Alexion Pharmaceuticals

Alexion Pharmaceuticals Inc. is an American pharmaceutical company best known for its development of Soliris, a drug used to treat the rare disorders atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH).[3][4] The company is also involved in immune system research related to autoimmune diseases. It employs around 2,400 people worldwide.[5] In February 2016, the company held the dedication ceremony for its new headquarters in New Haven, Connecticut, not far from the company's starting point in the same city.[6]

Alexion Pharmaceuticals, Inc.
Public
Traded as
ISINUS0153511094 
IndustryPharmaceutical
Founded1992
FounderLeonard Bell
Headquarters
Boston, Massachusetts, U.S.
Key people
Leonard Bell (Chairman)
Ludwig N. Hantson (CEO)
ProductsSoliris
Revenue US$3,551.1 million (2017)
US$627.4 million (2017)
US$443.3 million (2017)
Total assets US$13,583.3 million (2017)
Total equity US$8,893.1 million (2017)
Number of employees
2,525 (2017)
Websitewww.alxn.com
Footnotes / references
[1][2]

In September 2017, Alexion announced it would be moving its headquarters to Boston, Massachusetts, in mid-2018.[7]

History

Alexion Pharmaceuticals was founded in 1992 at Science Park in New Haven, Connecticut by Steven Squinto and Leonard Bell.[8][9] Bell served as the company's CEO until 2015.[10] In 2000, Alexion moved its headquarters from New Haven to Cheshire, Connecticut. Alexion moved back to New Haven following the completion of New Haven's Downtown Crossing project in December 2015.

Since 2006, Alexion has been a supporter of healthcare research and quality studies at Duke University for aspirin and Clopidogrel (trade name Plavix).[8]

Alexion received U.S. Food and Drug Administration (FDA) approval for Soliris in 2007. It was initially approved to treat paroxysmal nocturnal hemoglobinuria, a rare blood disorder.[5] In 2010, there was an outbreak of hemolytic-uremic syndrome caused by Enterohaemorrhagic Escherichia coli (EHEC) in Germany. Soliris was considered a treatment option because of its effectiveness in treating Atypical hemolytic uremic syndrome, an illness similar to the one caused by the EHEC infection.[11]

In April 2011, Alexion was added to the NASDAQ-100, a group composed of the 100 largest non-financial stocks traded on the NASDAQ; with a market value of USD 8.5 billion it replaced Genzyme Corporation.[12]

In April 2015, Bell was replaced as CEO by David Hallal.[10] In 2016, the company became a member of the Pharmaceutical Research and Manufacturers of America (PhRMA).[13]

In December 2016, Alexion's board of directors announced new leadership. David Brennan, a current board member, became interim CEO. David Anderson, formerly the CFO of Honeywell, was appointed CFO, replacing Vikas Sinha.[14] In March 2017, Alexion named Ludwig N. Hantson as its new CEO.[15]

In September 2017, Alexion announced that it would be closing its Smithfield, RI manufacturing facility.

Acquisitions

In 2000, Alexion purchased Proliferon Inc., a San Diego, California-based development-stage biopharmaceutical firm, for US$41 million in Alexion stock. Alexion CEO, Leonard Bell, cited Proliferon's ability to produce an "unlimited amount of antibodies" as the reason for the acquisition. At the time Proliferon's annual revenue was about $2.5 million and its assets were valued at $2.1 million.[16][17] The company has since been renamed Alexion Antibody Technologies Inc.

In December 2011, Alexion acquired Montreal-based Enobia Pharma Corp, the developer of asfotase alfa, a drug used to treat the genetic disorder hypophosphatasia.[18]

In May 2015, Alexion announced plans to purchase the Lexington firm Synageva BioPharma, a maker of rare disease treatments, in a $8.4 billion stock-and-cash deal.[19] The price represented more than a 135% premium over Synageva's market cap at the time.[10] It also represented a valuation of about ten times projected peak sales, double what is typical for the biotech industry.[20]

In April 2018, Alexion announced the acquisition of Wilson Therapeutics for $855 million.[21][22] In September the company announced it was to acquire Syntimmune for $1.2 billion - expanding its rare disease offering.[23][24]

In October 2019, the business announced it would acquire Achillion Pharmaceuticals for $930 million, boosting its immune system disease pipeline.[25]

In May 2020, Alexion announced an agreement to acquire Portola Pharmaceuticals for $18 per share using cash. This move was aimed to diversify Alexion's hematology, neurology, and critical care commercial portfolio with Portola's Factor Xa inhibitor reversal agent.[26] In May 2020, the hedge fund Elliott Management Corporation, which acquired a position in Alexion in 2017, had - again - pushed for Alexion to sell itself, months after the drugmaker had rejected the hedge fund's earlier demand. Elliott argues that Alexion management's actions, including the o.m. recent move to acquire Portola for about $1.4 billion, are leading in the "wrong direction." In December 2019, Alexion's board unanimously rejected a recommendation by Elliott to immediately launch a proactive sale.[27]


Acquisition history

The following is an illustration of the company's mergers, acquisitions, spin-offs and historical predecessors:

Alexion Pharmaceuticals
(Founded 1992)

Proliferon Inc
(Acq 2000, restructured into Alexion Antibody Technologies Inc)

Enobia Pharma Corp
(Acq 2011)

Synageva BioPharma
(Acq 2015)

Wilson Therapeutics
(Acq 2018)

Syntimmune
(Acq 2018)

Achillion Pharmaceuticals
(Acq 2019)

Alexion Pharmaceuticals

Ownership

As of 2017 Alexion Pharmaceuticals shares are mainly held by 735 institutional investors (Fidelity Investments, T. Rowe Price, BlackRock and others[28])

Products

Specialty drugs

Alexion has employed a strategy of developing drugs to combat rare diseases. Since the targeted user base is small for such drugs, clinical drugs tend to be quicker and cheaper than those for mass market drugs. Additionally, big pharmaceutical companies have tended to ignore these markets, creating a niche with minimal competition for Alexion. Insurance companies have generally been willing to pay high prices for such drugs; since few of their customers need the drugs, a high price does not significantly impact the insurance companies' outlays.[20] "The success of specialty drugs for rare diseases comes at a time when the traditional drug business of selling medicines to the masses is in decline...Specialty drugs have gotten more expensive than anyone imagined."[29]

Soliris

Alexion's first drug, Soliris, first launched in 2007,[9] used to treat the rare disorders atypical hemolytic uremic syndrome (aHUS) and Paroxysmal nocturnal hemoglobinuria (PNH).[4] It has been approved for use in Canada, the European Union, Japan, and the United States; however, availability in Canada is limited. In Canada, access to the drug is mostly through private clinics; groups such as the Canadian Association of PNH Patients are lobbying to change that.[30] The drug costs roughly $450,000 a year, and is considered the world's most expensive drug.[5][10] The price of the drug is so high that very few individuals can pay the price. As a result, Alexion hires public relations firms to help families institute campaigns to pressure their governments to pay for the drug. Alexion is putting pressure on to governments to receive their payments from the public purse. The prices charged have a very high margin above the cost price. In addition, much of the research for the development of Soliris originates from publicly funded universities. There is an ethical question as to the pricing of the drug and the ethics of the drug manufacturer. Alexion is well on the way to developing a second very high price and high margined drug.[31]

In September 2011, the FDA officially approved the use of Soliris as a treatment for atypical hemolytic-uremic syndrome in both adults and children. More than half of people with aHUS end up dying of it as a result of damage to vital organs/organ failure (usually involving the kidneys) caused by uncontrolled complement activation. The FDA's decision to grant approval received a positive response from the medical community with the director of Pediatric Nephrology at Atlanta's Children's hospital calling it "the most important advance that has been made for patients and families with this disease".[32]

By 2010 Soliris was considered to be the most expensive drug in the world.[29] It costs £340,200 per year for treatment in the UK[33][34] and $500,000 a year in Canada.[33][34][35] and US$409,500 a year in the United States (2010).[29] In the case of the rarest diseases that afflict fewer than 10,000 people, biotech companies who own the only approved drugs to treat those diseases "can charge pretty much whatever they want." "Before testing Soliris for PNH, Alexion tested the drug for rheumatoid arthritis, which afflicts 1 million Americans. The trials failed. But if it had worked for arthritis, Alexion would likely have had to charge a much lower price for this use, as it would have to compete against drugs that cost a mere $20,000." Alexion started selling Soliris in 2008 making $295 million in 2007 with its stock price rising to 130% in 2010.[35]

In April and May 2013, a controversy arose in Belgium when the media revealed that the government had refused to pay for a seven-year-old boy's treatment because Soliris was too expensive. The boy's medicine cost 9,000 euros every two weeks.[36] On May 4, 2013, De Standaard reported that a press relations (PR) agency working for Alexion had helped the boy's parents communicate their story to the press.[37] It was also reported that the parents had believed their benefactor was a Dutch organization for patients, and that the PR agency acted with permission from Alexion.[38][39] Several politicians stated that the company was attempting to 'blackmail' the government, charges which Alexion denied.[40] By May 7, 2013 an agreement had been reached to reimburse the medicine.[41][42]

Pharma, the Belgian pharmaceutical industry's association, opened an internal investigation into the affair, for possible breach of the association's ethical standards by Alexion. However, on June 12, Alexion received a court gag order against Pharma, preventing it from communicating its investigation. At the same time, Pharma opened a court case against Alexion Pharma Belgium. The gag order was revoked by the end of September 2013,[43] but the case was still pending in March 2015.[42]

In October 2017 the FDA approved the use of Soliris to treat adult patients with generalized myasthenia gravis (gMG).[44] In November 2017 the company received a patent for Soliris from the Japanese Patent Office.[45]

Strensiq

In October 2015, Alexion's second drug, Strensiq (asfotase alfa), was approved by the US FDA. It is used to treat hypophosphatasia, a rare metabolic disorder.

Kanuma

Kanuma, which Alexion acquired in its acquisition of Synageva, was approved in 2015 to treat lysosomal acid lipase deficiency, a fatal genetic disorder that cause fatty material to build up in blood vessel walls, the liver, and other tissues.[10] Alexion estimates that the drug could eventually have annual sales of more than $1 billion.[46]

Financials

In 2013, 36% Alexion's sales originated in the US, down from 37% the previous year; 33% came from Europe, down from 35%; Japan accounted for just over 10%. Revenue was impacted by higher unit volumes for Soliris (up 40%), and a decreased average price related to rebates in Europe. Acquisition related costs fell significantly from $22 million to just $5 million.[47] R&D spending reached a record high of $317 million in 2013 up 83% from the previous year.[8]

When Soliris was first approved, peak annual sales were estimated at $150 million.[20] However, by September 2013 quarterly sales of Soliris topped $400 million. Sales during the first quarter of 2015 were just over US$600 million, and are still on the rise.[10][20]

Before the Synageva purchase announcement, Alexion was valued at $34 billion.[10] The stock is up roughly 800% in the last five years and is currently trading at 46 times estimated earnings. Due to the niche nature of its market and the high cost of Soliris, the company has enjoyed a high profit margin.[20]

References

  1. "Alexion Pharmaceuticals 2017 Annual Report Form (10-K)". U.S. Securities and Exchange Commission. February 8, 2018. Retrieved August 26, 2018.
  2. "Alexion Pharmaceuticals". Fortune. Retrieved 2019-02-09.
  3. "Alexion Submits Application for Soliris". 2011-04-08.
  4. "Alexion Pharmaceuticals on the Forbes World's Most Innovative Companies List". forbes.com. Retrieved 28 September 2012.
  5. Don Seiffert (May 6, 2015). "Everything you need to know about the $8.4B acquisition of Synageva". Boston Business Journal. Retrieved May 8, 2015.
  6. "Photos of Alexion Pharmaceuticals World HQ Dedication".
  7. Singer, Stephen (2017-09-12). "Alexion Exits New Haven For Boston, Agrees To Repay Millions In State Aid". Hartford Courant. Retrieved 2017-09-12.
  8. "More Support for Long-Term Plavix to Improve Stent Safety". Dec 5, 2006. Retrieved Jul 18, 2013.
  9. Herper, Matthew. "How A $440,000 Drug Is Turning Alexion Into Biotech's New Innovation Powerhouse". Forbes. Retrieved 2017-11-07.
  10. Chelsey Dulaney (May 6, 2015). "Alexion to Buy Synageva for $8.4 Billion". The Wall Street Journal. Retrieved May 7, 2015.
  11. "Alexion treating Europe's E coli victims". 2011-05-31.
  12. "Alexion Pharmaceuticals, Inc. to Join the NASDAQ-100 Index Beginning April 4, 2011". 2011-03-29. Archived from the original on April 4, 2011. Retrieved April 9, 2011.
  13. "Teva wins controversial PhRMA bid despite protests from branded rivals - FiercePharma".
  14. "Alexion's Board of Directors Announces New Leadership Appointments | Alexion Pharmaceuticals, Inc". news.alexionpharma.com (Press release). Retrieved 2016-12-12.
  15. Grover, Natalie (March 27, 2017). "Alexion Pharma names former Baxalta chief Ludwig Hantson CEO". Reuters. Retrieved March 27, 2017.
  16. "Alexion Buys Calif. Firm;Proliferon acquired in $41 million deal". 2000-02-10. Archived from the original on 2011-08-18. Retrieved 2011-04-09.
  17. "Securities and Exchange Commission Alexion 8-K 2000 Report". 2000-09-18. Archived from the original on 2011-08-18. Retrieved 2011-04-09.
  18. "Alexion to Pay as Much as $1.08 Billion to Buy Enobia Pharma". Business Week. December 29, 2011.
  19. Robert Weisman (12 July 2015). "How Genzyme became a source of biotech executives". The Boston Globe. Retrieved 17 July 2015.
  20. Robert Cyran (May 6, 2015). "Alexion Puts Its Soaring Stock Price to Good Use". The New York Times. Retrieved May 7, 2015.
  21. Hirschler, Ben. "Biotech M&A rolls on as Alexion snaps up Wilson for $855 million". U.S. Retrieved 2018-04-11.
  22. "Alexion to Acquire Wilson Therapeutics for $855M - GEN". GEN.
  23. "Alexion to Acquire Syntimmune for Up to $1.2B, Expanding Rare Disease Pipeline". 26 September 2018.
  24. "Alexion to buy biotech firm Syntimmune for up to $1.2 billion". 26 September 2018 via uk.reuters.com.
  25. https://www.biospace.com/article/alexion-buys-achillion-in-930-million-cash-deal/?s=79
  26. "Alexion to Acquire Portola". www.businesswire.com. 2020-05-05. Retrieved 2020-05-06.
  27. Elliott Advisors (UK) Limited. "Elliott Advisors (UK) Limited sent the following letter to the Board of Alexion today" (PDF). elliottletters.com. Retrieved 13 May 2020.
  28. "Alexion Pharmaceuticals, Inc. (ALXN) Ownership Summary". NASDAQ.com.
  29. Herper, Matthew (February 19, 2010), "The World's Most Expensive Drugs", Forbes, retrieved June 25, 2015
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  31. Kelly Crowe (25 June 2015), A Price to Pay: how the manufacturer pulls on emotions - patients, families, politicians and governments around the world, CBC News, retrieved 18 July 2015
  32. "Soliris® (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)". September 23, 2011.
  33. "Doctors must tell patients of errors, under new Varadkar law".
  34. "High cost of treatment for rare blood disorder needs to be clarified, says NICE in draft guidance". nice.org.uk.
  35. Gallant, Jacques (December 4, 2014), Toronto woman with rare disease fights province for life-saving but costly drug Soliris, which costs $500,000 a year, would treat Toni Vernon's blood disease, but the health ministry is holding back, retrieved June 25, 2015
  36. "Viktor (7) moet elke twee weken infuus krijgen van 9.000 euro". April 30, 2013.
  37. "Pr-bureau van farmabedrijf adviseerde ook ouders Viktor". May 4, 2013.
  38. "Farmabedrijf Alexion heeft Viktor "gebruikt"". May 4, 2013.
  39. "Farmabaas fluit Alexion terug in zaak-Viktor". May 6, 2013.
  40. "Detiège: "Dit is chantage van het farmabedrijf"". May 2, 2013.
  41. "Medicijn Viktor vanaf juli terugbetaald". May 7, 2013.
  42. "Contract van Onkelinx met farmareus opent doos van Pandora". 2015-03-23. Retrieved 2015-03-24.
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  45. "Alexion Pharma (ALXN) Receives New Japanese Patent for Soliris". StreetInsider.com. Retrieved 2017-11-07.
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