Posts Tagged arrhythmia
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on January 19, 2013
Disclaimer – Below is my best attempt to capture highlights from company presentations. Please check details against more authentic sources, before making any financial decisions.
The overview of the conference can be found at this link – http://bit.ly/UY1Cpk . In the next few links, I will share some highlights from presentations of big pharmaceutical companies. The recent global recession with challenges pertaining to price/volume issues, healthcare reforms, more restrictive regulatory environment, medical device taxes, medical reimbursement cuts, and extreme pressure to contain costs have put a lot of pressure on the device industry. Big Pharma is slightly different. Historically the industry has enjoyed growth rates in double digits and 20% operating margins with growing demand and big profits. But times are also changing for big pharma. Many firms responded to initial challenges by investing heavily in next-generation drugs, often based on biotechnology. Though promise of biotech has not panned out as expected, there is more fat in big pharma than in device industry. Below are highlights from some medical device companies.
Medtronic – Looking at returning 50% of capital back to shareholders over next several years
President & CEO, Omar Ishrak talked about the efforts undertaken during the last 18 months to operate more effectively in the changing healthcare environment. There is tight alignment and the company has made changes in business teams, making them accountable for growth. Three major US markets, ICDs, Core Spine, and Pacing, have started to stabilize. Additionally, Medtronic is focusing on multiple high growth platforms, including advanced energy, afib, glucose monitoring, deep brain stimulation and so on. As opposed to 10% return in 2012, for several coming years, Medtronic is looking at 20% revenue growth, for several years to come, said Ishrak. Medtronic is expecting to recoup $25B, in next 5 years, mostly from outside the US and is expecting to continue 50% rate of return to the shareholders, that is, $12.5B return to shareholders, over next 5 years.
Medtronic will also focus on generating more cash in the US, through increasing demand, visibility of supply chain, minimizing idle inventory, optimizing supply chain, reducing operating expenses, and finally repatriating cash from outside the US, if the tax policy becomes fair, said Ishrak. With increasing globalization, there will be continued focus on premium segments in emerging markets, particularly India and China. Additionally, Medtronic will also focus on value segment and underserved segments through creating infrastructure capability and then aim to bring the innovation back and disrupt developed markets. Medtronic is quickly adapting to the changing healthcare landscape, and moving from old fee for service model to new pay for value model, said Ishrak.
Stryker – Continued focus on M&A, share buy backs, and cash flow generation
Stryker CEO, Kevin Lobo said the company is focused on innovation, has a robust balance sheet and will continue strong cash flow generation. In 2012, the total revenue was $8.7B, up 4% from previous year and adjusted earnings per share increased 9%. Stryker has a very diversified market focus, with no single market representing more than 16%, said Lobo. US represents 2/3rd of total Stryker sales or 65% of the business. 29% is in Europe and the rest 6% is in emerging markets and Stryker aims to grow in these markets. Although 2012 was a quieter year from acquisition standpoint, Stryker will continue to focus on M&A and will continue to buy back shares and is looking at strong steady cash flow generation, said Lobo.
Hansen Medical – Maintains Leadership in Intravascular Robotics with Launch of New Products
CEO, Bruce Barclay asserted that Hansen continues to be a global leader in intravascular robotics and sees it as a platform technology in EP (electrophysiology) and vascular space. Hansen also has a strong pipeline and is developing a full suite of catheters to go with its technology. Hansen catheters and other flexible robotics have largely known to be used in catheter based interventional medical procedures, particularly for treatment of irregular heart arrhythmias.
In 2012, Hansen launched Magellan (TM) Robotic System in the US that allows Hansen to enter much larger vascular market, on account of greater precision and predictability of the distal tip control. Hansen has also launched some new products in the EP space. Artisan Extend catheter was approved in the US, last year and just got approval in the Europe. Improved procedure predictability of Hansen products offers an opportunity to hospitals for lowering cost and incremental patient turnaround. Additionally, it is vastly helpful to the physician, who can sit comfortably at a console, does not have to wear lead coat, is away from the radiation field, and has lower risk of orthopedic injuries. Therefore, this is a good ROI model.
Hansen has had five consecutive quarters of procedure growth on the robotic side and is now approaching 10,000 cases. Hansen had 14 new patents issued in 2012 and new transaction with Intuitive Surgical added $30M to the balance sheet. Hansen focuses on early adopters of new technology and on training them well, in this $2B+ medical robotics market, said Barclay.
St. Jude – Poised to deal with challenges and deliver long term growth
Daniel Starks, President, Chairman and CEO of St. Jude reported that preliminary sales for Q4, 2012 were as expected, at approximately $ 1.372 billion. The company initiated $1B share repurchase program, at the end of 2012, and expects a favorable impact from this in 2013.
Globally ICD market declined 3%, in 2012. St. Jude’s ICD market share has been stable, with some decline offset by CRT-D and replacement segments. Most recent data also allays previous market concern about reliability and safety of Durata line of (HV) high voltage leads. Durata lead survival at 5 years is shown to be 98.7% and compares favorably with MDT line of HV leads. FDA inspection of SymarCA facility generated form 483. None of the observations were pertaining to performance of Durata HV leads and all will be remedied with urgency, assured Starks. HV lead revenue comprises of less than 4% of STJ global sales.
Various cost saving initiatives have generated more than $100 million in cost reductions in 2012 and are expected to generate more than $100 million in additional cost savings in 2013. These cost savings plus $1B share repurchase will enable STJ to fund incremental R&D investments, expand market share development activities, and absorb the US medical device excise tax. While sales growth is expected to remain challenging due to macro-economic factors, STJ is well position to deal with the headwinds and deliver long term growth. Some of the growth drivers in 2013 will be, MediGuide non-fluoroscopic catheter tracking technology with STJ AF platform, LAA and PFO closure to reduce risk of stroke, STJ’s FFR and OCT product lines, STJ next generation EnligHTN renal denervation technology, TAVR and Trifecta tissue valve product lines, and the recovery of STJ neuromodulation franchise, said Starks.
Glaukos – Private Opthalmic Medical Device Company for management of Glaucoma
Glaukos is a private opthalmic medical device company. Thomas Burns, CEO and President of the company shared about Glaukos for management of glaucoma. Glaucoma is a long lasting, permanent condition that does not cause immediate blindness but causes dark patches or areas of blindness. High pressure caused by excessive fluid produced by the eye, can damage the optic nerve and lead to glaucoma. Glaukos technology is primarily an infinitesimal titanium stent, iStent, that can be implanted in the eye to drain fluid and thus reduce the pressure that leads to glaucoma. The iStent is the smallest medical device ever approved the FDA and is placed in the eye during cataract surgery. It is small enough that the patient will not see or feel it after surgery and post surgery, it continues to work to help reduce eye pressure. The 2nd generation G2 device is smaller than the first generation device, and can be loaded into a needle and injected at a predictable rate. Glaukos suprachoroidal stent model G3 device is currently in phase 3 trials.
All products are CE marked and there is great progress in reimbursement, said Burns. The current number of about 70 million patients in the US is expected to reach 80 M by 2020. CPT codes are established and currently 4100 stents are implanted to date.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on January 13, 2013
EPPIC 2013 Annual Life Science Conference Highlights
The annual EPPIC Life Science Conference (www.eppicglobal.org) takes place on the day before the start of the J. P. Morgan Healthcare Conference, each year, and offers a forum for information, networking, and mentoring. This year, the conference took place at the Westin SF Airport Hotel on January 6, 2013 and was jointly chaired by Ramani Aiyer, EPPIC President & Principal at Shasta Bio Ventures and Geetha Rao, CEO of Springborne Life Sciences and VP of Corporate Development at Triple Ring Technologies. The Gold sponsors of the event were Global Industry Analysts http://www.strategyr.com, Camargo http://www.camargoblog.com, Merchant & Gould http://www.merchantgould.com, Morrison Foerster http://www.mofo.com, Vivo http://www.vivoventures.com, and WSGR http://www.wsgr.com. Below are the highlights from the conference.
Plenary Talk – Carlos Olguin
The conference opened with plenary remarks by Carlos Olguin, Head of Bio/Nanotechnology/Programmable Matter Group at Autodesk and was moderated by John Cumbers, Head of Synthetic Biology & Resource Utilization in Space at NASA Ames. If you are wondering what has Autodesk to do with life sciences, the talk was an eye opener about interesting things happening on the boundary between bio-nano technology with 3D visualization, simulation, and design. Autodesk professionals bring design and engineering knowledge and look at ways to program matter, through scan, modify, and print pattern, said Olguin. Scan in the case of molecular biology is akin to sequencing DNA, modify refers to modeling, simulation, and optimization and print alludes to synthesizing the DNA. Looking beyond molecular biology, design and engineering in manufacturing as a whole may shift from being top down to self assembled, from being inert to being alive, from being generic to personalized, and from being product oriented to being service oriented, said Olguin. The talk was a clear indication that interesting, cutting edge stuff is happening on the boundaries between disciplines and that is where we will see some breakthrough advances take place in the years to come.
Personalized Medicine Panel
Personalized Medicine Panel was moderated by Sara Kenkare-Mitra, SVP of Development Sciences at Genentech. Brian Naughton, Founding Scientist, 23 and Me, Eric Sasso, VP of Medical and Scientific Affairs at Crescendo Bioscience, and Deborah Kilpatrick, Chief Commercial Officer at CardioDx discussed the implications of efforts in personalized medicine for chronic diseases.
Crescendo Bioscience is a molecular diagnostics laboratory focused on rheumatology. Currently, assessment of rheumatoid arthritis disease activity depends on subjective clinical indicators and is a time consuming process. Crescendo is developing quantitative, objective, biology-based tests intended to provide rheumatologists with deeper clinical insights, said Naughton. The blood test, commercially available since 2010, integrates the concentrations of 12 serum proteins associated with rheumatoid arthritis disease activity into a single objective score to help physicians make more informed treatment decisions.
CardioDx offers Corus CAD blood test that can quickly and safely identify symptomatic patients unlikely to have obstructive coronary artery disease (CAD). However, getting physicians to think differently about using these tests versus imaging based tools, is a challenge, and “we are asking them to trust biology and not just an image”, said Kilpatrick. Currently, 75% of its commercial use is by primary care physicians and about 25% by cardiologists. Cardio Dx works the referral channel from an advocacy standpoint. An additional benefit observed by CardioDx is that after the test, the compliance to statins among patients is dramatically improved. Thus the test leads to a behavior change that would not otherwise occur.
23 and Me has an exciting story and it will again be covered in greater detail in my JPM post. The exciting development is in dramatic reduction of cost. Naughton shared that now it is within the reach of everyone and for $99, any consumer can get all sorts of information about their genetics, including increased risks for diseases like AMD, Alzheimer’s and others The panelists discussed their strategies for broadening the use of their tests with partnership opportunities and for other indications. Hearing about advances in personalized medicine, beyond oncology, was exciting.
Panel on Repurposing of Drugs
Mahendra Shah, partner with Vivo Ventures, moderated the panel that focused on repurposing of drugs. While new drugs cost upwards of $1.1B to develop and bring to market, and take over 10 years, once approved, there is no guarantee that they would be commercially successful, said Shah. The knowledge accumulated, can be analyzed to see the effectiveness of old drug for new usage. NIH is also planning to make an extensive database of old drugs available, to enable scientists to look for new indications.
Ken Phelps, CEO of Camargo Pharmaceutical Services, talked about the regulatory pathway in repurposing of drugs. Camargo specializes in FDA’s 505(b)(2) drug approval process. In 2011, more 505(b)(2) NDAs were approved than 505(b)(1) compounds, said Phelps. Sharing the history of 505(b)(2), Phelps emphasized that currently over 3000 drugs are still on the market that were introduced prior to 1962, when they were not required to be shown to be efficacious, and they are for taking. There are also compounds with new chemical entities and new indications that are available. He observed that it is important to identify compelling commercial differentiation and then take the knowledge available in the public domain, think outside the box, and use it effectively.
Warren Cooper, President at Coalescence was CEO of Prism Pharmaceuticals, a venture backed company that he led from inception to sale of the company to Baxter in 2011. According to Cooper, in repurposing a drug, same criteria should be used as NCE; identification of well defined clinical need, market value, and willingness to adopt and obtain reimbursement, technical feasibility, ability to protect from generics for meaningful period of time, and positive financial justification. What is different from NCE is that compound has a history and sometimes that is helpful and sometimes a hindrance. The deeper the history, the higher the challenge it may cause in the regulatory pathway of repurposing. Cooper discussed the example of injectable amiodarone that was originally developed for use in cardiac arrhythmias and was transferred at Prism Phrama, into NEXTERONE, from IV to ready to use pre-mixed product. The regulatory challenges required rewriting of the label and negotiations with FDA on labeling.
Jaisim Shah, Board Director at Igdrasol, discussed the key drivers for drug repurposing that include, reduction in cycle time, lower cost, better success rate, and quicker ROI for investors. Drug repurposing sales are up, to $20 B this year, said Shah. In 2012, as Chief Business Officer of Elevation Pharma, Shah led the sale of the company to Sunovian for upto $430 million, contingency based deal. The company took glycoyrrolate, a generic drug, approved decades ago by the FDA, and reformulated the compound for use with a nebulizer for chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis. It is found to be a well tolerated, tasteless, and stable formulation.
Panel on Technology Innovations that Shorten Therapeutic Product Development Life-Cycles
Moderated by Mohan Srinivasan, Director at Bristol-Myers Squibb, the panel discussed diverse and new technology adaptations aimed at compressing lifecycle and boosting success rates for drug development. Currently, for each new therapeutic, the product life-cycle ranges between 9 to 15 years and costs over a billion dollars. Can this be significantly shortened by adapting technology advancements in other sectors?
Chunlin Wang is Senior Scientist & Director of Informatics at Stanford Genome Technology Center. In last several years, Wang has been analyzing sequencing data generated by 454 FLX, I1-lumina GAIIx, HiSeq, MiSq, Ion Torrent and Pacific Bioscience platforms for various projects including drug-resistant mutation detection, whole genome sequencing, immune repertoire sequencing, high resolution high-throughput HLA genotyping and new virus discoveries. Using novel sequencing approaches to speed up drug development is one of the best ways to reduce costs, said Wang.
Scott Turner is EVP of R&D at Kinemed Inc. focused on the field of stable isotope research. Turner is leading the research into novel in vivo applications of stable isotopes in diseases. With its patented isotopic tracer technology, Kinemed enables its clients to track key chemical pathways within living systems and look at bio-chemical processes that are targets of drugs. Focusing on study in intact organism provides integrated systems biology information underlying the root causes of disease, said Turner.
Nikesh Kotecha is CEO of Cytobank Inc., a company focused on providing scientific, informatics and software solutions for cytometry. Cytobank focuses on analyzing single cell technologies and has created Cytobank, a cloud-computing platform for flow cytometry data. The Cytobank project grew out of Kotecha’s focus in Dr. Garry Nolan’s lab at Stanford University in developing a diagnostic for juvenile myelomonocytic leukemia and on analysis methods for single cell assays. Thus they take an interdisciplinary approach to address biological and clinical problems to help companies bring together their laboratory bench work and informatics needs. Cytobank is taking this beyond flow cytometry to mass cytometry, for identifying biomarkers, useful in personalized medicine, said Kotecha.
Pradeep Fernandes, co-founder and President of Cellworks Group, was most recently VP and GM of Synthesis Solutions at Cadence Design Systems, following its very successful $120M acquisition of Get2Chip in 2003. Currently, a great deal of data is being generated. Software is a tool that can be leveraged to manage and visualize large data, extract trends, generate insightful data and eventually predict information from large data sets, said Fernandes. CellWorks takes in vivo and in vitro data and clinical trends and tries to build dynamic models that simulate disease phenotypes in computers and can be used to perform mechanistic studies. This information is used to predict effects of new therapy and gain new biological insights regarding toxicity and biological efficacy of drugs. CellWorks has an internal pipeline of therapies and is in collaboration with Astra Zeneca, Genentech and other companies interested in driving selection of therapies.
Speed Pitch, Accent on Youth, Speed Networking
In Speed Pitch, early stage life sciences companies were given the stage for a quick 5-minute pitch about their idea, technology, or company. The companies presented to the entire audience and obtained quick feedback from the distinguished VC panel and gained exposure to showcase to various potential collaborators, partners, and investors. Selected presentations are highlighted on the EPPIC website and other promotional material.
The Youth Panel was An Eppic Annual Conference First. This panel gave an opportunity to budding high school and college age scientists to showcase their outstanding research and later ask questions of each other’s research and future goals etc. The purpose of this panel was to inspire excellence among young people but these exceptionally bright, charming youngsters inspired the audience and left everyone spell bound.
Finally the Speed Networking event gave an opportunity to meet conference attendees in quick three-minute introduction and card exchange rounds.
This was a great conference that provided wonderful networking opportunity and was followed by more relaxed networking and wine reception.