April 2013

   

 

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Pharma, Biotech & Medical Device  

Greetings!

 

Welcome to BioMarketing Insight's monthly newsletter.

 

This industry has gone through a lot of changes with many negative effects including Obamacare, as noted in a previous newsletter. Last month I discussed a positive change in Pharma/Biotech with the new regulatory path for "Breakthrough Therapies." This month I will give an update on the medical device tax repeal initiatives and which devices are exempt from this tax.

 

Read on to learn more about this topic and other current news. On the right are quick links to the topics covered in this month's newsletter. The next newsletter will be published on May 15th.


We encourage you to share this newsletter with your colleagues by using the social media icons at the top left, or by simply forwarding the newsletter via email.

 

Please email me, Regina Au, if you have any questions, comments, or suggestions.

 

 

Sincerely,

Regina Au

Principal, Strategic Marketing Consultant

BioMarketing Insight 

 

 

In This Issue
Save the Date: April 16th, 2013
Medical Device Tax Update
Closing Thoughts
New Technology - What If You Could Identify a Heart Failure Patient with Just a Breath Test?
Twenty Medical Device and Five Pharma/Biotech Funding Deals
Sixteen Mergers & Acquisitions
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 Save the Date: April 16th, 2013     


Are you looking for an alternative career in the Life Sciences? The Association for Women in Sciences (AWIS) is holding a Speed Alternative Career Networking Event on Tuesday, April 16th, 2013 at MIT, building 46, 3rd Floor Atrium. Men and Women are welcome. I will be on the panel for consulting careers. For more information and to register, click here


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Medical Device Tax Update

 

If you haven't had a chance to follow the Medical Device Tax (2.3% tax on revenue) repeal initiative, here is an update on where it stands. When Obama first proposed the Medical Device Tax reform, the US House of Representatives, led by Representative Erik Paulsen (R-Minnestota), was the first to initiate a bill to repeal the device tax.

 

"The House has taken a stand for American leadership in medical device innovation and the nearly half million U.S. jobs it supports," said Paulsen. "This new ill-conceived tax would force many of our nation's bright medical technology innovators to lay off workers, move jobs overseas, or worse yet, close their doors altogether. With today's vote," he said, "we show the nation what we can accomplish when we put progress before partisanship. I appreciate the support from my colleagues on both sides of the aisle and look forward to action in the Senate on this vital bill for American jobs."

 

The "Healthcare Costs Reduction Act" was passed on June 8, 2012 by a bipartisan vote of 270 to 146. The bill was then passed to the Senate.

 

But it wasn't until March 21st, 2013, 9 months later, that the U.S. Senate voted 79-20 in favor of a bipartisan amendment that would repeal the Medical Device Tax and establish a reserve fund to help pay for it.  

 

It took a while for the bill to pass in the Senate because some members of the Democrat-led Senate voiced concern about how the government would make up for the $30 billion in revenue the tax is slated to generate over 10 years. The Klobuchar-Hatch amendment would establish a deficit-neutral reserve fund to help offset the cost of repealing the tax.

 

In preparation for the Device Tax, many medical device companies have pared down their R&D budgets, shifted R&D oversees, acquired other companies as a method to offer a full product line, laid off workers, and focused on emerging markets for growth. I gave a run down on the layoffs in my October 2012 newsletter. Other companies are also passing some of this tax on to their customers.  The device tax went into effect as of January 1st, 2013. It was estimated that the top 19 medical device companies would pay an estimated $411 million in additional taxes this year, as reported by the Boston Business Journal. 

 

The tax exempts eyeglasses, contact lenses, hearing aids and devices usually sold over-the-counter to the general public. But  Tom Sommer, president of MassMEDIC, the state's industry advocacy group, said those exemptions won't amount to much locally. "Innovation ... is the hallmark of the medical device industry in Massachusetts," he said.   

 

The House of Representatives recently passed a new bill that would provide a Medical Device Tax exemption for products used by emergency responders.   "The exemption for emergency medical devices would apply to any medical device that is used by ambulance services or first responders providing pre-hospital care, out-of-hospital care and transportation. In addition, any "qualified emergency medical device" would be exempted."

 

Bureaucratic Mismanagement

 

Just when you thought things were looking up with the Device Tax repeal, the Obama Administration, or more specifically the Centers for Medicare and Medicaid Services, has stopped paying the bills from hundreds of health care companies, and it has nothing to do with sequestration. It's bureaucratic mismanagement and it is hurting the diagnostic testing industry. I know I was only speaking to the positive changes, but if you don't already know about this change and in the diagnostic industry, then you need to know.

 

The issue at hand is how Medicare reimburses for diagnostic tests. Diagnostics were reimbursed using a method called "code stacking." Under this current approach, reimbursement was determined by adding up the "cost" of each discrete step needed to perform a particular molecular test.   Since there was no standard method of code stacking, reimbursement was dependent on how the laboratory calculated its pricing for reimbursement. This resulted in a lot of variability in what was paid for similar diagnostic tests, depending on which lab ran the test, and how good it was at "stacking" codes.

 

Medicare decided to change the way it reimburses these diagnostic tests, but has been slow to decide on its new policy. So in the absence of a policy, the Medicare program is simply not paying its bills. To read the full story, click here.  

 

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Closing Thoughts 

 

There has been much debate as to whether the 2.3% medical device tax will be repealed. Although the Senate has voted to repeal the tax, the stipulation on the fund to make up for lost tax revenue will inspire still more debate and result in still more delay. Since the House and Senate can't really agree on anything nowadays and neither side wants to budge, I'm not sure when the repeal will go into effect, if it does at all.

 

Companies have already started to pay this tax and the longer the debate goes on for the repeal and the creation of a reserve fund, the more companies will continue to respond to the tax resulting in less innovation, fewer jobs, less revenue, lower stock prices, and higher prices for products. The focus on innovation may be shifted exclusively to devices used by emergency responders.

 

Budget cuts alone are not going to solve the problem of rising healthcare costs. It may seem to be the obvious choice, but it's not efficient in the long run. I think one way to cut costs and save money is to look for inefficiencies within in the system. This applies to the healthcare side and medical manufacturer side. I hear about all the "waste" that goes on in terms of duplication of paper work or test, inexcusable clerical and medical errors, and unnecessary tests performed to decrease malpractice risk. It all piles on to the cost of health care in America.

 

I know the manufacturers are trying to improve the product development process and hopefully the manufacturing/regulatory process as well.

 

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New Technology - What If You Could Identify a Heart Failure Patient with Just a Breath Test?

 

Researchers at the Cleveland Clinic have been able to identify heart failure patients by using exhaled breath analysis according to a study published in the Journal of the American College of Cardiology. Researchers through the analysis of volatile organic compounds (VOCs) in exhaled breath have identified VOCs that correlate with the presence of cardiovascular diseases.

 

"While additional examination is needed to determine the true potential of breath analysis for heart failure identification in our patients, we're very encouraged by these results," said Raed Dweik, MD, a pulmonologist in the Respiratory Institute at Cleveland Clinic, and lead investigator for the study. "The ability to identify patients with heart failure using a breath test has the potential for broad application due to its non-invasive nature and ease of application.  These exciting new observations may lead to future studies to determine how to best utilize these information to reduce heart failure re-hospitalizations."  

 

For more information from FierceMedicalDevice, click here.

 

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Twenty Medical Device and Five Pharma/Biotech Funding Deals

 

To determine whether funding is picking up, I will be focusing on all types of funding that are $1 million or greater in seed investments and series A or B (or the valley of death) that are pre-IPO. Even though VCs are investing, they continue to invest in their existing portfolio companies and less in start-ups. Incubators, state funding, and business competitions are great for initial seed money but not enough to keep the company going long-term.  These are worldwide funding deals. 

 

Partnerships and licensing deals with upfront payments and milestones will not be included.

 

Medical device funding includes IT companies because they are the current focus of investors for faster return on investments.

 

 

Funding Device
Funding deals are in chronological order by date.
 

$0 = No financial terms disclosed. For more information, read more ....

 

 

Funding Pharma
Funding deals are in chronological order by date.

$0 = No financial terms disclosed. For more information, read more...     

 

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Sixteen Mergers & Acquisitions

 

Mergers & Acquisitions continue to be made for both medical device (12) and pharma/biotech (4).  

   

This month Shire acquired two companies: Swedish biotech Premacure AB and SARcode Bioscience,

a Brisbane, Calif.-based company.    

 

Argon Medical Devices had the largest announced acquisition this month in acquiring Angiotech Pharmaceutical's interventional device business.    

 

 

M&A
Acquisitions are in chronological order by date with Medical Device/Diagnostics followed by Pharma/Biotech.

$0 = No financial terms disclosed. For more information, read more ....

 

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We help companies de-risk their product development process by conducting the business due diligence to ensure that it is the right product for the right market and the market opportunity for the product meets the business goals of the company. We can then develop marketing strategies to drive adoption for the product.

 

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