EX-99.3 4 a18-40306_1ex99d3.htm EX-99.3

Exhibit 99.3

 

Condensed consolidated interim financial statements

 

Condensed consolidated income statements for the three and nine month periods ended September 30, 2018 and 2017 and the twelve month period ended December 31, 2017

 

 

 

 

 

 

 

Restated

 

 

 

Restated

 

Restated

 

DKK thousand

 

Note

 

1.7-30.9.18

 

1.7- 30.9.17

 

1.1-30.9.18

 

1.1-30.9.17

 

1.1-31.12.17

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

2

 

0

 

39,089

 

24,858

 

125,799

 

136,322

 

Royatly expenses

 

 

 

0

 

-1,261

 

-3,356

 

-12,742

 

-14,163

 

Research and development expenses

 

 

 

-84,296

 

-69,059

 

-300,468

 

-221,204

 

-324,667

 

Administrative expenses

 

 

 

-9,171

 

-7,936

 

-30,153

 

-30,991

 

-47,470

 

Other operating income

 

3

 

1,098,952

 

96

 

1,099,201

 

493

 

607

 

Operating result

 

 

 

1,005,485

 

-39,071

 

790,082

 

-138,645

 

-249,371

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial income

 

 

 

1,196

 

1,016

 

10,132

 

2,252

 

2,122

 

Financial expenses

 

8

 

-26,357

 

-6,440

 

-42,166

 

-32,334

 

-33,509

 

Result before tax

 

 

 

980,324

 

-44,495

 

758,048

 

-168,727

 

-280,758

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax

 

4

 

-56,543

 

1,375

 

-53,793

 

4,125

 

5,500

 

Net result for the period

 

 

 

923,781

 

-43,120

 

704,255

 

-164,602

 

-275,258

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic earnings per share

 

6

 

30.10

 

-1.51

 

22.95

 

-6.22

 

-9.88

 

Diluted earnings per share

 

6

 

30.03

 

-1.51

 

22.90

 

-6.22

 

-9.88

 

 

Condensed consolidated statements of comprehensive income (loss) for the three and nine month periods ended September 30, 2018 and 2017 and the twelve month period ended December 31, 2017

 

 

 

 

 

 

 

Restated

 

 

 

Restated

 

Restated

 

DKK thousand

 

Note

 

1.7-30.9.18

 

1.7- 30.9.17

 

1.1-30.9.18

 

1.1-30.9.17

 

1.1-31.12.17

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net result for the period

 

 

 

923,781

 

-43,120

 

704,255

 

-164,602

 

-275,258

 

Other comprehensive income

 

 

 

0

 

0

 

0

 

0

 

0

 

Comprehensive result for the period

 

 

 

923,781

 

-43,120

 

704,255

 

-164,602

 

-275,258

 

 


 

Condensed consolidated statements of cash flow for the nine month periods ended September 30, 2018 and 2017

 

 

 

 

 

 

 

Restated

 

DKK thousand

 

 

 

1.1-30.9.18

 

1.1-30.9.17

 

 

 

 

 

 

 

 

 

Net result for the period

 

 

 

704,255

 

-164,602

 

Adjustments for non-cash items

 

 

 

54,376

 

35,855

 

Change in working capital

 

 

 

218,192

 

-24,926

 

Financial income received

 

 

 

4,080

 

1,262

 

Financial expenses paid

 

 

 

-15,847

 

-20,381

 

Sale of future royalties and milestones

 

3

 

-1,276,521

 

0

 

Cash flow from operating activities

 

 

 

-311,465

 

-172,792

 

 

 

 

 

 

 

 

 

Transfer to restricted cash related to the royalty bond

 

8

 

0

 

-60,675

 

Transfer from restricted cash related to the royalty bond

 

8

 

6,124

 

365,795

 

Transfer from restricted cash for royalty bond interest payments

 

 

 

0

 

7,637

 

Sale of future royalties and milestones

 

3

 

1,276,521

 

0

 

Change in deposit

 

 

 

-33

 

-39

 

Sale of securities

 

 

 

74,230

 

0

 

Purchase of property, plant and equipment

 

 

 

-2,657

 

-3,933

 

Sale of fixed assets

 

 

 

0

 

120

 

Cash flow from investing activities

 

 

 

1,354,185

 

308,905

 

 

 

 

 

 

 

 

 

Proceeds from issue of shares related to exercise of warrants

 

 

 

748

 

6,572

 

Proceeds from initial public offering

 

 

 

0

 

567,076

 

Costs related to initial public offering

 

 

 

0

 

-70,892

 

Repayment of royalty bond

 

8

 

-158,311

 

-176,360

 

Cash flow from financing activities

 

 

 

-157,563

 

326,396

 

 

 

 

 

 

 

 

 

Decrease/increase in cash and cash equivalents

 

 

 

885,157

 

462,509

 

Cash and cash equivalents at beginning of period

 

 

 

588,718

 

323,330

 

Exchange rate adjustments

 

 

 

4,737

 

-11,185

 

Cash and cash equivalents at end of period

 

 

 

1,478,612

 

774,654

 

 


 

Condensed consolidated statements of financial position as of September 30, 2018 and December 31, 2017

 

 

 

 

 

 

 

Restated

 

DKK thousand

 

Note

 

September 30,
2018

 

December 31,
2017

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

Plant and machinery

 

 

 

13,266

 

14,855

 

Other fixtures and fittings, tools and equipment

 

 

 

1,910

 

953

 

Leasehold improvements

 

 

 

217

 

304

 

Deposits

 

 

 

2,762

 

2,729

 

Restricted cash

 

 

 

0

 

5,892

 

Other investments

 

10

 

9,662

 

9,312

 

Total non-current assets

 

 

 

27,817

 

34,045

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

Trade receivables

 

 

 

13

 

5,679

 

Prepaid expenses

 

 

 

8,779

 

7,253

 

Income tax receivable

 

 

 

5,500

 

5,500

 

Other receivables

 

 

 

2,349

 

4,979

 

Securities

 

10

 

0

 

75,111

 

Cash and cash equivalents

 

7

 

1,478,612

 

588,718

 

Total current assets

 

 

 

1,495,253

 

687,240

 

 

 

 

 

 

 

 

 

Total assets

 

 

 

1,523,070

 

721,285

 

 

 

 

 

 

 

 

 

EQUITY AND LIABILITIES

 

 

 

 

 

 

 

Share capital

 

5

 

30,759

 

30,751

 

Share premium

 

11

 

1,981,033

 

1,959,199

 

Retained loss

 

 

 

-771,026

 

-1,475,281

 

Equity

 

 

 

1,240,766

 

514,669

 

 

 

 

 

 

 

 

 

Royalty bond

 

8

 

0

 

132,986

 

Non-current liabilities

 

 

 

0

 

132,986

 

 

 

 

 

 

 

 

 

Trade payables

 

 

 

24,511

 

29,428

 

Tax payables

 

 

 

53,793

 

0

 

Royalty bond

 

8

 

0

 

2,748

 

Other liabilities

 

9

 

204,000

 

41,454

 

Current liabilities

 

 

 

282,304

 

73,630

 

 

 

 

 

 

 

 

 

Total liabilities

 

 

 

282,304

 

206,616

 

 

 

 

 

 

 

 

 

Total equity and liabilities

 

 

 

1,523,070

 

721,285

 

 


 

Condensed consolidated statements of changes in equity at September 30, 2018 and 2017

 

 

 

 

 

 

 

Retained

 

 

 

 

 

Share

 

Share

 

loss

 

 

 

DKK thousand

 

capital

 

premium

 

(restated)

 

Total

 

Equity at January 1, 2017

 

26,142

 

1,441,263

 

-1,189,211

 

278,194

 

Restatement

 

0

 

0

 

-10,813

 

-10,813

 

Comprehensive loss for the period

 

 

 

 

 

 

 

 

 

Net loss for the period

 

0

 

0

 

-164,602

 

-164,602

 

Warrants compensation expenses

 

0

 

20,293

 

0

 

20,293

 

Capital increase

 

4,607

 

569,041

 

0

 

573,648

 

Costs related to capital increase

 

0

 

-70,892

 

0

 

-70,892

 

Equity at September 30, 2017

 

30,749

 

1,959,705

 

-1,364,626

 

625,828

 

 

 

 

 

 

 

 

 

 

 

Equity at January 1, 2018

 

30,751

 

1,959,199

 

-1,461,482

 

528,468

 

Restatement

 

0

 

0

 

-13,799

 

-13,799

 

Comprehensive loss for the period

 

 

 

 

 

 

 

 

 

Net profit for the period

 

0

 

0

 

704,255

 

704,255

 

Warrant compensation expenses

 

0

 

21,094

 

0

 

21,094

 

Capital increase

 

8

 

740

 

0

 

748

 

Equity at September 30, 2018

 

30,759

 

1,981,033

 

-771,026

 

1,240,766

 

 

Equity at January 1, 2017 and 2018 have been restated due to certain misstatements. See Note 1 to the condensed consolidated interim financial statements.

 


 

Note 1 — Significant accounting policies and significant accounting estimates and assessments

 

The condensed consolidated interim financial statements of Zealand Pharma A/S (“the Company”) have been prepared in accordance with IAS 34, Interim Financial Reporting, as adopted by EU and the additional Danish requirements for submission of interim reports for companies listed on Nasdaq Copenhagen. The condensed consolidated interim financial statements are presented in Danish kroner (DKK) which is the functional currency of the parent company.

 

Accounting policies

 

The accounting policies used in the condensed consolidated interim financial statements are consistent with those used in the Company’s Annual report for the year ended December 31, 2017, except for clarification to the accounting policy on ‘Other operating income’, included below, and all new, amended or revised accounting standards and interpretations endorsed by the EU effective for the accounting period beginning on January 1, 2018, being IFRS 9 ‘Financial Instruments’ and IFRS 15 ‘Revenue from contracts with customers’.

 

Other operating income comprises the sale of future royalties and milestones, net of directly related costs to the sale, research funding from business partners and government grants. The sale of future royalties and milestones is recognized in accordance with contract terms and on the date which the sale occured. Research funding is recognized in the period when the research activities have been performed, and government grants are recognized periodically when the work supported by the grant has been reported. Government grants are recognized when a final and firm right to the grant has been obtained. Government grants are included in Other operating income, as the grants are considered to be cost refunds.

 

The Group’s implementation of IFRS 9 ‘Financial Instruments’, that replaces IAS 39 ‘Financial Instruments: Recognition and Measurement’, has lead to the implementation of a new impairment model that requires the recognition of impairment provisions based on the “expected credit loss model” rather than the “incurred-loss model.” The majority of Zealand’s receivables are receivables from sales with its strategic partners, Boehringer Ingelheim and Sanofi, and due to the low credit risk in the Group, the new rules have not had a significant impact on the valuation of trade receivables. In the annual report for 2017, Management indicated an expected increase of DKK 5 million to financial liabilities. Based on further analyses, Management has concluded that the current accounting treatment is in line with IFRS 9 ‘Financial Instruments’, hence no impact is recognized as the cost of the amendment to the royalty bond from March 2017 is considered transaction costs, which are deducted in financial liabilities.

 

The Group has implemented IFRS 15 ‘Revenue from Contracts with Customers’ using the modified retrospective approach. IFRS 15 replaces the current standards on revenue (IAS 11 ‘Construction Contracts’ and IAS 18 ‘Revenue’). There is no significant effect on the interim financial statements related to the implementation of IFRS 15 ‘Revenue from Contracts with Customers’. Extended disclosures will be provided in the 2018 Annual report.

 

Significant accounting estimates and assessments

 

In the preparation of the condensed consolidated interim financial statements, Management makes several accounting estimates that form the basis for the presentation, recognition and measurement of the Company’s assets and liabilities.

 

In the application of the Company’s accounting policies, the Management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that

 


 

are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future periods if the revision affects both current and future periods. The estimates used are based on assumptions assessed as reasonable by Management; however, estimates are inherently uncertain and unpredictable. The assumptions can be incomplete or inaccurate, and unexpected events or circumstances might occur. Furthermore, the Company is subject to risks and uncertainties that might result in deviations in actual results compared with estimates.

 

For further information regarding significant accounting estimates and assessments related to revenue recognition and employee incentive programs, please see Note 1 in the Annual Report 2017.

 

No significant changes have been made in accounting estimates and assessments in the period January 1 – September 30, 2018.

 

Restatement

 

The Company has been eligible to receive royalty revenue of 10% on Sanofi’s net sales of Lyxumia® / Adlyxin® (lixisenatide) in countries with a valid IP protection for Zealand and potentially up to USD 100 million in commercial milestones.

 

During Q2 2018 it was determined that royalty revenue from Sanofi recognized from 2013 until Q1 2018 included DKK 17.1 million of royalty revenue on net sales in countries with no valid IP protection for Zealand and therefore revenue has been overstated in this period. As a consequence of this, royalty expenses from 2013 until Q1 2018 were misstated by DKK 2.3 million and therefore royalty expense has been overstated in this same period. Such misstatements have been corrected with retrospective impact and thus comparable periods as of and for the three and nine month periods ended September 30, 2017 and the years ended December 31, 2017, 2016 and, 2015 have been restated to reflect this impact.

 

The nature and impact of each restatement is described below, including tickmarks linking the descriptions to the restated condensed consolidated income statements and condensed consolidated statement of financial position for Zealand.

 

Income statement:

 

A) Revenue

 

Royalty revenue has been restated as Zealand has previously recognized royalty revenue on net sales in countries with no valid IP protection.

 

B) Royalty expenses

 

Royalty expenses comprise contractual amounts due to third parties that are derived from royalty revenue earned from the corresponding collaboration agreements. The restatement on royalty revenue therefore leads to a corresponding restatement of royalty expenses.

 

Statement of financial position:

 

C) Trade receivables and other liabilities

 

The restatement related to trade receivables and other liabilities corresponds to the restatement on royalty revenue and royalty expenses, as discussed in tickmark A and B.

 


 

D) Retained loss

 

The restatement related to net loss for the period amounts to the combined impact of the restatements on royalty revenue and royalty expenses from 2013 through December 2017.

 

Statement of cash flow:

 

The impact of the restatement on the statement of cash flow is solely a reclassification between “Net loss for the period” and “Change in working capital”. The restatement related to net loss for the period amounts to the net impact of the restatements for the respective years on royalty revenue and royalty expenses while the restatement related to working capital for the period amounts to the net impact of the misstatements in trade receivables and other liabilities in the statement of financial position. Hence, there is no impact on the cash flow from operating activities. Based on the above outlined factors, the Company deemed irrelevant to present restated statements of cash flow for the three and nine month periods ended September 30, 2017 and the years ended December 31, 2017, 2016 and 2015.

 

Condensed consolidated income statement for the three month period ended September 30, 2017

 

DKK thousand

 

As originally
reported,
September
30, 2017

 

Restatement

 

Tickmark

 

Amount as
adjusted,
September 30,
2017

 

Revenue

 

40,079

 

-990

 

A

 

39,089

 

Royalty expenses

 

-1,395

 

134

 

B

 

-1,261

 

Research and development expenses

 

-69,059

 

0

 

 

 

-69,059

 

Administrative expenses

 

-7,936

 

0

 

 

 

-7,936

 

Other operating income

 

96

 

0

 

 

 

96

 

Operating loss

 

-38,215

 

-856

 

 

 

-39,071

 

 

 

 

 

 

 

 

 

 

 

Financial income

 

1,016

 

0

 

 

 

1,016

 

Financial expenses

 

-6,440

 

0

 

 

 

-6,440

 

Loss before tax

 

-43,639

 

-856

 

 

 

-44,495

 

 

 

 

 

 

 

 

 

 

 

Income tax benefit

 

1,375

 

0

 

 

 

1,375

 

Net loss for the period

 

-42,264

 

-856

 

 

 

-43,120

 

 

 

 

 

 

 

 

 

 

 

Loss per share - basic (DKK)

 

-1.48

 

-0.03

 

 

 

-1.51

 

Loss per share - diluted (DKK)

 

-1.48

 

-0.03

 

 

 

-1.51

 

 

Condensed consolidated statements of comprehensive income for the three month period ended September 30, 2017

 

DKK thousand

 

 

 

 

 

 

 

 

 

Net loss for the period

 

-42,264

 

-856

 

 

 

-43,120

 

Other comprehensive income (loss)

 

0

 

0

 

 

 

0

 

Net loss for the period

 

-42,264

 

-856

 

 

 

-43,120

 

 


 

Condensed consolidated income statement for the nine month period ended September 30, 2017

 

DKK thousand

 

As originally
reported,
September 30,
2017

 

Restatement

 

Tickmark

 

Amount as
adjusted,
September 30,
2017

 

Revenue

 

128,500

 

-2,701

 

A

 

125,799

 

Royalty expenses

 

-13,107

 

365

 

B

 

-12,742

 

Research and development expenses

 

-221,204

 

0

 

 

 

-221,204

 

Administrative expenses

 

-30,991

 

0

 

 

 

-30,991

 

Other operating income

 

493

 

0

 

 

 

493

 

Operating loss

 

-136,309

 

-2,336

 

 

 

-138,645

 

 

 

 

 

 

 

 

 

 

 

Financial income

 

2,252

 

0

 

 

 

2,252

 

Financial expenses

 

-32,334

 

0

 

 

 

-32,334

 

Loss before tax

 

-166,391

 

-2,336

 

 

 

-168,727

 

 

 

 

 

 

 

 

 

 

 

Income tax benefit

 

4,125

 

0

 

 

 

4,125

 

Net loss for the period

 

-162,266

 

-2,336

 

 

 

-164,602

 

 

 

 

 

 

 

 

 

 

 

Loss per share - basic (DKK)

 

-6.13

 

-0.09

 

 

 

-6.22

 

Loss per share - diluted (DKK)

 

-6.13

 

-0.09

 

 

 

-6.22

 

 

Condensed consolidated statements of comprehensive income for the nine month period ended September 30, 2017

 

DKK thousand

 

 

 

 

 

 

 

 

 

Net loss for the period

 

-162,266

 

-2,336

 

 

 

-164,602

 

Other comprehensive income (loss)

 

0

 

0

 

 

 

0

 

Net loss for the period

 

-162,266

 

-2,336

 

 

 

-164,602

 

 


 

Condensed consolidated income statement for the twelve month period ended December 31, 2017

 

DKK thousand

 

As originally
reported,
December 31,
2017

 

Restatement

 

Tickmark

 

Amount as
adjusted,
December 31,
2017

 

Revenue

 

139,775

 

-3,453

 

A

 

136,322

 

Royalty expenses

 

-14,629

 

466

 

B

 

-14,163

 

Research and development expenses

 

-324,667

 

0

 

 

 

-324,667

 

Administrative expenses

 

-47,470

 

0

 

 

 

-47,470

 

Other operating income

 

607

 

0

 

 

 

607

 

Operating loss

 

-246,384

 

-2,987

 

 

 

-249,371

 

 

 

 

 

 

 

 

 

 

 

Financial income

 

2,122

 

0

 

 

 

2,122

 

Financial expenses

 

-33,509

 

0

 

 

 

-33,509

 

Loss before tax

 

-277,771

 

-2,987

 

 

 

-280,758

 

 

 

 

 

 

 

 

 

 

 

Income tax benefit

 

5,500

 

0

 

 

 

5,500

 

Net loss for the period

 

-272,271

 

-2,987

 

 

 

-275,258

 

 

 

 

 

 

 

 

 

 

 

Loss per share - basic (DKK)

 

-9.77

 

-0.11

 

 

 

-9.88

 

Loss per share - diluted (DKK)

 

-9.77

 

-0.11

 

 

 

-9.88

 

 

Condensed consolidated statements of comprehensive income for the twelve month period ended December 31, 2017

 

DKK thousand

 

 

 

 

 

 

 

 

 

Net loss for the period

 

-272,271

 

-2,987

 

 

 

-275,258

 

Other comprehensive income (loss)

 

0

 

0

 

 

 

0

 

Net loss for the period

 

-272,271

 

-2,987

 

 

 

-275,258

 

 


 

Condensed consolidated income statement for the twelve month period ended December 31, 2016

 

DKK thousand

 

As originally
reported,
December 31,
2016

 

Restatement

 

Tickmark

 

Amount as
adjusted,
December 31,
2016

 

Revenue

 

234,778

 

-3,914

 

A

 

230,864

 

Royalty expenses

 

-31,459

 

528

 

B

 

-30,931

 

Research and development expenses

 

-268,159

 

0

 

 

 

-268,159

 

Administrative expenses

 

-52,503

 

0

 

 

 

-52,503

 

Other operating income

 

1,697

 

0

 

 

 

1,697

 

Operating loss

 

-115,646

 

-3,386

 

 

 

-119,032

 

 

 

 

 

 

 

 

 

 

 

Financial income

 

592

 

0

 

 

 

592

 

Financial expenses

 

-44,356

 

0

 

 

 

-44,356

 

Loss before tax

 

-159,410

 

-3,386

 

 

 

-162,796

 

 

 

 

 

 

 

 

 

 

 

Income tax benefit

 

5,500

 

0

 

 

 

5,500

 

Net loss for the period

 

-153,910

 

-3,386

 

 

 

-157,296

 

 

 

 

 

 

 

 

 

 

 

Loss per share - basic (DKK)

 

-6.33

 

-0.14

 

 

 

-6.47

 

Loss per share - diluted (DKK)

 

-6.33

 

-0.14

 

 

 

-6.47

 

 

Condensed consolidated statements of comprehensive income for the twelve month period ended December 31, 2016

 

DKK thousand

 

 

 

 

 

 

 

 

 

Net loss for the period

 

-153,910

 

-3,386

 

 

 

-157,296

 

Other comprehensive income (loss)

 

0

 

0

 

 

 

0

 

Net loss for the period

 

-153,910

 

-3,386

 

 

 

-157,296

 

 


 

Condensed consolidated income statement for the twelve month period ended December 31, 2015

 

DKK thousand

 

As originally
reported,
December 31,
2015

 

Restatement

 

Tickmark

 

Amount as
adjusted,
December 31,
2015

 

Revenue

 

187,677

 

-5,104

 

A

 

182,573

 

Royalty expenses

 

-22,267

 

689

 

B

 

-21,578

 

Research and development expenses

 

-217,741

 

0

 

 

 

-217,741

 

Administrative expenses

 

-41,824

 

0

 

 

 

-41,824

 

Other operating income

 

12,828

 

0

 

 

 

12,828

 

Operating loss

 

-81,327

 

-4,415

 

 

 

-85,742

 

 

 

 

 

 

 

 

 

 

 

Financial income

 

3,889

 

0

 

 

 

3,889

 

Financial expenses

 

-42,394

 

0

 

 

 

-42,394

 

Loss before tax

 

-119,832

 

-4,415

 

 

 

-124,247

 

 

 

 

 

 

 

 

 

 

 

Income tax benefit

 

5,875

 

0

 

 

 

5,875

 

Net loss for the period

 

-113,957

 

-4,415

 

 

 

-118,372

 

 

 

 

 

 

 

 

 

 

 

Loss per share - basic (DKK)

 

-4.94

 

-0.19

 

 

 

-5.13

 

Loss per share - diluted (DKK)

 

-4.94

 

-0.19

 

 

 

-5.13

 

 

Condensed consolidated statements of comprehensive income for the twelve month period ended December 31, 2015

 

DKK thousand

 

 

 

 

 

 

 

 

 

Net loss for the period

 

-113,957

 

-4,415

 

 

 

-118,372

 

Other comprehensive income (loss)

 

0

 

0

 

 

 

0

 

Net loss for the period

 

-113,957

 

-4,415

 

 

 

-118,372

 

 


 

Condensed consolidated statement of financial position as of December 31, 2017

 

DKK thousand

 

As originally
reported,
December 31,
2017

 

Restatement

 

Tickmark

 

Amount as
adjusted,
December 31,
2017

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

 

Plant and machinery

 

14,855

 

 

 

 

 

14,855

 

Other fixtures and fittings, tools and equipment

 

953

 

 

 

 

 

953

 

Leasehold improvements

 

304

 

 

 

 

 

304

 

Deposits

 

2,729

 

 

 

 

 

2,729

 

Restricted cash

 

5,892

 

 

 

 

 

5,892

 

Other investments

 

9,312

 

 

 

 

 

9,312

 

Total non-current assets

 

34,045

 

0

 

 

 

34,045

 

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

 

Trade receivables

 

21,632

 

-15,953

 

C

 

5,679

 

Prepaid expenses

 

7,253

 

 

 

 

 

7,253

 

Income tax receivable

 

5,500

 

 

 

 

 

5,500

 

Other receivables

 

4,979

 

 

 

 

 

4,979

 

Securities

 

75,111

 

 

 

 

 

75,111

 

Cash and cash equivalents

 

588,718

 

 

 

 

 

588,718

 

Total current assets

 

703,193

 

-15,953

 

 

 

687,240

 

 

 

 

 

 

 

 

 

 

 

Total assets

 

737,238

 

-15,953

 

 

 

721,285

 

 

 

 

 

 

 

 

 

 

 

EQUITY AND LIABILITIES

 

 

 

 

 

 

 

 

 

Share capital

 

30,751

 

 

 

 

 

30,751

 

Share premium

 

1,959,199

 

 

 

 

 

1,959,199

 

Retained loss

 

-1,461,482

 

-13,799

 

D

 

-1,475,281

 

Equity

 

528,468

 

-13,799

 

 

 

514,669

 

 

 

 

 

 

 

 

 

 

 

Royalty bond

 

132,986

 

 

 

 

 

132,986

 

Non-current liabilities

 

132,986

 

0

 

 

 

132,986

 

 

 

 

 

 

 

 

 

 

 

Trade payables

 

29,428

 

 

 

 

 

29,428

 

Royalty bond

 

2,748

 

 

 

 

 

2,748

 

Other liabilities

 

43,608

 

-2,154

 

C

 

41,454

 

Current liabilities

 

75,784

 

-2,154

 

 

 

73,630

 

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

208,770

 

-2,154

 

 

 

206,616

 

 

 

 

 

 

 

 

 

 

 

Total equity and liabilities

 

737,238

 

-15,953

 

 

 

721,285

 

 


 

Condensed consolidated statement of financial position as of December 31, 2016

 

DKK thousand

 

As originally
reported,
December 31,
2016

 

Restatement

 

Tickmark

 

Amount as
adjusted,
December 31,
2016

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

 

Plant and machinery

 

12,081

 

 

 

 

 

12,081

 

Other fixtures and fittings, tools and equipment

 

1,154

 

 

 

 

 

1,154

 

Leasehold improvements

 

408

 

 

 

 

 

408

 

Deposits

 

2,690

 

 

 

 

 

2,690

 

Restricted cash

 

305,120

 

 

 

 

 

305,120

 

Total non-current assets

 

321,453

 

0

 

 

 

321,453

 

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

 

Trade receivables

 

11,510

 

-11,510

 

C

 

0

 

Prepaid expenses

 

13,837

 

 

 

 

 

13,837

 

Income tax receivable

 

5,500

 

 

 

 

 

5,500

 

Other receivables

 

5,379

 

 

 

 

 

5,379

 

Restricted cash

 

13,617

 

 

 

 

 

13,617

 

Cash and cash equivalents

 

323,330

 

 

 

 

 

323,330

 

Total current assets

 

373,173

 

-11,510

 

 

 

361,663

 

 

 

 

 

 

 

 

 

 

 

Total assets

 

694,626

 

-11,510

 

 

 

683,116

 

 

 

 

 

 

 

 

 

 

 

EQUITY AND LIABILITIES

 

 

 

 

 

 

 

 

 

Share capital

 

26,142

 

 

 

 

 

26,142

 

Share premium

 

1,441,263

 

 

 

 

 

1,441,263

 

Retained loss

 

-1,189,211

 

-10,813

 

D

 

-1,200,024

 

Equity

 

278,194

 

-10,813

 

 

 

267,381

 

 

 

 

 

 

 

 

 

 

 

Royalty bond

 

328,878

 

 

 

 

 

328,878

 

Non-current liabilities

 

328,878

 

0

 

 

 

328,878

 

 

 

 

 

 

 

 

 

 

 

Trade payables

 

19,739

 

 

 

 

 

19,739

 

Royalty bond

 

3,365

 

 

 

 

 

3,365

 

Other liabilities

 

64,450

 

-697

 

C

 

63,753

 

Current liabilities

 

87,554

 

-697

 

 

 

86,857

 

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

416,432

 

-697

 

 

 

415,735

 

 

 

 

 

 

 

 

 

 

 

Total equity and liabilities

 

694,626

 

-11,510

 

 

 

683,116

 

 


 

Condensed consolidated statement of financial position as of December 31, 2015

 

DKK thousand

 

As originally
reported,
December 31,
2015

 

Restatement

 

Tickmark

 

Amount as
adjusted,
December 31,
2015

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

 

Plant and machinery

 

14,672

 

 

 

 

 

14,672

 

Other fixtures and fittings, tools and equipment

 

1,153

 

 

 

 

 

1,153

 

Leasehold improvements

 

628

 

 

 

 

 

628

 

Deposits

 

2,666

 

 

 

 

 

2,666

 

Total non-current assets

 

19,119

 

0

 

 

 

19,119

 

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

 

Trade receivables

 

158,158

 

-8,587

 

C

 

149,571

 

Prepaid expenses

 

2,430

 

 

 

 

 

2,430

 

Income tax receivable

 

5,875

 

 

 

 

 

5,875

 

Other receivables

 

10,427

 

 

 

 

 

10,427

 

Restricted cash

 

21,403

 

 

 

 

 

21,403

 

Cash and cash equivalents

 

418,796

 

 

 

 

 

418,796

 

Total current assets

 

617,089

 

-8,587

 

 

 

608,502

 

 

 

 

 

 

 

 

 

 

 

Total assets

 

636,208

 

-8,587

 

 

 

627,621

 

 

 

 

 

 

 

 

 

 

 

EQUITY AND LIABILITIES

 

 

 

 

 

 

 

 

 

Share capital

 

24,353

 

 

 

 

 

24,353

 

Share premium

 

1,263,179

 

 

 

 

 

1,263,179

 

Retained loss

 

-1,035,301

 

-7,428

 

D

 

-1,042,729

 

Equity

 

252,231

 

-7,428

 

 

 

244,803

 

 

 

 

 

 

 

 

 

 

 

Royalty bond

 

312,951

 

 

 

 

 

312,951

 

Non-current liabilities

 

312,951

 

0

 

 

 

312,951

 

 

 

 

 

 

 

 

 

 

 

Trade payables

 

21,676

 

 

 

 

 

21,676

 

Other liabilities

 

49,350

 

-1,159

 

C

 

48,191

 

Current liabilities

 

71,026

 

-1,159

 

 

 

69,867

 

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

383,977

 

-1,159

 

 

 

382,818

 

 

 

 

 

 

 

 

 

 

 

Total equity and liabilities

 

636,208

 

-8,587

 

 

 

627,621

 

 


 

Note 2 — Revenue

 

 

 

 

 

Restated

 

 

 

Restated

 

Restated

 

DKK thousand

 

1.7-30.9.18

 

1.7-30.9.17

 

1.1-30.9.18

 

1.1-30.9.17

 

1.1-31.12.17

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanofi-Aventis Deutschland GmbH

 

0

 

0

 

0

 

69,603

 

69,603

 

Boehringer Ingelheim International GmbH

 

0

 

29,750

 

0

 

29,750

 

29,750

 

Protagonist Therapeutics, Inc.

 

0

 

0

 

0

 

1,662

 

1,662

 

Total license and milestone revenue

 

0

 

29,750

 

0

 

101,015

 

101,015

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanofi-Aventis Deutschland GmbH

 

0

 

9,339

 

24,858

 

24,784

 

35,307

 

Total royalty income

 

0

 

9,339

 

24,858

 

24,784

 

35,307

 

Total revenue

 

0

 

39,089

 

24,858

 

125,799

 

136,322

 

 

Milestone revenue amounted to DKK 0.0 million (101.0) in the first nine months of 2018. The milestone revenue in the first nine months of 2017 primarily related to a USD 10 million milestone for the approval of Suliqua® in the EU in January 2017 and a EUR 4 million milestone from Boehringer Ingelheim related to initiation of Phase 1 with the long-acting amylin analog.

 

DKK 17.8 million (12.0) related to royalty revenue on Sanofi’s sales of Soliqua® 100/33 and DKK 7.1 million (12.8) related to royalty revenue on Sanofi’s sales of Lyxumia® / Adlyxin™ (lixisenatide).

 

Note 3 — Other operating income

 

DKK thousand

 

1.7-30.9.18

 

1.7-30.9.17

 

1.1-30.9.18

 

1.1-30.9.17

 

1.1-31.12.17

 

 

 

 

 

 

 

 

 

 

 

 

 

Sale of future royalties and milestones

 

1,310,237

 

0

 

1,310,237

 

0

 

0

 

Royalty expenses regarding sale of future royalties and milestones

 

-176,882

 

0

 

-176,882

 

0

 

0

 

Fee, advisors regarding sale of future royalties and milestones

 

-34,453

 

0

 

-34,453

 

0

 

0

 

Research funding

 

0

 

27

 

0

 

40

 

40

 

Governments grants

 

50

 

69

 

299

 

453

 

567

 

Total other operating income

 

1,098,952

 

96

 

1,099,201

 

493

 

607

 

 

Zealand has on September 6, 2018 entered into an agreement to sell future royalties and USD 85.0 million of potential commercial milestones for Soliqua® 100/33/ Suliqua® and Lyxumia®/Adlyxin® to Royalty Pharma. Zealand has received USD 205.0 million (DKK 1,310.2 million) upon closing of the transaction on September 17, 2018. Royalty expenses to third parties amounts to 13.5% or DKK 176.9 million and fees to advisors amounts to DKK 34.5 million. Zealand has also redeemed the outstanding royalty bond of USD 24.7 million (DKK 157.6 million), after which Zealand is debt free. Zealand will remain eligible for a payment from Sanofi of up to USD 15.0 million, expected in 2020 (see note 12).

 


 

Note 4 — Tax

 

As a consequence of the sale of future royalties and milestones in Q3 2018, Zealand is no longer eligible to receive up to DKK 5.5 million in income tax benefit for 2018. The tax cost recognized in the income statement for the first nine months of 2018 is calculated on the basis of the accounting profit before tax and an estimated effective tax rate for the Group as a whole for 2018. We expect an effective tax rate of about 7.1% for 2018.

 

As a consequence of tax losses from previous years, no deferred net tax assets have been recognized. Deferred tax reductions (tax assets) have not been recognized in the statement of financial position due to uncertainty as to when and whether they can be utilized.

 

 

 

September 30,
2018

 

December 31,
2017

 

Breakdown of unrecognized deferred tax assets:

 

 

 

 

 

Tax losses carried forward (available indefinitely)

 

457,463

 

873,515

 

Research and development expenses

 

155,103

 

210,148

 

Rights

 

37,642

 

43,019

 

Non-current assets

 

51,699

 

67,590

 

Other

 

101,462

 

104,377

 

Total temporary differences

 

803,369

 

1,298,649

 

 

 

 

 

 

 

Tax rate

 

22

%

22

%

Calculated potential deferred tax asset at local tax rate

 

176,741

 

285,703

 

Write-down of deferred tax asset

 

-176,741

 

-285,703

 

Recognized deferred tax asset

 

0

 

0

 

 

Note 5 — Changes in share capital

 

The following changes have occurred in the share capital during the respective interim periods:

 

 

 

No. of shares

 

Share capital at January 1, 2017

 

26,142,365

 

Capital increase on March 23, 2017

 

9,500

 

Capital increase on April 13, 2017

 

22,000

 

Capital increase on May 30, 2017

 

5,000

 

Capital increase on June 15, 2017

 

8,537

 

Capital increase on August 14, 2017

 

4,375,000

 

Capital increase on August 18, 2017

 

156,250

 

Capital increase on September 1, 2017

 

1,500

 

Capital increase on September 22, 2017

 

28,675

 

Share capital at September 30, 2017

 

30,748,827

 

 

 

 

 

Share capital at January 1, 2018

 

30,751,327

 

Capital increase on September 14, 2018

 

7,500

 

Share capital at September 30, 2018

 

30,758,827

 

 


 

Note 6 — Earnings per share

 

The earnings and weighted average number of ordinary shares used in the calculation of basic and diluted earnings per share are as follows:

 

 

 

 

 

Restated

 

 

 

Restated

 

Restated

 

DKK thousand

 

1.7-30.9.18

 

1.7-30.9.17

 

1.1-30.9.18

 

1.1-30.9.17

 

1.1-31.12.17

 

 

 

 

 

 

 

 

 

 

 

 

 

Net result for the period

 

923,781

 

-43,120

 

704,255

 

-164,602

 

-275,258

 

Net result used in the calculation of basic and diluted earnings per share

 

923,781

 

-43,120

 

704,255

 

-164,602

 

-275,258

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of ordinary shares

 

30,752,713

 

28,811,622

 

30,751,794

 

26,947,290

 

27,918,271

 

Weighted average number of treasury shares

 

-64,223

 

-334,160

 

-64,223

 

-485,468

 

-64,223

 

Weighted average number of ordinary shares used in the calculation of basic earnings per share

 

30,688,490

 

28,477,462

 

30,687,571

 

26,461,822

 

27,854,048

 

Weighted average number of ordinary shares used in the calculation of diluted earnings per share

 

30,760,559

 

28,477,462

 

30,759,640

 

26,461,822

 

27,854,048

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic earnings per share (DKK)

 

30.10

 

-1.51

 

22.95

 

-6.22

 

-9.88

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted earnings per share (DKK)

 

30.03

 

-1.51

 

22.90

 

-6.22

 

-9.88

 

 

The following potential ordinary shares are dilutive at September 30, 2018 (anti-dilutive at September 30, 2017 and December 31, 2017) and are therefore included in the weighted average number of ordinary shares for the purpose of diluted earnings per share:

 

Potential ordinary shares are included at September 30, 2018 due to dilutive effect (excluded at September 30, 2017 and December 31, 2017) related to:

 

 

 

September 30,
2018

 

September 30,
2017

 

December 31,
2017

 

 

 

 

 

 

 

 

 

Outstanding warrants under the 2010 Employee incentive program

 

246,359

 

647,167

 

429,784

 

Outstanding warrants under the 2015 Employee incentive program

 

2,005,000

 

1,442,000

 

1,424,000

 

Total outstanding warrants

 

2,251,359

 

2,089,167

 

1,853,784

 

 

 

 

 

 

 

 

 

- out of which these warrants are dilutive

 

1,201,609

 

0

 

0

 

- out of which these warrants are anti-dilutive

 

1,049,750

 

2,089,167

 

1,853,784

 

 


 

Note 7 - Cash and cash equivalents

 

DKK thousand

 

September 30,
2018

 

December 31,
2017

 

 

 

 

 

 

 

DKK

 

1,184,754

 

12,824

 

USD

 

260,447

 

252,884

 

EUR

 

33,411

 

323,010

 

Total cash and cash equivalents

 

1,478,612

 

588,718

 

 

As of September 30, 2018, Zealand had cash and cash equivalents of DKK 1,478.6 million (December 31, 2017: DKK 588.7 million). In addition, DKK 0.0 million (December 31, 2017: DKK 5.9 million) are held as collateral for the royalty bond. The total cash position, including restricted cash, as of September 30, 2018 is DKK 1,478.6 million (December 31, 2017: DKK 594.6 million).

 

Note 8 — Royalty bond

 

In December 2014, Zealand entered into a USD 50 million royalty bond financing arrangement, based on part of the royalties from lixisenatide as a stand-alone product. The bond carried an interest rate of 9.375%. As security for the royalty bond, certain milestone payments relating to lixisenatide was held as collateral in the form of restricted cash. On March 15, 2017, Zealand used restricted cash of USD 25 million (DKK 175 million) to repay half of the outstanding bond. Furthermore, additional restricted cash of USD 25 million (DKK 175 million) held as collateral for the bond was released to Zealand in exchange for a parent company guarantee.

 

On September 6, 2018 Zealand entered into an agreement to sell future royalties and USD 85 million of potential commercial milestones for Soliqua® 100/33/ Suliqua® and Lyxumia®/Adlyxin® to Royalty Pharma. Zealand has received USD 205.0 million (DKK 1,310.2 million) upon closing of the transaction on September 17, 2018. Zealand has also redeemed the outstanding royalty bond of USD 24.7 million (DKK 157.6 million), after which Zealand is debt free. Zealand will remain eligible for a payment from Sanofi up to USD 15.0 million, expected in 2020 (see note 12).

 

For further information regarding the royalty bond please see note 20 in the Annual Report for 2017.

 

Note 9 — Other liabilities

 

 

 

 

 

Restated

 

 

 

September 30,
2018

 

December 31,
2017

 

 

 

 

 

 

 

Severance payment

 

1,417

 

896

 

Employee benefits

 

17,440

 

28,165

 

Royalty payable to third party

 

179,466

 

763

 

Interest payable on royalty bond

 

0

 

4,295

 

Other payables

 

5,677

 

7,335

 

Total other liabilities

 

204,000

 

41,454

 

 


 

Note 10 - Financial instruments

 

As of September 30, 2018 and December 31, 2017, the following financial instruments are carried at fair value:

 

 

 

September 30,
2018

 

December 31,
2017

 

 

 

 

 

 

 

Securities

 

0

 

75,111

 

Other investments

 

9,662

 

9,312

 

Financial assets measured at fair value

 

9,662

 

84,423

 

 

The fair value of securities is based on Level 1 in the fair value hierarchy.

 

The fair value of other investments is based on level 3 in the fair value hierarchy.

 

Below shows the fair value hierarchy for financial instruments measured at fair value in the balance sheet. The financial instruments in question are grouped into levels 1 to 3 based on the degree to which the fair value is observable.

 

·                  Level 1 fair value measurements are those derived from quoted prices (unadjusted) in active markets for identical assets or liabilities

·                  Level 2 fair value measurements are those derived from input other than quoted prices included within level 1 that are observable for the asset or liability, either directly (as prices) or indirectly (derived from prices)

·                  Level 3 fair value measurements are those derived from valuation techniques that include input for the asset or liability that are not based on observable market data (unobservable input)

 

The carrying amount of financial assets and financial liabilities approximates the fair value.

 

Note 11 — Warrant programs

 

On May 22, 2018, Zealand granted 615,500 new warrants to the Company’s Executive Management, Corporate Management and employees. The warrants give the holders the right to subscribe for 615,500 new Zealand shares with a nominal value of DKK 1 each, corresponding to 2.0% of the Company’s total outstanding share capital. The exercise price is fixed at DKK 100.80, reflecting the closing price of Zealand’s shares on Nasdaq Copenhagen on May 18, 2018.

 

The total number of new warrants granted has a combined market value of DKK 21.1 million calculated on the basis of the Black—Scholes model, including a five-year historic volatility of 42.6%, a five-year historic risk-free interest rate of 0.05% and a share price of DKK 100.80.

 

The exercise of warrants is by default subject to continuing employment with the Group. The warrants granted are subject to the provisions of the Danish Public Companies Act regarding termination of employees prior to their exercise of warrants in the case of recipients who are subject to the act.

 

Warrants expire automatically after five years. Warrants are considered vested at grant date and may be exercised after three years. The exercise of the warrants may take place four times a year

 


 

during a four-week period starting from the time of the publication of Zealand’s annual report or quarterly or semi-annual reports.

 

Effect on income statement

 

For the nine month periods ended September 30, 2018 and 2017, the fair value of warrants recognized in the income statement amounted to DKK 21.1 million (20.3), of which DKK 5.9 million (6.5) related to the Executive Management.

 

DKK thousand

 

1.1-30.9.18

 

1.1-30.9.17

 

 

 

 

 

 

 

Research and development expenses

 

13,761

 

12,261

 

Administrative expenses

 

7,334

 

8,036

 

Total

 

21,094

 

20,297

 

 

Note 12 — Contingent assets

 

Zealand is eligible for a payment from Sanofi of up to USD 15.0 million, expected in 2020. However, it is Management’s opinion that the amount of any payment cannot be determined on a sufficiently reliable basis, and therefore not recognized an asset in the financial position of the Group.

 

Note 13 — Significant events after the end of the reporting period

 

On October 15, 2018, Zealand granted 40,000 new warrants to the Company’s Senior Vice President of Corporate and Business Development, Marino Garcia.

 

The warrants give the holder the rights to subscribe for up to 40,000 new Zealand shares with a nominal value of DKK 1 each, corresponding to 0.13% of the Company’s total outstanding share capital. The exercise price is DKK 90.00, calculated as the closing price of Zealand’s shares on Nasdaq Copenhagen on Friday October 12, 2018.

 

The warrants will vest monthly over a three year period, and the exercise of the warrants may take place, in whole or in part, in defined time windows from October 15, 2021 up to and including October 15, 2023. Zealand may under the contract decide to offer settlement of these 40,000 warrants in cash.

 

The total new warrants granted have a combined market value of DKK 1,313,395.86 calculated on the basis of the Black-Scholes model, including a five-year historic volatility of 42.5%, a five-year risk-free interest rate of -0.03% and a share price of DKK 90.00.

 

Except as noted above, no other significant events have occurred after the end of the reporting period.