Life Sciences MAP Info Session

Transcription

1 Life Sciences MAP Info Session FY 15 Application opens December 8 Investing in the State of Innovation

2 Background 2

3 The Massachusetts Life Sciences Initiative Major objectives State investments in the life sciences Super Cluster to: Promote economic development Support the Commonwealth s world-class academic medical centers, research institutions, universities and industry leaders Promote a highly skilled and educated workforce Create an industry-friendly environment Strengthen and protect Massachusetts global leadership position in the Life Sciences Support the development of treatments, therapies and cures 3

4 MLSC Investment Tools and Programming Budget 10 Years $1 Billion Investment 4

5 MLSC Board of Directors Secretary of Housing and Economic Development Gregory Bialecki Secretary of Administration and Finance Glen Shor President of University of Massachusetts System Robert Caret, Ph.D. A researcher involved in the commercialization of biotechnology, pharmaceuticals or medical diagnostic products Lydia Villa-Komaroff, Ph.D., Director and CSO, Cytonome/ST A physician licensed to practice medicine in the Commonwealth and affiliated with an academic medical center Edward Benz, M.D., President & CEO, Dana-Farber Cancer Institute A person with financial expertise in the life sciences Peter Parker, President, BioInnovation LLC A CEO of a Massachusetts based life sciences corporation Adelene Perkins, Chair, President and Chief Executive Officer of Infinity Pharmaceuticals, Inc. 5 *as of November 2014

6 MLSC Scientific Advisory Board* CHAIR: Harvey Lodish, Ph.D., Whitehead Institute and Massachusetts Institute of Technology (MIT) Academia Industry Venture Capital Entrepreneurs James J. Collins, Ph.D., Boston University John M. Collins, Ph.D., Center for Integration of Medicine & Innovative Technology (CIMIT) Robert D Amato, M.D., Ph.D., Center for Macular Degeneration Research, Harvard Medical School and Boston Children s Hospital Rainer Fuchs, Ph.D., Harvard Medical School Glenn R. Gaudette, Ph.D., Worcester Polytechnic Institute (WPI) Judith Lieberman, Ph.D., Immune Disease Institute, Boston Children s Hospital and Harvard Medical School Lita L. Nelsen, Massachusetts Institute Barbara Osborne, Ph.D., UMass Amherst Guillermo Tearney, M.D., Ph.D., Harvard Medical School, Harvard-MIT Division of Health Sciences and Technology (HST) and Massachusetts General Hospital David Walt, Ph.D., Tufts University School of Medicine Philip Zamore, Ph.D., UMass Medical School Frederick J. Schoen, M.D., Ph.D. Professor Harvard Medical School James Barry, Ph.D., InspireMD, Inc. Dalia Cohen, Ph.D., ALN Associates José-Carlos Gutiérrez- Ramos, Ph.D., Pfizer Dale Larson, Draper Laboratory Alan Smith, Ph.D., CBE, FRS, Genzyme (Retired) Alison Lawton Board of Directors for Cubist Pharmaceuticals and Verastem Inc. Kevin Bitterman, Ph.D., Polaris Venture Partners T. (Teo) Dagi, M.D., M.B.A., HLM Venture Partners Andrew Jay, DMD, Siemens Venture Capital Henry Kay, Boston Harbor Angels Carmichael Roberts, Ph.D., M.B.A., North Bridge Venture Partners Lauren Silverman, Ph.D., Novartis Option Fund Frederick Jones, M.D. Broadview Ventures Alison Taunton-Rigby, Ph.D., RiboNovix, Inc. Hillel Bachrach 20/20 HealthCare Partners LLC 6 *as of August 2014

7 The Program 7

8 Goals MassBio should work with the State of Massachusetts to expand the funds available to early-stage companies through the MLSC. -- MassBio and Health Advances Impact 2020 Report April 2014 To fill an existing gap in the funding environment To enable companies to meet essential value creating milestones To empower companies to attract additional outside funding 8

9 Program At-a-Glance Up to $2 million approved for FY 15 Competitive Grant Process Milestone driven proposal Awards between $50,000 and $200,000 Min. funding of $50,000 required, max of $1 million of equity or convertible debt Max of $100,000 in non-convertible debt and max of $5 million in grants allowed Must be a life sciences company registered to do business in MA and in good standing (Life science sectors: medical devices, diagnostics, biotech, pharmaceuticals, bioinformatics) 9

10 Threshold Criteria 1. Must be a life sciences company located in MA, registered to do business in MA, and in good standing 2. Must have raised at least $50,000 (equity, founders equity, debt, grants) 3. Must not exceed $1M in equity or convertible debt 4. Must not exceed $100,000 in non-convertible debt or $5M in grants 5. Must have a NEW defined milestone to be achieved with MLSC funds 6. Must be working with a mentor or have previously been mentored 7. Must be in compliance with all other MLSC agreements, if any 10

11 Threshold Criteria continued 8. Must be able to issue own equity if majority owned by a parent 9. Must not be an Accelerator Loan awardee 10. Must submit a complete application by February 2, :00 p.m. EST 11

12 Funding to meet minimum Funding to meet minimum includes: Invested equity (cash for equity) Debt Convertible debt into equity Founders equity Grant awards (federal or private) Crowdsourcing Funding to meet minimum does not include: Like kind exchanges Advance licensing/royalty payments Revenues Vendor lines of credit or vendor payables Deferred compensation Other MLSC or state funding 12

13 Examples of fundable milestones Product Development & Scale Up Prototype development Technology Assessments Manufacturing scale-up Production of clinical supply Clinical Evaluation & Regulatory Process Pre-clinical and Clinical trials Publishing papers Filing 510k, IDE, IND Regulatory and reimbursement strategy Business Strategy Business plan development Freedom to operate Patent filing Trademark searches and filing Market Validation Market analyses Sales demonstrations KOL Interviews Competitive assessments 13

14 Examples of what is not fundable Fees for Board members or SAB members Paying off debt, including accounts payable Buying another company Change in legal structure Expenses not directly related to achievement of the milestone Wondering if your milestone is fundable? Please contact as soon as possible 14

15 Mentoring requirement Applicants must be working with a mentor or have previously worked with one (no required length of time) Mentor is defined as someone who is familiar with your company strategy, technology, and/or market and has provided input to future planning may be located outside of MA / US Mentors may include Small business network advisors Unpaid advisory board members Mentors through an incubator or Accelerator program (i.e. MassChallenge, MedTech IGNITE, MassCONNECT) If you don t have a mentor, you should identify one prior to applying (check out SCORE and MSBDC to start) We have allowed for uploads of letters of support (up to 3 pages total) from mentors 15

16 Differences from Accelerator Program Life Sciences MAP Grant $50k - $200k Capital required Min. $50k, Max. $1M Grant supports completion of a well-defined milestone Data or proof of concept not required Mentorship is required No full-time employee requirement Loan Up to $1M Accelerator At-risk capital required Min. $300k, Max. $7.5M/$15M Loan provides working capital for company Applicants must have data and/or proof of concept/evidence Mentorship is not required Full time W-2 employee required 16

17 Application Guidelines Online submissions only paper submissions not accepted Certification Identifying information (name, address, etc.) Statutory questions Good corporate actor Certificates of Good Standing from both the MA Secretary of State and the MA Department of Revenue, dated no earlier than October 1, If Certificates do not arrive in time for application deadline, supply to MLSC no later than March 20, 2015 at Management Team CV s (4 pages max in PDF) Letters of Support - optional (3 pages max in PDF) Executive Summary of Business Plan (1 2 pages max in PDF) Recommended sections include: Company History, Technology/Service, Market Need, Financials Milestone Proposal (5 pages max in PDF) 17

18 Application Guidelines continued Milestone Proposal 5 pages max, must be in narrative PDF format, 11 pt. font Define the milestone What is the focus? (e.g. physician interviews, building a prototype, mouse study, etc.) What are the tasks? Who will be involved? (vendors, contractors, current staff) Explain the need Why is milestone needed? What will it allow you to accomplish? Outline budget and timeline How long will it take? What is the expected cost? Highlight the Team (1 page summary, not where CV s should go) 18

19 Online Application Tips Use Sample Application Template from website to plan your submission (available online 12/8) Save your work often Store your question responses in a back-up location Save the unique link provided outside of your cache, clipboard Download and print a copy of application before submitting Check that your responses are visible on the downloaded copy Upload only one merged PDF per upload field provided Multiple documents should be merged prior to upload; i.e. CV s, Milestone Proposal, Letters of support 19

20 Corporate Consortium The MLSC Corporate Consortium Program Roche is a current member of program Sanofi and Johnson & Johnson were previous members Members join and provide funds to the MLSC s early-stage company programs Members receive access to early stage applications and may attend SAB and Investment Committee meetings Applicant asked if Roche is allowed to view the company s application 100% optional 20

21 Process (awards announced May 2015) Launch MLSC conducts info sessions Application opens Dec. 8 Deadline Feb. 2 MLSC performs admin. Review Finalist pool selected Applicants provide answers Questions posed to applicants, if any Peer reviewers and SAB review *** MLSC conducts due diligence MLSC Investment Committee forms recommendations MLSC Board Votes on Awards, awardees notified Funding *** Applicants notified if they will not progress here May 2015 Board meeting Upon execution of Grant Agreement 21

22 Evaluation Criteria Defined Milestone and Need Team/Mentorship Strengths Milestone Budget and Timeline Technology Strengths MLSC Assessment Of Applicants Business Impact 22

23 Parameters of Award Minimum grant of $50,000, max of $200,000 Project must begin within 4 months of award notice Awards of $50,000 to $100,000 will be disbursed: 90% at grant agreement, 10% upon final report submission Awards over $100,000 to $200,000 will be disbursed: 50% at grant agreement, 40% at approval of interim report, 10% upon final report submission Interim and final reports must include documentation of use of funds 23

24 Information Sessions Date Host Location Time January 8, 2015 January 14, 2015 January 22, 2015 MBI / WPI 60 Prescott St., 4 th Floor Worcester, MA LabCentral 700 Main St., Cambridge, MA Bay Colony 1000 Winter St, North Entrance, 1 st Fl. Waltham, MA 3:00 4:15 p.m. ** 3:00 4:15 p.m. ** 8:30 9:45 a.m. ** ** followed by Accelerator Loan info session You must RSVP to: map@masslifesciences.com Space is limited 24

25 The MLSC Accelerator Loan Program: Opens Dec. 18, 2014 Due Feb. 2, 2015 Noon Objective: Provide working capital to early stage life sciences companies with a high potential for technology commercialization, rapid growth, and private equity financing 30 companies have received $20.8M 8 companies have paid back with interest 5-Year Loan, 10% interest rate Up to $1M unsecured loan $300,000 in at-risk capital required Warrant coverage of 4% Payable on financing event of at least $5M in any 12 month period Sample6 Technologies, Boston In 2014, repaid $750,000 loan with interest after raising $11 million in private financing 25

26 The UP program will fund grants ($50k-$200k) to Massachusetts companies to support milestone-based R&D collaborations with international organizations. Successful completion of the milestone is expected to contribute to the overall development of a new or significantly improved product or process intended for commercialization. 26

27 UP Basics Maximum Flexibility: MA companies can partner with organizations such as: a company, a research institution or a university, in any non-u.s. geography where their needs can be satisfied Goal: UP will support work contributing to a specific, focused, R&D milestone within the context of an overall product or process development program. Milestones will typically last up to 1 year Accelerated Review: Year-round review process will ensure a rapid response time. Applications can be submitted at any time Evaluation & Approval: Evaluation recommendations will be made by MLSC s SAB and approved by the Board 27

28 The MLSC International Partnership Assistance Portal (IP-ap) Objective: Facilitate the ability of international and Massachusetts companies to identify and pursue potential partnerships 24/7/365. Free, password-protected, cloud-based portal Open to all MA-based life sciences companies and international life sciences companies Companies provide the qualities they are seeking in a partner Searchable database Create your user profile at 28

29 The MLSC Internship Challenge Program Increases interest, skill development and employment readiness for life sciences careers by providing real-world experience Funds interns working at Massachusetts companies with fewer than 100 employees Over 1,700 internships placed 165 different colleges and universities represented 432 companies have participated Over $12 million committed to the program to date More than 160 participating interns have been offered full or part-time jobs at the conclusion of their internships 29

30 Keep in Touch with Us! News updates Program information Application portal Life Sciences Center List 5,000 recipients Weekly event listings Sign up today! Social Media Like Mass Life Sciences on Facebook on Twitter Connect with Massachusetts Life Sciences Center on LinkedIn 30