Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Q3 2019 Earnings Presentation
36 slides from Therapeuticsmd's earnings presentation, Nov 6, 2019
Slide 1: 3Q 2019 Earnings
3Q 2019 Earnings November 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: Trend in Net Revenue
Trend in Net Revenue Net Revenue Q3 2019 $23.7M Licensing Net Revenue Q2 2019 Net Revenue $6.1M ANNOVERA Q3 2018 BIJUVA BIJUVA $3.5M IMVEXXY IMVEXXY IMVEXXY IMVEXXY IMVEXXY Prenatal Vitamin Prenatal Vitamin Prenatal Vitamin Prenatal Vitamin Prenatal Vitamin Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 3
Slide 4: 3Q19 Financial Results
3Q19 Financial Results -Total Product Revenue Came in at Upper End of Guidance- 3Q2019 3Q2019 Guidance Financial Results FDA-Approved Products $4.50 - $6.50M $5.7M Net Revenue Prenatal Vitamins $2.25 - $2.50M $2.5M Net Revenue Total TXMD Product $6.75 - $9.00M $8.2M Net Revenue § As our sales force
Slide 5: IMVEXXY Net Revenue Growth Faster than Unit Growth
IMVEXXY Net Revenue Growth Faster than Unit Growth Net Revenue vs. Sales of Units to Patients IMVEXXY NET REVENUE IMVEXXY TRX 27% 135,000 106,700 42% $4.8M 53% 75,100 61% 55% $3.1M 46,500 137% $2.0M 14,500 $0.9M $0.2M Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 1.Total prescription data is based on IQVI
Slide 6: BIJUVA Net Revenue Growth Faster than Unit Growth
BIJUVA Net Revenue Growth Faster than Unit Growth Net Revenue vs. Sales of Units to Patients BIJUVA NET REVENUE BIJUVA TRX 15,800 236% $490,000 265% 4,700 $134,000 Q2 2019 Q3 2019 1.Total prescription data is based on IQVIA prescriber level data plus additional unique patient data identified through
Slide 7: ANNOVERA Launch Insights
ANNOVERA LAUNCH INSIGHTS § ANNOVERA launched late in third quarter with recorded sales of $400,000 § Initial average net revenue of ~$1,250 per unit 7
Slide 8: Financial Summary
Financial Summary § Operating expenses – SG&A expenses § Net loss and basic & diluted per share 8
Slide 9: Cash Balance at End of Each Quarter
Cash Balance at End of Each Quarter (Millions) $190.0 $182.9 $161.6 $154.4 $155.3 $122.9 $107.4 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 9
Slide 10: Proforma Cash Balance at End of Each Quarter with Equity Raise
Proforma Cash Balance at End of Each Quarter with Equity Raise (Millions) Proforma Cash $232.3M Equity Raise $190.0 $77.0 $182.9 $161.6 $154.4 $155.3 $122.9 $107.4 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 10 10
Slide 11: Non-Dilutive Term Loan Financing
Non-Dilutive Term Loan Financing $200M accessed to date with up to additional $100M through Specific Company Milestones Amount TXMD Company Contractual Timing ($) Milestone1 Tranche 1 $200M Closing of the facility Completed in April 2019 Tranche 2 $50M Designation of ANNOVERA as 4Q 2019 a new catego
Slide 12: Reaffirm 4Q2019 Financial Guidance
Reaffirm 4Q2019 Financial Guidance 4Q2019 Estimate FDA-Approved Products Net Revenue $11.00 - $13.00M Prenatal Vitamins $1.75 - $2.25M Net Revenue Total TXMD Product Net Revenue $12.75 - $15.25M Important Guidance Notes: § As our sales force focus shifts to our FDA-approved products and payer headwi
Slide 13: Commercial Update
COMMERCIAL UPDATE TherapeuticsMD’ For Her. For Life. 13
Slide 14: IMVEXXY Calculated Net Revenue Per Unit Increases as Adjudication Rates Increases
IMVEXXY Calculated Net Revenue Per Unit Increases as Adjudication Rates Increases CALCULATED IMVEXXY NET REVENUE PER UNIT § Start of copay optimization IMVEXXY OVERALL ADJUDICATION RATE 52% on 10/1/19 increased cost from $35 to $50 for Estimated non-covered patients 38% $48-$52 § Cost of copay progr
Slide 15: Improvement in Adjudication Rates
Improvement in Adjudication Rates § Addition of CVS in September contributing to overall adjudication rates § Adjudication in Commercial Patients at 72% in October 2Q19 3Q19 Sept 2019 Oct 2019 Commercial 50% 55% 62% 72% Adjudication % Medicare Part D 8% 12% 13% 17% Adjudication % Overall % 34% 38% 4
Slide 16: BIJUVA Calculated Net Revenue Per Unit Increases as Adjudication Rates Increase
BIJUVA Calculated Net Revenue Per Unit Increases as Adjudication Rates Increase CALCULATED BIJUVA NET REVENUE PER UNIT § Start of copay optimization 56% BIJUVA OVERALL ADJUDICATION RATE on 10/1/19 increased cost from $35 to $50 for 45% non-covered patients Estimated § Cost of copay program 34% $40-$
Slide 17: Improvement in Adjudication Rates
Improvement in Adjudication Rates § Addition of United, OptumRx in August and Cigna in September contributing to overall adjudication rates 2Q19 3Q19 Sept 2019 Oct 2019 Commercial 38% 50% 54% 62% Adjudication % Medicare Part D 7% 15% 14% 21% Adjudication % Overall % 34% 45% 49% 56% 17 17
Slide 18: ANNOVERA
NNOVvVera’ (segesterone acetate and ~ ethinyl estradiol vaginal system) Delivers 0.15 mg/0.013 mg per day TherapeuticsMD’ Lor Her. For Life. 18
Slide 19: ANNOVERA Commercial Payer Update
ANNOVERA Commercial Payer Update Already Achieved ~62% Unrestricted Access1 Top 10 Plans Account for ~74% of all Commercial Pharmacy Lives1 Plan % of Lives2 Status3 New CVS 16% Adjudicating with no copay as of October 2019 ESI 16% Adjudicating at T3 as of September 2019 United 8% In discussions Anth
Slide 20: ANNOVERA Status
ANNOVERA Status $1,250 to $1,400 STARTED PILLPACK 4Q19 EXPECTED NET SOFT- LAUNCH PARTERSHIP REVENUE PER UNIT 36 REPS + SALES LAUNCHED RANGE MANAGEMENT 20 20
Slide 21: The Power of a Women's Health Portfolio
The Power of a Women’s Health Portfolio Prenatal Vitamins No Image CONTRACEPTION/ DYSPAREUNIA PRENATAL FAMILY PLANNING - VASOMOTOR (Vulvar & Vaginal CONTRACEPTION CARE SYMPTOMS PERIMENOPAUSE Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT 21 21
Slide 22: TherapeuticsMD for Her. For Life.
TherapeuticsMD’ for Her: For Life. 22
Slide 23: Appendix
APPENDIX TherapeuticsMD° For Her. For Life. 23
Slide 24: ANNOVERA Deal Terms
ANNOVERA Deal Terms Milestone Payments Royalty % § Upon FDA approval: $20M Step structure: § First commercial batch release: $20M § Annual net sales < $50M: 5% § $200M in cumulative net sales: $40M § Annual net sales > $50M and < $150M: 10% § $400M in cumulative net sales: $40M § Annual net sales >
Slide 25: 3Q 2019 Key Performance Metrics
3Q 2019 Key Performance Metrics IMVEXXY § IMVEXXY net revenue totaled $4.8M for 3Q19 (up from $3.1M for 2Q19) § Net revenue continues to grow faster than units due to improving adjudication rates § TRx increased 26% to ~134,000 units for 3Q19 (up from106,000 for 2Q19) § Overall adjudication increase
Slide 26: IMVEXXY October Launch Metrics
IMVEXXY October Launch Metrics IMVEXXY Launch Metrics Total paid scripts1 ~41,500 (October 1-31, 2019) Total patients ~103,900 (since launch through October 31, 2019) Total prescribers2 ~16,400 (since launch through October 31, 2019) 1 Total prescription data is based on IQVIA prescriber level data
Slide 27: Launch Results Remain Strong
Launch Results Remain Strong Imvexxy TRx Launch Comparison 70,000 10.0% 9.1% 57,700 56,500 60,000 52,600 8.0% 7.9% 47,900 48,700 50,000 6.0% 43,200 6.0% 40,000 44,600 44,900 4.0% 41,500 4.0% 28,700 37,500 30,000 1.9% 2.0% 21,000 28,100 20,000 0.0% 19,800 8,800 10,000 -2.0% 8,400 0 Month Month Month
Slide 28: Continued Strong Patient Adherence
Continued Strong Patient Adherence IMVEXXY Patient Adherence1,2 Maximum Average # Fills Month Initial Allowable Fills for Those Prescription Filled Given the Month Patients of Initial Fill Oct 2019 1 Fill 1 Fill IMVEXXY: 4.0 fills/yr3 (through Oct) Sep 2019 1.7 Fills 2 Fills • Vaginal creams: averag
Slide 29: Commercial Payer Status
Commercial Payer Status Achieved ~68% Unrestricted Commercial Access1 9 of the Top 10 Commercial Payers Secured Top 10 Plans Account for ~74% of all Commercial Pharmacy Lives1 Plan % of Lives2 Status3 CVS 16% Adjudicating as of September 2019 ESI 16% Adjudicating as of 10/1/18 United 8% Adjudicating
Slide 30: Medicare Part D Payer Status
Medicare Part D Payer Status Additional Decisions Expected This Quarter Top 8 Plans Account for ~83% of all Medicare Part D Pharmacy Lives1 Plan % of Lives2 Status3 United 21% Adjudicating as of 2/1/19 Humana 18% Decision expected 4Q19 CVS Caremark 14% Decision expected 4Q19 Wellcare with Aetna live
Slide 31: BIJUVA Update
BIJUVA Update P l a n t o S u b m i t B I J U VA 0 . 5 / 1 0 0 m g D o s e § TXMD plans to submit a New Drug Application (NDA) supplement for the 0.5/100 mg dose of BIJUVA to FDA for approval § After meeting with FDA, TXMD plans to submit an NDA efficacy supplement using existing REPLENISH Phase 3 d
Slide 32: BIJUVA Commercial Payer Update
BIJUVA Commercial Payer Update Additional Coverage Decisions Expected This Quarter Achieved ~55% Unrestricted Commercial Access1 6 of the Top 10 Commercial Payers Secured1 Top 10 Plans Account for ~74% of all Commercial Pharmacy Lives1 Plan % of Lives2 Status3 CVS 16% In discussions ESI 16% Adjudica
Slide 33: BIJUVA October Launch Metrics
BIJUVA October Launch Metrics BIJUVA Launch Metrics Total paid scripts dispensed to patients1 (since launch through October 31, 2019) ~26,900 Total paid scripts (October 1-31, 2019) ~6,500 Total patients (since launch through October 31, 2019) ~11,300 Total prescribers2 (since launch through October
Slide 34: ANNOVERA Commercial Payer Update
ANNOVERA Commercial Payer Update Already Achieved ~62% Unrestricted Access1 Top 10 Plans Account for ~74% of all Commercial Pharmacy Lives1 Plan % of Lives2 Status3 New CVS 16% Adjudicating with no copay as of October 2019 ESI 16% Adjudicating at T3 as of September 2019 United 8% In discussions Anth
Slide 35: ANNOVERA Commercial Payer Update
ANNOVERA Commercial Payer Update Fast Uptake in Regional Plans Selected Regional Plan Coverage Plan % of Lives1 Status2 MC-Rx (ProcareRx) 0.64% Adjudicating as of April 2019 Magellan Rx 0.4% Adjudicating as of August 2019 BCBS of 0.47% Adjudicating at no copay as of August 2019 Massachusetts EmblemH
Slide 36: 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 $184M $257.6M $331.2M $404.8M $100 $230M $322M $414M $506M Total Addressable FDA Market : 3.8M Total Addressable Compoun