ALXN Alexion Pharmaceuticals Inc.

155.01
+0.54  (+0%)
Previous Close 154.47
Open 154.89
52 Week Low 94.23
52 Week High 162.6
Market Cap $34,078,632,280
Shares 219,847,960
Float 210,444,553
Enterprise Value $33,699,614,381
Volume 1,113,370
Av. Daily Volume 2,477,203
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Upcoming Catalysts

Drug Stage Catalyst Date
ALXN1840 (WTX101)
Wilson disease
Phase 3
Phase 3
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ULTOMIRIS (ravulizumab-cwvz)
Generalized myasthenia gravis (gMG)
Phase 3
Phase 3
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ULTOMIRIS (ravulizumab) - CHAMPION-ALS
Amyotrophic lateral sclerosis (ALS)
Phase 3
Phase 3
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ULTOMIRIS
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Phase 3
Phase 3
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CAEL‐101
AL amyloidosis
Phase 3
Phase 3
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ALXN2040 add-on therapy
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ALXN2050
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
Phase 2
Phase 2 trial has been paused pending further data from Phase 1 trial.
ALXN2040
COVID-19
Phase 2
Phase 2
Phase 2 trial has been initiated.
ALXN2040
Geographic Atrophy (GA)
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 2021.
ULTOMIRIS
Dermatomyositis (DM)
Phase 2/3
Phase 2/3
Phase 2/3 trial to be initiated 2H 2021.
ULTOMIRIS (ravulizumab-cwvz)
COVID-19 Coronavirus
Phase 3
Phase 3
Independent data monitoring committee recommended pausing enrollment due to lack of efficacy in pre-specified interim analysis - January 13, 2021.
ULTOMIRIS
Hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA)
Phase 3
Phase 3
Phase 3 trial initiated 4Q 2020.
ALXN1830
Warm autoimmune hemolytic anemia (WAIHA)
Phase 1/2
Phase 1/2
Phase 2/3 trial to be initiated 2H 2021.
AG10 / BBP-265
ATTR-PN
Phase 2
Phase 2
Phase 3 trial has been initiated.
Eculizumab
Neuromyelitis Optica Spectrum Disorder (NMOSD) - children
Phase 2/3
Phase 2/3
Phase 2/3 trial underway.
Cerdulatinib (PRT2070)
Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia - cancer
Phase 2
Phase 2
Phase 2a data presented at ASH December 9, 2019. ORR 48%; 76% in combo cohort.
Elamipretide
Leber’s hereditary optic neuropathy (LHON)
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint.
ULTOMIRIS (ravulizumab-cwvz) subcutaneous
Paroxysmal nocturnal hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - June 24, 2020. Regulatory filing due 3Q 2021.
ALXN2040
C3 Glomerulopathy (C3G)
Phase 2
Phase 2
Development discontinued - noted July 29, 2020.
Bevyxxa (betrixaban)
Venous thromboembolism (VTE) Prevention
Approved
Approved
FDA Approval noted June 23, 2017.
Andexxa
Factor Xa inhibitor reversal agent
Approved
Approved
Prior Approval Supplement (PAS) FDA Approval announced December 31, 2018.
ULTOMIRIS (ravulizumab-cwvz)
atypical Hemolytic Uremic Syndrome (aHUS)
Approved
Approved
FDA Approval announced October 18, 2019.
Eculizumab
Generalized myasthenia gravis (gMG) - children
Phase 3
Phase 3
Phase 3 trial has commenced - noted October 23, 2019.
Eculizumab
Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)
Approved
Approved
FDA Approval announced June 27, 2019.
ULTOMIRIS (ravulizumab-cwvz)
Paroxysmal nocturnal hemoglobinuria (PNH)
Approved
Approved
FDA approval announced December 21, 2018.
Eculizumab
Refractory generalized myasthenia gravis (gMG)
Approved
Approved
Approval announced October 23, 2017.

Latest News

  1. – Data highlight long-term and real-world efficacy of SOLIRIS® (eculizumab) in patients living with rare neurologic complement-mediated disorders, including neuromyelitis optica spectrum disorder (NMOSD) and generalized myasthenia gravis (gMG) –

    Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that three abstracts have been accepted for presentation at the 73rd annual meeting of the American Academy of Neurology (AAN), taking place virtually from April 17 through April 22, 2021. New real-world data will be presented evaluating SOLIRIS® (eculizumab) for the treatment of generalized myasthenia gravis (gMG) in the United States, suggesting substantial reductions in myasthenic crises, exacerbations and related hospitalizations, consistent…

    – Data highlight long-term and real-world efficacy of SOLIRIS® (eculizumab) in patients living with rare neurologic complement-mediated disorders, including neuromyelitis optica spectrum disorder (NMOSD) and generalized myasthenia gravis (gMG) –

    Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that three abstracts have been accepted for presentation at the 73rd annual meeting of the American Academy of Neurology (AAN), taking place virtually from April 17 through April 22, 2021. New real-world data will be presented evaluating SOLIRIS® (eculizumab) for the treatment of generalized myasthenia gravis (gMG) in the United States, suggesting substantial reductions in myasthenic crises, exacerbations and related hospitalizations, consistent with results from the Phase 3 REGAIN clinical trial and the open-label extension. Additionally, long-term data on SOLIRIS for the treatment of neuromyelitis optica spectrum disorder (NMOSD) will be presented, including a disease model assessing the benefits of treatment and Phase 3 PREVENT clinical trial results evaluating SOLIRIS as a monotherapy.

    The accepted abstracts are listed below and are now available on the AAN website. Posters will be available throughout the duration of the Congress.

    Neuromyelitis Optica Spectrum Disorder (NMOSD)

    Long-Term Efficacy and Safety of Eculizumab Monotherapy in AQP4+ Neuromyelitis Optica Spectrum Disorder. Oral presentation, Program Number S29.004, Session S29: Autoimmune Neurology: Clinical Trials, Treatment, and Diagnosis of CNS and PNS Autoimmune Neurologic Disorders, April 21, 2021, 4:00 p.m. – 5:00 p.m. Eastern Time.

    The Potential Impact of Long-Term Relapse Reduction: A Disease Model of Eculizumab in Neuromyelitis Optica Spectrum Disorder. ePoster presentation, Program Number P15.055, Session P15: MS Clinical Practice and Decision Making.

    Generalized Myasthenia Gravis (gMG)

    Real-World Use of Eculizumab in Generalized Myasthenia Gravis in the United States: Results from a Pilot Retrospective Chart-Review Study. ePoster presentation, Program Number P2.062, Session P2: Autoimmune Neurology: Inflammatory Neuropathies and Stiff Person Syndrome.

    About Neuromyelitis Optica Spectrum Disorder (NMOSD)

    Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune disease of the central nervous system (CNS). Approximately three-quarters of NMOSD patients have anti-AQP4 antibody-positive NMOSD. In patients with these antibodies, NMOSD occurs when the complement system—a part of the body's immune system—over-responds—leading the body to primarily attack the optic nerves and/or spinal cord in the CNS. People living with NMOSD often experience unpredictable attacks, also referred to as relapses, which tend to be severe and recurrent and may result in permanent disability. The most common symptoms of NMOSD are optic neuritis, which can cause visual problems including blindness, and transverse myelitis, which can cause mobility problems including paralysis. The disease primarily affects women, with an average age of onset of 39 years. NMOSD is more common and more severe in non-Caucasian populations worldwide.

    About Generalized Myasthenia Gravis (gMG)

    Myasthenia gravis (MG) is a rare, progressive, autoimmune neuromuscular disease. In patients with anti-acetylcholine receptor (AchR) antibody-positive MG, the body's own immune system over-responds, leading the body to attack its own healthy cells and produce antibodies to fight against AchR, a receptor located on muscle cells at the neuromuscular junction. As a result, communication between the nerves and muscles is impaired, leading to a loss of normal muscle function. MG typically begins with weakness in the muscles that control the movements of the eyes and eyelids and often progresses to the more severe and generalized form, known as generalized myasthenia gravis (gMG). People with gMG can suffer from slurred speech, choking, difficulty swallowing, drooping of the eyelids, double or blurred vision, disabling fatigue, immobility requiring assistance, shortness of breath and episodes of respiratory failure that can be life-threatening. Complications, exacerbations and myasthenic crises can require hospital and intensive care unit admissions with prolonged stays. gMG can occur at any age but most commonly begins before the age of 40 in women and after the age of 60 in men.

    About SOLIRIS®

    SOLIRIS® (eculizumab) is a first-in-class C5 complement inhibitor. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body's immune system. When activated in an uncontrolled manner, the terminal complement cascade over-responds, leading the body to attack its own healthy cells. SOLIRIS is administered intravenously every two weeks, following an introductory dosing period. In many countries around the world, SOLIRIS is approved to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), adults with generalized myasthenia gravis (gMG) who are acetylcholine receptor (AchR) antibody positive and/or adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. SOLIRIS is not indicated for the treatment of patients with Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). To learn more about the regulatory status of SOLIRIS in the countries that we serve, please visit www.alexion.com.

    INDICATIONS & IMPORTANT SAFETY INFORMATION FOR SOLIRIS® (eculizumab)

    INDICATIONS

    What is SOLIRIS?

    SOLIRIS is a prescription medicine used to treat:

    • patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH) .
    • adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
    • adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
    • adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

    It is not known if SOLIRIS is safe and effective in children with PNH, gMG, or NMOSD.

    IMPORTANT SAFETY INFORMATION

    What is the most important information I should know about SOLIRIS?

    SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.

    • SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early.
    1. You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you are not vaccinated.
    2. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.
    3. If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations.
    4. If you had a meningococcal vaccine in the past, you might need additional vaccination. Your doctor will decide if you need additional vaccination.
    5. Meningococcal vaccines reduce but do not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms, and eyes sensitive to light.

    Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly.

    SOLIRIS is only available through a program called the SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must enroll in the SOLIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with the meningococcal vaccine and, if needed, get revaccinated with the meningococcal vaccine. Ask your doctor if you are not sure if you need to be revaccinated.

    SOLIRIS may also increase the risk of other types of serious infections. Make sure your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if treated with SOLIRIS. Certain people may be at risk of serious infections with gonorrhea. Certain fungal infections (Aspergillus) may occur if you take SOLIRIS and have a weak immune system or a low white blood cell count.

    Who should not receive SOLIRIS?

    Do not receive SOLIRIS if you have a meningococcal infection or have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed.

    Before you receive SOLIRIS, tell your doctor about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. It is not known if SOLIRIS will harm your unborn baby or if it passes into your breast milk.

    Tell your doctor about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. It is important that you have all recommended vaccinations before you start SOLIRIS, receive 2 weeks of antibiotics if you immediately start SOLIRIS, and stay up-to-date with all recommended vaccinations during treatment with SOLIRIS.

    If you have PNH, your doctor will need to monitor you closely for at least 8 weeks after stopping SOLIRIS. Stopping treatment with SOLIRIS may cause breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include: drop in the number of your red blood cell count, drop in your platelet count, confusion, kidney problems, blood clots, difficulty breathing, and chest pain.

    If you have aHUS, your doctor will need to monitor you closely during and for at least 12 weeks after stopping treatment for signs of worsening aHUS symptoms or problems related to abnormal clotting (thrombotic microangiopathy). Symptoms or problems that can happen with abnormal clotting may include: stroke, confusion, seizure, chest pain (angina), difficulty breathing, kidney problems, swelling in arms or legs, and a drop in your platelet count.

    What are the possible side effects of SOLIRIS?

    SOLIRIS can cause serious side effects including serious infusion-related reactions.
    Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out. If you have an infusion-related reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS.

    The most common side effects in people with PNH treated with SOLIRIS include: headache, pain or swelling of your nose or throat (nasopharyngitis), back pain, and nausea.

    The most common side effects in people with aHUS treated with SOLIRIS include: headache, diarrhea, high blood pressure (hypertension), common cold (upper respiratory infection), stomach-area (abdominal) pain, vomiting, pain or swelling of your nose or throat (nasopharyngitis), low red blood cell count (anemia), cough, swelling of legs or feet (peripheral edema), nausea, urinary tract infections, and fever.

    The most common side effects in people with gMG treated with SOLIRIS include: muscle and joint (musculoskeletal) pain.

    The most common side effects in people with NMOSD treated with SOLIRIS include: common cold (upper respiratory infection), pain or swelling of your nose or throat (nasopharyngitis), diarrhea, back pain, dizziness, flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches, joint pain (arthralgia), throat irritation (pharyngitis), and bruising (contusion).

    Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of SOLIRIS. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

    Please see the accompanying full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.

    About Alexion

    Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: www.alexion.com.

    [ALXN-P]

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  2. -- Key additions deepen commercial and manufacturing expertise and position Company to capture full potential across businesses --

    ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced the addition of three key pharmaceutical executives: Christopher K. Mutz as Chief Commercial Officer and Head of Rare Diseases; Ori Gutwerg as Senior Vice President of Generics; and Davinder Singh as General Manager, Canadian Operations.

    "We are delighted to welcome Chris, Ori and Davinder to ANI. Their collective experience and individual areas of expertise strengthen our team to accelerate future growth across our business units. Chris will build and lead the Cortrophin commercial franchise, including our launch strategy and commercial…

    -- Key additions deepen commercial and manufacturing expertise and position Company to capture full potential across businesses --

    ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced the addition of three key pharmaceutical executives: Christopher K. Mutz as Chief Commercial Officer and Head of Rare Diseases; Ori Gutwerg as Senior Vice President of Generics; and Davinder Singh as General Manager, Canadian Operations.

    "We are delighted to welcome Chris, Ori and Davinder to ANI. Their collective experience and individual areas of expertise strengthen our team to accelerate future growth across our business units. Chris will build and lead the Cortrophin commercial franchise, including our launch strategy and commercial plan. Ori and Davinder will bolster our Generics and CDMO businesses. Since taking on the CEO role at ANI, I have taken the time to understand our capabilities and have identified ways in which to leverage our industry-leading infrastructure to maximize current and future market opportunities. Enhancing our leadership team reinforces our strong foundation to capture these opportunities and achieve the full potential of our business," stated Nikhil Lalwani, President and CEO.

    Chris Mutz brings deep experience in the successful commercialization of rare disease therapies, spending more than eight years with Alexion Pharmaceuticals (NASDAQ:ALXN). Most recently, as Vice President of the U.S. Neurology Business Unit, he was responsible for building and leading the successful launch of Soliris (eculizumab) for gMG and NMOSD in the United States. At Alexion, he also served as Vice President, U.S. Metabolic Business Unit and National Sales Director, U.S. Metabolic Business Unit. Prior to joining Alexion in 2011, Mr. Mutz served in commercial roles of increasing responsibility over the course of 11 years at Merck and Co. Mr. Mutz obtained his BA in Biology from the University of Virginia and his MBA from the Johnson Graduate School of Management at Cornell University.

    Ori Gutwerg is a seasoned leader and brings more than 17 years of experience building and driving growth in pharmaceutical companies. Most recently, Mr. Gutwerg served as Vice President, Head of U.S. Generics Rx at Taro Pharmaceuticals, overseeing a portfolio of nearly 300 generic and branded products. In that role, he drove double-digit top- and bottom-line growth, improved working capital through cost savings and efficiencies, rationalized the R&D pipeline and negotiated numerous business development deals to accelerate growth. Prior to joining Taro, he held positions with Xiromed US, Perrigo Pharmaceuticals, and Agis Group. Throughout his career, he has managed sales teams, built a commercial operations team, led M&A due diligence activities, and negotiated new business development and joint venture agreements. Mr. Gutwerg has a BS in Communications and Economics from The College of Management and an MBA from Tel Aviv University.

    Davinder Singh joined ANI in December 2020. He is a results-oriented business leader with more than 30 years of experience managing multiple sites within the pharmaceuticals, nutraceuticals, cosmetics and food industries. He has significant expertise across various dosage forms, including solids, semi-solids, liquids and APIs. Mr. Singh has held management positions at several multinational pharmaceutical companies, most recently at Eurofins CDMO Alphora, where he was responsible for five sites. Prior to that, Mr. Singh held positions at Valeant Pharmaceuticals, Apotex, and Fisher Scientific/Patheon. His experience and expertise include business expansion strategy, integration, acquisitions, change management, new drug submissions, building and expanding plants and laboratories, consolidations, manufacturing, logistics, engineering, quality, safety, and information technology security. Mr. Singh has a BA in Economics and English from Punjab University, a B.Sc from York University and an MBA from University of Guelph.

    ANI also announced today that Robert Schrepfer, Senior Vice President, Business Development and Specialty Sales, has notified the Company that he will be leaving ANI next month to pursue a new opportunity. "Rob has played a critical leadership role in ANI's journey over the years including, but not limited to prolific deal-making. We appreciate very much Rob's unstinted efforts for ANI over 15 years and wish him the very best in his future endeavors," stated Lalwani.

    About ANI

    ANI Pharmaceuticals, Inc. is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website www.anipharmaceuticals.com.

    Forward-Looking Statements

    To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the development, manufacturing and commercialization of the product and any additional product launches from the Company's generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," other words of similar meaning, derivations of such words and the use of future dates.

    Uncertainties and risks may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; competition from other products; acquisitions; contract manufacturing arrangements; delays or failure in obtaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing.

    More detailed information on these and additional factors that could affect the Company's actual results are described in the Company's filings with the Securities and Exchange Commission ("SEC"), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company's current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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    • 4Q20 total revenues of $1,591.8 million, a 15% increase over 4Q19
    • 4Q20 GAAP diluted EPS of $2.42; non-GAAP diluted EPS of $2.96
    • Announced agreement to be acquired by AstraZeneca; transaction expected to close in Q3 2021
    • Received EU approval for ULTOMIRIS® (ravulizumab) 100 mg/mL higher concentration formulation in paroxysmal nocturnal hemoglobinuria (PNH) & atypical hemolytic uremic syndrome (aHUS)
    • Continued advancement of pipeline, including initiation of three Phase 3 development programs and two novel IND filings in Q4 2020

    Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the fourth quarter and full year of 2020. Total revenues for the full year of 2020 were $6,069.9 million, a 22 percent increase…

    • 4Q20 total revenues of $1,591.8 million, a 15% increase over 4Q19
    • 4Q20 GAAP diluted EPS of $2.42; non-GAAP diluted EPS of $2.96
    • Announced agreement to be acquired by AstraZeneca; transaction expected to close in Q3 2021
    • Received EU approval for ULTOMIRIS® (ravulizumab) 100 mg/mL higher concentration formulation in paroxysmal nocturnal hemoglobinuria (PNH) & atypical hemolytic uremic syndrome (aHUS)
    • Continued advancement of pipeline, including initiation of three Phase 3 development programs and two novel IND filings in Q4 2020

    Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the fourth quarter and full year of 2020. Total revenues for the full year of 2020 were $6,069.9 million, a 22 percent increase compared to the same period in 2019. The negative impact of foreign currency on total revenues year-over-year was 1 percent, or $52.0 million, inclusive of hedging activities. On a GAAP basis, diluted EPS for the full year of 2020 was $2.72, compared to $10.70 in the prior year. Full year 2020 includes impairment charges of $2,053.3 million primarily relating to the KANUMA intangible asset and a related deferred tax benefit of $377.3 million. Full year 2019 includes one-time tax benefits of $382.2 million related to intra-entity asset transfers of intellectual property. Non-GAAP diluted EPS for the full year of 2020 was $12.51, a 19 percent increase versus the prior year.

    Total revenues in the fourth quarter were $1,591.8 million, a 15 percent increase compared to the same period in 2019. The positive impact of foreign currency on total revenues year-over-year was less than 1 percent, or $0.1 million, inclusive of hedging activities. On a GAAP basis, diluted EPS in the quarter was $2.42, compared to $4.00 in the prior year, inclusive of one-time tax benefits of $382.2 million related to intra-entity asset transfers of intellectual property in the fourth quarter of 2019. Non-GAAP diluted EPS for the fourth quarter of 2020 was $2.96, a 9 percent increase versus the fourth quarter of 2019.

    "In 2020, we delivered on our LEAD-EXPAND-DIVERSIFY strategy - progressing our commercial portfolio with multiple global regulatory approvals, and further building our pipeline, which now spans more than 20 development programs. I am so proud of our team's remarkable execution and perseverance amidst the uncertainties of COVID-19," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "We enter 2021 with significant momentum, a strong foundation and a promising future. I am confident we are well positioned to build on our success and further advance our mission of delivering life-changing medicines to people with rare diseases and devastating conditions in the coming months and once we become part of AstraZeneca."

    Full Year 2020 Financial Highlights

    • Net product sales were $6,069.1 million, compared to $4,990.0 million in 2019.
    • SOLIRIS net product sales were $4,064.2 million, compared to $3,946.4 million in 2019, representing a 3 percent increase.
    • ULTOMIRIS net product sales were $1,076.7 million, compared to $338.9 million in 2019, representing a 218 percent increase.
    • STRENSIQ net product sales were $731.8 million, compared to $592.5 million in 2019, representing a 24 percent increase.
    • KANUMA net product sales were $117.9 million, compared to $112.2 million in 2019, representing a 5 percent increase.
    • ANDEXXA/ONDEXXYA net product sales were $78.5 million.
    • GAAP cost of sales was $553.5 million, compared to $394.5 million in 2019. Non-GAAP cost of sales was $518.2 million, compared to $380.3 million in 2019.
    • GAAP R&D expense was $1,002.9 million, compared to $886.0 million in 2019. Non-GAAP R&D expense was $929.4 million, compared to $720.9 million in 2019.
    • GAAP SG&A expense was $1,399.9 million, compared to $1,261.1 million in 2019. Non-GAAP SG&A expense was $1,198.6 million, compared to $1,099.9 million in 2019.
    • GAAP impairment of intangible assets was $2,053.3 million primarily related to an impairment charge recorded during the second quarter 2020 related to the KANUMA intangible asset.
    • GAAP income tax benefit was $34.4 million, compared to $225.5 million in 2019. GAAP income tax benefit for 2020 includes a deferred tax benefit of $377.3 million associated with the impairment charge related to the KANUMA intangible asset. GAAP income tax benefit for 2019 includes one-time tax benefits of $382.2 million related to intra-entity asset transfers of intellectual property in 2019. Non-GAAP income tax expense was $512.8 million, compared to $359.4 million in 2019.
    • GAAP diluted EPS was $2.72, compared to $10.70 in 2019. GAAP diluted EPS for 2020 includes impairment charges of $2,053.3 million primarily relating to the KANUMA intangible asset, offset by a deferred tax benefit of $377.3 million associated with the KANUMA impairment charge. GAAP diluted EPS for 2019 includes one-time tax benefits of $382.2 million related to intra-entity asset transfers of intellectual property in 2019. Non-GAAP diluted EPS was $12.51, compared to $10.53 in 2019.

    Fourth Quarter 2020 Financial Highlights

    • Net product sales were $1,591.7 million in the fourth quarter of 2020, compared to $1,384.2 million in the fourth quarter of 2019.
    • SOLIRIS net product sales were $1,023.5 million, compared to $1,013.1 million in the fourth quarter of 2019, representing a 1 percent increase.
    • ULTOMIRIS net product sales were $313.5 million, compared to $170.2 million in the fourth quarter of 2019, representing an 84 percent increase.
    • STRENSIQ net product sales were $185.9 million, compared to $166.8 million in the fourth quarter of 2019, representing an 11 percent increase.
    • KANUMA net product sales were $29.2 million, compared to $34.1 million in the fourth quarter of 2019, representing a 14 percent decrease.
    • ANDEXXA/ONDEXXYA net product sales were $39.6 million in the fourth quarter of 2020.
    • GAAP cost of sales was $152.2 million, compared to $114.3 million in the fourth quarter of 2019. Non-GAAP cost of sales was $138.0 million, compared to $110.8 million in the fourth quarter of 2019.
    • GAAP R&D expense was $295.0 million, compared to $269.6 million in the fourth quarter of 2019. Non-GAAP R&D expense was $269.8 million, compared to $226.7 million in the fourth quarter of 2019.
    • GAAP SG&A expense was $444.4 million, compared to $381.0 million in the fourth quarter of 2019. Non-GAAP SG&A expense was $384.6 million, compared to $340.0 million in the fourth quarter of 2019.
    • GAAP income tax expense was $54.8 million, compared to income tax benefit of $287.0 million in the fourth quarter of 2019, inclusive of one-time tax benefits related to intra-entity asset transfers of intellectual property in the fourth quarter of 2019. Non-GAAP income tax expense was $111.0 million, compared to $85.8 million in the fourth quarter of 2019.
    • GAAP diluted EPS was $2.42, compared to $4.00 in the fourth quarter of 2019, inclusive of one-time tax benefits related to intra-entity asset transfers of intellectual property in the fourth quarter of 2019. Non-GAAP diluted EPS was $2.96, compared to $2.71 in the fourth quarter of 2019.

    COVID-19

    We continue to take steps to proactively respond to the evolving COVID-19 pandemic and to plan for related uncertainties. We remain focused on continuing to serve patients, protecting the health and safety of our employees and the communities in which we live and work, and supporting patients in clinical trials. We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible.

    • Clinical Trials: We have implemented a pandemic response business continuity plan designed to protect patients and site staff safety while continuing our clinical trials with limited interruption to the extent we are able. The COVID-19 impact has varied by study and program, but there has been little timing impact on fully-enrolled trials. By the third quarter of 2020, we had successfully re-initiated the majority of studies that had been temporarily paused earlier in the year. However, increasing COVID-19 cases have had further effects on the timing of healthy volunteer studies in particular. In addition, there has been, and may continue to be, an impact to the timing of trials that are enrolling patients and activating sites, or have not yet started to do so, based on local dynamics where these studies are being conducted.
    • Business Impact: We continue to take proactive measures designed to mitigate the risk of potential interruptions in supply and/or access to patients' customary site-of-care locations. Treatment compliance rates across all our medicines have remained strong. We have also seen the predicted slowing of new patient initiations and delays in treatment starts, and we are continuing to closely monitor this environment as the pandemic continues.

    Research and Development

    PHASE 3/4

    • SOLIRIS - Guillain-Barre Syndrome (GBS): SOLIRIS in GBS has been granted SAKIGAKE designation by Japan's Ministry of Health, Labour and Welfare (MHLW). Alexion plans to initiate a Phase 3 study of SOLIRIS in GBS in Japan in the first half of 2021.
    • ULTOMIRIS - 100 mg/mL: In November 2020, the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS was approved in the EU. An application for approval is under review in Japan. This higher concentration formulation is designed to reduce infusion time by more than 60 percent to approximately 45 minutes.
    • ULTOMIRIS - Subcutaneous: The Phase 3 study of weekly subcutaneous (SC) ULTOMIRIS demonstrated PK-based non-inferiority versus intravenous ULTOMIRIS. Pending collection of 12-month safety and drug-device combination data, Alexion plans to file for approval in the U.S. and EU for the ULTOMIRIS SC formulation and device combination in PNH and aHUS in the third quarter of 2021.
    • ULTOMIRIS - gMG: In November 2020, Alexion completed enrollment in the Phase 3 study of ULTOMIRIS in adults with gMG. Study results are expected in the second half of 2021.
    • ULTOMIRIS - NMOSD: A Phase 3 study of ULTOMIRIS in NMOSD is underway.
    • ULTOMIRIS - Amyotrophic Lateral Sclerosis (ALS): As completion of full enrollment nears, screening of new patients has closed for the Phase 3 study of ULTOMIRIS in ALS.
    • ULTOMIRIS - Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA): Dosing is underway in Phase 3 studies of ULTOMIRIS in adults and children with HSCT-TMA.
    • ULTOMIRIS - Complement Mediated Thrombotic Microangiopathy (CM-TMA): In January 2021, Alexion submitted an Investigational New Drug (IND) application for ULTOMIRIS in CM-TMA and plans to initiate a Phase 3 study in the first half of 2021.
    • ULTOMIRIS - Severe COVID-19: In January 2021, Alexion paused further enrollment in a Phase 3 trial of ULTOMIRIS in adults hospitalized with severe COVID-19 requiring mechanical ventilation, due to lack of efficacy, pending further analysis of the data. This decision was made based on the recommendation of an independent data monitoring committee, following their review of data from a pre-specified interim analysis. Alexion continues to provide ULTOMIRIS for the ongoing TACTIC-R platform study led by Cambridge University Hospitals NHS Foundation Trust, which is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus.
    • ULTOMIRIS - Dermatomyositis (DM): Alexion plans to initiate a Phase 2/3 study of ULTOMIRIS in DM in the second half of 2021, pending regulatory feedback.
    • ALXN1840 - Wilson Disease: Enrollment is complete in a Phase 3 study of ALXN1840 in Wilson disease. Study results are expected in the first half of 2021.
    • CAEL-101 - Caelum Biosciences: Alexion and Caelum Biosciences are conducting the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care therapy in AL amyloidosis. Dosing is underway in two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease.
    • ALXN2060 (AG10): Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Eidos is currently evaluating AG10 in two Phase 3 studies in the U.S. and Europe – one for ATTR cardiomyopathy (ATTR-CM) and one for ATTR polyneuropathy (ATTR-PN). In October 2020, Alexion initiated a Phase 3 bridging study of ALXN2060 for patients with ATTR-CM in Japan and dosing is underway.
    • ALXN2040 (Danicopan) - PNH with Extravascular Hemolysis (EVH): In December 2020, Alexion initiated a Phase 3 study of ALXN2040 as an add-on therapy for PNH patients with EVH and dosing is underway.
    • ANDEXXA - Acute Intracranial Hemorrhage (ICH): The Phase 4 ANNEXA-I study - designed to provide clinical data supporting full approval - is underway to assess ANDEXXA compared to usual standard of care in patients presenting with acute intracranial hemorrhage while taking an oral Factor Xa inhibitor. In December 2020, Alexion submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA to enable the addition of edoxaban and enoxaparin to the U.S. label. Alexion plans to file for regulatory approval of ANDEXXA in Japan in the first quarter of 2021.

    PHASE 1/2

    • ULTOMIRIS - Renal Diseases: In November 2020, Alexion initiated a proof-of-concept study of ULTOMIRIS in patients with IgA nephropathy and lupus nephritis.
    • ALXN1830: Due to COVID-19, Alexion discontinued the Phase 2 study of ALXN1830, administered intravenously, in warm autoimmune hemolytic anemia (WAIHA) and the Phase 1 study of a subcutaneous formulation of ALXN1830 in healthy volunteers. In January 2021, a Clinical Trial Application (CTA) for a new Phase 1 study of subcutaneous ALXN1830 was approved in New Zealand; study initiation is planned for the first quarter of 2021. Following successful completion of the Phase 1 study, Alexion plans to initiate Phase 2 studies of subcutaneous ALXN1830 in gMG and WAIHA in 2021, pending regulatory feedback.
    • ALXN2040 - Geographic Atrophy (GA): Alexion plans to initiate a Phase 2 study of ALXN2040 in GA in the second half of 2021.
    • ALXN2040 - COVID-19: Alexion has agreed to provide ALXN2040 to the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, for the ACTIV-5 Big Effect Trial in adults hospitalized with COVID-19. This Phase 2 platform trial is comparing different investigational therapies to a common control arm with the intent of identifying promising treatments to enter a more definitive study.
    • ALXN2050 - PNH: Alexion has paused additional enrollment in the Phase 2 study of ALXN2050 monotherapy in PNH patients, pending the receipt of further Phase 1 data (expected in the second quarter of 2021) that will allow for dose escalation in the Phase 2 study.
    • ALXN2050 - Renal Diseases: Alexion plans to initiate a proof-of-concept study of ALXN2050 in patients with various renal diseases in 2021, pending regulatory feedback.
    • ALXN1720: The Phase 1 healthy volunteer study of ALXN1720, a novel anti-C5 albumin-binding bi-specific mini-body that is designed to bind and prevent activation of human C5, has been paused for a second time due to COVID-19. Additional cohorts have been added to the study to explore higher doses and enable the initiation of a Phase 3 study in gMG, pending successful completion of the Phase 1 study as has been agreed with the FDA. Data from the Phase 1 study are expected in the second half of 2021. Alexion also plans to initiate a study of ALXN1720 in DM.
    • ANDEXXA - Urgent Surgery: ANDEXXA is currently being evaluated in a single-arm, open-label Phase 2 study in patients taking apixaban, rivaroxaban, edoxaban, or enoxaparin who require urgent surgery. The results of this study will inform the design of a randomized controlled Phase 3 clinical trial to expand the label in this population.
    • ALXN2075 (cerdulatinib): Acquired as part of the Portola acquisition, ALXN2075 is a dual spleen tyrosine kinase and janus kinase (SYK/JAK) inhibitor being evaluated in a Phase 1/2a study in patients with relapsed/refractory chronic lymphocytic leukemia or B-cell or T-cell non-Hodgkin lymphoma. Data are expected in the first half of 2021.
    • ALXN1820: In January 2021, Alexion initiated a Phase 1 study of ALXN1820, its bi-specific anti-properdin mini-body, in healthy volunteers.
    • ALXN1850 - Hypophosphatasia (HPP): In November 2020, Alexion submitted an IND application to the FDA for ALXN1850, its next generation asfotase alfa asset. Initiation of a Phase 1 study in adults with HPP is planned for the second quarter of 2021.

    Conference Call/Earnings Materials:

    Given the recently announced agreement for Alexion to be acquired by AstraZeneca, Alexion will not be hosting a conference call. Earnings materials are available publicly on the Investor Relations page of our website at http://ir.alexion.com. Questions may be directed to the Investor Relations team via e-mail at or the contact information below.

    About Alexion

    Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: www.alexion.com.

    [ALXN-E]

    Additional Information and Where to Find It

    In connection with the proposed transaction, AstraZeneca PLC ("AstraZeneca") intends to file with the SEC a registration statement on Form F-4 that will include a proxy statement of Alexion and that also constitutes a prospectus of AstraZeneca. Each of Alexion and AstraZeneca may also file other relevant documents with the U.S. Securities and Exchange Commission ("SEC") regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or registration statement or any other document that Alexion or AstraZeneca may file with the SEC. The definitive proxy statement/prospectus (if and when available) will be mailed to stockholders of Alexion. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the registration statement and proxy statement/prospectus (if and when available) and other documents containing important information about Alexion, AstraZeneca and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion's website at http://www.alexion.com or by contacting Alexion's Investor Relations Department by email at . Copies of the documents filed with the SEC by AstraZeneca will be available free of charge on AstraZeneca's website at https://www.astrazeneca.com/investor-relations.html or by contacting AstraZeneca's Investor Relations department by email at .

    Participants in the Solicitation

    Alexion, AstraZeneca, their respective directors and certain of their executive officers and other employees may be deemed to be participants in the solicitation of proxies from Alexion's stockholders in connection with the proposed transaction. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Alexion stockholders in connection with the proposed mergers, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the proxy statement/prospectus when it is filed with the SEC. Information about Alexion's directors and executive officers is available in Alexion's proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on March 26, 2020, Alexion's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on February 4, 2020, and other documents subsequently filed by Alexion with the SEC. Information about AstraZeneca's directors and executive officers is available in AstraZeneca's Form 20-F filed with the SEC on March 3, 2020, and other documents subsequently filed by AstraZeneca with the SEC.

    No Offer or Solicitation

    This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

    Forward Looking Statements

    This communication contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You can generally identify forward-looking statements by the use of forward-looking terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "explore," "evaluate," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," or "will," or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond Alexion's control. Statements in this communication regarding Alexion, AstraZeneca and the combined company that are forward-looking, including anticipated benefits of the proposed transaction, the impact of the proposed transaction on Alexion's and AstraZeneca's businesses, that Alexion is well positioned to build on its success, the anticipated timing of initiation, enrollment, reporting results of clinical trials, the timing of filing for regulatory approvals and receipt of approvals are based on management's estimates, assumptions and projections, and are subject to significant uncertainties and other factors, many of which are beyond Alexion's and AstraZeneca's control. These factors include, among other things, market factors, completion of the audit of Alexion's fiscal year 2020 financial results, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the ultimate outcome of any litigation matter. Additional information concerning these risks, uncertainties and assumptions can be found in Alexion's filings with the SEC, including the risk factors discussed in Alexion's most recent Annual Report on Form 10-K, as updated by its Quarterly Reports on Form 10-Q, and in Alexion's future filings with the SEC. Important risk factors could cause actual future results and other future events to differ materially from those currently estimated by management, including, but not limited to, the risks that: a condition to the closing the proposed acquisition may not be satisfied; a regulatory approval that may be required for the proposed acquisition is delayed, is not obtained or is obtained subject to conditions that are not anticipated; management's time and attention is diverted on transaction related issues; disruption from the transaction makes it more difficult to maintain business, contractual and operational relationships; the credit ratings of the combined company declines following the proposed acquisition; legal proceedings are instituted against Alexion, AstraZeneca or the combined company; Alexion is unable to retain key personnel; and the announcement or the consummation of the proposed acquisition has a negative effect on the market price of the capital stock of Alexion or on Alexion's operating results. No assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do occur, what impact they will have on the results of operations, financial condition or cash flows of Alexion. Should any risks and uncertainties develop into actual events, these developments could have a material adverse effect on the proposed transaction and/or Alexion. You are cautioned not to rely on Alexion's forward-looking statements. These forward-looking statements are and will be based upon management's then-current views and assumptions regarding future events and operating performance, and are applicable only as of the dates of such statements. Alexion assumes no duty to update or revise forward-looking statements, whether as a result of new information, future events or otherwise, as of any future date.

    In addition to financial information prepared in accordance with GAAP, this press release also contains non-GAAP financial measures that Alexion believes, when considered together with the GAAP information, provide investors and management with supplemental information relating to performance, trends and prospects that promote a more complete understanding of our operating results and financial position during different periods. Alexion also uses these non-GAAP financial measures to establish budgets, set operational goals and to evaluate the performance of the business. The non-GAAP results, determined in accordance with our internal policies, exclude the impact of the following GAAP items (see reconciliation tables below for additional information): share-based compensation expense, fair value adjustment of inventory acquired, amortization of purchased intangible assets, changes in fair value of contingent consideration, restructuring and related expenses, upfront payments related to licenses and other strategic agreements, acquired in-process research and development, impairment of purchased intangible assets, gains and losses related to strategic equity investments, litigation charges, gain or loss on sale of a business or asset, gain or loss related to modification of purchase options, contingent milestone payments associated with acquisitions of legal entities accounted for as asset acquisitions, acquisition-related costs and certain adjustments to income tax expense. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for, or superior to, the financial measures prepared and presented in accordance with GAAP, and should be reviewed in conjunction with the relevant GAAP financial measures. Please refer to the attached Reconciliation of GAAP to non-GAAP Financial Results for explanations of the amounts adjusted to arrive at non-GAAP net income and non-GAAP earnings per share amounts for the three and twelve month periods ended December 31, 2020 and 2019.

    (Tables Follow)

     

    ALEXION PHARMACEUTICALS, INC.

    TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in millions, except per share amounts)

    (unaudited)

     

     

    Three months ended

     

    Twelve months ended

     

    December 31,

     

    December 31,

     

    2020

     

    2019

     

    2020

     

    2019

    Net product sales

    $

    1,591.7

     

     

    $

    1,384.2

     

     

    $

    6,069.1

     

     

    $

    4,990.0

     

    Other revenue

    0.1

     

     

    0.1

     

     

    0.8

     

     

    1.1

     

    Total revenues

    1,591.8

     

     

    1,384.3

     

     

    6,069.9

     

     

    4,991.1

     

    Costs and expenses:

     

     

     

     

     

     

     

    Cost of sales (exclusive of amortization of purchased intangible assets)

    152.2

     

     

    114.3

     

     

    553.5

     

     

    394.5

     

    Research and development

    295.0

     

     

    269.6

     

     

    1,002.9

     

     

    886.0

     

    Selling, general and administrative

    444.4

     

     

    381.0

     

     

    1,399.9

     

     

    1,261.1

     

    Acquired in-process research and development

     

     

     

     

     

     

    (4.1)

     

    Amortization of purchased intangible assets

    53.2

    73.9

    253.7

    309.6

     

    Change in fair value of contingent consideration

    16.2

     

     

    4.4

     

     

    61.2

     

     

    11.6

     

    Acquisition-related costs

    11.9

     

     

     

     

    117.6

     

     

     

    Restructuring expenses

    (3.2)

     

     

    0.1

     

     

    10.3

     

     

    12.0

     

    Impairment of intangible assets

    2,053.3

     

    Gain on sale of asset

     

     

     

     

    (14.8)

     

     

     

    Total costs and expenses

    969.7

     

     

    843.3

     

     

    5,437.6

     

     

    2,870.7

     

    Operating income

    622.1

     

     

    541.0

     

     

    632.3

     

     

    2,120.4

     

    Other income and expense:

     

     

     

     

     

     

     

    Investment income, net

    (3.1)

     

     

    49.7

     

     

    44.7

     

     

    100.3

     

    Interest expense

    (27.7)

     

     

    (21.7)

     

     

    (104.7)

     

     

    (77.8)

     

    Other income and (expense)

    (0.7)

     

     

    33.0

     

     

    (3.3)

     

     

    35.9

     

    Income before income taxes

    590.6

     

     

    602.0

     

     

    569.0

     

     

    2,178.8

     

    Income tax expense (benefit)

    54.8

     

     

    (287.0)

     

     

    (34.4)

     

     

    (225.5)

     

    Net income

    $

    535.8

     

     

    $

    889.0

     

     

    $

    603.4

     

     

    $

    2,404.3

     

    Earnings per common share

     

     

     

     

     

     

     

    Basic

    $

    2.45

     

     

    $

    4.02

     

     

    $

    2.74

     

     

    $

    10.77

     

    Diluted

    $

    2.42

     

     

    $

    4.00

     

     

    $

    2.72

     

     

    $

    10.70

     

    Shares used in computing earnings per common share

     

     

     

     

     

     

     

    Basic

    218.9

     

     

    221.3

     

     

    220.1

     

     

    223.2

     

    Diluted

    221.3

     

     

    222.5

     

     

    222.0

     

     

    224.8

     

    ALEXION PHARMACEUTICALS, INC.

    TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS

    (in millions, except per share amounts)

    (unaudited)

     

     

    Three months ended

     

    Twelve months ended

     

    December 31,

     

    December 31,

     

    2020

     

    2019

     

    2020

     

    2019

    GAAP net income

    $

    535.8

     

     

    $

    889.0

     

     

    $

    603.4

     

     

    $

    2,404.3

     

    Before tax adjustments:

     

     

     

     

     

     

     

    Cost of sales:

     

     

     

     

     

     

     

    Share-based compensation

    3.1

     

     

    3.5

     

     

    12.4

     

     

    14.2

     

    Fair value adjustment in inventory acquired (1)

    11.1

     

     

     

     

    22.9

     

     

     

    Research and development expense:

     

     

     

     

     

     

     

    Share-based compensation

    21.0

     

     

    15.8

     

     

    68.6

     

     

    61.7

     

    Upfront payments related to licenses and other strategic agreements (2)

     

     

    27.1

     

     

     

     

    103.4

     

    Fair value adjustment in inventory acquired (1)

    4.2

     

     

     

     

    4.9

     

     

     

    Selling, general and administrative expense:

     

     

     

     

     

     

     

    Share-based compensation

    59.8

     

     

    41.0

     

     

    179.7

     

     

    161.1

     

    Litigation charges (3)

     

     

     

     

    21.6

     

     

    0.1

     

    Acquired in-process research and development

     

     

     

     

     

     

    (4.1)

     

    Amortization of purchased intangible assets

    53.2

     

     

    73.9

     

     

    253.7

     

     

    309.6

     

    Change in fair value of contingent consideration (4)

    16.2

     

     

    4.4

     

     

    61.2

     

     

    11.6

     

    Acquisition-related costs (5)

    11.9

     

     

     

     

    117.6

     

     

     

    Restructuring expenses (6)

    (3.2)

     

     

    0.1

     

     

    10.3

     

     

    12.0

     

    Impairment of intangible assets (7)

     

     

     

     

    2,053.3

     

     

     

    Gain on sale of asset (8)

     

     

     

     

    (14.8)

     

     

     

    Investment income (expense):

     

     

     

     

     

     

     

    (Gains) and losses related to strategic equity investments(9)

    7.6

     

     

    (39.0)

     

     

    (26.6)

     

     

    (59.7)

     

    Other income and (expense):

     

     

     

     

     

     

     

    Gain related to modification of purchase option(10)

     

     

    (32.0)

     

     

     

     

    (32.0)

     

    Adjustments to income tax expense (11)

    (56.2)

     

     

    (372.8)

     

     

    (547.2)

     

     

    (584.9)

     

    Non-GAAP net income

    $

    664.5

     

     

    $

    611.0

     

     

    $

    2,821.0

     

     

    $

    2,397.3

     

     

     

     

     

     

     

     

     

    GAAP earnings per common share - diluted

    $

    2.42

     

     

    $

    4.00

     

     

    $

    2.72

     

     

    $

    10.70

     

    Non-GAAP earnings per common share - diluted

    $

    2.96

     

     

    $

    2.71

     

     

    $

    12.51

     

     

    $

    10.53

     

     

     

     

     

     

     

     

     

    Shares used in computing diluted earnings per common share (GAAP)

    221.3

     

     

    222.5

     

     

    222.0

     

     

    224.8

     

    Shares used in computing diluted earnings per common share (non-GAAP)

    224.4

     

     

    225.6

     

     

    225.5

     

     

    227.6

     

    (1)

    During the three months ended December 31, 2020, we recorded $11.1 million and $4.2 million within cost of sales and research and development expense, respectively, related to the amortization of the excess fair value of ANDEXXA inventory over the estimated historical cost basis of the inventory, recognized in connection with the acquisition of Portola Pharmaceuticals, Inc. During the twelve months ended December 31, 2020 we recorded $22.9 million and $4.9 million within cost of sales and research and development expense, respectively.

     

    (2)

    During the three months ended December 31, 2019, we recorded expense of $27.1 million in connection with upfront payments on strategic agreements that we entered into with Stealth BioTherapeutics Corp. (Stealth) and Immune Pharmaceuticals (Immune Pharma). During the twelve months ended December 31, 2019, we recorded expense of $103.4 million in connection with upfront payments on strategic agreements that we entered into with Stealth, Immune Pharma, Eidos Therapeutics, Inc., Affibody AB, and Zealand Pharma A/S.

     

    (3)

    During the twelve months ended December 31, 2020, we recorded $21.6 million in litigation charges in connection with legal proceedings.

     

    (4)

    Changes in the fair value of contingent consideration expense for the three and twelve months ended December 31, 2020 reflect changes in the expected timing and probability of achieving contingent milestone payments and the interest component of contingent consideration related to changes in discount rates and the passage of time. Changes in fair value of contingent consideration expense for the three and twelve months ended December 31, 2019 reflect changes in the expected timing of achieving contingent milestone payments and the interest component of contingent consideration related to the passage of time.

     

    (5)

    For the three and twelve months ended December 31, 2020, we recorded $11.9 million and $117.6 million, respectively, of acquisition-related costs primarily in connection with the Achillion Pharmaceuticals, Inc. and Portola Pharmaceuticals, Inc. acquisitions. Acquisition-related costs primarily consist of transaction costs, costs associated with the accelerated vesting of equity awards previously granted to employees and employee separation costs.

     

    (6)

    During the three and twelve months ended December 31, 2020, we recorded a benefit of $3.2 million and expense of $10.3 million, respectively, of restructuring expenses relating to restructuring activities initiated during the third quarter 2020 primarily within our commercial organization.

     

    (7)

    In the second quarter 2020, we recognized impairment charges of $2,053.3 million, primarily related to our KANUMA intangible asset.

     

    (8)

    In July 2020, we sold certain intellectual property rights and assets to Inozyme Pharma in exchange for $14.8 million of Inozyme common stock. As a result, we recognized a gain on the sale during the twelve months ended December 31, 2020.

     

    (9)

    (Gains) and losses related to strategic equity investments include unrealized gains and losses in investment income to adjust our strategic equity investments to fair value. In addition, during the three and twelve months ended December 31, 2020 we recognized an impairment charge of $49.0 million on our option to acquire the remaining equity of Caelum Biosciences (Caelum). In connection with entering into the Merger Agreement with AstraZeneca in December 2020, we determined that the fair value of our option decreased as a result of a change to the expected option exercise date.

     

    (10)

    In December 2019, we amended the terms our of our agreement with Caelum with respect to the option to acquire the remaining equity in Caelum. In conjunction with this amendment, we recognized a gain of $32.0 million in other income and (expense), which reflects an increase in the fair value of the option, less incremental upfront funding and the change in the fair value of contingent payments which we also modified as a part of amendment.

     

    (11)

    Alexion's non-GAAP income tax expense for the three and twelve months ended December 31, 2020 and 2019 excludes the tax effect of pre-tax adjustments to GAAP profit. Non-GAAP income tax expense for the three and twelve months ended December 31, 2019 excludes a one-time tax benefit of $382.2 million related to the intra-entity asset transfer of intellectual property within our captive foreign partnership. Non-GAAP income tax expense for the twelve months ended December 31, 2019 also excludes certain one-time tax benefits of $95.7 million and $30.3 million associated with a tax election made with respect to intellectual property of Wilson and a release of an existing valuation allowance, respectively.

    ALEXION PHARMACEUTICALS, INC.

    TABLE 3: NET PRODUCT SALES BY GEOGRAPHY

    (in millions)

    (unaudited)

     

     

     

    Three months ended

     

    Twelve months ended

     

     

    December 31,

     

    December 31,

     

     

    2020

     

    2019

     

    2020

     

    2019

    SOLIRIS

     

     

     

     

     

     

     

     

    United States

     

    $

    587.4

     

     

    $

    557.2

     

     

    $

    2,259.7

     

     

    $

    2,014.0

     

    Europe

     

    267.6

     

     

    249.6

     

     

    1,033.3

     

     

    1,049.8

     

    Asia Pacific

     

    87.5

     

     

    94.3

     

     

    343.0

     

     

    423.5

     

    Rest of World

     

    81.0

     

     

    112.0

     

     

    428.2

     

     

    459.1

     

    Total SOLIRIS

     

    $

    1,023.5

     

     

    $

    1,013.1

     

     

    $

    4,064.2

     

     

    $

    3,946.4

     

    ULTOMIRIS

     

     

     

     

     

     

     

     

    United States

     

    $

    185.7

     

     

    $

    92.9

     

     

    $

    646.0

     

     

    $

    236.8

     

    Europe

     

    58.0

     

     

    31.1

     

     

    170.4

     

     

    52.2

     

    Asia Pacific

     

    69.0

     

     

    46.2

     

     

    255.3

     

     

    49.9

     

    Rest of World

     

    0.8

     

     

     

     

    5.0

     

     

     

    Total ULTOMIRIS

     

    $

    313.5

     

     

    $

    170.2

     

     

    $

    1,076.7

     

     

    $

    338.9

     

    STRENSIQ

     

     

     

     

     

     

     

     

    United States

     

    $

    144.8

     

     

    $

    128.0

     

     

    $

    562.9

     

     

    $

    451.7

     

    Europe

     

    19.2

     

     

    21.0

     

     

    80.8

     

     

    77.0

     

    Asia Pacific

     

    16.3

     

     

    14.4

     

     

    61.0

     

     

    50.4

     

    Rest of World

     

    5.6

     

     

    3.4

     

     

    27.1

     

     

    13.4

     

    Total STRENSIQ

     

    $

    185.9

     

     

    $

    166.8

     

     

    $

    731.8

     

     

    $

    592.5

     

    ANDEXXA

     

     

     

     

     

     

     

     

    United States

     

    $

    35.5

     

     

    $

     

     

    $

    71.7

     

     

    $

     

    Europe

     

    4.1

     

     

     

     

    6.8

     

     

     

    Asia Pacific

     

     

     

     

     

     

     

     

    Rest of World

     

     

     

     

     

     

     

     

    Total ANDEXXA

     

    $

    39.6

     

     

    $

     

     

    $

    78.5

     

     

    $

     

    KANUMA

     

     

     

     

     

     

     

     

    United States

     

    $

    16.1

     

     

    $

    14.9

     

     

    $

    63.7

     

     

    $

    60.0

     

    Europe

     

    10.2

     

     

    7.7

     

     

    35.6

     

     

    27.1

     

    Asia Pacific

     

    1.4

     

     

    1.2

     

     

    4.3

     

     

    4.6

     

    Rest of World

     

    1.5

     

     

    10.3

     

     

    14.3

     

     

    20.5

     

    Total KANUMA

     

    $

    29.2

     

     

    $

    34.1

     

     

    $

    117.9

     

     

    $

    112.2

     

     

     

     

     

     

     

     

     

     

    Net Product Sales

     

     

     

     

     

     

     

     

    United States

     

    $

    969.5

     

     

    $

    793.0

     

     

    $

    3,604.0

     

     

    $

    2,762.5

     

    Europe

     

    359.1

     

     

    309.4

     

     

    1,326.9

     

     

    1,206.1

     

    Asia Pacific

     

    174.2

     

     

    156.1

     

     

    663.6

     

     

    528.4

     

    Rest of World

     

    88.9

     

     

    125.7

     

     

    474.6

     

     

    493.0

     

    Total Net Product Sales

     

    $

    1,591.7

     

     

    $

    1,384.2

     

     

    $

    6,069.1

     

     

    $

    4,990.0

     

    ALEXION PHARMACEUTICALS, INC.

    TABLE 4: CONDENSED CONSOLIDATED BALANCE SHEETS

    (in millions)

    (unaudited)

     

     

    December 31,

     

    December 31,

     

    2020

     

    2019

    Cash and cash equivalents

    $

    2,964.5

     

     

    $

    2,685.5

     

    Marketable securities

    34.9

     

     

    64.0

     

    Trade accounts receivable, net

    1,409.3

     

     

    1,243.2

     

    Inventories

    775.7

     

     

    627.6

     

    Prepaid expenses and other current assets

    648.6

     

     

    456.1

     

    Property, plant and equipment, net

    1,238.8

     

     

    1,163.3

     

    Intangible assets, net

    3,002.4

     

     

    3,344.3

     

    Goodwill

    5,100.1

     

     

    5,037.4

     

    Right of use operating assets

    223.1

     

     

    204.0

     

    Deferred tax assets

    2,199.4

     

     

    2,290.2

     

    Other assets

    506.2

     

     

    429.0

     

    Total assets

    $

    18,103.0

     

     

    $

    17,544.6

     

     

     

     

     

    Accounts payable and accrued expenses

    $

    1,203.3

     

     

    $

    966.7

     

    Current portion of long-term debt

    142.4

     

     

    126.7

     

    Current portion of contingent consideration

    114.9

     

     

     

    Other current liabilities

    164.1

     

     

    100.9

     

    Long-term debt, less current portion

    2,419.6

     

     

    2,375.0

     

    Deferred tax liabilities

    1,632.2

     

     

    2,081.4

     

    Contingent consideration

    299.4

     

     

    192.4

     

    Noncurrent operating lease liabilities

    177.1

     

     

    164.1

     

    Other liabilities

    298.8

     

     

    265.6

     

    Total liabilities

    6,451.8

     

     

    6,272.8

     

    Total stockholders' equity

    11,651.2

     

     

    11,271.8

     

    Total liabilities and stockholders' equity

    $

    18,103.0

     

     

    $

    17,544.6

     

    ALEXION PHARMACEUTICALS, INC.

    TABLE 5: CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

    (in millions)

    (unaudited)

     

     

    Year Ended December 31,

     

    2020

     

    2019

    Cash flows from operating activities:

     

     

     

    Net income

    $

    603.4

     

     

    $

    2,404.3

     

    Adjustments to reconcile net income to net cash flows from operating activities:

     

     

     

    Depreciation and amortization

    329.4

     

     

    376.8

     

    Impairment of intangible assets

    2,053.3

     

     

     

    Change in fair value of contingent consideration

    61.2

     

     

    11.6

     

    Payments of contingent consideration

     

     

    (100.0)

     

    Share-based compensation expense

    281.1

     

     

    237.0

     

    Non-cash expense for acquired IPR&D

     

     

     

    Deferred tax (benefit) expense

    (283.4)

     

     

    (455.4)

     

    Unrealized foreign currency (gain) loss

    (5.2)

     

     

    (2.1)

     

    Unrealized loss (gain) on forward contracts

    6.4

     

     

    (16.5)

     

    Unrealized loss (gain) on strategic equity investments

    3.0

     

     

    (26.9)

     

    Gain on sale of strategic equity investments

     

     

    (32.8)

     

    Gain on sale of asset

    (14.8)

     

     

     

    Gain on modification of purchase option

     

     

    (32.0)

     

    Gain on derecognition of Portola strategic equity investment

    (29.7)

     

     

     

    Inventory obsolescence charge

    27.5

     

     

    3.3

     

    Other

    4.5

     

     

    (2.7)

     

    Changes in operating assets and liabilities, excluding the effect of acquisitions:

     

     

     

    Accounts receivable

    (139.4)

     

     

    (319.2)

     

    Inventories

    95.0

     

     

    (160.2)

     

    Prepaid expenses, right of use operating assets and other assets

    (111.9)

     

     

    (31.0)

     

    Accounts payable, accrued expenses, lease liabilities and other liabilities

    122.5

     

     

    230.7

     

    Net cash provided by operating activities

    3,002.9

     

     

    2,084.9

     

    Cash flows from investing activities:

     

     

     

    Purchases of available-for-sale debt securities

    (19.4)

     

     

    (80.2)

     

    Proceeds from maturity or sale of available-for-sale debt securities

    184.2

     

     

    222.2

     

    Purchases of mutual funds related to nonqualified deferred compensation plan

    (19.7)

     

     

    (17.6)

     

    Proceeds from sale of mutual funds related to nonqualified deferred compensation plan

    12.1

     

     

    14.7

     

    Purchases of property, plant and equipment

    (106.7)

     

     

    (154.7)

     

    Purchases of strategic equity investments and options

    (38.1)

     

     

    (73.3)

     

    Proceeds from sale of strategic equity investments

     

     

    114.7

     

    Payments for acquisitions of businesses, net of cash and restricted cash acquired

    (2,111.9)

     

     

     

    Purchases of intangible assets

     

     

    (16.0)

     

    Other

     

     

    (0.1)

     

    Net cash (used in) provided by investing activities

    (2,099.5)

     

     

    9.7

     

    Cash flows from financing activities:

     

     

     

    Proceeds from revolving credit facility

     

     

     

    Payments on revolving credit facility

     

     

    (250.0)

     

    Payments on term loan

    (130.6)

     

     

    (98.0)

     

    Repurchase of common stock

    (510.8)

     

     

    (416.0)

     

    Net proceeds from issuance of stock under share-based compensation arrangements

    58.7

     

     

    29.9

     

    Other

    (29.2)

     

     

    (5.0)

     

    Net cash used in financing activities

    (611.9)

     

     

    (739.1)

     

    Effect of exchange rate changes on cash and cash equivalents and restricted cash

    19.5

     

     

    0.8

     

    Net change in cash and cash equivalents and restricted cash

    311.0

     

     

    1,356.3

     

    Cash and cash equivalents and restricted cash at beginning of period

    $

    2,723.6

     

     

    $

    1,367.3

     

    Cash and cash equivalents and restricted cash at end of period

    $

    3,034.6

     

     

    $

    2,723.6

     

     

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  3. Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the Company will report its financial results for the fourth quarter and full year ended December 31, 2020 before the US financial markets open on February 4, 2021.

    Given the recently announced agreement to be acquired by AstraZeneca, Alexion will not be hosting a conference call. Earnings materials will be made available publicly on the Investor Relations page of our website at http://ir.alexion.com. Questions may be directed to the Investor Relations team via e-mail at or the contact information below.

    AstraZeneca and Alexion Combination

    On December 12, 2020, AstraZeneca and Alexion announced that the companies entered into a definitive agreement…

    Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the Company will report its financial results for the fourth quarter and full year ended December 31, 2020 before the US financial markets open on February 4, 2021.

    Given the recently announced agreement to be acquired by AstraZeneca, Alexion will not be hosting a conference call. Earnings materials will be made available publicly on the Investor Relations page of our website at http://ir.alexion.com. Questions may be directed to the Investor Relations team via e-mail at or the contact information below.

    AstraZeneca and Alexion Combination

    On December 12, 2020, AstraZeneca and Alexion announced that the companies entered into a definitive agreement for AstraZeneca to acquire Alexion, in which Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares (ADSs) for each Alexion share. Based on AstraZeneca's reference average ADR price of $54.14 at the time of the announcement, this implied total consideration to Alexion shareholders of $39 billion or $175 per share. The acquisition has the potential to advance the shared science-led mission of both companies to leverage complementary approaches to developing life-changing medicines. The proposed combination will broaden Alexion's footprint, enabling the company to help more patients, pursue innovative science in new areas and expand its therapies in additional geographies. In addition, the transaction delivers significant value for Alexion's shareholders, who will have an important stake in the combined company's future results. Subject to receipt of regulatory clearances and the approval by AstraZeneca and Alexion shareholders, the companies expect the acquisition to close in the third quarter of 2021.

    Additional Information and Where to Find It

    In connection with the proposed transaction, AstraZeneca PLC ("AstraZeneca") intends to file with the SEC a registration statement on Form F-4 that will include a proxy statement of Alexion and that also constitutes a prospectus of AstraZeneca. Each of Alexion and AstraZeneca may also file other relevant documents with the U.S. Securities and Exchange Commission ("SEC") regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or registration statement or any other document that Alexion or AstraZeneca may file with the SEC. The definitive proxy statement/prospectus (if and when available) will be mailed to stockholders of Alexion. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the registration statement and proxy statement/prospectus (if and when available) and other documents containing important information about Alexion, AstraZeneca and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion's website at http://www.alexion.com or by contacting Alexion's Investor Relations Department by email at . Copies of the documents filed with the SEC by AstraZeneca will be available free of charge on AstraZeneca's website at https://www.astrazeneca.com/investor-relations.html or by contacting AstraZeneca's Investor Relations department by email at .

    Participants in the Solicitation

    Alexion, AstraZeneca, their respective directors and certain of their executive officers and other employees may be deemed to be participants in the solicitation of proxies from Alexion's stockholders in connection with the proposed transaction. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Alexion stockholders in connection with the proposed mergers, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the proxy statement/prospectus when it is filed with the SEC. Information about Alexion's directors and executive officers is available in Alexion's proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on March 26, 2020, Alexion's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on February 4, 2020, and other documents subsequently filed by Alexion with the SEC. Information about AstraZeneca's directors and executive officers is available in AstraZeneca's Form 20-F filed with the SEC on March 3, 2020, and other documents subsequently filed by AstraZeneca with the SEC.

    No Offer or Solicitation

    This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

    Forward Looking Statements

    This communication contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You can generally identify forward-looking statements by the use of forward-looking terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "explore," "evaluate," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," or "will," or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond Alexion's and AstraZeneca's control. Statements in this communication regarding Alexion, AstraZeneca and the combined company that are forward-looking, including projections as to expected revenue for Alexion for the fiscal year ended December 31, 2020, anticipated benefits of the proposed transaction, the impact of the proposed transaction on Alexion's and AstraZeneca's businesses and future financial and operating results, the amount and timing of synergies from the proposed transaction, the terms and scope of the expected financing for the proposed transaction, the aggregate amount of indebtedness of the combined company following the closing of the proposed transaction, are based on management's estimates, assumptions and projections, and are subject to significant uncertainties and other factors, many of which are beyond Alexion's and AstraZeneca's control. These factors include, among other things, market factors, completion of the audit of Alexion's fiscal year 2020 financial results, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the ultimate outcome of any litigation matter. Additional information concerning these risks, uncertainties and assumptions can be found in Alexion's and AstraZeneca's respective filings with the SEC, including the risk factors discussed in Alexion's most recent Annual Report on Form 10-K, as updated by its Quarterly Reports on Form 10-Q, in AstraZeneca's most recent Annual Report on Form 20-F and in each company's future filings with the SEC. Important risk factors could cause actual future results and other future events to differ materially from those currently estimated by management, including, but not limited to, the risks that: a condition to the closing the proposed acquisition may not be satisfied; a regulatory approval that may be required for the proposed acquisition is delayed, is not obtained or is obtained subject to conditions that are not anticipated; AstraZeneca is unable to achieve the synergies and value creation contemplated by the proposed acquisition; AstraZeneca is unable to promptly and effectively integrate Alexion's businesses; management's time and attention is diverted on transaction related issues; disruption from the transaction makes it more difficult to maintain business, contractual and operational relationships; the credit ratings of the combined company declines following the proposed acquisition; legal proceedings are instituted against Alexion, AstraZeneca or the combined company; Alexion, AstraZeneca or the combined company is unable to retain key personnel; and the announcement or the consummation of the proposed acquisition has a negative effect on the market price of the capital stock of Alexion or AstraZeneca or on Alexion's or AstraZeneca's operating results. No assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do occur, what impact they will have on the results of operations, financial condition or cash flows of Alexion or AstraZeneca. Should any risks and uncertainties develop into actual events, these developments could have a material adverse effect on the proposed transaction and/or Alexion or AstraZeneca, AstraZeneca's ability to successfully complete the proposed transaction and/or realize the expected benefits from the proposed transaction. You are cautioned not to rely on Alexion's and AstraZeneca's forward-looking statements. These forward-looking statements are and will be based upon management's then-current views and assumptions regarding future events and operating performance, and are applicable only as of the dates of such statements. Neither Alexion nor AstraZeneca assumes any duty to update or revise forward-looking statements, whether as a result of new information, future events or otherwise, as of any future date.

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  4. – Independent data monitoring committee recommends pausing study enrollment due to lack of efficacy in pre-specified interim analysis –

    – Company will conduct further analysis of trial data to determine next steps –

    – No new safety findings were observed for ULTOMIRIS use in COVID-19 –

    Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the decision to pause further enrollment in the global Phase 3 study of ULTOMIRIS® (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation. This decision is based on the recommendation of an independent data monitoring committee (IDMC), following their review of data from a pre-specified interim analysis. The IDMC recommended that additional enrollment be paused, pending…

    – Independent data monitoring committee recommends pausing study enrollment due to lack of efficacy in pre-specified interim analysis –

    – Company will conduct further analysis of trial data to determine next steps –

    – No new safety findings were observed for ULTOMIRIS use in COVID-19 –

    Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the decision to pause further enrollment in the global Phase 3 study of ULTOMIRIS® (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation. This decision is based on the recommendation of an independent data monitoring committee (IDMC), following their review of data from a pre-specified interim analysis. The IDMC recommended that additional enrollment be paused, pending further analysis of the data, due to lack of efficacy when ULTOMIRIS was added to best supportive care, compared to best supportive care alone. There were no new safety findings observed. The study will continue for patients already enrolled, including completion of all study visits and planned ULTOMIRIS dosing according to the study protocol.

    "We would like to thank the patients and their families, as well as investigators and healthcare professionals, who were essential to this study. We greatly value their contributions to help investigate potential ways to address this devastating pandemic," said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. "While initial anecdotal reports from compassionate use cases were promising, these results demonstrate the importance of conducting controlled clinical trials to fully evaluate the potential of new treatment approaches and generate the necessary evidence to make informed decisions. We are disappointed in this initial outcome, but plan to further analyze the data to identify potential subgroups who may benefit and to determine next steps. In addition, we remain fully committed to our efforts to serve the rare disease community and to continuing to provide ULTOMIRIS to the patients who currently rely on it."

    The IDMC's recommendation was based on a pre-planned interim analysis of the primary endpoint – survival at Day 29 – once 122 patients completed the 29-day primary evaluation period. No secondary endpoints were analyzed as part of the interim analysis.

    In the UK, the TACTIC-R platform study led by Cambridge University Hospitals NHS Foundation Trust, which includes an ULTOMIRIS cohort, is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus, including reducing the need for ICU admission and ventilation. This independent study remains ongoing.

    About ULTOMIRIS® (ravulizumab-cwvz)

    ULTOMIRIS® (ravulizumab--cwvz) is the first and only long-acting C5 complement inhibitor. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body's immune system. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells. ULTOMIRIS is administered intravenously every eight weeks or, for pediatric patients less than 20 kg, every four weeks, following a loading dose. ULTOMIRIS is approved in the United States (U.S.), European Union (EU) and Japan as a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH). It is also approved in the U.S. and Japan for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric (one month of age and older) patients, as well as in the EU for the treatment of adults and children with a body weight of at least 10 kg with aHUS.

    INDICATIONS & IMPORTANT SAFETY INFORMATION for ULTOMIRIS® (ravulizumab-cwvz)

    INDICATIONS

    What is ULTOMIRIS?

    ULTOMIRIS is a prescription medicine used to treat:

    • adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH).
    • adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

    It is not known if ULTOMIRIS is safe and effective in children with PNH.

    It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.

    IMPORTANT SAFETY INFORMATION

    What is the most important information I should know about ULTOMIRIS?

    ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.

    • ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early.
    1. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you are not vaccinated.
    2. If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible.
    3. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
    4. If you had a meningococcal vaccine in the past, you might need additional vaccination. Your doctor will decide if you need additional vaccination.
    5. Meningococcal vaccines reduce but do not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms and eyes sensitive to light.

    Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly.

    ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your doctor must: enroll in the ULTOMIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. Ask your doctor if you are not sure if you need to be revaccinated.

    ULTOMIRIS may also increase the risk of other types of serious infections. Make sure your child receives vaccinations against Streptococcus pneumoniae and Haemophilis influenzae type b (Hib) if treated with ULTOMIRIS. Call your doctor right away if you have any new signs or symptoms of infection.

    Who should not receive ULTOMIRIS?

    Do not receive ULTOMIRIS if you have a meningococcal infection or have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed.

    Before you receive ULTOMIRIS, tell your doctor about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.

    Tell your doctor about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment.

    If you have PNH and you stop receiving ULTOMIRIS, your doctor will need to monitor you closely for at least 16 weeks after you stop ULTOMIRIS. Stopping ULTOMIRIS may cause breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include: drop in your red blood cell count, tiredness, blood in your urine, stomach-area (abdomen) pain, shortness of breath, blood clots, trouble swallowing, and erectile dysfunction (ED) in males.

    If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke.

    What are the possible side effects of ULTOMIRIS?

    ULTOMIRIS can cause serious side effects including infusion-related reactions. Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, pain with the infusion, feeling faint or discomfort in your arms or legs. Tell your doctor or nurse right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion reaction, including: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out.

    The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory infection and headache.

    The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever.

    Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of ULTOMIRIS. For more information, ask your doctor or pharmacist. Call your doctor right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis.

    About Alexion

    Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: www.alexion.com.

    [ALXN-G]

    Forward-Looking Statement

    This press release may include statements that are or may be deemed to be forward-looking statements. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "envisages", "plans", "projects", "anticipates", "targets", "aims", "expects", "intends", "may", "will" or "should" or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions and include, but are not limited to the plans of Alexion with respect to ULTOMIRIS as a potential treatment for severe COVID-19 patients. Economic, competitive, governmental, technological and other factors that may affect Alexion's operations are discussed in the section entitled "Risk Factors," Alexion's Quarterly Report on Form 10-Q for the Period ended 30 September 2020, as amended by any subsequent filings made with the SEC. These forward-looking statements include all matters that are not historical facts and involve predictions. Forward-looking statements may and often do differ materially from actual results. Any forward-looking statements reflect Alexion's current views with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to Alexion's results of operations, financial position, liquidity, prospects, growth or strategies and the industries in which they operate. Forward-looking statements speak only as of the date they are made and cannot be relied upon as a guide to future performance. Save as required by law or regulation, Alexion disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements in this press release that may occur due to any change in its expectations or to reflect events or circumstances after the date of this press release.

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