MediCult. DnB NOR 2008 Health Seminar. Life s Beginning in Safe Hands

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Hillary Ferguson
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1 MediCult DnB NOR 2008 Health Seminar Life s Beginning in Safe Hands

2 Agenda I. Company and Market Overview II. Product and Pipeline Focus III. Financial Highlights IV. Future Developments Sept. 9, 2008 DnB Seminar 2

About MediCult Our products Vision: facilitate human To conception make the every #1 8 dream minutes, of all every around infertile the worldcouple come true Mission: More

3 About MediCult Our products Vision: facilitate human To conception make the every #1 8 dream minutes, of all every around infertile the worldcouple come true Mission: More than We births deliver per year leading, are innovative conceived ART using solutions MediCult and to the benefit Humagen of families products Sept. 9, 2008 DnB Seminar 3

IVF in the News Infertile couples to be priority for NHS IVF treatment August 18, 2008 Lots of life in IVF market August 10, 2008 Frozen embryos ensure successful

4 IVF in the News Infertile couples to be priority for NHS IVF treatment August 18, 2008 Lots of life in IVF market August 10, 2008 Frozen embryos ensure successful pregnancies August 24, 2008 Infertility at the Olympics: Cheering on Dara Torres August 19, 2008 Couples to get more IVF treatment July 14, 2008 Sept. 9, 2008 DnB Seminar 4

5 Country Need: Low Reproduction Capacity In OECD Children born per female aged yrs a country has to score 2,1 to reproduce itself. If not it can (1) accept, (2) open up borders or (3) incentivise. IVF can make a difference 0 Poland Korea Czech Russia Spain Japan Italy Hungary Greece Germany China Swiss Austria Canada UK Sweden Holland Finland Denmark Norway Australia France USA Ireland Mexico Indonesia Brazil India Source: OECD and FN Sept. 9, 2008 DnB Seminar 5

6 Parental Need: Serving an Underpenetrated Market Number of ART cycles per year per million capita 3,500 3,000 2,500 2,000 1,500 1, If no cost and good infrastructure (infertility ~10-15%) All larger countries still have low ART penetration, especially developing nations India China Brazil Russia Poland Global Avg. USA Italy UK Germany France Japan Norway Sweden Finland DK Australia Israel Source: Fertility and Sterility, June 2006, MediCult analysis Sept. 9, 2008 DnB Seminar 6

7 Company Overview 20 year track record in fertility market with media applications Based on pioneering work of Norwegian doctors for novel Synthetic Serum Replacement (SSRTM ) for media production Serving highly attractive growth market (demographic/lifestyle) Offering broadest assortment today within both ART media and micropipets Manufacturing sites Denmark (ART media) USA (ART micropipettes) Sales subsidiaries USA, France, United Kingdom, Germany, Italy, Spain, China and Australia ~190 person strong team globally Profitable, cash generating and with an industry leading pipeline IVF, IVM and Stem Cells Sept. 9, 2008 DnB Seminar 7

Fertilization, Culture and Transfer ICSI Micropipets Stem cell/ research pipets Custom

8 MEC Product Portfolio In Vitro Maturation Biopsy Micropipets Oocyte Retrieval Sperm Preparation Holding Micropipets Pasteur pipets Cryopreservation Microtechniques Fertilization, Culture and Transfer ICSI Micropipets Stem cell/ research pipets Custom Micropipets Broadest assortment in ART media Broadest assortment in ART micropipets Sept. 9, 2008 DnB Seminar 8

9 Consistent Strategic Focus Maintain industry leading pipeline and commercialise Invest in organic growth through sales/marketing Ensure continued high quality, cost-effective manufacturing Continuously explore M+A opportunities Sept. 9, 2008 DnB Seminar 9

10 Product Development Portfolio (IVF) PRODUCTS Preclinical Human Safety Human Efficacy wo transfer w transfer Regulatory Milestones Research Development FF-MAS IVM Q4 08 Commercial collaboration GM-CSF Q3 TBD 08 Complete data Iloprost IGF-II IVF Q2 09 Q1 TBD 08 External pilot study Mouse Effic. KODE FEM Q1 09 Mouse Saf. & Eff. TBD TBD Sept. 9, 2008 DnB Seminar 10

11 GM-CSF efficacy Study: Overall Design and Plan Control Test Control Test World largest prospective IVF media study: Multicentre (11 centres in DK/Sweden) Randomised Parallel group Placebo-controlled Double-blinded Adaptive design Follow-up Patient randomisation Interim analysis ~300 patients with embryo transfer CIR CIR ~1100 patients. To be confirmed(tbc) CIR follow-up data Stop for patient inclusion during interim analysis Dependent on no. of patients Dec 07 Jul 08 Oct 08 Q4 09 tbc Q3 10 tbc Sept. 9, 2008 DnB Seminar 11

12 Interim Results GM-CSF. From Press Release Interim results indicated an increased embryo implantation in line with the primary objective of the trial Susanne H. Bendz, PhD, Chief Science Officer and Executive Vice President at MediCult says: We are pleased that the results allow us to continue the study in line with the original plan If this early data remains positive, this media product has the potential to help many more couples with a successful pregnancy. We need to be cautious in our interpretation of the data as this is interim data based on approximately one third of the expected total study population. Details in regard to total patient sample size and time schedule will be communicated in connection with the presentation of the Q3 results (October 30, 2008). Sept. 9, 2008 DnB Seminar 12

13 Stem Cells Update Focus on developing 1st generation medium for hasc optimised for growth Animal-free content and low concentration of patient serum Evaluation of key performance indicators for acquired technology know-how May lead to additional product development efforts (alone and combination with SSRx) Simultaneous testing of media cultures for hesc Targeting launch of 1st generation product +1-2 yrs Long-term Commercial Objectives Validation in key trials addressing the different markets Solidify intellectual patent position Pursue international licensing opportunities Ensure feasibility of reliable large-scale manufacturing Develop/Co-develop off-the-shelf products Stage x x Sept. 9, 2008 DnB Seminar 13

14 MEC Widening Global Footprint Sept. 9, 2008 DnB Seminar 14

15 New MediCult HQ Måløv, Denmark Production capacity increase >4x Basic Design phase completed mid 2008 Relocation expected H On budget with total building cost : approx. DKK 190 million Sept. 9, 2008 DnB Seminar 15

16 Development in Key Financials (YTD DKK Million) Revenue Pre Tax Profit Before Amortisation CAGR=30% Operating Cash Flow Q2 04 Q2 05 Q2 06 Q2 07 Q2 08 Market 3leading global player in IVF media + Market 1 leading global player in IVF micropipets -1 = #1 dedicated company globally for IVF Sept. 9, 2008 DnB Seminar 16

17 MEC Group Growth Drivers Q2 and 2008 YTD Break-down of Q2 Growth +31% +42% +15% -4% Organic Currency Acquisitions Total 2008 YTD +15% -3% +38% +50% Sept. 9, 2008 DnB Seminar 17

18 Catalysts For Coming 12 Months Continued solid financial and growth progress Pipeline developments/product launches GM-CSF next steps (update on clinicals, regulatory, launch planning) Progress/clarification vs. FF-MAS, KODE FEM, IGF-II, Illoprost Launch of new/non-pipeline pipet and media products Regulatory US FDA (510K) approval expected for new culture media Further Australian TGA approval expected Further CE markings expected Prospects for additional acquisitions within IVF (or stem cells) Sept. 9, 2008 DnB Seminar 18

19 Investment Highlights Strong combination of financial and strategic upside in IVF and stem cell media ART media pipeline projects with active components (GM-CSF et al) Media for adult and embryonic stem cells Well-positioned to continue expanding market share in growing ART space Strong market position Promising pipeline Scalable business model Attractive financials Globally #1 focused ART company Strong brand positioning within key disposable areas Seizing on key strategic M&A opportunities Sept. 9, 2008 DnB Seminar 19

Sperm donation Oocyte donation. Hong Kong þ Guideline þ þ Hungary þ þ þ þ Israel þ þ þ þ Italy þ þ þ. Germany þ þ þ þ Greece þ þ þ þ

Sperm donation Oocyte donation. Hong Kong þ Guideline þ þ Hungary þ þ þ þ Israel þ þ þ þ Italy þ þ þ. Germany þ þ þ þ Greece þ þ þ þ CHAPTER 8: Donation Although there has been a reduction in the use of donor sperm because of ICSI and the impact of the removal of anonymity in some countries (1), sperm donation is still used and has