KOL DISCUSSION: IVF, EMBRYO TRANSFER, AND ...obseva.across.health/.../KOL-Event-July-2019-FINAL_Jul18.pdfpresentation reflect our views as of the date of this presentation about future

J u l y 1 7 , 2 0 1 9

Innovating Women’s Reproductive

Health and Pregnancy Therapeutics

KOL DISCUSSION:

IVF, EMBRYO

TRANSFER, AND

NOLASIBAN

©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED.

DISCLAIMER

Matters discussed in this presentation may constitute forward-looking statements. The forward-looking statements contained in thispresentation reflect our views as of the date of this presentation about future events and are subject to risks, uncertainties,assumptions, and changes in circumstances that may cause our actual results, performance, or achievements to differ significantlyfrom those expressed or implied in any forward-looking statement. Although we believe that the expectations reflected in theforward-looking statements are reasonable, we cannot guarantee future events, results, performance, or achievements. Some ofthe key factors that could cause actual results to differ from our expectations include our plans to develop and potentiallycommercialize our product candidates; our planned clinical trials and preclinical studies for our product candidates; the timing ofand our ability to obtain and maintain regulatory approvals for our product candidates; the extent of clinical trials potentially requiredfor our product candidates; the clinical utility and market acceptance of our product candidates; our commercialization, marketingand manufacturing capabilities and strategy; our intellectual property position; and our ability to identify and in-license additionalproduct candidates. For further information regarding these risks, uncertainties and other factors that could cause our actual resultsto differ from our expectations, you should read our Annual Report on Form 20-F for the year ended December 31, 2018, as filedwith the Securities and Exchange Commission on March 5, 2019 and our other filings we make with the Securities and ExchangeCommission from time to time. We expressly disclaim any obligation to update or revise the information herein, including theforward-looking statements, except as required by law. Please also note that this presentation does not constitute an offer to sell ora solicitation of an offer to buy any securities.

This presentation concerns products that are under clinical investigation and which have not yet been approved for marketing by theU.S. Food and Drug Administration. It is currently limited by federal law to investigational use, and no representation is made as toits safety or effectiveness for the purposes for which it is being investigated. The trademarks included herein are the property of theowners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products.

This presentation also contains estimates and other statistical data made by independent parties and by us relating to market sizeand growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautionednot to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and thefuture performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.

2


TODAY’S AGENDA

Welcome and Introductions 9:00 - 9:05 Tim Adams

Overview of IMPLANT Trial results and progress 9:05 - 9:20 Ernest Loumaye

Nolasiban Market Assessment 9:20 - 9:35 Wim Souverijns

Discussion topics/questions

• Current trends in IVF

• Costs of failure

• Improving success rates

• Day 5 SET

• SET vs. DET implications

• Nolasiban potential

9:35 - 9:45

9:45 - 9:55

9:55 - 10:05

10:05 - 10:15

10:15 - 10:25

10:25 - 10:35

Dr. Pauli, Dr. Schnell, Dr. Sharara

Moderator:

Jean-Pierre Gotteland

Final Audience Q&A 10:35 - 10:55

3


PANEL OF KEY OPINION LEADERS

4

Samuel Pauli, M.D.

Boston IVF

Lexington, MA

Surgical Director at Boston IVF

Member of Ohana Biosciences Clinical Advisory Board - Massachusetts

Vicki Schnell, M.D., FACOG

Center of Reproductive Medicine

Houston, TX

Fellow of the American Congress of Obstetricians and Gynecologists

Founder and Medical Director for the Center of Reproductive Medicine - Texas

Fady I. Sharara, M.D., FACOG

Virginia Center of RM

Reston, VA

Medical Director and Founder of VCRM

Clinical Professor at George Washington University – Washington, D.C.


J u l y 1 7 , 2 0 1 9

Innovating Women’s Reproductive Health and Pregnancy Therapeutics

NOLASIBAN FOR

IMPROVING

LIVE BIRTH RATE

FOLLOWING BLASTOCYST

TRANSFER

5


UTERINE CONTRACTIONS AT THE T IME OF EMBRYO

TRANSFER AFFECT PREGNANCY RATES AFTER IVFFA N C H I N E T A L . H U M A N R E P R O D . 1 9 9 8

Uterine contractions assessed by transvaginal ultrasound

Figure 1. Computerized assessment of uterine contraction (UC) frequency. After

determining the uterine section to be analysed (left panel), time-dependent changes

in endo–myometrial interfaces corresponding to UC were assessed (right panel).

6

Stepwise decrease in clinical pregnancy rates from the lowest to the highest

uterine contraction (UC) frequency groups (P, 0.001: ANOVA).

60%

40%

20%

0%

UC/min

≤3.0 3.1 – 4.0 4.1 – 5.0 >5.0


OXYTOCIN ANTAGONISM FOR IVF: 1 ST CASE REPORT

7


OXYTOCIN RECEPTOR ANTAGONIST GIVEN AT THE T IME

OF EMBRYO TRANSFERM E TA - A N A LY S I S ( H U A N G E T A L . P L O S O N E 2 0 1 7 )

8

Forest plot for clinical pregnancy rate in women undergoing in vitro fertilization

Control Atosiban

Clinical Pregnancy Rate (6 studies; n = 1754) 40.7% 51.2%


OXYTOCIN ANTAGONISMMECHANISM OF ACTION: HYPOTHESIS

9

Functional Oxytocin receptors expressed

on human non pregnant uterus:

• Myometrium smooth muscle cells

• Uterus arteries smooth muscle cells

• Endometrium glandular epithelial cells

Oxytocin receptor antagonists :

• Reduce myometrium contractions1

• Enhance uterus blood flow2

• May enhance endometrium receptivity3

1ObsEva data on file; 2Kalmantis et al. 2012; 3Pierzinsky et al., 2019


NOLASIBANFIRST, ORALLY ACTIVE, OXYTOCIN ANTAGONIST

10

Parameter Nolasiban

hKi Oxytocin Receptor (OTR) 48 nM

hKi Vasopressin 1a Receptor (V1a) 120 nM

Selectivity 2.5-fold OTR selective

Dose form and regimen Single oral administration 4 h prior ET

Tmax 1–4 h

Half-life 12 h

Duration of exposure ~ 48 h

©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 11

Trial Phase Treatments Purpose Status

IMPLANT 1Phase 2

EU

100, 300, 900 mg

placebo

Proof of concept and dose ranging in

D3 SET and DETCompleted

IMPLANT 2Phase 3

EU

900 mg

placeboConfirmatory trial in D3 and D5 SET Completed

IMPLANT 4Phase 3

EU

900 mg

placeboConfirmatory trial in D5 SET On going

IMPLANT 3Phase 3

US

900 mg

placeboConfirmatory trial in D5 SET In planning

NOLASIBAN COMPLETED CLINICAL TRIALSP H A S E 2 : 9 0 0 M G S E L E C T E D F O R F U R T H E R D E V E L O P M E N T

P H A S E 3 : P R I M A RY A N D S E C O N D A RY E N D P O I N T S M E T


• Age 18–36 y

• Fresh D3 or D5 SET

• Max 1 failed previous IVF

• P4 ≤ 4.7 nmol on day hCG

• Vaginal P4 for luteal support

NOLASIBAN: PHASE 3 TRIAL IN IVFIMPLANT 2

Main study Follow Up

D3 ET

D5 ET

900mg nolasiban

n=194

900mg nolasiban

n=194

Placebo

n=194

Placebo

n=196

Not pregnant

Pregnant W6 W10Infant

FU

Randomize

2 weeks Primary Analysis

Ongoing

pregnancy

10 weeks

28 days 6 months

Birth

Screening

– IVF

9 weeks

Neonatal

FU

778 Patients enrolled – Trial conducted in 41 fertility centers in 9 European countries

12


BASELINE CHARACTERISTICS (1/2)

13

Characteristicmean ± SD unless indicated otherwise

Pooled D3/D5 D3 ET D5 ET

Placebo

N=390

Nolasiban

N=388

Placebo

N=194

Nolasiban

N=194

Placebo

N=196

Nolasiban

N=194

Age — years 31.4 ± 3.2 31.1 ± 3.3 31.4 ± 3.3 31.1 ± 3.2 31.3 ± 3.2 31.1 ± 3.3

Body-mass index – kg.m-2 23.8 ± 4.3 24.0 ± 4.4 23.9 ± 4.1 24.1 ± 4.1 23.7 ± 4.5 23.8 ± 4.7

Primary Infertility – no. (%) 263 (67.4) 267 (68.8) 137 (70.6) 136 (70.1) 126 (64.3) 131 (67.5)

Type of infertility – no. (%)

Male factor only 122 (31.3) 131 (33.8) 62 (32.0) 70 (36.1) 60 (30.6) 61 (31.4)

Tubal factor 73 (40.1) 78 (46.7) 48 (50.5) 39 (44.3) 25 (28.7) 39 (49.4)

Ovulation dysfunction 53 (29.1) 42 (25.1) 20 (21.1) 21 (23.9) 33 (37.9) 21 (26.6)

Endometriosis 35 (19.2) 40 (24.0) 17 (17.9) 20 (22.7) 18 (20.7) 20 (25.3)

Menstrual irregularity 26 (14.3) 22 (13.2) 11 (11.6) 11 (12.5) 15 (17.2) 11 (13.9)


BASELINE CHARACTERISTICS (2/2)

14

Characteristic mean ± SD

Pooled D3/D5 D3 ET D5 ET

Placebo

N=390

Nolasiban

N=388

Placebo

N=194

Nolasiban

N=194

Placebo

N=196

Nolasiban

N=194

Duration of stimulation – days 9.4 ± 1.8 9.4 ± 1.8 9.5 ± 1.8 9.7 ± 1.9 9.3 ± 1.8 9.2 ± 1.7

Gonadotrophin total dose – IU 1846 ± 645 1870 ± 650 1824 ± 722 1891 ± 727 1868 ± 561 1849 ± 563

Fertilization method – no. (%)

IVF 35 (9.0) 44 (11.3) 16 (8.2) 25 (12.9) 19 (9.7) 19 (9.8)

ICSI 355 (91.0) 344 (88.7) 178 (92) 169 (87.1) 177 (90.3) 175 (90.2)

Serum E2 on day of hCG – nmol/L 6653 ± 4283 7383 ± 4205 6400 ± 4726 6564 ± 3401 6906 ± 3553 8201 ± 4749

Serum P4 on day of hCG – nmol/L 1.97 ± 1.15 1.88 ± 0.99 2.01 ± 1.26 1.82 ± 0.99 1.93 ± 1.03 1.94 ± 0.98

No. of oocytes retrieved – no. 9.4 ± 4.4 9.7 ± 4.3 9.0 ± 4.6 8.6 ± 4.2 9.8 ± 4.1 10.9 ± 4.2

No. good quality embryos* – no. 2.5 ± 2.0 2.6 ± 2.0 2.7 ± 2.2 2.5 ± 1.9 2.3 ± 1.6 2.7 ± 2.0

* Good quality embryos defined according to Istanbul conference 2010 (D3) and Gardner grading scale (D5)


7.1% absolute

increase or 25% relative increase in

LBR versus placebo

for pooled D3 and

D5 SET data

50%

40%

30%

20%

10%

0

Ongoing pregnancy

rate at 10 weeks (%)

Live birth rate (%)

p=0.031

28.5%

35.6%

p=0.025

27.7%

34.8%Placebo n=390

Nolasiban 900mg, n=388

15

EFFICACY RESULTS: PRIMARY ANALYSIS

POOLED D3/D5


D3 SET D5 SET

50%

40%

30%

20%

10%

0Ongoing pregnancy


Live birth rate (%)

p=0.034

34.7%

45.9%

p=0.025

33.2%

44.8%

Placebo n=194 Nolasiban n=194

50%

40%

30%

20%

10%

0Ongoing pregnancy


Live birth rate (%)

22.7%24.7%

22.2%

25.3%

p=0.477 p=0.552

Placebo n=196 Nolasiban n=194

16

EFFICACY RESULTS FOR D5 ET: 35% RELATIVE INCREASE

IN LBR FOR NOLASIBAN VS. PLACEBO



MATERNAL OUTCOMES A D V E R S E E V E N T S : N O L A S I B A N N O T D I F F E R E N T F R O M P L A C E B O

17

Spontaneously reported adverse

events up to week 10 post-ET

≥1% in any group

Placebo

N=391

Nolasiban

900 mg

N=387

Difference

(95% CI)

Abortion – no. (%) 44 (11.3) 38 (9.8) -1.4 (-8.4, 5.6)

Headache – no. (%) 11 (2.8) 11 (2.8) 0.0 (-7.0, 7.1)

Vaginal hemorrhage – no. (%) 11 (2.8) 8 (2.1) -0.8 (-7.8, 6.4)

Nausea – no. (%) 3 (0.8) 6 (1.6) 0.8 (-6.3, 7.9)

OHSS – no. (%) 4 (1.0) 4 (1.0) 0.0 (-7.1, 7.1)

Ectopic pregnancy – no. (%) 4 (1.0) 1 (0.3) -0.8 (-7.9, 6.3)


NEONATAL OUTCOMES AT DELIVERY

18

Outcomemean ± SD unless indicated otherwise

Placebo

N=109

Nolasiban

900 mg

N=136

Difference

(95% CI)

Male – no. (%) 49 (45.0) 67 (49.3) 4.3 (-8.4, 16.8)

Female – no. (%) 60 (55.0) 69 (50.7) -4.3 (-16.8, 8.4)

Gestational age – weeks 38.7 ± 1.9 38.2 ± 2.8 -0.55 (-1.18, 0.07)

Weight – g 3174 ± 517 3137 ± 690 -37 (-194, 120)

Height – cm 50.9 ± 3.7 50.4 ± 4.6 -0.4 (-1.5, 0.6)

Head circumference – cm 34.3 ± 1.6 33.7 ± 2.2 -0.6 (-1.1, -0.04)

Apgar score 1 min 9.09 ± 1.28 9.01 ± 1.50 -0.08 (-0.44, 0.28)

Apgar score 5 min 9.65 ± 0.76 9.61 ± 0.84 -0.04 (-0.25, 0.17)

Congenital anomaly – no. (%) 4 (3.7) 5 (3.7) 0.0 (-12.6, 12.6)


INFANT FOLLOW-UP ASQ-3 AT 6 MONTHSB O X P L O T F O R A G E S A N D S TA G E S Q U E S T I O N N A I R E ( A S Q - 3 )

TO TA L S C O R E S F O R P O O L E D D 3 / D 5

19

• Box – 25th to 75th percentiles

• Horizontal line – median

• Diamond – mean

• Whiskers – 1.5 times the interquartile

range above the 75th percentile and

below the 25th percentile.

N=99 N=124


IMPLANT 2: CONCLUSIONS

• Nolasiban significantly increased live birth rate (LBR)

• The largest increase in LBR was seen with D5 SET

• Maternal, neonatal and infant outcomes were similar

between the nolasiban and placebo groups

20


NOLASIBAN CLINICAL DEVELOPMENT PROGRAMO N G O I N G A N D P L A N N E D P H A S E 3 T R I A L S

21

Trial Phase Treatments Purpose Status

IMPLANT 1Phase 2

EU

100, 300, 900 mg

placebo

Proof of concept and dose ranging in D3

SET and DETCompleted

IMPLANT 2Phase 3

EU

900 mg

placeboConfirmatory trial in D3 and D5 SET Completed

IMPLANT 4Phase 3

EU

900 mg

placeboConfirmatory trial in D5 SET Ongoing

IMPLANT 3Phase 3

US

900 mg

placeboConfirmatory trial in D5 SET Planned


Sample Size

Total (per arm)Endpoint

Study

PowerPlacebo Active

820 (410) Ongoing pregnancy 34.7% 45.9% 90%

IMPLANT 4 EU STUDY DESIGNREADOUT 4Q:19

Main study Follow Up

Screening D5 Set

900mg

n = 410

Placebo

n = 410

Not Pregnant

Pregnant W6 W10Preg.

FU

Infant

FU

2 weeks

Randomize

10 week

pregnancy rate

28 days 6 & 12

months

9 weeks

Primary analysis

22


IMPLANT4 Trial initiated Q4:18 – MAA filing 4Q:19

800 patients, 40 centers in Europe, Russia, Canada

Day 5, Fresh SET

Primary endpoint 10 week ongoing pregnancy

Planning U.S. Ph3 program start

EOP2 FDA meeting completed Q2:19

Finalizing protocol and updating IND, trial start Q4:19/Q1:20

Getting started in China

Opening IND

Assessing development and commercial strategic options

2019 NOLASIBAN DEVELOPMENT PLAN

23

1 7 J u l y 2 0 1 9

N A S D A Q : O B S V | S I X : O B S N



INFERTILITY AND IVF MARKET SIZE,

NOT LIKE TRADITIONAL PHARMA

1 9% of 20-44 years of age (ESHRE 2018 ART Fact Sheet), 20-40 years of age (World Databank 2017)2 A TFR below 2.1 indicates a declining population

Women (20-44 year) with

Infertility1 7.2M 22.7M 4.8M 36.3M

ART Cycles/Year >800k >800k >260k >2.2M

Total Fertility Rate (TFR) 1.6 1.5 1.8 < 2.12

Fertility Drugs Sales (2017) $0.7B $0.3B(16% CAGR)

$1.2B $2.7B(10% CAGR)

Major

Markets

1 2 3

25


NOLASIBAN – WHY GOING IT ON OUR OWN

Breakthrough clinical data

No competition anticipated

No change to standard of care

1

2

3

Strong value proposition4

12% absolute (35% relative) increase in LBR1 with no

observed safety or tolerability issues in IMPLANT 2

Simple & convenient addition to current practice

Nothing approved, nor in development

Increased productivity & similar LBR with single embryo

transfer while avoiding health & cost risks of multiple

pregnancies from multiple embryo transfer

Concentrated market5Modest commercial infrastructure to drive blockbuster

opportunity in US and EU

1 A 3-5% absolute increase considered clinically significant, Capri Group report, Human Reproduction, 2018

26


A LEAN OPERATION TO COMMERCIALIZE

NOLASIBAN EFFECTIVELY

Highly concentrated

No competition

Sophisticated B2B market

1

2

3

100 FTEs can drive a blockbuster business

105 134 354 231 82 ~ 500ART Centers (#)

27


COMMERCIALIZATION – A TWO PRONGED APPROACH

PUSH – CLINICIAN PATIENT – PULL

• Maximize success for

patients

• Thought leadership

• Business & economics

• Maximize chances of

having a baby

• High ‘pain’ of failure

• High willingness to pay

1 2

Dual Targeting for Optimal Outcomes

28


FOR PATIENTS, MAXIMIZING SINGLE IVF CYCLE

SUCCESS IS CRITICAL

• Fresh IVF procedure cost

range $8-25K, +$20K with

additional drugs, tests1

• 2-3 cycles typical

• Large OOP* US (+60%), ES

(85%), UK (60%), DE (50%)

Pain of IVF Failure

Emotional Physical Financial

• IVF procedure is

physically demanding

with anxiety and

disappointment over

repeat cycles

1 www.FertilityIQ.com/cost March 2018 * OOP = out-of-pocket

29

http://www.fertilityiq.com/cost


COSTS FOR AN IVF CYCLE & TYPICAL

ADDITIONAL SERVICES IN THE US

PROCEDURE COST ($)1

IVF cycle including stimulation medication 8,000 – 25,000

Additional cost items

• ICSI treatment 1,000 – 2,500

• PGT-A genetic testing 1,800 – 7,500

• Embryo freezing, yearly storage fees 200 – 800

• Cost for frozen embryo transfer 3,000 – 5,000

• Cost for using egg donor 25,000 – 30,000

• Surrogacy including all legal fees 50,000 – 100,000

• Embryo donor 5,000 – 7,000

1 www.FertilityIQ.com/cost March 2018

30



VALUE OF NOLASIBAN DRIVEN BY IMPROVING

SUCCESS RATES & REDUCING COSTS

Significant opportunity to add value to IVF

1 www.verywellfamily.com/how-much-does-ivf-cost-1960212 March 2019; www.FertilityIQ.com/cost March 20182 www.ncbi.nlm.nih.gov/pmc/articles/PMC5584795/; Fertil Steril. 2015 May, 103(5): 1332–13393 Lemos et al. Healthcare expenses associated with multiple vs singleton pregnancies in the US. AJOG, 2013

Higher success rate135% relative (11.7% absolute) increase in live birth rate in

IMPLANT 2 means more chances for taking a baby home

Reduced number of IVF cycles2Less procedures to get a baby for same IVF investment,

i.e., each saved cycle ~$15,000 in the US1

Improving patients QoL3Higher success reduces costs from treating depression,

anxiety, & lower productivity which can cost up to $1,5002

Reduced costs from preterm

delivery of multiple pregnancies4

From 40% to 3% multiple pregnancies with incremental

preterm born costs from $80,000 (twins) to over

$350,000 (triplets)3

31

http://www.verywellfamily.com/how-much-does-ivf-cost-1960212


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5584795/


VALUE BASED PRICE – NOLASIBAN OFFSETS

SIGNIFICANT COSTS IN IVF, US

Example based on

US LBR & costs

‒ $12.8KAssuming 55% LBR, Value

Based Price is ~ $7.7K

Unit Costs

Driver

AVERAGE COST PER IVF BABY

BORN WITHOUT NOLASIBAN

IVF

Procedure

Cost

~ $1.4K

~ $12.7K

~ $28.1K

Anxiety &

Depression

Pre-term

Multiple

Pregnancies

~ $42.3K

Total

$15,000

45% LBR

$1,500

55% failure

$80,000

18.8% MPs*

AVERAGE COST PER IVF BABY

BORN WITH NOLASIBAN

~ $26.7K

~ $1.2K~ $1.6K

IVF

Procedure

Cost

Anxiety &

Depression

Pre-term

Multiple

Pregnancies

~ $29.5K

$80,000

2% MPs*

$1,500

45% failure

$15,000

55% LBR

* MP = multiple pregnancies

Benchmark:

WAC of GONAL-F

~ $4,400 per cycle1

1 Based on IHS 2019 list

price of $2,195 for 900IU

32


SIGNIFICANT MARKET OPPORTUNITY ACROSS

KEY GEOGRAPHIES – PEAK SALES SCENARIOS*

LOW MID HIGH

Share in Fresh (%) 15% 25% 30%

Share in Frozen (%) 15% 25% 30%

Price ($) $ 800 $ 1,100 $ 1,100

LOW MID HIGH



Price ($) $ 1,500 $ 2,000 $ 2,500

LOW MID HIGH



Price ($) $ 3,000 $ 5,000 $ 7,000

$0.0B

$0.4B

$0.8B

$1.2B

$1.6B

~ $245M

~ $590M

~ $420M

MID

~ $290M

~ $800M

~ $710M

HIGH

~ $0.45B ~ $1.2B ~ $1.8B

~ $105M

~ $220M

~ $125M

LOW* Assumes 3% year on year growth of IVF market

33


KEY TAKEAWAYS

34

In our reach

Strong value proposition

Offsetting the pain of IVF

1

2

3

Significant opportunity4

Concentrated nature of market allows us to go it

ourselves

Nolasiban can impact the physical, mental &

financial pain of IVF

High economic value of nolasiban

Peak sales ranging from $0.5B to nearly $2B

depending on share & price assumptions


J u l y 1 7 , 2 0 1 9


Sett ing the Scene

CURRENT TRENDS

IN IVF AND EMBRYO

TRANSFER

35


Infertility – a health & societal issue

9% of women 20-44 affected globally

Ageing population problematic

Too few healthy babies

Despite good quality embryos & using

best practice transfer techniques,

IVF success rate not optimal

IVF comes with a significant cost

Patients often self-fund

Payers see an unacceptably high multiple

pregnancy rate

Society pays a higher cost per healthy baby

1 WHO infertility website, April 2018. – http://www.who.int/reproductivehealth/topics/infertility/perspective/en/

U.S.: ~4.8 million women aged 20–44

Europe: ~7.2 million

women aged 20–44

Japan: ~1.6 million

women aged 20–44

China: ~22.7 million

women aged 20–44

1

2

3

36

INFERTIL ITY IS A GLOBAL PUBLIC HEALTH ISSUE


US CDC 2016 ART National Summary Report

THE NUMBER OF ART CYCLES CONTINUES TO INCREASE

Other(25,236 cycles)

Egg or embryo banking(65,840 cycles)

Fresh embryo from fresh non-donor egg(86,237 cycles)

Frozen embryo from non-donor egg(86,266 cycles)

• Total 260,000 ART cycles in 2016

• 91% used eggs or embryos

from non-donor

33% ET fresh embryos

33% ET frozen embryos

25% Banking egg or embryo

25.0%

9.6%

32.7%

32.7%


U.S. ART CYCLES BY AGE

Source: US CDC 2016 ART National Summary Report

• 60% of patients <38 years

• Only ~20% over 40 years

Age: 43 – 44

Age: 41 – 42

Age: 35 – 37

Age: <35

Age: >44

Age: 38 - 40

19.1%

9.6%

38.3%

21.5%

6.0%

5.5%Age: 43 – 44

Age: 41 – 42

Age: 35 – 37

Age: <35

Age: >44

Age: 38 - 40

19.1%

9.6%

38.3%

21.5%

6.0%

5.5%


(46)(44)

(47)(49)

(45)

(22)

(50) (51)(45)

(34)

(22)

(13)

(5)(9)

(50)

4% 5%

(12)

(24)

(50)

0%

20%

40%

60%

80%

100%

<35 35-37 38-40 41-42 43-44 >44

Pe

rcen

t

Age (years)

Fresh non-donor Frozen non-donor Fresh donor Frozen non-donor

TYPES OF U.S. CYCLES BY AGE

39

>95% of cycles aged <38 years were from non-donor eggs


<35 35 – 37 38 – 40 41 – 42 43 – 44 >44

96% 95% 92%

83%

67%

33%35%

65%

17%

9%



DAY 5 ET BETTER THAN DAY 3 ET… BUT A LARGE MAJORITY OF ET STILL FAILS

Majority of embryos

were transferred on

day 5 after retrieval

0

0,1

0,2

0,3

0,4

0,5

0,6

<35 35-37 38-40 41-42 43-44 >44

Pe

rce

nt

Age (years)Day 3 Day 5

60

50

40

30

20

10

0

*Cycles using GIFT or ZIFT are excluded. Embryo transfers performed on days 1, 2, 4, and 6 are not included because

each of these accounted for a small proportion of procedures.

Percentages of Day 3 and Day 5 Embryo Transfers using fresh embryos

from fresh non-donor eggs that resulted in live births, by age group,* 2016



ALTHOUGH SET INCREASING, 60% STILL MULTIPLE ET

Percentages of transfers

of one, two, three, or four

or more fresh embryos

from fresh non-donor eggs,

2007-2016

2007* 2008 2009 2010 2011 2012 2013* 2014 2015 2016

Pe

rce

nt

YearNumber of Embryos Transferred

One Two Three Four or more*Totals do no equal 100% due to rounding.


• >50% of day 5 transfers with 2 or more embryos

• Relative 15% higher live birth rate

• Relative 2000% higher multiple birth rate

No. ETLive

birth %

Multiple

birth %

Single ET 50.2% 2.0%

Multiple ET 58.0% 43.8%

Four or more

0.7%

Two

48.9%

One

45.8%


MULTIPLE EMBRYO TRANSFERS SIGNIF ICANTLY

INCREASE MULTIPLE BIRTHS

Three

4.6%

42



. . . AND NEARLY 20% OF ART L IVE BIRTHS ARE

MULTIPLE VS 2 .0% IN THE GENERAL POPULATION

Percentages of single

infants, twins, and triplets

or more among ART

transfers using fresh

embryos from fresh

non-donor eggs that

resulted in live births,

2007-2016

*Totals do no equal 100% due to rounding.

2007 2008 2009 2010 2011* 2012 2013 2014* 2015* 2016

Pe

rcen

t

Year

Single infants Twin Triplets or more


CURRENT ART PRACTICES SUMMARY

44

• U.S. ART cycles growing, estimate ~300K annual cycles presently

• Age matters: most <38 years, smallest group >40 years

• Success rates higher for D5 vs. D3, D5 usage growing toward 70%+

• DET a poor tradeoff: 8% higher success=42% higher multiple births, but still used most often

• Overall >50% of transfers fail to result in a live birth


TOPIC 1: PAIN OF FAILURE

45

Question:

Can you describe the financial and emotional pain of failure that your patients experience?


TOPIC 2: INCREASING SUCCESS RATES

46

Question:

What would be considered a meaningful improvement in ET success as measured by LBR?


TOPIC 3: DAY 5 SET TRENDS

47

Question:

What % of your ET practice is Day 5 SET, and how much could this increase?


TOPIC 4: SET VS. DET

48

Question:

How problematic is the rate of multiple births resulting from DET, in terms of both medical risks and financial costs?


TOPIC 5: NOLASIBAN POTENTIAL

49

Question:

Given IMPLANT 2 trial results, how would you envision nolasiban being utilized if available?

KOL DISCUSSION: IVF, EMBRYO TRANSFER, AND ...obseva.across.health/.../KOL-Event-July-2019-FINAL_Jul18.pdfpresentation reflect our views as of the date of this presentation about future

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