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Biotest to sell US therapy business to ADMA Biologics, Inc., and will receive approximately 50% of the shares of ADMA Biologics, Inc. at closing, which is anticipated to occur in the first half of 2017.

01/23/2017

Biotest to sell US therapy business to ADMA Biologics, Inc., and will receive approximately 50% of the shares of ADMA Biologics, Inc. at closing, which is anticipated to occur in the first half of 2017.

  • Earnings before interest and taxes of Continued Operations in 2016 increases by approx. €30 million
  • Biotest secures participation in future success of ADMA Biologics,
  • Biotest receives distribution rights of specified current product and a right of first offer for the distribution of future products of ADMA for Europe, Near and Middle East and selected Asian countries
  • Including one-time expenses Biotest will report a loss of € 80 million as Discontinued Operations

 

Dreieich, 23 January 2017. Biotest’s US subsidiary, Biotest Pharmaceuticals Corporation, Boca Raton, Florida, USA, (BPC), has entered into a definitive agreement with ADMA Biologics, Inc., Ramsey, New Jersey, USA, (ADMA) to sell certain assets of the US therapy business. Included in the assets to be transferred at closing are BPC’s plasma fractionation facility, its commercial products, contract manufacturing agreements as well as BPC’s Boca Raton, Florida headquarters and real properties.

Upon closing of this transaction, Biotest will receive equity interest in ADMA’s issued and outstanding capital stock in the form of 50% minus one share representing 25% of the voting rights. In addition, Biotest will:

  • Receive two ADMA plasma centers in the USA on January 1, 2019
  • Obtain distribution rights for ADMA’s innovative product (RI-002) and a right of first offer for the distribution of future ADMA developed plasma- based products in Europe, Near and Middle East and selected Asian countries
  • Participate from the future development of products in the USA

As part of the transaction, Biotest will contribute €11.5 million in cash as well as a €14 million loan. The loan bears 6% interest and has a term of 5 years. In addition, Biotest will contribute up to €11.5 million towards a future capital increase of ADMA on equal terms as third party investors.

BPC will maintain its focus on its plasma operations business which includes 22 plasma centers located across the USA.

Due to an unforeseeable delay in the contractually required ramp up of the manufacturing of Bivigam® at the Boca Raton production site of BPC, Biotest and Kedrion Biopharma Inc., Fort Lee, New Jersey, USA (Kedrion Biopharma) mutually terminated the contract of the Bivigam® distribution agreement in the USA effective immediately

Effective immediately, Biotest will report the US therapy business of BPC as Discontinued Operations. For the fiscal year 2016, Biotest expects this business unit to report a loss of approximately €80 million. This includes the loss of the therapy business, the depreciation of inventory and the impairment of the remaining goodwill, the expected expenses for the termination of the Kedrion Biopharma distribution agreement as well as re-structuring expenses.

The EBIT of the Continued Operations is expected to improve by approx. €30 million in the fiscal year 2016.

“Biotest and ADMA look forward to the closing of this promising transaction, which is anticipated to occur during the first half of 2017,” said Dr. Bernhard Ehmer, Chief Executive Officer and Chairman of the Board of Management of Biotest AG. “Given the Company’s significant experience in the plasma products industry, we are confident that ADMA is ideally suited to maximize the commercial potential of the acquired assets.”

This transaction is part of the Biotest Group strategy to limit risks, utilize competencies by developing partnerships and creating new options for future strategic development. After the closing of this transaction, Biotest will continue to have an equity ratio of almost 40%, will focus its resources on “Biotest Next Level”, the on-going manufacturing expansion project at Biotest’s headquarters located in Dreieich, Germany, and the successful expansion of its plasma center network.

The transaction, subject to customary closing conditions, including approval of ADMA's shareholders, is expected to close during the first half of 2017.

Conference Call:

Dr. Bernhard Ehmer (CEO) and Dr. Michael Ramroth (CFO) will explain the transaction and answer your questions in a conference call today at 02:00 pm CET.

Please find below the dial-in details of the Biotest conference call: Germany:                                               +49-69 2475 0189 5

United Kingdom                     +44-203 3679 216

The call will available for download on our webpage: www.biotest.com after the conference call.

About ADMA Biologics, Inc.

ADMA is a biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma-based biologics for the treatment and prevention of Primary Immune Deficiency Disease (PIDD) and certain infectious diseases. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune-compromised for medical reasons. For more information, please visit the company's website at www.admabiologics.com.

About RI-002

ADMA's lead product candidate, RI-002, is a specialty plasma-derived, polyclonal, intravenous immune globulin (IGIV) derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, cytomegalovirus (CMV), measles, tetanus, etc.) as well as standardized, high levels of antibodies to respiratory syncytial virus (RSV). ADMA is pursuing an indication for the use of this specialty intravenous immune globulin (IGIV) product for treatment of patients diagnosed with PIDD. Polyclonal antibodies are the primary active component of IGIV products. Polyclonal antibodies are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses. Data review indicates that the polyclonal antibodies present in RI-002 support its ability to prevent infections in immune-compromised patients.

About Bivigam

Bivigam is a immunoglobulin (IGIV) solely licensed in the US.

About Biotest

Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,500 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

IR contact

Dr. Monika Buttkereit phone: +49-6103-801-4406

email: investor.relations@biotest.com

PR contact

Dirk Neumüller

phone: +49-6103-801-269

email: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.de

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201 Preference shares: securities’ ID No. 522723; ISIN DE0005227235 Listing: Prime Standard

Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hanover, Munich, Stuttgart

Disclaimer

This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.