Item 1. Financial Statements
Item 1. Financial Statements
uniQure N.V.
UNAUDITED CONSOLIDATED BALANCE SHEETS
June 30,
December 31,
2023
2022
(in thousands, except share and per share amounts)
Current assets
Cash and cash equivalents
$
513,598
$
228,012
Current investment securities
114,989
124,831
Accounts receivable and contract asset
102,559
102,376
Inventories
10,212
6,924
Prepaid expenses
12,351
11,817
Other current assets and receivables
3,250
2,814
Total current assets
756,959
476,774
Non-current assets
Property, plant and equipment, net of accumulated depreciation of $ 49.4 million as of June 30, 2023 and $ 44.1 million as of December 31, 2022
48,567
50,532
Non-current investment securities
—
39,984
Operating lease right-of-use assets
31,395
32,726
Intangible assets, net, including in-process research and development asset of $ 58.3 million as of June 30, 2023 and $ 57.3 million as of December 31, 2022
59,713
58,778
Goodwill
26,016
25,581
Deferred tax assets, net
13,995
14,528
Other non-current assets
6,124
6,061
Total non-current assets
185,810
228,190
Total assets
$
942,769
$
704,964
Current liabilities
Accounts payable
$
9,373
$
10,984
Accrued expenses and other current liabilities
23,537
30,571
Current portion of contingent consideration
27,666
25,982
Current portion of operating lease liabilities
7,780
8,382
Total current liabilities
68,356
75,919
Non-current liabilities
Long-term debt
101,110
102,791
Liability from royalty financing agreement
372,445
—
Operating lease liabilities, net of current portion
30,195
31,719
Contingent consideration, net of current portion
9,581
9,334
Deferred tax liability, net
6,802
8,257
Other non-current liabilities
960
935
Total non-current liabilities
521,093
153,036
Total liabilities
589,449
228,955
Commitments and contingencies
Shareholders' equity
Ordinary shares, € 0.05 par value: 80,000,000 shares authorized as of June 30, 2023 and December 31, 2022 and 47,702,331 and 46,968,032 ordinary shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively
2,877
2,838
Additional paid-in-capital
1,130,515
1,113,393
Accumulated other comprehensive loss
( 52,440 )
( 58,291 )
Accumulated deficit
( 727,632 )
( 581,931 )
Total shareholders' equity
353,320
476,009
Total liabilities and shareholders' equity
$
942,769
$
704,964
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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uniQure N.V.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
(in thousands, except share and per share amounts)
(in thousands, except share and per share amounts)
License revenues
$
793
$
—
$
793
$
—
Contract manufacturing revenues
1,310
—
$
6,247
$
—
Collaboration revenues
319
497
707
2,289
Total revenues
2,422
497
7,747
2,289
Operating expenses:
Cost of contract manufacturing revenues
( 1,352 )
( 832 )
( 3,787 )
( 832 )
Research and development expenses
( 46,036 )
( 46,192 )
( 106,845 )
( 91,195 )
Selling, general and administrative expenses
( 21,181 )
( 12,491 )
( 39,029 )
( 23,478 )
Total operating expenses
( 68,569 )
( 59,515 )
( 149,661 )
( 115,505 )
Other income
1,302
3,186
3,113
3,496
Other expense
( 229 )
( 229 )
( 445 )
( 422 )
Loss from operations
( 65,074 )
( 56,061 )
( 139,246 )
( 110,142 )
Interest income
3,229
35
4,898
78
Interest expense
( 6,840 )
( 2,694 )
( 10,402 )
( 5,210 )
Foreign currency gains / (losses), net
374
19,398
( 1,995 )
27,966
Other non-operating gains, net
—
( 57 )
—
635
Loss before income tax benefit
$
( 68,311 )
$
( 39,379 )
$
( 146,745 )
$
( 86,673 )
Income tax (expense )/ benefit
( 163 )
318
1,044
934
Net loss
$
( 68,474 )
$
( 39,061 )
$
( 145,701 )
$
( 85,739 )
Other comprehensive loss:
Foreign currency translation adjustments
54
( 28,324 )
5,851
( 38,774 )
Total comprehensive loss
$
( 68,420 )
$
( 67,385 )
$
( 139,850 )
$
( 124,513 )
Basic and diluted net loss per ordinary share
( 1.44 )
( 0.84 )
( 3.06 )
( 1.84 )
Weighted average shares used in computing basic and diluted net loss per ordinary share
47,649,520
46,668,554
47,543,516
46,634,026
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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uniQure N.V.
UNAUDITED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
FOR THE THREE MONTHS ENDED JUNE 30, 2023 AND 2022
Accumulated
Additional
other
Total
Ordinary shares
paid-in
comprehensive
Accumulated
shareholders’
No. of shares
Amount
capital
income / (loss)
deficit
equity
(in thousands, except share and per share amounts)
Balance at March 31, 2022
46,641,448
$
2,821
$
1,084,306
$
( 39,306 )
$
( 501,820 )
$
546,001
Loss for the period
—
—
—
—
( 39,061 )
( 39,061 )
Other comprehensive loss
—
—
—
( 28,324 )
—
( 28,324 )
Exercises of share options
4,470
—
29
—
—
29
Restricted share units distributed during the period
36,333
2
( 2 )
—
—
—
Share-based compensation expense
—
—
7,813
—
—
7,813
Issuance of ordinary shares relating to employee stock purchase plan
2,332
—
30
—
—
30
Balance at June 30, 2022
46,684,583
$
2,823
$
1,092,176
$
( 67,630 )
$
( 540,881 )
$
486,488
Balance at March 31, 2023
47,546,673
$
2,869
$
1,121,554
$
( 52,494 )
$
( 659,158 )
$
412,771
Loss for the period
—
—
—
—
( 68,474 )
( 68,474 )
Other comprehensive gain
—
—
—
54
—
54
Exercises of share options
2,427
—
34
—
—
34
Restricted and performance share units distributed during the period
150,720
8
( 8 )
—
—
—
Share-based compensation expense
—
—
8,894
—
—
8,894
Issuance of ordinary shares relating to employee stock purchase plan
2,511
0
41
—
—
41
Balance at June 30, 2023
47,702,331
$
2,877
$
1,130,515
$
( 52,440 )
$
( 727,632 )
$
353,320
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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uniQure N.V.
UNAUDITED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
Accumulated
Additional
other
Total
Ordinary shares
paid-in
comprehensive
Accumulated
shareholders’
No. of shares
Amount
capital
income / (loss)
deficit
equity
(in thousands, except share and per share amounts)
Balance at December 31, 2021
46,298,635
$
2,802
$
1,076,972
$
( 28,856 )
$
( 455,142 )
$
595,776
Loss for the period
—
—
—
—
( 85,739 )
( 85,739 )
Other comprehensive loss
—
—
—
( 38,774 )
—
( 38,774 )
Exercises of share options
72,594
4
449
—
—
453
Restricted and performance share units distributed during the period
307,464
17
( 17 )
—
—
—
Share-based compensation expense
—
—
14,682
—
—
14,682
Issuance of ordinary shares relating to employee stock purchase plan
5,890
—
90
—
—
90
Balance at June 30, 2022
46,684,583
$
2,823
$
1,092,176
$
( 67,630 )
$
( 540,881 )
$
486,488
Balance at December 31, 2022
46,968,032
$
2,838
$
1,113,393
$
( 58,291 )
$
( 581,931 )
$
476,009
Loss for the period
—
—
—
—
( 145,701 )
( 145,701 )
Other comprehensive gain
—
—
—
5,851
—
5,851
Exercises of share options
12,482
1
120
—
—
121
Restricted and performance share units distributed during the period
716,811
38
( 38 )
—
—
—
Share-based compensation expense
—
—
16,955
—
—
16,955
Issuance of ordinary shares relating to employee stock purchase plan
5,006
0
85
—
—
85
Balance at June 30, 2023
47,702,331
$
2,877
$
1,130,515
$
( 52,440 )
$
( 727,632 )
$
353,320
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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uniQure N.V.
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
Six months ended June 30,
2023
2022
(in thousands)
Cash flows from operating activities
Net loss
$
( 145,701 )
$
( 85,739 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
5,115
4,103
Share-based compensation expense
16,955
14,682
Royalty financing agreement interest expense
3,154
-
Deferred tax income
( 1,044 )
( 934 )
Changes in fair value of contingent consideration and derivative financial instrument, net
1,212
1,371
Unrealized foreign exchange losses / (gains), net
944
( 24,491 )
Other items, net
( 831 )
( 257 )
Changes in operating assets and liabilities:
Accounts receivable and contract asset, prepaid expenses, and other current assets and receivables
813
46,492
Inventories
( 3,288 )
( 2,949 )
Accounts payable
( 1,212 )
7,632
Accrued expenses, other liabilities, and operating leases
( 11,416 )
( 1,299 )
Net cash used in operating activities
( 135,299 )
( 41,389 )
Cash flows from investing activities
Purchases of property, plant, and equipment
( 3,416 )
( 8,637 )
Proceeds on maturity of investment securities
52,234
-
Acquisition of uniQure France SAS, net of cash acquired
-
( 822 )
Net cash generated from / (used in) investing activities
48,818
( 9,459 )
Cash flows from financing activities
Proceeds from royalty financing agreement
374,350
-
Payment of debt issuance costs
( 4,288 )
-
Proceeds from issuance of ordinary shares related to employee stock option and purchase plans
206
543
Net cash generated from financing activities
370,268
543
Currency effect on cash, cash equivalents and restricted cash
1,812
( 5,382 )
Net decrease in cash, cash equivalents and restricted cash
285,599
( 55,687 )
Cash, cash equivalents and restricted cash at beginning of period
231,173
559,353
Cash, cash equivalents and restricted cash at the end of period
$
516,772
$
503,666
Cash and cash equivalents
$
513,598
$
500,524
Restricted cash related to leasehold and other deposits
3,174
3,142
Total cash, cash equivalents and restricted cash
$
516,772
$
503,666
Supplemental cash flow disclosures:
Cash paid for interest
$
( 8,882 )
$
( 3,980 )
Non-cash (decrease) / increase in accounts payables and accrued expenses and other current liabilities related to purchases of property, plant, and equipment
$
( 651 )
$
( 277 )
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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1 General business information
uniQure N.V. (the “Company”) was incorporated on January 9, 2012, initially as a private company with limited liability ( besloten vennootschap met beperkte aansprakelijkheid ) under the laws of the Netherlands. The Company is a leader in the field of gene therapy and seeks to deliver to patients suffering from rare and other devastating diseases single treatments with potentially curative results. The Company’s business was founded in 1998 and was initially operated through its predecessor company, Amsterdam Molecular Therapeutics Holding N.V. (“AMT”). In 2012, AMT undertook a corporate reorganization, pursuant to which uniQure B.V. acquired the entire business and assets of AMT and completed a share-for-share exchange with the shareholders of AMT. Effective February 10, 2014, in connection with its initial public offering on the Nasdaq Global Select Market, the Company converted into a public company with limited liability ( naamloze vennootschap ) and changed its legal name from uniQure B.V. to uniQure N.V.
The Company is registered in the trade register of the Chamber of Commerce ( Kamer van Koophandel ) in Amsterdam, the Netherlands under number 54385229. The Company’s headquarters are in Amsterdam, the Netherlands, and its registered office is located at Paasheuvelweg 25a, Amsterdam 1105 BP, the Netherlands and its telephone number is +31 20 240 6000.
The Company’s ordinary shares are listed on the Nasdaq Global Select Market and trade under the symbol “QURE”.
2 Summary of significant accounting policies
2.1 Basis of preparation
The Company prepared these unaudited consolidated financial statements in compliance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the United States Securities and Exchange Commission (the “SEC”) regarding interim financial reporting. Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
The unaudited consolidated financial statements are presented in United States (“U.S.”) dollars, except where otherwise indicated. Transactions denominated in currencies other than U.S. dollars are presented in the transaction currency with the U.S. dollar amount included in parenthesis, converted at the foreign exchange rate as of the transaction date.
2.2 Unaudited interim financial information
The interim financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the financial position, results of operations and changes in financial position for the period presented.
Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted. The results of operations for the three and six months ended June 30, 2023, are not necessarily indicative of the results to be expected for the full year ending December 31, 2023, or for any other future year or interim period. The accompanying financial statements should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed by the Company with the SEC on February 27, 2023 (the “Annual Report”).
2.3 Use of estimates
The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
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2.4 Accounting policies
The principal accounting policies applied in the preparation of these unaudited consolidated financial
statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Annual Report . There have been no material changes in the Company’s significant accounting policies during the six months ended June 30, 2023, except as noted below.
Royalty Financing Agreement
In May 2023, uniQure biopharma B.V. (“uniQure biopharma”), a wholly-owned subsidiary of the Company entered into an agreement (the “Royalty Financing Agreement”) with HemB SPV (the “Purchaser”) to sell certain current and future royalties due to uniQure biopharma from CSL Behring LLC (“CSL Behring”) under the Commercialization and License Agreement (“the CSL Behring Agreement”) by and between uniQure biopharma and CSL Behring from the net sales of HEMGENIX®. Refer to Note 9 “Royalty Financing Agreement” for further details of the Royalty Financing Agreement. The Company determined that the Royalty Financing Agreement should be accounted for as debt in accordance with topic ASC 470, Debt . The Company initially recognized the debt at fair value. The Company subsequently records the debt at amortized cost and determines the effective interest rate based on its projection of contractual cash flows. Interest expense (presented as “Interest Expense” in the consolidated statements of operations and comprehensive loss) is recorded over the projected repayment period using the effective interest method. The Company periodically assesses and adjusts the effective interest rate to reflect changes in projected cash flows. The Company prospectively applies the adjusted effective interest rate following the date of change.
In accordance with topic ASC 835, Interest , debt issuance costs incurred in relation to the Royalty Financing Agreement are presented as a reduction of carrying amount of the debt. Debt issuance cost is amortized together with the interest expense recorded.
2.5 Recent accounting pronouncements
There have been no new accounting pronouncements or changes to accounting pronouncements during the six months ended June 30, 2023, as compared to the recent accounting pronouncements described in Note 2.3.25 of the Annual Report , which could be expected to materially impact the Company’s unaudited consolidated financial statements.
3
CSL Behring collaboration
On June 24, 2020, uniQure biopharma B.V. entered into the CSL Behring Agreement with CSL Behring, pursuant to which CSL Behring received exclusive global rights to HEMGENIX® .
The transaction became fully effective on May 6, 2021.
License revenue
The Company recognized $ 0.8 million of royalty revenue in each of the three and six months ended June 30, 2023, compared to nil in the three and six months ended June 30, 2022. Royalties on the sale of the HEMGENIX® are recorded once earned and are presented as license revenue.
Accounts receivable and contract asset
As of December 31, 2022, the Company recorded accounts receivable of $ 2.2 million from CSL Behring related to collaboration services as well as a contract asset of $ 100.0 million for a milestone due from CSL Behring following the first sale of HEMGENIX® in the U.S. , which was deemed to be probable.
As of June 30, 2023, the Company had accounts receivable of $ 102.5 million from CSL Behring. The $ 100.0 million milestone is included in accounts receivable as of June 30, 2023 following the achievement of the milestone event in June 2023. The Company collected the $ 100.0 million in July 2023. The remaining accounts receivable related to collaboration services, contract manufacturing revenue, and royalty revenue.
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4
Investment securities
The following tables summarize the Company’s investments in sovereign debt as of June 30, 2023 and December 31, 2022:
At June 30, 2023
Amortized cost, as adjusted
Gross unrealized holding gains
Gross unrealized holding losses
Estimated fair value
(in thousands)
Current investments:
Government debt securities (held-to-maturity)
$
114,989
$
—
$
( 363 )
$
114,626
Total
$
114,989
$
—
$
( 363 )
$
114,626
At December 31, 2022
Amortized cost, as adjusted
Gross unrealized holding gains
Gross unrealized holding losses
Estimated fair value
(in thousands)
Current investments:
Government debt securities (held-to-maturity)
$
124,831
$
—
$
( 283 )
$
124,548
Non-current investments:
Government debt securities (held-to-maturity)
39,984
—
( 43 )
39,941
Total
$
164,815
$
—
$
( 326 )
$
164,489
Inputs to the fair value of the investments are considered Level 2 inputs.
5
Inventories
The following table summarizes the inventory balances as of June 30, 2023 and December 31, 2022:
June 30,
December 31,
2023
2022
(in thousands)
Raw materials
$
6,013
$
3,584
Work in progress
4,059
1,874
Finished goods
140
1,466
Inventories
$
10,212
$
6,924
6
Fair value measurement
The Company measures certain financial assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting. ASC 820, Fair Value Measurements and Disclosures requires disclosure of methodologies used in determining the reported fair values and establishes a hierarchy of inputs used when available. The three levels of the fair value hierarchy are described below:
Level 1 – Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company can access at the measurement date.
Level 2 – Valuations based on quoted prices for similar assets or liabilities in markets that are not active or models for which the inputs are observable, either directly or indirectly.
Level 3 – Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and are unobservable.
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To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
The carrying amount of cash and cash equivalents, accounts receivable from licensing and collaboration partners, prepaid expenses, other assets, accounts payable, accrued expenses and other current liabilities reflected in the Consolidated balance sheets approximate their fair values due to their short-term maturities.
The following table sets forth the Company’s assets and liabilities that are required to be measured at fair value on a recurring basis as of June 30, 2023, and December 31, 2022:
Quoted prices
in active
markets
(Level 1)
Significant
other
observable
inputs
(Level 2)
Significant
unobservable
inputs
(Level 3)
Total
Classification in Consolidated
balance sheets
(in thousands)
At December 31, 2022
Assets:
Cash and cash equivalents
$
228,012
$
—
$
—
$
228,012
Cash and cash equivalents
Restricted cash
3,161
—
—
3,161
Other non-current assets
Total assets
$
231,173
$
—
$
—
$
231,173
Liabilities:
Contingent consideration
—
—
35,316
35,316
Contingent consideration
Consideration for post-acquisition services
—
—
297
297
Other non-current liabilities
Total liabilities
$
—
$
—
$
35,613
$
35,613
At June 30, 2023
Assets:
Cash and cash equivalents
$
513,598
$
—
$
—
$
513,598
Cash and cash equivalents
Restricted cash
3,174
—
—
3,174
Other non-current assets
Total assets
$
516,772
$
—
$
—
$
516,772
Liabilities:
Contingent consideration
—
—
37,247
37,247
Contingent consideration
Consideration for post-acquisition services
—
—
326
326
Other non-current liabilities
Total liabilities
$
—
$
—
$
37,573
$
37,573
Contingent consideration
The Company is required to pay up to EUR 178.8 million (or $ 194.6 million based on the foreign exchange rate on June 30, 2023) to the former shareholders of Corlieve Therapeutics SAS (“uniQure France SAS”) upon the achievement of contractually defined milestones in connection with the Company’s July 2021 acquisition of uniQure France SAS.
The fair value of the contingent consideration as of June 30, 2023 was $ 37.2 million (December 31, 2022: $ 35.3 million) using discount rates of approximately 15.0 % to 15.3 % (December 31, 2022: 14.0 % to 14.4 %) as well as a 66.0 % (December 31, 2022: 66.0 %) likelihood of the target candidate for treatment of temporal lobe epilepsy (“AMT-260”) advancing into clinical development by no later than late 2023. If as of June 30, 2023 the Company had assumed a 100 % likelihood of AMT-260 advancing into clinical development, then the fair value of the contingent consideration would have increased to $ 51.5 million. If as of June 30, 2023 the Company had assumed that it would discontinue development of the AMT-260 program, then the contingent consideration would be released to income. Changes in fair value of the contingent consideration are recognized within research and development expenses in the consolidated statements of operations and comprehensive loss.
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The following table presents the changes in fair value of contingent consideration between December 31, 2022 and June 30, 2023:
Amount of
contingent
consideration
2023
(in thousands)
Balance at December 31, 2022
$
35,316
Change in fair value (presented within research and development expenses)
1,212
Currency translation effects
719
Balance at June 30, 2023
$
37,247
As of June 30, 2023, the Company classified $ 27.7 million of the total contingent consideration of $ 37.2 million as current liabilities. The balance sheet classification between current and non-current liabilities is based upon the Company’s best estimate of the timing of settlement of the remaining relevant milestones.
Investment securities
Refer to Note 4 “ Investment securities ” for the fair value of the investment securities as of June 30, 2023 and December 31, 2022.
7
Accrued expenses and other current liabilities
Accrued expenses and other current liabilities include the following items:
June 30,
December 31,
2023
2022
(in thousands)
Accruals for goods received from and services provided by vendors-not yet billed
$
10,454
$
11,120
Personnel related accruals and liabilities
12,312
17,201
Liability owed to the Purchaser pursuant to the Royalty Financing Agreement
771
—
Accrued contract fulfillment costs and costs to obtain a contract
—
2,250
Total
$
23,537
$
30,571
8 Long-term debt
On June 14, 2013, the Company entered into a venture debt loan facility with Hercules Capital, Inc. (formerly known as Hercules Technology Growth Capital, Inc.) (“Hercules”). The facility was amended and restated in 2014, 2016, 2018, January 2021, December 2021 (the “2021 Restated Facility”) and on May 12, 2023 (the “2023 Amended Facility”).
Upon entering into the 2021 Restated Facility, the Company drew down an additional $ 30.0 million, resulting in total principal outstanding of $ 100.0 million.
The 2023 Amended Facility extends the maturity date and interest-only period from December 1, 2025 to January 5, 2027 (the “Maturity Date”).
The Company is required to repay the entire principal balance on the Maturity Date. The interest rate is adjustable and is the greater of (i) 7.95 % and (ii) 7.95 % plus the prime rate less 3.25 % per annum. The Company paid a $ 2.5 million back-end fee in June 2023. Under the 2023 Amended Facility, the Company owes a back-end fee of $ 4.9 million on December 1, 2025 and a back-end fee of $ 1.3 million on the Maturity Date.
The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2023 Amended Facility was $ 102.2 million as of June 30, 2023, compared to $ 103.8 million as of December 31, 2022, and is recorded net of discount and debt issuance costs. The foreign currency gain on the facility in the three and six months ended June 30, 2023 was $ 0.8 million and $ 1.6 million, respectively, compared to a foreign currency loss of $ 6.3 million and $ 8.4 million during the same period in 2022.
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Interest expense associated with the 2023 Amended Facility during the three and six months ended June 30, 2023 was $ 3.7 million and $ 7.3 million, respectively, compared to $ 2.6 million and $ 5.0 million during the same period in 2022.
Under the 2023 Amended Facility the Company must remain current in its periodic reporting requirements and is required to keep a minimum cash balance deposited in bank accounts in the U.S. equivalent to the lesser of (i) 65 % of the outstanding balance of principal due or (ii) 100 % of worldwide cash and cash equivalents. This restriction on cash and cash equivalents only relates to the location of the cash and cash equivalents, and such cash and cash equivalents can be used at the discretion of the Company. Beginning on April 1, 2024, the Company is required to keep a minimum of unrestricted cash equal to at least 30 % of the loan amount outstanding. In combination with other covenants, the 2023 Amended Facility restricts the Company’s ability to, among other things, incur future indebtedness and obtain additional debt financing, to make investments in securities or in other companies, to transfer assets, to perform certain corporate changes, to make loans to employees, officers, and directors, and to make dividend payments and other distributions to its shareholders. The Company secured the facilities by directly or indirectly pledging its total assets of $ 942.8 million, less $ 3.9 million of cash and cash equivalents and other current assets held by the Company, $ 86.7 million of other current assets and investment held by uniQure France SAS as well as receivables sold to the Purchaser.
Under the 2023 Amended Facility, the occurrence of a material adverse effect, as defined therein, would entitle Hercules to declare all principal, interest and other amounts owed by the Company immediately due and payable. As of June 30, 2023, the Company was in material compliance with all covenants and provisions.
9 Royalty Financing Agreement
On May 12, 2023, the Company entered into the Royalty Financing Agreement with the Purchaser. Under the terms of the Royalty Financing Agreement the Company received an upfront payment of $ 375.0 million in exchange for its rights to the lowest royalty tier on CSL Behring’s worldwide net sales of HEMGENIX® for certain current and future royalties due to us. The Company is also eligible to receive an additional $ 25.0 million milestone payment under the Royalty Financing Agreement if 2024 net sales of HEMGENIX® exceed certain thresholds, as set forth in the Royalty Financing Agreement. The Purchaser will receive 1.85 times the upfront payment (or $ 693.8 million) and 1.85 times the $ 25.0 million milestone payment (if paid) until June 30, 2032 (“First Hard Cap Date”) if such thresholds are met or, if such cap is not met by June 30, 2032, up to 2.25 times of the upfront and milestone payment (if paid) through December 31, 2038. If 2024 net sales do not exceed the pre-specified threshold, the Company will be obligated to pay $ 25.0 million to the Purchaser but only to the extent that the Company achieves a future sales milestone under the CSL Behring Agreement. If such milestone payment is not due from CSL Behring, the Company is not obligated to pay any amounts to the Purchaser.
The Company has retained the rights to all other royalties, as well as contractual milestones totaling up to $ 1.5 billion, under the terms of the CSL Behring Agreement.
Net proceeds from the Royalty Financing Agreement, after deducting professional and financial advisory fees related to the transaction of $ 4.9 million, were $ 370.1 million. The Company initially recorded these net proceeds as “Liability from royalty financing agreement” on its balance sheet as of closing of the transaction on June 5, 2023. Following the initial recognition, the Company records the debt at amortized cost.
The Company expects to satisfy its commitment to Purchaser prior to the First Hard Cap Date. The Company will record the difference of $ 323.7 million between the total expected payments of $ 693.8 million to the Purchaser and the $ 370.1 million net proceeds as interest expense using the effective interest rate method. The Company determined the effective interest rate based on the projected cash flows up to the First Hard Cap Date. Based on the Company’s projections the effective interest rate is expected to be within a range of 12.0 % per annum to 13.5 % per annum. The Company would have recorded $ 3.1 million and $ 3.5 million of interest expense, with a rate of 12.0 % and 13.5 % respectively, for the three and six months ended June 30, 2023. The Company will prospectively update the effective interest rate at each reporting date based on updated projections.
The liability was initially recognized at fair value and inputs were considered Level 3 inputs.
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The following table presents the movement in the liability related to the Royalty Financing Agreement between the closing of the transaction on June 5, 2023 and June 30, 2023:
Amount of liability
(in thousands)
Gross proceeds from royalty financing agreement on June 5, 2023
$
375,000
Debt issuance costs paid
( 4,938 )
Liability owed to the Purchaser (presented as "Accrued expense and other current liabilities")
( 771 )
Interest expense for the period June 5, 2023 to June 30, 2023
3,154
Liability related to the royalty financing agreement
$
372,445
10 Share-based compensation
The Company’s share-based compensation plans include the 2014 Amended and Restated Share Option Plan (the “2014 Plan”) and inducement grants under Rule 5653(c)(4) of the Nasdaq Global Select Market with terms similar to the 2014 Plan (together the “2014 Plans”). The number of shares authorized for issuance under the 2014 Plan is 12,601,471 . The 2014 Plan expires on January 9, 2024.
In June 2018, the Company’s shareholders adopted and approved an employee share purchase plan (the “ESPP”) allowing the Company to issue up to 150,000 ordinary shares. The ESPP is intended to qualify under Section 423 of the Internal Revenue Code of 1986. Under the ESPP, employees are eligible to purchase ordinary shares through payroll deductions, subject to any plan limitations. The purchase price of the ordinary shares on each purchase date is equal to 85 % of the lower of the closing market price on the offering date and the closing market price on the purchase date of each three-month offering period.
2014 Plans and ESPP
Share-based compensation expense recognized by classification included in the Consolidated Statements of Operations and Comprehensive Loss in relation to the 2014 Plans and the ESPP for the periods indicated below was as follows:
Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
(in thousands)
(in thousands)
Cost of manufacturing services revenue
$
138
$
148
$
162
$
148
Research and development
4,732
4,306
9,037
8,360
Selling, general and administrative
4,024
3,359
7,756
6,174
Total
$
8,894
$
7,813
$
16,955
$
14,682
Share-based compensation expense recognized by award type for the 2014 Plans as well as the ESPP was as follows:
Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
(in thousands)
(in thousands)
Award type/ESPP
Share options
$
3,485
$
3,438
$
6,759
$
6,693
Restricted share units
5,388
4,127
10,018
7,397
Performance share units
12
242
162
580
Employee share purchase plan
9
6
16
12
Total
$
8,894
$
7,813
$
16,955
$
14,682
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As of June 30, 2023, the unrecognized share-based compensation expense related to unvested awards under the 2014 Plans were:
Unrecognized
Weighted average
share-based
remaining
compensation
period for
expense
recognition
(in thousands)
(in years)
Award type
Share options
$
31,265
2.75
Restricted share units
41,298
2.21
Performance share units
—
—
Total
$
72,563
2.44
The Company satisfies the exercise of share options and vesting of Restricted Share Units (“RSUs”) and Performance Share Units (“PSUs”) through newly issued ordinary shares.
Share options
Share options are priced on the date of grant and, except for certain grants made to non-executive directors, vest over a period of four years . The first 25 % of each grant vests after one year from the initial grant date and the remainder vests in equal quarterly installments over years two, three and four. Certain grants to non-executive directors vest in full after one year . All share options must be exercised by the tenth anniversary of the initial grant date.
The following tables summarize share option activity under the 2014 Plans for the six months ended June 30, 2023:
Options
Number of
Weighted average
ordinary shares
exercise price
Outstanding at December 31, 2022
4,237,917
$
26.13
Granted
1,484,930
$
19.40
Forfeited
( 236,145 )
$
22.51
Expired
( 61,142 )
$
52.43
Exercised
( 12,482 )
$
9.72
Outstanding at June 30, 2023
5,413,078
$
24.18
Thereof, fully vested, and exercisable on June 30, 2023
2,748,537
$
26.61
Thereof, outstanding and expected to vest after June 30, 2023
2,664,540
$
21.67
Total weighted average grant date fair value of options issued during the period (in $ millions)
$
16.8
Proceeds from option sales during the period (in $ millions)
$
0.1
The fair value of each share option issued is estimated at the respective grant date using the Hull & White option pricing model with the following weighted-average assumptions:
Three months ended June 30,
Six months ended June 30,
Assumptions
2023
2022
2023
2022
Expected volatility
70 %
70 %
70 %
70 %
Expected terms
10 years
10 years
10 years
10 years
Risk free interest rate
3.71 % - 4.00 %
3.03 % - 3.44 %
3.71 % - 4.10 %
2.12 % - 3.44 %
Expected dividend yield
0 %
0 %
0 %
0 %
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RSUs
The following table summarizes the RSU activity for the six months ended June 30, 2023:
RSUs
Weighted average
Number of
grant-date fair
ordinary shares
value
Non-vested at December 31, 2022
1,818,774
$
20.46
Granted
1,516,025
$
19.68
Vested
( 662,393 )
$
21.85
Forfeited
( 183,734 )
$
19.52
Non-vested at June 30, 2023
2,488,672
$
19.68
Total weighted average grant date fair value of RSUs granted during the period (in $ millions)
$
29.8
RSUs vest over one to three years , as specified when granted. RSUs granted to non-executive directors vest one year from the date of grant.
PSUs
The following table summarizes the PSU activity for the six months ended June 30, 2023:
PSUs
Weighted average
Number of
grant-date fair
ordinary shares
value
Non-vested at December 31, 2022
400,690
$
28.82
Vested
( 54,550 )
$
26.45
Forfeited
( 38,260 )
$
27.85
Non-vested at June 30, 2023
307,880
$
29.36
The Company granted ordinary shares to certain employees in September and December 2021 and at various dates during the year ended December 31, 2022 that will be earned upon the achievement of defined milestones. Such ordinary shares will vest upon the later of a minimum service period of one year or three years , or the achievement of defined milestones, subject to the grantee’s continued employment. In addition, portions of the ordinary shares granted in December 2021 to executives and other members of senior management are subject to achieving a minimum total shareholder return relative to the NASDAQ Biotechnology Index. The Company recognizes the compensation cost related to these grants to the extent it considers achievement of the milestones to be probable. Achievement of one of the total five defined milestones was met as of December 31, 2022 and another one of the total five defined milestones was met as of June 30, 2023. The remaining three milestones have not yet been met.
The ESPP
During the six months ended June 30, 2023, 5,006 ordinary shares were issued under the ESPP compared to 5,890 during the same period in 2022. As of June 30, 2023, 111,054 ordinary shares remain available for issuance under the ESPP compared to a total of 121,414 as of June 30, 2022.
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11
Income taxes
The Company recorded $ 0.2 million deferred tax loss and $ 1.0 million deferred tax benefit in relation to its operations in the U.S. and France during the three and six months ended June 30, 2023, respectively. The Company recorded $ 0.3 million and $ 0.9 million deferred tax benefit in relation to its operations in the U.S. and France during the three and six months ended June 30, 2022, respectively.
The effective income tax rate of 0.2 % and ( 0.7 %) during the three and six months ended June 30, 2023 is substantially lower than the enacted rate of 25.8 % in the Netherlands as the Company records a valuation allowance against its net deferred tax assets in the Netherlands. The effective income tax rate during the three and six months ended June 30, 2022 was ( 0.8 %) and ( 1.1 %), respectively, as the Company had recorded a valuation allowance against its net deferred tax assets in the Netherlands.
12 Basic and diluted earnings per share
Diluted earnings per share are calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potentially dilutive ordinary shares. As the Company has incurred a loss in the three and six months ended June 30, 2023, all potentially dilutive ordinary shares would have an antidilutive effect, if converted, and thus have been excluded from the computation of loss per share for the three and six months ended June 30, 2023. The ordinary shares are presented without giving effect to the application of the treasury method or exercise prices that would be above the share price as of June 30, 2023 and June 30, 2022, respectively.
The potentially dilutive ordinary shares are summarized below:
Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
Anti-dilutive ordinary share equivalents
Stock options under 2014 Plans and previous plan
5,297,277
4,420,474
5,297,277
4,420,474
Non-vested RSUs and PSUs
2,730,672
2,447,570
2,730,672
2,447,570
ESPP
2,455
1,464
2,455
1,464
Total anti-dilutive ordinary share equivalents
8,030,404
6,869,508
8,030,404
6,869,508
13 Subsequent events
None.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.