Commencement of in-court restructuring of Orphazyme A/S
Orphazyme A/SCompany
announcementNo. 10/2022Inside
informationwww.orphazyme.comCompany Registration No. 32266355
- Will
institute a reduction of approximately 50% of current work
force
- Intends
to delist American Depositary Shares from Nasdaq US
Copenhagen,
Denmark, March
10, 2022 –
Orphazyme A/S (ORPHA.CO; ORPH) (“Orphazyme” or the “Company”), a
late-stage biopharmaceutical company, announces that, following the
receipt of the negative Trend Vote as announced on February 23,
2022 (please see company announcement no. 07/2022), and considering
the Company’s financial position, the Board of Directors of the
Company has today decided to file a petition for an in-court
restructuring of Orphazyme. As a part of the restructuring efforts,
the Company will also institute a reduction of approximately 50% of
the Company’s current global workforce.
The aim of the in-court restructuring is to
explore whether a basis can be established which allows for all or
part of the Company’s operations to continue, including a basis for
injecting further capital, and/or a basis for a sale of all or
parts of the Company’s assets.
As part of the Company’s efforts to reduce
costs, Orphazyme recently closed its commercial operations in
Germany, the UK, and the US. Specifically in Denmark, Orphazyme
will tomorrow, March 11, 2022, initiate negotiations under the
Danish Act on Collective Redundancies and the Act on Information
and Consultation.
“Following the very disappointing outcomes from
the regulatory authorities in the US and EU, we are forced to
consider some extremely difficult choices. Our employees have
worked tirelessly with a focus on bringing arimoclomol as a
potential new treatment option to patients with Niemann-Pick
disease type C”, commented Orphazyme Chief Executive Officer,
Anders Vadsholt. “It is with a heavy heart that we are faced with
the prospect of parting ways with valued colleagues, and I want to
thank them for their hard work, their commitment to Orphazyme, and
their outstanding dedication to showing up for patients in
need.”
The Company moreover announced that it plans to
voluntarily delist American Depositary Shares (ADSs) representing
its ordinary shares from the Nasdaq Global Select Market (Nasdaq).
Orphazyme has given formal notice to Nasdaq of its intention to
voluntarily delist the ADSs. Orphazyme intends to file a Form 25
with the Securities and Exchange Commission (SEC) on March 21,
2022, to initiate the delisting, which is expected to become
effective on March 31, 2022. As soon thereafter as the Company is
eligible, the Company intends to file a Form 15 with the SEC to
suspend its reporting obligations under the Securities Exchange of
1934, as amended. The Company expects that the deregistration of
the ADSs and the underlying ordinary shares will become effective
90 days after the filing of the Form 25 with the SEC.
For additional information, please
contact
Orphazyme A/S
Georges Gemayel, Chairman of the Board of
Directors Bo
Jesper Hansen, Deputy Chairman of the Board of
Directors
Anders Vadsholt, Chief Executive Officer and
Chief Financial
Officer +45 2898
9055
About Orphazyme
A/S Orphazyme is a late-stage biopharmaceutical
company developing arimoclomol for Niemann-Pick disease type C
(NPC). Orphazyme is headquartered in Denmark and has operations in
Switzerland. ADSs representing Orphazyme’s shares are listed on
Nasdaq U.S. (ORPH) and its shares are listed on Nasdaq Copenhagen
(ORPHA).
About arimoclomolArimoclomol is
an investigational drug candidate that amplifies the production of
heat shock proteins (HSPs). HSPs can rescue defective misfolded
proteins and improve the function of lysosomes. Arimoclomol is
administered orally, and has now been studied in 10 Phase 1, four
Phase 2, and three pivotal Phase 2/3 trials. Arimoclomol has
received Orphan Drug Designation (ODD) for NPC in the US and EU.
Arimoclomol has received Fast-Track Designation (FTD), Breakthrough
Therapy Designation (BTD), and Rare Pediatric Disease Designation
(RPDD) from the U.S. Food and Drug Administration (FDA) for NPC. On
June 17, 2021, Orphazyme received a Complete Response Letter from
the FDA regarding its New Drug Application for arimoclomol for the
treatment of NPC. A marketing authorization application (MAA) for
arimoclomol in NPC has been filed with the European Medicines
Agency (EMA) and is under review. On February 17, 2022, the EMA
Committee for Medicinal Products for Human Use (CHMP) issued a
negative Trend Vote on the MAA following an Oral Explanation,
indicating that its current orientation was to not approve
arimoclomol when it convenes by the end of March 2022, and
Orphazyme considers it unlikely that this position will change
before the formal vote is undertaken.
Forward-looking
statement This company announcement may contain
certain forward-looking statements under the U.S. Private
Securities Litigation Reform Act of 1995 and otherwise, including
forward-looking statements about the U.S. and EU regulatory
processes for the potential approval of arimoclomol by the FDA or
EMA, the size of the Company’s potential downsizing, the impact of
the Company’s restructuring process, and the Company’s intention to
delist the ADSs from Nasdaq and deregister the ADSs and ordinary
shares with the SEC. Although the Company believes its expectations
are based on reasonable assumptions, all statements other than
statements of historical fact included in this company announcement
about future events are subject to (i) change without notice and
(ii) factors beyond the Company’s control. These statements may
include, without limitation, any statements preceded by, followed
by, or including words such as “target,” “believe,” “expect,”
“aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,”
“project,” “will,” “can have,” “likely,” “should,” “would,”
“could”, and other words and terms of similar meaning or the
negative thereof. Forward-looking statements are subject to
inherent risks and uncertainties beyond the Company’s control that
could cause the Company’s actual results, performance, or
achievements to be materially different from the expected results,
performance, or achievements expressed or implied by such
forward-looking statements, including the risks and uncertainties
that are described in the Risk Factors section of the Company’s
Annual Report on Form 20-F for the year ended December 31, 2020
filed with the U.S. Securities and Exchange Commission (SEC) on
March 2, 2021, the Company’s Report on Form 6-K filed with the SEC
on June 11, 2021, and other filings Orphazyme makes with the SEC
from time to time. These documents are available on the “Investors
& Media” section of Orphazyme’s website at www.orphazyme.com.
Except as required by law, the Company assumes no obligation to
update these forward-looking statements publicly, or to update the
reasons actual results could differ materially from those
anticipated in the forward-looking statements, even if new
information becomes available in the future.
- 10-2022 Commencement of in-court restructuring of
Orphazyme
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