ProQR Therapeutics N.V 6-K, filed Nov 9, 2022
ProQR Therapeutics N.V. (PRQR)
About this 6-K
ProQR Therapeutics N.V filed this 6-K on November 9, 2022.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
November 9, 2022
Commission File Number: 001-36622
PROQR THERAPEUTICS N.V.
Zernikedreef 9
2333 CK Leiden
The Netherlands
Tel: +31 88 166 7000
(Address, Including ZIP Code, and Telephone Number,
Including Area Code, of Registrant’s Principal Executive Offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ⌧ Form 40-F ◻
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ◻
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ◻
Furnished as Exhibit 99.1 to this Report on Form 6-K are the unaudited financial statements of ProQR Therapeutics N.V. (the “Company”) for the three and nine-month periods ended September 30, 2022, and furnished as Exhibit 99.2 to this Report on Form 6-K is a press release of ProQR Therapeutics N.V. dated November 9, 2022, announcing the Company’s results for the three and nine-month periods ended September 30, 2022.
On November 9, 2022, the Company issued a press release titled, “ProQR Announces Third Quarter 2022 Operating and Financial Results,” announcing the Company’s results for the three- and nine-month periods ended September 30, 2022 and providing updates related to business and corporate governance. A copy of this press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
As disclosed in the Company’s press release, on November 9, 2022, the Company announced the appointment of Jurriaan Dekkers as the Company’s Chief Financial Officer. He brings to the role more than 20 years of experience in finance, management and leadership roles in biopharma and healthcare companies, as well as in audit and consulting services. Prior to joining ProQR he most recently served as CFO of AstraZeneca in the Netherlands and CEO of Acerta Pharma (part of the AstraZeneca Group). Mr. Dekkers is a Supervisory Board member at ‘Stichting Kinderpostzegels’ in the Netherlands.
The Company hereby incorporates by reference the information contained herein into the Company’s registration statements on Form F-3 (File No. 333-260775, File No. 333-260780 and File No. 333-248740).
INDEX TO EXHIBITS
Number |
| Description |
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99.1 | | |
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99.2 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| PROQR THERAPEUTICS N.V. | |
| | |
| | |
Date: November 9, 2022 | By: | /s/ Smital Shah |
| | Smital Shah |
| | Chief Financial Officer |
PROQR THERAPEUTICS N.V.
Index to Unaudited Condensed Consolidated Financial Statements
| PAGE |
1 | |
2 | |
3 | |
4 | |
Notes to Unaudited Condensed Consolidated Financial Statements | 5 |
PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Financial Position
| | September 30, | | December 31, |
|
| 2022 |
| 2021 |
| | € 1,000 | | € 1,000 |
Assets | |
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Current assets | |
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Cash and cash equivalents | | | ||
Prepayments and other receivables | | | ||
Other taxes | | | ||
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Total current assets | | | ||
| | | | |
Property, plant and equipment | | | ||
Investments in associates | | — | | |
Investments in financial assets | | | ||
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Total assets | | | ||
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Equity and liabilities | |
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Equity | | | |
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Equity attributable to owners of the Company | | | ||
Non-controlling interests | | ( | | ( |
Total equity | | | ||
| | | | |
Current liabilities | |
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Borrowings | | | ||
Lease liabilities | | | ||
Derivative financial instruments | | | ||
Trade payables | | | ||
Current income tax liability | | — | | — |
Social securities and other taxes | | | ||
Deferred income | | | ||
Other current liabilities | | | ||
| | | | |
Total current liabilities | | | ||
| | | | |
Borrowings | | | ||
Lease liabilities | | | ||
Deferred income | | | ||
| | | | |
Total liabilities | | | ||
| | | | |
Total equity and liabilities | | |
The notes are an integral part of these 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, | ||||
|
| 2022 | | 2021 |
| 2022 | | 2021 |
| | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 |
Revenue | | | | | ||||
| | | | | | | | |
Other income | | | | | ||||
| | | | | | | | |
Research and development costs | | ( | | ( | | ( | | ( |
General and administrative costs | | ( | | ( | | ( | | ( |
Total operating costs | | ( | | ( | | ( | | ( |
| |
| |
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Operating result | | ( | | ( | | ( | | ( |
Finance income and expense | | ( | | | ( | | ( | |
Results related to associates | | — | | ( | | ( | | ( |
Gain on disposal of associate | | — | | — | | — | | |
Results related to derecognition of financial liabilities | | ( | | — | | ( | | — |
Results related to financial liabilities measured at fair value through profit or loss | | | ( | | | ( | ||
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Result before corporate income taxes | | ( | | ( | | ( | | ( |
Income taxes | | ( | | ( | | ( | | ( |
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Result for the period | | ( | | ( | | ( | | ( |
Other comprehensive income (foreign exchange differences on foreign operation) | | | | | ||||
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Total comprehensive income | | ( | | ( | | ( | | ( |
| | | | | | | | |
Result attributable to | |
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Owners of the Company | | ( | | ( | | ( | | ( |
Non-controlling interests | | | ( | | | ( | ||
| | ( | | ( | | ( | | ( |
Total comprehensive income attributable to | | | | | | | | |
Owners of the Company | | ( | | ( | | ( | | ( |
Non-controlling interests | | | ( | | | ( | ||
| | ( | | ( | | ( | | ( |
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Share information | |
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Weighted average number of shares outstanding1 | | | | | ||||
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Earnings per share attributable to owners of the Company (Euro per share) | | | | | | | | |
Basic loss per share1 | | ( | | ( | | ( | | ( |
Diluted loss per share1 | | ( | | ( | | ( | | ( |
The notes are an integral part of these condensed consolidated financial statements.
| 1. |
PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Changes in Equity
| Attributable to owners of the Company | | | | | |||||||||||||||
|
| Number |
| Share |
| Share |
| Equity settled |
| Option |
| Translation |
| Accumulated |
| Total |
| Non- |
| Total |
|
|
| | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 |
Balance at January 1, 2021 |
| | | | | | ( | | ( | | | ( | | |||||||
Result for the period |
| — | | — | | — | | — | | — | | — | | ( | | ( | | ( | | ( |
Other comprehensive income |
| — | | — | | — | | — | | — | | | — | | | — | | |||
Recognition of share-based payments |
| | | | | — | | — | | — | | | — | | ||||||
Issuance of ordinary shares | | | | | — | | — | | — | | — | | | — | | |||||
Treasury shares transferred | | ( | | — | | — | | — | | — | | — | | — | | — | | — | | — |
Share options lapsed | | — | | — | | — | | ( | | — | | — | | | — | | — | | — | |
Share options exercised | | | | | ( | | — | | — | | | | — | | ||||||
| | | | | | | | | | | | | | | | | | | | |
Balance at September 30, 2021 |
| | | | | | | ( | | | ( | | ||||||||
| | | | | | | | | | | | | | | | | | | | |
Balance at January 1, 2022 |
| | | | | | | ( | | | ( | | ||||||||
Result for the period |
| — | | — | | — | | — | | — | | — | | ( | | ( | | | ( | |
Other comprehensive income |
| — | | — | | — | | — | | — | | | — | | | — | | |||
Recognition of share-based payments |
| — | | — | | — | | | — | | — | | — | | | — | | |||
Issuance of ordinary shares | | — | | — | | — | | — | | — | | — | | — | | — | | — | | — |
Treasury shares transferred | | ( | | — | | — | | — | | — | | — | | — | | — | | — | | — |
Share options lapsed | | — | | — | | — | | ( | | — | | — | | | — | | — | | — | |
Share options exercised / RSUs vested | | | — | | | ( | | — | | — | | | | — | | |||||
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Balance at September 30, 2022 |
| | | | | | | ( | | | ( | | ||||||||
The notes are an integral part of these 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, | ||||
| | | | | | | | |
|
| 2022 | | 2021 | | 2022 | | 2021 |
| | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 |
Cash flows from operating activities | |
| |
| |
| |
|
Net result | | ( | | ( | | ( | | ( |
Adjustments for: | | | | | | | | |
— Depreciation | | | | | ||||
— Share-based compensation | | | | | ||||
— Financial income and expenses | | | ( | | | |||
— Results related to associates | | — | | | | |||
— Gain on disposal of associate | | — | | — | | — | | ( |
— Results related to financial liabilities measured at fair value through profit or loss | | ( | | | ( | | ||
— Result related to derecognition of financial liabilities | | | — | | | — | ||
— Income tax expenses | | | | | ||||
| | | | | | | | |
Changes in working capital | | | | | ||||
Cash used in operations | | ( | | ( | | ( | | ( |
| |
| |
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Corporate income tax paid | | ( | | ( | | ( | | ( |
Interest received | | | — | | | |||
Interest paid | | ( | | ( | | ( | | ( |
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Net cash used in operating activities | | ( | | ( | | ( | | ( |
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Cash flow from investing activities | | | | | | | | |
Purchases of property, plant and equipment | | ( | | ( | | ( | | ( |
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Net cash used in investing activities | | ( | | ( | | ( | | ( |
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Cash flow from financing activities | |
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Proceeds from issuance of shares, net of transaction costs | | — | | | — | | ||
Proceeds from exercise of share options | | — | | | | |||
Proceeds from borrowings | | — | | | — | | ||
Repayment of convertible loans | | ( | | — | | ( | | — |
Repayment of lease liability | | ( | | ( | | ( | | ( |
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Net cash (used in)/generated by financing activities | | ( | | | ( | | ||
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Net increase (decrease) in cash and cash equivalents | | ( | | | ( | | ||
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Currency effect cash and cash equivalents | | | | | ||||
Cash and cash equivalents, at beginning of the period | | | | | ||||
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Cash and cash equivalents at the end of the period | | | | | ||||
The notes are an integral part of these 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 biotechnology company domiciled in the Netherlands that primarily focuses on the development of novel therapeutic medicines.
Nasdaq accepted a listing transfer application from ProQR to transfer from Nasdaq Global Market to Nasdaq Capital Markets, effective as of November 2, 2022.
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. ( |
| ● | ProQR Therapeutics I B.V. ( |
| ● | ProQR Therapeutics II B.V. ( |
| ● | ProQR Therapeutics III B.V. ( |
| ● | ProQR Therapeutics IV B.V. ( |
| ● | ProQR Therapeutics V B.V. ( |
| ● | ProQR Therapeutics VI B.V. ( |
| ● | ProQR Therapeutics VII B.V. ( |
| ● | ProQR Therapeutics VIII B.V. ( |
| ● | ProQR Therapeutics IX B.V. ( |
| ● | ProQR Therapeutics I Inc. ( |
| ● | Amylon Therapeutics B.V. ( |
ProQR Therapeutics N.V. is also statutory director of Stichting Bewaarneming Aandelen ProQR (“ESOP Foundation”) and has full control over this entity. The Company holds a
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 the recognition and measurement criteria of IFRS. Certain disclosures required by IAS 34 Interim Financial Statements 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, 2021. In the opinion of management, all events and transactions that are significant to an understanding of the changes in financial position and performance of the Company since the end of the last annual reporting period are disclosed in these 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
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, 2021.
New Standards and Interpretations, which became effective as of January 1, 2022, 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.
The significant judgements made by management in applying the Company’s accounting policies and the key sources of estimation uncertainty were the same as those described in the Company’s annual financial statements for the year ended December 31, 2021.
Revenue recognition for the Eli Lilly collaboration and license agreement
a. Identification of the performance obligation
Note 11 describes the Company’s collaboration and license agreement with Eli Lilly. Under this agreement, ProQR provides Eli Lilly with a license (with a right to sub-license) to exploit compounds resulting from the collaboration. A significant amount of judgement is required to determine whether the license is distinct from the other promises in the contract. The license was concluded not to be distinct from the other promises in the contract based on the following considerations:
| ● | the license has no stand-alone value to Eli Lilly without the Company being involved in the research and development collaboration, and; |
| ● | there are significant interdependencies between the license and the research and development services to be provided by the Company. |
b. Determining the timing of satisfaction of performance obligations
For the Eli Lilly collaboration, the Company recognizes revenue over time, using an input method that estimates the satisfaction of the performance obligation as the percentage of labor hours incurred compared to the total estimated labor hours required to complete the promised services. As our estimate of the total labor hours required is dependent on the evolution of the research and development activities, it may be subject to change. If the progression and/or outcome of certain research and development activities would be different from the assumptions that were made during the preparation of these financial statements, this could lead to material adjustments to the total estimated labor hours, which might result in a reallocation of revenue between current and future periods.
c. Determining the transaction price
The Company applied judgement to determine whether the equity investment made by Eli Lilly in ProQR is part of the transaction price for the collaboration and license agreement. The Company concluded that the premium that Eli Lilly paid above the closing price on the day of entering into the equity investment agreement was paid because of the Company’s existing obligations to deliver research and development services to Eli Lilly under the terms of the collaboration and license agreement. Therefore, the premium paid by Eli Lilly on the equity investment is considered to be part of the transaction price. The contract also includes variable consideration, but no variable consideration was included in the transaction price, as it is not highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
Research and development expenditures
Development 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.
Convertible debt
The terms of our convertible debt agreements are evaluated to determine whether the convertible debt instruments contain both liability and equity components, in which case the instrument is a compound financial instrument. Convertible debt agreements are also evaluated to determine whether they contain embedded derivatives, in which case the instrument is a hybrid financial instrument. Judgement is required to determine the classification of such financial instruments based on the terms and conditions of the convertible debt agreements, the currencies in which the debt instruments are denominated and the Company’s functional currency.
Estimation methods are used to determine the fair values of the liability and equity components of compound financial instruments and to determine the fair value of embedded derivatives included in hybrid financial instruments. The determination of the effective interest used for the host contracts of hybrid financial instruments and the liability components of compound financial instruments is dependent on the outcome of such estimations. Evaluating the reasonableness of these estimations and the assumptions and inputs used in the valuation methods requires a significant amount of judgement and is therefore subject to an inherent risk of error.
5. Cash and cash equivalents
At September 30, 2022, the Company’s cash and cash equivalents were €
6. Property, plant and equipment
At September 30, 2022 and December 31, 2021, 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 €
7. Current liabilities
The following table summarizes details of deferred income at September 30, 2022 and December 31, 2021. The nature of the deferred income relating to Eli Lilly and Yarrow is described in Note 11.
| | September 30, | | December 31, |
| | 2022 | | 2021 |
| | | | |
|
| 2022 |
| 2021 |
| | € 1,000 | | € 1,000 |
| | | | |
Eli Lilly up-front payment and premium on equity consideration | | | ||
Yarrow up-front payment and premium on equity consideration | | — | | |
Foundation for Fighting Blindness grant | | | ||
Horizon 2020 grant | | — | | |
| | | | |
Total deferred income | | | ||
Current portion | | ( | | ( |
| | |
At September 30, 2022, other current liabilities amount to €
8. Borrowings
| | September 30, | | December 31, |
|
| 2022 |
| 2021 |
| | € 1,000 | | € 1,000 |
Innovation credit | | | ||
Accrued interest on innovation credit | | | ||
Convertible notes | | | ||
Accrued interest on convertible notes | | | ||
| |
| |
|
Total borrowings | | | ||
Current portion | | ( | | ( |
Non-current portion | | |
On December 10, 2018 ProQR was awarded an Innovation credit for the sepofarsen program for LCA 10. Amounts were drawn under this facility from 2018 through 2022. The credit was 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
Convertible loans
In July 2020, the Company entered into a convertible debt financing agreement with Pontifax Medison Debt Financing. Under the agreement, the Company had access to up to $
A second close of the convertible debt financing agreement was completed in August 2020 with Kreos Capital. Under the second agreement, the Company had access to up to €
In connection with the loan agreement, the Company issued to Pontifax and Kreos warrants to purchase up to an aggregate of
On December 29, 2021, the Company amended its convertible debt financing agreement with the Lenders. Under the amended agreement the Company drew down an additional $
In connection with the loan agreement, the Company issued to the Lenders warrants to purchase up to an aggregate of
In September 2022, ProQR extinguished its debt with Pontifax and Kreos by repaying all outstanding principal amounts. In addition, an early repayment penalty was incurred. The results related to the derecognition of these financial liabilities are disclosed in note 17.
Pontifax’ and Kreos’ warrants remain in place until their
Convertible loans were issued to Amylon Therapeutics B.V. (‘Amylon’) and are interest-bearing at an average rate of
In 2022, Amylon entered into waiver agreements with certain lenders. Such lenders’ loan agreements with Amylon are severed and any claims to repayment of any outstanding debt and accumulated interest are renounced. The total amount of convertible loans and accumulated interest waived under these agreements in 2022 year-to-date is €
9. Lease liabilities
At September 30, 2022 and December 31, 2021, lease liabilities primarily consisted of the Company’s lease of office and laboratory facilities at Zernikedreef in Leiden, the Netherlands.
The lease agreement for our Leiden headquarters, where our main offices and laboratories are located, was put in place on July 1, 2020 and the current lease term is
10. Shareholders’ equity
The authorized share capital of the Company amounting to €
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 $
In April 2021, the Company consummated an underwritten public offering of
In September 2021, the Company issued
On November 4, 2021, 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 $
On November 4, 2021, 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 $
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 and RSUs 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 nine month period ended September 30, 2022 were €
11. Revenue
Eli Lilly
In September 2021, the Company entered into a global licensing and research collaboration with Eli Lilly and Company (‘Eli Lilly’) focused on the discovery, development, and commercialization of potential new medicines for genetic disorders in the liver and nervous system. ProQR and Eli Lilly use ProQR’s proprietary Axiomer® RNA editing platform to progress new drug targets toward clinical development and commercialization.
Under the terms of the agreement, ProQR received an upfront payment and equity consideration, and is eligible to receive milestone payments and royalties on the net sales of any resulting products. In September 2021, the Company issued
With regard to its collaboration with Eli Lilly, the Company concluded as follows:
| ● | There is one single performance obligation under IFRS 15, which is the transfer of a license combined with the performance of research and development activities. The Company concluded that the license is not capable of being distinct and is not distinct in the context of the contract. |
| ● | The transaction price of this agreement currently only includes fixed parts, consisting of an up-front fee and an equity component. The agreement also contains variable parts, but those are not yet included in the transaction price. Milestone payments will only be included to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the milestones is subsequently resolved. Sales-based milestones and sales-based royalties will be included as the underlying sales occur. |
| ● | The Company recognizes revenue over time, using an input method that estimates the satisfaction of the performance obligation as the percentage of labor hours incurred compared to the total estimated labor hours required to complete the promised services. |
Yarrow Biotechnology
In May 2021, the Company entered into an exclusive worldwide license and discovery collaboration for an undisclosed target with Yarrow Biotechnology, Inc. (“Yarrow”). Under the terms of the agreement, ProQR received an upfront payment, equity consideration and reimbursement for ongoing R&D services. ProQR is also eligible to receive milestone payments and royalties on the net sales of any resulting products. In May 2021, ProQR received an up-front payment of €
With regard to its collaboration with Yarrow, the Company concluded as follows:
| ● | There is one single performance obligation under IFRS 15, which is the transfer of a license combined with the performance of research and development activities. The Company concluded that the license is not capable of being distinct and is not distinct in the context of the contract. |
| ● | The transaction price of this agreement currently includes both fixed and variable parts. The fixed part consists of an up-front fee and an equity component. The variable part consists of a cost reimbursement for research and development activities. The agreement also contains other variable parts, but those are not yet included in the transaction price. Milestone payments will only be included to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the milestones is subsequently resolved. Sales-based milestones and sales-based royalties will be included as the underlying sales occur. |
| ● | The Company recognizes revenue over time, using an input method that estimates the satisfaction of the performance obligation as the percentage of labor hours incurred compared to the total estimated labor hours required to complete the promised services. |
The Yarrow collaboration was terminated in Q3 2022.
| | Nine month period | ||
| | ended September 30, | ||
| | | | |
|
| 2022 | | 2021 |
| | € 1,000 | | € 1,000 |
| | | | |
Eli Lilly collaboration revenue | | | ||
Yarrow collaboration revenue | | | ||
| | | ||
The revenues relating to providing IP licenses and research and development services under the Company’s collaboration agreements have no directly associable cost of sales. Costs incurred to fulfill the associated performance obligations are recognized in research and development expenses, due to their being part of the Company’s primary activities of biopharmaceutical research and development.
12. Other income
| | Nine month period | ||
| | ended September 30, | ||
|
| 2022 | | 2021 |
| | € 1,000 | | € 1,000 |
| | | | |
Grant income | | | ||
Other income | | | ||
| | | ||
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 $
Grants are recognized in other income in the same period in which the related R&D costs are recognized.
13. Research and development costs
Research and development costs amount to €
14. General and administrative costs
General and administrative costs amount to €
15. Investments in associates and results related to associates
As disclosed in note 11, in May 2021, the Company obtained an
The results related to associates for the nine month period ended September 30, 2022 amounting to a loss of €
16. Investment in financial asset and gain on disposal of associate
In January 2021, Wings Therapeutics Inc. merged into Phoenicis Therapeutics Inc. by means of a non-cash transaction. ProQR holds a
The net gain on disposal of associate for the nine month period ended September 30, 2021 of €
17. Results related to derecognition of financial liabilities
| | Nine month period | ||
| | ended September 30, | ||
|
| 2022 | | 2021 |
| | € 1,000 | | € 1,000 |
| | | | |
Gain on waiver of Amylon convertible loans | | | — | |
Loss on extinguishment of Pontifax and Kreos convertible loans | | ( | | — |
| | ( | | — |
18. Income taxes
The current income tax liability amounts to €
Tax losses may be carried forward indefinitely. However, the offset of losses will be limited in a given year against the first € 1 million of taxable profit. For taxable profit in excess of this amount, losses may only be offset up to 50% of this excess.
19. Events after balance sheet date
No significant events occurred after the balance sheet date.
Exhibit 99.2
ProQR Announces Third Quarter 2022 Operating and Financial Results
| ● | Development of Axiomer® RNA base editing technology platform continues across multiple therapeutic areas; initial pipeline targets to be disclosed in early 2023 with Analyst and Investor R&D event to be held in Q1 2023 |
| ● | Management Team appointments and planned additions to the Supervisory Board further strengthen leadership |
| ● | Repayment of debt with cash runway into 2026 |
LEIDEN, Netherlands & CAMBRIDGE, Mass., November 9, 2022 -- ProQR Therapeutics N.V. (Nasdaq: PRQR) (the “Company”), a company dedicated to changing lives through the creation of transformative RNA therapies, today reported its financial and operating results for the third quarter ended September 30, 2022, and provided a business update.
Axiomer® Program and Business Operations Updates
Axiomer Program:
| ● | In August, ProQR announced the Company will focus exclusively on the development of its Axiomer RNA editing technology platform across multiple therapeutic areas with an initial focus on liver and CNS. The Company also announced it is seeking a strategic partner for its ophthalmology assets. |
| ● | ProQR continues to execute on its global licensing and research partnership with Eli Lilly, focused on the discovery, development, and commercialization of potential new medicines for genetic disorders in the liver and nervous system, and may selectively enter additional partnerships designed to advance and capture the full potential value of the platform. |
| ● | In November, the Company plans to present its proprietary RNA base-editing Axiomer technology at the Oligonucleotide and Peptide Therapeutics EUROPE conference. |
Presentation title: Progress on Development of RNA Base Editing Technologies for Precision Medicines
Date: November 18, 2022 at 2:30pm CET
| ● | ProQR will announce its initial Axiomer pipeline targets in early 2023 and will host an analyst and investor R&D event in Q1 2023. |
Business updates:
| ● | Management Team appointments and Supervisory Board nominations and updates: |
| ● | In October, Jurriaan Dekkers was appointed to the Company’s Management Team as Chief Financial Officer where he leads ProQR’s finance function. He brings to the role more than 20 years of experience in finance, management and leadership roles in biopharma and healthcare companies, as well as in audit and consulting services. Prior to joining ProQR he most recently served as CFO of AstraZeneca in the Netherlands and CEO of Acerta Pharma (part of the AstraZeneca Group). Mr. Dekkers is a Supervisory Board member at ‘Stichting Kinderpostzegels’ in the Netherlands. |
| ● | Also in October, Sheila Sponselee was appointed to the Management Team as VP, Head of People and Operations where she leads Human Resources, Recruitment, Information Technology, and Facilities. Ms. Sponselee joined ProQR in 2020 as VP of Human Resources and has more than 15 years of experience in human resources, recruitment, and operations across varied industries, including information technology and biopharma. Prior to joining ProQR, she most recently led Human Resources at MyTomorrows in the Netherlands. Ms. Sponselee studied human resource management at the University of Applied Science (BSc) and completed leadership programs at IMD Business School for Management and Leadership. |
| ● | Begoña Carreño, PhD, will be nominated for election to the Supervisory Board at the next Annual General Meeting of Shareholders. Dr. Carreño was most recently Global Business Development & Licensing Head (BD&L) in the Ophthalmology franchise at Novartis Pharma, AG, based in Basel, Switzerland. She has more than 20 years of pharmaceutical development and strategy leadership, having led BD&L efforts at Novartis across five different therapeutic franchises, as well as a proven track record in licensing deals and M&A. Before joining Novartis, she was the Head of External Pharmaceutical projects at Almirall (Barcelona, Spain). Dr. Carreño holds a PhD in Drug Delivery from the London School of Pharmacy (UK) and a BSc in Biochemistry from Keele University (UK). In anticipation of her election to the Supervisory Board she will join all meetings as member-elect effective immediately. |
| ● | Theresa Heggie will be nominated for election to the Supervisory Board at the next Annual General Meeting of Shareholders. In light of her anticipated re-election to the Supervisory Board, Ms. Heggie departed from the Management Team at the end of October, where she served as the Chief Operating Officer, after originally joining the Management Team in 2021 as the Chief Commercial Officer. Prior to ProQR, she served as Chief Executive Officer of Freeline Therapeutics. She had senior commercial and operating roles at Alnylam Pharmaceuticals as Senior Vice President, Head of CEMEA and Shire where she built the EMEA rare disease business. Earlier in her career, Ms. Heggie held increasingly senior positions in the commercial organizations at Janssen |
| Pharmaceuticals and Baxter Healthcare. She previously served on the ProQR Supervisory Board from 2019-2021. In anticipation of her re-election to the Supervisory Board, she will join all meetings as member-elect effective immediately. |
| ● | Antoine Papiernik, Chairman and Managing Partner at Sofinnova Partners, has indicated his planned rotation off the ProQR Supervisory Board at the next Annual General Meeting of Shareholders. He has served on ProQR’s Supervisory Board since 2014. |
“During the third quarter and in line with our corporate strategy update earlier this year, we focused the business exclusively on the development of our Axiomer RNA base editing technology platform,” said Daniel A. de Boer, Chief Executive Officer of ProQR Therapeutics. “Over the course of the next several months, we will be providing additional details about the progress we have made advancing Axiomer, including our presentation at TIDES Europe later this month, disclosure of our pipeline targets in early 2023, and during an R&D event in late Q1 2023. We also continue to execute on our global licensing and research partnership with Eli Lilly and may selectively enter into additional partnerships to further advance and capture the full potential value of the platform.”
De Boer continued: “To further support our focus on Axiomer, we are pleased to share several updates to our Management Team and Supervisory Board. I welcome Jurriaan and Sheila to the Management Team, and look forward to Theresa and Begoña joining the Supervisory Board. Each brings tremendous experience in relevant areas to support the Company in this next phase of our evolution. In light of his planned departure mid next year at the AGM, I also want to thank Antoine for his important contributions as a Supervisory Board member over the last 8 years. With robust science, leading IP, an experienced team, and a strong balance sheet with cash runway into 2026, we are well resourced to continue to support the advancement of our proprietary platform and pipeline.”
| ● | In September 2022, ProQR repaid its loan balance with Pontifax Ventures and Kreos Capital, terminating its convertible debt financing agreement. |
| ● | In November 2022, ProQR received formal notice that the Listing Qualifications Staff of The Nasdaq Stock Market has granted the Company an additional 180-day compliance period, through May 1, 2023, to regain compliance with the $1.00 bid price requirement for continued listing on The Nasdaq Capital Market. In conjunction with the Annual General Meeting held in June, ProQR announced several leadership updates. |
Financial Highlights
At September 30, 2022, ProQR held cash and cash equivalents of €100.4 million following full repayment of its convertible debt financing agreement with Pontifax Ventures and Kreos Capital in September 2022, compared to €187.5 million at December 31, 2021. Net cash used in
operating activities during the three-month period ended September 30, 2022 was €15.4 million, compared to €8.1 million for the same period last year.
Research and development costs were €15.4 million for the quarter ended September 30, 2022, compared to €11.1 million for the same period last year. General and administrative costs were €5.4 million for the quarter ended September 30, 2022 compared to €4.6 million for the same period last year.
Net loss for the three-month period ended September 30, 2022 was €24.4 million or €0.34 per share, compared to a €15.1 million loss or €0.22 per share for the same period last year.
For further financial information for the period ended September 30, 2022, please refer to the financial statements appearing at the end of this release.
About ProQR
ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA therapies. ProQR is pioneering a next-generation RNA technology called Axiomer®, which uses a cell’s own editing machinery called ADAR to make specific single nucleotide edits in RNA to reverse a mutation or modulate protein expression and could potentially yield a new class of medicines for genetic diseases. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind.
Learn more about ProQR at www.proqr.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Such forward-looking statements include, but are not limited to, statements regarding the potential of our technologies and platforms (including Axiomer®), our other programs and business operations, our current and planned partnerships and collaborators and the intended benefits thereof, the planned changes to our Supervisory Board, our updated strategic plans and the intended benefits thereof, our continued listing on The Nasdaq Capital Market, and our financial position and cash runway. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors in our filings made with the Securities and Exchange Commission, including certain
sections of our annual report filed on Form 20-F. These risks and uncertainties include, among others, the cost, timing and results of preclinical studies and other development activities by us and our collaborative partners whose operations and activities may be slowed or halted by shortage and pressure on supply and logistics on the global market; our reliance on contract manufacturers to supply materials for research and development and the risk of supply interruption or delays from suppliers and/or contract manufacturers; the ability to secure, maintain and realize the intended benefits of collaborations with partners; the possible impairment of, inability to obtain, and costs to obtain intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated in research and development; the possibility that we will not be able to regain compliance with or effectuate a reversed stock split to regain compliance with Nasdaq’s Minimum Bid Price Requirement, or maintain compliance with any of the other Nasdaq continued listing requirements. general business, operational, financial and accounting risks; and risks related to litigation and disputes with third parties. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.
Cautionary Note on Future Updates
The statements contained in this press release reflect our current views with respect to future events. Accordingly, we do not undertake and specifically disclaim any obligation to update any forward-looking statements.
ProQR Therapeutics N.V.
Investor Contact:
Sarah Kiely
ProQR Therapeutics N.V.
T: +1 617 599 6228
skiely@proqr.com
or
Hans Vitzthum
LifeSci Advisors
T: +1 617 430 7578
hans@lifesciadvisors.com
Media Contact:
Robert Stanislaro
FTI Consulting
T: +1 212 850 5657
robert.stanislaro@fticonsulting.com
Financial Tables
PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Financial Position
|
| September 30, |
| December 31, |
| | 2022 | | 2021 |
| | € 1,000 | | € 1,000 |
Assets | |
| |
|
Current assets | |
| |
|
Cash and cash equivalents | | 100,431 | | 187,524 |
Prepayments and other receivables | | 3,104 | | 3,404 |
Other taxes | | 570 | | 555 |
| | | | |
Total current assets | | 104,105 | | 191,483 |
| | | | |
Property, plant and equipment | | 17,007 | | 17,467 |
Investments in associates | | — | | 8 |
Investments in financial assets | | 621 | | 621 |
| | | | |
Total assets | | 121,733 | | 209,579 |
| | | | |
Equity and liabilities | |
| |
|
Equity | | | |
|
Equity attributable to owners of the Company | | 64,921 | | 113,833 |
Non-controlling interests | | (381) | | (604) |
Total equity | | 64,540 | | 113,229 |
| | | | |
Current liabilities | |
| |
|
Borrowings | | 1,888 | | 4,771 |
Lease liabilities | | 1,370 | | 1,534 |
Derivative financial instruments | | 144 | | 3,995 |
Trade payables | | 425 | | 191 |
Current income tax liability | | — | | — |
Social securities and other taxes | | 824 | | 1,230 |
Deferred income | | 8,624 | | 5,115 |
Other current liabilities | | 13,697 | | 10,760 |
| | | | |
Total current liabilities | | 26,972 | | 27,596 |
| | | | |
Borrowings | | 4,770 | | 39,319 |
Lease liabilities | | 14,190 | | 14,748 |
Deferred income | | 11,261 | | 14,687 |
| | | | |
Total liabilities | | 57,193 | | 96,350 |
| | | | |
Total equity and liabilities | | 121,733 | | 209,579 |
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, | ||||
|
| 2022 | | 2021 |
| 2022 | | 2021 |
| | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 |
Revenue | | 956 | | 872 | | 3,215 | | 1,115 |
| | | | | | | | |
Other income | | 74 | | 286 | | 274 | | 838 |
| | | | | | | | |
Research and development costs | | (15,352) | | (11,124) | | (40,168) | | (29,764) |
General and administrative costs | | (5,359) | | (4,591) | | (15,679) | | (12,052) |
Total operating costs | | (20,711) | | (15,715) | | (55,847) | | (41,816) |
| |
| |
| |
| |
|
Operating result | | (19,681) | | (14,557) | | (52,358) | | (39,863) |
Finance income and expense | | (620) | | 266 | | (1,998) | | (2,491) |
Results related to associates | | — | | (132) | | (8) | | (132) |
Gain on disposal of associate | | — | | — | | — | | 514 |
Results related to derecognition of financial liabilities | | (4,016) | | — | | (2,872) | | — |
Results related to financial liabilities measured at fair value through profit or loss | | 5 | | (611) | | 3,831 | | (1,373) |
| |
| |
| |
| |
|
Result before corporate income taxes | | (24,312) | | (15,034) | | (53,405) | | (43,345) |
Income taxes | | (69) | | (35) | | (96) | | (95) |
| |
| |
| |
| |
|
Result for the period | | (24,381) | | (15,069) | | (53,501) | | (43,440) |
Other comprehensive income (foreign exchange differences on foreign operation) | | 612 | | 206 | | 1,523 | | 461 |
| |
| |
| |
| |
|
Total comprehensive income | | (23,769) | | (14,863) | | (51,978) | | (42,979) |
| | | | | | | | |
Result attributable to | |
| |
| |
| |
|
Owners of the Company | | (24,395) | | (15,047) | | (53,724) | | (43,400) |
Non-controlling interests | | 14 | | (22) | | 223 | | (40) |
| | (24,381) | | (15,069) | | (53,501) | | (43,440) |
Total comprehensive income attributable to | | | | | | | | |
Owners of the Company | | (23,783) | | (14,841) | | (52,201) | | (42,939) |
Non-controlling interests | | 14 | | (22) | | 223 | | (40) |
| | (23,769) | | (14,863) | | (51,978) | | (42,979) |
| |
| |
| |
| |
|
Share information | |
| |
| |
| |
|
Weighted average number of shares outstanding1 | | 71,382,837 | | 68,263,034 | | 71,367,459 | | 61,804,367 |
| | | | | | | | |
Earnings per share attributable to owners of the Company (Euro per share) | | | | | | | | |
Basic loss per share1 | | (0.34) | | (0.22) | | (0.75) | | (0.70) |
Diluted loss per share1 | | (0.34) | | (0.22) | | (0.75) | | (0.70) |
| 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 N.V.
Unaudited Condensed Consolidated Statement of Changes in Equity
| | Attributable to owners of the Company | | | | | ||||||||||||||
|
| Number |
| Share |
| Share |
| Equity settled |
| Option |
| Translation |
| Accumulated |
| Total |
| Non- |
| Total |
|
|
| | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 |
Balance at January 1, 2021 |
| 54,131,553 | | 2,165 | | 288,757 | | 23,825 | | 280 | | (189) | | (257,747) | | 57,091 | | (545) | | 56,546 |
Result for the period |
| — | | — | | — | | — | | — | | — | | (43,400) | | (43,400) | | (40) | | (43,440) |
Other comprehensive income |
| — | | — | | — | | — | | — | | 461 | | — | | 461 | | — | | 461 |
Recognition of share-based payments |
| 112,657 | | 5 | | 382 | | 4,435 | | — | | — | | — | | 4,822 | | — | | 4,822 |
Issuance of ordinary shares | | 20,498,451 | | 820 | | 107,657 | | — | | — | | — | | — | | 108,477 | | — | | 108,477 |
Treasury shares transferred | | (217,933) | | — | | — | | — | | — | | — | | — | | — | | — | | — |
Share options lapsed | | — | | — | | — | | (391) | | — | | — | | 391 | | — | | — | | — |
Share options exercised | | 338,653 | | 5 | | 1,150 | | (821) | | — | | — | | 821 | | 1,155 | | — | | 1,155 |
| | | | | | | | | | | | | | | | | | | | |
Balance at September 30, 2021 |
| 74,863,381 | | 2,995 | | 397,946 | | 27,048 | | 280 | | 272 | | (299,935) | | 128,606 | | (585) | | 128,021 |
| | | | | | | | | | | | | | | | | | | | |
Balance at January 1, 2022 |
| 74,865,381 | | 2,995 | | 398,309 | | 28,443 | | 1,426 | | 430 | | (317,770) | | 113,833 | | (604) | | 113,229 |
Result for the period |
| — | | — | | — | | — | | — | | — | | (53,724) | | (53,724) | | 223 | | (53,501) |
Other comprehensive income |
| — | | — | | — | | — | | — | | 1,523 | | — | | 1,523 | | — | | 1,523 |
Recognition of share-based payments |
| — | | — | | — | | 3,256 | | — | | — | | — | | 3,256 | | — | | 3,256 |
Issuance of ordinary shares | | — | | — | | — | | — | | — | | — | | — | | — | | — | | — |
Treasury shares transferred | | (143,094) | | — | | — | | — | | — | | — | | — | | — | | — | | — |
Share options lapsed | | — | | — | | — | | (647) | | — | | — | | 647 | | — | | — | | — |
Share options exercised / RSUs vested | | 143,094 | | — | | 33 | | (362) | | — | | — | | 362 | | 33 | | — | | 33 |
|
|
| |
| |
| |
| |
| |
| |
| |
| |
| |
|
Balance at September 30, 2022 |
| 74,865,381 | | 2,995 | | 398,342 | | 30,690 | | 1,426 | | 1,953 | | (370,485) | | 64,921 | | (381) | | 64,540 |
PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Cash Flows
| | Three month period | | Nine month period | ||||
| | ended September 30, |
| ended September 30, | ||||
| | | | | | | | |
|
| 2022 | | 2021 | | 2022 | | 2021 |
| | € 1,000 | | € 1,000 | | € 1,000 | | € 1,000 |
Cash flows from operating activities | |
| |
| |
| |
|
Net result | | (24,381) | | (15,069) | | (53,501) | | (43,440) |
Adjustments for: | | | | | | | | |
— Depreciation | | 612 | | 544 | | 1,773 | | 1,777 |
— Share-based compensation | | 1,335 | | 1,716 | | 3,256 | | 4,435 |
— Financial income and expenses | | 620 | | (266) | | 1,998 | | 2,491 |
— Results related to associates | | — | | 132 | | 8 | | 132 |
— Gain on disposal of associate | | — | | — | | — | | (514) |
— Results related to financial liabilities measured at fair value through profit or loss | | (5) | | 611 | | (3,831) | | 1,373 |
— Results related to derecognition of financial liabilities | | 4,016 | | — | | 2,872 | | — |
— Income tax expenses | | 69 | | 35 | | 96 | | 95 |
| | | | | | | | |
Changes in working capital | | 3,465 | | 4,836 | | 231 | | 5,658 |
Cash used in operations | | (14,269) | | (7,461) | | (47,098) | | (27,993) |
| |
| |
| |
| |
|
Corporate income tax paid | | (69) | | (35) | | (96) | | (95) |
Interest received | | 67 | | — | | 67 | | 5 |
Interest paid | | (1,093) | | (561) | | (3,548) | | (1,714) |
| |
| |
| |
| |
|
Net cash used in operating activities | | (15,364) | | (8,057) | | (50,675) | | (29,797) |
| |
| |
| |
| |
|
Cash flow from investing activities | | | | | | | | |
Purchases of property, plant and equipment | | (246) | | (175) | | (721) | | (259) |
| |
| |
| |
| |
|
Net cash used in investing activities | | (246) | | (175) | | (721) | | (259) |
| |
| |
| |
| |
|
Cash flow from financing activities | |
| |
| |
| |
|
Proceeds from issuance of shares, net of transaction costs | | — | | 23,223 | | — | | 108,477 |
Proceeds from exercise of share options | | — | | 402 | | 33 | | 1,155 |
Proceeds from borrowings | | — | | 284 | | — | | 853 |
Repayment of convertible loans | | (43,373) | | — | | (43,373) | | — |
Repayment of lease liability | | (381) | | (347) | | (1,314) | | (597) |
| |
| |
| |
| |
|
Net cash (used in)/generated by financing activities | | (43,754) | | 23,562 | | (44,654) | | 109,888 |
| |
| |
| |
| |
|
Net increase (decrease) in cash and cash equivalents | | (59,364) | | 15,330 | | (96,050) | | 79,832 |
| |
| |
| |
| |
|
Currency effect cash and cash equivalents | | 3,393 | | 1,369 | | 8,957 | | 471 |
Cash and cash equivalents, at beginning of the period | | 156,402 | | 139,442 | | 187,524 | | 75,838 |
| |
| |
| |
| |
|
Cash and cash equivalents at the end of the period | | 100,431 | | 156,141 | | 100,431 | | 156,141 |