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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):
November 7, 2023
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 November 7, 2023, uniQure N.V. (the “Company”)
issued a press release announcing its financial results for the quarter ended September 30, 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.
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) Exhibit
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: November 7, 2023 |
By: |
/s/ Jeannette Potts |
|
|
Jeannette Potts |
|
|
Chief Legal and Compliance Officer |
Exhibit 99.1
uniQure Announces
Third Quarter 2023 Financial Results
and Highlights
Recent Company Progress
~ Announced FDA
clearance of Investigational New Drug (IND) application for AMT-260 in
refractory mesial
temporal lobe epilepsy ~
~ On track to
provide clinical update from U.S. and European Phase I/II trials of AMT-130 in
Huntington’s
disease later in the fourth quarter of 2023 ~
~ uniQure and
CSL win 2023 Prix Galien USA award for HEMGENIX® ~
~ Announced strategic
reorganization to focus on advancing multiple clinical-stage programs and expect
to deliver $180
million of cost savings over the next three years ~
~ Strong cash
position of approximately $660 million as of September 30, 2023 expected to
fund operations
into the second quarter of 2027 ~
Lexington,
MA and Amsterdam, the Netherlands, November 7, 2023 — 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 third quarter of 2023 and highlighted recent progress across its business.
“In the third
quarter we made significant progress towards our goal of advancing multiple clinical-stage programs and focusing resources to generate
value from these important investments,” stated Matt Kapusta, chief executive officer of uniQure. “We are very pleased
to have achieved FDA clearance of the IND for AMT-260 in refractory mesial temporal lobe epilepsy and look forward to initiating patient
enrollment in the Phase I/IIa study as soon as possible. In addition, we are making good progress toward initiating patient screening
for a Phase I/II trial of AMT-162 in SOD1-ALS and the submission of an IND for AMT-191 in Fabry disease. We also look forward to providing
another clinical update later this quarter from our ongoing Phase I/II studies of AMT-130 in Huntington’s disease, which will include
up to 2.5 years of patient follow-up.”
“As we prepare
for 2024, we remain laser focused on execution across our portfolio of gene therapy product candidates with the goal of achieving clinical
proof-of-concept as rapidly as possible. We also remain committed to carefully managing costs, prudently
allocating capital, and thoughtfully evaluating strategies that can enhance value for shareholders in an increasingly challenging market
environment.”
Recent Updates
|
· | Advancing
AMT-130 for the treatment of Huntington’s disease |
| · | Later
in the fourth quarter of 2023, the Company plans to provide a clinical update from the U.S.
and European Phase I/II studies of AMT-130, including 18- and 30-month follow-up data from
the treated patients in the high- and low-dose U.S. cohorts, respectively. The
data update will include safety and tolerability, biomarker, imaging and functional data
across both high and low-dose cohorts. |
| · | A
total of 33 patients have now been treated with AMT-130 across two dose cohorts in the U.S.
and EU clinical trials. The Company recently initiated patient screening for a third cohort
in up to 12 patients to
further investigate both doses in combination with perioperative immunosuppression, with
a focus on evaluating near-term safety and tolerability. |
| · | In
the first quarter of 2024, the Company plans to request regulatory interactions with the
Food and Drug Administration (FDA) to discuss the U.S. and EU data and potential late-stage
development pathways for AMT-130. |
|
· | Advancing
additional programs into the clinic |
| · | AMT-260
for the treatment of refractory mesial temporal lobe epilepsy (rMTLE) – In the
third quarter of 2023, the Company announced the clearance of an investigational new drug
(IND) for the Phase I/IIa clinical study of AMT-260. Screening and patient enrollment is
expected to begin in the fourth quarter of 2023 with first patient dosing planned to occur
in the first quarter 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 AMT-162
for the treatment of superoxide dismutase 1 (SOD1) ALS, a rare, genetic form of ALS. The
Company expects to initiate patient screening in the fourth quarter of 2023 with first patient
dosing planned to occur in the first quarter of 2024. |
| · | AMT-191
for the treatment of Fabry disease – The Company expects to submit an IND in the
fourth quarter of 2023 and to begin patient dosing in 2024. |
|
· | Supporting
the commercial launch of HEMGENIX® in the United States and European Union |
| · | In
October 2023, uniQure and CSL Behring LLC (“CSL”) announced that the companies
received the 2023 Prix Galien USA Award in the category of Best Product for Rare/Orphan Diseases
for HEMGENIX®. HEMGENIX® was one of several product nominations
in this category. Created in 1970, the Prix Galien Awards recognizes outstanding innovation
and scientific advancement and is regarded as the equivalent of the Nobel Prize for the life
science industry. |
| · | In
July 2023, uniQure received a $100 million milestone payment from CSL associated with the
first commercial sale of HEMGENIX® in the United States. |
|
· | Implementing
strategic reorganization focused on advancing multiple clinical-stage programs, achieving
cost savings, and extending cash runway |
| · | In
October 2023, the Company announced a strategic reorganization plan which included a reduction
of 28% of the workforce not related to manufacturing HEMGENIX®, the discontinuation
of more than half of the research and technology projects, and a focus on executing across
four clinical-stage programs. The Company expects a total cost savings of approximately
$180 million over the next three years, which is expected to extend cash runway into the
second quarter of 2027. |
| · | As
part of the strategic reorganization and the significant reduction in research activities,
Ricardo Dolmetsch, Ph.D., the Company’s former chief scientific officer, departed the
Company and will remain as a scientific consultant through the end of the year. Richard Porter,
Ph.D., assumed responsibilities for research, as well as non-clinical and vector development
in his new role as Chief Business and Scientific Officer. Dr. Porter has more than 25 years
of neuroscience leadership in the biopharma
industry and joined uniQure in June 2021 through the acquisition of uniQure France SAS (formerly, Corlieve Therapeutics), where he was
founder and chief executive officer. |
Upcoming Investor Events
|
· | Stifel
2023 Healthcare Conference, November 14, 2023 – New York, NY |
Financial Highlights
Cash
position: As of September 30, 2023, the Company held cash and cash equivalents and investment securities of $658.9 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.
Revenues:
Revenues for the three months ended September 30, 2023 were $1.4 million, compared to $1.4 million in the same period in 2022. The
current period included an increase in license revenues of $0.5 million and contract manufacturing revenues of $0.4 million related to
contract manufacturing HEMGENIX® for CSL, and a decrease
of $0.9 million in collaboration revenues.
R&D expenses:
Research and development expenses were $65.4 million for the three months ended September 30, 2023, compared to $48.1 million in
the same period in 2022. The change was primarily related to a non-cash, $8.8 million increase in the fair value of contingent consideration
associated with the Company’s acquisition of Corlieve Therapeutics in 2021.
SG&A expenses:
Selling, general and administrative expenses were $18.1 million for the three months ended September 30, 2023, compared to $13.3
million in the same period in 2022. The increase was primarily related to an increase in personnel and contractor-related expenses, and
in legal fees associated with various corporate initiatives.
Other non-operating
items, net:
Other non-operating
items, net was an expense of $7.8 million for the three months ended September 30, 2023, compared to net income of $11.3 million for
the same period in 2022. The decrease in other non-operating items, net was primarily related to a decrease in foreign currency gains,
net of $14.2 million and an increase in interest expense of $12.4 million primarily related to the royalty agreement that the Company
entered into in May 2023, which partially was offset by an increase of $7.5 million in interest income earned on investment securities
and cash on hand.
Net loss:
The net loss for
the three months ended September 30, 2023, was $89.6 million, or $1.88 basic and diluted loss per ordinary share, compared to $47.9 million
net loss for the same period in 2022, or $1.02 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. These forward-looking statements include, but are not limited to, the Company’s statements about its
cash runway and its ability to fund operations into 2027, the Company’s cost savings related to the recently-announced strategic
organization, whether there will be continued progress on the commercialization of HEMGENIX®, the Company’s plans
to announce follow up data from the U.S. and European Phase I/II clinical study of AMT-130 in 2023, whether that data will help to further
guide our ongoing clinical development of AMT-130, the Company’s expectation to submit an investigational new drug application
for AMT-191 in Fabry disease in 2023 and begin patient dosing in 2024, the Company’s expectation to initiate patient screening
in AMT-162 and AMT-260 in the fourth quarter of 2023 and begin patient dosing in each in the first quarter of 2024, and whether the Company
will begin interactions with regulatory agencies in the first quarter of 2024 with respect to AMT-130. The Company’s actual results
could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks
associated with the regulatory approval and commercial launch of HEMGENIX®, material changes to our interim or preliminary
data, our clinical trial for Huntington’s disease, the impact of financial and geopolitical events on our Company and the wider
economy and health care system, the Company’s ability to raise additional capital to support late stage development of the Company’s
clinical program(s) if supported by future data, our Commercialization and License Agreement with CSL Behring, our clinical development
activities, clinical results, collaboration arrangements, regulatory oversight, product commercialization and intellectual property claims
and ongoing litigation, as well as the risks, uncertainties and other factors described under
the heading "Risk Factors" in the Company’s periodic securities filings, including its Annual Report on Form 10-K filed
February 27, 2023 and the Quarterly Report on Form 10-Q filed November 7, 2023. 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
| |
September 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(in thousands, except share and per share amounts) | |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 229,484 | | |
$ | 228,012 | |
Current investment securities | |
| 429,428 | | |
| 124,831 | |
Accounts receivable and contract asset | |
| 1,644 | | |
| 102,376 | |
Inventories | |
| 15,654 | | |
| 6,924 | |
Prepaid expenses | |
| 14,884 | | |
| 11,817 | |
Other current assets and receivables | |
| 2,532 | | |
| 2,814 | |
Total current assets | |
| 693,626 | | |
| 476,774 | |
Non-current assets | |
| | | |
| | |
Property, plant and equipment, net | |
| 45,946 | | |
| 50,532 | |
Non-current investment securities | |
| — | | |
| 39,984 | |
Operating lease right-of-use assets | |
| 30,360 | | |
| 32,726 | |
Intangible assets, net | |
| 57,976 | | |
| 58,778 | |
Goodwill | |
| 25,273 | | |
| 25,581 | |
Deferred tax assets, net | |
| 12,351 | | |
| 14,528 | |
Other non-current assets | |
| 6,018 | | |
| 6,061 | |
Total non-current assets | |
| 177,924 | | |
| 228,190 | |
Total assets | |
$ | 871,550 | | |
$ | 704,964 | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 5,584 | | |
$ | 10,984 | |
Accrued expenses and other current liabilities | |
| 28,427 | | |
| 30,571 | |
Current portion of contingent consideration | |
| 26,708 | | |
| 25,982 | |
Current portion of operating lease liabilities | |
| 7,888 | | |
| 8,382 | |
Total current liabilities | |
| 68,607 | | |
| 75,919 | |
Non-current liabilities | |
| | | |
| | |
Long-term debt | |
| 101,431 | | |
| 102,791 | |
Liability from royalty financing agreement | |
| 383,711 | | |
| — | |
Operating lease liabilities, net of current portion | |
| 28,977 | | |
| 31,719 | |
Contingent consideration, net of current portion | |
| 14,030 | | |
| 9,334 | |
Deferred tax liability, net | |
| 4,917 | | |
| 8,257 | |
Other non-current liabilities | |
| 1,093 | | |
| 935 | |
Total non-current liabilities | |
| 534,159 | | |
| 153,036 | |
Total liabilities | |
| 602,766 | | |
| 228,955 | |
Shareholders' equity | |
| | | |
| | |
Total shareholders' equity | |
| 268,784 | | |
| 476,009 | |
Total liabilities and shareholders' equity | |
$ | 871,550 | | |
$ | 704,964 | |
uniQure N.V.
UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS
| |
Three months ended September 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(in thousands, except share and per share amounts) | |
Total revenues | |
$ | 1,407 | | |
$ | 1,449 | |
Operating expenses: | |
| | | |
| | |
Cost of contract manufacturing revenues | |
| (1,006 | ) | |
| (861 | ) |
Research and development expenses | |
| (65,400 | ) | |
| (48,068 | ) |
Selling, general and administrative expenses | |
| (18,074 | ) | |
| (13,324 | ) |
Total operating expenses | |
| (84,480 | ) | |
| (62,253 | ) |
Other income | |
| 1,424 | | |
| 1,485 | |
Other expense | |
| (228 | ) | |
| (199 | ) |
Loss from operations | |
| (81,877 | ) | |
| (59,518 | ) |
Non-operating items, net | |
| (7,763 | ) | |
| 11,332 | |
Loss before income tax (expense)
/ benefit | |
$ | (89,640 | ) | |
$ | (48,186 | ) |
Income tax (expense) / benefit | |
| 69 | | |
| 329 | |
Net loss | |
$ | (89,571 | ) | |
$ | (47,857 | ) |
| |
| | | |
| | |
Basic and diluted net loss per ordinary share | |
$ | (1.88 | ) | |
$ | (1.02 | ) |
Weighted average shares used in computing basic and diluted net loss per ordinary share | |
| 47,770,101 | | |
| 46,772,430 | |
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uniQure NV (NASDAQ:QURE)
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