1. FROM IDEA TO EXECUTION HOW TO START AN EGG BANK

2. RELEVANT DISCLOSURES  Shareholder/Co-founder – Donor Egg Bank USA, LLC

3. OBJECTIVES  Understand the current cultural climate impacting women’s decisions to freeze  Provoke thought regarding variables to successful egg banking – autologous & donor  Identify different models for third party egg banking  Discuss methods of execution  Review future trends and lessons learned

4. IDEA TO EXECUTION  Identify the market  Manage quality nuances  Lab  Clinical  Set realistic expectations  Put operational logistics in place  Consents & Legal documents  Determine the right model It seemed so simple…

5. FROZEN EGG BASIC MODEL  Frozen eggs decouple the traditional process of stimulation followed by transfer. Frozen Egg Cycle Stimulation Cycle Storage or Coordination Fee Transfer Cycle

6. THE FROZEN EGG MARKET

7. CULTURAL SHIFTS DRIVE FROZEN EGG BANKING  900% increase in women >35 having their first child since 1970  35% increase among women ages 40-44  Autologous: More women freezing eggs as “insurance against an uncertain future.”  Third Party: US Foreign Adoptions are at the lowest level since 1982  (6,441 adopted in 2014 vs. 23,000 in 2004) Source: US State Department Report to Congress, April 1, 2015 Source: May 2014; www.cdc.gov

8. REASONS FOR NOT HAVING CHILDREN EARLIER Fertil Steril. 2013;100(5): 1343-49 Survey of 500 women after completion of 1 egg freezing cycle

9. WHY DO WOMEN FREEZE THEIR EGGS? Source: Fertil Steril. 2013;100(3): S24 Rank in order of importance: (some women ranked more than one option)

10. HOW WOMEN FIRST LEARNED ABOUT EGG FREEZING Source: Fertil Steril. 2013;100(5): 1343-49

11. QUALITY

12. QUALITY FACTORS 1.Oocyte potential 2.Oocyte stimulation 3.Freeze/Thaw Technician 4.Lab environment 5.Device Carrier 6.Storage and handling 7.Endometrial prep 8.Sperm quality 9.Media culture 10.Transfer technique

13. QUALITY CONSISTENCY Freeze Tech# Ongoing/ET # 20132014 S-F2627%660% TB-S2639%3455% JL-S11351%1650% K-R2241%250% JG-S5256%5349% K-S2861%4544% PD-S2259%4243% T-C757%6940% B-B2741%938% B-F1822%925%

14. FREEZE VS THAW SKILLSET © 2014 Pro Baseball Insider, LLC (PBI)

15. FREEZE VS THAW DIFFERENTIALS Tech# Freeze # Thaw On-going/ETOngoing/ET S-A1233%875% TO-C6240%850% R-F922%1943% S-F560%1560% M-R4363%727% C-R0n/a2145% T-R1060%1450% N-RS1070%40% J-S5349%1250% L-S2250%2035%

16. HOW DO YOU KNOW?  High enough “N” to see trend  Comparison data  Between embryologists  Multiple cohort thaws  Track everything – device, # of eggs thawed, media, storage, etc.  Mechanism to monitor/analyze  Clinical Impact Creative Commons Licensing

17. OTHER LAB CONSIDERATIONS  Who on the embryology team?  Vit: Best hands, best adherence to protocol  Thaw: Highly skilled, best troubleshooter  Set-up for egg vit vs. thaw  Lab environment and set up  Thermometer  Stop watch (count up function)  Vit/thaw products/devices  Staffing on day of vit/thaw  Practice & review of protocol  Egg storage

18. DEVICE CARRIER  Open Systems  Cryotop  Cryolock  Cryotec Etc.  Closed Systems  CryoTip  Rapid-I  Etc.

19. OPERATIONAL LOGISTICS  Freezing –of eggs sets of 1, 2, 4  Thaw protocols  Thaw until…  Set number of eggs – ie. 6  Guarantee  Survival/Embryo/Blast  $$ value on autologous

20. OPERATIONAL LOGISTICS  Consents specific to the process  cryo-preserved eggs to freeze  cryo-preserved eggs to thaw & make embryos  Disposition  Autologous  Eggs not needed  Premature death  Donation  Research  Third Party  Look backs –eggs not usable  Questionable quality – identifiable track record  Unselectability  Donor updates over time  Abandoned eggs – returnable?  Capital loss from poor quality or lookbacks (recalls)

21. REALISTIC EXPECTATIONS  ASRM Guidelines - “There are not sufficient data to recommend oocyte cryopreservation for the sole purpose of circumventing reproductive aging in healthy women. “ ASRM/SART Practice Committees, Mature oocyte cryopreservation: a guideline, Fertil Steril. 2013;99:37-43  Egg freezing parties, Google/Facebook, newest “graduation gift”, 401K  How fear fuels the business of egg freezing, Danielle Paquette, Washington Post, March 6, 2015  Slogan “Lean in. But freeze first.”

22. EGG THAW OUTCOMES IR= Implantation Rate Courtesy of Shady Grove Fertility 1.877.411.9292

23. THIRD PARTY MODELS  Independent egg bank  Shared cycles  Greater risk - $$ and unused inventory  Network – open/closed egg banking  Limits risk  Increases interdependency  Minimizes unused inventory  Agency driven models  Liability?

24. LESSONS LEARNED  More challenging than originally thought  Lab environments and embryologists are not equally skilled to freeze/thaw eggs  Quality tracking is key – you can’t assume all is well.  Logistics and infrastructure is essential  Technology continues to evolve and best practices are becoming known  Economically beneficial and efficient use of egg resources Egg banking is the newest frontier in ART and much remains unexplored