Category Archives: Gene Therapy Clinics

Muscular Dystrophy Association Announces Formation of Strategic Medical Advisory Team of Experts in Neuromuscular Care and Research – BioSpace

NEW YORK, April 2, 2020 /PRNewswire/ --TheMuscular Dystrophy Association(MDA) announced today the formation of its formal Medical Advisory Team who provide MDA with strategic guidance on issues that impact research and clinical care for people living with muscular dystrophy, amyotrophic lateral sclerosis (ALS) and related neuromuscular disorders more than 43 diseases. Each of the team members is a leading clinician at an MDA Care Center and is an internationally known expert in muscular dystrophy, ALS and related neuromuscular diseases. The MDA Care Center network spans over 150 locations at the nation's top medical institutions.

"We believe that engaging this team of world-class experts across neuromuscular diseases will enable MDA to lead the way in speeding the development of groundbreaking therapies and treatment paradigms that will transform the lives of those we serve," says Lynn O'Connor Vos, President and CEO of MDA. "These physicians are pillars of the neuromuscular disease community, each with focused expertise in specific diseases. Together, they will provide critical advice to MDA on our innovations in science and care programs and help ensure that we are making the maximum impact as the landscape of neuromuscular research, care and treatments evolve."

MDA's medical advisors will help lead the effort, along with more than 2,000 health care providers, to establish new clinical trials geared toward integration of MDA's innovative MOVR technology hub, which allows clinicians and researchers to share a wealth of disease-related information, establish professional protocols, and accelerate innovation.

Tonight, Dr. Barry Byrne, who will serve as chief medical advisor for the team, is joining MDA's EVP, Chief Advocacy & Care Services Officer, Kristin Stephenson for an MDA Facebook Live conversation about the precautions and best practices needed to protect the neuromuscular community in light of COVID-19. The event, scheduled for Thursday, April 2 from 6:00 to 6:30 pm EDT is accessible at https://www.facebook.com/MDAOrg/. The recording will be available for viewing after the event on MDA's COVID-19 resource page. The conversation will feature a live Q&A answering questions from people living with muscular dystrophy, ALS and related neuromuscular diseases including MDA families, and aims to provide the answers to questions regarding care duringthese uncertain times, and will cover topics related to preparedness, community impact, telemedicine and MDA's Care Center network of over 150 multidisciplinary care teams at top medical institutions nationwide.

Barry J. Byrne, MD, PhD, is an ardent supporter of newborn screening and has been an innovator and early adopter of new FDA-approved therapies that have the potential to alter the course of some neuromuscular disorders. He was the first physician to administer an approved gene therapy to a neuromuscular patient in the U.S.

"We are just beginning to realize the impact of the current revolution in the treatment of neuromuscular disorders. Newborn screening and access to newly-approved therapies are changing patients' lives when diagnosed with neuromuscular diseases; the MDA Care Center network is ready to provide these innovative treatments," says Dr. Byrne. "Disease-modifying therapies are no longer a thing of the future. There is an urgent need to bring innovative care, cutting-edge clinical research and new breakthrough treatments to the community."

Dr. Byrne will continue in his role as the associate chair of pediatrics and director of the Powell Gene Therapy Center at the University of Florida College of Medicine as he assumes this new position. He is also director of the MDA Care Center at the University of Florida.

Matthew B Harms, MD, will serve as a medical expert on ALS and other neuromuscular disorders. He is active in clinical research. Dr. Harms is associate professor of neurology at Columbia University's Vagelos College of Physicians and Surgeonsand serves at MDA's ALS Care Center at Columbia University. Dr. Harms received MDA's Diamond Award for his work directing an international effort with whole genome and transcriptome sequencing to bring precision medicine to ALS treatments.

John W. Day, MD, PhD, completes the Medical Advisory Team. Dr. Day is professor of neurology and pediatrics and director, Division of Neuromuscular Medicine at Stanford University. He directs Stanford's MDA Care Centers, which uniquely integrate the Lucile Packard Children's Hospital Pediatric and Transitional Neuromuscular Clinic with the Stanford Hospital Neuroscience Health Center's Neuromuscular and ALS Research and Clinic.The comprehensive team of investigators and clinicians in the Stanford Neuromuscular Program have helped develop novel gene modification and gene replacement treatments for spinal muscular atrophy, muscular dystrophy and ALS, and have spearheaded development of centralized data hubs like MDA's MOVR for neuromuscular disease.

About Barry J. Byrne, MD, PhD

Dr. Byrne is a clinician scientist who is studying a variety of rare diseases with the specific goal of developing therapies for inherited muscle disease. As a pediatric cardiologist, his focus is on conditions that lead to skeletal muscle weakness and abnormalities in heart and respiratory function. His group has made significant contributions to the understanding and treatment of Pompe disease, a type of neuromuscular disorder caused by an excess of a type of sugar (glycogen) in certain muscles. The research team has pioneered the use of adeno-associated virus (AAV) mediated gene therapy to restore heart and skeletal muscle function in Duchenne muscular dystrophy, Pompe, Friedrich's ataxia and other neuromuscular diseases. His group at the Powell Center has also established a series of new methods for large-scale AAV manufacturing to enable access for a wide variety of conditions.

About Matthew B. Harms, MD

Dr. Harms' post-doctoral and faculty work in neurogenetics led to the discovery of genes for dominant spinal muscular atrophy and limb-girdle muscular dystrophy type 1D. He sees patients in the Eleanor and Lou Gehrig ALS Center, the Adult Muscular Dystrophy Association Clinic, the Pediatric Muscular Dystrophy Association Clinic, and until recently, the ALS Clinic of the Bronx VA Hospital. His laboratory straddles Columbia's Motor Neuron Center and the Institute for Genomic Medicine, with a focus on generating, integrating, and analyzing clinical, genomic and transcriptomic datasets for amyotrophic lateral sclerosis and other neurological disorders.

About John W. Day, MD, PhD

Dr. Day has combined his expertise in synaptic physiology, genetics and neuromuscular medicine to help define the molecular mechanisms underlying myotonic dystrophy and other muscular dystrophies, neuropathies and ataxias. Under his leadership, the Stanford Neuromuscular Program is dedicated to the elucidation and treatment of neuromuscular diseases, integrating clinical care and clinical research with Stanford's basic science and translational programs. All Stanford pediatric and adult neuromuscular patients are asked to participate in research and are followed over time with functional evaluations. The Stanford Neuromuscular Program mission aligns fully with the goals of the MDA: to diagnose, investigate and characterize neuromuscular disorders precisely and completely; to develop novel treatments for neuromuscular disease; to incorporate novel treatments into the comprehensive care of patients with neuromuscular disorders; to advocate and support patients and families affected by neuromuscular disease so they can live life as fully and independently as possible; and to train the next generation of experts in neuromuscular diagnosis, care and research.

About MDA

MDA is committed to transforming the lives of people affected by muscular dystrophy, ALS, and related neuromuscular diseases. We do this through innovations in science and innovations in care. As the largest source of funding for neuromuscular disease research outside of the federal government, MDA has committed more than$1 billionsince our inception to accelerate the discovery of therapies and cures. Research we have supported is directly linked to life-changing therapies across multiple neuromuscular diseases. MDA's MOVR is the first and only data hub that aggregates clinical, genetic, and patient-reported data for multiple neuromuscular diseases to improve health outcomes and accelerate drug development. MDA supports the largest network of multidisciplinary clinics providing best in class care at more than 150 of the nation's top medical institutions. Our Resource Center serves the community with one-on-one specialized support, and we offer educational conferences, events, and materials for families and healthcare providers. Each year thousands of children and young adults learn vital life skills and gain independence at summer camp and through recreational programs, at no cost to families. For more information visitmda.org.

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Muscular Dystrophy Association Announces Formation of Strategic Medical Advisory Team of Experts in Neuromuscular Care and Research - BioSpace

Retinal Dystrophy Treatment Market Overview,Outlook,Recent Trend by 2026|Novartis AG, GlaxoSmithKline, Applied Genetic Technologies Corporation -…

Complete study of the global Retinal Dystrophy Treatment market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Retinal Dystrophy Treatment industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Retinal Dystrophy Treatment production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

Key companies operating in the global Retinal Dystrophy Treatment market include _, Spark Therapeutics (Roche), Novartis AG, GlaxoSmithKline, Applied Genetic Technologies Corporation, Oxford BioMedica, Biogen, HORAMA S.A., MeiraGTx Limited, Novelion Therapeutics, IVERIC bio, Reflection Biotechnologies

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

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Segmental Analysis

The report has classified the global Retinal Dystrophy Treatment industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Retinal Dystrophy Treatment manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Retinal Dystrophy Treatment industry.

Global Retinal Dystrophy Treatment Market Segment By Type:

Gene Therapy Treatment, Symptomatic Treatment

Global Retinal Dystrophy Treatment Market Segment By Application:

Hospitals, Specialty Clinics, Others

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Retinal Dystrophy Treatment industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Retinal Dystrophy Treatment market include _, Spark Therapeutics (Roche), Novartis AG, GlaxoSmithKline, Applied Genetic Technologies Corporation, Oxford BioMedica, Biogen, HORAMA S.A., MeiraGTx Limited, Novelion Therapeutics, IVERIC bio, Reflection Biotechnologies

Key questions answered in the report:

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TOC

1 Market Overview of Retinal Dystrophy Treatment1.1 Retinal Dystrophy Treatment Market Overview1.1.1 Retinal Dystrophy Treatment Product Scope1.1.2 Market Status and Outlook1.2 Global Retinal Dystrophy Treatment Market Size Overview by Region 2015 VS 2020 VS 20261.3 Global Retinal Dystrophy Treatment Market Size by Region (2015-2026)1.4 Global Retinal Dystrophy Treatment Historic Market Size by Region (2015-2020)1.5 Global Retinal Dystrophy Treatment Market Size Forecast by Region (2021-2026)1.6 Key Regions Retinal Dystrophy Treatment Market Size YoY Growth (2015-2026)1.6.1 North America Retinal Dystrophy Treatment Market Size YoY Growth (2015-2026)1.6.2 Europe Retinal Dystrophy Treatment Market Size YoY Growth (2015-2026)1.6.3 China Retinal Dystrophy Treatment Market Size YoY Growth (2015-2026)1.6.4 Rest of Asia Pacific Retinal Dystrophy Treatment Market Size YoY Growth (2015-2026)1.6.5 Latin America Retinal Dystrophy Treatment Market Size YoY Growth (2015-2026)1.6.6 Middle East & Africa Retinal Dystrophy Treatment Market Size YoY Growth (2015-2026)1.7 Coronavirus Disease 2019 (Covid-19): Retinal Dystrophy Treatment Industry Impact1.7.1 How the Covid-19 is Affecting the Retinal Dystrophy Treatment Industry1.7.1.1 Retinal Dystrophy Treatment Business Impact Assessment Covid-191.7.1.2 Supply Chain Challenges1.7.1.3 COVID-19s Impact On Crude Oil and Refined Products1.7.2 Market Trends and Retinal Dystrophy Treatment Potential Opportunities in the COVID-19 Landscape1.7.3 Measures / Proposal against Covid-191.7.3.1 Government Measures to Combat Covid-19 Impact1.7.3.2 Proposal for Retinal Dystrophy Treatment Players to Combat Covid-19 Impact 2 Retinal Dystrophy Treatment Market Overview by Type2.1 Global Retinal Dystrophy Treatment Market Size by Type: 2015 VS 2020 VS 20262.2 Global Retinal Dystrophy Treatment Historic Market Size by Type (2015-2020)2.3 Global Retinal Dystrophy Treatment Forecasted Market Size by Type (2021-2026)2.4 Gene Therapy Treatment2.5 Symptomatic Treatment 3 Retinal Dystrophy Treatment Market Overview by Type3.1 Global Retinal Dystrophy Treatment Market Size by Application: 2015 VS 2020 VS 20263.2 Global Retinal Dystrophy Treatment Historic Market Size by Application (2015-2020)3.3 Global Retinal Dystrophy Treatment Forecasted Market Size by Application (2021-2026)3.4 Hospitals3.5 Specialty Clinics3.6 Others 4 Global Retinal Dystrophy Treatment Competition Analysis by Players4.1 Global Retinal Dystrophy Treatment Market Size (Million US$) by Players (2015-2020)4.2 Global Top Manufacturers by Company Type (Tier 1, Tier 2 and Tier 3) (based on the Revenue in Retinal Dystrophy Treatment as of 2019)4.3 Date of Key Manufacturers Enter into Retinal Dystrophy Treatment Market4.4 Global Top Players Retinal Dystrophy Treatment Headquarters and Area Served4.5 Key Players Retinal Dystrophy Treatment Product Solution and Service4.6 Competitive Status4.6.1 Retinal Dystrophy Treatment Market Concentration Rate4.6.2 Mergers & Acquisitions, Expansion Plans 5 Company (Top Players) Profiles and Key Data5.1 Spark Therapeutics (Roche)5.1.1 Spark Therapeutics (Roche) Profile5.1.2 Spark Therapeutics (Roche) Main Business and Companys Total Revenue5.1.3 Spark Therapeutics (Roche) Products, Services and Solutions5.1.4 Spark Therapeutics (Roche) Revenue (US$ Million) (2015-2020)5.1.5 Spark Therapeutics (Roche) Recent Developments5.2 Novartis AG5.2.1 Novartis AG Profile5.2.2 Novartis AG Main Business and Companys Total Revenue5.2.3 Novartis AG Products, Services and Solutions5.2.4 Novartis AG Revenue (US$ Million) (2015-2020)5.2.5 Novartis AG Recent Developments5.3 GlaxoSmithKline5.5.1 GlaxoSmithKline Profile5.3.2 GlaxoSmithKline Main Business and Companys Total Revenue5.3.3 GlaxoSmithKline Products, Services and Solutions5.3.4 GlaxoSmithKline Revenue (US$ Million) (2015-2020)5.3.5 Applied Genetic Technologies Corporation Recent Developments5.4 Applied Genetic Technologies Corporation5.4.1 Applied Genetic Technologies Corporation Profile5.4.2 Applied Genetic Technologies Corporation Main Business and Companys Total Revenue5.4.3 Applied Genetic Technologies Corporation Products, Services and Solutions5.4.4 Applied Genetic Technologies Corporation Revenue (US$ Million) (2015-2020)5.4.5 Applied Genetic Technologies Corporation Recent Developments5.5 Oxford BioMedica5.5.1 Oxford BioMedica Profile5.5.2 Oxford BioMedica Main Business and Companys Total Revenue5.5.3 Oxford BioMedica Products, Services and Solutions5.5.4 Oxford BioMedica Revenue (US$ Million) (2015-2020)5.5.5 Oxford BioMedica Recent Developments5.6 Biogen5.6.1 Biogen Profile5.6.2 Biogen Main Business and Companys Total Revenue5.6.3 Biogen Products, Services and Solutions5.6.4 Biogen Revenue (US$ Million) (2015-2020)5.6.5 Biogen Recent Developments5.7 HORAMA S.A.5.7.1 HORAMA S.A. Profile5.7.2 HORAMA S.A. Main Business and Companys Total Revenue5.7.3 HORAMA S.A. Products, Services and Solutions5.7.4 HORAMA S.A. Revenue (US$ Million) (2015-2020)5.7.5 HORAMA S.A. Recent Developments5.8 MeiraGTx Limited5.8.1 MeiraGTx Limited Profile5.8.2 MeiraGTx Limited Main Business and Companys Total Revenue5.8.3 MeiraGTx Limited Products, Services and Solutions5.8.4 MeiraGTx Limited Revenue (US$ Million) (2015-2020)5.8.5 MeiraGTx Limited Recent Developments5.9 Novelion Therapeutics5.9.1 Novelion Therapeutics Profile5.9.2 Novelion Therapeutics Main Business and Companys Total Revenue5.9.3 Novelion Therapeutics Products, Services and Solutions5.9.4 Novelion Therapeutics Revenue (US$ Million) (2015-2020)5.9.5 Novelion Therapeutics Recent Developments5.10 IVERIC bio5.10.1 IVERIC bio Profile5.10.2 IVERIC bio Main Business and Companys Total Revenue5.10.3 IVERIC bio Products, Services and Solutions5.10.4 IVERIC bio Revenue (US$ Million) (2015-2020)5.10.5 IVERIC bio Recent Developments5.11 Reflection Biotechnologies5.11.1 Reflection Biotechnologies Profile5.11.2 Reflection Biotechnologies Main Business and Companys Total Revenue5.11.3 Reflection Biotechnologies Products, Services and Solutions5.11.4 Reflection Biotechnologies Revenue (US$ Million) (2015-2020)5.11.5 Reflection Biotechnologies Recent Developments 6 North America Retinal Dystrophy Treatment by Players and by Application6.1 North America Retinal Dystrophy Treatment Market Size and Market Share by Players (2015-2020)6.2 North America Retinal Dystrophy Treatment Market Size by Application (2015-2020) 7 Europe Retinal Dystrophy Treatment by Players and by Application7.1 Europe Retinal Dystrophy Treatment Market Size and Market Share by Players (2015-2020)7.2 Europe Retinal Dystrophy Treatment Market Size by Application (2015-2020) 8 China Retinal Dystrophy Treatment by Players and by Application8.1 China Retinal Dystrophy Treatment Market Size and Market Share by Players (2015-2020)8.2 China Retinal Dystrophy Treatment Market Size by Application (2015-2020) 9 Rest of Asia Pacific Retinal Dystrophy Treatment by Players and by Application9.1 Rest of Asia Pacific Retinal Dystrophy Treatment Market Size and Market Share by Players (2015-2020)9.2 Rest of Asia Pacific Retinal Dystrophy Treatment Market Size by Application (2015-2020) 10 Latin America Retinal Dystrophy Treatment by Players and by Application10.1 Latin America Retinal Dystrophy Treatment Market Size and Market Share by Players (2015-2020)10.2 Latin America Retinal Dystrophy Treatment Market Size by Application (2015-2020) 11 Middle East & Africa Retinal Dystrophy Treatment by Players and by Application11.1 Middle East & Africa Retinal Dystrophy Treatment Market Size and Market Share by Players (2015-2020)11.2 Middle East & Africa Retinal Dystrophy Treatment Market Size by Application (2015-2020) 12 Retinal Dystrophy Treatment Market Dynamics12.1 Industry Trends12.2 Market Drivers12.3 Market Challenges12.4 Porters Five Forces Analysis 13 Research Finding /Conclusion 14 Methodology and Data Source14.1 Methodology/Research Approach14.1.1 Research Programs/Design14.1.2 Market Size Estimation14.1.3 Market Breakdown and Data Triangulation14.2 Data Source14.2.1 Secondary Sources14.2.2 Primary Sources14.3 Disclaimer14.4 Author List

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Retinal Dystrophy Treatment Market Overview,Outlook,Recent Trend by 2026|Novartis AG, GlaxoSmithKline, Applied Genetic Technologies Corporation -...

iCAD Launches New Initiatives Leveraging Unique Capabilities of its Robust Product Portfolio to Reduce Health Care System Pressures During the…

ProFound AI can assist radiologists in prioritizing patients for breast cancer screening and address the growing mammography backlog

Xoft breast IORT offers single-fraction therapy alternative to weeks of daily radiation, reducing resources needed and minimizing patients risk of COVID-19 exposure

NASHUA, N.H., March 23, 2020 (GLOBE NEWSWIRE) -- iCAD, Inc. (ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced the launch of new initiatives to address emerging challenges hospitals are facing due to the pandemic of the coronavirus disease, or COVID-19. The Company and its portfolio of technologies supporting cancer detection and therapy continue to offer a strong value proposition and multiple benefits to clinicians and patients, which may be particularly relevant in light of the coronavirus outbreak:

ProFound AI, the first artificial intelligence (AI) software for digital breast tomosynthesis (DBT) to be FDA-cleared, provides crucial data, such as Case Scores, which can help radiologists prioritize which patients should not delay screening and presents a solution to the growing mammography backlog that will need to be cleared once COVID-19 passes. It is also clinically proven to decrease the rate of false positives and unnecessary recalls,1 which reduces resources needed and minimizes patient risk of COVID-19 exposure.

The Xoft Axxent Electronic Brachytherapy (eBx) System offers a single-fraction therapy option that allows patients who are candidates to replace weeks of daily radiation with one treatment, delivered at the time of surgery. This could also significantly reduce the healthcare system resources needed and reduce patients risk of COVID-19 exposure.

iCAD is mobilized to support critical facility and physician needs related to both its Detection and Therapy businesses.

A ProFound Impact on ScreeningIn recent weeks the number of people diagnosed with COVID-19 has rapidly increased, placing a growing burden upon hospitals and clinicians worldwide, and this issue may continue to proliferate in the near-term. According to recent guidance from the American College of Radiology and the American Cancer Society, some women should consider rescheduling routine mammograms to allow hospitals to address critical COVID-19 cases. Due to this emerging issue, some patients with more urgent and higher risk factors may be deferred, which could have negative consequences in the long run, according to Michael Klein, Chairman and CEO of iCAD.

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Studies from published academic research show that on average, a mammography provider can expect to detect up to 6 cancers per 1,000 screening mammograms,2 which indicates that even in the face of this pandemic, cancer is not going away, according to Stacey Stevens, President of iCAD. Now more than ever, it is increasingly critical to empower radiologists with the technology to quickly and effectively prioritize mammography screening.

Where breast cancer screening is concerned, our initiative involving ProFound AI could be exceptionally helpful for radiologists, as the technology can be used on patients prior year mammograms to prioritize which women may be at higher risk of developing breast cancer, and thereby should work with their healthcare provider to determine the availability of expedient follow up screening. Further, when the threat of COVID-19 passes, physicians and the healthcare system as a whole will be faced with an enormous backlog of mammograms. ProFound AI is uniquely positioned to address these emerging challenges, added Klein.

In the face of COVID-19, improving accuracy and efficiency for breast cancer screening is now more essential than ever. Using this leading-edge technology, radiologists have the ability to review prior year mammograms and prioritize which patients should not delay breast cancer screening based on the technologys unique Case Score, which represents a relative level of suspicion for the case containing potentially cancerous findings that may require further workup, according to Mark Traill, MD, radiologist at University of Michigan Health, Metro Health. It is clinically proven to help radiologists significantly increase their productivity. ProFound AI can also reduce the rate of false positives,1 which are not only stressful for patients, but also place a significant additional burden on providers. Clinicians using ProFound AI will be very happy they have such a sophisticated tool helping them better position their screening programs recovery from this unprecedented global disruption.

Trained with one of the largest available DBT datasets, ProFound AI rapidly and accurately analyzes each DBT image, or slice, and provides radiologists with key information, such as Certainty of Finding lesion and Case Scores, which assists radiologists in clinical decision-making and improving reading efficiency. Featuring the latest in deep-learning artificial intelligence, the algorithm also allows for continuously improved performance via ongoing updates.

Single-Fraction Therapy Shaves Treatment Time to One DayThe burden COVID-19 is placing on hospitals is resulting in some healthcare facilities needing to reschedule surgeries and other procedures, including cancer treatments, noted Klein. As COVID-19 is forcing hospital systems to begin to reframe protocols relating to the treatment of cancer, our initiative for the Xoft System may help to address this emerging burden placed on the system and patient concerns related to potential COVID-19 exposure, as it offers significant time savings benefits to clinicians and patients.

The Xoft System offers the ability to deliver an entire course of treatment to an early-stage breast cancer patient in just one day, at the time of lumpectomy, which not only frees up space in hospitals and allows clinicians to focus on more critical needs, it reduces immunocompromised patients time in hospitals and therefore minimizes their potential exposure to the virus, Stevens added.

Clinical guidelines from several national medical societies support an abbreviated course of radiation for appropriate breast cancer candidates, and a growing body of clinical evidence suggests Xoft breast IORT is a viable alternative to traditional radiation therapy, 3,4,5 according to Barbara Schwartzberg, MD, Western Surgical Care. IORT with the Xoft System offers significant cost savings and quality of life benefits to patients, while enabling them to get the cancer care they need in just one day, versus weeks of daily radiation treatments. As healthcare systems adjust to the emergent needs relating to the coronavirus, IORT offers a valuable solution for early-stage breast cancer patients, and physicians delivering their care.

The American Society for Radiation Oncology (ASTRO) recently recommended shorter courses of radiation therapy, such as intraoperative radiation therapy (IORT) and hypofractionated radiation therapy, for appropriate patients in its recent recommendations on COVID-19.6 Recognizing the potential for staff reductions, ASTRO advised radiation oncologists to follow evidence-based guidelines while striving for the shortest possible course of radiotherapy, where appropriate. The overall goal is to reduce the risk of transmission of COVID-19 and to allow cancer care to continue for those most likely to benefit.

For the treatment of early-stage breast cancer, IORT with the Xoft System offers a single-fraction therapy option that allows patients who are candidates to be treated for breast cancer in just one day. This targeted treatment option enables some women to potentially replace four to six weeks of daily fractions of post-operative external beam radiation therapy (EBRT) with a single-fraction of radiation that can last as little as eight minutes, thereby reducing the amount of time women need to be in the hospital and allowing doctors to treat more women in less time.

In addition to early-stage breast cancer, Xoft IORT technology is also being explored in the treatment of other types of tumors. iCAD recently announced the first metastatic brain tumor was treated in the U.S. with IORT using the Xoft System at the James Graham Brown Cancer Center at the University of Louisville. The Xoft System is also currently being studied for the treatment of other types of brain tumors in leading institutions worldwide, including the European Medical Center, one of the largest private medical clinics in Russia and an international leader in comprehensive care and oncology. The Company continues to work with key neurosurgeons to enroll patients in a multi-institutional study on Xoft IORT for the treatment of recurrent glioblastoma (GBM).

Homegrown Technology Positioned to Sustain in the Face of PandemiciCAD has quickly mobilized to support critical facility and physician needs related to both sides of our business, said Scott Areglado, Chief Financial Officer of iCAD.

Health systems are increasingly seeking alternative ways to accomplish daily clinical challenges, drive operational efficiency, and streamline patient management, and our technologies are well-positioned to address this demand, particularly as facilities fight against COVID-19, added Klein. Our world-class core technology is homegrown and entirely manufactured in the United States. We have minimal reliance upon outside vendors or external suppliers, and therefore we will continue to be able to offer our cutting-edge solutions to more hospitals and imaging centers as demand continues to grow. We are partnering and collaborating with virtually all of our OEM and PACS partners, particularly those aligned with our risk and remote access support initiatives, and we are also partnering with healthcare systems and large imaging chains to get these proven technologies into peoples hands as fast as possible.

References:

Conant, E et al. (2019). Improving Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4). Accessed via https://pubs.rsna.org/doi/10.1148/ryai.2019180096

Conant, E. et al. (2020). Five Consecutive Years of Screening with Digital Breast Tomosynthesis: Outcomes by Screening Year and Round. Radiology. Accessed via https://doi.org/10.1148/radiol.2020191751.

Correa, Candace et al. (2017) Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Practical Radiation Oncology, Volume 7, Issue 2, 73 79. Accessed via https://www.practicalradonc.org/article/S1879-8500(16)30184-9/fulltext.

Schwartzberg, BS. et al. (2018). Application of 21-gene recurrence score results and ASTRO suitability criteria in breast cancer patients treated with intraoperative radiation therapy (IORT). American Journal of Surgery. 216(4): 689-693. Accessed via https://www.americanjournalofsurgery.com/article/S0002-9610(18)30097-7/fulltext

Silverstein, M.J., Epstein, M., Kim, B. et al. Intraoperative Radiation Therapy (IORT): A Series of 1000 Tumors. Ann Surg Oncol 25, 29872993 (2018). https://doi.org/10.1245/s10434-018-6614-3

American Society for Radiation Oncology (ASTRO) COVID-19 Recommendations to Radiation Oncology Practices. (2020). Accessed via https://www.astro.org/Daily-Practice/COVID-19-Recommendations-and-Information

About iCAD, Inc.

Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions.

ProFound AI is a high-performing workflow solution for 2D and 3D mammography, or digital breast tomosynthesis (DBT), featuring the latest in deep-learning artificial intelligence. In 2018, ProFound AI for Digital Breast Tomosynthesis (DBT) became the first artificial intelligence (AI) software for DBT to be FDA-cleared; it was also CE marked and Health Canada licensed that same year. It offers clinically proven time-savings benefits to radiologists, including a reduction of reading time by 52.7 percent, thereby halving the amount of time it takes radiologists to read 3D mammography datasets. Additionally, ProFound AI for DBT improved radiologist sensitivity by 8 percent and reduced unnecessary patient recall rates by 7.2 percent.1

The Xoft System is FDA-cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. It uses a proprietary miniaturized x-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site, while minimizing risk of damage to healthy tissue in nearby areas of the body.

For more information, visitwww.icadmed.com and http://www.xoftinc.com.

Forward-Looking Statements

Certain statements contained in this News Release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the future prospects for the Companys technology platforms and products. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited, to the Companys ability to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, to defend itself in litigation matters, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Companys filings with the Securities and Exchange Commission. The words believe, demonstrate, intend, expect, estimate, will, continue, anticipate, likely, seek, and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website athttp://www.icadmed.comand on the SECs website athttp://www.sec.gov.

Contacts:Media inquiries:Jessica Burns, iCAD +1-201-423-4492jburns@icadmed.com

Investor relations:Jonathan Wexler+1-203-247-8767jonathan@scopeir.com

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iCAD Launches New Initiatives Leveraging Unique Capabilities of its Robust Product Portfolio to Reduce Health Care System Pressures During the...

Why soap can kill coronavirus and how its discovery changed human history – The Irish Times

It probably began with an accident thousands of years ago. According to one legend, rain washed the fat and ash from frequent animal sacrifices into a nearby river, where they formed a lather with a remarkable ability to clean skin and clothes. Perhaps the inspiration had a vegetal origin in the frothy solutions produced by boiling or mashing certain plants. However it happened, the ancient discovery of soap altered human history. Although our ancestors could not have foreseen it, soap would ultimately become one of our most effective defenses against invisible pathogens.

People typically think of soap as gentle and soothing, but from the perspective of microorganisms, it is often extremely destructive. A drop of ordinary soap diluted in water is sufficient to rupture and kill many types of bacteria and viruses, including the new coronavirus that is currently circling the globe. The secret to soaps impressive might is its hybrid structure.

Soap is made of pin-shaped molecules, each of which has a hydrophilic head ? it readily bonds with water ? and a hydrophobic tail, which shuns water and prefers to link up with oils and fats. These molecules, when suspended in water, alternately float about as solitary units, interact with other molecules in the solution and assemble themselves into little bubbles called micelles, with heads pointing outward and tails tucked inside.

Some bacteria and viruses have lipid membranes that resemble double-layered micelles with two bands of hydrophobic tails sandwiched between two rings of hydrophilic heads. These membranes are studded with important proteins that allow viruses to infect cells and perform vital tasks that keep bacteria alive. Pathogens wrapped in lipid membranes include coronaviruses, HIV, the viruses that cause hepatitis B and C, herpes, Ebola, Zika, dengue, and numerous bacteria that attack the intestines and respiratory tract.

When you wash your hands with soap and water, you surround any microorganisms on your skin with soap molecules. The hydrophobic tails of the free-floating soap molecules attempt to evade water; in the process, they wedge themselves into the lipid envelopes of certain microbes and viruses, prying them apart.

They act like crowbars and destabilize the whole system, said professor Pall Thordarson, acting head of chemistry at the University of New South Wales. Essential proteins spill from the ruptured membranes into the surrounding water, killing the bacteria and rendering the viruses useless.

In tandem, some soap molecules disrupt the chemical bonds that allow bacteria, viruses and grime to stick to surfaces, lifting them off the skin. Micelles can also form around particles of dirt and fragments of viruses and bacteria, suspending them in floating cages. When you rinse your hands, all the microorganisms that have been damaged, trapped and killed by soap molecules are washed away.

On the whole, hand sanitisers are not as reliable as soap. Sanitisers with at least 60 per cent ethanol do act similarly, defeating bacteria and viruses by destabilising their lipid membranes. But they cannot easily remove microorganisms from the skin. There are also viruses that do not depend on lipid membranes to infect cells, as well as bacteria that protect their delicate membranes with sturdy shields of protein and sugar. Examples include bacteria that can cause meningitis, pneumonia, diarrhea and skin infections, as well as the hepatitis A virus, poliovirus, rhinoviruses and adenoviruses (frequent causes of the common cold).

These more resilient microbes are generally less susceptible to the chemical onslaught of ethanol and soap. But vigorous scrubbing with soap and water can still expunge these microbes from the skin, which is partly why hand-washing is more effective than sanitiser. Alcohol-based sanitiser is a good backup when soap and water are not accessible.

In an age of robotic surgery and gene therapy, it is all the more wondrous that a bit of soap in water, an ancient and fundamentally unaltered recipe, remains one of our most valuable medical interventions. Throughout the course of a day, we pick up all sorts of viruses and microorganisms from the objects and people in the environment. When we absentmindedly touch our eyes, nose and mouth a habit, one study suggests, that recurs as often as every 2 1/2 minutes we offer potentially dangerous microbes a portal to our internal organs.

As a foundation of everyday hygiene, hand-washing was broadly adopted relatively recently. In the 1840s Dr Ignaz Semmelweis, a Hungarian physician, discovered that if doctors washed their hands, far fewer women died after childbirth. At the time, microbes were not widely recognised as vectors of disease, and many doctors ridiculed the notion that a lack of personal cleanliness could be responsible for their patients deaths. Ostracised by his colleagues, Semmelweis was eventually committed to an asylum, where he was severely beaten by guards and died from infected wounds.

Florence Nightingale, the English nurse and statistician, also promoted handwashing in the mid-1800s, but it was not until the 1980s that the Centers for Disease Control and Prevention issued the worlds first nationally endorsed hand hygiene guidelines.

Washing with soap and water is one of the key public health practices that can significantly slow the rate of a pandemic and limit the number of infections, preventing a disastrous overburdening of hospitals and clinics. But the technique works only if everyone washes their hands frequently and thoroughly: Work up a good lather, scrub your palms and the back of your hands, interlace your fingers, rub your fingertips against your palms, and twist a soapy fist around your thumbs.

Or as the Canadian health officer Bonnie Henry said recently, Wash your hands like youve been chopping jalapenos and you need to change your contacts. Even people who are relatively young and healthy should regularly wash their hands, especially during a pandemic, because they can spread the disease to those who are more vulnerable.

Soap is more than a personal protectant; when used properly, it becomes part of a communal safety net. At the molecular level, soap works by breaking things apart, but at the level of society, it helps hold everything together. Remember this the next time you have the impulse to bypass the sink: Other peoples lives are in your hands. New York Times

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Why soap can kill coronavirus and how its discovery changed human history - The Irish Times

Contract Development and Manufacturing Organization Market worth USD 278.98 Billion by 2026; Increasing Demand for Pharmaceutical Products Will Aid…

Pune, March 24, 2020 (GLOBE NEWSWIRE) -- The global contract development and manufacturing organization market size is projected to reach USD 278.98 billion by the end of 2026. Mergers and acquisitions are a growing trend among major companies across the world. According to a report published by Fortune Business Insights, titled "Contract Development and Manufacturing Organization (CDMO) Market Size, Share & Industry Analysis, By Service {By CMO (API, Finished Product {Solid Dosage Forms, Injectables, and Others}, and Packaging)} {By CRO (Discovery, Preclinical, Clinical Trial, and Laboratory Services)} and Regional Forecast, 2019-2026," the market was worth USD 130.80 billion in 2018 and will exhibit a CAGR of 10.0% during the forecast period, 2019-2026.

For more information in the analysis of this report, visit: https://www.fortunebusinessinsights.com/contract-development-and-manufacturing-organization-cdmo-outsourcing-market-102502

Report Overview:

The contract development and manufacturing organization market is segmented on the basis of factors such as service and geographies. The report provides forecast values for the market for the period of 2019-2026. The factual figures have been obtained through trusted sources. Moreover, these predictions are made on the basis of extensive research analysis methods, coupled with the opinions of experienced market research professionals. The report highlights the latest product launches and labels major innovations in the market. In addition to this, it states the impact of these products on the growth of the market. The competitive landscape has been discussed in detail and predictions are made with respect to leading companies and products in the coming years.

Product Overview:

A contract development and manufacturing organization (CDMO) helps healthcare companies for the development of drugs. It is involved in the overall process, right from the clinical trials till the commercialization and distribution of the drugs. The complexities in therapies and lack of in-house manufacturing capabilities will have a positive impact on the growth of the market in the coming years. The high investment in CDMOs will bode well for the overall market in the coming years. Moreover, the increasing number of strategic mergers and collaborations will contribute to the growth of the market. The use of advanced technologies in drug development processes will emerge in favor of the companies operating in the market.

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Recipharm AB Introduces New Fully Integrated Service Platform

Accounting to the huge potential held by CDMOs, several companies are looking to invest more in the development of newer products. The huge investments have yielded a few exceptional products in recent years. In May 2019, Recipharm AB announced the launch of a fully integrated service platform for inhalation products. This will include the early stages of the products including the pre-clinical trials to the commercialization of the products. Recipharm's latest product will generate huge sales and subsequently high revenues for the company. This will not just benefit the company, but will have a positive impact on the growth of the overall market in the coming years.

Asia Pacific to Register Highest CAGR; Increasing Company Collaborations Will Aid Growth of the Regional Market

The report analyses the ongoing CDMO market trends across North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. Among these regions, the market in Asia Pacific will register the highest CAGR in the coming years driven by the increasing number of company collaborations and mergers in several countries across the world. The market in North America is projected to emerge dominant in the coming years, owing to the presence of several well-established companies. As of 2018, the market in North America was worth USD 48.72 billion in 2018 and this value is projected to increase further in the coming years.

List of key companies profiled in theCDMO Market Research Report are report:

Industry Developments:

February 2019: Jubilant Biosys collaborated with Sanofi to develop small molecule inhibitors for in the CNS therapeutic area.

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Detailed Table of Content:

1. Introduction 1.1. Research Scope 1.2. Market Segmentation 1.3. Research Methodology 1.4. Definitions and Assumptions2. Executive Summary3. Market Dynamics 3.1. Market Trends 3.2. Market Drivers 3.3. Market Restraints 3.4. Market Opportunities4. Key Insights 4.1. Key Industry Developments (Mergers, Acquisitions, & Partnerships,) 4.2. The Regulatory Scenario for key countries/Regions 4.3. Key Market Trends 4.4. Key Services Mapping by Leading Players5. Global Contract Development and Manufacturing Organization (CDMO) Market Analysis, Insights and Forecast, 2015-2026 5.1. Key Findings / Summary 5.2. Market Analysis, Insights and Forecast By Service 5.2.1. CMO 5.2.1.1. API Manufacturing 5.2.1.2. Finished Product Manufacturing 5.2.1.2.1. Solid Dosage Forms 5.2.1.2.2. Injectables 5.2.1.2.3. Others (Semisolids/liquids, Powder) 5.2.1.3. Packaging 5.2.2. CRO 5.2.2.1. Discovery 5.2.2.2. Preclinical 5.2.2.3. Clinical 5.2.2.4. Laboratory Services5.3. Market Analysis, Insights and Forecast By Region 5.3.1. North America 5.3.2. Europe 5.3.3. Asia Pacific 5.3.4. Rest of the World

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Contract Development and Manufacturing Organization Market worth USD 278.98 Billion by 2026; Increasing Demand for Pharmaceutical Products Will Aid...

Coronavirus weekend update: Plans outlined to prepare hospitals for surge in patients – Mountain View Voice

Santa Clara County is working with local hospitals to prepare for an expected surge in coronavirus patients, county Board of Supervisors President Cindy Chavez and Santa Clara Valley Medical Center CEO Paul Lorenz said at a press conference on Sunday.

Lorenz said there are approximately 2,500 hospital beds in the county. Roughly 400 of the beds are dedicated to pediatric care and 350 are for critical care, 75% to 80% of which are currently occupied. Approximately 290 additional beds can be converted to an "ICU level of care," he said.

"If in fact the demand goes beyond our capacity, we are working with the county emergency operations center to come up with a communitywide search plan," he said. "That plan would include looking at all 2,100 adult beds that we can equip and staff for critically ill patients."

Lorenz added that "less acute patients" could then be taken to alternative facilities in the county to free up room at hospitals.

The county is also looking to hire more health care workers and is bringing retired employees back into the workforce. The county can reach out to the state and federal governments for additional staff should that be necessary, Lorenz said.

"We need to have the surge capacity in place as quickly as possible," he said. "We are moving as rapidly as we can. ... All of the hospitals in this county have prepared their own surge capacity plans, and that allows those facilities to ramp up their own facilities beyond what they're currently staffed at.

"I think the most important variable in all of this is to maintain our health care workforce and to grow that workforce ... and the ability for us to equip those hospital beds with ventilators and other necessary equipment. We are also moving very rapidly with the county EOC, the state and the federal government to make sure we have those items in place as quickly as possible."

He said the community has been "really helpful" in following the directions of local health officials, adding that local emergency rooms are now seeing a "much lower volume." Anyone with symptoms of COVID-19 is being asked to call their health care provider or 211 before going to urgent care or an emergency room.

"We were not expecting to have the results so quickly of the emergency rooms not being crowded because people are actually taking those steps, and that's really critical," Chavez said. "We want to make sure we have beds for people who are in the highest need."

Chavez provided another piece of good news: Community members have donated thousands of masks, gowns and other personal protective equipment for health care workers amid a national shortage of such items. The Valley Medical Center Foundation is continuing to collect monetary donations online and protective equipment, which can be dropped off beginning at 8 a.m. Monday, March 23, at the foundation's office on the Santa Clara Valley Medical Center campus, 2400 Clove Drive in San Jose.

Masks and gloves that aren't hospital grade are also needed for local food bank workers, she noted.

Chavez also encouraged those who are healthy and want to volunteer to deliver meals to sign up at siliconvalleystrong.org.

Access a recording of the press conference here.

Santa Clara County

Santa Clara County reported two more deaths and 39 new infections as a result of the coronavirus on Sunday afternoon, bringing the total number of cases to 302.

Chavez said in a press conference Sunday that the ninth and 10th recorded deaths in the county were women in their 60s and 40s, respectively. Both women died Saturday, March 21. The woman in her 40s was hospitalized Monday, March 16, according to the county. Further information was not provided.

Officials also announced in a press release Sunday that Santa Clara County Director of Communications and Public Affairs Maria Leticia Gmez has tested positive for COVID-19.

She became ill on March 13 and received her positive test result on Sunday, March 22.

Gmez agreed to share her health status publicly, according to the press release. She has been isolated at home since March 13.

"The county has instructed all employees, including those who have been in contact with Ms. Gmez, that they should not go to work if they show any symptoms of illness," the county said. "We are also notifying all members of the county workforce with whom Ms. Gmez may have had contact while contagious that they may have been exposed."

Of Santa Clara County's COVID-19 cases, 108 people are hospitalized; 77 are presumed to have been community transmitted; 75 are close contacts of known cases; 22 are associated with international travel; and 10 people have died, according to the county's public health department.

On Saturday, the county reported 67 new cases of coronavirus, which marked the biggest jump in cases in one day for the county.

"This increased case count is not unexpected given community transmission, an increase in provider reporting, and growing testing capacity through the commercial market," according to a county press release.

San Mateo County

As of Sunday morning, March 22, San Mateo County announced seven new COVID-19 cases, bringing its county total to 117, and one death.

Parking restrictions near Windy Hill Preserve

Portola Valley Town Manager Jeremy Dennis issued an emergency order on Sunday that prohibits parking adjacent to the entrances to Windy Hill Preserve's trails on Portola and Alpine roads and Willowbrook Drive, according to a Sunday afternoon email sent out to residents by Mayor Jeff Aalfs.

"Our experiences (including reports from many of you) over the last two days at Windy Hill indicate that not only are some of the trails incompatible with social distancing, the use of our streets for parking and trail entry is creating unsafe conditions as well," Aalfs wrote.

The order will be enforced beginning Monday, March 23, "until the County Order is lifted," he said. There will be increased signage in the affected areas.

Windy Hill, a Midpeninsula Regional Open Space District preserve, is among several local spots that have seen an uptick in visitors in recent days. The National Park Service announced in a tweet Saturday night that it would close multiple gates at Point Reyes National Seashore beginning Sunday, March 22, "after unprecedented visitation."

The open space district reaffirmed Friday, March 20, that its preserves and trails are open to the public with new health and safety measures in place, including: restrooms are closed; areas with high use will be intermittently closed without notice to promote safe social distancing; group gathering areas are closed; and group activities are suspended.

Aalfs noted in his email that town staff "has been in touch with San Mateo and Santa Clara County officials, MROSD officials, the Sheriff's Office, and others in discussion about the use of open space facilities during the current shelter in place crisis," but did not specify whether further measures are being considered at this time.

SAFE farmers market

For three weeks beginning Thursday, March 26, the SAFE (Sanitary Allocation of Food Essentials) Portola Valley Farmers Market will operate from 2 to 6 p.m. at the site of the usual Thursday farmers market, 765 Portola Road, according to an email from the town Sunday.

The market will be pre-order only with drive-thru pickup. Food will be prepacked, and households will be limited to five bags per order. The deadline for all orders will be 7 p.m. the Wednesday before the market, and products for the following week's market will become available online at noon every Friday.

The market will also offer special delivery for residents of the Sequoias retirement community and those in vulnerable populations.

For more information or to pre-order, visit the SAFE Portola Valley Market website.

Menlo Park-based lab to process coronavirus tests from new Hayward center

A partnership with a Menlo Park genetics laboratory firm will allow Hayward to open a dedicated center offering free COVID-19 coronavirus testing on Monday, March 23.

The COVID-19 testing center at the city's fire station at 28270 Huntwood Ave. can handle up to 370 tests a day, "But we don't expect it to get that high," said city spokesman Chuck Finnie.

Tests are intended for those displaying symptoms, first responders, and health care workers with recent suspected exposures to the novel coronavirus.

The intent is "to take pressure off hospital emergency rooms, provide quicker answers for recently exposed first responders and health care workers, and to enhance the region's capacity to suppress new transmissions through isolation after testing," the city said in an announcement Sunday.

"We don't want the wondering and the worried to come they need to stay home," Finnie said. "We want sick people to come."

He added, "It's not a test people are going to want to take unless they have to. It's not pleasant."

The test involves swabbing of nasal cavities and the back of the throat.

Hayward Fire Department firefighter-paramedics will staff the center, with assistance from ambulance company emergency-medical technicians.

"No referral from a medical doctor is required to be screened," the city said.

The center will operate from 9 a.m. to 6 p.m. daily and is free and open to "anyone regardless of where they live or immigration status," according to the announcement.

"We know it's going to be chaotic on the first day," Finnie said.

People will first undergo a two-part screening for illness, which includes fever, cough and/or shortness of breath, and/or other respiratory symptoms.

At an initial drive-up station, people will be asked about symptoms, then either be cleared to leave or sent to a walk-up tent to be screened for illness.

The city has appropriated funding for the center with the hope of reimbursement from county and state public health agencies.

The center is made possible through a city partnership with Menlo Park-based Avellino Lab USA Inc., a company that specializes in "gene therapy and molecular diagnostics with a focus in precision medicine for eye care."

The laboratory will analyze the tests and "Results can be available in as little as six hours or the next day in most cases."

Finnie said Avellino is a civic-minded company that is supplying the tests "at a very, very good price" and is also looking for similar partnerships with other jurisdictions to open additional centers.

He said officials from Fremont were assessing the Hayward center on Sunday.

Menlo fire begins pandemic response unit

The Menlo Park Fire Protection District now has a Pandemic Emergency Response Unit staffed by a two-person team. The unit is tasked with taking calls of suspected COVID-19 cases, according to a press release issued Saturday.

The district recently received seven calls of suspected COVID-19 in one day and expects to see that number go up.

Staff assigned to the unit will utilize the "highest level of Emergency Medical Services" and personal protective equipment. The district said they will aim to minimize contact with whoever may have COVID-19 while on a call to decrease possible exposure to the disease.

They will also be responsible for decontaminating each scene they visit and fire apparatus used on the call to prevent traces of the virus on equipment, clothing and/or the apparatus as outlined by district guidelines.

"We believe that by raising the bar on our personal protective clothing and by putting this new special response unit in place, we can slow or help to hopefully more effectively stop its spread," Chief Harold Schapelhouman said in the press release.

Some fire district personnel have volunteered to serve on the unit, he said.

"The number of our off-duty firefighters grew again today, as yet another Menlo Park Firefighter, the seventh, was home sick and scheduled for testing.

"At some point, we know one of our firefighters will contract COVID-19," Schapelhouman added, "most are not in the risk categories and all are extremely healthy and fit based upon the daily expectations of our profession, but our collective goal is to delay, or stop, spread for as long as possible."

Increasing health care capacity

To create more space at hospitals, Santa Clara County has teamed up with the U.S. Office of Public Health Preparedness and Response to establish a temporary Federal Medical Station at the Santa Clara Convention Center to accommodate up to 250 people, according to a statement issued Saturday. The station will be managed by the federal office to serve patients in need of short-term, subacute care and do not have COVID-19. It will be equipped with beds, supplies and medicines, according to the county.

The station, being developed with federal, state and local agencies, is expected to help make more acute hospital beds available.

Chavez said Sunday that the county is considering other sites besides the convention center for coronavirus response efforts but didn't offer any specific details.

The state can also increase capacity at clinics, mobile health care units and adult day care facilities as part of its COVID-19 response under an executive order issued by Gov. Gavin Newsom on Saturday. In addition, local governments are allowed to work with retired employees in addressing the public health crisis. The order also "reinforces the importance of the delivery of food, medicine and emergency supplies," according to a press release from the governor's office. To read a copy of the order, visit gov.ca.gov.

Reporting violations and fraud

On Saturday, Santa Clara County announced an updated resource for the public to report nonessential businesses they see operating in violation of the shelter-at-home order, which was issued on Tuesday and will last through April 7.

The public can notify the Santa Clara County District Attorney's Office of such breaches at a new phone number, 408-792-2300. Callers can leave a voicemail in English, Spanish and Vietnamese.

Additionally, the U.S. Department of Justice is encouraging people to report suspected fraud schemes related to the coronavirus by calling the National Center for Disaster Fraud hotline at 866-720-5721 or by sending an email to disaster@leo.gov. So far there have been reports of individuals and businesses selling fake cures for COVID-19 online; phishing emails from entities posing as the World Health Organization or the Centers for Disease Control and Prevention; malicious websites and apps that appear to share virus-related information to gain and lock access to devices until payment is received; and people seeking donations for illegitimate or nonexistent charities, according to the department.

Shelter at home orders

Last week started off with the announcement of a shelter-at-home order for most of the Bay Area and ended with a similar mandate extending throughout the state, actions taken in response to the growing coronavirus crisis.

On Monday, March 16, public health leaders from six Bay Area counties joined together to announce the shelter-at-home order for their respective jurisdictions. The measure limits the public to essential activities, such as health care operations; businesses that provide food, shelter and social services; and other necessities.

The state followed suit through its own order announced Thursday night by Gov. Gavin Newsom, who pointed to more than 1,030 confirmed cases and 18 deaths across California as factors in the decision.

Bay City News Service contributed to this report.

Find comprehensive coverage on the Midpeninsula's response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.

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Follow the Mountain View Voice on Twitter at @MVvoice, Facebook and Instagram at @MVvoice for breaking news, local events, photos, videos and more.

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Coronavirus weekend update: Plans outlined to prepare hospitals for surge in patients - Mountain View Voice

Edited Transcript of SRPT earnings conference call or presentation 26-Feb-20 9:30pm GMT – Yahoo Finance

BOTHELL Mar 21, 2020 (Thomson StreetEvents) -- Edited Transcript of Sarepta Therapeutics Inc earnings conference call or presentation Wednesday, February 26, 2020 at 9:30:00pm GMT

* Alexander G. Cumbo

Sarepta Therapeutics, Inc. - Executive VP & Chief Commercial Officer

* Douglas S. Ingram

Sarepta Therapeutics, Inc. - President, CEO & Director

Sarepta Therapeutics, Inc. - Executive VP of R&D and Chief Medical Officer

* Ian M. Estepan

Sarepta Therapeutics, Inc. - Senior VP of Corporate Affairs & Chief of Staff

Sarepta Therapeutics, Inc. - SVP of Gene Therapy

Sarepta Therapeutics, Inc. - Executive VP, CFO & Chief Business Officer

* Christopher N. Marai

Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology

* Debjit D. Chattopadhyay

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Peter B. Kim

Sanford C. Bernstein & Co., LLC., Research Division - VP

Ladies and gentlemen, thank you for standing by, and welcome to the Sarepta Therapeutics Fourth Quarter 2019 Earnings Call. (Operator Instructions) As a reminder, today's program may be recorded.

I would now like to introduce your host for today's program, Ian Estepan, Senior Vice President, Chief of Staff and Corporate Affairs. Please go ahead, sir.

Ian M. Estepan, Sarepta Therapeutics, Inc. - Senior VP of Corporate Affairs & Chief of Staff [2]

Thank you so much, John, and thank you all for joining today's call. Earlier today, we released our financial results for the fourth quarter and full year 2019. The press release is available on our website at http://www.sarepta.com, and our 10-K was filed with the SEC earlier this afternoon. Joining us on the call today are Doug Ingram, Sandy Mahatme, Bo Cumbo, Dr. Gilmore O'Neill and Dr. Louise Rodino-Klapac. After our formal remarks, we'll open up the call for Q&A.

I'd like to note that during this call, we will be making a number of forward-looking statements. Please take a moment to review our slide on the webcast, which contains our forward-looking statements. These forward-looking statements involve risks and uncertainties, any of which are beyond Sarepta's control. Actual results could materially differ from these forward-looking statements, and any and such risks can materially and adversely affect the business, the results of operations and trading prices for Sarepta's common stock. For a detailed description of applicable risks and uncertainties, we encourage you to review the company's most recent annual report on Form 10-K filed with the Securities and Exchange Commission as well as the company's other SEC filings. The company does not undertake any obligation to publicly update its forward-looking statements, including any financial projections provided today based on subsequent events or circumstances.

And with that, I'd like to turn the call over to Doug Ingram for our corporate update.

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Douglas S. Ingram, Sarepta Therapeutics, Inc. - President, CEO & Director [3]

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Thank you, Ian. Good afternoon, and thank you all for joining Sarepta Therapeutics Fourth Quarter 2019 Conference Call.

In 2018, we defined our vision to become one of the world's leaders in precision genetic medicine to treat rare disease, founded both on our precise and efficient RNA platform and on the build of a gene therapy engine capable of rapidly advancing multiple constructs through development into the patient community. In 2019, we executed, further matured and brought that vision into greater focus. And in 2020 -- through 2020 we will, if successful, realize much of that vision.

We have an enormous number of milestones in 2020. But before we discuss them, let us review the progress that we have made in 2019. I will begin with our RNA platform.

As we announced at the JPMorgan conference in January, our fourth quarter 2019 revenue stands at $100 million. In our third full year since launch, our 2019 revenue was $381 million, a 26% increase over prior year. I will remind you that we have never taken a price increase since launch, so our growth comes from continuing to serve the Duchenne community.

Our 2020 guidance for EXONDYS is $420 million to $430 million. As we are just launching VYONDYS, we will wait until later this year before providing revenue guidance, but you can expect the launch curve similar to that of EXONDYS.

In the fourth quarter, we obtained FDA approval for our second RNA therapy, VYONDYS 53. The approval of VYONDYS was a win for objective evidence-based decision-making. It was a win for hard-working professionals at the FDA neurology division that was responsible for this review, and most importantly, it was a win for exon 53 amenable patients.

With regulatory pathway reconfirmed, we submitted our rolling NDA for casimersen, having announced positive results earlier in 2019. Assuming casimersen is approved, we will have 3 therapies capable of treating approximately 30% of the Duchenne community in the United States. We will have doubled the number of patients who may benefit from our PMO technology versus EXONDYS alone, and we will be among the exceedingly small number of biotechnology companies who have internally discovered, developed and brought to the patient community 3 or more medicines.

In 2019, we commenced our multi-ascending dose study for our next-generation PMO technology, the peptide-conjugated PMO or PPMO for short.

Now let's move on to our gene therapy engine. There, we've made great progress in 2019 as well. Starting with SRP-9001, our gene therapy for the treatment of Duchenne muscular dystrophy using our microdystrophin construct. We have completed all dosing in what became a 41-patient, placebo-controlled trial, Study 102. Patients are now crossing over at the end of their 48-week period. By now, between our first proof-of-concept study, our main study for 102 and our crossover, we have dosed more than 30 Duchenne boys with active gene therapy. The study continues uninterrupted, and the last patient last visit should occur in December of this year.

We have designed our next placebo-controlled trial using our commercial process material, and we've taken initial feedback from the agency. This trial, which we call Study 301 is designed as a global placebo-controlled, multi-center trial. We have made significant progress on manufacturing. With our partners Thermo Fisher and Catalent, we have built significant capacity with a dedicated facility completed in Lexington, Massachusetts and even greater capacity than that built at Catalent. Our hybrid manufacturing approach is taking shape with ADPD expertise at our Columbus site and a dedicated ADPD site in Burlington, Massachusetts. This intellectual hub has been responsible for some of our most meaningful advances in 2019.

Consider that we have now achieved at scale, commercially viable yields for SRP-9001, we announced at JPMorgan that we had commenced engineering runs. By now, I can tell you that we have commenced our GMP runs for SRP-9001, and we're making great progress on assay development as well.

We've made great progress on our limb-girdle pipeline in 2019. To remind you, LGMD, or limb-girdle muscular dystrophy, is an umbrella name for a collection of serious, often fatal neuromuscular diseases. None of these diseases have available therapies, so the opportunity to bring a better life for these patients is compelling. In the first quarter of 2019, we exercised our option and acquired Myonexus, gaining access to its 5 LGMD programs. And then we later entered into a license option with NCH to gain access to Dr. Zarife Sahenk's LGMD candidate for LGMD2A. These 6 programs together have the potential of providing treatments for over 70% of patients with LGMD.

In the first quarter of 2019, we presented expression and safety data from our first 3 patient proof-of-concept cohort for LGMD2E, and it was impressive. Expression was 50% on IHC and 30% -- 37% abnormal on Western blot. We came back in the fourth quarter, and we updated with 9-month functional data, indicating that every child was improving on every functional end point.

We commenced 1 additional higher-dose, 3-patient cohort in 2019 at a 4x higher dose with the goal of making a dose selection in 2020 this year.

Moving on to the rest of our gene therapy engine. 2019 was equally consequential. With our partner, Lysogene, we commenced a gene therapy trial for MPS IIIA or Sanfilippo Syndrome Type A devastating neurological lysosomal storage disease. We built out our gene therapy center of excellence in Columbus, Ohio. Our center of excellence is already building new constructs and advancing the science of gene therapy.

We entered into 14 transactions in 2019, and we in-licensed or purchased 18 new constructs, bringing the total number of research and development programs to 42 across our 2 platforms. And we have employed a clever incubation strategy that allows us to build an enormously large pipeline while still permitting us to remain laser-focused on our near-term objectives and milestones.

And of course, we entered into a transformational alliance with Roche in the fourth quarter of 2019 where Roche will take SRP-9001 to patients outside the United States. This alliance, by far, the largest ex-U. S. single candidate, license and biopharmaceutical history, validates our approach, our progress and the value of our program, but it also serves our mission. If SRP-9001 proves successful, Roche, with its very impressive ex-U. S. resources and international expertise, will bring our therapy to far more patients far faster than we could have ever done on our own. And it places us in an enviable position with the resources to drive our vision and to execute our plans. With the close of our alliance this quarter, we have well over $2 billion of cash on our balance sheet today; add to that the fact that we have just entered into an agreement to sell our VYONDYS priority review voucher for $111 million; add again to that our revenue this year for EXONDYS and VYONDYS, and it should become clear that we are well positioned with the resources, the assets and the talent to drive our ambitious strategy to fruition.

Looking forward, you will see that 2020 is dense with milestones. So starting with our gene therapy portfolio for 2020, with respect to SRP-9001, we will continue to execute Study 102 with our 48-week last patient last visit in December of this year. We will unblind, evaluate and release those results, which should occur in the first quarter of 2021.

We are preparing to commence our commercial supply trial, Study 301. Broadly, we have 3 work streams for Study 301. We must complete site initiation and training. We must complete our assay work, our engineering work and our GMP runs. And if all goes well, we should have GMP material released this July. We need to work with the division to obtain their concurrence on the commencement of Study 301. So of course, there's a lot to do here, but the team is making exceptional progress to date.

With respect to our LGMD pipeline, we have dosed all 3 patients now in our high-dose cohort for LGMD2E. We will have expression and safety results available in the second quarter, and we anticipate announcing that data at an appropriate medical meeting in the second quarter. We will make a formal dose selection decision in the third quarter. We will complete the assay and process development work for LGMD2E with the goal of having GMP material available in time to commence a trial in early 2021. We will also begin the ADPD work for other of our LGMD constructs as well.

We will continue our dialogue with the FDA and come to a view on the development and regulatory pathway for LGMD2E and then the remainder of the LGMD pipeline. Our goal is to have all of that completed by year-end, so we could commence a trial with commercial process material early next year.

We've also dosed 17 patients on our MPS IIIA gene therapy program and intend to complete all the dosing by the middle of the year. Our collaborator on CMT, otherwise known as Charcot-Marie-Tooth, Dr. Zarife Sahenk at Nationwide Children's Hospital, had intended to commence our proof-of-concept study for CMT last year but did not have NCH released material, enabling her to do that. That material should be available this year, and Dr. Sahenk intends to commence that study in 2020.

In addition to our gene therapy center of excellence in Columbus, Ohio, we are also building a separate gene-editing innovation center under the guidance of Dr. Charlie Gersbach of Duke University in Durham, North Carolina and should have that largely complete this year.

We have also significant milestones for our RNA platform this year. We should complete our rolling submission for casimersen in the second quarter of 2020. We plan to result -- to release the results from our PROMOVI study at the MDA Scientific Conference in March. These results from patients that met the enrollment criteria for 201/202, that's the study, which formed the basis for the eteplirsen approval, are consistent with the 201/202 data set. And we will have dosing and safety insight on our next-generation RNA platform, the PPMO, this year as well. If the PPMO is successful, it could be a significant advancement in our RNA technology and platform.

In summary, we have an enormous amount of work to do this year. But that work will be profoundly consequential for Sarepta and, of course, more importantly, for the patients that we serve. To those who may say our plans are ambitious, I would agree. But they are not driven by hubris. They are formed instead by the binding conviction founded on objective evidence that the science of genetic medicine has come of age, that a revolution in health care is upon us now, and that Sarepta is playing a leading role in translating that science to practical therapies that improve countless lives otherwise stolen by serious, rare genetic diseases. And it is in that spirit that I would invite you to join Sarepta and rare disease patients in the U.S. and around the world in recognizing Rare Disease Day this Saturday, February 29, as we continue to bring awareness about rare diseases and the work that remains to bring therapies to patients fighting those diseases every day.

And with that, I will turn the call over to Sandy to provide an update on the financials. Sandy?

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Sandesh Mahatme, Sarepta Therapeutics, Inc. - Executive VP, CFO & Chief Business Officer [4]

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Thanks, Doug. Good afternoon, everyone. Over the course of 2019, we advanced the business in several significant ways: we beat revenue guidance for EXONDYS 51; launched another of our RNA medicines, VYONDYS 53; significantly bolstered our financial position; and struck several new licensing deals, bringing our total number of development programs up to 42. We also started a partnership with Roche that closed earlier this month and that brought in $1.15 billion into the company. This collaboration brings significant capital to fully fund our pipeline, including our sharing payments, and it provides us access to Roche's significant expertise and greatly expand the global opportunity for our lead gene therapy program, SRP-9001.

Now moving to the financials. This afternoon's press release provided details for the fourth quarter of 2019 on a non-GAAP basis as well as a GAAP basis. The press release is available on Sarepta's website. Please refer to it for full reconciliation of GAAP to non-GAAP.

Net product revenue for the fourth quarter of 2019 was $100.1 million compared to $84.4 million for the same period of 2018. The increase primarily reflects higher demand for EXONDYS 51. On a GAAP basis, the company reported a net loss of $235.7 million and $140.9 million or $3.16 and $2.05 for basic and diluted shares for the fourth quarter of 2019 and '18, respectively.

We reported a non-GAAP net loss of $116.9 million or $1.57 per basic and diluted share in the fourth quarter of 2019 compared to a non-GAAP net loss of $58.7 million or $0.85 per basic and diluted shares in the fourth quarter of 2018.

In the last quarter of 2019, we recorded approximately $15.6 million in cost of sales compared to $13.1 million in the same period of last year. The increase was driven by royalties due to BioMarin Pharmaceuticals and University of Western Australia as well as higher production costs as a result of increasing demand for EXONDYS 51.

On a GAAP basis, we recorded $223.1 million and $146.2 million in R&D expenses for the fourth quarters of 2019 and 2018, respectively, which is a year-over-year increase of $76.9 million. This increase is primarily related to $40 million of increasing expenses in clinical and manufacturing, a $10.8 million increase in compensation and other personnel expenses as well as a $10.4 million increase in milestone cadence.

On a non-GAAP basis, R&D expenses were $135.4 million for the fourth quarter of 2019 compared to $77 million for the same period in 2018, an increase of $58.4 million. The year-over-year growth in non-GAAP R&D expenses was driven primarily due to a continuing ramp-up of our micro-dystrophin distribution program, our ESSENCE program and initiation of certain post-market studies for EXONDYS 51.

Turning to SG&A. On a GAAP basis, we recorded $81.4 million and $64.2 million of expenses in the fourth quarters of 2019 and 2018, respectively, a year-over-year increase of $17.2 million. On a non-GAAP basis, the SG&A expenses were $65.8 million for the fourth quarter of last year compared to $52.9 million for the same period of 2018, an increase of $12.9 million. The year-over-year increase was driven by significant organizational growth and expansion, supporting our commercial launch as well as 40 therapies in various stages of development across several therapeutic modalities.

On a GAAP basis, we recorded $4.8 million in other expenses for the fourth quarter of 2019 compared to $2.3 million of expenses for the same period of 2018. The unfavorable change is primarily driven by increase in interest expense, which is recognized for our new term loans that was received by the company in December of 2019.

We had approximately $1.1 billion in cash, cash equivalents and investments as of the end of last year. In addition to the closing of our alliance with Roche this quarter, we have well over $2 billion in cash on our balance sheet today.

With that, I would like to turn the call over to Bo for a commercial update. Bo?

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Alexander G. Cumbo, Sarepta Therapeutics, Inc. - Executive VP & Chief Commercial Officer [5]

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Thank you, Sandy. Good afternoon, everyone. Toward our 2019 objectives around execution and our commitment to deliver on our stated goals, I am pleased to report the following on behalf of the organization. We exceeded revenue consensus expectations for both the fourth quarter and the full year of 2019, totaling $100.1 million and $380.8 million, respectively. As Doug mentioned, our 2020 guidance for EXONDYS 51 is $420 million to $430 million. In terms of continuing to serve the community, we know that there are additional patients who may benefit from EXONDYS 51, and we will continue to overcome access and reimbursement challenges to get patients on therapy.

golodirsen, or VYONDYS 53, received accelerated approval by the FDA on December 12, 2019. VYONDYS 53 treats Duchenne muscular dystrophy patients who are amenable to skipping exon 53. Acting with urgency and the knowledge that patients were waiting, we launched VYONDYS 53 within 24 hours of FDA approval, just as we did with EXONDYS 51. We submitted all of our compendia, contracting and reporting requirements, and vyondys53.com, a critically important resource for families, went live. While we are leveraging our deep knowledge and expertise for the EXONDYS 51 launch, it is important to understand that there will be standard procedures and required reimbursement policies associated with launching a new drug with a unique NDC or National Drug Code. Our team is prepared to work through these requirements as we have in the past, and we anticipate a measured and steady launch trajectory for VYONDYS 53, resembling the launch curve for EXONDYS 51. The only difference is that we are preparing and planning for the amenable exon 53 space to be competitive.

In support of our goal to increase access for VYONDYS 53, we are pursuing a multi-pronged strategy. Although commercial and state Medicaid plans now have a much better understanding of Duchenne, we are continuing to educate about disease progression and the benefits of treatment. Our goal is to work towards coverage to be all-inclusive regardless of ambulation status, age or gender. We do expect commercial payers to have medical policies in place faster than Medicaid. We also understand that from our previous launch that the mix of commercial to Medicaid patients will adjust over time, and we believe it will eventually move towards a 50-50 mix or higher for Medicaid.

Further, we are continuing to engage with state Medicaid plans regarding the CMS guidance letter on the obligation of state Medicaid to make accelerated approval treatments available to patients. As you know, this is critically important for Duchenne based on the percent of patients covered under Medicaid plans.

While the launch over Christmas holiday did delay some physician and patients seeking treatment during that period of time, we have been receiving START Forms from top-tier centers across the U.S. and are working with health care providers to ensure they are educated around amendability for skipping exon 53, as this population is different from exon 51 with some exceptions. Epidemiology suggests that VYONDYS 53 can serve approximately 8% of the Duchenne community. But we will have to take into consideration that there are a number of patients already enrolled in or being recruited for clinical trials, or have a deletion that would be amenable to exon 51 and, therefore, could already be on EXONDYS 51.

With that said, we continue to have conversations with health care providers about the number of patients within their clinics and with payers about the number of patients eligible for treatment under their plan. We are working with both health care providers and payers to get all amenable patients on VYONDYS 53 as soon as possible. Our mission to be the global leader in precision-genetic medicine started with EXONDYS 51 and have continued with the approval and launch of VYONDYS 53. We are now preparing for the potential launch of casimersen for patients amenable to skipping exon 45. Behind these important medicines is an industry-leading pipeline of programs, 42 in all, driven by new modalities designed to treat complex rare diseases, including MPS IIIA and neuromuscular dystrophy. Sarepta is working with urgency and is focused on understanding the epidemiology and global prevalence of these diseases.

We are continuing to refine our analysis and uncover additional insights while collaborating with top neuromuscular specialists. Each day, we are learning more about these diseases. And with each piece of evidence that we gather, we are able to apply these insights to our disease awareness and patient identification efforts that are already underway.

2019 was a great -- was a year of great accomplishments, not only for the commercial organization but the company overall. Looking to the future, patient care will continue to be our driving force as we translate scientific innovations into medicines designed to improve the lives of patients around the world.

And with that, I'll turn the call back over to Doug.

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Douglas S. Ingram, Sarepta Therapeutics, Inc. - President, CEO & Director [6]

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Thank you, Bo, and thank you, Bo and Sandy. With that, let's open the call for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Ritu Baral from Cowen.

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Ritu Subhalaksmi Baral, Cowen and Company, LLC, Research Division - MD & Senior Biotechnology Analyst [2]

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Doug, can you let us know when the last patients for gene therapy was dosed? Basically, what is the shortest follow-up period, both for microdystrophin as well as limb-girdle? And can you talk about the safety profile, especially liver, especially platelets, that you've seen in that time period for both programs?

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Douglas S. Ingram, Sarepta Therapeutics, Inc. - President, CEO & Director [3]

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Well, I can just tell you very broadly that as I sort of backward engineer, we're going to have the -- for the 41-patient study, 102, the last patient last visit will be in December. So if you work backwards, you'll see that the last patient was right at -- I think it actually might have been the very first weekend in 2020. So that was the first 41 patients dosed. We're continuing on an ongoing basis to those patients on crossover as well. There's a significant number, as I've mentioned to you now. But in the Study 102, between the proof-of-concept 101, between the main 41-patient study and between the crossovers, we've dosed over 30 patients with active therapy. We have now dosed 6 patients with limb-girdle, both the previous dose and now the higher dose in limb-girdle. And of course, a lot of that's blinded, so that we'll all see together both the safety and -- the full safety and efficacy. But broadly speaking, I will say, again, consistent with our preclinical models, we have never seen anything that looks like a complement or reductions in platelet counts below the normal level. So things continue as they were. Study 102 continues, completely uninterrupted, making great progress there. The exciting thing about 102 is that we'll have last patient in December, and we'll have a readout in the first quarter of 2021. And I will remind you that is a readout, not merely on expression and on safety but also on function using NSAA. Thank you for that question.

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Operator [4]

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Our next question comes from the line of Tazeen Ahmad from Bank of America.

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Continue reading here:
Edited Transcript of SRPT earnings conference call or presentation 26-Feb-20 9:30pm GMT - Yahoo Finance

A history of soap: How it began and how it fights coronavirus – The Independent

It probably began with an accident thousands of years ago. According to one legend, rain washed the fat and ash from frequent animal sacrifices into a nearby river, where they formed a lather with a remarkable ability to clean skin and clothes. Perhaps the inspiration had a vegetal origin in the frothy solutions produced by boiling or mashing certain plants. However it happened, the ancient discovery of soap altered human history. Although our ancestors could not have foreseen it, soap would ultimately become one of our most effective defences against invisible pathogens.

People typically think of soap as gentle and soothing, but from the perspective of microorganisms, it is often extremely destructive. A drop of ordinary soap diluted in water is sufficient to rupture and kill many types of bacteria and viruses, including the new coronavirus that is currently circling the globe. The secret to soaps impressive might is its hybrid structure.

Soap is made of pin-shaped molecules, each of which has a hydrophilic head it readily bonds with water and a hydrophobic tail, which shuns water and prefers to link up with oils and fats. These molecules, when suspended in water, alternately float about as solitary units, interact with other molecules in the solution and assemble themselves into little bubbles called micelles, with heads pointing outward and tails tucked inside.

Sharing the full story, not just the headlines

Some bacteria and viruses have lipid membranes that resemble double-layered micelles with two bands of hydrophobic tails sandwiched between two rings of hydrophilic heads. These membranes are studded with important proteins that allow viruses to infect cells and perform vital tasks that keep bacteria alive. Pathogens wrapped in lipid membranes include coronaviruses, HIV, the viruses that cause hepatitis B and C, herpes, Ebola, Zika, dengue, and numerous bacteria that attack the intestines and respiratory tract.

When you wash your hands with soap and water, you surround any microorganisms on your skin with soap molecules. The hydrophobic tails of the free-floating soap molecules attempt to evade water; in the process, they wedge themselves into the lipid envelopes of certain microbes and viruses, prying them apart.

They act like crowbars and destabilise the whole system, says Professor Pall Thordarson, acting head of chemistry at the University of New South Wales. Essential proteins spill from the ruptured membranes into the surrounding water, killing the bacteria and rendering the viruses useless.

In tandem, some soap molecules disrupt the chemical bonds that allow bacteria, viruses and grime to stick to surfaces, lifting them off the skin. Micelles can also form around particles of dirt and fragments of viruses and bacteria, suspending them in floating cages. When you rinse your hands, all the microorganisms that have been damaged, trapped and killed by soap molecules are washed away.

On the whole, hand sanitisers are not as reliable as soap. Sanitisers with at least 60 per centethanol do act similarly, defeating bacteria and viruses by destabilising their lipid membranes. But they cannot easily remove microorganisms from the skin. There are also viruses that do not depend on lipid membranes to infect cells, as well as bacteria that protect their delicate membranes with sturdy shields of protein and sugar. Examples include bacteria that can cause meningitis, pneumonia, diarrhoea and skin infections, as well as the hepatitis A virus, poliovirus, rhinoviruses and adenoviruses (frequent causes of the common cold).

These more resilient microbes are generally less susceptible to the chemical onslaught of ethanol and soap. But vigorous scrubbing with soap and water can still expunge these microbes from the skin, which is partly why hand-washing is more effective than sanitiser. Alcohol-based sanitiser is a good back-up when soap and water are not accessible.

In an age of robotic surgery and gene therapy, it is all the more wondrous that a bit of soap in water, an ancient and fundamentally unaltered recipe, remains one of our most valuable medical interventions. Throughout the course of a day, we pick up all sorts of viruses and microorganisms from the objects and people in the environment. When we absentmindedly touch our eyes, nose and mouth a habit, one study suggests, that recurs as often as every two and a halfminutes we offer potentially dangerous microbes a portal to our internal organs.

No hype, just the advice and analysis you need

As a foundation of everyday hygiene, hand-washing was broadly adopted relatively recently. In the 1840s DrIgnaz Semmelweis, a Hungarian physician, discovered that if doctors washed their hands, far fewer women died after childbirth. At the time, microbes were not widely recognised as vectors of disease, and many doctors ridiculed the notion that a lack of personal cleanliness could be responsible for their patients deaths. Ostracised by his colleagues, Semmelweis was eventually committed to an asylum, where he was severely beaten by guards and died from infected wounds.

Florence Nightingale, the English nurse and statistician, also promoted hand-washing in the mid-1800s, but it was not until the 1980s that the US Centres for Disease Control and Prevention issued the worlds first nationally endorsed hand-hygiene guidelines.

Washing with soap and water is one of the key public health practices that can significantly slow the rate of a pandemic and limit the number of infections, preventing a disastrous overburdening of hospitals and clinics. But the technique works only if everyone washes their hands frequently and thoroughly: work up a good lather, scrub your palms and the back of your hands, interlace your fingers, rub your fingertips against your palms, and twist a soapy fist around your thumbs.

Or as the Canadian health officer Bonnie Henry said recently:Wash your hands like youve been chopping jalapenos and you need to change your contacts. Even people who are relatively young and healthy should regularly wash their hands, especially during a pandemic, because they can spread the disease to those who are more vulnerable.

Soap is more than a personal protectant; when used properly, it becomes part of a communal safety net. At the molecular level, soap works by breaking things apart, but at the level of society, it helps hold everything together. Remember this the next time you have the impulse to bypass the sink: other peoples lives are in your hands.

New York Times

More:
A history of soap: How it began and how it fights coronavirus - The Independent

Edited Transcript of FLXN earnings conference call or presentation 12-Mar-20 8:30pm GMT – Yahoo Finance

Woburn Mar 16, 2020 (Thomson StreetEvents) -- Edited Transcript of Flexion Therapeutics Inc earnings conference call or presentation Thursday, March 12, 2020 at 8:30:00pm GMT

* David A. Arkowitz

Flexion Therapeutics, Inc. - CFO

* Michael D. Clayman

Flexion Therapeutics, Inc. - Co-Founder, President, CEO & Director

Flexion Therapeutics, Inc. - VP of Corporate Communications & IR

The Benchmark Company, LLC, Research Division - Senior Healthcare Technology Research Analyst

Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst

* Serge D. Belanger

Good afternoon, ladies and gentlemen. And welcome to the Flexion Therapeutics Fourth Quarter and Full Year 2019 Financial Results Conference Call. My name is Daniel, and I will be your coordinator for today. (Operator Instructions)

I'll now turn the call over to the company.

Scott Young, Flexion Therapeutics, Inc. - VP of Corporate Communications & IR [2]

Thank you, Dan. Good afternoon. This is Scott Young, Vice President for Corporate Communications and Investor Relations. Before we begin, I would call your attention to the metrics slide that we will discuss in today's presentation. Those slides can be viewed directly via the webcast, in the 8-K we issued this afternoon or under the Investors tab on flexiontherapeutics.com.

In addition, our Q4 earnings press release and an archive of this conference call, can also be found there. Today's call will be led by Flexion's Chief Executive Officer, Dr. Michael Clayman; and he is joined by David Arkowitz, Flexion's Chief Financial Officer; and Melissa Layman, Flexion's newly appointed Chief Commercial Officer.

On today's call, we will be making forward-looking statements that include commercial, financial, clinical and regulatory projections. Statements relating to future financial or business performance, conditions or strategies

matters, including expectations regarding net sales, operating expenses, cash utilization, clinical, regulatory and commercial developments and anticipated milestones are forward-looking statements within the meaning of the Private Securities Litigation Reform Act.

Flexion cautions that these forward-looking statements are subject to various assumptions, risks and uncertainties, which change over time. Additional information on the factors and risks that could affect Flexion's business, financial conditions and results of operations are contained in Flexion's Form 10-K for the year ended December 31, 2019, which was filed with the SEC and other filings, which are available at http://www.sec.gov as well as Flexion's website.

These forward-looking statements speak only as of the date of this call, and Flexion assumes no duty to update such statements. I will now turn the call over to Flexion's CEO, Mike Clayman.

Michael D. Clayman, Flexion Therapeutics, Inc. - Co-Founder, President, CEO & Director [3]

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Thanks, Scott, and thank you all for joining. Today, I'll recap our commercial progress in 2019, review our life cycle management activities, provide an update on our pipeline and discuss our priorities for this year. After that, I'll turn it over to David for a deeper review of our commercial metrics and a summary of our financial performance, and then we will open the line and take questions.

To begin, as we reported today, we recorded full year ZILRETTA net sales of $73 million for 2019, which is fully in line with the preliminary unaudited revenue estimate we provided in early January. We are very pleased with our sales performance in 2019, which represents growth of more than 220%, compared to our 2018 full year net sales of $22.5 million. Those numbers tell a very compelling story, and they speak to the outstanding work of our field-based teams, the excellent coverage we have for ZILRETTA, the impact from our judicious use of volume-based rebates, but most importantly, our sales performance speaks to the remarkable experience that patients and clinicians are having with ZILRETTA. As you will see in the commercial metrics that David will review, by the end of 2019, our customers had purchased 175,000 units of ZILRETTA. While our data are limited to the account level, that number provides a reasonable surrogate for the number of patients who have been treated with ZILRETTA since it was introduced to the market in late 2017. And we know that many of those patients have received unprecedented pain relief from ZILRETTA. I say this based on real-world feedback from the countless conversations I've had with grateful ZILRETTA patients and their physicians, feedback that is wholly consistent with our compelling clinical trial data.

In fact, last year, we became aware of several professional athletes who received ZILRETTA, namely Rod Woodson, the NFL Hall of Fame Defensive back named as one of the top 100 players of all time. Michael Eruzione, the captain of the 1980 Gold medal winning U.S. Olympic Hockey team and the player who scored the game winning goal against the Russians during the Miracle On Ice; and Chris Dickerson, a former outfielder who played from the New York Yankees and other major league baseball teams. From snow blowing a driveway to playing with their children and grandchildren, to jogging for the first time in years, they all have profoundly moving stories about how ZILRETTA has helped each of them manage their knee OA pain, and thereby, improve their ability to participate in regular everyday activities. As part of our ongoing physician marketing initiatives, we brought all 3 athletes together at a major orthopedic conference last December, where they and their treating physicians, spoke to a standing room crowd of some of the country's leading sports medicine experts. They shared their stories of how ZILRETTA has helped them, and the best words I can use to describe that session are inspiring and humbling.

While all are elite athletes, their ZILRETTA stories echo the scores of e-mails and letters I've received from patients who are so grateful to reengage in things they love doing with less pain. From gardening, playing a round of golf, walking on the beach, hiking, each of these stories serves as a reminder to all of us that while we have impacted more than 175,000 patients, there are 15 million people who see their doctor every year for OA knee pain. And 5 million of them receive an intra-articular injection. The opportunity for ZILRETTA and Flexion is truly massive, which brings me back to our performance in 2019 and our goals for 2020.

Throughout the course of 2019, we saw existing practices increase their use of ZILRETTA and more than 1,600 new accounts start using the product. Today, with the benefit of 2 years in the market, we have actual claims [data that show some slight] (added by company after the call) changes in the payer mix versus our assumptions prior to launch. We now see that the actual payer mix is skewed slightly more toward Medicare, which accounts for roughly 55% of the market versus previous estimates of 50%. 40% is still commercial, but Medicaid, VA and 340B plans are making up roughly 5% of the mix. We view this modest increase in Medicare patients to be incrementally positive as Medicare patients can be injected the same-day they visit without any need for prior authorization. In addition, it is important to point out that commercial coverage for ZILRETTA remains excellent. As we discussed in December, the recent approval of our sNDA resulted in a significantly improved label, which most importantly, removed the onerous not intended for repeat administration wording in the limitation of use statement. Within days of the approval, we developed materials to help our MBMs communicate the label update and we have anecdotal feedback from the field that tells us that the changes have been very well received. While we clearly view the label update as a tailwind. We have always said that we continue to believe that the meaningful impact will be seen over the following quarters and years. From a commercial perspective, our progress in 2019 strengthens our belief that ZILRETTA can become the new standard of care for the intra-articular treatment for OA knee pain in the years ahead. While under normal circumstances, these factors would give us confidence that our 2020 ZILRETTA net sales guidance of $120 million to $135 million is both credible and achievable. Like all businesses, we are acutely attuned to the potential impacts of the coronavirus global pandemic, and we are monitoring this dynamic situation very closely. To date, we have not seen any material impacts on ZILRETTA sales, our ability to access customers or to initiate our clinical trials. However, it is impossible to predict how the outbreak could evolve in the months ahead or what impacts more aggressive social distancing or other containment efforts might have on patients or practices. Regarding our supply chain, we believe we are in a very strong position. We do not source any of our key materials from China, and we presently have approximately 10 months worth of finished product inventory in our warehouses in the U.S. Furthermore, we have an additional 12 months of API, triamcinolone acetonide at our manufacturing facility in the U.K. Again, it is impossible to predict the long-term impacts of the outbreak. But we feel very good about our ability to provide ZILRETTA to patients over the quarters ahead.

Shifting to our clinical development activities, our Phase II trial to investigate the safety and efficacy of ZILRETTA in shoulder OA and adhesive capsulitis, also known as frozen shoulder syndrome continues to advance, and we anticipate data from that trial in 2021.

As we've previously discussed, these 2 conditions combined account for roughly 800,000 injections, and they present an opportunity for us to expand the use of ZILRETTA with a subset of orthopedists, who primarily focus on sports medicine and commonly treat these conditions with steroid injections.

With respect to our pipeline, we've also been making progress with our 2 drug candidates, FX201 and FX301. FX201 is our gene therapy, which holds the potential to provide OA pain relief for at least a year, improve function and potentially modify disease. As we announced last year, the IND for FX201 was accepted by the FDA, and we recently treated the first 2 patients in our Phase I dose-ranging study. We anticipate treating approximately 15 to 24 patients, who will be followed for 104 weeks with initial readout in 2021.

Now we'll move to FX301. Our NAV 1.7 inhibitor, formulated within a thermosensitive hydrogel for administration as a peripheral nerve block for control of postoperative pain. We've held our pre-IND meeting with FDA, and we remain on track to initiate our first FX301 clinical trial in 2021.

Unlike typical local anesthetics, we believe the selective pharmacology of FX301 has the potential to deliver at least 3 to 5 days of effective pain relief, while preserving motor function, which could enable ambulation, rapid discharge from the hospital and early rehabilitation following musculoskeletal surgery.

Finally, regarding our search for a Chief Commercial Officer. We were very excited to announce the appointment of Melissa Layman earlier this week, and I'm delighted that she is able to join us for today's call. As we've said repeatedly, in our search for a CCO, we were looking for someone who had had success leading an entire commercial enterprise, who had deep experience and expertise in each of the key commercial functional domains, who had a track record as a very strong leader and who would positively contribute to our already strong culture. Because Melissa fulfills all of these criteria and is simply a terrific person to interact with. We could not be more pleased to have her take the helm of our commercial organization. Before David summarizes our fourth quarter financials and walks through the commercial metrics, I'd like to give Melissa the opportunity to make a few remarks. Melissa?

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Melissa Layman, [4]

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Thank you, Mike, and thank you for the kind words. It is such a pleasure to be here today and such an honor to join Flexion. While I've barely been in my role for a day, I can already see what an amazing group of people work here. The team has been welcoming, engaging and candid, and that was consistent throughout the entire interview process from the Executive Committee to the Board members. The commitment to patients and passion for winning has been universal, and that was one of the many reasons I wanted to join. Put simply, I can't begin to convey how excited I am about the opportunity that's ahead of us. The strong foundation that's been laid by Mike, David, Steve Meyers, and the rest of the commercial leadership team is truly impressive, and I'm looking forward to working together to grow ZILRETTA's market share and help make it the leading IA treatment in this space. Over the next few months, I'll be working intensively with our commercial organization, and I look forward to representing our commercial effort on future calls. At this point, I'll turn it over to David.

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David A. Arkowitz, Flexion Therapeutics, Inc. - CFO [5]

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Thank you, Melissa. I'll start by walking through our commercial metrics which, as Scott mentioned, can be found on our website and in the 8-K we issued today.

If you look at Slide 2, you can see that we recorded ZILRETTA net sales of $23.7 million in the fourth quarter of 2019, bringing full year 2019 net sales to $73 million. As Mike mentioned, year-over-year growth topped [220%] (corrected by company after the call). As in previous quarters, we expanded our list of target accounts in the fourth quarter to 4,972, and by December 31, 2019, we've called on almost all of them. At the end of the fourth quarter, 3,488 accounts had purchased ZILRETTA, which is an increase of nearly 360 purchasing accounts compared to the end of the third quarter.

As of the end of December, we had 2,642 accounts or 76% of all purchasing accounts place at least 1 reorder for ZILRETTA. Notably, we saw our reorder rate increase in each quarter throughout 2019, and this occurred on a successively growing customer base. Slide 3 charts our quarterly sales from launch through the fourth quarter of 2019, which provides a very compelling view of ZILRETTA's growth in the market, especially since the introduction of the permanent J Code on January 1, 2019. We do not provide quarterly guidance, but based on routine seasonality impacts, directionally, we anticipate first quarter net sales to be roughly flat versus the fourth quarter of last year.

Moving to Slide 4. This slide and the remaining 2 slides reflect purchases of ZILRETTA by accounts, which represent physician practices, clinics and hospitals of various sizes and purchasing potential. As we look at the distribution of accounts that have purchased ZILRETTA since launch, we stayed with the same groupings that we've used in previous quarters, accounts that have purchased 1 to 10 units, purchased 11 to 50 units or purchased more than 50 units. We continue to see a significant number of accounts with purchases of 1 to 10 units. And as of December 31, 2019, roughly 1,670 accounts had made purchases in this range. While approximately 1,030 accounts had purchased 11 of 50 units. In addition, 794 accounts had purchased more than 50 units, which represents growth of 150% as compared to Q1 2019 when 313 accounts had purchased in this category.

Looking at Slide number 5. You can clearly see the distribution of purchases by accounts. Those 794 accounts that have each purchased more than 50 units are in total, responsible for approximately 143,000 units or roughly 81% of all units purchased since launch. As we have mentioned previously, accounts generally move along a utilization continuum from 1 to 10 units to 11 to 50 units and then to more than 50 units. Importantly, none of our purchasing accounts has fully incorporated ZILRETTA into their practice. And this holds true for even the highest utilizers. As a result, we believe there is tremendous opportunity for us to increase utilization across each of these groups. Before I leave this slide, I would like to point out that the total ZILRETTA purchases by accounts in the fourth quarter were approximately 37,500 units, which is lower than the 48,600 units purchased in the third quarter. We believe this quarter-over-quarter reduction was primarily the result of the broad-based rebate program that we introduced in the third quarter. There was a strong amount of enthusiasm and pent-up demand for this program, and we believe that some purchases that otherwise would have occurred in the fourth quarter instead occurred in the third quarter. To a much lesser extent, we believe that the holidays in the fourth quarter had an impact on the sequential quarter reduction as well. Nevertheless, we saw total ZILRETTA purchases by accounts increased by more than 70% in the second half of 2019 versus the first half of 2019.

Moving to Slide 6. Here, we break out ZILRETTA purchases by new and existing accounts. And in the fourth quarter, we added about 350 new purchasing accounts. While we expect to eventually see a slowing in the number of new accounts coming on board each quarter, we continue to be pleased with the progress we are making with new accounts as they typically work their way through the ZILRETTA utilization continuum.

So at this point, I will briefly walk through the fourth quarter and full year 2019 financial results, which we included in the press release issued this afternoon and in our 10-K. We reported a net loss of $149.8 million for full year 2019 as compared to a net loss of $169.7 million for full year 2018. Net sales of ZILRETTA were $23.7 million for the fourth quarter of 2019 and totaled $73 million for full-year 2019. The cost of sales for full-year 2019 was $10 million. The fourth quarter 2019 net sales reflect a gross to net reduction of 11%. A gross to net reduction is primarily comprised of distributor and service fees, returns reserve, health care provider rebates and mandatory government discounts and rebates, such as Medicaid, 340B institutions, and Veterans Administration, Department of Defense. As we previously mentioned, in the third quarter, we started offering rebates to eligible health care providers that are variable based on the volume of product purchased. These provider rebates contributed 4% of the fourth quarter total gross to net reduction of 11%. Research and development expenses were $69.6 million, and $53.1 million for the years ended December 31, 2019 and 2018, respectively. The increase in research and development expenses year-over-year of $16.5 million was primarily due to an increase in salary and other related costs for additional headcount and stock-based compensation expense, an increase in expenses related to portfolio expansion and other program costs, including an upfront payment to Xenon Pharmaceuticals related to FX301, and an increase in development expenses for ZILRETTA. Selling, general and administrative expenses were $129.7 million and $121.3 million for the years ended December 31, 2019, and 2018, respectively. Selling expenses were $96.3 million and $87.3 million for the years ended December 31, 2019 and 2018, respectively. The year-over-year increase in selling expenses of $9 million was primarily due to salary and other employee-related costs and external costs related to marketing and reimbursement support activities.

General and administrative expenses were $33.4 million and $34 million for the years ended December 31, 2019 and 2018, respectively, which represents a decrease of $0.6 million year-over-year. Interest expense was $17.1 million and $15.7 million for the years ended December 31, 2019 and 2018, respectively. We expect that while our operating expenses will continue to increase in the near term, primarily driven by commercial activities in support of ZILRETTA, line extension clinical trials for ZILRETTA, continued development of FX201 and FX301 and development activities associated with future additions to the pipeline. We believe we will be able to increasingly leverage our infrastructure in support of these efforts. As of December 31, 2019, we had approximately $136.7 million in cash, cash equivalents and marketable securities compared with $258.8 million as of December 31, 2018. In addition, earlier this quarter, we fully drew down $20 million from our revolving credit facility, which is secured by our accounts receivables. We believe that our current cash balance with the expected future sales [of ZILRETTA] (added by company after the call) and the ongoing prudent management of our expenses will enable us to reach profitability. However, our projections are based on certain market assumptions, which may or may not be affected by the coronavirus pandemic. As a result, we will continue to review and reassess our [assumptions] (added by company after the call)

in light of those factors. In addition, we will remain opportunistic as it relates to potential funding decisions, and we will do what we believe is in the best long-term interest of Flexion and our shareholders.

At this point, I would ask the operator to please open the line for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Our first question comes from Randall Stanicky with RBC Capital Markets.

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Daniel James Busby, RBC Capital Markets, Research Division - Senior Associate [2]

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This is Dan Busby on for Randall. A couple of questions. First, among the high-prescribing accounts, in particular, can you give us a sense of how much more room there is to grow within those practices? I think I heard you mentioned that you haven't fully penetrated any of those accounts yet. And of the physicians in those accounts who aren't using it, what's the pushback you're hearing?

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David A. Arkowitz, Flexion Therapeutics, Inc. - CFO [3]

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Yes, Dan, this is David. So as we shared in our prepared remarks and in the deck, we've got almost 800 accounts that have purchased 50 units, more than 50 units of ZILRETTA launch to date. In the vast, vast majority of those accounts, ZILRETTA has not been fully adopted, incorporated into their practices and even there's a subset within those accounts of almost 50 accounts that have purchased more than 500 of units of ZILRETTA launch to date. So there's room to run with those almost 800 accounts as well as the other accounts that are less than 50 units of ZILRETTA purchased launch to date. And in terms of the other part of your question, in terms of why have they not fully incorporated ZILRETTA at this juncture. The way this will typically work is take a practice with 5 or 6 physicians [1 or] (added by company after the call) 2 of those physicians have started to use ZILRETTA and are using ZILRETTA for their patient -- appropriate patient population. But there just hasn't been awareness and experience with ZILRETTA for the other 3 or 4 docs in the practice. So it's a process. It's a process for the docs that are treating the existing patients to talk to their colleagues or our representatives to be making those physicians that are not yet using ZILRETTA, aware of ZILRETTA, getting them comfortable with reimbursement. So that's really what is going on.

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Daniel James Busby, RBC Capital Markets, Research Division - Senior Associate [4]

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Okay, that's helpful. And I guess, as a follow-up to that, if 1 practice, if 1 or 2 physicians within a practice, have secured reimbursement? Is it typically the case that other doctors who aren't using it, but may in the future, they would have reimbursement set up already? Or is that more kind of doctor by doctor?

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David A. Arkowitz, Flexion Therapeutics, Inc. - CFO [5]

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No, it's typically at the office level, at the clinic level. But the -- it's an issue of just getting familiar and comfortable with reimbursement, experiencing reimbursement, and that takes those docs that have not achieved that to just go through the process.

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Operator [6]

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Our next question comes from Elliot Wilbur with Raymond James.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [7]

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A couple of questions. First, Mike, I believe you mentioned in your commentary that you expect 1Q 2020 ZILRETTA sales to be essentially flat versus 4Q '19. Just want to get maybe a little bit more color behind that? How much of that you think is attributable to high deductible plans, perhaps influencing utilization versus other factors such as seasonality or just sort of overall company conservatism kind of in light of potentially increased macro uncertainty here in the short term?

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Michael D. Clayman, Flexion Therapeutics, Inc. - Co-Founder, President, CEO & Director [8]

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Yes. So I think there are a few things, Elliot. So it's a good and important question. First, just to recognize, historically, in this space, the hyaluronic acids are typically down 10% in the first quarter, with the driver being, as you point out, deductible. That is a key driver. I think that you also have to look at an older population may be less active in the winter months. And as a result, have less need to go to their physicians. So there are a couple of reasons why there is a basis for, relatively speaking, the first quarter being softer than other quarters and why we have guided to flat in the first quarter.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [9]

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Okay. And then with respect to your commentary around some of the data points that emerge from the claims data that you're referring to in terms of the payer mix with Medicare representing now a higher proportion. How should we think about the relative opportunity with respect to additional growth levers such as repeat administration, bilateral administration within the context of a greater Medicare book of business versus commercial?

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Michael D. Clayman, Flexion Therapeutics, Inc. - Co-Founder, President, CEO & Director [10]

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Yes, it's a good question. We -- as you know, the Medicare population has the opportunity to benefit most directly in a sense from ZILRETTA and that physicians can use same-day without any hesitancy and proceed with confidence that they will be reimbursed. They can repeat dose without any concern about reimbursement. They can do bilateral injections, et cetera. So we like the Medicare population. We also like the commercial population. It's very straightforward with Medicare. And I would say directionally, as a modest bump up in the representation of Medicare is, wind in our sails and will improve our circumstances. As we often say, this is not a light switch, but it's directionally encouraging.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [11]

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Okay. And then just a couple of financial questions for David as well. With respect to SG&A trends, they've held relatively flat in the $32 million, $33 million range over the last 4 quarters, not sure kind of directionally would expect it to increase, but obviously, you've been able to get a lot more leverage out of that line than probably what we would have expected at the beginning of the year. So how should we think about progression of that number over the course of 2020?

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David A. Arkowitz, Flexion Therapeutics, Inc. - CFO [12]

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Yes, Elliot, great question. So to your point, it has been relatively flat quarter-over-quarter in 2019 the G&A component of that. So if you just look at quarterly SG&A for fourth quarter about 20 -- excuse me, about $32 million, about $8 million of it is G&A, that will stay flat in the ensuing quarters. $24 million of it is commercial. And as we've talked about before, slightly more than half of that is related to headcount and support of spend, and we are right-size from a headcount standpoint. So increases in that portion will be minimal, where we're going to see some increases over time are external marketing activities in support of increasing ZILRETTA sales. But because that's only less than half of the selling and marketing spend, you're not going to see SG&A go up by meaningful amounts quarter-over-quarter. And on top of all that, as you might imagine, we're very focused on leveraging as best we can, our SG&A infrastructure that we've built up over the past 4 quarters.

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Edited Transcript of FLXN earnings conference call or presentation 12-Mar-20 8:30pm GMT - Yahoo Finance

Why soap works – even on coronavirus – and how its discovery altered human history – Chattanooga Times Free Press

It probably began with an accident thousands of years ago. According to one legend, rain washed the fat and ash from frequent animal sacrifices into a nearby river, where they formed a lather with a remarkable ability to clean skin and clothes. Perhaps the inspiration had a vegetal origin in the frothy solutions produced by boiling or mashing certain plants. However it happened, the ancient discovery of soap altered human history. Although our ancestors could not have foreseen it, soap would ultimately become one of our most effective defenses against invisible pathogens.

People typically think of soap as gentle and soothing, but from the perspective of microorganisms, it is often extremely destructive. A drop of ordinary soap diluted in water is sufficient to rupture and kill many types of bacteria and viruses, including the new coronavirus that is currently circling the globe. The secret to soap's impressive might is its hybrid structure.

Soap is made of pin-shaped molecules, each of which has a hydrophilic head -- it readily bonds with water -- and a hydrophobic tail, which shuns water and prefers to link up with oils and fats. These molecules, when suspended in water, alternately float about as solitary units, interact with other molecules in the solution and assemble themselves into little bubbles called micelles, with heads pointing outward and tails tucked inside.

Some bacteria and viruses have lipid membranes that resemble double-layered micelles with two bands of hydrophobic tails sandwiched between two rings of hydrophilic heads. These membranes are studded with important proteins that allow viruses to infect cells and perform vital tasks that keep bacteria alive. Pathogens wrapped in lipid membranes include coronaviruses, HIV, the viruses that cause hepatitis B and C, herpes, Ebola, Zika, dengue, and numerous bacteria that attack the intestines and respiratory tract.

When you wash your hands with soap and water, you surround any microorganisms on your skin with soap molecules. The hydrophobic tails of the free-floating soap molecules attempt to evade water; in the process, they wedge themselves into the lipid envelopes of certain microbes and viruses, prying them apart.

"They act like crowbars and destabilize the whole system," said professor Pall Thordarson, acting head of chemistry at the University of New South Wales. Essential proteins spill from the ruptured membranes into the surrounding water, killing the bacteria and rendering the viruses useless.

In tandem, some soap molecules disrupt the chemical bonds that allow bacteria, viruses and grime to stick to surfaces, lifting them off the skin. Micelles can also form around particles of dirt and fragments of viruses and bacteria, suspending them in floating cages. When you rinse your hands, all the microorganisms that have been damaged, trapped and killed by soap molecules are washed away.

On the whole, hand sanitizers are not as reliable as soap. Sanitizers with at least 60% ethanol do act similarly, defeating bacteria and viruses by destabilizing their lipid membranes. But they cannot easily remove microorganisms from the skin. There are also viruses that do not depend on lipid membranes to infect cells, as well as bacteria that protect their delicate membranes with sturdy shields of protein and sugar. Examples include bacteria that can cause meningitis, pneumonia, diarrhea and skin infections, as well as the hepatitis A virus, poliovirus, rhinoviruses and adenoviruses (frequent causes of the common cold).

These more resilient microbes are generally less susceptible to the chemical onslaught of ethanol and soap. But vigorous scrubbing with soap and water can still expunge these microbes from the skin, which is partly why hand-washing is more effective than sanitizer. Alcohol-based sanitizer is a good backup when soap and water are not accessible.

In an age of robotic surgery and gene therapy, it is all the more wondrous that a bit of soap in water, an ancient and fundamentally unaltered recipe, remains one of our most valuable medical interventions. Throughout the course of a day, we pick up all sorts of viruses and microorganisms from the objects and people in the environment. When we absentmindedly touch our eyes, nose and mouth -- a habit, one study suggests, that recurs as often as every 2 1/2 minutes -- we offer potentially dangerous microbes a portal to our internal organs.

Washing with soap and water is one of the key public health practices that can significantly slow the rate of a pandemic and limit the number of infections, preventing a disastrous overburdening of hospitals and clinics. But the technique works only if everyone washes their hands frequently and thoroughly: Work up a good lather, scrub your palms and the back of your hands, interlace your fingers, rub your fingertips against your palms, and twist a soapy fist around your thumbs.

Or as the Canadian health officer Bonnie Henry said recently, "Wash your hands like you've been chopping jalapeos and you need to change your contacts." Even people who are relatively young and healthy should regularly wash their hands, especially during a pandemic, because they can spread the disease to those who are more vulnerable.

Soap is more than a personal protectant; when used properly, it becomes part of a communal safety net. At the molecular level, soap works by breaking things apart, but at the level of society, it helps hold everything together. Remember this the next time you have the impulse to bypass the sink: Other people's lives are in your hands.

The New York Times

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Why soap works - even on coronavirus - and how its discovery altered human history - Chattanooga Times Free Press