Orphazyme reports financial results in Interim Report First

Company announcement
Orphazyme A/S
No. 36/2022
     
        
www.orphazyme.com
Company Registration No. 32266355

Copenhagen, Denmark, September 26, 2022 – Orphazyme A/S (ORPHA.CO) (the “Company”) in the present day broadcasts its Interim Report First Half 2021 for the interval January 1 – June 30, 2022.

Anders Vadsholt, Chief Executive Officer and Chief Financial Officer stated, “During the first half of 2022, we executed the sale of substantially all of Orphazyme’s assets, including the continuing development of arimoclomol, to KemPharm Denmark A/S, a wholly owned subsidiary of KemPharm, Inc. Our employees demonstrated unwavering commitment throughout this difficult time, and I am delighted that many of them are pursuing their mission to bring new treatment options to patients with NPC at KemPharm. We are now focused on exploring ways to realize value from the Company’s remaining assets and may engage in activities and investments related to biopharmaceutical research and development, participate in partnerships or co-operate with other businesses.”

Corporate Updates First Half 2022

• In January 2022, Christophe Bourdon, Chief Executive Officer (CEO), resigned from his place as CEO of Orphazyme to tackle the function of CEO at one other firm. Anders Vadsholt was appointed CEO of Orphazyme, efficient March 1, 2022, in addition to his place as Chief Financial Officer (CFO).
• In February 2022, Orphazyme was notified of a detrimental development vote by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine’s Agency (EMA) referring to its advertising and marketing authorization utility (MAA) for arimoclomol in Niemann-Pick illness kind C, or NPC, in Europe. The Company withdrew the MAA in March 2022, forward of the CHMP’s ultimate vote.
• On March 11, 2022, the Company’s board of administrators (the “Board of Directors”) filed to provoke in-court restructuring proceedings below the Danish Insolvency Act with the intention of exploring whether or not a foundation could possibly be established for all or a part of Orphazyme’s operations to proceed, together with a foundation for injecting additional capital, and/or a foundation for a sale of all or elements of its property.
• In March 2022, the Company voluntarily delisted American Depositary Shares (ADSs) representing Orphazyme’s bizarre shares from the Nasdaq Global Select Market in the United States, efficient March 31, 2022.
• In May 2022, the Company signed an settlement to promote considerably all Orphazyme’s property and business actions, together with these referring to the event and approval of arimoclomol and the total claw again legal responsibility associated to the French early entry program, to KemPharm Denmark A/S (“KemPharm”), a completely owned subsidiary of KemPharm, Inc., for a complete quantity of USD 12.8 million in money and assumed liabilities estimated to equal roughly USD 5.2 million (the “Sale of Assets”).
• Stephanie Okey, Carrolee Barlow and Martin Bonde stepped down from their positions as members of the Board of Directors as of May 23, 2022.
• The restructuring proposal was authorised on May 30, 2022, by Orphazyme’s identified collectors and affirmed by the Danish Maritime and Commercial High Court; the in-court restructuring proceedings have been discontinued on May 30, 2022, and the Sale of Assets was accomplished on May 31, 2022.
• In June 2022, Bo Jesper Hansen was elected Chairman of the Board of Directors and John Sommer Schmidt and Anders Vadsholt have been elected to the Board of Directors. Georges Gemayel, former Chairman of the Board of Directors and Andrew Mercieca, member of the Board of Directors didn’t stand for re-election on the Company’s Annual General Meeting.

Financial Highlights First Half 2022
Unless in any other case said, feedback in this announcement consult with H1 efficiency from persevering with operations. From January 1, 2022, the business operations and actions that have been a part of the Sale of Assets settlement with KemPharm have been reclassified as discontinued operations. 2021 figures have been restated in keeping with IFRS.

• Operating bills for persevering with operations for the six months ended June 30, 2022 totaled DKK 27.3 million in comparison with DKK 57.3 million for a similar interval in 2021.
• Loss from persevering with operations totaled DKK 24.4 million in contrast DKK 55.0 million for a similar interval in 2021.
• The web consequence from operations held on the market (discontinued operations) was a revenue of DKK 87.4 million in comparison with a web lack of DKK 408.8 million for a similar interval in 2021, primarily as a result of Sale of Assets to KemPharm.
• The complete complete revenue/loss (each persevering with and discontinued operations) for the primary half 2022 was a web revenue of DKK 62.5 million, or DKK 1.79 per share (fundamental and diluted), in comparison with a complete complete lack of DKK 463.7 million, or DKK (13.27) per share (fundamental and diluted) for a similar interval in 2021.
• As of June 30, 2022, Orphazyme held money totaling DKK 49.5 million in comparison with DKK 102.3 million as of December 31, 2021.

Subsequent Events

• As introduced in April 2022, the Deposit Agreement among the many Company, The Bank of New York Mellon, as depositary, and homeowners and American Depositary Receipt (ADRs) holders was terminated, efficient July 6, 2022.
• On August 11, 2022, the U.S. District Court for the Northern District of Illinois granted in half and denied in half defendants’ movement to dismiss the amended criticism in the putative class motion lawsuit, captioned Busic v. Orphazyme A/S, et al., No. 21- cv-03640 (N.D. Ill.). The Court dismissed all claims below the Securities Act of 1933 referring to the Company’s registration assertion for its IPO of ADSs and dismissed as inactionable numerous challenged statements for the lead plaintiff’s claims below the Securities Exchange Act of 1934. On August 26, 2022, the Court amended its August 11, 2022 order to additionally dismiss sure claims towards sure particular person defendants. The Court’s dismissal of claims in its August 11 and 26, 2022 orders was with out prejudice to the submitting of an extra amended criticism. On September 8, 2022, the lead plaintiff filed a second amended criticism. Defendants have till October 6, 2022 to reply to the second amended criticism. Management doesn’t imagine these claims have any benefit and imagine that the end result is not going to materially have an effect on the Company’s financial place.

Outlook
As introduced September 25, 2022 (Company announcement No. 35/2022), Orphazyme has adjusted its outlook for 2022, as revealed on June 7, 2022. The change is pushed by the separation of actions into persevering with and discontinued operations. The discontinued actions are associated to the sale of property to KemPharm A/S. The persevering with business actions are the restricted ongoing operational business actions with solely two staff. For the full-year 2022, we anticipate a loss from persevering with operations in the vary DKK 40 – 45 million and a constructive consequence from discontinued operations referring to the Sale of Assets to KemPharm of DKK 87.4 million (beforehand working revenue in the vary DKK 10 – 30 million). As beforehand communicated, we anticipate to finish 2022 with greater than DKK 30 million in money and equivalents.

For further data, please contact

Orphazyme A/S

Anders Vadsholt, Chief Executive Officer and Chief Financial Officer +45 28 98 90 55

Forward-looking assertion
This firm announcement could comprise sure forward-looking statements inside the which means of the Private Securities Litigation Reform Act of 1995, together with in respect of the corporate’s anticipated working plans and efficiency, financial place and skill to function as a going concern. Although the Company believes its expectations are based mostly on cheap assumptions, all statements apart from statements of historic reality included in this firm announcement about future occasions are topic to (i) change with out discover and (ii) elements past the Company’s management, together with actions by regulatory businesses, results of the worldwide COVID-19 pandemic, and the influence of the Company’s Sale of Assets. These statements could embody, with out limitation, any statements preceded by, adopted by, or together with phrases resembling “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and different phrases and phrases of comparable which means or the detrimental thereof. Forward-looking statements are topic to inherent dangers and uncertainties past the Company’s management that would trigger the Company’s precise results, efficiency, or achievements to be materially completely different from the anticipated results, efficiency, or achievements expressed or implied by such forward-looking statements. In gentle of those dangers and uncertainties, and different dangers and uncertainties which might be described in the Risk Factors part and different sections of the Company’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 2, 2021, and different filings that the Company makes with the SEC every now and then (which can be found at http://www.sec.gov), the occasions and circumstances mentioned in such forward-looking statements could not happen, and the Company’s precise results may differ materially and adversely from these anticipated or implied thereby. Although the Company’s forward-looking statements mirror the great religion judgment of its administration, these statements are based mostly solely on information and elements presently identified by the Company. As a consequence, you might be cautioned to not depend on these forward-looking statements. Except as required by regulation, the Company assumes no obligation to replace these forward-looking statements publicly, or to replace the explanations precise results may differ materially from these anticipated in the forward-looking statements, even when new data turns into out there in the longer term.

• 36-2022 Orphazyme Interim Report H1 2022
• 36-2022 Orphazyme reports financial results in Interim Report First Half 2022