MassMEDIC Annual Meeting

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1 MassMEDIC Annual Meeting Sector and Massachusetts EvaluateMedTech Analysis Tom Sommer, President MassMedic

2 Celebrating 20 years Founded in member companies Played a key role in the FDA Modernization Act Also involved in reimbursement reform, MDUFMA and proposed revisions to the FDA s 510(k)s Helped established Mass state tax credit for payment of medical device user fees to the FDA Focused on supporting early stage companies and helping established medical device companies thrive and grow

3 Massachusetts Medtech Economic Impacts Venture Financing MA HQ only rounds $2.9b 42 rounds $714m FDA Approvals MA Applicants MA Filed 167 MA Filed MASS MEDTECH Based on: MA HQ = 432 cos. MA+ = 436 cos. IPOs IPOs $509m+ raised $51m+ avg Revenues M&A $33.3b (MA HQ) $117b (MA+) $17b (MA HQ) $83b (MA+) $2.0b (MA HQ) $54.6b (MA+) Cumulative $81b (MA HQ) $414b (MA+) $25b (MA HQ) $103b (MA+)

4 Key Sector Trend: Fewer, Bigger Deals In 2015 the medtech industry saw the same pattern repeat itself across a number of metrics: fewer, bigger deals. The total expenditure on M&A soared to previously unimagined heights, but the deals dropped from ayear earlier. The total amount of venture capital raised by medtech groups remained level, but the number of deals declined. The explosion in IPOs that characterized 2014 slackened, but 2015 IPOs were larger on average. The US FDA approved more novel products (1 st PMA, HDE) in 2015 than in any year in the previous decade.

5 Key Trends in Massachusetts Medtech In 2015, Mass Venture Financing was at the highest level since 2012: fewer rounds, but bigger rounds. Mass headquartered companies received more Venture Financing on average then the rest of USA medtech companies. Mass is seeing a decline in the number of M&A deals from , with mega deals driving the overall value was a 5 year low for the number of Mass FDA approvals. In the last 5 years, Mass headquartered IPOs raised an average of $51+M, significantly higher than the US average of $46M. Mass headquartered medtech companies revenues expected to have a CAGR of 7% reaching $25B by 2020.

6 Sector Venture Financing Is innovation at risk? Venture cash stays steady but more VC money going into larger rounds for established companies versus early stage companies.

7 Investment ($m) Massachusetts HQ Companies Venture Financing MA Venture Financing: Total Amount Invested # of Rounds Total investment and average investment for MA headquartered companies at highest level since Fewer rounds, but bigger rounds in Total Invesment # Rounds # Rounds MA HQ Total Investment ($m) MA HQ Average Investment ($m) $517 $ $657 $ $564 $ $402 $ $714 $18

8 Massachusetts HQ vs. USA Companies Venture Financing Average Invesment ($m) Average Venture Financing Investment (USA vs. MA) MA headquartered companies received more Venture Financing on average then the rest of USA medtech companies in 2012, 2013, USA Average Investment MA Average Investment USA Total Investment ($m) USA Average Investment ($m) MA Total Investment ($m) MA Average Investment ($m) USA # Rounds MA # Rounds $4,067 $10 61 $517 $ $3,638 $10 57 $657 $ $3,876 $10 40 $564 $ $4,348 $12 41 $402 $ $4,344 $16 42 $714 $18

9 Sector View: M&A Sums spent on M&A in medtech were unprecedented in $127bn was reached despite 2015 seeing fewest deals since Excluding Covidien deal, average amount paid was $804m, highest ever on record.

10 Mass. HQ & Large MA Presence Cos. (MA+) Mergers and Acquisitions MA seeing a decline in the number of M&A deals , with mega deals driving overall deal value for the year when we include large MA presence companies. M&A Activity $b (MA) M&A Activity $b (MA+) Deal Value ($B) # of Deals Deal Value ($B) # of Deals Total Deal Value # of Deals Total Deal Value # of Deals Year Company Deal Type Company Acquired Deal Value ($m) HQ State 2015 Medtronic Company Acquisition Covidien 49,900 Minnesota 2015 Boston Scientific Business Unit Men's Health and Prostate Health businesses of American Medical Systems 1,650 Massachusetts

11 FDA Approvals FDA approved more novel products in 2015 (1 st PMA, HDE) than in any year in the previous decade, a 55% increase over 2014.

12 Massachusetts Filed FDA Approvals First PMA, HDE, 510(k) and 510(k) De Novo Number of Approvals Number of Approvals Filed in MA Number of Approvals filed in MA in 2015 HDE Approval 1 PMA First Approval 1 510(k) Clearance (De Novo) 3 510(k) Clearance was a 5 year low for number of approvals filed in Massachusetts. # of Approvals # of PMAs and HDEs Filed in MA

13 In Depth: Mass Filed FDA Approvals Year and Approval Type Number of Approvals (k) Clearance 230 PMA First Approval 3 PMA Supplementary Approval (k) Clearance 208 PMA First Approval 2 PMA Supplementary Approval (k) Clearance 213 PMA Supplementary Approval (k) Clearance (k) Clearance (De Novo) 4 PMA First Approval 2 PMA Supplementary Approval (k) Clearance (k) Clearance (De Novo) 3 HDE Approval 1 PMA First Approval 1 PMA Supplementary Approval (k) Clearance (k) Clearance (De Novo) 1 PMA Supplementary Approval 16 Grand Total 1484

14 IPOs on Western Exchanges Steady decrease in IPO activity across the sector in 2015 Shareholders, like VCs, are interested in revenue stage companies.

15 Massachusetts IPOs According to data, about 2 MA headquartered companies go public each year. In the last 5 years, MA headquartered companies did better than the national average for IPO amount raised. IPO Date Company Sector Segment Amount Raised ($m) 2011 BG Medicine Biotechnology; In Vitro Diagnostics 40 MedTech 2011 GI Dynamics MedTech Gastroenterology Pathfinder Cell Therapy Biotechnology; MedTech Ear, Nose & Throat (ENT); General & Plastic Surgery; In Vitro Diagnostics 2012 OvaScience MedTech Obstetrics & Gynecology (OB/GYN) 2012 Arch Therapeutics MedTech Blood; General & 0.02 Plastic Surgery 2013 Foundation Medicine MedTech In Vitro Diagnostics Ocular Therapeutix Specialty (Pharma); Ophthalmics 65 MedTech 2014 T2 Biosystems MedTech In Vitro Diagnostics ConforMIS MedTech Orthopedics Viatar CTC Solutions MedTech In Vitro Diagnostics 5 $51m+ (MA) $46m (USA)

16 Revenues and Forecasts Mass HQ Cos. and MA+ Worldwide MedTech Revenues (MA HQ) Sales ($B) $30B $20B $10B % 5% 0% 5% Growth per Year (%) Revenues $17b (MA HQ) $83b (MA+) Cumulative $81b (MA HQ) $414b (MA+) $25b (MA HQ) $103b (MA+) $0B % Sales ($) Growth per Year (%) Worldwide MedTech Revenues (MA+) CAGR of 7% reaching $25B by 2020 for MA HQ companies Sales ($B) $120B $80B $40B % 5% 0% 5% Growth per Year (%) $0B % Sales ($) Growth per Year (%)

17 Massachusetts MedTech Innovation Engine Continue to encourage support of emerging company innovation in Massachusetts Angel investing Crowdfunding platforms Larger companies buying early stage firms Newly merged, up and coming large medtech buying early stage firms Assisting emerging companies through mentoring, advisory programs Emerging companies using R&D resources wisely Increased exposure to investors

18 A life science market analytics and intelligence company, known for its consensus sales forecasts to 2022 became a gold-standard benchmark London (HQ), Boston, San Francisco, Tokyo Complimentary Reports: Annual Medtech World Preview report launches yearly in October at AdvaMed Annual Meeting.

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