100MT of metformin HCl annually at its manufacturing plant at Fikkjebakke, Norway, which is currently the plant's maximum capacity. To secure the production capacity needed to meet the expected future long-term demand for metformin HCl, from both existing and potentially new customers, the Company will increase the production capacity by an additional 3,000MT, by installing a second production line. The new production line is expected to be ready for commercial production in 2019. Test production is scheduled for the first

Market developments

Metformin tablets are the most widely prescribed diabetes medication in the world. Approximately 90 per cent of people with diabetes are affected by Type 2 Diabetes (hereinafter T2D). T2D usually occurs in adults, but is increasingly prevalent amongst children and adolescents. The growth in T2D is associated with aging populations, economic development, increasing urbanisation, less healthy diets and reduced physical activity. While a human body suffering from T2D is still able to produce insulin, it becomes resistant so that the insulin is ineffective. Over time, insulin levels may half of 2019. The detailed engineering work has been completed, reconfirming the approximately NOK 120 million capex estimate. Key components will be ordered in the fourth quarter of 2017 and early 2018.

The capacity expansion will be financed through existing cash reserves, cash generation and debt.

In parallel, the Company is working on stretching the current capacity by approximately 300 - 400MT through an efficiency program. The objective is to ensure that Vistin Pharma can meet the expected increase in demand from existing customers until the new 3,000MT capacity is available. At the same time, the Company is focusing on securing volumes from new customer by the time the new line is fully operational.

With the new 3,000MT production capacity installed, the Company expects to grow its current share of the growing global metformin market significantly.

Discontinued operations

Discontinued operations consists of the opioids and CMO business sold to TPI Enterprises subsequent to quarter end. Revenues and other income for the third quarter from discontinued operations were NOK 49.9 million, compared to NOK 48.9 million in the third quarter of 2016.

subsequently become insufficient. Both the insulin resistance and the deficiency lead to high blood glucose levels. According to the International Diabetes Federation (IDF), more than 415 million people are estimated to be living with this condition. This number is expected to increase to 642 million by 2040, with the largest increase in developing economies. Metformin has limited side effects, a long-term safety profile, and is an affordable treatment alternative. Therefore, Metformin is the preferred first line treatment for T2D patients. Metformin is expected to maintain its position as the Gold Standard treatment in the foreseeable future. The global finished product sales of metformin are estimated to increase from USD 2.9 billion in 2015 to approximately USD 4.3 billion in 2025. The market is thus expected to grow by four to five per cent per annum in the coming years. The most significant driver of this growth is an increasing T2D prevalence (source: GlobalData, 2016).

The API market is highly competitive, with manufacturers mainly located in India and China. Approximately 65 per cent of the total volume of metformin API is currently produced in India. Many producers of metformin are operating multipurpose facilities, and there is an underlying unused capacity among the metformin producers that can absorb the growing demand for metformin. According to Vistin Pharma's estimates, the Group currently controls about eight percent of the global metformin market with its annual manufacturing capacity of 3,100MT.

Vistin Pharma is focusing on customers that sell patented products, as well as large professional generic players.

Events after the reporting period

On 2 October, Vistin Pharma announced that the Company had successfully completed the sale of its opioids and CMO business to TPI Enterprises Limited ("TPI").

TPI has paid provisional cash consideration of NOK 159.6 million, which will be adjusted for changes in inventory between the time of signing the Sales and Purchase Agreement and the completion date. The transaction is expected to have a positive net cash effect of NOK 140 – 150 million, before any transaction costs.

As a result of the significant proceeds received from the sale of these activities, the Board has called for an EGM to be held on 2 November, to approve an additional dividend of NOK 7.00 per share (NOK 119.4 million).

Risks and uncertainties

As a pharmaceutical manufacturing company, Vistin Pharma is exposed to several types of risks. Fluctuations in the price and availability of raw materials and the development in foreign exchange (USD and EUR) are among the most prominent. Therefore, risk management is a priority area for the Group. Approximately twothirds of the EUR currency exposure (cash inflow) for 2017 and 2018 has been hedged at an average EUR/NOK rate of 9.17 and 9.28, respectively.

In addition, risk related to regulatory changes and environmental issues concerning emission levels and emission permits represent central risk factors to the Group.

For further information, please refer to the Annual Report for 2016, available on the Group's website www.vistin.com.

Outlook

The metformin business is expected to continue to grow. Diabetes is one of the largest global health emergencies of the 21st century, and metformin is expected to remain the gold standard treatment of type 2 diabetes for the foreseeable future. To meet the expected growth in demand for metformin globally, the Company will increase the current production capacity by another 3,000MT, a doubling from the current capacity. The expansion will be financed through existing cash reserves, cash generation and debt, and will be completed in 2019.

Share information

The Company had 17 054 935 issued shares on 30 September 2017. The 20 largest shareholders control 71.3 percent of the total number of outstanding shares.

Largest shareholders at 19 October 2017

NAME SHAREHOLDING % SHARE
STATE STREET BANK 2 348 717 13,77 %
STRATA MARINE & OFFSHORE* 1 965 943 11,53 %
STOREBRAND VEKST 1 245 828 7,30 %
MP PENSJON 877 870 5,15 %
SKANDINAVISKE ENSKILDA 839 352 4,92 %
HOLMEN SPESIALFOND 800 000 4,69 %
NORDEA 599 489 3,52 %
FERNCLIFF LISTED DAI* 582 282 3,41 %
TVENGE TORSTEIN INGVALD 510 000 2,99 %
SPETALEN ØYSTEIN STRAY* 323 650 1,90 %
HANDELSBANKEN 270 000 1,58 %
DUKAT AS 256 621 1,50 %
DEUTSCHE BANK 250 635 1,47 %
SOLAN CAPITAL AS 225 910 1,32 %
UCITS FUND AKTIA NORDIC MICRO CAP 220 581 1,29 %
NORDBY KJELL ERIK** 200 000 1,17 %
GRANT INVEST AS 184 407 1,08 %
STAAVI TOM RAGNAR PRESTEGÅRD 155 000 0,91 %
MALISE AS 151 750 0,89 %
CAMACA AS 150 000 0,88 %
Total 20 largest shareholders 12 158 035 71,3%
Other shareholders 4 896 900 28,7%
Total number of shares 17 054 935 100,0%

* Board members of Vistin Pharma, or companies controlled by Board members ** Executive management

Consolidated Statement of Comprehensive Income

(NOK 1 000) Note Q3 2017 Q3 2016 YTD 2017 YTD2016 FY 2016
Revenue 46 725 38 265 135 415 139 367 170 513
Other income - 1 063 8 810 1 424 2 748
Total revenue and income 2 46 725 39 329 144 225 140 791 173 261
Cost of materials 15 283 13 099 45 676 46 842 62 299
Payroll expenses 13 328 12 040 39 031 35 594 45 129
Other operating expenses 13 848 9 041 37 712 31 629 41 814
Depreciation, amortisation and impairment 655 492 1 886 1 438 2 086
Operating profit/(loss) 3 610 4 657 19 920 25 288 21 934
Finance income 3 780 - 3 780 - 176
Finance costs - 573 7 558 419 991
Profit/(loss) before tax from continuing operations 7 390 4 084 16 142 24 869 21 119
Income tax expense 1 774 1 021 3 874 6 217 5 178
Profit/(loss) for the period from continuing operations 5 616 3 063 12 268 18 652 15 941
Profit/(loss) for the period from discontinued operations 3 (2 424) 1 207 382 2 044 (3 022)
Profit/(loss) for the period 3 192 4 270 12 650 20 695 12 919
Total comprehensive income for the period 3 192 4 270 12 650 20 695 12 919
Earnings per share (NOK): basic 0,19 0,25 0,74 1,21 0,76
Earnings per share (NOK): diluted 0,19 0,25 0,74 1,21 0,76
Earnings per share for continuing operation (NOK): basic 0,33 0,18 0,72 1,09 0,93
Earnings per share for continuing operations (NOK): diluted 0,33 0,18 0,72 1,09 0,93

Consolidated Statement of Financial Position

(NOK 1 000) Note 30.09.2017 30.09.2016 31.12.2016
ASSETS
Non-current assets
Property, plant & equipment 57 434 46 202 53 552
Total non-current assets 57 434 46 202 53 552
Current assets
Inventory 24 025 86 711 79 316
Trade receivables 64 264 57 005 45 365
Other receivables 9 721 8 416 11 844
Cash & cash equivalents 6
33 524
72 709 89 440
Assets held for sale 83 386 - -
Total current assets 214 921 224 841 225 965
Total Assets 272 355 271 043 279 517
EQUITY AND LIABILITIES
Equity
Share capital 4
17 055
17 055 17 055
Share premium 120 459 137 514 137 514
Retained earnings 44 692 39 818 32 042
Total equity 182 205 194 386 186 610
Non-current liabilities
Deferred tax liabilities 3 996 6 950 2
Other long-term liabilities 13 711 10 332 12 288
Total non-current liabilities 17 708 17 282 12 290
Current liabilities
Trade payables 36 297 29 729 37 459
Tax Payables - - 4 221
Other current liabilities 36 145 29 646 38 937
Total current liabilities 72 442 59 375 80 617
Total liabilities 90 150 76 657 92 907
Total Equity and Liabilities 272 355 271 044 279 517

Statement of Changes in Equity

Share Share Retained
(NOK 1 000) Note capital premium earnings Total equity
Equity as at 01.01.2016 17 055 147 747 19 122 183 924
Total comprehensive income - - 20 695 20 695
Dividend paid - (10 233) - (10 233)
Equity as at 30.09.2016 17 055 137 514 39 817 194 386
Equity as at 31.12.2016 17 055 137 514 32 041 186 610
Total comprehensive income - - 12 650 12 650
Dividend paid 7 - (17 055) - (17 055)
Equity as at 30.09.2017 17 055 120 459 44 692 182 206

Cash Flow Statement

(NOK 1 000) Note Q3 2017 Q3 2016 YTD 2017 YTD 2016 FY 2016
Cash flow from operating activities
Net profit/(loss) before income tax from continuing operations 7 390 4 084 16 142 24 869 21 119
Net profit/(loss) before income tax from discontinued operations 3 (3 190) 1 609 502 2 725 (4 030)
Net profit/(loss) before income tax 4 200 5 693 16 644 27 594 17 089
Income tax paid - - (4 221) (4 915) (4 915)
Depreciation, amortisation and impairment 1 305 1 052 3 711 2 943 4 053
Unrealised foreign currency (gains)/losses (5 349) 661 2 393 (778) (966)
Changes in working capital:
Changes in trade receivables and trade creditors (14 423) 15 866 (20 061) (707) 18 663
Changes in inventory (3 153) (555) (15 979) 6 001 13 396
Changes in other accruals 471 (4 739) (1 642) (1 369) 6 639
Net cash flow from operating activities (16 949) 17 977 (19 154) 28 768 53 959
Cash flow from investing activities
Purchase of equipment (9 235) (979) (19 709) (7 814) (16 274)
Net cash flow from investing activities (9 235) (979) (19 709) (7 814) (16 274)
Cash flow from financing activities
Dividend paid 7 - - (17 055) (10 233) (10 233)
Net cash flow from financing activities - - (17 055) (10 233) (10 233)
Net change in cash and cash equivalents (26 184) 16 998 (55 916) 10 720 27 451
Cash and cash equivalents beginning period 59 708 55 710 89 440 61 989 61 989
Cash and cash equivalents end period 33 525 72 708 33 524 72 709 89 440

Notes to the Condensed Interim Financial Statement

1. Basis of 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 31 December 2016, prepared in accordance with International Financial Reporting Standards ("IFRS"). The presentation of the Interim Financial Statements is consistent with the Annual Financial Statements. The figures are unaudited.

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.

2. Segment reporting

Following the sale of Vistin Pharma's opioids and CMO business, the Group only has one operating segment, which is the sale and production of metformin products, and no segment information is presented in these interim financial statements.

3. Discontinued operations reporting

On 2 October 2017, Vistin Pharma announced that the Company had completed the sale of its opioids and CMO business (collectively, the "Business") to TPI Enterprises Limited ("TPI"). The transaction was completed through a demerger of the Business from Vistin Pharma's subsidiary Vistin Pharma AS to a newly established wholly-owned subsidiary of Vistin Pharma, TPI Norway AS ("TPIN"), and a sale of the shares in TPIN to TPI. The results of the Business are presented below:

(NOK 1 000) Q3 2017 Q3 2016 YTD 2017 YTD 2016 2016
Revenue 46 576 48 908 153 892 160 339 221 512
Other income 3 296 - 5 390 - -
Total operating income 49 872 48 908 159 282 160 339 221 512
Cost of materials 25 711 21 032 76 607 70 320 100 899
Payroll expenses 19 305 19 297 57 394 60 148 87 738
Other operating expenses 7 395 6 411 22 953 25 641 34 938
Depreciation, amortisation and impairment 650 560 1 825 1 505 1 967
Total operating expenses 53 061 47 299 158 780 157 614 225 542
Profit/(loss) before tax from discontinued operations (3 190) 1 609 502 2 725 (4 030)
Income tax expense (765) 402 120 681 (1 007)
Profit/(loss) for the period from discontinued operations (2 424) 1 207 382 2 044 (3 022)

The major classes of assets and liabilities of the Business classified as held for sale as at 30 September are, as follows:

(NOK 1 000) 30.09.2017
Assets
Property, plant & equipment 12 117
Inventory 71 269
Assets held for sale 83 386

The net cash flows incurred by the Business are, as follows:

(NOK 1 000) Q3 2017 Q3 2016 YTD 2017 YTD 2016 FY 2016
Net cash flow from operating activities (2 203) (1 037) (15 925) 5 860 11 734
Net cash flow from investing activities (281) (848) (3 066) (3 510) (3 566)
Net cash flow from financing activities - - - - -
Net cash ( outflow ) inflow (2 484) (1 885) (18 991) 2 350 8 168
Earnings per share for discontinued operation (NOK): basic (0,14) 0,07 0,02 0,12 (0,18)
Earnings per share for discontinued operations (NOK): diluted (0,14) 0,07 0,02 0,12 (0,18)

4. Share capital

Note 4: Issued shares and share capital

Number of shares Share capital
(1 000) (NOK 1 000)
At 01.01.2016 17 055 17 055
At 30 September 2016 17 055 17 055
At 31 December 2016 17 055 17 055
At 30 September 2017 17 055 17 055

5. Interest-bearing debt

Vistin Pharma ASA had no interest bearing debt as of 30 September 2017 (30.09.16: 0)

6. Cash and cash equivalents

(NOK 1 000) 30.09.2017 30.09.2016 31.12.2016
Cash at bank 33 524 72 709 89 440
Cash and cash equivalents 33 524 72 709 89 440

The Group has a restricted bank account of NOK 3.0 million relating to employees withholding taxes.

7. Dividend

On 7 June 2017, Vistin Pharma ASA paid a total dividend of NOK 17,055 million for 2016 (NOK 1.00 per share). The dividend was approved by the Annual General Meeting held on 24 May, and was distributed as a repayment of paid-in capital (share premium).

Following the sale of the opioids and CMO business, the Board has proposed an additional dividend of NOK 7.00 per share (NOK 119.4 million) to be approved by an extraordinary general meeting to be held on 2 November 2017. The dividend will be paid as a repayment of paid-in capital (share premium).