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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
February 28, 2024
uniQure
N.V.
(Exact Name of Registrant as Specified in Charter)
The Netherlands |
|
001-36294 |
|
N/A |
(State or Other
Jurisdiction of Incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
Paasheuvelweg
25a,
1105 BP Amsterdam,
The Netherlands |
|
N/A |
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: +31-20-566-7394
(Former Name or Former Address, if Changed Since
Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant
to Section 12(b) of the Act:
Title of each class: |
|
Trading
Symbol(s) |
|
Name of each exchange on which
registered: |
Ordinary
Shares, par value €0.05 per share |
|
QURE |
|
The
Nasdaq Stock Market LLC
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02 | Results of Operations and Financial Condition. |
On February 28, 2024, uniQure N.V. (the “Company”)
issued a press release announcing its financial results for the quarter and full year ended December 31, 2023 and highlighting Company
progress. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein
by reference.
The information furnished pursuant to this Item 2.02, including Exhibit 99.1,
shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities under that section, and shall not be deemed to be incorporated by reference
into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth
by specific reference in such filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
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.
|
UNIQURE N.V. |
|
|
|
|
|
Date: February 28, 2024 |
By: |
/S/ JEANNETTE POTTS |
|
|
Jeannette Potts |
|
|
Chief Legal and Compliance Officer |
Exhibit 99.1
uniQure Announces
2023 Financial Results
and Highlights
Recent Company Progress
~ Presented promising clinical update from U.S.
and European Phase I/II trials of AMT-130 in Huntington’s disease; Up to three years of follow-up data to be presented in mid-2024;
Regulatory interactions and clarity on potential strategies for clinical development expected in 2024 ~
~ Announced FDA clearance of two Investigational
New Drug (IND) applications; Initiation of Phase I/II clinical trials in mesial temporal lobe epilepsy (mTLE) and Fabry disease, in addition
to SOD1-ALS, are expected in the first half of 2024 ~
~ Announced strategic reorganization to advance
multiple clinical-stage programs and deliver $180 million of cost savings over the next three years ~
~ Cash position of approximately $618 million
as of December 31, 2023 expected to fund operations into the second quarter of 2027 ~
Lexington, MA and Amsterdam, the Netherlands,
February 28, 2024 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies
for patients with severe medical needs, today reported its financial results for the fourth quarter and full year 2023 and highlighted
recent progress across its business.
“We are pleased with the progress made
across the company in 2023 and are now laser-focused on execution across multiple clinical programs,” stated Matt Kapusta, chief
executive officer of uniQure. “Our top priorities are to engage with regulatory authorities to clarify the approval pathway
for AMT-130 in Huntington’s disease and to initiate patient enrollment across three additional clinical trials as expeditiously
as possible.”
“While we enter 2024 with a strong balance
sheet, we remain disciplined on the prudent and efficient allocation of our capital,” he continued. “Any decision to advance
AMT-130 into late-stage development will necessitate a clear and timely approval pathway and financial feasibility, including through
a partnership which we would secure before beginning any Phase III trial.”
Recent Updates
| · | Advancing AMT-130 for the treatment of Huntington’s
disease |
| · | In December 2023, the Company announced
updated clinical data from the ongoing U.S. and European Phase I/II studies of AMT-130 for the treatment of early-stage Huntington’s
disease. |
| o | Patients treated with AMT-130 continued to show evidence of preserved neurological function with potential
dose-dependent clinical benefits relative to a non-concurrent criteria-matched natural history of the disease. When compared to the expected
rate of decline from an inclusion criteria-matched natural history data set, AMT-130 showed favorable trends in composite Unified Huntington’s
Disease Rating Scale (cUHDRS), Total Functional Capacity (TFC) and Total Motor Score (TMS) key clinical rating scales designed to assess
disease progression. |
| o | Further declines in neurofilament light chain (NfL), an exploratory biomarker for the measurement of neuronal
degradation and disease progression were observed among patients treated with AMT-130. Mean NfL in the cerebrospinal fluid (CSL) for low-dose
patients remained below baseline at 30 months of follow-up and high-dose patients were near baseline at 18 months. |
| o | AMT-130 continued to be generally well-tolerated with a manageable safety profile across both doses. |
| · | In the fourth quarter of 2023,
the Company initiated patient dosing in a third cohort of up to 12 patients to
further investigate both doses of AMT-130 in combination with perioperative immunosuppression, with a focus on evaluating near-term safety
and tolerability. Enrollment in this cohort is expected to be completed in the second half of 2024. |
| · | In the second quarter of 2024, the Company expects
to initiate regulatory interactions with the U.S. Food and Drug Administration (FDA) to discuss data from the ongoing Phase I/II studies
and potential strategies for the further development of AMT-130. By the end of 2024, the Company expects to have greater clarity regarding
a potential approval pathway for AMT-130. |
| · | In mid-2024, the Company expects to provide an
interim update from the ongoing Phase I/II studies of AMT-130, including up to 24- and 36-month follow-up data from all treated patients
in the U.S. and European trials. |
| · | Advancing additional programs into the clinic |
| · | AMT-260 for the treatment of refractory mesial
temporal lobe epilepsy (rMTLE) – In September 2023, the Company announced the clearance of an IND for the Phase I/IIa clinical
study of AMT-260. Site initiation is underway, and patient enrollment is expected to begin in the first half of 2024. |
| · | AMT-162 for the treatment of SOD1 amyotrophic
lateral sclerosis (ALS) - In January 2023, the Company entered into a global licensing agreement with Apic Bio for ABP-102, now
known as AMT-162, for the treatment of superoxide dismutase 1 (SOD1) ALS, a rare, genetic form of ALS. Patient enrollment in a Phase I/II
clinical trial is expected to begin in the first half of 2024. |
| · | AMT-191 for the treatment of Fabry disease
– In November 2023, the Company announced the clearance of an IND for the Phase I/IIa clinical study of AMT-191. Patient enrollment
is expected to begin in the first half of 2024. |
| · | Generating value from the commercial launch
of HEMGENIX® |
| · | The Company continues to provide commercial supply
of etranacogene dezaparvovec (HEMGENIX®) to its partner CSL Behring and manufactures the product at its cGMP facility
in Lexington, MA. The Company is one of a select number of gene therapy companies with a qualified facility producing routine commercial
manufacturing for the market. |
Upcoming Investor Events
| · | 44th Annual Cowen Health Care Conference, March 5, 2024 –
Boston, MA |
| · | Leerink Global Biopharma Conference 2024, March 12, 2024 – Miami,
FL |
| · | UBS Virtual CNS Day, March 18, 2024 |
Financial Highlights
Cash position: As of December 31,
2023, the Company held cash and cash equivalents and investment securities of $617.9 million, compared to $392.8 million as of December 31,
2022. The Company entered into a royalty agreement in May 2023 and received an upfront payment of $375.0 million, and collected $100.0
million in July 2023 for a milestone due from CSL following the first sale of HEMGENIX®
in the U.S. The Company expects cash, cash equivalents and investment securities will fund operations into the second quarter
of 2027.
Revenues: Revenue for the year ended December 31,
2023 was $15.8 million, compared to $106.5 million in the same period in 2022. Revenues in 2022
included $100.0 million of license revenue related to the U.S. first sale milestone payment of HEMGENIX®
that the Company expected to receive in 2023. Revenue from contract manufacturing HEMGENIX®
for CSL increased $9.1 million in 2023 compared to 2022.
Cost of contract manufacturing revenues: Cost
of contract manufacturing revenues were $13.6 million for the year ended December 31, 2023, compared to $2.1 million for the same
period in 2022. The increase relates to an increase in activities related to contract manufacturing HEMGENIX®
for CSL.
R&D expenses: Research and development
expenses were $214.9 million for the year ended December 31, 2023, compared to $197.6 million during the same period in 2022. The
$17.2 million increase was primarily related to a $5.9 million net increase of external research and development expenses including a
$10.0 million payment made to Apic Bio to acquire AMT-162, an $8.8 million non-cash increase related to the fair value of contingent consideration
associated with the Company’s acquisition of Corlieve Therapeutics in 2021 as well as a $1.4 million non-cash impairment loss related
to our Lexington research facility.
SG&A expenses: Selling, general and
administrative expenses were $74.6 million for the year ended December 31, 2023, compared to $55.1 million during the same period
in 2022. The $19.5 million increase was primarily related to a $9.7 million increase of professional, financial advisory and intellectual
property fees, a $3.7 million increase in information technology expenses as well as a $3.7 million increase in personnel and contractor-related
expenses.
Other non-operating items, net:
Other non-operating items, net was an expense
of $23.7 million for the year ended December 31, 2023, compared to net income of $14.9 million for the same period in 2022. The $38.6
million decrease in other non-operating items, net was primarily related to a decrease in foreign currency gains, net of $24.9 million
and an increase in non-cash interest expense of $26.9 million related to the royalty agreement that the Company entered into in May 2023,
which partially was offset by an increase of $19.0 million in interest income earned on investment securities and cash on hand.
Net loss:
The net loss for the year ended December 31,
2023, was $308.5 million, or $6.47 basic and diluted loss per ordinary share, compared to $126.8 million net loss for the same period
in 2022, or $2.71 basic and diluted loss per ordinary share.
About uniQure
uniQure’s mission is to reimagine the future
of medicine by delivering innovative cures that transform lives. The recent approvals of our gene therapy for hemophilia B – a
historic achievement based on more than a decade of research and clinical development – represent a major milestone in the field
of genomic medicine and ushers in a new treatment approach for patients living with hemophilia. We are now leveraging our modular and
validated technology and manufacturing platform to advance a pipeline of proprietary gene therapies for the treatment of patients
with Huntington's disease, refractory mesial temporal lobe epilepsy, amyotrophic lateral sclerosis (ALS), Fabry disease, and other severe
diseases. www.uniQure.com
uniQure 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," “establish,” "estimate," "expect,"
"goal," "intend," "look forward to", "may," "plan," "potential," "predict,"
"project," “seek,” "should," "will," "would" and similar expressions. 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. Examples of these forward-looking statements include, but are not limited to, statements concerning the Company’s cash
runway and its ability to fund its operations into the second quarter of 2027; the Company’s expected cost savings related to its
strategic reorganization; the Company’s plans to announce additional follow up data from the ongoing U.S. and European Phase I/II
clinical studies of AMT-130; the Company’s plans to initiate interactions with regulatory authorities regarding the further development
of AMT-130 and the timing of regulatory clarity from such interactions; and the Company’s plans to initiate patient enrollment for
AMT-260, AMT-162 and AMT-191 in the first half of 2024. The Company’s actual results could differ materially from those anticipated
in these forward-looking statements for many reasons. These risks and uncertainties include, among others: risks associated with
the clinical results and the development and timing of the Company’s programs; the Company’s interactions with regulatory
authorities, which may affect the initiation, timing and progress of clinical trials and pathways to approval; the Company’s ability
to continue to build and maintain the company infrastructure and personnel needed to achieve its goals; the Company’s effectiveness
in managing current and future clinical trials and regulatory processes; the continued development and acceptance of gene therapies; the
Company’s ability to demonstrate the therapeutic benefits of its gene therapy candidates in clinical trials; the Company’s
ability to obtain, maintain and protect intellectual property; the Company’s ability to fund its operations and to raise additional
capital as needed; and the impact of global economic uncertainty, rising inflation, rising interest rates or market disruptions on its
business. These risks and uncertainties are more fully described under the heading "Risk Factors" in the Company’s periodic
filings with the U.S. Securities & Exchange Commission (“SEC”), including its Annual Report on Form 10-K filed
February 28, 2024 and in other filings that the Company makes with the SEC from time to time. Given these risks, uncertainties and
other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update
these forward-looking statements, even if new information becomes available in the future.
uniQure Contacts:
FOR INVESTORS: |
|
FOR MEDIA: |
|
|
|
Maria E. Cantor |
Chiara Russo |
Tom Malone |
Direct: 339-970-7536 |
Direct: 617-306-9137 |
Direct: 339-970-7558 |
Mobile: 617-680-9452 |
Mobile: 617-306-9137 |
Mobile:339-223-8541 |
m.cantor@uniQure.com |
c.russo@uniQure.com |
t.malone@uniQure.com |
uniQure N.V.
UNAUDITED CONSOLIDATED BALANCE SHEETS
| |
December 31, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(in thousands, except share and per share amounts) | |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 241,360 | | |
$ | 228,012 | |
Current investment securities | |
| 376,532 | | |
| 124,831 | |
Accounts receivable and contract asset | |
| 4,193 | | |
| 102,376 | |
Inventories, net | |
| 12,024 | | |
| 6,924 | |
Prepaid expenses | |
| 15,089 | | |
| 11,817 | |
Other current assets and receivables | |
| 2,655 | | |
| 2,814 | |
Total current assets | |
| 651,853 | | |
| 476,774 | |
Non-current assets | |
| | | |
| | |
Property, plant and equipment, net | |
| 46,548 | | |
| 50,532 | |
Non-current investment securities | |
| — | | |
| 39,984 | |
Operating lease right-of-use assets | |
| 28,789 | | |
| 32,726 | |
Intangible assets, net | |
| 60,481 | | |
| 58,778 | |
Goodwill | |
| 26,379 | | |
| 25,581 | |
Deferred tax assets, net | |
| 12,276 | | |
| 14,528 | |
Other non-current assets | |
| 5,363 | | |
| 6,061 | |
Total non-current assets | |
| 179,836 | | |
| 228,190 | |
Total assets | |
$ | 831,689 | | |
$ | 704,964 | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 6,586 | | |
$ | 10,984 | |
Accrued expenses and other current liabilities | |
$ | 30,534 | | |
$ | 30,571 | |
Current portion of contingent consideration | |
| 28,211 | | |
| 25,982 | |
Current portion of operating lease liabilities | |
| 8,344 | | |
| 8,382 | |
Total current liabilities | |
| 73,675 | | |
| 75,919 | |
Non-current liabilities | |
| | | |
| | |
Long-term debt | |
| 101,749 | | |
| 102,791 | |
Liability from royalty financing agreement | |
| 394,241 | | |
| — | |
Operating lease liabilities, net of current portion | |
| 28,316 | | |
| 31,719 | |
Contingent consideration, net of current portion | |
| 14,795 | | |
| 9,334 | |
Deferred tax liability, net | |
| 7,543 | | |
| 8,257 | |
Other non-current liabilities | |
| 3,700 | | |
| 935 | |
Total non-current liabilities | |
| 550,344 | | |
| 153,036 | |
Total liabilities | |
| 624,019 | | |
| 228,955 | |
Shareholders' equity | |
| | | |
| | |
Total shareholders' equity | |
| 207,670 | | |
| 476,009 | |
Total liabilities and shareholders' equity | |
$ | 831,689 | | |
$ | 704,964 | |
uniQure N.V.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
| |
Years ended December 31, | |
| |
2023 | | |
2022 | | |
2021 | |
| |
| | |
| | |
| |
| |
(in thousands, except share and per share amounts) | |
License revenues | |
$ | 2,758 | | |
$ | 100,000 | | |
$ | 517,400 | |
Contract manfuacturing revenues | |
| 10,835 | | |
| 1,717 | | |
| - | |
Collaboration revenues | |
| 2,250 | | |
| 4,766 | | |
| 6,602 | |
Total revenues | |
| 15,843 | | |
| 106,483 | | |
| 524,002 | |
Operating expenses: | |
| | | |
| | | |
| | |
Cost of license revenues | |
| (65 | ) | |
| (1,254 | ) | |
| (24,976 | ) |
Cost of contract manufacturing revenues | |
| (13,563 | ) | |
| (2,089 | ) | |
| - | |
Research and development expenses | |
| (214,864 | ) | |
| (197,591 | ) | |
| (143,548 | ) |
Selling, general and administrative expenses | |
| (74,591 | ) | |
| (55,059 | ) | |
| (56,290 | ) |
Total operating expenses | |
| (303,083 | ) | |
| (255,993 | ) | |
| (224,814 | ) |
Other income | |
| 6,059 | | |
| 7,171 | | |
| 12,306 | |
Other expense | |
| (1,690 | ) | |
| (820 | ) | |
| (876 | ) |
(Loss) / income from operations | |
| (282,871 | ) | |
| (143,159 | ) | |
| 310,618 | |
Non-operating items, net | |
| (23,686 | ) | |
| 14,900 | | |
| 22,188 | |
(Loss) / income before income tax (expense) / benefit | |
$ | (306,557 | ) | |
$ | (128,259 | ) | |
$ | 332,806 | |
Income tax (expense) / benefit | |
| (1,921 | ) | |
| 1,470 | | |
| (3,217 | ) |
Net (loss) / income | |
$ | (308,478 | ) | |
$ | (126,789 | ) | |
$ | 329,589 | |
Earnings per ordinary share - basic | |
| | | |
| | | |
| | |
Basic net (loss) / income per ordinary share | |
$ | (6.47 | ) | |
$ | (2.71 | ) | |
$ | 7.17 | |
Earnings per ordinary share - diluted | |
| | | |
| | | |
| | |
Diluted net (loss) / income per ordinary share | |
$ | (6.47 | ) | |
$ | (2.71 | ) | |
$ | 7.04 | |
Weighted average shares - basic | |
| 47,670,986 | | |
| 46,735,045 | | |
| 45,986,467 | |
Weighted average shares - diluted | |
| 47,670,986 | | |
| 46,735,045 | | |
| 46,840,972 | |
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