EX-99.1 2 prqr-20200930ex9919c6559.htm EX-99.1

Table of Contents

PAGE 1

Unaudited Condensed Consolidated Financial Statements

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Financial Position

September 30, 

December 31, 

2020

2019

€ 1,000

€ 1,000

Assets

  

  

Current assets

  

  

Cash and cash equivalents

88,847

111,950

Prepayments and other receivables

2,759

1,866

Social securities and other taxes

552

850

Total current assets

92,158

114,666

Property, plant and equipment

17,875

2,440

Investments in associates

159

429

Total assets

110,192

117,535

Equity and liabilities

  

  

Equity

  

Equity attributable to owners of the Company

68,626

94,329

Non-controlling interests

(534)

(496)

Total equity

68,092

93,833

Current liabilities

  

  

Borrowings

949

343

Lease liabilities

1,308

508

Derivative financial instruments

1,092

Trade payables

291

445

Current income tax liability

64

Social securities and other taxes

155

108

Pension premiums

2

Deferred income

863

711

Other current liabilities

6,159

8,812

Total current liabilities

10,817

10,993

Borrowings

16,577

12,709

Lease liabilities

14,706

Total liabilities

42,100

23,702

Total equity and liabilities

110,192

117,535

The notes are an integral part of these condensed consolidated financial statements.

   PROQR THERAPEUTICS   

   ZERNIKEDREEF 9   

   2333 CK LEIDEN   

   THE NETHERLANDS   

   +31 88 166 7000   

   WWW.PROQR.COM


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PAGE 2

Unaudited Condensed Consolidated Financial Statements

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Profit or Loss and OCI

(€ in thousands, except share and per share data)

Three month period

Nine month period

ended September 30, 

ended September 30, 

    

2020

2019

  

2020

2019

€ 1,000

€ 1,000

€ 1,000

€ 1,000

Other income

251

530

9,188

1,509

Research and development costs

(8,304)

(11,074)

(29,716)

(32,560)

General and administrative costs

(2,809)

(2,903)

(10,173)

(8,970)

  

  

  

  

Total operating costs

(11,113)

(13,977)

(39,889)

(41,530)

  

  

  

  

Operating result

(10,862)

(13,447)

(30,701)

(40,021)

Finance income and expense

(1,863)

1,375

(2,024)

1,339

Results related to financial liabilities measured at fair value through profit or loss

(305)

(305)

Results related to associates

(84)

(119)

(270)

579

  

  

  

  

Result before corporate income taxes

(13,114)

(12,191)

(33,300)

(38,103)

Income taxes

(75)

(86)

(64)

  

  

  

  

Result for the period

(13,189)

(12,191)

(33,386)

(38,167)

Other comprehensive income

(255)

147

(134)

121

  

  

  

  

Total comprehensive income (attributable to owners of the Company)

(13,444)

(12,044)

(33,520)

(38,046)

Result attributable to

  

  

Owners of the Company

(13,181)

(12,139)

(33,348)

(37,945)

Non-controlling interests

(8)

(52)

(38)

(222)

(13,189)

(12,191)

(33,386)

(38,167)

  

  

  

  

Share information

  

  

  

  

Weighted average number of shares outstanding1

50,143,262

38,912,701

50,017,990

38,902,203

Earnings per share attributable to the equity holders of the Company (expressed in Euro per share)

Basic loss per share1

(0.26)

(0.31)

(0.67)

(0.98)

Diluted loss per share1

(0.26)

(0.31)

(0.67)

(0.98)

The notes are an integral part of these condensed consolidated financial statements.

1.For this period presented in these financial statements, the potential exercise of share options is not included in the diluted earnings per share calculation as the Company was loss-making in all periods. Due to the anti-dilutive nature of the outstanding options, basic and diluted earnings per share are equal in this period.

   PROQR THERAPEUTICS   

   ZERNIKEDREEF 9   

   2333 CK LEIDEN   

   THE NETHERLANDS   

   +31 88 166 7000   

   WWW.PROQR.COM


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PAGE 3

Unaudited Condensed Consolidated Financial Statements

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Changes in Equity

Attributable to owners of the Company

  

Number of
shares

  

Share
Capital

  

Share
Premium

  

Equity settled
Employee
Benefit
Reserve

  

Option
premium on
convertible
loan

  

Translation
Reserve

  

Accumulated
Deficit

  

Total

  

Non-
controlling
interests

  

Total
Equity

 

  

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

Balance at January 1, 2019

 

43,149,987

1,726

235,744

10,780

108

(155,443)

92,915

(230)

92,685

Result for the period

 

(37,945)

(37,945)

(222)

(38,167)

Other comprehensive income

 

121

121

121

Recognition of share-based payments

 

4,614

4,614

4,614

Issuance of ordinary shares

Treasury shares transferred

(40,259)

Share options lapsed

(33)

33

Share options exercised

 

40,259

166

(115)

115

166

166

Balance at September 30, 2019

 

43,149,987

1,726

235,910

15,246

229

(193,240)

59,871

(452)

59,419

Balance at January 1, 2020

 

53,975,838

2,159

287,214

16,551

151

(211,746)

94,329

(496)

93,833

Result for the period

 

(33,348)

(33,348)

(38)

(33,386)

Other comprehensive income

 

(134)

(134)

(134)

Recognition of share-based payments

 

2

283

6,218

6,503

6,503

Issuance of ordinary shares

100,902

2

270

272

272

Treasury shares transferred

(299,615)

Recognition of equity component of convertible loan

280

280

280

Share options lapsed

(63)

63

Share options exercised

299,615

724

(466)

466

724

724

 

  

  

  

  

  

  

  

  

  

  

Balance at September 30, 2020

 

54,076,740

2,163

288,491

22,240

280

17

(244,565)

68,626

(534)

68,092

The notes are an integral part of these condensed consolidated financial statements

   PROQR THERAPEUTICS   

   ZERNIKEDREEF 9   

   2333 CK LEIDEN   

   THE NETHERLANDS   

   +31 88 166 7000   

   WWW.PROQR.COM


Table of Contents

PAGE 4

Unaudited Condensed Consolidated Financial Statements

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Cash Flows

Three month period 

Nine month period

ended September 30, 

ended September 30, 

    

2020

2019

2020

2019

€ 1,000

€ 1,000

€ 1,000

€ 1,000

Cash flows from operating activities

  

  

  

  

Net result

(13,189)

(12,191)

(33,386)

(38,167)

Adjustments for:

— Depreciation

651

506

1,703

1,543

— Share-based compensation

1,676

1,226

6,348

4,614

— Other income

(8,423)

— Financial income and expenses

1,863

(1,375)

2,024

(1,339)

— Results related to associates

84

119

270

(579)

— Results related to financial liabilities measured at fair value through profit or loss

305

305

— Net foreign exchange gain / (loss)

(255)

148

(134)

122

Changes in working capital

(246)

2,718

(3,354)

1,744

Cash used in operations

(9,111)

(8,849)

(34,647)

(32,062)

  

  

  

  

Corporate income tax paid

(157)

(168)

(64)

Interest received

27

90

118

176

Interest paid

(569)

(13)

(607)

(64)

  

  

  

  

Net cash used in operating activities

(9,810)

(8,772)

(35,304)

(32,014)

  

  

  

  

Cash flow from investing activities

  

  

  

  

Purchases of property, plant and equipment

(264)

(32)

(806)

(341)

  

  

  

  

Net cash used in investing activities

(264)

(32)

(806)

(341)

  

  

  

  

Cash flow from financing activities

  

  

  

  

Proceeds from issuance of shares, net of transaction costs

Proceeds from exercise of share options

12

2

724

166

Proceeds from borrowings

579

Proceeds from convertible loans

13,477

13,542

690

Repayment of lease liability

(235)

(290)

(542)

(861)

  

  

  

Net cash generated by/(used in) financing activities

13,254

(288)

14,303

(5)

  

  

  

  

Net increase/(decrease) in cash and cash equivalents

3,180

(9,092)

(21,807)

(32,360)

  

  

  

  

Currency effect cash and cash equivalents

(1,474)

1,420

(1,296)

1,572

Cash and cash equivalents, at beginning of the period

87,141

82,464

111,950

105,580

  

  

  

  

Cash and cash equivalents at the end of the period

88,847

74,792

88,847

74,792

The notes are an integral part of these condensed consolidated financial statements.

   PROQR THERAPEUTICS   

   ZERNIKEDREEF 9   

   2333 CK LEIDEN   

   THE NETHERLANDS   

   +31 88 166 7000   

   WWW.PROQR.COM


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PAGE 5

Unaudited Condensed Consolidated Financial Statements

PROQR THERAPEUTICS N.V.
Notes to Unaudited Condensed Consolidated Financial Statements

1. General information

ProQR Therapeutics N.V., or “ProQR” or the “Company”, is a development stage company domiciled in the Netherlands that primarily focuses on the development and commercialization of novel therapeutic medicines.

Since September 18, 2014, the Company’s ordinary shares are listed on the NASDAQ Global Market under ticker symbol PRQR.

The Company was incorporated in the Netherlands, on February 21, 2012 and was reorganized from a private company with limited liability to a public company with limited liability on September 23, 2014. The Company has its statutory seat in Leiden, the Netherlands. The address of its headquarters and registered office is Zernikedreef 9, 2333 CK Leiden, the Netherlands.

ProQR Therapeutics N.V. is the ultimate parent company of the following entities:

ProQR Therapeutics Holding B.V. (100%);
ProQR Therapeutics I B.V. (100%);
ProQR Therapeutics II B.V. (100%);
ProQR Therapeutics III B.V. (100%);
ProQR Therapeutics IV B.V. (100%);
ProQR Therapeutics VI B.V. (100%);
ProQR Therapeutics VII B.V. (100%);
ProQR Therapeutics VIII B.V. (100%);
ProQR Therapeutics IX B.V. (100%);
ProQR Therapeutics I Inc. (100%);
Amylon Therapeutics B.V. (80%);
Amylon Therapeutics Inc. (80%);

ProQR Therapeutics N.V. is also statutory director of Stichting Bewaarneming Aandelen ProQR (“ESOP Foundation”) and has full control over this entity. ProQR Therapeutics N.V. holds a 20% minority shareholding in Wings Therapeutics Inc.

As used in these condensed consolidated financial statements, unless the context indicates otherwise, all references to “ProQR” or the “Company” refer to ProQR Therapeutics N.V. including its subsidiaries and the ESOP Foundation.

2. Significant Accounting Policies

These condensed consolidated financial statements have been prepared in accordance with IAS 34 - Interim Financial Reporting. Certain information and disclosures normally included in financial statements prepared in accordance with IFRS have been condensed or omitted. Accordingly, these condensed consolidated financial statements should be read in conjunction with the Company’s annual financial statements for the year ended December 31, 2019. In the opinion of management, all adjustments, consisting of normal recurring nature, considered necessary for a fair presentation have been included in the condensed consolidated financial statements.

   PROQR THERAPEUTICS   

   ZERNIKEDREEF 9   

   2333 CK LEIDEN   

   THE NETHERLANDS   

   +31 88 166 7000   

   WWW.PROQR.COM


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PAGE 6

Unaudited Condensed Consolidated Financial Statements

The Company’s financial results have varied substantially, and are expected to continue to vary, from period to period. The Company believes that its ordinary activities are not linked to any particular seasonal factors.

The Company operates in one reportable segment, which comprises the discovery and development of innovative, RNA based therapeutics.

3. Adoption of new and revised International Financial Reporting Standards

The accounting policies adopted in the preparation of the condensed consolidated financial statements are consistent with those applied in the preparation of the Company’s annual financial statements for the year ended December 31, 2019.

New Standards and Interpretations, which became effective as of January 1, 2020, did not have a material impact on our condensed consolidated financial statements.

4. Critical Accounting Estimates and Judgments

In the application of the Company’s accounting policies, 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.

Research and development expenditures

Research expenditures are currently not capitalized but are reflected in the income statement because the criteria for capitalization are not met. At each balance sheet date, the Company estimates the level of service performed by the vendors and the associated costs incurred for the services performed.

Although we do not expect the estimates to be materially different from amounts actually incurred, the understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in reporting amounts that are too high or too low in any particular period.

5. Cash and Cash Equivalents

At September 30, 2020, the Company’s cash and equivalents were € 88,847,000 as compared to € 111,950,000 at December 31, 2019. The cash balances are held at banks with investment grade credit ratings. The cash at banks is at full disposal of the Company.

6. Property, plant and equipment

At September 30, 2020 and December 31, 2019, property plant and equipment consisted of buildings and leasehold improvements, laboratory equipment and other assets. Buildings and leasehold improvements include a right-of-use asset relating to the lease of our Leiden office and laboratory space, with a carrying amount of € 15,923,000 at September 30, 2020 (December 31, 2019: € 606,000).

   PROQR THERAPEUTICS   

   ZERNIKEDREEF 9   

   2333 CK LEIDEN   

   THE NETHERLANDS   

   +31 88 166 7000   

   WWW.PROQR.COM


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PAGE 7

Unaudited Condensed Consolidated Financial Statements

7. Current liabilities

At September 30, 2020 and December 31, 2019, the other current liabilities consisted principally of accruals for services provided by vendors not yet billed, payroll related accruals and other miscellaneous liabilities.

8. Borrowings

September 30, 

December 31, 

    

2020

2019

€ 1,000

€ 1,000

Innovation credit

2,771

7,191

Accrued interest on innovation credit

237

3,124

Convertible notes

14,140

2,473

Accrued interest on convertible notes

378

264

  

  

Total borrowings

17,526

13,052

Current portion

(949)

(343)

16,577

12,709

On June 1, 2012, ProQR was awarded an Innovation credit by the Dutch government, through its agency RVO of the Ministry of Economic Affairs, for the Company’s cystic fibrosis program. Amounts were drawn under this facility in the course of the years 2013 through 2017. The credit covered 35% of the costs incurred in respect of the program up to € 5.0 million. The credit was interest-bearing at a rate of 10% per annum. In June 2020 ProQR received a final waiver of the full amount of the Innovation credit, including accumulated interest. Consequently, the carrying amount of € 8.4 million, including accumulated interest, was recognized in Other Income in the second quarter of 2020.

On December 10, 2018 ProQR was awarded an Innovation credit for the sepofarsen program for LCA 10. Amounts will be drawn under this facility from 2018 through 2021. The total credit of € 4.7 million will be used to conduct the Phase 2/3 clinical study for sepofarsen and to finance efforts to obtain regulatory and ethical market approval (NDA/MAA). The credit, including accrued interest of 10% per annum, is repayable depending on ProQR obtaining market approval for sepofarsen. An amount of € 2.8 million had been received as at September 30, 2020. Accumulated interest amounted to € 0.2 million as at September 30, 2020. The assets that are co-financed with the granted innovation credit are subject to a right of pledge for the benefit of RVO.

Convertible loans

On July 14, 2020, the Company entered into a convertible debt financing agreement with Pontifax Medison Debt Financing. Under the agreement, the Company will have access to up to $ 30 million in convertible debt financing in three tranches of $ 10 million each that will mature over a 54-month period and have an interest-only period of 24 months. One tranch of $ 10 million was drawn down at the end of the current reporting period and is recognized at amortized cost. A second close of the convertible debt financing agreement was completed on August 6, 2020 with Kreos Capital. Under the second agreement, the Company will have access to up to € 15 million in convertible debt financing in three tranches of € 5 million each that will mature over a 54-month period and have an interest-only period of 24 months. One tranche of € 5 million was drawn down at the end of the current reporting.

   PROQR THERAPEUTICS   

   ZERNIKEDREEF 9   

   2333 CK LEIDEN   

   THE NETHERLANDS   

   +31 88 166 7000   

   WWW.PROQR.COM


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PAGE 8

Unaudited Condensed Consolidated Financial Statements

Pontifax and/or Kreos may elect to convert the outstanding loans into ProQR ordinary shares at any time prior to repayment at a fixed conversion price. ProQR also has the ability to convert the loans into its ordinary shares, at the same conversion price, if the Company’s stock price reaches a pre-determined threshold. In connection with the loan agreement, the Company issued to Pontifax and Kreos warrants to purchase up to an aggregate of 302,676 shares of its common stock at a fixed exercise price.

Pontifax’ conversion option and warrants are accounted for as embedded derivatives and are recognized separately from the host contract as financial liabilities at fair value through profit or loss. The host contract is recognized at amortized cost.

The Kreos loan is accounted for as a compound financial instrument. The liability component is recognized at amortized cost. The equity component is initially recognized at fair value as option premium on convertible loan and will not be subsequently remeasured. Kreos’ warrants are accounted for as embedded derivatives and are recognized as financial liabilities at fair value through profit or loss.

Convertible loans were issued to Amylon Therapeutics B.V. and are interest-bearing at an average rate of 8% per annum. They are convertible into a variable number of ordinary shares within 36 months at the option of the holder or the Company in case financing criteria are met. Any unconverted loans become payable on demand after 24 – 36 months in equal quarterly terms.

9. Lease liabilities

At September 30, 2020 and December 31, 2019, lease liabilities consisted of the Company’s lease of office and laboratory facilities at Zernikedreef in Leiden, the Netherlands, where our headquarters and our laboratories are located. A new lease agreement was put in place on July 1, 2020 for a 10-year period, which may be extended for subsequent 5-year terms. The carrying amount of the right-of-use asset is disclosed under note 6 Property, plant & equipment.

10. Shareholders’ equity

The authorized share capital of the Company amounting to € 7,200,000 consists of 90,000,000 ordinary shares and 90,000,000 preference shares with a par value of € 0.04 per share. At September 30, 2020, 54,076,740 ordinary shares were issued and fully paid in cash, of which 3,930,536 were held by the Company as treasury shares (December 31, 2019: 4,230,151).

On November 7, 2018, the Company filed a shelf registration statement, which permitted the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $ 300,000,000 of its ordinary shares, warrants and/or units.

In October 2019, the Company consummated an underwritten public offering of 10,454,545 ordinary shares at an issue price of $ 5.50 per share. The gross proceeds from this offering amounted to € 51,597,000 while the transaction costs amounted to € 3,047,000, resulting in net proceeds of € 48,550,000.

In December 2019, the Company issued 371,306 shares in the aggregate amount of $3.5 million, at $9.43 (€8.51) per share to Ionis Pharmaceuticals, Inc. Under the terms of the agreement, the second installment of the upfront payment in

   PROQR THERAPEUTICS   

   ZERNIKEDREEF 9   

   2333 CK LEIDEN   

   THE NETHERLANDS   

   +31 88 166 7000   

   WWW.PROQR.COM


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PAGE 9

Unaudited Condensed Consolidated Financial Statements

ordinary shares to the Company’s common stock was made to Ionis upon the dosing of the first patient in the phase 1/2 Aurora clinical trial for QR-1123.

On March 31, 2020, the Company entered into a sales agreement, which permitted the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $ 75,000,000 of its ordinary shares that may be issued and sold in one or more at-the-market offerings with Citigroup Global Markets, Inc. and Cantor Fitzgerald & Co. In 2020, no shares were issued pursuant to this ATM facility.

Translation reserve

The translation reserve comprises all foreign currency differences arising from the translation of the financial statements of foreign operations.

Share options

The Company operates an equity-settled share-based compensation plan, which was introduced in 2013. Options may be granted to employees, members of the Supervisory Board, members of the Management Board and consultants. The compensation expenses included in operating costs for this plan in the three month period ended September 30, 2020 were € 1,675,000 (2019: € 1,226,000), of which € 1,108,000 (2019: € 835,000) was recorded in general and administrative costs and € 567,000 (2019: € 391,000) was recorded in research and development costs.

11. Other income

Three month period

ended September 30, 

    

2020

2019

€ 1,000

€ 1,000

Grant income

212

518

Other income

39

12

251

530

In June 2020 ProQR received a final waiver of the full amount of the Innovation credit for the Company’s cystic fibrosis program. Consequently, the carrying amount of €8.4 million, including accumulated interest, was recognized in Other Income in Q2 2020.

On February 9, 2018, the Company entered into a partnership agreement with Foundation Fighting Blindness (FFB), under which FFB has agreed to provide funding of $7.5 million for the pre-clinical and clinical development of QR-421a for Usher syndrome type 2A targeting mutations in exon 13.

In addition, funding was received for the Huntington’s disease program.

Grants are recognized in other income in the same period in which the related R&D costs are recognized.

   PROQR THERAPEUTICS   

   ZERNIKEDREEF 9   

   2333 CK LEIDEN   

   THE NETHERLANDS   

   +31 88 166 7000   

   WWW.PROQR.COM


Table of Contents

PAGE 10

Unaudited Condensed Consolidated Financial Statements

12. Research and development costs

Research and development costs amount to € 8,304,000 for the three month period ended September 30, 2020 (2019: € 11,074,000) and are comprised of allocated employee costs including share-based payments, the costs of materials and laboratory consumables, outsourced activities, license and intellectual property costs and other allocated costs.

13. General and administrative costs

General and administrative costs amount to € 2,809,000 for the three month period ended September 30, 2020 (2019: € 2,903,000).

14. Results related to associates

The results related to associates for the three month period ended September 30, 2020 amount to € 84,000 (2019: € 119,000) and consist of our share of the net losses of Wings Therapeutics Inc.

15. Income taxes

The current income tax liability amounts to € nil at September 30, 2020 (December 31, 2019: € 64,000). No significant temporary differences exist between accounting and tax results. Realization of deferred tax assets is dependent on future earnings, if any, the timing and amount of which are uncertain. Accordingly, the Company has not yet recognized any deferred tax asset related to operating losses.

16. Events after balance sheet date

No significant events have occurred after the balance sheet date.

   PROQR THERAPEUTICS   

   ZERNIKEDREEF 9   

   2333 CK LEIDEN   

   THE NETHERLANDS   

   +31 88 166 7000   

   WWW.PROQR.COM