Company Announcements

16 April 2020

Clinigen signs exclusive global licensing and distribution agreement with
Porton Biopharma to commercialise Erwinase® / Erwinaze®

Group provides trading update on COVID-19

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has signed an exclusive licensing and distribution agreement with Porton Biopharma Limited ('PBL') to commercialise Erwinase® / Erwinaze® ('Erwinase') and is issuing a trading update regarding COVID-19.

Global licensing and distribution agreement with Porton Biopharma for Erwinase®/ Erwinaze®

Erwinase is approved for patients with Acute Lymphoblastic Leukaemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase in 19 countries, including the US, Europe and Japan.

Clinigen will look to expand the market opportunity for Erwinase by driving awareness of the product's availability, ensuring uninterrupted patient access, launching in select new countries and increasing the global supply of the product into unlicensed markets utilising its global infrastructure through a global access program.

Erwinase will be the Group's third biologic and fits well within Clinigen's existing haematology and oncology product portfolio and customer base. It further strengthens and leverages Clinigen's newly established commercial infrastructure in both the EU and higher value US market where it currently owns the rights to Proleukin®, Foscavir®, Ethyol® and Totect®.

In the year to 31 December 2019, net sales of Erwinase were $177m. Whilst the agreement will start on 1 January 2021, it is anticipated that net sales for Clinigen will begin in the second half of 2021 as the product is transitioned from PBL's current licensing partner. PBL will maintain the trademarks and manufacture the product, whilst Clinigen will be responsible for product marketing, packaging, labelling, storage and distribution of the product.

Clinigen will pay PBL £5m upfront in cash consideration plus future sales-based milestone payments of up to £20m, alongside tiered royalty payments based upon worldwide net sales of Erwinase. Upon onboarding the product, Clinigen expects a modest amount of working capital investment (£10m-£20m across FY21/22) to support the product which can be funded through its current debt facilities.

Trading update regarding COVID-19

Clinigen has implemented a range of measures to prioritize keeping its employees safe, including extensive home working, whilst ensuring it can support hospitals and their patients during these times.

The Group has been working closely with its pharmaceutical clients as well as its hospital customers to ensure that the supply of critical medicines to patients on a global basis continues uninterrupted.

Trading for the year to 30 June 2020 continues to be in line with the Board's expectations and the business had a strong first nine months of the year with organic gross profit growth of over 10% to the end of March 2020.

To date the Group has experienced only marginal disruption from COVID-19 which is a testament to the strength of its global diversified platform and its partners in the industry.

The cash generation delivered in the first three months of the second half has proceeded in line with the Board's expectations as the Group has made material strides in alleviating issues related to the ERP system.

The fundamental positive cash generation characteristic of Clinigen remains unchanged with significant levels of liquidity available to the Group from its £430m debt facility. Clinigen expects to keep well within its 3.0x net debt / EBTIDA covenant limit throughout FY20 before reducing this leverage ratio to below 2.0x during FY21.

Shaun Chilton, Group Chief Executive Officer, Clinigen, said:

"This licensing agreement fits with our strategy to partner with pharmaceutical companies to expand and extend the lifecycle of their products by utilising our global platform and expertise in the supply and distribution of both unlicensed and licensed medicines.

"As part of our portfolio in oncology and haematology, Erwinase strengthens our commercial offering in key markets and will be a priority product for the Group. The agreement will ensure healthcare professionals have the broadest possible access to this important treatment for their patients.

"As the COVID-19 situation continues to evolve, our priority remains the safety of our employees and our clients. We have also performed well during these challenging times.  Our unique business has the international reach and capability to continue to offer a meaningful contribution to helping our customers and partners at a time when they need us the most."

- Ends -

Information within this announcement is deemed by the Company to constitute inside information under the Market Abuse Regulations (EU) No. 596/2014.

Contact details

Notes to Editors

About Erwinase® / Erwinaze®

Erwinase is indicated for the treatment of Acute Lymphoblastic Leukaemia (ALL), a type of cancer that particularly affects children. Erwinase is an asparaginase enzyme derived from the bacterium Erwinia chrysanthemi that is used as part of the treatment protocols in conjunction with radiotherapy or chemotherapy.

Asparagine is an amino acid that is essential for cell growth; it is produced by most but not all cells. Mutated cancer cells in ALL rely on asparagine circulating in the blood for growth. L-asparaginases are a group of enzymes that lower circulating asparagine levels in the blood, thereby depriving the mutated cells of asparagine and inhibiting their growth.

There are several different types of L-asparaginase available on the market, each derived from a different bacterium. Patients receiving treatment with L-asparaginase derived from Escherichia coli (E. coli), who develop hypersensitivity to that form of the enzyme, may be able to continue treatment with Erwinase as the enzymes are immunologically distinct. Antibodies targeting E. coli derived L-Asparaginase have been shown not to cross-react with Erwinase.

About Acute Lymphoblastic Leukaemia (ALL)

Acute lymphoblastic leukaemia (ALL) is a type of blood cancer that starts from young white blood cells called lymphocytes in the bone marrow. Both adults and children can get the illness, but it is most often diagnosed in younger people. There are approximately 5,000 new cases each year in the US and 4,000 in Europe. The disease is the most common childhood cancer and is responsible for more than 80 percent of childhood leukaemia cases.

About Porton Biopharma Limited (PBL)

PBL is a biopharmaceutical development and manufacturing company. It was formed in April 2015 as a spin-out company of Public Health England, part of the Department of Health and Social Care.  PBL is based at Porton Down, Wiltshire, which has a long history of pharmaceutical development and manufacturing. Erwinase, the UK's anthrax vaccine, Dysport and other medical treatments have been developed at the site by the forerunners to PBL. PBL has approximately 350 staff and has a sole shareholder in the Department of Health and Social Care.

About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines. The Group has sites in North America, Europe, Africa and Asia Pacific.

Clinigen now has over 1,100 employees across five continents in 14 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 22 of the top 25 pharmaceutical companies; interacting with over 15,000 registered users across over 100 countries, shipping approximately 6.4 million units in the year.

For more information on Clinigen, please visit www.clinigengroup.com.

Cautionary statement

This announcement contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Clinigen Group plc. These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. Except as required by law, Clinigen undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.

The information contained in this statement has not been audited and may be subject to further review.