HZNP Horizon Therapeutics Public Limited Company

77.68
-0.48  -1%
Previous Close 78.16
Open 78.16
52 Week Low 23.81
52 Week High 82.6
Market Cap $17,116,531,578
Shares 220,346,699
Float 217,480,993
Enterprise Value $17,998,639,509
Volume 1,867,937
Av. Daily Volume 2,354,516
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Upcoming Catalysts

Drug Stage Catalyst Date
Krystexxa with Methotrexate - MIRROR RCT
Gout
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Teprotumumab
Thyroid Eye Disease (TED)
Approved
Approved
FDA Approval announced January 21, 2020.
ACTIMMUNE
Friedreich's Ataxia (FA)
Phase 3
Phase 3
Phase 3 data released December 8, 2016 - primary endpoint not met.

Latest News

  1. -- Data adds to growing body of evidence on immunomodulation with KRYSTEXXA and emerging approaches to reduce the impact of uncontrolled gout on patients' lives --

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced the publication of the complete dataset on the primary endpoint from its Methotrexate to Increase Response Rates in Patients With Uncontrolled GOut Receiving KRYSTEXXA (MIRROR) open-label trial in the Journal of Rheumatology [https://doi.org/10.3899/jrheum.200460].

    Horizon's MIRROR clinical program includes the completed multi-center, open-label trial as well as an ongoing randomized controlled trial (RCT). The trial series seeks to validate clinical practice experience showing that adding commonly-used immunomodulatory therapies…

    -- Data adds to growing body of evidence on immunomodulation with KRYSTEXXA and emerging approaches to reduce the impact of uncontrolled gout on patients' lives --

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced the publication of the complete dataset on the primary endpoint from its Methotrexate to Increase Response Rates in Patients With Uncontrolled GOut Receiving KRYSTEXXA (MIRROR) open-label trial in the Journal of Rheumatology [https://doi.org/10.3899/jrheum.200460].

    Horizon's MIRROR clinical program includes the completed multi-center, open-label trial as well as an ongoing randomized controlled trial (RCT). The trial series seeks to validate clinical practice experience showing that adding commonly-used immunomodulatory therapies, such as methotrexate, to the KRYSTEXXA (pegloticase injection) treatment regimen for chronic gout refractory to conventional therapies – also known as uncontrolled gout – may help to reduce patients' immune reaction to biologic therapy and thus potentially increase the durability of response.

    In the open-label trial, 79 percent of patients who received both KRYSTEXXA and methotrexate (11 of 14 enrolled patients) maintained therapeutic response during Month 6 (defined as sUA <6 mg/dL).1 The safety and efficacy of KRYSTEXXA co-prescribed with methotrexate has not been established by any health authorities.

    "Treatment with biologic medicines such as KRYSTEXXA can, in some people, trigger the body's immune system to develop anti-drug antibodies," said John R. P. Tesser, M.D., FACP, FACR, practicing rheumatologist and principal investigator at Arizona Arthritis & Rheumatology Associates in Phoenix. "When we look at rheumatoid arthritis, collective experience shows that many biologics have an improved response rate when they are co-prescribed with methotrexate. This is due both to methotrexate's direct effect on the disease and its ability to reduce anti-drug antibodies that may neutralize or clear the biologic. The co-prescription of KRYSTEXXA with methotrexate employs insights on how this immunomodulator may reduce the development of anti-drug antibodies and ultimately shift treatment approaches for uncontrolled gout."

    In addition, the journal Rheumatology and Therapy recently published an independent, in-practice case series which showed that 80 percent (8 of 10 patients) received a full course of treatment with the concomitant use of KRYSTEXXA and methotrexate. 2 A prospective observational case series presented at EULAR 2019 showed 100 percent of patients (10 of 10 patients) received a full course of treatment with the concomitant use of KRYSTEXXA and methotrexate. 3 No new safety concerns were identified in these studies, but the findings are limited by the study sizes.

    "When used concomitantly, the trends we have seen in rheumatology practices are increasingly validated through this body of peer-reviewed data, giving more credence to an immunomodulation strategy and the paradigm shift we're seeing in treatment approaches," said Paul M. Peloso, M.D., M.Sc., vice president and therapeutic area head, rheumatology, Horizon. "Our goal through the ongoing MIRROR clinical program is to provide robust, controlled evidence to support clinicians as they seek to reduce the burden of urate and improve outcomes for patients living with uncontrolled gout."

    As Horizon continues to evaluate its therapeutic approaches to help every patient achieve the best possible outcomes, the company recently announced that the MIRROR RCT has reached target enrollment. Patients are randomized to receive methotrexate or placebo for four weeks and then treatment with KRYSTEXXA and methotrexate or KRYSTEXXA and placebo for 52 weeks. Preliminary results are expected in the first half of 2021.4 More information about the MIRROR RCT is available at clinicaltrials.gov (NCT03994731).

    About KRYSTEXXA

    INDICATIONS AND USAGE

    KRYSTEXXA® (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

    Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

    Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

    IMPORTANT SAFETY INFORMATION

    WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

    Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Serum uric acid levels should be monitored prior to infusions, and healthcare providers should consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

    The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

    Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

    In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

    Patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

    CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

    Patients should be screened for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA should not be administered to these patients.

    GOUT FLARES

    An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

    CONGESTIVE HEART FAILURE

    KRYSTEXXA has not been studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Caution should be exercised when using KRYSTEXXA in patients who have congestive heart failure, and patients should be monitored closely following infusion.

    ADVERSE REACTIONS

    The most commonly reported adverse reactions in clinical trials with KRYSTEXXA were gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

    Please see Full Prescribing Information and Medication Guide for more information.

    About Horizon

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding the potential benefits of combining immunomodulator (including methotrexate) treatment with KRYSTEXXA, expectations regarding the MIRROR RCT, including expected timelines for data, and expectations regarding physicians adopting a combination approach in treating patients with uncontrolled gout. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, risks regarding whether results of the MIRROR RCT will be consistent with results of prior trials or other data or Horizon's expectations, the risks associated with clinical development of drug candidates and risks related to competition or other factors that may change physician treatment strategies. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.

    References

    1. Botson J, Tesser JHR, Bennett R, et al. Pegloticase in combination with methotrexate in patients with uncontrolled gout: A multicenter, open-label study (MIRROR). J Rheumatol. 2020:jrheum.200460.
    2. Albert J, Hosey T, LaMoreaux B. Increased Efficacy and Tolerability of Pegloticase in Patients With Uncontrolled Gout Co-Treated With Methotrexate: A Retrospective Study. Rheumatol Ther. 2020;7(3):639-648.
    3. Botson J, Peterson J. Pretreatment and co-administration with methotrexate improved durability of pegloticase response: A prospective, observational, proof-of-concept, case series. Poster presented at the European League Against Rheumatism (EULAR) Annual European of Rheumatology 2019, Barcelona, Spain; June 12-15, 2019.
    4. National Institute of Health. Study of KRYSTEXXA® (pegloticase) plus methotrexate in patients with uncontrolled gout (MIRROR RCT). https://www.clinicaltrials.gov/ct2/show/NCT03994731. Accessed Sept. 1, 2020.

     

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  2. Horizon Therapeutics plc (NASDAQ:HZNP) today announced that it has been named one of PEOPLE's "50 Companies That Care" for 2020. The 2020 "50 Companies That Care" list spotlights 50 U.S. companies with 1,000 or more employees and their response to taking care of their employees, their communities and the world during the COVID-19 crisis. The list will be featured in the Sept. 14, 2020 print issue of PEOPLE.

    "It is a special honor to be recognized by PEOPLE and Great Place to Work as one of the 50 Companies That Care, especially during this challenging time," said Tim Walbert, chairman, president and chief executive officer, Horizon. "As COVID-19 took hold around the world, we doubled down on our commitment to supporting our employees and…

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced that it has been named one of PEOPLE's "50 Companies That Care" for 2020. The 2020 "50 Companies That Care" list spotlights 50 U.S. companies with 1,000 or more employees and their response to taking care of their employees, their communities and the world during the COVID-19 crisis. The list will be featured in the Sept. 14, 2020 print issue of PEOPLE.

    "It is a special honor to be recognized by PEOPLE and Great Place to Work as one of the 50 Companies That Care, especially during this challenging time," said Tim Walbert, chairman, president and chief executive officer, Horizon. "As COVID-19 took hold around the world, we doubled down on our commitment to supporting our employees and communities. We've implemented leave policies for our nearly 1,300 team members, seeded and contributed to several local and international pandemic relief funds and helped patients in need with access to medical facilities. Through it all, we've stayed close to our foundational principle of doing the right thing for people, with great compassion and care."

    The 2020 PEOPLE "50 Companies That Care" rankings represent the experience of over 4.7 million U.S. employees. PEOPLE partnered with Great Place to Work®, a global people analytics and consulting firm, to analyze employees' survey feedback on how their workplaces make a difference in their lives and communities, and how companies responded to the COVID-19 crisis.

    When addressing the COVID-19 situation, Horizon's COVID-19 leave policy surpassed government recommended guidelines with 100 percent pay continuation to employees impacted by the virus. The company also instituted companywide paid days off and issued an appreciation bonus, providing an opportunity for employees to support their health and wellbeing and recharge.

    Stepping up for the community, Horizon was one of the first organizations in Illinois to seed the Illinois COVID-19 Relief Fund and gave more than $1.5 million overall to support the purchase of personal protective equipment and provide other necessary resources to organizations in areas where Horizon employees live and work, including in Dublin, South San Francisco, Canada and Washington D.C.

    Most recently, Horizon and its employees provided 526 laptops and Wi-Fi hotspots for students at its partner school, Perspectives/IIT Math & Science Academy (MSA) in Chicago, ensuring that there would be no lack of technology and access for the under-resourced school as a result of COVID-19 and the upcoming virtual school year.

    About Great Place to Work®

    Great Place to Work is the global authority on workplace culture. They help organizations quantify their culture and produce better business results by creating a high-trust work experience for all employees. Emprising®, their culture management platform, empowers leaders with the surveys, real-time reporting, and insights they need to make data-driven people decisions. They recognize Great Place to Work-Certified™ companies and the Best Workplaces™ in the US and more than 60 countries, including the 100 Best Companies to Work For® list published annually in Fortune. Learn more at greatplacetowork.com and join the community on LinkedIn, Twitter, and Instagram.

    About Horizon Therapeutics plc

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

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  3. Horizon Therapeutics plc (NASDAQ:HZNP) today announced that the Company will participate in the following conference in September:

    Morgan Stanley 18th Annual Global Healthcare Conference (Virtual)

    • Date: Wednesday, Sept. 16, 2020
    • Presentation Time: 12:30 p.m. ET

    The conference presentation will be webcast live and may be accessed by visiting Horizon's website at http://ir.horizontherapeutics.com. A replay of the webcast will be available for the event.

    About Horizon

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to…

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced that the Company will participate in the following conference in September:

    Morgan Stanley 18th Annual Global Healthcare Conference (Virtual)

    • Date: Wednesday, Sept. 16, 2020
    • Presentation Time: 12:30 p.m. ET

    The conference presentation will be webcast live and may be accessed by visiting Horizon's website at http://ir.horizontherapeutics.com. A replay of the webcast will be available for the event.

    About Horizon

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

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  4. -- Total offering size of $963.5 million --

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced the closing of its underwritten public offering of 13,570,000 of its ordinary shares at a price to the public of $71.00 per share. This includes the exercise in full by the underwriters of their option to purchase up to 1,770,000 additional ordinary shares. The net proceeds to the Company from this offering are expected to be approximately $919.3 million, after deducting underwriting discounts and other estimated offering expenses payable by the Company. Following the closing of the offering, there were 220,346,699 ordinary shares of the Company outstanding as of August 11, 2020.

    Citigroup, Morgan Stanley, J.P. Morgan, Piper Sandler and Stifel…

    -- Total offering size of $963.5 million --

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced the closing of its underwritten public offering of 13,570,000 of its ordinary shares at a price to the public of $71.00 per share. This includes the exercise in full by the underwriters of their option to purchase up to 1,770,000 additional ordinary shares. The net proceeds to the Company from this offering are expected to be approximately $919.3 million, after deducting underwriting discounts and other estimated offering expenses payable by the Company. Following the closing of the offering, there were 220,346,699 ordinary shares of the Company outstanding as of August 11, 2020.

    Citigroup, Morgan Stanley, J.P. Morgan, Piper Sandler and Stifel acted as joint book-running managers for the offering. Cowen acted as a financial advisor to the Company for the offering.

    A registration statement relating to the ordinary shares described above was previously filed with and became effective by rule of the Securities and Exchange Commission ("SEC"). A final prospectus supplement and accompanying prospectus related to the offering was filed with the SEC and is available on the SEC's website located at http://www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC's website or by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by phone at 800-831-9146; Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department or by email at ; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at or by phone at 866-803-9204; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by email at or by phone at 800-747-3924; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by email at or by phone at 415-364-2720.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the shares in any state or other jurisdiction which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Horizon Therapeutics plc

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives.

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  5. Horizon Therapeutics plc (NASDAQ:HZNP) today announced that it has been named to the Crain's Chicago Business 2020 Best Places to Work in Chicago list.

    "It's a tremendous honor that Crain's Chicago Business ranked us among the Best Places to Work in Chicago where many Horizon employees live and work," said Tim Walbert, chairman, president and chief executive officer, Horizon. "Despite these challenging times, working at Horizon remains grounded in the strength of our culture which is centered on doing the right thing for patients, the community and our employees."

    The Crain's Chicago Business 2020 Best Places to Work in Chicago designation is based on evaluating company workplace policies, practices and demographics, and employee surveys…

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced that it has been named to the Crain's Chicago Business 2020 Best Places to Work in Chicago list.

    "It's a tremendous honor that Crain's Chicago Business ranked us among the Best Places to Work in Chicago where many Horizon employees live and work," said Tim Walbert, chairman, president and chief executive officer, Horizon. "Despite these challenging times, working at Horizon remains grounded in the strength of our culture which is centered on doing the right thing for patients, the community and our employees."

    The Crain's Chicago Business 2020 Best Places to Work in Chicago designation is based on evaluating company workplace policies, practices and demographics, and employee surveys aimed at assessing the experiences and attitudes of individual employees with respect to working conditions, benefits and corporate culture. Best Companies Group analyzed the data to determine final rankings.

    Horizon was also recently ranked No. 1 on the Great Place to Work "Best Workplaces in Chicago" list, as well as honored as one of the "Best Workplaces for Millennials" by Fortune.

    About Horizon

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

    About Crain's Chicago Business

    Crain's Chicago Business is the top source of news, analysis and information on business in metropolitan Chicago for decision-makers in the private and public sectors. Crain's publishes a weekly business magazine, providing deeper analysis, commentary, special reports and features. Crain's also produces databases, live events and sponsored content, all with the aim of deepening readers' understanding of local business. Crain's Chicago Business is the leading source of information on Chicago's economy, the companies, industries and institutions that operate here and the entrepreneurs and innovators who drive the city's growth.

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