Tuesday, January 29, 2019
FibroGen shares have ‘significant upside’ on positive data, says Mizuho
Following positive efficacy results from roxadustat in December, investor attention remains focused on the upcoming MACE safety data expected around April, Mizuho analyst Difei Yang tells investors in a research note. The analyst sees “strong potential” in roxadustat and believes the drug could be a safer alternative to erythropoiesis-stimulating agents. Yang’s base case scenario has $21 per share of upside on the data readout versus $8 per share downside in her bear case scenario. She sees “significant upside” if the data are positive and reiterates a Buy rating on FibroGen with a $74 price target.
https://thefly.com/landingPageNews.php?id=2854859
Monday, January 28, 2019
Antimicrobial Fragrance Shows Efficacy against Tuberculosis
Singapore Exchange-listed Singapore eDevelopment Limited (Stock Code 40V) (“SeD”) wishes to announce today that its U.S. biomedical subsidiary, Global BioLife Inc. (“Global BioLife”) has a product known as 3F Antimicrobial Fragrance which shows efficacy against tuberculosis.
Tuberculosis is the leading cause of deaths from a single infectious agent, infecting about one quarter of the world’s population. The bacteria that causes the tuberculosis disease is spread through the air by infected tuberculosis patients when they cough, sneeze, or otherwise eject infected fluids into the air. Tuberculosis has caused over 1.6 million deaths and has infected over 10 million people in 2017, placing it in among the top 10 leading causes of deaths worldwide according to the World Health Organisation.
Mr. Daryl Thompson, Global BioLife’s Director of Scientific Initiatives, a biochemist nominated for the Nobel Prize in 2015 and 2016 for his research on pandemic technology, leads the 3F research, including the research and development of the 3F Antimicrobial Fragrance.
“The 3F project was designed to provide a solution for open environment defence strategies to prevent or suppress the transmission of aerosoled viral and bacterial particles that cause the spread of influenza, MRSA and tuberculosis in congested areas. 3F works by taking advantage and exploiting the bacterial or viral sophisticated communication system called quorum sensing. In essence, we can utilise quorum sensing to instruct the bacterial or viral agent to shut down or stop replication. The process has been demonstrated to be very effective.”
The fragrance was shown to inhibit Mycobacterium tuberculosis (MTB), the causative bacterial agent of tuberculosis. These experiments were performed at ATCC, as a custom service, within its High Containment Laboratory under BioSafety Level 3 conditions. Since 1925, ATCC has been a premier global biological materials and information resource and standards organization. The company has a proven expertise in the safe handling and experimentation on dangerous pathogens such as MTB.
“As a leading developer and supplier of authenticated cells lines and microorganisms, ATCC was honored to provide Global BioLife, Inc., with its custom susceptibility testing services to determine if their product was able to kill MTB,” said Dr. Manzour Hazbon, ATCC Senior Scientist at ATCC. “To find new drugs to kill TB is very difficult and this fragrance proves to be very effective even in low concentrations – this is an excellent tentative candidate to treat tuberculosis, which is particularly important because there are few antibiotics effective in treating antibiotic-resistant tuberculosis cases”, explains Dr. Hazbon.
Mr Chan Heng Fai, Executive Chairman of SeD said, “We are excited about the potential of this breakthrough in 3F Antimicrobial and Global GioLife will step up in its continued efforts to provide cutting edge research into real solutions for global healthcare problems.”
A highly-regarded public health expert and former Senior Assistant Surgeon General of the U.S., Dr. Roscoe M. Moore Jr., serves as Senior Scientific Adviser to Global BioLife.
“I’m excited about 3F’s potential to address a global epidemic by providing safe and versatile protection layers,” says Dr. Roscoe M. Moore Jr.. “Tuberculosis is a global priority and Global BioLife’s solution will help save lives on a global scale.”
Dr. Roscoe M. Moore Jr. served as an Epidemic Intelligence Service Officer with the U.S. Center for Disease Control and Prevention and as the Chief Epidemiologist with the Center for Devices and Radiological Health in the U.S. Food and Drug Administration.
Also advising Global BioLife is Lieutenant Colonel William H. Lyerly Jr., a retired Career Senior Executive / Scientific Professional (ST) from the U.S. Government Civil Service, and also a retired U.S. Army Medical Service Corps Officer. Lieutenant Colonel William H. Lyerly Jr. has an extensive medical background including a significant operational and policy-level experience in disaster relief, development, biodefense, interagency and civilmilitary cooperation and teaching.
“As TB’s person-to-person spread requires only the inhalation of a small number of the MTB bacteria, transmission is most rapid in confined spaces, such as in prisons, nursing homes, chronic care conditions, detoxification centers, refugee camps, hospitals, schools and airplanes. It is for this reason that such an important breakthrough in the 3F Antimicrobial Fragrance’s efficacy against tuberculosis is especially promising. Further, as multidrug-resistant TB continues to be a global public health crisis and health security threat, the prospect for preventing MTB transmission through a cost-effective environmental intervention such as 3F rather than relying on treatment of infected individuals, could represent a very effective and less-costly TB control strategy in hightransmission areas, worldwide.”
During his 43-year career, Lieutenant Colonel William H. Lyerly Jr. served in the U.S. Agency for International Development (USAID) as the Tropical and Infectious Diseases Coordinator for Africa, and HIV/AIDS Coordinator for Africa. He also served a year in the Executive Office of the President as the Bio-Countermeasures Lead in the White House’s Office of Homeland Security Transition Planning.
Global Biolife Inc. has partnered with consulting firm, Destum Partners Inc., to evaluate and license both 3F Mosquito and 3F Antimicrobial technology globally to manufacturers and distributers. 3F Mosquito is a revolutionary alternative to traditional mosquito repellents like DEET. 3F Mosquito was developed as an additive to laundry detergents, shampoos, and lotions to provide layered protection against mosquitos. 3F Antimicrobial is designed to be added into sprays, filters and air dispersal systems in airplanes, transit areas, arenas, hospitals, and open areas worldwide to provide multifaceted protection against bacteria and viruses.
Richmond, Va., has $500M+ of hospital projects planned or under construction
- The Richmond, Virginia, region has more than $500 million of hospital projects under construction and more are at various stages in the development pipeline, the Richmond Times-Dispatch reported.
- The VCU Health System has $534 million of projects underway — a 16-story, 603,000-square-foot outpatient building ($349 million); a 114-bed, 212,000-square-foot rehabilitation hospital ($95 million) and an eight-level, 154,000-square-foot Virginia Commonwealth University College of Health Professions building ($87 million). HCA Virginia and Bon Secours Virginia Health System also have construction, expansions, major and minor renovations of ambulatory, outpatient, specialty, emergency and medical office projects in design and development stages.
- Many of the projects are aimed at reaching patients who don’t currently live near a major hospital, and the pace is being driven, in large part, by the needs of aging residents and population growth in the area.
Hospitals and health systems in some areas are building and expanding despite difficult financial circumstances arising from softening admissions and reimbursement rates. Massachusetts General Hospital, for example, just announced a $1 billion project adding to its downtown Boston campus. Renovations are more of the trend, along with construction of outpatient facilities, according to a 2018 Health Facilities Management survey.
Just as with many other sectors, there are construction companies that specialize in healthcare projects, particularly big hospitals, and these contractors must be well-versed in what the Facilities Guidelines Institute has set out as design and construction best practices for medical projects. The state of Virginia is one of 39 U.S. states that have incorporated FGI guidelines into their healthcare construction regulations.
Adherence to these best practices is important not only for process reasons — cost control and scheduling — but for patient health as well. According to general contractor and construction manager Structure Tone, 5% to 7% of the 100,000 deaths from hospital-acquired infections each year are a result of something they were exposed to during the course of a construction project.
Like the specifications for many construction projects, the FGI guidelinesput forth lots of specifics. These include directions on maintaining a one-way, dirty-to-clean workflow in sterile processing areas; dimensions for different types of rooms, like those for operating, critical care and imaging; accommodations for special needs patients; the placement and number of grab bars; and ventilation requirements. The most recent edition of the FGI guidelines was published in 2018, and the next one is due in 2022.
Contractors like Turner Construction, McCarthy Holdings, Brasfield & Gorrie, Skanska USA and DPR Construction are some of the foremost experts in the healthcare construction field, according to Building Design + Construction, and that expertise is reflected in the revenue they bring in for these types of projects.
Turner Construction is overseeing construction of a 10-story, $738 million addition at New York City Health and Hospitals/Coney Island Hospital in Brooklyn, New York City. In addition to the new building, Turner is also supervising construction of a flood wall that will help to increase the facility’s ability to withstand and recover from major storms and flood events.
Why home health tech is capturing investment
Enthusiasm for home health technologies continues to mount, fueled by the aging population, demands for personalized healthcare and convenience, population health efforts and the shift to value-based care.
The global smart home healthcare market is set to hit $30 billion by 2023, up from $4.5 billion in 2017, according to ResearchAndMarkets. Of that, fall prevention and detection accounts for the largest share with 39% in 2017. Other major categories include safety and security monitoring, health status monitoring, memory aids and nutrition and diet monitoring.
That includes popular home assistants like Google and Amazon, as well as apps, wearables and devices for monitoring glucose and blood pressure. In September, voice-powered care assistant Aiva Health got an undisclosed injection from the Google Assistant Investment Program. The startup uses Google Home, Amazon Echo and other smart speakers to engage patients and the elderly and connect them with their caregivers.
Retailers are eyeing the market, too. Last summer, Best Buy put down $800 million in cash to acquire GreatCall, a mobile device that connects health and emergency response services to older people and their caregivers. The deal is part of a broader plan to expand Best Buy’s electronics expertise into the aging-in-place and personal health technologies markets.
Meanwhile, investors are pouring billions of dollars into technologies that can enhance care in the home. Patient empowerment tools received the most funding of any function in 2018, according to a recent StartUp Health report. The bulk of these tools focus on helping patients navigate the health system, telehealth and patient engagement. The top-funded specialty within this function was primary care at $591.8 million, followed by specialty agnostic companies at $463.4 million and aging/senior care at $417.5 million.
Looking ahead to the coming year, two themes pop up over and over again: convenience and communication.
“Anytime you see solutions where it’s saving time for the care provider and making it easier for them to connect with the patient, but it’s also doing the same thing for the patient, is where we’re seeing success,” says Unity Stoakes, president and cofounder of StartUp Health, which invests in healthcare companies.
Providers eye diagnostics, patient monitoring
While aging-in-place is a big investment category, Stoakes sees home health products targeting all demographics and age groups because of convenience and cost savings.
One Medical and Forward for example are targeting millennials and younger consumers who want to schedule an appointment or fill their prescriptions online, or have a video chat with their doctor from the convenience of home.
Enthusiasm for telehealth has grown steadily and will continue to do, with major health systems like Kaiser Permanente, Mayo Clinic and Intermountain Healthcare investing heavily in the technology. For example, Kaiser Permanent CEO Bernard Tyson has attributed a shift from in-person to virtual visits — 52% of the integrated health system’s 100 million annual encounters in 2017 — to strong investment in technology. Roughly a quarter of Kaiser Permanente’s $3.8 billion annual capital spend that year was IT-related.
Mayo Clinic has a teleneonatology program that has helped reduce unnecessary transfers and increased patient referrals to the health system. And Intermountain Healthcare launched a ‘virtual hospital’ to spur the transition to digital health while addressing population health issues.
Diagnostics and continuous monitoring are very big areas, as are products that focus on prevention and wellness, stress reduction, behavior change and other things that impact long-term health and outcomes, Stoakes told Healthcare Dive.
In the senior healthcare monitoring area, two companies generating buzz are CarePredict and Emerald. Plantation, Florida-based CarePredict uses a wearable and smart sensor system placed throughout the home to learn behaviors and trigger interventions by caregivers or families if Grandma didn’t get out of bed, use the bathroom, eat or show other signs of normal activity.
Similarly, MIT startup Emerald creates a radio mesh network that interacts with the water composition in a person’s body and measures their breathing, heart rate and movements on an entire floor of a home. It can also tell if a person is sitting, standing, crawling or falling, making it useful in fall detection and prevention.
“Anything where you can measure gait and get out in front of it — we can anticipate there may be a problem — is super important,” says Andy Miller, senior vice president for innovation and product development at AARP.
Digital therapeutics
Digital therapeutics and technologies to improve medication compliance are also hot items. Last fall, Otsuka America Pharmaceutical rolled out a digital version of its antipsychotic drug Abilify, called Abilify MyCite, which contains an ingestible device that tracks whether the pill was taken. The digital drug is indicated for people with schizophrenia, bipolar 1 disease and major depressive disorder.
Another player in this area is Pillo Health, which uses a robotic companion and facial recognition technology to dispense medications to people at home. The hands-free, HIPAA-compliant platform also acts as an extension to the caregiving team, allowing clinicians and family members to push content, such as side effects or a nutritional plan, into the device.
There’s also smart pill bottle AdhereTech, which notes whether patients take their medication, in the right amount and at the right time, and wirelessly beams the data to their care provider. If someone forgets to take their meds or takes the wrong dose, the provider can contact them and help them get on track. The device also includes reminders and alerts.
In the area of diagnostics, Butterfly Health sells a low-cost, handheld, personal ultrasound and smartphone app that lets users upload images to the cloud for analysis by a healthcare professional. The device — which sells for about $2,000 versus $15,000 and more for a standard ultrasound machine — received FDA clearance in 2017 for diagnostic imaging of urological, cardiovascular, fetal, gynecological and musculoskeletal anatomies.
Butterfly raised $250 million last year in a Series D funding round led by financial services firm Fidelity. The round also included China-based Fosun Pharmaceutical and the Bill & Melinda Gates Foundation. While initially aimed at doctors and consumers, co-founder Jonathan Rothberg told MIT News that he hopes eventually to sell the device directly to consumers.
Integration
Experts say integration is key to advancing home health tools.
Like Amazon two years ago, Google Assistant “was everywhere” at 2019’s Consumer Electronics Show, Miller says. That’s noteworthy not just for Amazon or Google, but for what it means about the ability to leverage voice to navigate devices and information in a way that works for individuals.
“When you see this integration, as it’s happening with both Amazon and Google, it’s unlocking all kinds of potential with what were otherwise just thought of as point solutions,” he tells Healthcare Dive.
As more integration occurs, people will be able to seamlessly use a variety of devices to capture their health data, nutrition, activities and other information for personal use and to share with providers or loved ones.
Privacy and data security remain big issues where personal health data is involved. Users need to know what’s being integrated, who’s doing it, where the data are going and whether it is benefiting them and their outcomes, Miller says. But the potential to expand access and improve outcomes is there.
Stoakes agrees. “The more we see these larger platforms used, I think that’s better for the ecosystem,” he says.
Stoakes points to recent success in China and India, where healthcare tools are working on established platforms like WiiChat and others with hundreds of millions or billions of users. “It can be a very effective way to bring health into the home,” he says.
Barriers remain
Despite growing awareness and use of home health technologies, challenges remain. The main barriers are cost and perceived sophistication tied to integrating into or using technologies in the home, since it’s often adult children who are buying and setting up these tools, Miller says. Caregivers want to feel comfortable with setting up and maintaining technologies for their loved ones.
Unfortunately, there’s no ‘curated package’ of home technologies that work seamlessly together — plug this in and this in and this is and go, he adds. AARP recently started working with a company out of Brooklyn, New York, called tech.ur.elders, a chatbot to empower millennials caring for older parents.
Meanwhile, payers are trying to get out in front of the costs associated with people aging in place. Miller notes a UnitedHealthcare pilot around falls in the home found it was often cheaper to go into peoples’ homes and replace carpeting, which has edges people can trip over, with tile or hardwood floors than to reimburse for repeated falls.
“They’re very much looking at it,” Miller says. “I think they’re trying to figure out and qualify the data as to these difference devices or solutions and what it means for an ROI if they were to go down that path.”
HIMSS19: 5 panels you don’t want to miss
Come February, more than 45,000 healthcare execs will congregate in Orlando for the largest health IT conference of the year: HIMSS19.
Though most companies are tight-lipped about major announcements pegged to the conference, a HIMSS-owned publication has been teasing select tidbits.
Oracle plans to debut a remote patient monitoring system, global software company Infor will unveil its near-complete FHIR-based data management tech and a new risk assessment and documentation application will be offered by health IT vendor Arcadia.io.
One bit of news that won’t happen: Atul Gawande, originally a keynote speaker, dropped out of speaking in mid-January without explanation, deepening the air of mystery around the Amazon-Berkshire Hathaway-J.P. Morgan Chase venture (though Amazon still has a strong presence at the event).
Tried and true topics of interoperability, electronic medical records and meaningful use will have their place, as well as hospitals fighting to siphon extraneous cost out of the system.
“Everyone is seeing their margins shrinking because of payment mix changes and new regulation, and then a continual increase in their overall cost when it comes to both labor and materials,” Vince Vickers, healthcare technology leader at KPMG, told Healthcare Dive.
The big focus on HIMSS will be on tech and processes that help companies become more efficient, like cloud products, intelligent automation and machine learning, along with methods of gaining customers and locking them in, like stressing consumer interaction and cybersecurity, he predicts.
Here are five key panels to watch where big names are likely to make some major news around these trends.
Will Consumer-Directed Exchange Disrupt the Healthcare Marketplace?
The first can’t miss event is Tuesday’s opening keynote. The “Will Consumer-Directed Exchange Disrupt the Healthcare Marketplace,” panel includes CMS Administrator Seema Verma, former HHS head Mike Leavitt, President Obama’s acting HHS Secretary Karen DeSalvo and former Obama Chief Technology Officer Aneesh Copra.
More patients are picking sites of care and providers based on convenience and access than any other factor (including care quality itself).
Key to consumerism and competition driving the healthcare market, though, is transparent and actionable data, one focus of the Trump administration to ameliorate the myriad of problems plaguing care coordination.
It would be a mistake to attend the panel just because of Verma’s presence, though.
As HHS secretary under President George W. Bush from 2005 to 2009, Leavitt led the implementation of the Medicare Part D prescription drug program.
Leavitt Partners recently made news by issuing a report finding ACOs seeking to participate in the Medicare Shared Savings Program might need to expect a shorter time period to gain savings before CMS expects them to take on more risk.
Karen DeSalvo, now a professor at Dell Medical School at the University of Texas at Austin, will likely have some insight into interoperability and data access.
Aneesh Chopra served as the first CTO of the United States, appointed by President Obama in 2009. The original Blue Button program, a system that allowed veterans online access and the ability to download their medical records, was launched by his department in 2010 before being reincarnated last year by Verma for Medicare.
Moderated by HIMSS President Hal Wolf, the keynote will “explore the policy impact and market-disruption possibilities empowered consumers are having on healthcare delivery,” according to the HIMSS website.
Expect a conversation focused around what the government can do to facilitate personal health record access and price transparency for consumers, how the industry can move to seamless data sharing and how businesses and ACOs can leverage analytics to improve population health.
The keynote will be held Feb. 12 at 8:30 a.m. in the Valencia Ballroom.
Advancing Patient Matching to Promote Interoperability
Interoperability remains an evasive goal for the healthcare system as the U.S. pushes toward a future where digital patient records follow patients to different providers.
The Pew Charitable Trusts’ Ben Moscovitch and Rita Torkzadeh will host a discussion on the state of patient matching and the steps that need to be taken to achieve interoperability.
Pew has been actively pushing the government to adopt unique device identification numbers in claims data and improve data standardization.
Verma has also used her bully pulpit to advance the effort.
“As the head of CMS, one of my main missions is to break down any and all barriers to interoperability, and create that one-stop shop for health data that will help inform our health care decisions with a complete picture of our medical history,” Verma said in a speech at the ONC Interoperability Forum in August.
Moscovitch and Torkzadeh’s talk will share findings from interviews with hospital leaders, new research and focus groups with patients.
“We’re going to underscore the types of challenges that contribute to patient matching problems and provide an overview of research conducted by Pew to help address patient matching challenges,” Moscovitch said.
A pending Office of the National Coordinator for Health IT rule at the White House Office of Management and Budget is a key document to keep an eye on.
“We’ll also examine two key opportunities to improve patient matching: first, the benefits of standardizing demographic data and steps ONC can take to advance those standards, and second, focus groups we conducted with patients underscored patient interest in the use of biometrics, but several key question remain to protect privacy and security.”
The session will be held Feb. 12 at 10:30 a.m. in room W303A of the convention center.
Congressional Forum
With power now shared between Democrats and Republicans in Congress for the first time during President Donald Trump’s time at the White House, legislative priorities that are bipartisan are at top of mind for lawmakers.
This panel of top congressional staffers looks to be a prime opportunity for industry to get a glimpse into the thinking of the legislative branch.
While Congress has been relatively silent on the health IT front, further action to encourage interoperability, stopping information blocking and perhaps a renewed look at the Health Insurance Portability and Accountability Act are areas raised by Health IT Now. The trade organization is set to rebrand itself as the Health Innovation Alliance at HIMSS.
While health IT is at front of mind at HIMSS, drug pricing is another area that could be discussed. Last year, Trump’s HHS unveiled a proposal to benchmark certain drug prices to levels seen in foreign countries.
The congressional forum will be held at the same time as the patient matching session (10:30 a.m. on Feb. 12), but in room W300.
Interoperability and Patient Engagement
As the industry waits for more concrete guidance from the government on interoperability, forums like HIMSS are a prime setting for key players to discuss the biggest barriers to the open flow of information and how to cut them down.
A panel of experts earlier this month argued the bedrock of the technology is already there, and any more meaningful steps toward interoperability will involve streamlining the software side.
The panel will likely touch on the government’s work with interoperability and patient engagement programs such as MyHealthEData, Blue Button 2.0, Meaningful Use and the Office of the National Coordinator for Health IT’s Interoperability Standards Advisory.
Two officials with the power to move on the federal side, Verma of CMS and Azar, will speak Tuesday at the session. Verma is currently slated to speak at just two events and Azar only at this one, so it’s a can’t-miss.
The panel will be 2/12 at 5:30 p.m. in room W320.
Transparency in Prescription Drug Costs to Help Patients Save Money
Price spikes for prescription drugs have drawn fire from insurers, pharmacy benefit managers advocacy groups and across the political aisle.
This panel is stacked. The always eclectic Steve Miller, now chief clinical officer at Cigna, will be joined by Surescripts CEO Tom Skelton and CVS Health Chief Medical Officer Troyen Brennan.
The panel will focus on current drug pricing trends and efforts to bring transparency to the pricing system.
Azar has made it clear he places considerable blame on drug companies themselves for high list prices. But the powerful cabinet member has also slammed the role the PBM rebate system contributes to distorting pricing signals.
“What’s standing in the way of that competition is sometimes referred to as the ‘rebate wall.’ It’s only a good deal for defenders of the status quo, whether that’s manufacturers selling certain drugs or pharmacy benefit managers negotiating big rebates,” Azar said earlier this month at the Price of Good Health Summit.
With mergers between CVS and Aetna as well as Cigna and Express Scripts creating new entities that promise to lower healthcare costs, Miller and Brennan are in a position to shape how healthcare is delivered for millions of Americans.
You’ll be able to hear from them Feb. 13 at 8:30 a.m. in room W304A.
Innate Pharma gets FDA fast track for T-cell lymphoma type med
- Fast Track designation (FTD) is intended to expedite the development and regulatory review of IPH4102 for the treatment of adult patients with relapsed or refractory Sézarysyndrome (SS) who have received at least two prior systemic therapies
- FTD is based on the evaluation of Phase I results demonstrating strong clinical activity, favorable safety and substantial improvement in quality of life
- TELLOMAK, a global, multi-cohort, Phase II study evaluating the potential of IPH4102 in different subtypes of T-cell lymphomas, will be initiated in the first half of 2019
Innate Pharma SA (the “Company” – Euronext Paris: FR0010331421 – IPH) announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to IPH4102 for the treatment of adult patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies. IPH4102 is Innate Pharma’s wholly-owned first-in-class anti-KIR3DL2 antibody, developed for the treatment of T-cell lymphoma.
Fast Track is a process designed to facilitate the development and expedite the regulatory review of investigational drugs to treat serious conditions and fill an unmet medical need.
“We are pleased that the FDA has granted Fast Track designation to IPH4102 as there remains a high need for treatment options with strong efficacy and adequate safety profile to allow for treatment of Sézary syndrome, the most aggressive form of cutaneous T-cell lymphoma (CTCL),” said Pierre Dodion, Chief Medical Officer of Innate Pharma. “IPH4102 is a key element of our strategy to build a commercial franchise of treatments focused on rare cancers in the field of hemato-oncology. We intend to initiate a global multi-cohort Phase II study (TELLOMAK) in the first half of 2019 to confirm the clinical activity of IPH4102 in Sézary syndrome and evaluate the potential in other subtypes of T-cell lymphomas, including Mycosis fungoides (MF) and peripheral T-cell lymphoma (PTCL). We look forward to working with the FDA to advance this promising program through clinical development.”
Sézary syndrome is the leukemic variant of cutaneous T-cell lymphoma (CTCL), a heterogeneous group of non-Hodgkin’s lymphomas which arise primarily in the skin. Patients often experience very poor quality of life with severe and debilitating pruritus (chronic itchy skin). Despite recent advancements, Sézary syndrome is associated with a high relapse rate with currently available therapies.
Fast track designation is based on preliminary results of the Phase I dose-escalation and expansion study of IPH4102 in advanced CTCL (n=44). As of October 15, 2018, data from the subgroup of 35 SS patients revealed strong clinical activity, demonstrated by an overall response rate (ORR) of 42.9%, median duration of response (DoR) of 13.8 months and median progression-free survival (PFS) of 11.7 months. The ORR appeared to be higher (n=28, 53.6%) in patients with no histologic evidence of large cell transformation (LCT)1. Importantly, clinical activity was associated with a substantial improvement in quality of life as assessed by the SkinDex29 and Pruritus Visual Analog Scale (VAS) scores. IPH4102 displayed a favorable safety profile, consistent with previous observations.
Sartorius : ’18 Sales, Earnings up Double Digits; Profitable ’19 Growth Planned
- Group sales based on preliminary figures up 13.2% to 1.57 billion euros; earnings1) increase overproportionately by 14.7% to 405.0 million euros
- Growth in both divisions and across all regions; Bioprocess Solutions and the Americas especially strong
- Positive outlook for 2019: Management forecasts that revenue will increase by 7% to 11% and the earnings margin will further rise
Sartorius, a leading international partner of biopharmaceutical research and the industry, continued on the growth track in 2018 in both divisions and across all geographies, and thus achieved its forecast raised considerably at mid-year. According to preliminary figures, Group sales revenue rose in constant currencies by 13.2% to 1,566.0 million euros (reported: +11.5%). The non-organic share of the increase in consolidated sales was around one percentage point. Order intake rose in constant currencies by 12.5% to 1,662.5 million euros.
“Sartorius demonstrated its operational strength again in 2018 by its dynamic development. We achieved our ambitious revenue and earnings targets that we had raised as of the first half last year and further extended our strong international market position,” said Dr. Joachim Kreuzburg, CEO and Executive Board Chairman of Sartorius AG. “We are very optimistic about 2019, despite weaker economic indicators and a few macroeconomic risks, and plan to continue on our profitable growth track.”
The Group’s underlying earnings before interest, taxes, depreciation and amortization (underlying EBITDA) increased overproportionately by 14.7% to 405.0 million euros. Its corresponding margin rose by 0.8 percentage points to 25.9%. Relevant net profit2) for the Group surged 21.9% from 144.0 million euros a year earlier to 175.6 million euros. This yielded earnings per ordinary share of 2.56 euros (2017: 2.10 euros) and earnings per preference share of 2.57 euros (2017: 2.11 euros).
Regionally, the Americas showed the highest dynamics following moderate development in the previous year. Here, Sartorius increased its sales revenue by 16.6% to 520.1 million euros. The Asia | Pacific region achieved a gain of 15.5% to 388.2 million euros compared against a very strong previous year. In the EMEA region (Europe | Middle East | Africa), sales revenue was up 9.4%, to 657.7 million euros. (All regional figures in constant currencies.)
Key financial indicators
The Sartorius Group continues to have a very sound financial base. Its equity ratio at year-end was 38.5%, above the previous year’s level of 35.1%, and its ratio of net debt to underlying EBITDA edged down slightly from 2.5 in 2017 to 2.4 despite its extensive investment program.
Capital expenditures rose by 13.6% from the already high prior-year figure to 237.8 million euros. Investing activities focused on the expansion of production capacity levels at the company’s site in Yauco, Puerto Rico, and on the extension of Group headquarters as well as manufacturing capacity in Göttingen, Germany. The ratio of capital expenditures to sales revenue was 15.2% relative to 14.9% in the previous year.
Growth of the Group is also reflected by the increase yet again in the number of employees. For the year ended December 31, 2018, a total of 8,125 people were employed at Sartorius worldwide, representing a year-over-year gain of 600 new employees or 8.3%.
Business development of the divisions
The Bioprocess Solutions Division, which offers a wide array of innovative technologies for the manufacture of biopharmaceuticals, grew very dynamically and even better than expected at the beginning of the year. It increased its sales revenue in constant currencies by 14.8% to 1,143.1 million euros (reported: +13.1%). The division’s highly competitive product portfolio and rising demand across all product categories fueled growth, which was mainly organic, while acquisitions contributed about half a percentage point of non-organic growth. Order intake in constant currencies was up 14.9% from the year-earlier figure. The division’s underlying EBITDA rose slightly overproportionately by 15.7% to 326.9 million euros. Its underlying EBITDA margin increased accordingly by 0.6 percentage points to 28.6% due to economies of scale.
The Lab Products & Services Division, which offers laboratory instruments and technologies for R&D and quality assurance primarily in the life science sector, developed robustly following a very strong year earlier. Despite softer demand in Europe since the second half of 2018, the division increased its sales revenue by 9.1% (reported: +7.3%) to 423.0 million euros. Essen Bioscience acquired in March 2017 contributed some 2.5 percentage points of non-organic growth. In constant currencies, order intake for the division was up 6.3% from 2017. The division’s underlying EBITDA climbed 10.4% to 78.1 million euros; its earnings margin was positively influenced by economics of scale and product mix effects, and stood at 18.5%, half a percentage point above the prior-year figure.
Further profitable growth expected for 2019
Sartorius expects to grow profitably in 2019 as well. Consolidated sales revenue is thus projected to grow by about 7% to 11%. This forecast considers the changes to the sales alliance with the Lonza group in the area of cell culture media. Without these changes, sales growth would probably be some 2 percentage points higher. Regarding profitability, management forecasts that the company’s EBITDA margin will increase to slightly more than 27.0% over the prior-year figure of 25.9%, with the operating gain projected to be about half a percentage point and the remaining increase expected to result from a change in the accounting rules.3) The ratio of capital expenditures to sales revenue is forecasted to be around 12%, down from the 2018 figure of 15.2%.
For the Bioprocess Solutions Division, management expects dynamic growth to continue. It anticipates that sales will increase by about 8% to 12% over the previous year’s high revenue base (without considering the modification of our partnership with Lonza, between approx. 11% and 15%). Management forecasts that the company’s underlying EBITDA margin will increase to slightly more than 29.5% relative to the prior-year figure of 28.6%. The operating gain is expected to account for around half a percentage point.3)
The Lab Products & Services Division is partly dependent on the development of economic cycles. A number of indicators now signal that economic development is slowing in important economic regions. Against this backdrop, management forecasts that the division’s sales revenue will increase by about 5% to 9% and the underlying EBITDA margin to slightly more than 20.0% (previous year: 18.5%), with the operating gain accounting for about half a percentage point.3)
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