Orchard Therapeutics plc
orchard-tx.comNo Longer Reporting
The company has not filed an annual or quarterly report since its Q3 FY2023 10-Q, filed Nov 13, 2023. Its latest SEC filing is a SC 13G/A from Nov 14, 2024.
10-Q for Q3 FY2023, filed Nov 13, 2023
The sections below describe the company as of the FY2022 annual report.
What Did They Do?
Develops gene therapies made from patients’ own modified blood stem cells for people with rare diseases, with a commercial therapy for a rare nervous-system disorder and other candidates in development.
10-K for FY2022, filed Mar 14, 2023We are a global gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of…View ↗
We are currently focusing our ex vivo autologous HSC gene therapy approach on severe neurometabolic diseases and early research programs.…View ↗
Our portfolio includes a commercial-stage product and research and development-stage product candidates. We believe our approach of using…View ↗
We are currently focused on employing our ex vivo autologous HSC gene therapy approach in two therapeutic disease areas: neurodegenerative…View ↗
How Did They Make Money?
Hospitals and other payors pay for Libmeldy and Strimvelis, with Libmeldy revenue counted when a patient is infused and Strimvelis revenue when the product is transferred to the hospital. Pharming pays for research, development and manufacturing work as the work progresses.
10-K for FY2022, filed Mar 14, 2023The Company recognizes revenue when control of promised goods is transferred to a customer at an amount that reflects the consideration to…View ↗
The Company’s product sales of Strimvelis are currently distributed exclusively at the San Raffaele Hospital in Milan, Italy. The hospital…View ↗
We recognize collaboration revenue under our collaboration agreement with Pharming. Under revenue recognition guidance, we account for our…View ↗
$22.7M
-
10-K for FY2022, filed Mar 14, 2023
$22.7M ↗
Who Were Their Customers?
Specialized treatment centers and hospitals buy the therapies; in some regions, distributors help identify patients and perform related work, while the company fulfills Libmeldy orders. Pharming is a collaboration partner for OTL-105.
10-K for FY2022, filed Mar 14, 2023In certain regions of Europe and the Middle East, the Company utilizes distributors to act in an agent capacity including for patient…View ↗
The Company’s product sales of Strimvelis are currently distributed exclusively at the San Raffaele Hospital in Milan, Italy. The hospital…View ↗
In July 2021, we entered into a collaboration with Pharming Group N.V., or Pharming, pursuant to which we granted Pharming worldwide rights…View ↗
With the exception of OTL-105, our product candidate for the potential treatment of hereditary angioedema, or HAE, which we are pursuing in…View ↗
Did Revenues Turn Into Profits?
No. It lost $150.7M in FY2022.
10-K for FY2022, filed Mar 14, 2023
−$127.1MView ↗
10-K for FY2022, filed Mar 14, 2023
−$150.7MView ↗
10-K for FY2022, filed Mar 14, 2023
−$82.5MView ↗
How Were They Changing?
- Net income
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Sources
10-Q for Q3 FY2023, filed Nov 13, 2023
−$35.3MView ↗
- ▼ −26% (Loss)
- vs −$47.6M in Q3 FY2022
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Jan 24, 2024
Kyowa Kirin completed its acquisition of Orchard Therapeutics.
Orchard’s shares were transferred to Kyowa Kirin’s nominee, and shareholders became entitled to cash and contingent value rights.
Sources
8-K, filed Jan 24, 2024
At the Effective Time of the Scheme of Arrangement (the “Effective Time”) all voting and non-voting ordinary shares of the Company, each…View ↗
Grew. Revenue grew 10.9x in 4 years, from $2.1M in FY2018 to $22.7M in FY2022, about 82% a year.
Therapy focus
The earlier report described programs across primary immune deficiencies, neurometabolic disorders and blood disorders. The latest report focuses on severe neurometabolic diseases and early research, while limiting new investment in the blood-disorder program.
10-K for FY2019, filed Feb 27, 2020 10-K for FY2022, filed Mar 14, 2023
Commercial product
The earlier report identified Strimvelis as its commercial product and described another MLD program as in clinical development. The latest report describes Libmeldy as approved in Europe and generating product sales, and says investment in Strimvelis is being discontinued.
10-K for FY2019, filed Feb 27, 2020 10-K for FY2022, filed Mar 14, 2023We are currently focusing our ex vivo autologous HSC gene therapy approach on severe neurometabolic diseases and early research programs.…View ↗
Strimvelis for adenosine deaminase severe combined immunodeficiency, or ADA-SCID, is the only gammaretroviral vector-based gene therapy in…View ↗
We recognize product revenue, net, from sales of Libmeldy and Strimvelis in Europe. Product revenue is recorded net of estimates of…View ↗
Who Did They Compete With?
Competes with Homology Medicines, Passage Bio, Affinia, Takeda, Denali Therapeutics, REGENXBIO, bluebird bio, Immusoft, BioMarin, Sanofi Genzyme, JCR Pharmaceuticals, Lysogene, Abeona Therapeutics, Ultragenyx, Esteve, Amicus Therapeutics, Prevail Therapeutics, Eli Lilly &, and Alector
10-K for FY2022, filed Mar 14, 2023MLD: To our knowledge, beyond Libmeldy in Europe, there is currently no other effective treatment option for patients with MLD. HSCT, for…View ↗
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