On October 31, 2019 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, reported that UVADEX (methoxsalen) has received regulatory approval in Australia by the Therapeutic Goods Administration (TGA) for extracorporeal administration with the THERAKOS CELLEX Photopheresis System (Press release, Mallinckrodt, OCT 31, 2019, View Source [SID1234550156]). The treatment is indicated for steroid-refractory and steroid-intolerant chronic graft versus host disease (cGvHD) in adults following allogeneic hematopoietic stem cell (HSC) transplantation. The TGA also approved Uvadex in conjunction with the THERAKOS CELLEX Photopheresis System for the palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.

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The TGA approval marks the first combined indication label and the first regulatory approval in the world for UVADEX in conjunction with the THERAKOS Photopheresis System for the treatment of chronic graft versus host disease in adults.

"The TGA approval of UVADEX with the Therakos ECP platform opens up new treatment options for patients with these challenging conditions," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, Mallinckrodt. "The cGvHD indication is also an important milestone for Mallinckrodt, confirming the potential benefit of this therapeutic option for patients who are refractory to or intolerant of steroid treatments."

About Chronic Graft Versus Host Disease (cGvHD)
Graft-versus-host-disease is a common complication of hematopoietic stem cell (HSC) transplantation resulting in significant morbidity and mortality.1 It can be classified as acute or chronic based on the clinical presentation and the time of occurrence after the transplantation. Signs and symptoms of cGvHD nearly always occur within the first year post transplantation but can occasionally happen several years later.2 In cGvHD, the skin is the most frequently affected organ with manifestations of itchy rash, hyper or hypopigmentation and changes in texture. However, the disease can affect multiple sites, which may have a major impact upon a patient’s quality of life.2,3 Chronic GvHD can lead to debilitating consequences, such as joint contractures, loss of sight, end-stage lung disease, or mortality resulting from profound chronic immune suppression leading to recurrent or life-threatening infections.1

About Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-cell lymphoma (CTCL) is an umbrella term for a group of non-Hodgkin lymphomas involving T lymphocytes that localize in the skin. It is a relatively rare cancer, with 2,500 to 3,000 new cases per year in the United States.4 The age of onset of the condition is typically greater than 50 years, with the incidence rising significantly in the later decades of life.5 CTCL causes visible skin symptoms ranging from a small rash to extensive redness, peeling, burning, soreness, and itchiness all over the body.6,7 CTCL falls into different categories based on the severity of the disease and symptoms.8

Minimum Product Information: UVADEX (methoxsalen) Concentrated Injection for extracorporeal circulation via photopheresis (ECP)

This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

Indications in Australia: UVADEX (methoxsalen) is indicated for extracorporeal administration with the THERAKOS CELLEX Photopheresis System for the:

treatment of steroid‑refractory and steroid‑intolerant chronic graft versus host disease (cGVHD) in adults following allogeneic HSC transplantation.
palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.
Contraindications: History of idiosyncratic or hypersensitivity reaction to methoxsalen, psoralen compounds or any excipients of UVADEX; co‑existing melanoma, basal cell or squamous cell skin carcinoma; lactation; aphakia. ECP procedure contra-indications: Photosensitive disease; inability to tolerate extracorporeal volume loss; WBC count > 25,000 mm3; previous splenectomy; coagulation disorders. Special warnings and precautions: Only physicians who have special competence in the diagnosis and treatment of cGVHD and CTCL who have special training and experience with the THERAKOS CELLEX Photopheresis System should use UVADEX. Men and women being treated with UVADEX should take adequate contraceptive precautions both during and after completion of photopheresis treatment. Exposure to large doses of UVA causes cataracts in animals, an effect enhanced by the administration of oral methoxsalen. The patient’s eyes should be protected from UVA light by wearing wrap‑around, UVA‑opaque sunglasses during the treatment cycle and during the following 24 hours. Exposure to sunlight or ultraviolet radiation (even through window glass) may result in serious burns and, in the long‑term, "premature aging" of the skin therefore patients should avoid exposure to sunlight during the 24 hours following photopheresis treatment. Thromboembolic events, such as pulmonary embolism and deep vein thrombosis, have been reported with UVADEX administration through photopheresis systems for treatment of patients with graft versus host disease. This product contains 4.1% w/v ethanol and each 1 mL of UVADEX contains 40.55 mg of ethanol. Caution is advised in patients with liver disease, alcoholism, epilepsy, brain injury or disease. No specific information is available for use in renal or hepatic impairment and there is no evidence for dose adjustment in the elderly. The safety and efficacy of UVADEX have not been established in children. Use in pregnancy: Category D. Use in Lactation: UVADEX is contra-indicated. Interactions with other medicines: Effects on P450 system metabolism may affect clearance / activation of other drugs (caffeine, paracetamol) or may extend the methoxsalen half-life leading to prolonged photosensitivity in patients. Methoxsalen binding to albumin may be displaced by dicoumarol, warfarin, promethazine and tolbutamide with potential for enhanced photosensitivity. Caution when treating with concomitant photosensitising agents. Adverse effects: In the clinical trials, published information and postmarketing surveillance of UVADEX/ECP, adverse events were usually mild and transient and in most cases, related to the underlying pathology. Very common: diarrhoea, anaemia, nausea, headache, hypertension, sinusitis, upper respiratory tract infection, fatigue, pain in extremity, pyrexia, cough, dyspnoea, cushingoid, dry eye, photophobia, toothache, anorexia. Common: depression, lacrimation increased, abdominal pain, hypokalaemia, paraesthesia oral, pharyngolaryngeal pain, tachycardia, conjunctivitis, eye pain, visual acuity reduced, dysphagia, chills, mucosal inflammation, nasopharyngitis, contusion, blood pressure diastolic decreased, haemoglobin decreased, hyperglycaemia, hypocalcaemia, neuropathy peripheral, tremor, rash, hypotension. Additional adverse effects seen in clinical trials include vomiting, infections. Adverse events related to the ECP/CELLEX procedure – thromboembolism and severe allergic reactions, vascular access complication, vasovagal spasm, hickman catheter infection/thrombosis, headache, hypercoagulability, haemolysis. Additional adverse events identified post-marketing: anaphylactic reaction, allergic reaction, dysgeusia, exacerbation of congestive heart failure, sepsis, endocarditis, and vomiting. Dosage and Administration: Chronic Graft versus Host Disease: Three ECP treatments in the first week then two ECP treatments per week for at least 12 weeks, or as clinically indicated. Cutaneous T-cell Lymphoma: ECP treatment on two successive days each month for six months. Patients who show an increase in skin scores after eight treatment sessions may have their treatment schedule increased to two successive days every two weeks for the next three months. Refer to full Product Information and THERAKOS CELLEX Operator’s Manual for information regarding administration.

Store below 25°C. Date of first approval: 16 September 2019. Date of revision: 11 October 2019.

Indications and Prescribing Information for Uvadex vary globally. Please refer to the individual country product label for complete information.

Before prescribing Uvadex, please refer to the full Product Information also available by calling + 1 800.778.7898.

ABOUT THERAKOS
Mallinckrodt is the world’s only provider of approved, fully-integrated systems for administering immunomodulatory therapy through ECP. Its Therakos ECP platforms, including the latest generation THERAKOS CELLEX Photopheresis System, are used by academic medical centres, hospitals, and treatment centres in nearly 40 countries and have delivered more than 1 million treatments globally. For more information, please visit www.therakos.co.uk.

Terumo BCT is the exclusive distributor of the Therakos ECP platform in Australia, as well as Latin America and select countries in Europe. To learn more about Terumo BCT, visit www.terumobct.com.

UVADEX (methoxsalen) and THERAKOS CELLEX Photopheresis Systems are separately approved in a number of global markets. Please refer to your local approved labelling for Uvadex and the Operator’s Manual for CELLEX for more information on approved uses for specific indications.

On October 31, 2019 Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506), a leading Japanese pharmaceutical company, and Roivant Sciences Ltd., a technology-enabled healthcare company, reported that they have signed a definitive agreement for the creation of a novel and broad Strategic Alliance and to form a new company (the "New Company") owned and supported by Sumitomo Dainippon Pharma (Press release, Sumitomo Dainippon Pharma, OCT 31, 2019, View Source [SID1234550155]).

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As previously announced, this will include the transfer to Sumitomo Dainippon Pharma of Roivant’s ownership interests in five of their biopharmaceutical companies ("Vants") and access to Roivant’s proprietary technology platforms, DrugOme and Digital Innovation. In addition, Sumitomo Dainippon Pharma will take an equity stake of over 10% of shares outstanding in Roivant and will have options (the "Options") to acquire Roivant’s ownership interests in up to 6 additional Vants by 2024. These 11 Vants collectively have more than 25 innovative clinical programs, with multiple potential product launches expected from 2020 to 2022.

The transaction will be subject to customary closing conditions and any required governmental approvals. Roivant will receive USD $3 billion from Sumitomo Dainippon Pharma as a payment to enter the Alliance. Exercise of the Options by Sumitomo Dainippon Pharma will trigger additional payments to Roivant. In addition, Sumitomo Dainippon Pharma will enter separate strategic client relationships with Datavant and Alyvant to augment development and commercialization activities.

In addition to Myovant Sciences, Urovant Sciences, Enzyvant Therapeutics, and Altavant Sciences, the fifth Vant in the Alliance will be Spirovant Sciences, a newly unveiled Vant focused on developing innovative gene therapies for cystic fibrosis.

Sumitomo Dainippon Pharma plans to provide financial support to the five Vants in the New Company and intends to leverage potential benefits associated with Sumitomo Dainippon Pharma’s global commercial infrastructure. The New Company will be led by CEO Myrtle Potter, Vant Operating Chair at Roivant Pharma. Additional management team members will include Adele Gulfo, Chief of Commercial Development at Roivant Pharma, Dr. Sam Azoulay, Chief Medical Officer at Roivant Pharma, and Dan Rothman, Chief Information Officer.

Prior to joining Roivant, Ms. Potter served as President and Chief Operating Officer of Genentech. Under her leadership, Genentech achieved record sales and earnings growth each year. Prior to Genentech she was President of Bristol-Myers Squibb’s U.S. Cardiovascular and Metabolic business. Potter is a graduate of the University of Chicago, and she serves on the university’s board of trustees and also on the board of Liberty Mutual Insurance Group. She has also served on the boards of Amazon, Express Scripts, Medco Health Solutions, and Rite Aid.

"I am happy to announce that we have reached an agreement on the Strategic Alliance with Roivant, one of the strategic investments that we are making to address our challenges laid out in the Mid-Term Business Plan 2022," said Hiroshi Nomura, Representative Director, President and CEO of Sumitomo Dainippon Pharma. "This Strategic Alliance allows us to not only acquire potential blockbusters and innovative health technology platforms developed by Roivant, but it will also enable us to deepen our relationship with Roivant, a company that possesses an innovative business model and underlying culture. We expect this relationship will contribute significantly to the establishment of a position as a ‘Global Specialized Player’ which we aspire to be in by 2033."

"We are proud to enter this unique Alliance with Sumitomo Dainippon Pharma," said Vivek Ramaswamy, Founder and CEO of Roivant Sciences. "We hope that our contributions to this Alliance will enable Sumitomo Dainippon Pharma to realize its vision to be a global leader in the biopharmaceutical industry. In addition, we believe that this Alliance will increase the long-term value of each Vant in the Alliance through a combination of strong financial backing and other capabilities."

On October 31, 2019 Amgen, one of the world’s leading biotechnology companies, reported that launches its first biosimilar for cancer treatment in the Brazilian market (Press release, Amgen, OCT 31, 2019, View Source [SID1234550154]). KANJINTI 1,2 (trastuzumab) has been approved by ANVISA (National Health Surveillance Agency) after passing tests that have proven its biosimilarity to Herceptin 3 .

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Targeted therapy is indicated for patients with the HE2-positive mutation who are undergoing treatment for early, metastatic breast cancer and advanced gastric cancer. "The arrival of KANJINTI in the Brazilian market is a milestone for Amgen, which aims to make affordable high cost biological therapies for patients with serious diseases, complementing our portfolio of cancer therapies and expanding treatment options in the country," says the director. Amgen’s doctor in Brazil, Tatiana Castello Branco .

KANJINTI is the only biosimilar in the Brazilian market that has undergone a phase III clinical study in which the transition from the reference drug to the biosimilar with the maintenance of clinical results. The data show that the new drug has no relevant clinical differences from the reference drug, demonstrating its safety and corresponding immunogenicity in patients already using the originator molecule.

Biosimilars and Metastatic Breast Cancer

Breast cancer is the most common cancer among Brazilian women: 59,700 new breast cancer cases are estimated for each year in 2018-2019, with an estimated risk of 56.33 cases per 100,000 women 4 . The TCU (Federal Audit Court) operational audit identified that the diagnosis of cancer in Brazil is made late. The arrival of biosimilars represents a real opportunity for Brazilian patients to access these technologies, especially in these advanced cases.

"Targeted therapy acts on tumor mutation and increases the chances of a positive response to treatment, offering real benefit to patients and broadening therapeutic options, although there are barriers related to the high cost of these drugs. The arrival of biosimilars in this scenario represents a great achievement for doctors and patients, as they offer the same efficacy and safety ratios with the best cost-benefit ratio, "says Ricardo Caponero , clinical oncologist at Hospital Alemão Oswaldo Cruz .

On October 31, 2019 Amgen (NASDAQ:AMGN) reported that it has entered into a strategic collaboration with BeiGene that will significantly accelerate Amgen’s plans to expand its oncology presence in China, the world’s second-largest pharmaceutical market (Press release, Amgen, OCT 31, 2019, View Source [SID1234550153]). BeiGene is a research-based, oncology-focused biotechnology company with an established and highly experienced team in China, including a 700-person commercial organization and a 600-person clinical development organization.

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"This strategic collaboration with BeiGene will enable Amgen to serve significantly more patients by expanding our presence in the world’s most populous country," said Robert A. Bradway, Amgen’s chairman and chief executive officer. "Cancer is a leading cause of death in China and will only become a more pressing public health issue as the Chinese population ages. With its extensive commercial and clinical capabilities within China and a commitment to global quality standards, BeiGene is the ideal strategic collaborator as we seek to make a meaningful difference in the lives of millions of cancer patients in China and around the world."

As part of the collaboration:

Amgen will acquire a 20.5% stake in BeiGene for approximately $2.7 billion in cash. This represents a purchase price of $174.85 per BeiGene American Depositary Share on NASDAQ, a 36% premium to BeiGene’s 30-day volume-weighted average share price as of Oct. 30, 2019. Amgen will nominate one person to serve on BeiGene’s Board of Directors.
Under the agreement, BeiGene will commercialize XGEVA (denosumab), KYPROLIS (carfilzomib) and BLINCYTO (blinatumomab) in China during which time the parties will equally share profits and losses. Two of these products will revert to Amgen, one after five years and one after seven years. Following the commercialization period, BeiGene will have the right to retain one product and will be entitled to receive royalties on sales in China for an additional five years on the products not retained. XGEVA was launched in China in September of this year; KYPROLIS and BLINCYTO are both in Phase 3 trials in China.
Amgen and BeiGene will collaborate to advance 20 medicines from Amgen’s innovative oncology pipeline in China and globally. BeiGene will share global research and development costs and contribute up to $1.25 billion to advance these medicines. Amgen will pay royalties to BeiGene on the sales of these products outside of China, with the exception of AMG 510, Amgen’s first-in-class KRASG12C inhibitor that is being studied as a potential treatment for solid tumors. Amgen anticipates utilizing data from clinical trials conducted in China to advance the development of its oncology portfolio globally.
Of the 20 oncology medicines in development, BeiGene will assume commercial rights in China for seven years after launch for those that receive approval in China, including AMG 510. After this time, BeiGene will retain rights to up to six of these products in China, excluding AMG 510, while rights on remaining products revert to Amgen. Amgen and BeiGene will share profits in China equally on these products until the rights revert to Amgen, after which Amgen will pay royalties to BeiGene on sales in China for a period of five years after reversion.
Amgen will continue to commercialize its non-oncology product portfolio in China. Earlier this year, Amgen launched its first-ever product in China, Repatha (evolocumab), an LDL cholesterol-lowering treatment proven to reduce the risk of heart attacks and stroke. Amgen expects to launch a number of other non-oncology medicines in China over the next several years, including Prolia (denosumab), which reduces the risk of fracture in postmenopausal women with osteoporosis.
XGEVA, KYPROLIS and BLINCYTO, as well as the medicines in Amgen’s oncology pipeline, will be manufactured at Amgen’s existing facilities.
Since 2011, Amgen has expanded its geographic presence from approximately 50 to 100 countries, enabling the company to play a growing role in serving the rapidly increasing demand for better healthcare around the world. The pharmaceutical market in China is expected to grow briskly as access to new medicines continues to improve. With approximately four million people diagnosed with cancer annually and 2.3 million deaths from the disease each year, the need for new oncology treatments in China is particularly acute and the oncology market is one of the fastest-growing segments of the overall pharmaceutical market there.

Amgen will purchase its equity stake in BeiGene with available cash and expects to retain its investment grade credit rating.

"Amgen’s capital allocation priorities remain unchanged," said David W. Meline, executive vice president and chief financial officer at Amgen. "We will continue to grow our business through internal investment and business development, while providing attractive returns to our shareholders through a growing dividend and continued share repurchases."

The transaction is expected to close in early 2020 subject to BeiGene shareholder approval, the expiration or termination of waiting periods under all applicable antitrust laws, and satisfaction of other customary closing conditions.

Goldman Sachs & Co. LLC is acting as exclusive financial advisor, and Latham & Watkins LLP is serving as legal advisor to Amgen.

Webcast Details
Amgen will host a webcast call today at 2 p.m. PT. where members of Amgen’s executive management team will discuss the Company’s strategic collaboration with BeiGene.  

Live audio webcast of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.  

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.   

For more information about Amgen’s products, including important safety information, please visit www.xgeva.com, www.kyprolis.com, www.blincyto.com, www.repatha.com, and www.prolia.com.

On October 31, 2019 Bruker Corporation (Nasdaq: BRKR) reported financial results for its third quarter and for the nine months ended September 30, 2019 (Press release, Bruker, OCT 31, 2019, View Source [SID1234550152]).

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Third Quarter 2019 Financial Results

Bruker’s revenues for the third quarter of 2019 were $521.1 million, an increase of 11.7% compared to the third quarter of 2018. In the third quarter of 2019, Bruker’s year-over-year organic revenue growth was 7.6%. Growth from acquisitions was 6.4%, while foreign currency translation had a negative effect of 2.3%.

Third quarter 2019 Bruker Scientific Instruments (BSI) segment revenues of $471.8 million increased 13.1% year-over-year, including organic growth of 8.6%. Third quarter 2019 Bruker Energy & Supercon Technologies (BEST) segment revenues of $52.5 million increased 3.1% year-over-year, including an organic revenue decline of 0.8%, net of intercompany eliminations.

Third quarter 2019 GAAP operating income was $87.8 million, compared to $69.1 million in the third quarter of 2018, representing GAAP operating margins of 16.8% and 14.8%, respectively. Non-GAAP operating income was $95.5 million, compared to $83.3 million in the third quarter of 2018. Bruker’s third quarter 2019 non-GAAP operating margin of 18.3% increased 40 basis points from 17.9% in the third quarter of 2018.

Third quarter 2019 GAAP diluted earnings per share (EPS) were $0.39, compared to $0.28 in the third quarter of 2018. Non-GAAP EPS were $0.43, a 16.2% increase compared to $0.37 in the third quarter of 2018.

First Nine Months of 2019 Financial Results

For the first nine months of 2019, Bruker’s revenues were $1,472.7 million, an increase of 9.7% from $1,342.0 million in the first nine months of 2018. In the first nine months of 2019, Bruker’s organic revenue growth was 6.0% year-over-year. Growth from acquisitions was 7.0%, while foreign currency translation had a negative effect of 3.3%.

In the first nine months of 2019, BSI segment revenues of $1,331.0 million increased 10.3% year-over-year, including organic growth of 5.8%. First nine months 2019 BEST segment revenues of $152.2 million increased 9.3% year-over-year, including organic growth of 7.0%, net of intercompany eliminations.

In the first nine months of 2019, GAAP operating income was $183.2 million, compared to $156.0 million in the first nine months of 2018, representing GAAP operating margins of 12.4% and 11.6%, respectively. Non-GAAP operating income was $231.5 million, compared to $195.1 million in the first nine months of 2018. Bruker’s non-GAAP operating margin in the first nine months of 2019 was 15.7%, an increase of 120 basis points, compared to 14.5% in the first nine months of 2018.

In the first nine months of 2019, GAAP EPS were $0.82, compared to $0.65 in the first nine months of 2018. Non-GAAP EPS were $1.04, an increase of 20.9% over $0.86 in the first nine months of 2018.

A reconciliation of non-GAAP to GAAP financial measures is provided in the tables accompanying this press release.

Frank H. Laukien, President and CEO of Bruker, commented: "We are very pleased with our year-to-date progress, with 6% organic and 13% constant currency revenue growth, highlighted by our strong performance in life science mass spectrometry solutions and in microbiology. We are on track to deliver solid margin and EPS improvements in 2019, and we are increasing our non-GAAP EPS outlook for the full year."

Fiscal Year (FY) 2019 Financial Outlook

For FY 2019, Bruker continues to expect year-over-year revenue growth of 7.0% to 8.0%, which now includes the following estimates:

organic revenue growth of 4.5% to 5.5%;
growth from acquisitions of approximately 5.5%;
constant currency revenue growth of 10.0% to 11.0%; and
an increased foreign currency revenue headwind of approximately 3%.
Bruker continues to expect non-GAAP operating margin expansion in FY 2019 of 90 to 120 basis points over its FY 2018 non-GAAP operating margin of 16.8%. This now includes approximately 50 basis points of foreign currency tailwind. Bruker is raising its FY 2019 non-GAAP EPS outlook to a range between $1.59 and $1.62, representing a 13.5% to 15.5% increase compared to FY 2018.

For our outlook for FY 2019 non-GAAP operating margin and non-GAAP EPS, we are not able to provide without unreasonable effort the most directly comparable GAAP financial measures, or reconciliations to such GAAP financial measures on a forward-looking basis. Please see "Use of Non-GAAP Financial Measures" below for a description of items excluded from our expected non-GAAP operating margin and non-GAAP EPS.

Quarterly Earnings Call

Bruker will host a conference call and webcast to discuss its financial results, business outlook, and related corporate and financial matters today, October 31, at 4:30 p.m. Eastern Daylight Time. To listen to the webcast, investors can go to View Source and click on the "Q3 2019 Earnings Webcast" hyperlink. A slide presentation that will be referenced during the webcast will be posted to our Investor Relations website shortly before the webcast begins. Investors can also listen to the earnings webcast via telephone by dialing 1-888-437-2685 (US toll free) or +1-412-317-6702 (international) and referencing "Bruker’s Third Quarter 2019 Earnings Conference Call". A telephone replay of the conference call will be available by dialing 1-877-344-7529 (US toll free) or +1-412-317-0088 (international) and entering conference number: 10136323. The replay will be available beginning one hour after the end of the conference through December 1, 2019.