Orion Group Interim Report 1–9/2022

On October 20, 2022 Orion reported that it’s Interim Report 1–9/2022 (Press release, Orion , OCT 20, 2022, View Source [SID1234622233]). The complete report is attached to this stock exchange release and is available at View Source

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Net sales totalled EUR 1,046 million (EUR 765 million in 2021).
Operating profit was EUR 399 (203) million.
Profit before taxes was EUR 400 (202) million.
Equity ratio was 62% (71%).
Return on capital employed before taxes (ROCE) was 53% (32%).
Return on equity after taxes (ROE) was 49% (29%).
Basic earnings per share were EUR 2.26 (1.15).
Cash flow from operating activities per share was EUR 3.05 (0.99).
The outlook for 2022 remains unchanged. Orion estimates that net sales in 2022 will be clearly higher than in 2021 (net sales in 2021 were EUR 1,041 million). Operating profit is estimated to be clearly higher than in 2021 (operating profit in 2021 was EUR 243 million).

President and CEO Timo Lappalainen:
Sales developed well – milestone having material impact on net sales and operating profit

"Orion’s net sales and operating profit for January-September 2022 increased clearly compared to the comparative period. Both figures were boosted by the global development and commercialisation agreement for the ODM-208 molecule announced in July and the related upfront payment of USD 290 million, of which we recognised EUR 228 million in net sales and operating profit in the third quarter. Even without this milestone payment, net sales were slightly higher than in the comparative period due to positive development of sales and because the acquired animal health company VMD’s (Inovet) net sales is now included in Orion’s net sales.

Operating profit without the ODM-208 agreement related milestone payment and costs was slightly lower than in the comparative period, mainly due to clearly higher operating costs. The ODM-208 agreement related costs were approximately EUR 20 million. These expenses include, among others, non-recurring advisory fees and provisions for certain variable incentive systems. But even without the ODM-208 related costs, the operating costs were clearly higher than in the comparative period. Sales and marketing costs increased because of a clear increase in promotional activities since COVID-19. Research & development costs increased clearly mainly due to the timing of research and clinical development projects and their costs. However, excluding the ODM-208 agreement related milestone and costs, the year 2022 is proceeding as we anticipated in the beginning of the year.

Sales of the Proprietary Products unit excluding the ODM-208 milestone payment increased slightly, mainly due to strong growth of Nubeqa and the Easyhaler product family. Sales of Parkinson’s medicines also developed well. Nubeqa sales recorded by Orion show expected fluctuations between quarters due to the way Orion records Nubeqa sales and does not reflect the development of market sales of the product. Sales of Dexdor and Simdax continued to decline as expected due to generic competition and price erosion. The Specialty Products unit saw an increase in sales, driven by self-care products, but prescription sales also performed well. Various respiratory tract infections have occurred more abundantly than in previous years, which partly explains the increase. The acquisition of VMD’s animal health business in June is reflected in the net sales of the Animal Health unit. Fermion’s net sales decreased slightly from the comparative period. The decrease is mainly due to a higher share of Fermion’s capacity being used for the production of Orion’s proprietary active pharmaceutical ingredients.

We have started a Phase I clinical trial with the NaV 1.8 blocker that is intended for the treatment of acute and chronic pain (ODM-111), for which we acquired the rights earlier this year. The study will investigate the safety and tolerability of the drug candidate in healthy volunteers. We have completed a Phase I clinical trial with tasipimidine (ODM-105) and, based on the accumulated data, we are preparing to initiate a Phase II clinical trial to evaluate the efficacy and safety of the drug candidate in the treatment of psychiatric disorders. In addition, we have decided to discontinue the development of Easyhaler tiotropium for COPD. This decision is based on a reassessment of the product’s commercial potential. The decision will have no impact on the existing Easyhaler portfolio, which will continue to be an important and growing product group for Orion.

The operating environment remains challenging due to the impact of the COVID-19 pandemic, the war in Ukraine and cost inflation. Orion is continuously working hard to ensure continuity of production, product availability, patient safety and to manage risks in global supply chains. The impact of cost inflation has already started to show up in the income statement and is expected to intensify in 2023. Energy availability and price risks are also increasing across the supply chain.

I have worked for Orion since 1999 and as CEO since the beginning of 2008. I would like to express my sincere thanks to all Orion employees, customers and partners for these years. I also thank Orion’s shareholders and Board of Directors for their support and trust. From the beginning of November, I will take on the role of advisor and shareholder of Orion. Building of well-being continues and I have strong confidence in Orion’s future."

A note from the Board of Directors of Orion

The time under Timo Lappalainen’s leadership will remain as one of the most successful periods in Orion’s long history. Timo’s contribution for this has been significant. This period now ends at Orion history’s highest operating profit quarter. Ahead of Timo’s retirement as the CEO, the Board of Orion wants to use this opportunity to thank Timo for his great leadership and for the very supportive and collaborative way he has worked with the Board. Timo is very much respected and liked by the Board, as he is by the whole Orion family and partners alike. We wish him all the best for the future!

Outlook for 2022 (provided on 13 July 2022)

Orion estimates that net sales in 2022 will be clearly higher than in 2021
(net sales in 2021 were EUR 1,041 million).

Operating profit is estimated to be clearly higher than in 2021
(operating profit in 2021 was EUR 243 million).

News conference and conference call

A webcast and a conference call for analysts, investors and media will be held today on Thursday, 20 October 2022 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.

argenx to Report Third Quarter 2022 Financial Results and Business Update on October 27, 2022

On October 20, 2022 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported that it will host a conference call and audio webcast on Thursday, October 27, 2022 at 2:30 pm CET (8:30 am ET) to discuss its third quarter 2022 financial results and provide a business update (Press release, argenx, OCT 20, 2022, View Source [SID1234622232]).

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A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the presentation.

Neuren receives US$10 million milestone payment

On October 20, 2022 Neuren Pharmaceuticals (ASX: NEU) reported that it has now received the milestone payment of US$10 million from its US partner Acadia Pharmaceuticals (Nasdaq: ACAD) (Press release, Neuren, OCT 20, 2022, View Source;[email protected] [SID1234622231]). The payment was due following the US Food and Drug Administration (FDA) acceptance for review of Acadia’s New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome. The FDA granted a Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of 12 March 2023.

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Acadia has exclusive rights to develop and commercialize trofinetide in North America. Neuren retains all rights to trofinetide for all countries outside North America and has a fully paid-up, irrevocable licence for use in those countries to all data generated by Acadia. The development and commercialisation of trofinetide in North America is fully funded by Acadia.

If the NDA is approved by the FDA, the next potential milestone payment to Neuren would be US$40 million (A$62 million at an assumed exchange rate of 0.65), payable following the first commercial sale of trofinetide in the United States. Subsequently, Neuren is eligible to receive double-digit percentage royalties on net sales of trofinetide in North America, plus milestone payments of up to US$350 million (A$538 million) on achievement of a series of four thresholds of total annual net sales, plus one third of the market value of a Rare Pediatric Disease Priority Review Voucher if awarded by the FDA upon approval of the NDA, with the one third share estimated by Neuren as US$33 million (A$51 million).

Cerus Corporation to Release Third Quarter 2022 Financial Results on November 3, 2022

On October 20, 2022 Cerus Corporation (Nasdaq: CERS) reported that its third quarter 2022 financial results will be released on Thursday, November 3, 2022, after the close of the stock market (Press release, Cerus, OCT 20, 2022, View Source [SID1234622230]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Participants may register for the call here. While not required, interested participants are encouraged to join 10 minutes prior to the start of the event.

A replay will be available on Cerus’ website and will be available approximately three hours after the call through November 17, 2022.

Ashvattha Therapeutics Announces the Appointment of Steve Maricich, M.D., Ph.D. as Chief Medical Officer

On October 20, 2022 Ashvattha Therapeutics ("Ashvattha"), a clinical-stage company developing novel hydroxyl dendrimer therapeutics (HDTs), reported that Steve Maricich, M.D., Ph.D., joined the company as chief medical officer (Press release, Ashvattha Therapeutics, OCT 20, 2022, View Source [SID1234622229]). Dr. Maricich joins Ashvattha as a seasoned clinical development physician and translational scientist with more than 15 years of industry and academic experience that includes working with small molecules, biologics, cell and gene therapies across multiple therapeutic areas including cancer, GI disease, hematology, neurology, and rare disease.

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"We are thrilled to welcome Dr. Maricich to our senior management team," said Jeff Cleland, Ph.D., chairman and CEO of Ashvattha. "He joins at a pivotal time for the company as we prepare to initiate clinical trials of our neurology hydroxyl dendrimer candidates next year. His neurology background and expertise advancing preclinical programs to clinical development will be a major asset to our team and the growth of the company."

Dr. Maricich added, "I am excited to join Ashvattha, and I look forward to working with the team to unlock the full potential of the hydroxyl dendrimer platform. To date, attempts to deliver drugs to the brain via systemic administration have not translated to the clinic. I believe that HDTs represent a new precision medicine approach that transcends tissue barriers and possesses the ability to change the standard of care across a number of disease indications."

Dr. Maricich joins Ashvattha from Calibr and Scripps BioVentures, where he served as the chief medical officer. There, he oversaw the development of clinical-stage oncology and GI programs and designed clinical paths for preclinical programs across a wide range of indications. Dr. Maricich’s previous experience includes the CMO role at Allievex, a rare disease start-up company that he helped spin out of BioMarin Pharmaceuticals. Over the course of his career, Dr. Maricich has secured more than $2M in grant funding from the NIH and other privately operated organizations. Dr. Maricich earned his M.D. and Ph.D. degrees in neuroscience from Case Western Reserve University. He is a board-certified child neurologist with experience as a primary investigator while serving as pediatrics and child neurology faculty at Baylor College of Medicine/Texas Children’s Hospital, Case Western Reserve University/Rainbow Babies and Children’s Hospital, and the University of Pittsburgh/UPMC Children’s Hospital of Pittsburgh.