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{{Short description|Biotechnology company}}
{{Update|part=Entire article|reason=hasn't been materially touched since 2014|date=August 2022}}
{{Infobox company
| name = Repligen Corporation
| logo = Repligen_Logo.svg
| type = [[Public company|Public]]
| foundation = {{Start date and age|1981}}
| traded_as = {{NASDAQ|RGEN}}<br>[[List of S&P 400 companies|S&P 400 Component]]
| founders = Alexander Rich <br /> Paul Schimmel
| location_city = Waltham, Massachusetts
| location_country = United States
| key_people = Tony J. Hunt ([[President (corporate title)|president]] and [[Chief executive officer|CEO]])
| industry = Pharmaceutical industry
| products = Materials used in the manufacture of biological drugs
| num_employees = 116 <small>(2014)</small>
| homepage = {{url|https://repligen.com}}
| revenue = {{increase}}US$68 million <small>(2014)</small>
| operating_income = {{increase}}US$23 million <small>(2014)</small>
| assets = {{increase}}US$119 million <small>(2014)</small>
| equity = {{increase}}US$104 million <small>(2014)</small>
}}
'''Repligen Corporation''' is an American company devoted to the development and production of materials used in the manufacture of [[biological drug]]s.{{ref|International New York Times staff|2014}}  The company is based in [[Waltham, Massachusetts]],{{ref|International New York Times staff|2014}} and was [[Incorporation (business)#In the United State|incorporated]] in [[Delaware General Corporation Law|Delaware]] in 1981.{{sfn|Repligen 2013 10-K|2014|p=2}}  A [[public company]], Repligen is listed on the [[NASDAQ]] exchange under the symbol RGEN.<ref>{{NASDAQ|RGEN}}</ref>  In February 2014, Repligen had employed 116 people, about 50% of these based in Sweden.{{sfn|Repligen 2013 10-K|2014|p=6}}
== 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).{{sfn|Repligen 2013 10-K|2014|p=1}} A decision was made in 2012 to focus on the bioprocessing business and reduce research and development expenditures.{{sfn|Repligen 2013 10-K|2014|p=4}}  In the period of 2010 to 2013, the majority of sales by the company were concentrated in the single [[Protein A]] product line.{{sfn|Repligen 2013 10-K|2014|p=3}}
=== Sales and revenue ===
Repligen employs a [[direct sales]] model to users of its products in the United States, with some sales through [[Intermediary|intermediaries]] in "certain foreign markets".{{sfn|Repligen 2013 10-K|2014|p=5}}  More than 80% of sales have been to customers in the United States and Sweden during the 2010-2013 period.{{sfn|Repligen 2013 10-K|2014|p=5}} Long-term [[Project finance#Supply agreement|supply agreements]] have been established with major customers of the Protein A products, agreements which expire between 2016 and 2021 barring re-negotiation.{{sfn|Repligen 2013 10-K|2014|p=7}}
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.{{sfn|Repligen 2013 10-K|2014|p=6}}
As a consequence of current operations, about one-third each of revenue and cost and expenses are denominated in [[Swedish krona]] currency, the remaining two-thirds denominated in [[United States dollar]]s; this presents a risk to the business based on unpredictable fluctuations in currency [[exchange rate]]s.{{sfn|Repligen 2013 10-K|2014|p=18}}
=== Intellectual property ===
The company's Protein A-related offerings are supported by proprietary technology, trade secrets and patent filings.{{sfn|Repligen 2013 10-K|2014|p=6}}  One patent was granted in April 2010 and has been extended so that it remains in effect until 2028.{{sfn|Repligen 2013 10-K|2014|p=6}}<ref name=us7691608>{{Patent|US|7691608 B2|"Nucleic Acids Encoding Recombinant Protein A"}}</ref>  Patents are pending on elements of the OPUS chromatography product line,{{sfn|Repligen 2013 10-K|2014|p=6}} and enabling technology has been licensed from BioFlash Partners.{{sfn|Repligen 2013 10-K|2014|p=3}}  Repligen retains an [[exclusive license]] to intellectual property owned by the [[University of Michigan]] in relation to the [[Orencia]] product divested to Bristol-Myers Squibb.{{sfn|Repligen 2013 10-K|2014|p=5}}<ref name=us6685941>{{patent|US|6685941|"Methods of treating autoimmune disease via CTLA-4Ig"}}</ref>
==Facilities==
Repligen's company headquarters are housed together with its manufacturing facility in Waltham, Massachusetts.{{sfn|Repligen 2013 10-K|2014|p=19}}
Repligen maintains manufacturing facilities in [[Waltham, Massachusetts]] and [[Lund|Lund, Sweden]].{{sfn|Repligen 2013 10-K|2014|p=2}}  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.{{sfn|Repligen 2013 10-K|2014|p=7}}
The lease on the main Waltham facility extends through 2023.{{sfn|Repligen 2013 10-K|2014|p=19}}  A second, smaller Waltham facility was leased through the end of 2012 and is now rented on a monthly basis.{{sfn|Repligen 2013 10-K|2014|p=20}}  In Lund, four buildings are under lease, three expiring in mid-2017 and the fourth extending to late 2019.{{sfn|Repligen 2013 10-K|2014|p=20}}
==Corporate history and governance==
[[Alexander Rich]] was a co-founder of Repligen and served as Chairman Emeritus{{sfn|Motley Fool|2014}} of Repligen's [[board of directors]]. Rich had been a member of the Board since 1981.{{sfn|Forbes|2014}} [[Paul Schimmel]] 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]]. He used to be the John D. and Catherine T. MacArthur Professor of Biochemistry and Biophysics in the Department of Biology at [[MIT]].
{{As of|2015}}, the company's [[Company president|President]] and [[Chief executive officer|Chief Executive Officer]] 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.{{sfn|Repligen 2013 10-K|2014|p=3}}
In 2011, Repligen acquired [[bioproduction]] assets from [[Novozymes]] for $26.4 million, which doubled the company's bioprocessing capabilities.{{sfn|Repligen 2013 10-K|2014|p=1}}
In December 2016 the company acquired [[TangenX]] for $39 million<ref>{{Cite web|url=http://www.genengnews.com/gen-news-highlights/repligen-acquires-tangenx-for-39m/81253558|title = Repligen Acquires TangenX for $39M|date = 15 December 2016}}</ref>
In September 2023, Repligen acquired a fluid management company, Metenova.<ref>{{Cite news |date=September 27, 2023 |title=Repligen (RGEN) to Acquire Fluid Management Company Metenova |work=[[Nasdaq.com]] |url=https://www.nasdaq.com/articles/repligen-rgen-to-acquire-fluid-management-company-metenova}}</ref>
=== Divestments and out-licensing ===
In 2008, an agreement was struck to divest certain intellectual property rights to [[Bristol-Myers Squibb]] around the drug [[Orencia]] in exchange for ongoing [[Royalties|royalty]] payments through the end of 2013.{{sfn|Repligen 2013 10-K|2014|p=1}}
At the end of 2012, Repligen out-licensed its [[spinal muscular atrophy]] program, in particular the small molecule candidate drug [[RG3039]], to [[Pfizer]].{{sfn|Repligen 2013 10-K|2014|p=1}}  This divestment included licensing rights to two patents to Pfizer.{{sfn|Repligen 2013 10-K|2014|p=7}}<ref name=us7888366>{{Patent|US|7888366|"2,4-diaminoquinazolines for spinal muscular atrophy"}}</ref><ref name=us7985755>{{Patent|US|7985755|"2,4-DIAMINOQUINAZOLINES FOR SPINAL MUSCULAR ATROPHY"}}</ref>
At the start of 2014, the company out-licensed its [[Friedreich's ataxia]] program, including a library of [[histone deacetylase inhibitor]] compounds, to [[BioMarin Pharmaceutical]] for {{currency|2 million}} and future milestone and royalty payments.{{sfn|Repligen 2013 10-K|2014|p=2}}{{sfn|Gen. Eng. Biotechnol. News|2014}}
=== Terminations and moth-balling ===
Development of an [[Contrast medium|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]] (NDA) submission; a [[Marketing Authorization Application]] had been submitted in parallel to the [[European Medicines Agency|EMA]].{{sfn|Repligen 2013 10-K|2014|p=2}}
== Products and services ==
Repligen is a major supplier of [[Protein A]], both native and recombinant forms, to the pharmaceutical industry.{{sfn|Repligen 2013 10-K|2014|p=1}}  In 2010-2013, Protein A accounted for the majority of the company's product sales.{{sfn|Repligen 2013 10-K|2014|p=3}}  The company also provides [[growth factor]]s to increase the productivity of cell-based [[bioproduction]], multiple [[Cross-flow filtration#Alternating tangential flow (ATF)|alternating tangential flow]] (ATF) systems, and a line (OPUS) of [[Column chromatography|chromatography columns]] scaled to manufacture of product for testing in [[Clinical trial#Economics|clinical trials]].{{sfn|Repligen 2013 10-K|2014|p=1}}
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".{{sfn|Repligen 2013 10-K|2014|p=4}}  The smaller sizes of columns depend upon proprietary technology licensed from BioFlash Partners, while the larger sizes are based on Repligen-developed proprietary technology.{{sfn|Repligen 2013 10-K|2014|p=3}}
==Notes==
{{Reflist|30em}}
==References==
* {{cite web | author=Forbes | year=2014 | url=https://www.forbes.com/profile/alexander-rich/ | title=Alexander Rich | work=[[Forbes]] | access-date=15 March 2014 | department=Profiles | url-status=dead | archive-date=15 March 2014 | archive-url=https://web.archive.org/web/20140315192553/http://www.forbes.com/profile/alexander-rich/ }}
* {{Cite news | author=Gen. Eng. Biotechnol. News | title=BioMarin Nabs Repligen's HDACi Compound Library | date=February 15, 2014 | volume=34 | issue=4 | page=14| department=News: Discovery & Development | work=[[Gen. Eng. Biotechnol. News]] | type=paper }}
* {{cite web | author=International New York Times | year=2014 | title=Repligen Corporation | work=[[International New York Times]] | url=http://topics.nytimes.com/top/news/business/companies/repligen-corporation/ | access-date=15 March 2014 | department=Business Day | at=Company Information | url-status=live | archive-date=15 March 2014 | archive-url=https://web.archive.org/web/20140315184535/http://topics.nytimes.com/top/news/business/companies/repligen-corporation/ }}
* {{cite web | author=Motley Fool | year=2014 | url=http://www.fool.com/quote/nasdaq/repligen-corp/rgen/key-executives | title=Repligen Corp Key Executives RGEN | work=[[The Motley Fool]] | access-date=15 March 2014 | url-status=live | archive-date=15 March 2014 | archive-url=https://web.archive.org/web/20140315194147/http://www.fool.com/quote/nasdaq/repligen-corp/rgen/key-executives }}
* {{citation | ref={{harvid|Repligen 2013 10-K|2014}} | year=2014 | title=Repligen Corporation, Form 10-K, 2013 | id=Commission File Number 000-14656 | url=http://corporate.repligen.com/file.aspx?IID=4325751&FID=22568361&O=3&OSID=9 | publisher=Repligen | access-date=16 March 2014 | website=SEC Documents | series=[[Form 10-K]] }}
* {{cite news | author=Street Insider | title=Repligen (RGEN) Replaces Board Member Alex Rich with Alfred Goldberg | work=Street Insider | date=19 September 2011 | access-date=15 March 2014 | url=http://www.streetinsider.com/Management+Changes/Repligen+(RGEN)+Replaces+Board+Member+Alex+Rich+with+Alfred+Goldberg/6796218.html | url-status=live | archive-date=15 March 2014 | archive-url=https://web.archive.org/web/20140315195141/http://www.streetinsider.com/Management+Changes/Repligen+(RGEN)+Replaces+Board+Member+Alex+Rich+with+Alfred+Goldberg/6796218.html }}
==External links==
{{official|https://www.repligen.com}}
{{Finance links
| name = Repligen Corporation
| symbol = RGEN
| reuters = RGEN.O
| bloomberg = RGEN:US
| sec_cik = 730272
| yahoo = RGEN
| google = RGEN:NASDAQ
}}
{{S&P 400 companies}}
{{Authority control}}
[[Category:Manufacturing support companies]]
[[Category:Companies based in Massachusetts]]
[[Category:Companies listed on the Nasdaq]]
[[Category:1981 establishments in Massachusetts]]
[[Category:Companies in the S&P 400]]