Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Corporate Update (October 2018)
11 slides from Therapeuticsmd's corporate update, Oct 29, 2018
Slide 1: FDA Approval Conference Call October 29, 2018
FDA Approval Conference Call October 29 , 2018
Slide 2: Forward-Looking Statements
2 Forward - Looking Statements This presentation by TherapeuticsMD, Inc. (referred to as “we” and “our”) may contain forward - looking statements. Forward - lookin g statements may include, but are not limited to, statements relating to our objectives, plans and strategies, as well as state men ts,
Slide 3: TherapeuticsMD, A Premier Women's Health Company
3 TherapeuticsMD, A Premier Women’s Health Company CONTRACEPTION PRENATAL CARE CONTRACEPTION/ FAMILY PLANNING - PERIMENOPAUSE VASOMOTOR SYMPTOMS DYSPAREUNIA (Vulvar & Vaginal Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT Annovera ™ Annovera ™
Slide 4: BIJUVA key clinical and physical attributes
4 ▪ First and only bio - identical* combination of estradiol to reduce moderate to severe hot flashes combined with progesterone to help reduce the risk to the endometrium ▪ Strong efficacy and safety data ▪ Favorable lipid, coagulation and metabolic profiles, compared to the profiles separately est
Slide 5: BIJUVA Product Development Rationale
5 BIJUVA Product Development Rationale ▪ 2002 Post Women’s Health Initiative, women and healthcare providers shifted to compounded b io - identical hormone therapy containing estradiol and progesterone as an alternative despite being unapproved drugs that are not covered by insurance ― Over 90M+ scr
Slide 6: BIJUVA Fulfills the Therapeutic Gap For Stakeholders
6 BIJUVA Fulfills the Therapeutic Gap For Stakeholders ▪ Meets demand for bio - identical hormone therapy with a FDA approved product with established safety and efficacy profile ▪ One prescription, one copay, one pill daily reduces out - of - pocket costs via insurance coverage ▪ Eliminates the ris
Slide 7: BIJUVA Substitutable Market
7 Column 1 Column 2 Column 3 FDA - Approved Compounded Combination Bio - Identical E+P Off Label Separate Bio - Identical E & P Pills Combination Synthetic E+P 1 TRx US: ~3.8 million 1 ~3 million 2 12 – 18 million 3 BIJUVA Potential Substitutable Market $760M - $950M 4 $600M - $750M 4 $2.4B - $4.5B
Slide 8: BIO-IGNITE
8 BIO - IGNITE TM BIO - IGNITE TM started as an outreach program to quantify the number of compounded bio - identical estradiol and progesterone prescriptions currently dispensed by the 3,000 high - volume compounding pharmacies, and qualify their interests in distributing our hormone product candid
Slide 9: TherapeuticsMD, A Premier Women's Health Company
9 TherapeuticsMD, A Premier Women’s Health Company CONTRACEPTION PRENATAL CARE CONTRACEPTION/ FAMILY PLANNING - PERIMENOPAUSE VASOMOTOR SYMPTOMS DYSPAREUNIA (Vulvar & Vaginal Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT Annovera ™ Annovera ™
Slide 10: Executing Our Strategy
10 ▪ Track record of successful execution with 3 products approved by the FDA since May of this year for ~ $500 million in equity ▪ Developed two products, IMVEXXY and BIJUVA, from Phase 1 through approval ▪ Licensed - in 1 New Chemical Entity - ANNOVERA ▪ Primary focus now on commercializing IMVEXX
Slide 11: Thank You
Thank You A\S\\ TherapeuticsMD” For Her: For Life 4 —