Repligen Corporation is an American company devoted to the development and production of materials used in the manufacture of biological drugs. The company is based in

Waltham, Massachusetts Waltham ( ) is a city in Middlesex County, Massachusetts, United States, and was an early center for the labor movement as well as a major contributor to the Technological and industrial history of the United States, American Industrial Revoluti ...

, and was incorporated in

Delaware Delaware ( ) is a U.S. state, state in the Mid-Atlantic (United States), Mid-Atlantic and South Atlantic states, South Atlantic regions of the United States. It borders Maryland to its south and west, Pennsylvania to its north, New Jersey ...

in 1981. A

public company A public company is a company whose ownership is organized via shares of share capital, stock which are intended to be freely traded on a stock exchange or in over-the-counter (finance), over-the-counter markets. A public (publicly traded) co ...

, Repligen is listed on the

NASDAQ The Nasdaq Stock Market (; National Association of Securities Dealers Automated Quotations) is an American stock exchange based in New York City. It is the most active stock trading venue in the U.S. by volume, and ranked second on the list ...

exchange under the symbol RGEN. In February 2014, Repligen had employed 116 people, about 50% of these based in Sweden.

Business model

Before 2012, Repligen maintained dual capabilities in developing pharmaceutical therapeutics (drug discovery and development) and the development of materials supporting biological drug manufacture (bioprocessing business). A decision was made in 2012 to focus on the bioprocessing business and reduce research and development expenditures. In the period of 2010 to 2013, the majority of sales by the company were concentrated in the single Protein A product line.

Sales and revenue

Repligen employs a direct sales model to users of its products in the United States, with some sales through

intermediaries An intermediary, also known as a middleman or go-between, is defined differently by context. In law or diplomacy, an intermediary is a third party who offers intermediation services between two parties. In trade or barter, an intermediary acts ...

in "certain foreign markets". More than 80% of sales have been to customers in the United States and Sweden during the 2010-2013 period. Long-term supply agreements have been established with major customers of the Protein A products, agreements which expire between 2016 and 2021 barring re-negotiation. As a result of royalty-generating out-licensing, royalty revenue from Bristol-Myers Squibb has been in the 27% to 37% range as a proportion of total revenue during the 2010-2013 period; in comparison to revenue from sales, the largest customer accounted for 35% to 45% of revenue during the same period. As a consequence of current operations, about one-third each of revenue and cost and expenses are denominated in

Swedish krona The krona (; plural: ''kronor''; sign: kr; code: SEK) is the currency of Sweden. Both the ISO code "SEK" and currency sign "kr" are in common use for the krona; the former precedes or follows the value, the latter usually follows it but, espec ...

currency, the remaining two-thirds denominated in

United States dollar The United States dollar (Currency symbol, symbol: Dollar sign, $; ISO 4217, currency code: USD) is the official currency of the United States and International use of the U.S. dollar, several other countries. The Coinage Act of 1792 introdu ...

s; this presents a risk to the business based on unpredictable fluctuations in currency

exchange rate In finance, an exchange rate is the rate at which one currency will be exchanged for another currency. Currencies are most commonly national currencies, but may be sub-national as in the case of Hong Kong or supra-national as in the case of ...

Intellectual property

The company's Protein A-related offerings are supported by proprietary technology, trade secrets and patent filings. One patent was granted in April 2010 and has been extended so that it remains in effect until 2028. Patents are pending on elements of the OPUS chromatography product line, and enabling technology has been licensed from BioFlash Partners. Repligen retains an exclusive license to intellectual property owned by the

University of Michigan The University of Michigan (U-M, U of M, or Michigan) is a public university, public research university in Ann Arbor, Michigan, United States. Founded in 1817, it is the oldest institution of higher education in the state. The University of Mi ...

in relation to the Orencia product divested to Bristol-Myers Squibb.

Facilities

Repligen's company headquarters are housed together with its manufacturing facility in Waltham, Massachusetts. Repligen maintains manufacturing facilities in

and Lund, Sweden. Growth factor products and the native form of Protein A are manufactured in Sweden; recombinant forms of Protein A are manufactured in both the United States and Sweden; assembly of the OPUS chromatography product line is done in the United States. The lease on the main Waltham facility extends through 2023. A second, smaller Waltham facility was leased through the end of 2012 and is now rented on a monthly basis. In Lund, four buildings are under lease, three expiring in mid-2017 and the fourth extending to late 2019.

Corporate history and governance

Alexander Rich Alexander Rich (15 November 1924 – 27 April 2015) was an American biologist and biophysicist. He was the William Thompson Sedgwick Professor of Biophysics at MIT (since 1958) and Harvard Medical School. Rich earned an A.B. ('' magna cum ...

was a co-founder of Repligen and served as Chairman Emeritus of Repligen's

board of directors A board of directors is a governing body that supervises the activities of a business, a nonprofit organization, or a government agency. The powers, duties, and responsibilities of a board of directors are determined by government regulatio ...

. Rich had been a member of the Board since 1981.

Paul Schimmel Paul Reinhard Schimmel (born August 4, 1940) is an American biophysical chemist and translational medicine pioneer. Career Paul Schimmel is a Professor of Molecular Medicine at The Scripps Research Institute. Prior to joining The Scripps Resea ...

is also a co-founder of Repligen, and he is the Ernest and Jean Hahn Professor at The Skaggs Institute for Chemical Biology at

The Scripps Research Institute Scripps Research is a nonprofit American medical research facility that focuses on research and education in the biomedical sciences. Headquartered in San Diego, California, the institute has over 170 laboratories employing 2,100 scientists, tec ...

. He used to be the John D. and Catherine T. MacArthur Professor of Biochemistry and Biophysics in the Department of Biology at

MIT The Massachusetts Institute of Technology (MIT) is a private research university in Cambridge, Massachusetts, United States. Established in 1861, MIT has played a significant role in the development of many areas of modern technology and sc ...

. , the company's

President President most commonly refers to: *President (corporate title) * President (education), a leader of a college or university *President (government title) President may also refer to: Arts and entertainment Film and television *'' Præsident ...

and

Chief Executive Officer A chief executive officer (CEO), also known as a chief executive or managing director, is the top-ranking corporate officer charged with the management of an organization, usually a company or a nonprofit organization. CEOs find roles in variou ...

is Tony J. Hunt.

Acquisitions and in-licensing

In early 2010, Repligen licensed technology from BioFlash which it subsequently incorporated into the OPUS line of pre-packed chromatography columns. In 2011, Repligen acquired

bioproduction Biomanufacturing (or bioproduction) is a type of manufacturing or biotechnology that utilizes biological systems to produce commercially important biomaterial, biomaterials and biomolecule, biomolecules for use in pharmaceutical drug, medicines, foo ...

assets from

Novozymes Novozymes A/S was a global biotechnology company headquartered in Bagsværd, outside of Copenhagen, Denmark. The company's focus was the research, development and production of industrial enzymes, microorganisms, and biopharmaceutical ingredie ...

for $26.4 million, which doubled the company's bioprocessing capabilities. In December 2016 the company acquired TangenX for $39 million In September 2023, Repligen acquired a fluid management company, Metenova.

Divestments and out-licensing

In 2008, an agreement was struck to divest certain intellectual property rights to

Bristol-Myers Squibb The Bristol-Myers Squibb Company, doing business as Bristol Myers Squibb (BMS), is an American multinational pharmaceutical company. Headquartered in Princeton, New Jersey, BMS is one of the world's largest pharmaceutical companies and consist ...

around the drug Orencia in exchange for ongoing

royalty Royalty may refer to: * the mystique/prestige bestowed upon monarchs ** one or more monarchs, such as kings, queens, emperors, empresses, princes, princesses, etc. *** royal family, the immediate family of a king or queen-regnant, and sometimes h ...

payments through the end of 2013. At the end of 2012, Repligen out-licensed its

spinal muscular atrophy Spinal muscular atrophy (SMA) is a rare neuromuscular disorder that results in the loss of motor neurons and progressive muscle wasting. It is usually diagnosed in infancy or early childhood and if left untreated it is the most common geneti ...

program, in particular the small molecule candidate drug RG3039, to

Pfizer Pfizer Inc. ( ) is an American Multinational corporation, multinational Pharmaceutical industry, pharmaceutical and biotechnology corporation headquartered at The Spiral (New York City), The Spiral in Manhattan, New York City. Founded in 184 ...

. This divestment included licensing rights to two patents to Pfizer. At the start of 2014, the company out-licensed its

Friedreich's ataxia Friedreich's ataxia (FRDA) is a rare, inherited, autosomal recessive neurodegenerative disorder that primarily affects the nervous system, causing progressive damage to the spinal cord, peripheral nerves, and cerebellum, leading to impaired ...

program, including a library of

histone deacetylase inhibitor Histone deacetylase inhibitors (HDAC inhibitors, HDACi, HDIs) are chemical compounds that enzyme inhibitor, inhibit histone deacetylases. Since acetylation of histones, deacetylation of histones produces transcriptionally silenced heterochromatin ...

compounds, to BioMarin Pharmaceutical for and future milestone and royalty payments.

Terminations and moth-balling

Development of an imaging agent, designated RG1068, based on a synthetic human hormone was halted in 2012 following a request by the USFDA for additional safety and efficacy data beyond that provided in a

New Drug Application The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial ...

(NDA) submission; a Marketing Authorization Application had been submitted in parallel to the EMA.

Products and services

Repligen is a major supplier of Protein A, both native and recombinant forms, to the pharmaceutical industry. In 2010-2013, Protein A accounted for the majority of the company's product sales. The company also provides

growth factor A growth factor is a naturally occurring substance capable of stimulating cell proliferation, wound healing, and occasionally cellular differentiation. Usually it is a secreted protein or a steroid hormone. Growth factors are important for ...

s to increase the productivity of cell-based

, multiple alternating tangential flow (ATF) systems, and a line (OPUS) of chromatography columns scaled to manufacture of product for testing in

clinical trials Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

. The OPUS product line contains a range of column sizes, the size and composition of which are dependent upon customer requirements, thus the full name of "Open Platform, User Specified". The smaller sizes of columns depend upon proprietary technology licensed from BioFlash Partners, while the larger sizes are based on Repligen-developed proprietary technology.

Notes

References

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External links

{{Authority control Manufacturing support companies Companies based in Massachusetts Companies listed on the Nasdaq 1981 establishments in Massachusetts Companies in the S&P 400