T H E H O M E O F P H E X X I – T H E F I R S T A N D O N L Y F D A - A P P R O V E D O N - D E M A N D , N O N - H O R M O N A L C O N T R A C E P T I V E G E L . S C I E N C E W I T H A S O U L S A U N D R A P E L L E T I E R C H I E F E X E C U T I V E O F F I C E R O C T O B E R 2 0 2 2 O T C Q B : E V F M
O T C Q B : E V F M T h i s p r e s e n t a t i o n c o n t a i n s f o r w a r d l o o k i n g s t a t e m e n t s w i t h i n t h e m e a n i n g o f T h e P r i v a t e S e c u r i t i e s L i t i g a t i o n R e f o r m A c t o f 1 9 9 5 a n d o t h e r f e d e r a l s e c u r i t i e s l a w s . I n s o m e c a s e s , y o u c a n i d e n t i f y f o r w a r d l o o k i n g s t a t e m e n t s b y t e r m s s u c h a s “ m a y , ” ” w i l l , ” “ s h o u l d , ” “ e x p e c t , ” “ p l a n , ” “ a i m , ” “ a n t i c i p a t e , ” “ s t r a t e g y , ” “ o b j e c t i v e , ” “ d e s i g n e d , ” “ s u g g e s t , ” “ c u r r e n t l y , ” “ c o u l d , ” “ i n t e n d , ” “ t a r g e t , ” “ p r o j e c t , ” “ c o n t e m p l a t e , ” “ b e l i e v e , ” “ e s t i m a t e , ” “ p r e d i c t , ” “ p o t e n t i a l ” o r “ c o n t i n u e ” o r t h e n e g a t i v e o f t h e s e t e r m s o r o t h e r s i m i l a r e x p r e s s i o n s . E a c h o f t h e s e f o r w a r d - l o o k i n g s t a t e m e n t s i n v o l v e s r i s k s a n d u n c e r t a i n t i e s . A c t u a l r e s u l t s m a y d i f f e r m a t e r i a l l y f r o m t h o s e , e x p r e s s o r i m p l i e d , i n t h e s e f o r w a r d - l o o k i n g s t a t e m e n t s . F a c t o r s t h a t m a y c a u s e d i f f e r e n c e s b e t w e e n c u r r e n t e x p e c t a t i o n s a n d a c t u a l r e s u l t s i n c l u d e , b u t a r e n o t l i m i t e d t o , t h e f o l l o w i n g : • T h e r a t e a n d d e g r e e o f m a r k e t a c c e p t a n c e o f P h e x x i ® ( l a c t i c a c i d , c i t r i c a c i d a n d p o t a s s i u m b i t a r t r a t e ) v a g i n a l g e l • E v o f e m ’ s a b i l i t y t o s u c c e s s f u l l y c o m m e r c i a l i z e P h e x x i i n t h e U n i t e d S t a t e s a n d t o e n t e r i n t o s u c c e s s f u l p a r t n e r s h i p s t o c o m m e r c i a l i z e P h e x x i o u t s i d e o f t h e U n i t e d S t a t e s • E v o f e m ’ s e s t i m a t e s r e g a r d i n g e x p e n s e s , r e v e n u e s , f i n a n c i a l p e r f o r m a n c e a n d c a p i t a l r e q u i r e m e n t s , i n c l u d i n g t h e l e n g t h o f t i m e i t s c a p i t a l r e s o u r c e s w i l l s u s t a i n i t s o p e r a t i o n s , a n d i t s a b i l i t y t o r a i s e a d d i t i o n a l c a p i t a l t o f u n d i t s o p e r a t i o n s w h e n / i f n e e d e d • E v o f e m ’ s a b i l i t y t o c o n t i n u e a s a g o i n g c o n c e r n • E v o f e m ’ s a b i l i t y t o c o m p l y w i t h t h e p r o v i s i o n s a n d r e q u i r e m e n t s o f i t s d e b t a r r a n g e m e n t s a n d t o p a y a m o u n t s o w e d p u r s u a n t t o i t s d e b t a r r a n g e m e n t s • E v o f e m ’ s a b i l i t y t o m a i n t a i n a n d p r o t e c t i t s i n t e l l e c t u a l p r o p e r t y p o s i t i o n a n d i t s a b i l i t y t o o b t a i n a d d i t i o n a l p a t e n t p r o t e c t i o n f o r i t s p r o d u c t f o r c u r r e n t a n d i n v e s t i g a t i o n a l i n d i c a t i o n s • T h e p o t e n t i a l f o r c h a n g e s t o c u r r e n t r e g u l a t o r y m a n d a t e s r e q u i r i n g p a y e r s t o c o v e r F D A - a p p r o v e d o r – c l e a r e d c o n t r a c e p t i v e s w i t h o u t c o s t s h a r i n g • E v o f e m ’ s a b i l i t y t o o b t a i n o r m a i n t a i n t h i r d - p a r t y p a y e r c o v e r a g e a n d a d e q u a t e r e i m b u r s e m e n t , a n d i t s r e l i a n c e o n t h e w i l l i n g n e s s o f p a t i e n t s t o p a y o u t - o f - p o c k e t f o r P h e x x i a b s e n t f u l l o r p a r t i a l t h i r d - p a r t y p a y e r r e i m b u r s e m e n t • E v o f e m ’ s r e l i a n c e o n t h i r d - p a r t y p r o v i d e r s a n d l i c e n s o r s , s u c h a s t h i r d - p a r t y m a n u f a c t u r e r s a n d c l i n i c a l r e s e a r c h o r g a n i z a t i o n s • T h e p r e s e n c e o r a b s e n c e o f a n y a d v e r s e e v e n t s o r s i d e e f f e c t s r e l a t i n g t o t h e u s e o f P h e x x i • T h e o u t c o m e , c o s t , t i m i n g a n d s u c c e s s o f E v o f e m ’ s c l i n i c a l t r i a l s i n c l u d i n g E V O G U A R D • E v o f e m ’ s a b i l i t y t o r e t a i n m e m b e r s o f i t s m a n a g e m e n t a n d o t h e r k e y p e r s o n n e l a n d t o e x p a n d i t s o r g a n i z a t i o n t o a c c o m m o d a t e p o t e n t i a l g r o w t h • G e n e r a l r i s k s t o t h e e c o n o m y r e p r e s e n t e d b y s p r e a d a n d m u t a t i o n o f t h e C O V I D - 1 9 v i r u s i n c l u d i n g , w i t h o u t l i m i t a t i o n , i t s i m p a c t o n E v o f e m ’ s b u s i n e s s a n d t h e c o m m e r c i a l i z a t i o n o f P h e x x i • E v o f e m ’ s a b i l i t y t o o b t a i n t h e n e c e s s a r y r e g u l a t o r y a p p r o v a l s P h e x x i f o r p r e v e n t i o n o f c h l a m y d i a a n d g o n o r r h e a i n w o m e n a n d t h e t i m i n g o f s u c h a p p r o v a l s , a n d , • A n y o t h e r r i s k f a c t o r s d e t a i l e d i n E v o f e m ’ s f i l i n g s f r o m t i m e t o t i m e w i t h t h e U . S . S e c u r i t i e s a n d E x c h a n g e C o m m i s s i o n i n c l u d i n g , w i t h o u t l i m i t a t i o n , t h e 1 0 - K f o r t h e y e a r e n d e d D e c e m b e r 3 1 , 2 0 2 1 f i l e d w i t h t h e S E C o n M a r c h 1 0 , 2 0 2 2 , 1 0 - Q f o r t h e q u a r t e r e n d e d J u n e 3 0 , 2 0 2 2 f i l e d w i t h t h e S E C o n A u g u s t 1 2 , 2 0 2 2 , a n d s u b s e q u e n t f i l i n g s . T h e f o r w a r d l o o k i n g s t a t e m e n t s i n t h i s p r e s e n t a t i o n r e p r e s e n t E v o f e m ’ s v i e w s o n l y a s o f t h e d a t e o f t h i s p r e s e n t a t i o n , O c t o b e r 5 , 2 0 2 2 , a n d E v o f e m e x p r e s s l y d i s c l a i m s a n y o b l i g a t i o n o r u n d e r t a k i n g t o r e l e a s e p u b l i c l y a n y u p d a t e s o r r e v i s i o n s t o a n y f o r w a r d - l o o k i n g s t a t e m e n t s c o n t a i n e d h e r e i n t o r e f l e c t a n y c h a n g e i n E v o f e m ’ s e x p e c t a t i o n s w i t h r e g a r d t h e r e t o o r a n y c h a n g e i n e v e n t s , c o n d i t i o n s o r c i r c u m s t a n c e s o n w h i c h a n y s u c h s t a t e m e n t s a r e b a s e d f o r a n y r e a s o n , e x c e p t a s r e q u i r e d b y l a w , e v e n a s n e w i n f o r m a t i o n b e c o m e s a v a i l a b l e o r o t h e r e v e n t s o c c u r i n t h e f u t u r e . A l l f o r w a r d - l o o k i n g s t a t e m e n t s i n t h i s p r e s e n t a t i o n a r e q u a l i f i e d i n t h e i r e n t i r e t y b y t h i s c a u t i o n a r y s t a t e m e n t . T h i s p r e s e n t a t i o n a l s o d i s c u s s e s e s t i m a t e s a n d o t h e r s t a t i s t i c a l d a t a m a d e b y i n d e p e n d e n t p a r t i e s a n d b y E v o f e m r e l a t i n g t o m a r k e t s i z e a n d g r o w t h a n d o t h e r d a t a a b o u t i t s i n d u s t r y . T h i s d a t a i n v o l v e s a n u m b e r o f a s s u m p t i o n s a n d l i m i t a t i o n s , a n d y o u a r e c a u t i o n e d n o t t o g i v e u n d u e w e i g h t t o s u c h e s t i m a t e s . FORWARD-LOOKING STATEMENTS 2
O T C Q B : E V F M EVOFEM IS LEADING THE REVOLUTION With innovative women’s reproductive and sexual health solutions 3 THE FIRST AND ONLY ON-DEMAND, NON-HORMONAL PRESCRIPTION CONTRACEPTIVE VAGINAL GEL • Vaginal pH Modulator • Hormone-free • FDA-approved for prevention of pregnancy • Woman-controlled • Used only when you need it • Box of 12 Phexxi applicators Oct ober 5 , 2022
O T C Q B : E V F M 10.3 M WOMEN USE NON-PRESCRIPTION CONTRACEPTIVES N o n - R x m e t h o d s : b a r r i e r m e t h o d s ; w i t h d r a w a l ; p e r i o d i c a b s t i n e n c e ; t r a c k i n g ; o t h e r Other Non-Targets 12.2 Surgical Sterilization 17.2 Prescription Contraceptive, 20.0 No Contraceptive 13.0 Non-Prescription Contraceptive 10.3 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 13.0 M WOMEN USE NO CONTRACEPTIVE AT ALL 20.0 M WOMEN USE PRESCRIPTION CONTRACEPTIVES R x h o r m o n a l o r a l c o n t r a c e p t i v e s , r i n g s , p a t c h e s , s h o t s a n d I U D s / c o p p e r I U D S t u d y p r e d a t e s c o m m e r c i a l a v a i l a b i l i t y o f P h e x x i 1. Daniels-K-and-Abma-J.-Current-Contraceptive-Status-Among-Women-Aged-15-49_NCHS-Data-Brief-Number-388-October-2020.pdf (evofem.com) 2. Grandview Research. U.S. Contraceptive Market Size, Share & Trends Analysis Report By Product (Pills, Intrauterine Devices (IUD), Condoms, Vaginal Ring, Subdermal Implants, Injectable), And Segment Forecasts, 2022 – 2030. 4 O F T H E 7 2 .7 M IL LI O N W O M E N A G E D 1 5 -4 9 I N T H E U .S . U.S. MARKET BY CONTRACEPTIVE METHOD ( I N M I L L I O N S ) 43.3 MILLION POTENTIAL PHEXXI USERS IN THE U.S. (1 ) $7.9 BILLION CONTRACEPTIVE MARKET (U.S. 2021) ( 2 ) Oct ober 5 , 2022
O T C Q B : E V F M EVFM: KEY INVESTMENT CONSIDERATIONS ONGOING GROWTH IN $7.9 BILLION U.S. CONTRACEPTIVE MARKET • 42% increase in Phexxi net sales Q2 vs. Q1 2022 TOP-LINE DATA EXPECTED OCTOBER 2022 FROM PHASE 3 TRIAL OF PHEXXI FOR PREVENTION OF CHLAMYDIA & GONORRHEA IN WOMEN • Positive outcomes should enable sNDA submissions in 1H 2023 5 Oct ober 5 , 2022
O T C Q B : E V F M MOA - PHEXXI IS A pH MODULATOR Optimal vaginal pH levels can range from 3.5 – 4.5 WHEN SEMEN (pH 7.1-8) ENTERS THE VAGINA, IT RAISES THE ENVIRONMENTAL pH LEVEL ALLOWS SPERM TO BE MOBILE AND SWIM UP THE REPRODUCTIVE CANAL PHEXXI KEEPS VAGINAL pH IN THE OPTIMAL RANGE VAGINAL pH MODULATION UNDERLIES CURRENT PIPELINE PROGRAMS MANY BACTERIAL & VIRAL PATHOGENS REQUIRE HIGHER VAGINAL pH FOR SURVIVAL In i t ia l ta rgets : • G o n o rrh ea: Co n f i rm ato ry P h ase 3 co m p lete • Ch lam yd ia : Co n f i rm ato ry P h ase 3 co m p lete • B acter ia l vag in o s is : P h ase 2 - read y 6 Oct ober 5 , 2022
O T C Q B : E V F M PROVEN TO PREVENT PREGNANCIES W/O HORMONES Results of AMPOWER | A phase 3 multicenter, single-arm, open label clinical trial (n=1384) PRIMARY ENDPOINT 8 6 % EFF ICA CY R A TE O V ER 7 CYCLES KAPLAN-MEIER/TIME-TO-EVENT EFFICACY ANALYSIS OVER 7 CYCLES WITH TYPICAL USE . 7-CYCLE CUMULATIVE PREGNANCY RISK OF 13.7% POST HOC ANALYSIS 99% PREGNANCIES PREVENTED PER ACT OF INTERCOURSE BASED ON 101 PREGNANCIES (n=1182) OVER 24,289 ACTS OF INTERCOURSE. PER-ACT-OF- INTERCOURSE PREGNANCY RISK OF 0.415% 7 SECONDARY ANALYSIS 9 3 % EFF ICA CY R A TE O V ER 7 CYCLES KAPLAN-MEIER/TIME-TO-EVENT EFFICACY ANALYSIS OVER 7 CYCLES OF USE WHEN USED AS DIRECTED . 7-CYCLE CUMULATIVE PREGNANCY RISK OF 6.7% Oct ober 5 , 2022
O T C Q B : E V F M GROSS WAC: $338.10 (1) PER BOX OF 12 PHEXXI APPLICATORS 40% GTN ADJUSTMENTS $202.86 NET TO EVOFEM PER BOX OF PHEXXI 1. Effective October 1, 2022. WAC: Wholesale Acquisition Cost. 2. Annual net sales calculation: Net $ to EVFM per box * boxes/year/women * 423,000 women (1% of 42.3M women in Phexxi addressable market) P A ID B Y TH E P LA N , N O T TH E W O M A N . U N D E R F E D E R A L L A W , M O S T P A Y E R S M U S T C O V E R F D A - A P P R O V E D C O N T R A C E P T I V E S , I N C L U D I N G P H E X X I , A T N O C O S T T O W O M E N . 35% GTN ADJUSTMENTS $219.77 NET TO EVOFEM PER BOX OF PHEXXI EVERY 1% MARKET SHARE OF THE 42.3 MILLION WOMEN IN OUR ADDRESSABLE MARKET REPRESENTS SIGNIFICANT NET PRODUCT SALES P h exx i B o xes p er W o m an p er year 4 $343.2 M 6 $514.9 M 4 $371.8 M 6 $557.8 M A nnua l N e t Sa le s pe r 1 % m a rk e t p e n e tra t ion (2) X X X X 8 Oct ober 5 , 2022
O T C Q B : E V F M • Significant “earned media” coverage • A360 Media: Phexxi branded content in some of the most widely read entertainment and lifestyle magazines and websites in the U.S. I N C R E A S I N G B R A N D A W A R E N E S S 9 Oct ober 5 , 2022
O T C Q B : E V F M • Increasing Phexxi access through payer wins including: • Large PBM added Phexxi to national template formularies with no restrictions • National-level commercial payer added Phexxi to formulary for Standard Plans Nationwide • One of the largest commercial payers in California ($0 copay) • Largest payers in Hawaii , Utah & Pacific Northwest • Increased Phexxi shelf l i fe to 4 years • Intel lectual Property Protection bolstered thorough newly issued Composition of Matter patent • New Phexxi manufacturing agreement to decrease COGS up to 45% A D V A N C I N G O U R B U S I N E S S PHEXXI APPROVED CLAIM RATE WAS OVER 72% IN JULY 2022 - A NEW MONTHLY HIGH FOR THE YEAR - 10 Oct ober 5 , 2022
O T C Q B : E V F M The U.S. Department of Health and Human Services, alongside the Departments of Labor and of the Treasury, clarif ied: 1. It wil l enforce federal law requiring group health plans and health insurance issuers to cover contraceptives approved, granted, or cleared by the FDA at no cost to participants 2. Contraceptive coverage is guaranteed at no additional cost under the Affordable Care Act no matter where someone l ives or works R E C E N T C L A R I T Y F R O M U . S . G O V E R N M E N T O N C O N T R A C E P T I V E A C C E S S 1. https://www.einnews.com/pr_news/583484688/hhs-dol-and-treasury-issue-guidance-regarding-birth-control-coverage 30 ++6'2/DQG7UHDVXU\,VVXH*XLGDQFH5HJDUGLQJ%LUWK&RQWURO&RYHUDJH_++6JRY KWWSV ZZZKKVJRYDERXWQHZVKKVGROWUHDVXU\LVVXHJXLGDQFHUHJDUGLQJELUWKFRQWUROFRYHUDJHKWPO ++6JRY ++6'2/DQG7UHDVXU\,VVXH*XLGDQFH5HJDUGLQJ%LUWK &RQWURO&RYHUDJH 'HSDUWPHQWVPDNHFOHDUWKDWFRQWUDFHSWLYHFRYHUDJHLVJXDUDQWHHGDWQRDGGLWLRQDOFRVWXQGHUWKH $IIRUGDEOH&DUH$FWQRPDWWHUZKHUHVRPHRQHOLYHVRUZRUNV 7RGD\IROORZLQJ3UHVLGHQW%LGHQ·V([HFXWLYH2UGHURQHQVXULQJDFFHVVWRUHSURGXFWLYHKHDOWKFDUHWKH 86'HSDUWPHQWRI+HDOWKDQG+XPDQ6HUYLFHV ++6DORQJVLGHWKH'HSDUWPHQWVRI/DERUDQGRIWKH 7UHDVXU\ 'HSDUWPHQWVWRRNDFWLRQWRFODULI\SURWHFWLRQVIRUELUWKFRQWUROFRYHUDJHXQGHUWKH$IIRUGDEOH &DUH$FW $&$8QGHUWKH$&$PRVWSULYDWHKHDOWKSODQVDUHUHTXLUHGWRSURYLGHELUWKFRQWURODQGIDPLO\ SODQQLQJFRXQVHOLQJDWQRDGGLWLRQDOFRVW 7KHJXLGDQFHFRPHVRQWKHKHHOVRI++6·ZRUNWREROVWHUIDPLO\SODQQLQJVHUYLFHVLQFOXGLQJDFFHVVWR HPHUJHQF\FRQWUDFHSWLYHV$FFRUGLQJWRDUHSRUWUHOHDVHGE\++6LQPLOOLRQZRPHQEHQHÀWHG IURPWKH$&$·VSUHYHQWLYHVHUYLFHVDQGELUWKFRQWUROFRYHUDJHZKLFKKDVVDYHGELOOLRQVRIGROODUVLQRXW RISRFNHWVSHQGLQJRQFRQWUDFHSWLYHVVLQFHWKH$&$ZDVSDVVHG,QUHVSRQVHWRLQFUHDVLQJFRPSODLQWV IURPZRPHQDQGFRYHUHGGHSHQGHQWVDERXWQRWUHFHLYLQJWKLVFRYHUDJHWKH'HSDUWPHQWVLVVXHGWKLV JXLGDQFHWRUHPLQGSODQVDQGLVVXHUVRIWKH$&$·VFRQWUDFHSWLYHFRYHUDJHUHTXLUHPHQWVDQGHPSKDVL]H WKH'HSDUWPHQWV·FRPPLWPHQWWRHQIRUFHPHQW7RGD\·VDQQRXQFHPHQWLVSDUWRIDFRPSUHKHQVLYHHIIRUWE\ WKH%LGHQ+DUULV$GPLQLVWUDWLRQWRSURWHFWZRPHQ·VDFFHVVWRUHSURGXFWLYHKHDOWKFDUHZKLOHUHSURGXFWLYH ULJKWVDUHXQGHUDVVDXOWLQPDQ\VWDWHVDFURVVWKHFRXQWU\ ´8QGHUWKH$&$\RXKDYHWKHULJKWWRIUHHELUWKFRQWURO³QRPDWWHUZKDWVWDWH\RXOLYHLQµVDLG++6 6HFUHWDU\;DYLHU%HFHUUD´:LWKDERUWLRQFDUHXQGHUDWWDFNLWLVFULWLFDOWKDWZHHQVXUHELUWKFRQWUROLV DFFHVVLEOHQDWLRQZLGHDQGWKDWHPSOR\HUVDQGLQVXUHUVIROORZWKHODZDQGSURYLGHFRYHUDJHIRULWZLWKQR DGGLWLRQDOFRVW)DPLO\SODQQLQJRQHRIWKHJUHDWHVWSXEOLFKHDOWKDFKLHYHPHQWVRIWKHWKFHQWXU\LVNH\ WREHWWHUKHDOWKRXWFRPHV:HZLOOGRDOOZHFDQDW++6WRSURWHFWIDPLO\SODQQLQJDQGDOORWKHUIRUPVRI UHSURGXFWLYHKHDOWKFDUHLQFOXGLQJDERUWLRQFDUHEHFDXVHLWLVHVVHQWLDOKHDOWKFDUHµ +RPH!$ERXW!1HZV!++6'2/DQG7UHDVXU\,VVXH*XLGDQFH5HJDUGLQJ%LUWK&RQWURO&RYHUDJH 86'HSDUWPHQWRI+HDOWK +XPDQ6HUYLFHV )25,00(',$7(5(/($6( -XO\ &RQWDFW ++63UHVV2IÀFH PHGLD#KKVJRY PDLOWR PHGLD#KKVJRY THE SECRETARY OF HEALTH AND HUMAN SERVICES WASHINGTON, D.C. 20201 July 11, 2022 VIA ELECTRONIC MAIL Dear Health Care Providers: In light of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, I am writing regarding the Department of Health and Human Services (HHS) enforcement of the Emergency Medical Treatment and Active Labor Act (EMTALA). As frontline health care providers, the federal EMTALA statute protects your clinical judgment and the action that you take to provide stabilizing medical treatment to your pregnant patients, regardless of the restrictions in the state where you practice. The EMTALA statute requires that all patients receive an appropriate medical screening examination, stabilizing treatment, and transfer, if necessary, irrespective of any state laws or mandates that apply to specific procedures. It is critical that providers know that a physician or other qualified medical personnel’s professional and legal duty to provide stabilizing medical treatment to a patient who presents to the emergency department and is found to have an emergency medical condition preempts any directly conflicting state law or mandate that might otherwise prohibit such treatment. As indicated above and in our guidance1, the determination of an emergency medical condition is the responsibility of the examining physician or other qualified medical personnel. Emergency medical conditions involving pregnant patients may include, but are not limited to, ectopic pregnancy, complications of pregnancy loss, or emergent hypertensive disorders, such as preeclampsia with severe features. Any state laws or mandates that employ a more restrictive definition of an emergency medical condition are preempted by the EMTALA statute. The course of treatment necessary to stabilize such emergency medical conditions is also under the purview of the physician or other qualified medical personnel. Stabilizing treatment could include medical and/or surgical interventions (e.g., abortion, removal of one or both fallopian tubes, anti-hypertensive therapy, methotrexate therapy etc.), irrespective of any state laws or mandates that apply to specific procedures. Thus, if a physician believes that a pregnant patient presenting at an emergency department, including certain labor and delivery departments, is experiencing an emergency medical condition as defined by EMTALA, and that abortion is the stabilizing treatment necessary to resolve that condition, the physician must provide that treatment. And when a state law prohibits 1 Reinforcement of EMTALA Obligations specific to Patients who are Pregnant or are Experiencing Pregnancy Loss (QSO-21-22-Hospitals- UPDATED JULY 2022), available at https://www.cms.gov/medicareprovider-enrollment- and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/reinforcement-emtala-obligations-specific- patients-who-are-pregnant-or-are-experiencing-pregnancy-0 11 Oct ober 5 , 2022
O T C Q B : E V F M $1.9 $1.7 $3.6 $4.3 $6.0 $- $1.0 $2.0 $3.0 $4.0 $5.0 $6.0 $7.0 $8.0 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 42% INCREASE IN PHEXXI NET PRODUCT SALES 42% INCREASE Q2 vs. Q1 IN M IL LI O NS 12 Oct ober 5 , 2022
O T C Q B : E V F M $- $5.0 $10.0 $15.0 $20.0 $25.0 $30.0 $35.0 $40.0 $45.0 $50.0 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 REDUCING OUR OPERATING EXPENSES IN M IL LI O NS $ 30.5 $ 33.2 $ 41.0 $ 45.1 $ 43.0 C o s t o f g o o d s s o l d R e s e a r c h & d e v e l o p m e n t S a l e s & m a r k e t i n g G e n e r a l & a d m i n i s t r a t i v e W e e x p e c t R & D w i l l f u r t h e r d e c r e a s e n o w t h a t E V O G U A R D i s c o m p l e t e 13 Oct ober 5 , 2022
O T C Q B : E V F M $(41.1) $(43.4) $(37.4) $(28.9) $(24.4) $(50.0) $(45.0) $(40.0) $(35.0) $(30.0) $(25.0) $(20.0) $(15.0) $(10.0) $(5.0) $- Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 NARROWING OUR LOSS FROM OPERATIONS IN M IL LI O NS 16% DECREASE Q2 vs. Q1 14 Oct ober 5 , 2022
O T C Q B : E V F M CHLAMYDIA & GONORRHEA PREVENTION PHASE 3 EVOGUARD TRIAL
O T C Q B : E V F M 1. CDC (2021): Sexually Transmitted Disease Surveillance 2019. https://www.cdc.gov/std/statistics/2019/default.htm 2. CDC (2021): https://www.cdc.gov/media/releases/2021/p0125-sexualy-transmitted-infection.html 3. CDC. Sexually transmitted infections prevalence, incidence, and cost estimates in the United States. 2018 https://journals.lww.com/stdjournal/Fulltext/2021/04000/The_Estimated_Direct_Lifetime_Medical_Costs_of.3.aspx 4. Hoenderboom BM et al. Relation between chlamydia trachomatis infection and pelvic inflammatory disease, ectopic pregnancy and tubal factor infertility in a Dutch cohort of women previously tested for chlamydia in chlamydia screening trial. Sex Transm Infect. 2019 5. Sziller I et al. Chlamydia trachomatis infection, fallopian tube damage and a mannose-binding lectin codon 54 gene polymorphism. Hum Reprod Update. 2007 6. Dun EC and Nezhat CH. Tubal factor infertility: diagnosis and management in the era of assisted reproductive technology. Obstet Gynecol Clin North Am. 2012 CHLAMYDIA AND GONORRHEA | ALL SEXUALLY ACTIVE PEOPLE ARE AT RISK (1 ) PER THE U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC): • 2 0 % o f p eo p le in th e U .S . h ad a sexu a l ly t ran sm it ted in fect io n o n an y g iven d ay in 2 0 1 8 ( 2 ) CHLAMYDIA IS THE MOST FREQUENTLY REPORTED BACTERIAL INFECTION IN THE U.S. (1) • In c id en ce: 4 m i l l io n n ew cases in 2 0 1 8 ( 3 ) • D irect m ed ica l co st : $ 6 9 1 m i l l io n ( 3 ) • U p to 7 0 % o f in fect io n s are asym p to m at ic ( 4 ) • U n treated ch lam yd ia can resu l t in lo n g- term rep ro d u ct ive p ro b lem s ( 4 ) • Th e m o st co m m o n cau se o f in fer t i l i ty in th e U .S . ; acco u n ts fo r 3 0 % o f cases ( 5 , 6 ) GONORRHEA IS ON THE RISE AND INCREASINGLY ANTIBIOTIC RESISTANT • In c id en ce: 1 .6 m i l l io n n ew cases in 2 0 1 8 ( 3 ) • D irect m ed ica l co st in 2 0 1 8 : $ 2 7 1 m i l l io n ( 3 ) • 5 0 % o f a l l go n o rrh ea in fect io n s w ere es t im ated to b e res is tan t to a t leas t o n e an t ib io t ic in 2 0 2 0 16 Oct ober 5 , 2022
O T C Q B : E V F M EVOGUARD TRIAL DESIGN • Randomized, double-blind, placebo-controlled Phase 3 cl inical trial • Enrolled 1903 women at over 100 U.S. sites • Primary endpoint: reduction in chlamydia and gonorrhea infections among women using Phexxi vs. placebo BUILDS ON POSITIVE, STATISTICALLY SIGNIFICANT AMPREVENCE RESULTS • Randomized, double-blind, placebo-controlled Phase 2B/3 cl inical trial • 764 women at over 100 U.S. sites • 50% reduction in risk of chlamydia infection (P=0.0256) • 78% reduction in risk of gonorrhea infection (P=0.0316) • AEs were similar in both arms; few women discontinued due to AEs ( 2 ) 1. Chappell T et al. EVO100 Prevents Chlamydia and Gonorrhea in Women at High-Risk for Infection. AJOG. https://www.sciencedirect.com/science/article/abs/pii/S0002937821001563 2. AE: Adverse Event LATE-STAGE CLINICAL PROGRAM | PHEXXI FOR PREVENTION OF CHLAMYDIA & GONORRHEA IN WOMEN 17 Oct ober 5 , 2022
O T C Q B : E V F M 1. Assumes favorable outcomes of EVOGUARD 2. Assumes timely acceptance of sNDA submission(s) CHLAMYDIA & GONORRHEA PREVENTION | EXPECTED TIMELINE CLINICAL AND REGULATORY MILESTONES ü Last Subject Last V is it completed July 2022 • Top-l ine data readout expected mid-October 2022 • sNDA submissions expected 1H 2023 ( 1 ) • Potential FDA action by YE 2023 ( 1 , 2 ) • Fast track status shortens review t ime to 6 months from acceptance of f i l ing 18 Oct ober 5 , 2022
O T C Q B : E V F M OTHER GROWTH AND VALUE CREATION STRATEGIES
O T C Q B : E V F M OTHER GROWTH AND VALUE CREATION STRATEGIES Partnerships and more LEVERAGE U.S. SALES FORCE FOR OTHER WOMEN’S HEALTH PRODUCTS • Id en t i fy syn erg is t ic p ro d u cts to co -m arket to O B /G YN s an d a l l ied h ea l th care p ro v id ers • O ffset co m m erc ia l o p erat in g co sts SECURE PARTNERSHIP(S) FOR COMMERCIALIZATION OF PHEXXI IN FOREIGN MARKETS • U p fro n t cap i ta l • M ilesto n e p aym en ts • T iered ro ya l t ies o n fu tu re sa les OTHER STRATEGIC OPPORTUNITIES • Ear ly -s tage co l lab o rat io n w ith O r io n B io tech n o lo gy to p o ten t ia l ly d eve lo p f i r s t - in -c lass M u lt ip u rp o se P reven t io n Tech n o lo gy (M P T) p ro d u ct can d id ate fo r p reven t io n o f H IV , ch lam yd ia , go n o rrh ea an d p regn an cy in w o m en 20 Oct ober 5 , 2022
O T C Q B : E V F M U.S. INTELLECTUAL PROPERTY PROTECTS PHEXXI INTO AT LEAST 2033 NEWLY ISSUED PATENT COVERING PHEXXI COMPOSITION OF MATTER (1) • Expected to provide protect ion into at least 2033 TWO ORANGE BOOK LISTED PATENTS • 1 0 ,5 6 8 ,8 5 5 : M eth o d o f u se p aten t th at co vers co n tracep t io n u s in g th e L -Lact ic A c id P h exx i fo rm u lat io n • Expected to provide protect ion into March 2033 • 6 ,7 0 6 ,2 7 6 : Co m p o s i t io n o f m atter p aten t co ver in g P h exx i • Expected to provide protect ion into March 2026 DESIGNATED A QUALIFIED INFECTIOUS DISEASE PRODUCT (QIDP) BY U.S. FDA FOR PREVENTION OF CHLAMYDIA AND GONORRHEA IN WOMEN • Q ID P d es ign at io n q u a l i f ies p ro d u ct fo r an ad d it io n a l f ive years o f m arket in g exc lu s iv i ty fo l lo w in g FD A ap p ro va l fo r th at in d icat io n 21 1. U.S. Patent No. 11,439,610 “Compositions and Methods for Enhancing the Efficacy of Contraceptive Microbicides” Oct ober 5 , 2022
O T C Q B : E V F M CURRENT EXPECTATIONS 2022 NET PRODUCT SALES OF $30 - $35 MILLION • 264% - 325% growth year-over-year GROSS-TO-NET OF 40% OR BETTER REDUCE OPEX BY $50 MILLION IN 2022 vs. 2021 • $25.3 million lower in 1H 2022 vs. 1H 2021 CASHFLOW BREAKEVEN ON A QUARTERLY BASIS NO LATER THAN YEAR-END 2023 22 Oct ober 5 , 2022
O T C Q B : E V F M SHATTERING THE HORMONE GLASS CEILING
O T C Q B : E V F M T H E H O M E O F P H E X X I – O N - D E M A N D N O N - H O R M O N A L C O N T R A C E P T I V E G E L . S C I E N C E W I T H A S O U LO T C Q B : E V F M T H A N K Y O U