Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Q2 2019 Earnings Presentation
33 slides from Therapeuticsmd's earnings presentation, Aug 6, 2019
Slide 1: 2Q 2019 Earnings
2Q 2019 Earnings August 6, 2019 Building a Premier Women’s Health Portfolio 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation by TherapeuticsMD, Inc. (referred to as “we” and “our”) may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, as well as statements, other than
Slide 3: 2Q 2019 Quarterly Financial Results Above Guidance Range
2Q 2019 Quarterly Financial Results Above Guidance Range 2Q2019 Estimate 2Q2019 Actual* FDA-Approved Drugs $2.50-3.00M $3.25M* Net Revenue Prenatal Vitamins Net Revenue $2.00-2.50M $2.80M Total TXMD Net Revenue $4.50-5.50M ~$6.10M *Includes net revenues of approximately $3.12 million for IMVEXXY and
Slide 4: IMVEXXY Launch Metrics
IMVEXXY Launch Metrics IMVEXXY Launch Metrics Total paid scripts dispensed to patients1 ~289,500 (since launch through July 31, 2019) Total paid scripts ~45,500 (July 1-31, 2019) Total patients ~78,300 (since launch through July 31, 2019) Total prescribers2 ~13,800 (since launch through July 31, 201
Slide 5: Launch Results Remain Strong and On-Track: Strategy is Working
Launch Results Remain Strong and On-Track: Strategy is Working Imvexxy TRx Launch Comparison 70,000 1 0 . % 60,000 9% 8 .0 % 50,000 7% 43,200 45,900 6 .0 % 40,000 4% 45,500 4 .0 % 28,700 37,500 30,000 2% 21,000 2 .0 % 28,100 20,000 0 .0 % 8,800 19,800 10,000 -2 .0 % 8,400 0 Month 1 Month 2 Month 3 M
Slide 6: The VVA Market Exceeds $1.7B Gross Revenue Annually
The VVA Market Exceeds $1.7B Gross Revenue Annually 12 Months through June Gross Dollars of Brand & Product 2019 Total Generic for 20181 Units1 Estrace® Cream Brand & Generics 2,000,000 $554,450,000 Premarin® 1,190,000 $460,760,000 Vagifem® Brand & Generics 1,500,000 $454,550,000 Estring® 259,000 $1
Slide 7: Strong Patient Adherence = Women are Staying on IMVEXXY
Strong Patient Adherence = Women are Staying on IMVEXXY IMVEXXY Patient Adherence1,2 Maximum Average # Fills Month Initial Allowable Fills for Those Prescription Filled Given the Month Patients of Initial Fill Jul 2019 1 Fill 1 Fill IMVEXXY: 3.7 fills/yr3 (through July) Jun 2019 1.8 Fills 2 Fills Ma
Slide 8: Value of Additional Fills
Value of Additional Fills Percent of market based on patient count of 2.3M and 4 fills per year Average Net 4 Revenue / Unit 25% 35% 45% 55% Fills/year $80 $184,000,000 $257,600,000 $331,200,000 $404,800,000 $100 $230,000,000 $322,000,000 $414,000,000 $506,000,000 Percent of market based on patient
Slide 9: Commercial Payer Update
Commercial Payer Update Additional Coverage Decisions Expected 3Q19 Top 10 Plans Account for ~71% of all Commercial Pharmacy Lives Plan % of Lives1 Status2 CVS 15.4% Awaiting decision in 3Q ESI 15.3% Adjudicating as of 10/1/18 United 7.5% Adjudicating as of 3/1/19 Anthem 7.3% Adjudicating as of Aug.
Slide 10: Medicare Part D Payer Update
Medicare Part D Payer Update Decisions Expected 3Q/4Q19 Top 6 Plans Account for ~78% of all Medicare Part D Pharmacy Lives Plan % of Lives1 Status2 United 20.7% Adjudicating as of 2/1/19 Humana 17.9% Decision expected 3Q/4Q19 CVS Caremark 14.1% Decision expected 3Q/4Q19 Wellcare with 13.6% Decision
Slide 11: How Adjudication Rate Will Change When Payer Cycle Completes
How Adjudication Rate * Will Change When Payer Cycle Completes NOW: 2Q 2019 Actuals Column A Column B Column C Chart IMVEXXY No Insurance Commercial Medicare Eligible Insurance Patients 1 % of Business 3% 62% 35% % Adjudicated 0% 50% 8% Contribution to Overall Adjudication Rate 0% 31% 3% Overall Adj
Slide 12: IMVEXXY Catalysts
IMVEXXY Catalysts No Direct to Consumer Advertising Medicare Part D Decisions § Expect commercial coverage decisions from CVS and Aetna Begin Copay Optimization Image § Menopause Awareness § NAMS Premier Month - Satellite Media Sponsor Tour § NAMS Publications 3Q 2019 4Q 2019 12 12
Slide 13: BIJUVA
BiyUV ann BIJUVA (:stradiol and progesterone) capsules TherapeuticsMD° For Her. For Life. 13
Slide 14: A Large Target Market For BIJUVA
A Large Target Market For BIJUVA No Q2 Launched April 17, 2019 Target FDA-approved separate Reps directed to focus on ~10 Q2 bio-identical Estrogen & prescribers in their territory until improved payer Progesterone pills segment coverage Image ~3.9M TRx (each)1 I $836M2 TAM BIJUVA introduced into Bi
Slide 15: BIJUVA Launch Metrics
BIJUVA Launch Metrics BIJUVA Launch Metrics Total paid scripts dispensed to patients1 (since launch through July 31, 2019) ~8,900 Total paid scripts (July 1-31, 2019) ~4,300 Total patients (since launch through July 31, 2019) ~4,700 Total prescribers2 (since launch through July 31, 2019) ~2,300 1 To
Slide 16: BIJUVA Payer Update
BIJUVA Payer Update Quicker Process to Payer Coverage Top 10 Plans Account for ~71% § Contract amendments in larger of all Commercial Pharmacy Lives category with little Medicare Part D § Commercial segment represents vast Plan % of Lives1 Status2 majority of BIJUVA patients CVS 15.4% § Expect 3-4 q
Slide 17: Impact of Faster Payer Cycle on Adjudication Rate
Impact of Faster Payer Cycle on Adjudication Rate * NOW: 2Q 2019 Actuals Column A Column B Column C Chart No Insurance Commercial Medicare Eligible BIJUVA 1 Insurance Patients % of Business 3.1% 89.1% 7.8% % Adjudicated 0% 37.6% 7.6% Contribution to Overall Adjudication Rate 0% 33.4% 0.6% Overall Ad
Slide 18: Pharmacy Targeting
Pharmacy Targeting § Over 2,171 are high tier targets § These locations produce the highest volume of compounded bio-identical hormone 129 Contracting 8,642 replacement therapy (CBHRT) scripts CBHRT HCP’s PROCESS & STATUS 2,171 National High Tier Targets Reach In Vetting Process 52 74 Live Accounts
Slide 19: BIJUVA Market Opportunity
BIJUVA Market Opportunity Total Addressable FDA Market: 3,900,000 Total Addressable Compounding Market: 12,000,000 Percent of Addressable Market Average Net Revenue / Unit 25% 35% 45% 55% $80 $316,000,000 $442,400,000 $568,800,000 $695,200,000 $100 $395,000,000 $553,000,000 $711,000,000 $869,000,000
Slide 20: BIJUVA Catalysts
BIJUVA Catalysts No Commercial Payer Cycle Completion Expected § Menopause Awareness BIO-IGNITE Expansion Month - Satellite Media Tour Copay and Distribution Optimization Image § NAMS Premier Sponsor Direct to Consumer § NAMS Publications Advertising 3Q 19 3Q 2019 4Q 2019 1H 2020 20 20
Slide 21: ANNOVERA
LM ecerocarnd ANNOVERA ethinyl estradiol vaginal system) Delivers 0.15 mg/0.013 mg per day TherapeuticsMD’ For Her. For Life. 24
Slide 22: ANNOVERA: 2019 Prix Galien USA Award Nominee
ANNOVERA: 2019 Prix Galien USA Award Nominee The Prix Galien Award, counted among the global health innovation industry’s most prized honors, recognizes outstanding biomedical and medical technology product achievement that improves the human condition Best Pharmaceutical Product Past Award Winners
Slide 23: U.S. Contraceptive Market
U.S. Contraceptive Market $5B U.S. net sales1 ~ 90mm annual scripts to ~20 million women2 Complete control but no long acting benefits No Long-acting benefits without a procedure offering complete control over fertility and menstruation Long-acting benefits but requires a procedure and does not offe
Slide 24: ANNOVERA Launch Approach
ANNOVERA Launch Approach Pre-Launch Activities National Launch No § WAC Price set at $2,000/ § Test and learn market § Initial focus on OBGYN unit (1 year) introduction target overlap with § Continue dialogue with FDA § Production ramps to Menopause Products regarding potential ACA ~10,000 units for
Slide 25: ANNOVERA Market Opportunity
ANNOVERA Market Opportunity Addressable Birth Control Market Rx Options NRx 28,000,000 Percent of Overall Birth Control Market NRx Average Net Revenue / Unit 1.0% 1.5% 2.0% 2.5% $1,000 $280,000,000 $420,000,000 $560,000,000 $700,000,000 $1,500 $420,000,000 $630,000,000 $840,000,000 $1,050,000,000 $1
Slide 26: Financial Overview
¥ Imvexxy’ estradiol vaginal inserts 4 meg-10 meg eS B iJ UV intin (stradioland progesterone) capsules nnovera (segesterone acetate and ethinyl estradiol vaginal system) Delivers 0.15 mg/0.013 mg per day Financial Overview TherapeuticsMD’ For Fer. For Life.
Slide 27: 2Q 2019 Quarterly Financial Results Above Guidance Range
2Q 2019 Quarterly Financial Results Above Guidance Range 2Q2019 Estimate 2Q2019 Actual* FDA-Approved Drugs $2.50-3.00M $3.25M* Net Revenue Prenatal Vitamins Net Revenue $2.00-2.50M $2.80M Total TXMD Net Revenue $4.50-5.50M ~$6.10M *Includes net revenues of approximately $3.12 million for IMVEXXY and
Slide 28: Near-Term Access to Non-Dilutive Capital
Near-Term Access to Non-Dilutive Capital § $300M Non-Dilutive Term Loan Financing with TPG Sixth Street Partners § $200M accessed to date with up to additional $100M through Specific Company Milestones § Incurred a one-time charge in 2Q19 for extinguishment of debt of approximately $10 million as co
Slide 29: Revised 2019 Quarterly Financial Guidance
Revised 2019 Quarterly Financial Guidance Original Revised Original Revised 3Q2019 3Q2019 4Q2019 4Q2019 Delta1 Estimate Estimate Estimate Estimate FDA-Approved Products $4.50-6.50M unchanged $11.00-13.00M unchanged - Net Revenue Prenatal Vitamins $1.75-2.25M $2.25-2.50M $1.50-2.00M $1.75-2.25M +$0.6
Slide 30: Revised Full-Year Financial Guidance
R e v i s e d F u l l - Ye a r 2 0 1 9 Financial Guidance Original Revised FY2019 Actual FY2019 Estimate Delta1 FDA-Approved Products Net Revenue $20.00-24.50M $20.75-24.75M +0.5M Prenatal Vitamins Net Revenue $7.15-8.65M $8.70-9.45M +1.2M Total TXMD Net Revenue $27.10-33.10M $29.45-34.20M +1.7M § I
Slide 31: The Power of a Women's Health Portfolio
The Power of a Women’s Health Portfolio No Prenatal Vitamins Image PRENATAL CONTRACEPTION/ VASOMOTOR DYSPAREUNIA CONTRACEPTION CARE FAMILY PLANNING - SYMPTOMS (Vulvar & Vaginal PERIMENOPAUSE Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT 31 31
Slide 32: The Power of the Portfolio: Multiple Paths to $1B of Peak Sales
The Power of the Portfolio Multiple Paths to $1B of Peak Sales Percent of Market Based on Patient Count of 2.3M and 4 fills per year Average Net Revenue / Unit 25% 35% 45% 55% $80 $184,000,000 $257,600,000 $331,200,000 $404,800,000 $100 $230,000,000 $322,000,000 $414,000,000 $506,000,000 Total Addre
Slide 33: TherapeuticsMD
TherapeuticsMD’ For Her. For Life. 33