Phase 3 APPROACH Study Top-line Results
|
|
- Cleopatra McKenzie
- 5 years ago
- Views:
Transcription
1 Phase 3 APPROACH Study Top-line Results March 2017
2 Ionis and Akcea Participants Dr. Stanley Crooke CEO and Chairman Ionis Pharmaceuticals Dr. Louis St. L. O'Dea CMO Akcea Therapeutics Paula Soteropoulos President and CEO Akcea Therapeutics 2
3 Forward Looking Language Statement This presentation includes forward-looking statements regarding the business of Ionis Pharmaceuticals and Akcea Therapeutics, a subsidiary of Ionis, and the therapeutic and commercial potential of volanesorsen and other products in development. Any statement describing the companies' goals, expectations, financial or other projections, intentions or beliefs, including the commercial potential of volanesorsen, SPINRAZA, IONIS-TTR Rx, and other of the companies' drugs in development is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. The companies forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although the companies forward-looking statements reflect the good faith judgment of their management, these statements are based only on facts and factors currently known by the companies. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning the companies programs are described in additional detail in Ionis annual report on Form 10-K for the year ended December 31, 2016, which is on file with the SEC. Copies of this and other documents are available at In this presentation, unless the context requires otherwise, Ionis, Akcea, Company, Companies we, our, and us refers to Ionis Pharmaceuticals and/or Akcea Therapeutics. Ionis Pharmaceuticals is a trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutics is a trademark of Ionis Pharmaceuticals, Inc. SPINRAZA TM is a trademark of Biogen. 3
4 Agenda for Today s Presentation Topics Speakers Welcome and Introductions Dr. Stanley Crooke FCS: The Unmet Medical Need Volanesorsen: Phase 3 APPROACH Top-line Results Volanesorsen: Clinical Program Summary Dr. Louis St. L. O'Dea Commercialization Preparations and Next Steps Paula Soteropoulos Conclusion Dr. Stanley Crooke Q&A Dr. Stanley Crooke 4
5 Familial Chylomicronemia Syndrome (FCS) A severe, rare genetic disease affecting 3,000 5,000 patients Extremely elevated triglyceride levels Life-threatening disease with multiple, severe, daily and chronic manifestations No effective treatment currently available 5
6 Volanesorsen Achieved Primary Endpoint in the APPROACH Study Volanesorsen-treated patients achieved robust triglyceride reductions 77% mean reduction in TGs from baseline vs. 18% mean increase with placebo (p<0.0001) 1712 mg/dl mean absolute reduction in TGs vs. 92 mg/dl increase with placebo 50% of patients achieved TGs below 500 mg/dl TG-lowering effect sustained over the 52-week study period Volanesorsen-treated patients achieved additional therapeutic benefits Decreased incidence of pancreatitis attacks Reduced frequency and intensity of abdominal pain We believe the efficacy and safety data demonstrate a favorable risk:benefit profile for patients with FCS 6
7 Dr. Louis St. L. O'Dea, Chief Medical Officer, Akcea Therapeutics FCS: The Unmet Medical Need Volanesorsen: Phase 3 APPROACH Top-line Results Volanesorsen: Clinical Program Summary 7
8 FCS is a Life-threatening Disease with Multiple Severe Daily and Chronic Manifestations Physical complications Recurrent abdominal pain Recurrent acute pancreatitis Pancreatic failure Insulin-resistance/ diabetes Unnecessary surgery Other physical and metabolic symptoms Hematological manifestations Hyperviscosity Thrombocytosis Thrombocytopenia Neurological symptoms Cognitive impairment Memory loss Mild dementia Confusion Fatigue Affects 3,000 5,000 Patients Globally 8 $ Emotional burden Anxiety Depression Guilt Social isolation Severe dietary restrictions <10-20 g of total fat daily Financial burden Days missed from work ER/ICU visits Lengthy hospitalization Permanent disability
9 FCS Natural History: New Insights From the SMASH Initiative at ECOGENE and the IN-FOCUS Survey IN-FOCUS 1 Investigation of Findings and Observations Captured in Burden of Illness Survey in FCS Patients Documented and quantified experience of patients and burden of disease >140 patients (not in volanesorsen studies) from multiple countries SMASH Initiative 2 Set up to understand the natural history and burden of FCS Systematic review of medical files and hospitalizations of 87 FCS patients Includes medical records that go back for up to 20 years, from 1997 to present Quantifying medical burden of disease and identifying previously unreported manifestations of high triglycerides 1. IN-FOCUS Quantitative Study, Ref: European Atherosclerosis Society Congress June 1, Plenary session 4: Future therapeutic challenges. Specific talk title: Lessons Learned from Emerging Therapies for Severe HTG by Dr. Daniel Gaudet 9
10 IN-FOCUS: Quantifying the Severity and Frequency of the Disease Burden 1 1. IN-FOCUS Quantitative Study: Interim analysis based on 60 US respondents 10
11 IN-FOCUS: Quantifying the Severity and Frequency of the Disease Burden 1 1. IN-FOCUS Quantitative Study: Interim analysis based on 60 US respondents 11
12 SMASH Initiative: Natural History Study Documenting the Clinical Burden of FCS Clinical Manifestation of FCS n = 57 History of acute pancreatitis (%) 83 History of recurrent acute pancreatitis (%) 52 Acute pancreatitis events (# of events/pt) Lipemia retinalis (%) 54 Eruptive xanthomata (%) 27 12
13 SMASH Initiative: FCS is Associated with Substantial Variability in Platelet Counts SMASH Initiative natural history study in FCS patients demonstrates variability in platelet counts that may result in thrombocytosis and thrombocytopenia A large proportion of patients with FCS have experienced low platelet counts Fluctuations in triglycerides can be associated with fluctuations in platelet counts in FCS patients 13
14 SMASH Initiative: Natural History of FCS Demonstrates Significant Platelet Variability Platelet Variability in FCS Patients Platelet count (x 10 3 /µl) Thrombocytosis Thrombocytopenia Patients 14
15 SMASH Initiative: Thrombocytopenia Experienced by 55% of FCS Patients Thrombocytopenia (platelet count) n (%) Thrombocytosis (platelet count) n (%) 100, ,000/µL 31 (35.6) 450, ,000/µL 6 (6.9) 50,000 99,000/µL 15 (17.2) 600, ,000/µL 4 (4.6) < 50,000/µL 2 (2.4) 900,000m 1,000,000/µL 1 (1.1) Total 48 (55.2) Total 11 (12.6) 15
16 SMASH Initiative: Fluctuations in Platelet Counts can be Associated with Triglyceride Fluctuations in FCS Patients Patient 1 Patient 2 Platelet count (x 10 3 /µl) Platelet count (x 10 3 /µl) Triglycerides (mg/dl) Triglycerides (mg/dl) 4 years 20 years 16
17 SMASH Initiative: FCS Natural History Demonstrates Association Between Triglyceride and Platelet Levels Patients with FCS have variable platelet counts from well above normal to as low as 42,000/µL >55% of FCS patients have presented with at least one episode of thrombocytopenia Evidence that, in some patients, substantial variations in triglycerides can be associated with substantial variations in platelet counts 17
18 FCS: A Severe, Rare Genetic Disease Severe, rare genetic disease characterized by extremely elevated levels of triglycerides Life-threatening disease with multiple, severe, daily and chronic manifestations Natural history demonstrates association between triglyceride and platelet counts No effective treatment currently available 18
19 ApoC-III: Genetically Validated Target For Severe Triglyceride-Driven Diseases Volanesorsen targets ApoC-III to lower triglycerides ApoC-III is a key regulator of triglyceride clearance Reducing ApoC-III levels with volanesorsen shown to robustly lower triglyceride levels in multiple clinical studies in patients with a wide range of incoming triglyceride levels 19
20 APPROACH Phase 3 Study in Patients with FCS Global study in 67* patients Randomized, double-blind, placebo-controlled studies Primary efficacy endpoint: Percent change in fasting triglycerides from baseline after 3 months of dosing 1:1 R Primary endpoint: 3 months dosing OLE or 13-week f/u 6 weeks Screening and Diet stabilization 52 weekly SC injections *1 patient uncompliant with visit schedule, never dosed 20
21 Volanesorsen: Baseline Patient Demographics in Phase 3 APPROACH Study Relevant Baseline Demographics Placebo (n = 33) Volanesorsentreated (n = 33) Gender- % M/F 42.4/ /51.5 Age (years) - mean (range) 46 (20-68) 47 (22 75) Triglycerides - mean* History of acute pancreatitis n (%) 26 (78.8%) 24 (72.7%) Platelet count (x 10 3 /µl) mean (range) 228 ( ) 215 ( ) * Upper limit of normal is 150 mg/dl 21
22 Platelet Variability in Placebo-treated Patients Similar to that Observed in SMASH Initiative Platelet Variability in Placebo Cohort Over Study Period (n = 33) Thrombocytosis Platelet count (x 10 3 /µl) Thrombocytopenia Patients 22
23 Volanesorsen Met the Primary Endpoint of the APPROACH Study in Patients With FCS Triglycerides Month 3 Mean % Change from Baseline % Mean Reduction in Triglycerides at 3 Months Placebo (n = 33) +18% Volanesorsen (n = 33) Triglycerides Month 3 Mean Absolute Change from Baseline (mg/dl) 1712 mg/dl Absolute Reduction in Triglycerides at 3 Months % 400 Volanesorsen (n = 33) mg/dl p = p < Robust, statistically significant reductions continued over 12 months 23
24 Majority of Volanesorsen-treated Patients Achieved Triglyceride Levels Below Accepted Risk Thresholds Placebo* n = 31 n (%) Volanesorsen* n = 30 n (%) P value TG <1000 mg/dl 4 (12.9) 24 (80.0) p < TG <750 mg/dl 3 (9.7) 23 (76.7) p = TG <500 mg/dl 0 (0.0) 15 (50.0) p < *Data includes all patients with triglycerides 750 mg/dl at baseline 24
25 Reduced Frequency of Pancreatitis Attacks Statically significant decrease in pancreatitis attacks in patients with documented high frequency of pre-study attacks Positive trend in APPROACH in reduction of pancreatitis attacks (4 events with placebo, 1 event with volanesorsen) Across the Phase 3 program, statistically significant reduction in pancreatitis attacks 25
26 Statistically Significant Decrease in Pancreatitis Attacks In Patients With High Frequency of Pre-study Attacks Placebo n = 33 Volanesorsen n = 33 Patients Events Patients Events Patients with Multiple Adjudicated Events in Past 5 Years Events during Study p-value p =
27 Phase 3 Program: Lower Incidence of Pancreatitis in Treated Patients Compared to Placebo Incidence of Pancreatitis Placebo Volanesorsen APPROACH (n) # of Pancreatitis Events 4 1 COMPASS (n) # of Pancreatitis Events 6 0 COMPASS + APPROACH (n) # of Pancreatitis Events 10 1 (p = 0.007) Data include results from 52-week treatment period and 28 days after treatment (p = 0.01) 27
28 Reduced Frequency and Intensity of Patientreported Abdominal Pain in Patients Reporting Pre-study Pain Average Maximum Pain Intensity Intensity p = 0.03 Placebo (n = 10) Volanesorsen (n = 7) week Study Run-in 52-week Treatment Period Frequency of Pain Frequency 10 of Moderate to Severe Pain Worst Pain Intensity Frequency Frequency Intensity to 3 4 to 12 7 to 12 Study Months 0 0 to 3 4 to 12 7 to 12 Study Months 0 0 to 3 4 to 12 7 to 12 Study Months 28
29 Volanesorsen: Safety and Tolerability Observed in APPROACH Study No treatment-related liver AEs No increase in liver fat No treatment-related renal AEs Most common AEs were injection site reactions (ISRs), mostly mild 5 early terminations due to ISRs Declines in platelet counts observed in many patients Generally well-managed with dose adjustment 5 early terminations due to declines in platelet counts No terminations in the last 6 months of the study after platelet monitoring fully implemented 14 treatment-emergent SAEs 8 with volanesorsen, 2 considered related or possibly related Infrequent serious platelet events (grade 4 thrombocytopenia), which resolved without complication after cessation of dosing 6 with placebo 29
30 Volanesorsen: Two Positive Phase 3 Studies Volanesorsen Phase 3 Clinical Experience Phase 3 in 113 patients with severely elevated TGs Phase 3 in 66 patients with FCS Placebo Volanesorsen Treatment Placebo Volanesorsen Treatment n = 38 n = 75 n = 33 n = 33 FCS OLE Study 30
31 Phase 3 Program: Volanesorsen Demonstrated Consistent, Robust TG-lowering Volanesorsen-treated COMPASS All Patients (n = 75) COMPASS FCS Subset (n = 5) APPROACH (n = 33) Mean % Change in TGs from Baseline -71% -73% -77% (p < ) (p < ) Mean Absolute Change in TGs from Baseline -869 mg/dl mg/dl mg/dl Achieved TGs <500 mg/dl (%) 59 (82%)* 3 (60%) 15 (50.0%)** *n = 72; Data includes all patients with triglycerides 500 mg/dl at baseline **n = 30; Data includes all patients with triglycerides 750 mg/dl at baseline 31
32 Overall Clinical Experience Phase 1 Study Phase 2 Program Phase 3 in 113 patients with severely elevated TGs Phase 3 in 66 patients with FCS Phase 2 studies: Monotherapy, Add-on to Fibrates, High TGs with T2D, FCS Placebo Volanesorsen Treatment n = 29 n = 74 Placebo Volanesorsen Treatment n = 38 n = 75 Placebo FCS OLE Study Volanesorsen Treatment n = 33 n = 33 Overall Clinical Experience Volanesorsen-treated (all) n = 232 Volanesorsen-treated (FCS) n = 66 32
33 Overall Clinical Experience in Patients with FCS: Consistent, Substantial TG-lowering Triglycerides in Patients with FCS Phase 2 (n = 3) COMPASS (n = 5) APPROACH (n = 33) Mean % Change from Baseline -69% -73% -77% (p < ) Mean Absolute Change from Baseline mg/dl mg/dl mg/dl Achieved TGs <500 mg/dl (%) 3 (100%) 3 (60%) 15 (50.0%)* *n = 30; Data includes all patients with triglycerides 750 mg/dl at baseline 33
34 Overall Clinical Experience: Positive Effects in Multiple Disease Manifestations Across Several Studies Decreased triglycerides sustained through treatment period 1,2,3 Decreased incidence of pancreatitis attacks 2,3 Decreased incidence and severity of abdominal pain 3 Improved glucose control, insulin sensitivity 1 1) Phase 2 Program Results; 2) Phase 3 COMPASS Results; 3) Phase 3 APPROACH Results 34
35 Overall Clinical Experience: Volanesorsen Safety and Tolerability 1 No treatment-related liver AEs No treatment-related renal AEs Most common AEs were injection site reactions (ISRs), mostly mild Declines in platelet counts observed in many patients Generally well-managed with monitoring and dose adjustment 5 treatment-related or possibly treatment-related SAEs No deaths Infrequent serious platelet events (grade 4 thrombocytopenia), which resolved without complication after cessation of dosing 1. Results from Phase 1 study, Phase 2 Program, Phase 3 COMPASS study and Phase 3 APPROACH study 35
36 Overall Clinical Experience: Platelet Findings 178 individuals have been treated with 300mg of volanesorsen, including 66 FCS patients, with some treated for over 2 years 3 patients (all with FCS) experienced a serious platelet event (grade 4 thrombocytopenia); all patients recovered with cessation of dosing Measuring platelet counts is routine and can be done by any lab Monitoring platelet counts is part of our clinical program 36
37 Volanesorsen: Potentially the First Drug for Patients with FCS 1 Robust and sustained triglyceride lowering Decreased incidence of pancreatitis attacks Additional positive patient benefits in other endpoints including pain Consistent positive results across multiple clinical studies We believe the efficacy and safety data from volanesorsen studies demonstrate a favorable risk:benefit profile for patients with FCS 1. Results from Phase 1 study, Phase 2 Program, Phase 3 COMPASS study and Phase 3 APPROACH study 37
38 Paula Soteropoulos, President and Chief Executive Officer, Akcea Therapeutics Commercialization Preparations and Next Steps 38
39 Volanesorsen: Next Steps Prepare regulatory dossiers for 2017 regulatory submissions in US, EU and Canada Present full APPROACH results at an upcoming scientific conference Complete initial build out of commercial infrastructure for potential launch in
40 Making Significant Progress on Finding and Supporting Patients Disease education, simplifying diagnosis, and disease support Defining and quantifying burden of disease Finding patients through field, congress interactions and electronic medical record searches Our pre-launch patient database tracker is growing, focused in US, EU, Canada Independent patient-driven advocacy and awareness groups formed and active 40
41 Finding FCS Patients Through Comprehensive and Multiple Channels Speaker programs 1:1 Medical Affairs clinician engagement Scientific roundtables Expert theaters at key conferences FCS FOCUS Fcsfocus.com website The FCS FOUNDATION Patient advocacy partnership Patient identification Initiatives EMR (Electronic Medical Record) searches Digital initiatives Med Info booth at key conferences Society engagement Registry Sales team 41
42 Quantifying FCS Disease Burden: Substantial Economic Impact on Healthcare Systems 1 Clinical Outcomes in Acute Pancreatitis: Normal vs Severe Triglyceride Levels Triglycerides <150 mg/dl Triglycerides 1000 mg/dl Patients (%) 23% 60% 36% 50% 48% 17% 3% 8% Days n=115 n=25 n=74 n=22 n=115 n=25 n=115 n=25 Need for Intensive Care Pancreatic Necrosis Persistent Organ Failure Mortality 0 n=115 n=25 Median Hospital Stay 1. Nawaz H, et al. Am J Gastroenterol. 2015;110(10):
43 Clinical Outcomes in Acute Pancreatitis: Normal vs Severe Triglyceride Levels a Patients (%) Quantifying FCS Disease Burden: Substantial Economic Impact on Healthcare Systems 1 Hypertriglyceridemia-induced pancreatitis results in longer hospital stays, Triglycerides more days <150 mg/dl in intensive Triglycerides 1000 care mg/dl unit, increased risk of organ damage and higher mortality 23% 60% 36% 50% 48% 17% 3% 8% n=115 n=25 n=74 n=22 n=115 n=25 n=115 n=25 Need for Intensive Care Pancreatic Necrosis 1. Nawaz H, et al. Am J Gastroenterol. 2015;110(10): Persistent Organ Failure Mortality Days n=115 n=25 Median Hospital Stay 43
44 Akcea Pioneering the Understanding of FCS from the Patient s Perspective Investigation of Findings and Observations Captured in Burden of Illness Survey in FCS Patients 44
45 Building Commercial Capabilities Targeting Lipid Specialists Medical and sales force build-out initiated Small focused rare disease salesforce & field support: US, EU, Canada US in place by end 2017; EU, Canada in place early 2018 Focused on lipidologists, specialized endocrinologists and pancreatologists Leveraging the same call points/physicians across our pipeline Lipid Treatment Hubs: ~45 US, ~75 EU; physicians Building a specialized and focused global team centered around hightouch patient and physician support Patient-centered hub & case management including disease education, reimbursement, access, nursing and dietary support, platelet monitoring 45
46 Building High-Touch Patient Support Program for Successful Start & Retention The Core: Dedicated Case Management Highly skilled in relationship building and management with healthcare providers and patients Extensive experience working with healthcare providers, patients, insurers, pharmacy benefit manger, and specialty pharmacies Convenient platelet monitoring routinely measured at any lab or at home Reimbursement Support Specialty Pharmacy Injection Training Platelet Monitoring Dietary Support Persistence & Compliance 46
47 Volanesorsen: On Target, On Track Pivotal Phase 3 study in patients with FCS successfully completed Well along in preparations for regulatory filings and commercial launch Data presentations throughout
48 Dr. Stanley T. Crooke, Chief Executive Officer, Ionis Pharmaceuticals Conclusion Q&A 48
49 Volanesorsen: Potentially the First Drug for Patients with FCS FCS represents a severe, rare genetic disease characterized by severely elevated triglycerides Life-threatening disease with multiple severe daily and chronic symptoms No effective therapeutic options Volanesorsen demonstrated consistent results in multiple studies in patients with FCS Sustained, robust triglyceride lowering Decreased incidence of pancreatitis attacks Additional positive patient benefit in other endpoints, including pain We believe the efficacy and safety data demonstrate a favorable risk:benefit profile for patients with FCS 66 FCS patients treated, some for more than 2 years Akcea preparing for 2017 regulatory submissions and 2018 launch 49
50 Ionis: Near-Term Potentially Transformative Medicines with Significant Commercial Value SPINRAZA Actively launching in US Under Accelerated Assessment in EU Submit additional marketing applications globally Successful launch Volanesorsen Phase 3 COMPASS data Phase 3 APPROACH data in Q1:17 Submit marketing applications globally Successful launch IONIS-TTR Rx Phase 3 NEURO-TTR data in Q2:17 Submit marketing applications globally Successful launch 50
51 Revolutionizing Medicine. Saving Lives. 51
FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS)
FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS) Dr. Joseph L. Witztum Distinguished Professor of Medicine, Department of Medicine & Director, Atherosclerosis Research Group, University of California, San Diego
More informationIsis Pharmaceuticals. ISIS-APO(a) Rx and ISIS-APO(a)-L Rx Clinical Data
Isis Pharmaceuticals ISIS-APO(a) Rx and ISIS-APO(a)-L Rx Clinical Data November 8, 2015 Forward Looking Language This presentation includes forward-looking statements regarding Isis business, the business
More informationNASDAQ: ZGNX. Company Presentation. October 2017
NASDAQ: ZGNX Company Presentation October 2017 2 Forward Looking Statement Zogenix cautions you that statements included in this presentation that are not a description of historical facts are forward-looking
More informationLiquid Biopsies. Next Generation Cancer Molecular Diagnostics
Liquid Biopsies Next Generation Cancer Molecular Diagnostics Forward Looking Statements 2 Statements pertaining to future financial and/or operating results, future research, diagnostic tests and technology
More informationConference Call to Discuss FDA Approval of ONPATTRO (patisiran)
Conference Call to Discuss FDA Approval of ONPATTRO (patisiran) August 10, 2018 1 Agenda Welcome Christine Lindenboom Vice President, Investor Relations & Corporate Communications Introduction John Maraganore,
More informationDavid Zaccardelli, PharmD Chief Executive Officer. J.P. Morgan 37 th Annual Healthcare Conference January 8, 2019
David Zaccardelli, PharmD Chief Executive Officer J.P. Morgan 37 th Annual Healthcare Conference January 8, 2019 Disclaimer Certain information contained in this presentation relates to or is based on
More informationRevefenacin (TD-4208) Phase 3 Efficacy Results
Revefenacin (TD-4208) Phase 3 Efficacy Results Once-daily, Nebulized Long-Acting Muscarinic Antagonist (LAMA) October 20, 2016 THERAVANCE, the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE are registered
More informationPROMISE 2 Top-Line Data Results January 8, 2018
PROMISE 2 Top-Line Data Results January 8, 2018 Forward-Looking Statements This presentation and the accompanying commentary contains certain forward-looking statements within the meaning of Section 27A
More informationSoliris in NMOSD Phase 3 PREVENT Study Topline Results September 24, 2018
Soliris in NMOSD Phase 3 PREVENT Study Topline Results September 24, 2018 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation
More informationSavient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference EAST BRUNSWICK, N.J., Oct 27, 2008 /PRNewswire-FirstCall
More informationSlide 1. Welcome and strategy update. Lars Fruergaard Jørgensen President and CEO
Slide 1 Lars Fruergaard Jørgensen President and CEO Slide 2 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the company
More informationPhotocure ASA Executing the Strategy
Photocure ASA Executing the Strategy NOVEMBER 2012 ERIK DAHL, CFO KATHLEEN DEARDORFF, COO Disclaimer The information included in this Presentation contains certain forward-looking statements that address
More informationForward Looking Statements and Further Information
JANUARY 2015 [ 1 ] Forward Looking Statements and Further Information SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements. All statements other than
More informationMANIFEST Phase 2 Enhancement / Expansion
MANIFEST Phase 2 Enhancement / Expansion Investor Conference Call Stellar Science, Breakthrough Medicine October 11, 2018 Forward-Looking Statements This presentation contains forward-looking statements
More informationMedia Contacts: Amy Rose Investor Contact: Graeme Bell (908) (908)
News Release FOR IMMEDIATE RELEASE Media Contacts: Amy Rose Investor Contact: Graeme Bell (908) 423-6537 (908) 423-5185 Tracy Ogden (267) 305-0960 FDA Approves Once-Daily JANUVIA, the First and Only DPP-4
More informationCommitted to Transforming the Treatment Paradigm for Migraine Prevention
Committed to Transforming the Treatment Paradigm for Migraine Prevention 36th Annual J.P. Morgan Healthcare Conference January 8, 2018 Forward-Looking Statements This presentation and the accompanying
More informationPROMISE 1 Top-Line Data Results. June 27, 2017
PROMISE 1 Top-Line Data Results dd June 27, 2017 Forward Looking Statements This presentation and the accompanying commentary contains certain forward-looking statements within the meaning of Section 27A
More informationPatrick J. Sullivan, President & CEO March 7, 2016 Raymond James 37 th Annual Institutional Conference
Patrick J. Sullivan, President & CEO March 7, 2016 Raymond James 37 th Annual Institutional Conference Forward Looking Statement This presentation may contain forward-looking statements concerning Insulet's
More informationPhotocure ASA Executing the Strategy
Photocure ASA Executing the Strategy DECEMBER 6, 2012 KJETIL HESTDAL, CEO Disclaimer The information included in this Presentation contains certain forward-looking statements that address activities, events
More informationANCHOR Study Results Overview
TM ANCHOR Study Results Overview April 18, 2010 Nasdaq: AMRN www.amarincorp.com 1 Forward Looking Statement This presentation contains forward looking statements, including those relating to the Company
More informationAVEO Oncology Announces Strategic Restructuring. AVEO to Host Conference Call Wednesday, June 5 at 8:30 a.m. ET
NEWS RELEASE FOR IMMEDIATE RELEASE AVEO Oncology Announces Strategic Restructuring AVEO to Host Conference Call Wednesday, June 5 at 8:30 a.m. ET CAMBRIDGE, Mass., June 4, 2013 AVEO Oncology (NASDAQ: AVEO)
More informationLilly Diabetes: Pipeline Update
Lilly Diabetes: Pipeline Update June 16, 2014 Safe Harbor Provision This presentation contains forward-looking statements that are based on management's current expectations, but actual results may differ
More informationGIAPREZA (angiotensin II) Update
Corporate Presentation GIAPREZA (angiotensin II) Update NASDAQ: LJPC December 2017 0 Forward Looking Statement These slides contain forward-looking statements as that term is defined in the Private Securities
More informationCommitted to Transforming the Treatment Paradigm for Migraine Prevention
June 14, 2018 Committed to Transforming the Treatment Paradigm for Migraine Prevention September 6, 2018 Forward-Looking Statements This presentation and the accompanying commentary contains certain forward-looking
More informationBuilding a Global Neurotoxin Franchise
JUNE 2, 2014 Building a Global Neurotoxin Franchise DAN BROWNE President & CEO Forward-Looking Statements This presentation contains forward-looking statements, including statements related to the process
More informationAmylin Pharmaceuticals: Creating Value as a Leader in the Treatment of Diabetes
Amylin Pharmaceuticals: Creating Value as a Leader in the Treatment of Diabetes Daniel M. Bradbury President & Chief Executive Officer JPMorgan Healthcare Conference January 12, 2009 Safe Harbor Statement
More informationRimegepant Pivotal Phase 3 Trial Results - Conference Call March 26, Biohaven
Rimegepant Pivotal Phase 3 Trial Results - Conference Call March 26, 2018 1 Forward-Looking Statement This presentation contains forward-looking statements, including: statements about our plans to develop
More informationMainstay Medical Announces Headline Results from ReActiv8-B Clinical Study
Mainstay Medical Announces Headline Results from ReActiv8-B Clinical Study Responder rates at 120 days for treatment and active control groups were 56% vs. 47%; statistically significant difference on
More informationMerck & Co, Inc. Announced Approval of JANUVIA TM (INN: sitagliptin), a new oral treatment of diabetes, by the US FDA
October 23, 2006 Ono Pharmaceutical Co., Ltd., Public Relations Phone: +81-6-6263-5670 Banyu Pharmaceutical Co., Ltd., Public Relations Phone: +81-3-6272-1001 Merck & Co, Inc. Announced Approval of JANUVIA
More informationAVEO and Astellas Announce Positive Findings from TIVO-1 Superiority Study of Tivozanib in First-Line Advanced RCC
FOR IMMEDIATE RELEASE AVEO and Astellas Announce Positive Findings from TIVO-1 Superiority Study of Tivozanib in First-Line Advanced RCC - Tivozanib is the First Agent to Demonstrate Greater than One Year
More informationMichael L. Levitz Chief Financial Officer. November 15, 2017 Investor Presentation
Michael L. Levitz Chief Financial Officer November 15, 2017 Investor Presentation Forward Looking Statement This presentation may contain forward-looking statements concerning Insulet's expectations, anticipations,
More informationSlide 1. Welcome and introduction. Lars Rebien Sørensen President & CEO
Slide 1 Lars Rebien Sørensen President & CEO Slide 2 Capital Markets Day 2015 Slide 3 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities and Exchange Commission
More informationCorporate Presentation August 6, 2015
Corporate Presentation August 6, 2015 Creating the Next Generation of CNS Drugs Forward-Looking Statement This presentation contains forward-looking statements. These statements relate to future events
More informationMay 10, 2016 Q & Business Update
May 10, 2016 Q1 2016 Thank Financial you Results & Business Update Q1 2016 Financial Results Prepared Remarks Q1 Update Tom Hughes, Ph.D., Chief Executive Officer Clinical Update Dennis Kim, M.D., Chief
More informationOral semaglutide and production expansion. Henrik Wulff EVP Product Supply. Peter Kristensen SVP Global Development
YASMIN FIEDLER Germany Yasmin has type 1 diabetes Slide 1 Oral semaglutide and production expansion Henrik Wulff EVP Product Supply Peter Kristensen SVP Global Development Slide 2 Forward-looking statements
More informationInvestor Presentation
Investor Presentation June 2017 Joe Turgeon President and Chief Operating Officer Safe Harbor Statement This presentation contains forward-looking statements regarding future events and the future performance
More informationPath to Value and Profitability
Path to Value and Profitability June 4, 2015 Tim Clackson, Ph.D. President of R&D, Chief Scientific Officer ARIAD Pharmaceuticals, Inc. Elsa So Non-small cell lung cancer ARIAD clinical trial patient Some
More informationMARINE Study Results
TM MARINE Study Results Nasdaq: AMRN www.amarincorp.com 1 Forward-Looking Statement This presentation contains forward-looking statements, including those relating to the Company s product development
More informationAVEO and Astellas Announce TAURUS Patient Preference Clinical Study Comparing Tivozanib with Sunitinib in First-Line Kidney Cancer
FOR IMMEDIATE RELEASE AVEO and Astellas Announce TAURUS Patient Preference Clinical Study Comparing Tivozanib with Sunitinib in First-Line Kidney Cancer Study designed to build upon safety profile demonstrated
More informationNovartis announces Phase III STRIVE data published in NEJM demonstrating significant and sustained efficacy of erenumab in migraine prevention
Novartis International AG Novartis Global Communications CH-4002 Basel Switzerland http://www.novartis.com MEDIA RELEASE COMMUNIQUE AUX MEDIAS MEDIENMITTEILUNG Novartis announces Phase III STRIVE data
More informationSAKURA 3 Open-Label Phase 3 Safety Study with DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines
SAKURA 3 Open-Label Phase 3 Safety Study with DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines Presented by Dan Browne, Co-Founder, President & CEO, and
More informationJ.P. Morgan Healthcare Conference
J.P. Morgan Healthcare Conference Shire plc January 10, 2012 Angus Russell Chief Executive Officer Our purpose We enable people with life-altering conditions to lead better lives. THE SAFE HARBOR STATEMENT
More informationMadrigal s MGL-3196 Achieves Liver Biopsy Endpoints in Patients with Non-alcoholic Steatohepatitis (NASH) at 36 Weeks in Phase 2 Clinical Trial
Madrigal s MGL-3196 Achieves Liver Biopsy Endpoints in Patients with Non-alcoholic Steatohepatitis (NASH) at 36 Weeks in Phase 2 Clinical Trial -- Statistically significantly more patients treated with
More informationUCB announces first presentation of primary data from latest Phase 3 study evaluating brivaracetam
UCB announces first presentation of primary data from latest Phase 3 study evaluating brivaracetam as adjunctive treatment of partial-onset seizures in epilepsy Primary efficacy and safety data from the
More informationConference Call for Investment Community. Nov 19, 2018
Conference Call for Investment Community Nov 19, 2018 Agenda for Today s Call Topic Safe Harbor Statement Opening Remarks AR101 for Peanut Allergy Speaker Laura Hansen, PhD, VP, Investor Relations Jayson
More information37 th Annual J.P. Morgan Healthcare Conference. January 9, 2019
37 th Annual J.P. Morgan Healthcare Conference January 9, 2019 Forward Looking Statement This presentation includes forward-looking statements. All statements, other than statements of historical facts,
More informationSanofi Press Breakfast on Behavioral Science. Friday 22 September 2017
Sanofi Press Breakfast on Behavioral Science Friday 22 September 2017 Agenda WHY UNDERSTANDING BEHAVIORS CAN UNLOCK CARE SUCCESS 8.45-9.00 Welcome coffee 9.00 Kick-off 9.00-9.10 Introduction by Alexandra
More informationASCEND Phase 2 Trial of AXS-05 in MDD Topline Results Conference Call
NASDAQ: AXSM ASCEND Phase 2 Trial of in MDD Topline Results Conference Call January 7, 2019 Overview in MDD ASCEND Phase 2 Trial Topline Results Introduction Mark Jacobson, Senior Vice President, Operations
More information- Amendment accelerates anticipated PROSPER top-line results by two years -
Pfizer Contacts: For Media Dean Mastrojohn (212) 733-6944 dean.mastrojohn@pfizer.com For Investors Ryan Crowe (212) 733-8160 ryan.crowe@pfizer.com Astellas Contact: For Media Tyler Marciniak (847) 736-7145
More informationCreating a Leading Global HBV Therapeutics Company. ARB-1467 Update Call December 12, 2016
Creating a Leading Global HBV Therapeutics Company ARB-1467 Update Call December 12, 2016 NASDAQ: ABUS www.arbutusbio.com Forward Looking Statements This presentation contains forward-looking statements
More informationInarigivir ACHIEVE Trial Results and HBV Clinical Program Update. August 2, 2018
Inarigivir ACHIEVE Trial Results and HBV Clinical Program Update August 2, 2018 FORWARD LOOKING STATEMENT This presentation includes forward-looking statements within the meaning of the Private Securities
More information36th Annual J.P. Morgan Healthcare Conference. Kevin Conroy, Chairman and CEO January 9, 2018
36th Annual J.P. Morgan Healthcare Conference Kevin Conroy, Chairman and CEO January 9, 2018 1 Safe harbor statement This presentation contains forward-looking statements within the meaning of Section
More informationStudy 2 ( ) Pivotal Phase 3 Study Top-Line Results. October 29, 2018
Study 2 (1002-047) Pivotal Phase 3 Study Top-Line Results October 29, 2018 Safe Harbor Forward-Looking Statements These slides and the accompanying oral presentation contain forward-looking statements
More informationCEO Operational Report. Annual General Meeting 23 October 2013
CEO Operational Report Annual General Meeting 23 October 2013 Leading the Field Clinical Trials Axon Sports Cogstate Research COGNIGRAM Playing an integral role in cognition-related clinical trials Cutting
More informationStudy 1 ( ) Pivotal Phase 3 Long-Term Safety Study Top-Line Results
Study 1 (1002-040) Pivotal Phase 3 Long-Term Safety Study Top-Line Results May 2, 2018 1 COPYRIGHT 2018 ESPERION. ALL RIGHTS RESERVED DO NOT COPY OR DISTRIBUTE Safe Harbor Forward-Looking Statements These
More informationPhase 3 Top-Line Results Show IBRANCE in Combination with Fulvestrant Meets Progression-Free Survival (PFS) Primary Endpoint
For immediate release: April 15, 2015 Media Contact: Sally Beatty (212) 733-6566 Investor Contact: Ryan Crowe (212) 733-8160 Pfizer Announces PALOMA-3 Trial for IBRANCE (Palbociclib) Stopped Early Due
More informationAntisense Mediated Lowering of Plasma Apolipoprotein C-III by Volanesorsen Improves Dyslipidemia and Insulin Sensitivity in Type 2 Diabetes
Antisense Mediated Lowering of Plasma Apolipoprotein C-III by Volanesorsen Improves Dyslipidemia and Insulin Sensitivity in Type 2 Diabetes Andres Digenio, MD, PhD; Richard L. Dunbar, MD; Veronica J. Alexander,
More informationCowen Investor Conference March confidently live life with ease
Cowen Investor Conference March 2018 confidently live life with ease Forward-Looking Statements This presentation contains certain forward-looking statements that involve risks and uncertainties that could
More informationREWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES
REWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES May 18, 2017 Molecularly Defined Solid Tumor Program Update FORWARD-LOOKING STATEMENTS Any statements in this press release about future expectations,
More informationAugust 7, Q Financial Results
August 7, 2018 Q2 2018 Financial Results 1 Agenda Today s Speakers Paul Cox, Senior Director, Investor Relations Jeff Jonas, M.D., Chief Executive Officer Steve Kanes, M.D., Ph.D., Chief Medical Officer
More informationTheravance Announces Positive Results from Phase 1 and Phase 2 Clinical Studies with TD-1211 in Development for Opioid-Induced Constipation
Theravance Announces Positive Results from Phase 1 and Phase 2 Clinical Studies with TD-1211 in Development for Opioid-Induced Constipation TD-1211 Achieves Primary and Secondary Endpoints SOUTH SAN FRANCISCO,
More informationCommercial-Stage Bioelectronic Medicine Company 1 st FDA-cleared non-invasive vagus nerve stimulation platform therapy
Commercial-Stage Bioelectronic Medicine Company 1 st FDA-cleared non-invasive vagus nerve stimulation platform therapy 2018 electrocore. All rights reserved. 1 Disclaimer This presentation may contain
More informationVeriStrat Poor Patients Show Encouraging Overall Survival and Progression Free Survival Signal; Confirmatory Phase 2 Study Planned by Year-End
AVEO and Biodesix Announce Exploratory Analysis of VeriStrat-Selected Patients with Non-Small Cell Lung Cancer in Phase 2 Study of Ficlatuzumab Presented at ESMO 2014 Congress VeriStrat Poor Patients Show
More information34 th Annual JP Morgan Healthcare Conference. January 13, 2016
34 th Annual JP Morgan Healthcare Conference January 13, 2016 SAFE HARBOR Forward Looking Statements These slides and the accompanying oral presentation contain forward-looking statements and information.
More informationFirst-in-Class Treatment for Hyperinsulinemic Hypoglycemia. January 31, 2017
358 First-in-Class Treatment for Hyperinsulinemic Hypoglycemia January 31, 2017 Forward-Looking Statement Certain statements contained herein including, but not limited to, expected licensing transactions,
More informationOncology Therapeutics without Compromise APRIL 2011
Oncology Therapeutics without Compromise APRIL 2011 Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties, including among other
More informationNovember 2, Q Financial Results
November 2, 2017 Q3 2017 Financial Results Agenda Today s Speakers Paul Cox, Senior Director, Investor Relations Jeff Jonas, M.D., Chief Executive Officer Steve Kanes, M.D., Ph.D., Chief Medical Officer
More informationBig Data & Predictive Analytics Case Studies: Applying data science to human data Big-Data.AI Summit
Big Data & Predictive Analytics Case Studies: Applying data science to human data 1.03.2018 Big-Data.AI Summit Dr. Arnim Jost, Commercial Director Technology Copyright 2017 IQVIA. All rights reserved.
More informationPierre Legault CEO June 2, 2014
April 2012 Pierre Legault CEO June 2, 2014 Forward Looking Statements This presentation includes statements that are, or may be deemed, forward-looking statements. In some cases, these forward-looking
More informationCase 2:09-cv FSH-PS Document 1-3 Filed 08/24/2009 Page 1 of 5. Exhibit B
Case 2:09-cv-04329-FSH-PS Document 1-3 Filed 08/24/2009 Page 1 of 5 Exhibit B Case 2:09-cv-04329-FSH-PS Document 1-3 Filed 08/24/2009 Page 2 of 5 TO OUR FELLOW SHAREHOLDERS: In 2001 we made significant
More informationBioMarin Pharmaceutical Inc. Conference Call to Discuss Approval of
BioMarin Pharmaceutical Inc. Conference Call to Discuss Approval of For adult patients with PKU who have uncontrolled blood phenylalanine (Phe) concentrations > 600 µmol/l on existing management May 24,
More informationArQule Jefferies Global Healthcare Conference June 2015
ArQule Jefferies Global Healthcare Conference June 2015 1 ArQule Corporate Update Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning
More informationPatrick J. Sullivan Chief Executive Officer. January 9, 2018 Investor Presentation
Patrick J. Sullivan Chief Executive Officer January 9, 2018 Investor Presentation Forward Looking Statement This presentation may contain forward-looking statements concerning Insulet's expectations, anticipations,
More informationAcasti Pharma Provides Business Update for the Third Quarter of Fiscal 2019
Acasti Pharma Provides Business Update for the Third Quarter of Fiscal 2019 Planned Enrollment targets achieved in both TRILOGY studies with over 74% of patients randomized at more than 150 clinical sites
More informationJuly, ArQule, Inc.
July, 2012 Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to clinical
More informationCorporate Presentation Fourth Quarter 2017
Corporate Presentation Fourth Quarter 2017 November 2017 1 Safe harbor statement This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
More informationXP23829 PHASE 2 PSORIASIS TRIAL PRELIMINARY TOPLINE DATA PRESENTATION SEPTEMBER 15, 2015 COPYRIGHT 2015 XENOPORT, INC. ALL RIGHTS RESERVED.
XP23829 PHASE 2 PSORIASIS TRIAL PRELIMINARY TOPLINE DATA PRESENTATION SEPTEMBER 15, 2015 COPYRIGHT 2015 XENOPORT, INC. ALL RIGHTS RESERVED. SAFE HARBOR DISCLAIMER These slides and the accompanying oral
More informationBringing Together Clinical, Economic and Patient Reported Outcomes Data Future Of Real World Evidence. March IIeX Health, Philadelphia, PA
Bringing Together Clinical, Economic and Patient Reported Outcomes Data Future Of Real World Evidence March 27 2018 IIeX Health, Philadelphia, PA Overview Current Landscape Data Sources to generate Real
More informationExpanding the boundaries of nutrition Luis Cantarell
Expanding the boundaries of nutrition Luis Cantarell Nestlé Investor Seminar 30 September 2013 Disclaimer This presentation contains forward looking statements which reflect Management s current views
More informationApproved Care Model for Project 3gi: Integration of Palliative Care into the PCMH Model
1 Approved Care Model for Project 3gi: Integration of Palliative Care into the PCMH Model OneCity Health Webinar January 13, 2016 Overview of presentation 2 Approach to care model development Project overview
More informationAVEO and Astellas Report Final Overall Survival Results from TIVO-1
AVEO and Astellas Report Final Overall Survival Results from TIVO-1 - Median Overall Survival of 28.8 Months Reported for Tivozanib in Patients with Advanced Kidney Cancer - CAMBRIDGE, Mass. and TOKYO,
More informationIdenix Pharmaceuticals Building a Leading Antiviral Franchise. Cowen & Company 27 th Annual Healthcare Conference March 13, 2007 Boston
Idenix Pharmaceuticals Building a Leading Antiviral Franchise Cowen & Company 27 th Annual Healthcare Conference March 13, 2007 Boston Safe Harbor This presentation includes forward-looking statements
More informationMedSurg: Endoscopy Presentation for the Investment Community at DDW. Art Butcher Senior Vice President and President, Endoscopy
MedSurg: Endoscopy Presentation for the Investment Community at DDW Art Butcher Senior Vice President and President, Endoscopy Safe Harbor for Forward-Looking Statements This presentation contains forward-looking
More informationXARACOLL Phase 3 Results Webcast. MATRIX 1 and MATRIX 2 Clinical Trials May 25, 2016
XARACOLL Phase 3 Results Webcast MATRIX 1 and MATRIX 2 Clinical Trials May 25, 2016 Forward Looking Statements This presentation contains forward-looking statements about our ongoing development of XARACOLL
More informationNEUROSCIENCE TRIALS OF THE FUTURE: A WORKSHOP Pragmatic Trials: Challenges and Opportunities for Neuroscience Trials
NEUROSCIENCE TRIALS OF THE FUTURE: A WORKSHOP Pragmatic Trials: Challenges and Opportunities for Neuroscience Trials Mark J. Cziraky, PharmD, CLS Vice President of Research HealthCore Inc. Wilmington,
More informationTargeting and Treating Cancer
Targeting and Treating Cancer Mark R. Baker CEO Jefferies Healthcare Conference June 8, 2017 DISCLOSURE NOTICE This presentation may contain projections and other forward-looking statements regarding future
More informationSOLVAY GROUP London Morning Meeting. June 26, 2009
SOLVAY GROUP London Morning Meeting June 2, 9 1 Our fenofibrate franchise Klaus Kirchgassler, MD Sr VP Solvay Pharmaceuticals 2 Summary of lipid lowering market performance in Value Growth vs. previous
More informationLehman Brothers Eighth Annual Global Healthcare Conference March 30, 2005 Bruce A. Peacock President and Chief Executive Officer
Lehman Brothers Eighth Annual Global Healthcare Conference March 30, 2005 Bruce A. Peacock President and Chief Executive Officer 2005 Adolor Corporation. All rights reserved. Safe Harbor Statement This
More informationTheravance Biopharma, Inc. (NASDAQ: TBPH)
Theravance Biopharma, Inc. (NASDAQ: TBPH) FDA Approval of YUPELRI TM (revefenacin) Inhalation Solution November 9, 2018 THERAVANCE and the Cross/Star logo are registered trademarks of the Theravance Biopharma
More informationIRONWOOD AND FOREST ANNOUNCE POSITIVE LINACLOTIDE RESULTS FROM PHASE 3 TRIAL IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION
FOR IMMEDIATE RELEASE Ironwood Contact: Forest Contact: Susan Brady Frank J. Murdolo Corporate Communications Vice President, Investor Relations 617.621.8304 212.224.6714 sbrady@ironwoodpharma.com frank.murdolo@frx.com
More informationResults of the TITAN study for Caplacizumab
Results of the TITAN study for Webcast presentation 17th June 2014 Nanobodies - Inspired by nature Forward looking statements Certain statements, beliefs and opinions in this presentation are forward-looking,
More informationFebruary 23, Q4 and Year-End 2016 Financial Results
February 23, 2017 Q4 and Year-End 2016 Financial Results 2 RETHINKING CNS Agenda Today s Speakers Paul Cox, Senior Director, Investor Relations Jeff Jonas, M.D., Chief Executive Officer Jim Doherty, Ph.D.,
More informationDeveloping & Commercializing Targeted Small Molecule Drugs in Cancer
Developing & Commercializing Targeted Small Molecule Drugs in Cancer SAFE HARBOR STATEMENT 2 Forward-looking statements made in the course of this presentation are made pursuant to the safe harbor provisions
More informationSupernus Pharmaceuticals
Supernus Pharmaceuticals Jefferies 2016 Healthcare Conference May 2016 1 Safe Harbor Statement This presentation and other matters discussed today or answers that may be given to questions asked include
More informationKeyzilen TM Program Update
Keyzilen TM Program Update October 11, 2016 Forward-looking Statements This presentation and the accompanying oral commentary contain forward-looking statements that involve substantial risks and uncertainties.
More informationESTABLISH 2 Top Line Data Release
The Future of Anti-Infectives ESTABLISH 2 Top Line Data Release March 25, 2013 1 Forward Looking Statements Statements contained in this data release regarding matters that are not historical facts are
More informationTranslating Science. Transforming Lives. ACT DMD Clinical Trial Results
Translating Science. Transforming Lives ACT DMD Clinical Trial Results FORWARD LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of The Private Securities Litigation
More informationACTELION S NEW DUAL OREXIN RECEPTOR ANTAGONIST
ACTELION S NEW DUAL OREXIN RECEPTOR ANTAGONIST Investor Webcast July 2016 Copyright The following information contains certain forward-looking statements, relating to the company s business, which can
More informationSlide 1. Financial update and closing remarks. Jesper Brandgaard EVP and CFO. RAFAEL DE JESÚS FLORES, Mexico Rafael has haemophilia A
Slide 1 Financial update and closing remarks Jesper Brandgaard EVP and CFO RAFAEL DE JESÚS FLORES, Mexico Rafael has haemophilia A Slide 2 Forward-looking statements Novo Nordisk s reports filed with or
More information