Straight walk towards the exit 27. september 2012

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1 Straight walk towards the exit 27. september

2 Straight walk towards the exit Program 15.00: Registrering, networking 15.30: Velkomst Martin Bonde, formand for DANSK BIOTEK 15.40: Investing for the Exit Jack Beck Nielsen, Partner, Novo Ventures 16.10: Turnaround and exit Ingelise Saunders, tidligere CEO, Action Pharma, nu CEO SLS Invest 16.40: Deals and exits the legal stuff Jeppe Brinck-Jensen, Partner, Accura 17.10: Afrunding Martin Bonde, formand for DANSK BIOTEK 17.15: Networking

3 Tak til Accura et af vore advokatfirmaer

4 Company news

5 Straigth Walk Towards the Exit Jack B. Nielsen, Novo Ventures, Novo A/S 27 September 2012

6 2 27 September 2012 Dansk Biotek A Decade of Biotech Evolution 2000 Sustainable pipeline through an enabling platform that can throw of many drugs Now A lot has happened. But you can still recognize the industry FTE Mainly internal expertise, limited outsourcing Clinical indications, targets and a buyer? We will figure that out later, lets get the platform working first We raise more cash along the way as we will increase in value or we go public early We will sell our shares in the public market

7 3 27 September 2012 Dansk Biotek A Decade of Biotech Evolution 2000 Sustainable pipeline through an enabling platform that can throw of many drugs FTE Mainly internal expertise, limited outsourcing Clinical indications, targets and a buyer? We will figure that out later, lets get the platform working first We raise more cash along the way as we will increase in value or we go public early We will sell our shares in the public market However Normally only one lead drug 2-20 FTE Lots of outsourcing Front and center now Syndication risk is very significant big Series A M&A preferred

8 4 27 September 2012 Dansk Biotek The models have evolved, but not fundamentally changed Single drug, semi-virtual - These are more common today, incl. LLC s LLC s enables tax efficient distribution from licensing deals, but has structural issues for future funding Platform companies fewer than there used to be, in particular in Europe New protein or chemistry platforms Big Biology Indication focused pipeline we see a little more of those Oncology, inflammation Orphan disease portfolio Hodge-podge Various drugs for various indications Contract Development Companies Pharma partner very early, reduce investment need but retain significant rights Off-balance sheet drug development for Pharma!?

9 5 27 September 2012 Dansk Biotek What has changed the most? We have more focus these days on: Clear differentiation Breakthrough treatments Reimbursement risk Clinical development costs to an M&A window Syndication risk Licensing/deal structures that enable trade sale We obviously still need: Great Management Solid IP Significant market size Multiple potential buyers An exit horizon in our life-time

10 6 27 September 2012 Dansk Biotek Straight Walk Towards the Exit An exit ultimately equals cash in the bank But how do you get there? Trade sale/m&a? Yes normally, at least when proceeds is cash or very liquid stock An IPO? Could be eventually, after lock-up, and when significant liquidity is established. But getting there can be years after an IPO. Also, its more of a financing these days, so you may want to wait for future company events. Asset sale or Licensing deal? Rarely, but sometimes if proceeds are distributed. Tax-efficiency difficult when proceeds above 1x. Some corporate sturctures are more tax efficient, but come with their own set of problems.

11 7 27 September 2012 Dansk Biotek M&A - Significant biotech exits since 2007? Significant Exit *) is here defined as: 35 Private company trade sale only (IPO not an exit until significant liquidity is established) +100MEUR upfront (escrow included, but nothing else. Milestones normally quite uncertain and not transparent) Drug development, drug discovery, specialty pharma etc. *) Significant Exit does NOT mean that investors made a lot of money. One of the companies had more cash invested than the upfront, and 8 of the 35 got 2X or less return on the upfront. No wonder the industry is under pressure.

12 8 27 September 2012 Dansk Biotek The Lucky Few *) 35 globally, in chronologic order : Kai Pharmaceuticals, Avila Therapeutics, Enobia, Intellikine, Amira, GeminX, Plexxikon, Calistoga, Biovex, Advanced Biohealing, Marcadia, Arresto, Avid, FoldRx, Alnara, Ception, Novexel, Gloucester, Proteolix, Fovea, BiPar, ESBATech, Serenex, CoGenesys, U3 Pharma, Piramed, Agensys, Adnexus, Novacardia, Alantos, Ilypsa, Hypnion, Arrow, Morphotek, Biorexis *) I believe this is the complete list, if you know of others please let me know

13 9 27 September 2012 Dansk Biotek Geographic distributiuon USA Kai Pharmaceuticals, Avila Therapeutics, Intellikine, Amira, Plexxikon, Calistoga, Biovex, Advanced Biohealing, Marcadia, Arresto, Avid, FoldRx, Alnara, Ception, Gloucester, Proteolix, BiPar, Serenex, CoGenesys, Agensys, Adnexus, Novacardia, Alantos, Ilypsa, Hypnion, Morphotek, Biorexis Europe Novexel, Fovea, ESBATech, U3 Pharma, Piramed, Arrow Canada Enobia, GeminX

14 10 27 September 2012 Dansk Biotek Split on indications for lead program Oncology Avila Therapeutics, Intellikine, GeminX, Plexxikon, Calistoga, Biovex, Gloucester, Proteolix, BiPar, Serenex, U3 Pharma, Piramed, Agensys, Morphotek, Adnexus Metabolic/CV Kai Pharmaceuticals, Marcadia, NovaCardia, Alantos, Ilypsa, Biorexis Orphan Enobia, FoldRx, Alnara Respiratory Amira, Arresto, Ception Other Advanced Biohealing, Avid, Novexel, Fovea, ESBATech, CoGenesys, Hypnion, Arrow

15 11 27 September 2012 Dansk Biotek Did Novo ever evaluate them as an active opportunity? 11% 4 Investments 35 significant exits 83% 17% 29 were evaluated 6 that we did not see 51% 18 that we declined 20% 7 declined by company Novo Ventures evaluated companies in same period

16 12 27 September 2012 Dansk Biotek Novo learning's on the Significant Exits We looked at 80% of all companies that have had significant exits We closed an investment in 10% of all significant exits For 20%, the companies did not take our proposed terms; typically there was a parallel process or a competitive VC process or we were too cheap and internal shareholders funded it. We declined 50% of companies which latter had significant exits Key reason for declining were too early stage, too expensive, and clinical issues Early stage declines took about 1 year longer to exit than average, but had highest multiple return Price declines took about half a year less to exit than average, but had lowest multiple Average multiple for all 35 exits were 3,8X Only 1 of the 35 companies did not develop an NCE or novel biologic

17 13 27 September 2012 Dansk Biotek Straight Walk towards the Exit? What we are looking for these days: Clear differentiation Breakthrough treatments Clinical development costs to an M&A window Reimbursement risk Syndication risk Licensing/deal structures that enable trade sale We obviously still need Great Management Solid IP Significant market size Multiple potential buyers An exit horizon in our life-time You dont need to tick off on all of these, but make sure you get most of them! VC Hit Rate is very far from 100% so don t be discouraged by many no s

18 TURNAROUND AND EXIT :51 BIOTECH SWEDEN: Action Pharma i jätteaffär med amerikanskt bolag

19

20 Action Pharma A/S - Milepæle 2000: Action Pharma stiftes 2007: DKK 38 mio. i kapitaltilførsel (Sunstone Capital, Incuba Venture, Østjysk Innovation) 2003: SIP -teknologi indlicensieres fra Zealand Pharma : DKK 197 mio. i kapitaltilførsel (Sunstone Capital, Incuba, InnovationsKapital, SLS, GLSV) 2012: Salg af AP214 til Abbott : DKK 51 mio. i kapitaltilførsel (Vækstfonden, Incuba)) 2007: Sunstone Capital overtager Vækstfondens aktiepost i Action Pharma 2010: Restrukturering, Ingelise Saunders ny CEO, og Sten Verland ny bestyrelsesformand 2001: Seed-kapital fra Østjysk Innovation Kilde: Action Pharma A/S

21 SITUATIONEN EFTERÅRET 2009 Skuffende fase 1 data på et førende projekt Potentielle nye investorer bakker ud Ny kapital skal tilføres i januar

22 AKTIONÆRBESLUTNING DECEMBER 2009 Focus på et projekt: AP214 Alle andre projekter on hold Al preklinik nedlægges Bestyrelsen ændres til investor only med Sten Verland, Sunstone Capital, som formand Ny CEO med focus på salg baseret på AP

23 JANUAR 2010 Oplæg til strategi for exit baseret på AP214 Tilførsel af kapital fra eksisterende investorer Dramatisk nedskæring af omkostninger Virtuel organisation planlægges fra 1.8 Alle medarbejdere opsiges undtagen COO

24 Januar - februar: Detaljeret gennemgang af eksisterende data og planer Information memorandum udarbejdes Marts: SALG AF AP214 Interesse blandt ca 20 tidligere kontakter testes af CEO via mail Fint respons, men alle vil se fase 2-data Konklusion: Der er intresse for projektet

25 AP214 MILEPÆLE 2000: Action Pharma stiftes 2006: Møde med FDA om AP : Positive fase 2B data 2006: Fase 1 kliniske studier indledes 2012: Salg af AP214 til Abbott : Fase 2A klinisk studie igangsættes i hjertekirurgipatienter med øget risiko for nyreskader 2010: Fase 2B klinisk studie igangsættes 2004: Proof of concept data i dyresygdomsmodeller 2008: Fase 1 kliniske studier afsluttes 2010: Positive fase 2A data Kilde: Action Pharma A/S

26 SALGSPROCESS BBLSA hyres i maj 2010 til at køre processen, der skal baseres på fase 2a-data, der forventes i juli Det besluttes sideløbende at starte et fase 2b-studie med focus på effekt Møde med FDA i juni Studiet køres i både US og DK Fase 2a-data i juli viser tendens til effekt men forvirring omkring dosis Fase 2b startes i oktober Mål: 75 patienter og rapportering inden for 12 mdr Note: Back Bay Life Science Advisors (BBLSA)

27 BBLSA PARTNER PROCESS (1) Focuseret process startes i august firmaer kontaktes Stort respons, ca 15 management præsentationer gennemføres i september/oktober/november DD startes af en håndfuld firmaer men mange spørgsmål omkring effekt og dosis samt det kommercielle potentiale Marts 2011: BBLSA anbefaler, at vi sætter processen on hold og starter igen, når fase 2b er klar BBLSA udfører market research i USA for at dokumentere potentialet i den initiale indikation samt i yderligere potentielle indikationer Fase 2b-data klar i oktober, hvorefter vi og BBLSA bruger 1 måned på at gennembearbejde management præsentationen

28 UDVALGTE FIRMAER

29 KAPITALTILFØRSEL AP214 JANUAR JUNI OKT. JANUAR JULI MARTS JULI Fase 2a-data OKTOBER Fase 2b start OKTOBER Fase 2b-data MARTS AP214 salg

30 BBLSA PARTNER PROCESS (2) Process startes 1.11 med klar beskrivelse af process og timelines: non binding offers by end January deal by end March Krav til partner: Betingelse: JP Morgan: Global deal, stor upfront er afgørende, options aftale ikke af interesse Fase 2b-data sendes ikke ud F2F-møde eller video/telefonmøde Lang række møder til afklaring af specifikke spørgsmål samt socialt netværk Slutning af januar: 5 seriøse firmaer Abbott et af dem

31 BBLSA PARTNER PROCESS (3) Sidste uge af februar: ABBOTT PROCESS LOI prisen på $ 110 M upfront fastlagt Betingelse i LOI: Aftalen skal være på plads i april Første uge af marts: APA-forhandling i NY Første uge af april: Alle detaljer på plads Slut april: Godkendelse på Abbott s bestyrelsemøde Aftalen underskrevet 3 maj FTC-process initieres afsluttes efter 25 dage Closing 2 uge af juni

32 DEAL STRUKTUR $ 110 M at closing ingen earn out 15 % i escrow i 10 måneder

33

34 DEALS AND EXITS the legal stuff 27 September 2012 CONTACT: Jeppe Brinck-Jensen Attorney-at-law, Partner Accura Advokatpartnerselskab Tuborg Boulevard Hellerup Phone: Mobile:

35 ACCURA law firm 190 employees, 110 lawyers Established CORE AREAS M&A Real Estate Banking & Finance Private Equity IPR & Technology EU & Competition Insolvency & Restructuring Employment Corporate & commercial Capital 2

36 Focus on intellectual property due diligence A diligence team conducts a review of the assets, liabilities, and other information pertinent to the transaction and advises the investor. The team is usually composed of at least one lawyer, a financial specialist, and a technology expert. Due diligence is used when a company ("the investor") is about to merge with, acquire, or invest in another company, business, or technology or license ("the target ) Often a financial, technological and legal due diligences are combined IP due diligence is particularly important in transactions involving biotechnology, which relies heavily on patents and proprietary technical information. 3

37 M&A has become the preferred exit strategy for privately-held [biotech] companies as the market for initial public offerings in recent years was at first effectively shut down by the global recession and continues to be muted. Source: G. Steven Burrill, CEO of Burrill & Company and author of Biotech 2012: Innovating in the New Austerity 4

38 In 2011, there were 990 biopharma M&A transactions worldwide and it is expected to grow as biotechs continue to seek for new opportunities. 5

39 Agenda 1) Purposes of legal due diligence 2) Information requested in a due diligence process 3) Patent DD 4) Knowhow DD 5) Regulatory DD 6) Agreements DD 7) Seller s own due diligence 8) Our general advise 6

40 Purposes of IP due diligence The investor s way of managing risk and determining transaction viability and value Should the investor go forward with the transaction at all Does the investigation suggest a price adjustment To limit the liability of the Seller Ensure that all matters are disclosed which might otherwise result in a warranty claim 7

41 Information often requested from Target Strategic relationships with third parties Competing companies and technologies Target's business and marketing plans A list of current and former intellectual property counsel representing the target A list of all issued patents (both in force and expired) and patent applications (pending, published or abandoned) anywhere in the world that the target owns or has rights (such as a license) under, including country of filing, application and registration dates, status, expiration dates, owner, nature of target's interest and identity of inventors Access to records of proceedings involving the patents and patent applications (both pre-issuance proceedings before patent offices in commercially important countries, as well as interferences, oppositions, reissues, reexaminations, and other contested or post-grant proceedings) and a list of the principal impediments or potential impediments (such as prior patents or publications) to the target's obtaining broad patent protection A list of the technology, products, and processes on the market or under development and, with respect to each, a list of the patents and patent applications that are intended to protect it 8

42 Information often requested from Target A list of the technology, products, and processes for which patent protection has not been sought but which the target considers proprietary, (invention disclosures, patent applications in preparation, as well as biological materials required for any of the target's current or contemplated products or processes) A list of publications or public disclosures involving the target's products, processes or technology Relevant agreements, (license agreements, supply and distribution agreements, development agreements, collaborative, sponsored or contract research agreements, confidentiality agreements, materials transfer agreements, employee and consulting agreements); any policy or procedure statements regarding intellectual property (including the maintenance of invention or commercialization records, lab notebooks, conflicts policy) Legal opinions (patentability, validity, and infringement opinion) Documents from any current, past, or threatened litigation or dispute involving infringement or validity of, or rights in, any technical intellectual property of the target or of a third party, including inventorship disputes Regulatory licenses 9

43 IP due diligence Typical investigation begins with two main questions: What are the products or service involved with the transaction? Does the existing IP (patents, knowhow, design, trademark, copyright, data exclusivity, orphan drug, licenses etc.) cover those products? 10

44 Patent scope and validity Claim scope of key patents Do the patents cover Target s products or services Validity assessment of key patents (formal requirements, enablement, non obviousness) Existing options to expand patent protection Pending litigation associated with the use of the technology is considered 11

45 Freedom to operate Will the buyer be able to make, use and/or sell Target s products or services without infringing IP rights of a third party Possibilities of design-arounds? Scope and term of valid licenses from third parties Potential license fees to third partys 12

46 Ownership of patents Who are the inventors Have the inventions been assigned to Target? Are there co-owners e.g. due to public funding? Are the rights under opposition? Patent register does not dictate ownership Representation from Target that no unrecorded assignments or licenses Representation from employees and consultants that no rights reserved 13

47 Ownership of patents cont. Ownership issues a potential deal breaker: without clear title, the patent rights are worthless ownership conflict may freeze application proceedings for years, e.g. before EPO 14

48 Duration and territory Length of remaining term is often a critical factor Assessment of possible SPC Are the relevant territories covered by patents, or is still possible to have such territories covered 15

49 Knowhow due diligence Record-keeping Confidentiality physical environment Employees level of awareness are reports marked confidential are key employees covered by restrictive covenants Management adequate procedures to identify inventions and consider patentability Dealings with third parties wording of NDA/MTAs with third parties 16

50 Agreements (in- or out bound) Scope Territory IPR Payments Term Assignability Are there restrictive provisions that will prevent commercialization of a product, or the enforceability of the patents? 17

51 Regulatory exclusivity Data-exclusivity Orphan drug protection 18

52 Seller due diligence Seller prepares its own due diligence describing the main issues the level of risk associated with the issues in Seller s view the scope of possible design arounds or inbound licenses Enables Seller to distinguish between key technology and non-key and deflate any arguments from the investor 19

53 Our general advise to targets Put your house in order and increase the marketability of your company limit your potential liability Make sure that everybody involved in a transaction knows why the investor is considering the acquisition of that particular Target 20

54 Our general advise to investors Make sure that everybody involved in a transaction knows why the investor is considering the acquisition of that particular Target Which of Target s technologies are important to the investor? Are irrelevant technologies involved in the transaction? Are the important technologies covered by Target s IP? Is Target s key IP valid and enforceable? Can Target use the technology without infringing technology of third parties? Does Target have clear title to the key technology 21

55 QUESTIONS? 22

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