Mayne Pharma Group Ltd. · ASX:MYX
Mayne Pharma — Investor Presentation (August 2020)
28 slides from Mayne Pharma's investor presentation, Aug 21, 2020
Slide 1: FY20 Results Presentation
Mayne Pharma Group Limited FY20 Results Presentation 21 August 2020 Scott Richards, CEO Peter Paltoglou, Interim CFO 1
Slide 2: Disclaimer
Disclaimer The information provided is general in nature and is in summary form only. It is not complete and should be read in conjunction with the company’s audited Financial Statements and market disclosures. This material is not intended to be relied upon as advice to investors or potential inves
Slide 3: Executive summary
Executive summary ● Reported revenue of A$457m, reported EBITDA of A$80m and underlying EBITDA of A$95m - Second half underlying results in line with first half and reported EBITDA up 32% on 1HFY20 Financial ● Reported net loss after tax of A$(93)m impacted by non-cash intangible asset impairment re
Slide 4: Key financials
Key financials1 A$million FY20 FY19 Change 2HFY20 1HFY20 Change Reported revenue 457.0 525.2 (13%) 229.8 227.2 1% Reported gross profit2 211.5 290.9 (27%) 105.1 106.4 (1%) Reported EBITDA 80.3 111.6 (28%) 45.7 34.6 32% Reported net profit / (loss) (92.8) (279.1) nm (75.3) (17.5) nm Underlying EBITDA
Slide 5: Adjustments to earnings – FY20
Adjustments to earnings1 – FY20 EBITDA adjustments PBIT A$million Non cash 2HFY20 1HFY20 FY20 FY20 Comments Reported 45.7 34.6 80.3 (102.8) Abnormal level of gross to net charges (eg. Gross to net adjustments Yes 5.3 9.3 14.6 14.6 returns and govt rebates) relating to a change in accounting methodol
Slide 6: Continued portfolio rebalancing to more sustainable therapeutic areas and segments
Continued portfolio rebalancing to more sustainable therapeutic areas and segments Reported revenue by type (A$m) Reported gross profit by type (A$m) 100% 100% 90% 90% 25% 80% 38% 80% 42% 45% 70% 70% 60% 60% 50% 50% 40% 40% 75% 30% 55% 62% 62% 30% 62% 58% 20% 20% 10% 10% 0% 0% FY19 FY20 FY19 FY20 Sp
Slide 7: COVID-19 impact
COVID-19 impact Business continuity ● Pharmaceutical manufacturing considered an essential service ● Manufacturing sites fully operational - Greenville commercial dose volumes at record levels up 57% in FY20 versus pcp - US customer service DIFOT1 97% in FY20 ● Remote working where possible and virt
Slide 8: FY21 key goals and anticipated milestones
FY21 key goals and anticipated milestones ● FDA approval and successful launch of NEXTSTELLIS™ in the US Commercialisation of novel oral contraceptive ● TGA filing of NEXTSTELLIS™ in Australia NEXTSTELLIS™ ● Recruit new women’s health sales team in the US ● Successful launch of products pending at F
Slide 9: NEXTSTELLIS (E4/DRSP) a novel oral contraceptive
NEXTSTELLIS™ (E4/DRSP) a novel oral contraceptive ● Estetrol (E4) – unique, native estrogen with selective action in tissues (NEST) - Potential to be the first new estrogen introduced in the US for contraceptive use in ~50 years - Potential to have a lower adverse impact on the environment ● Drospir
Slide 10: US combined hormonal contraceptive (CHC) market
US combined hormonal contraceptive (CHC) market CHC market CHC weekly prescriptions – select products (TRx) 80,000 7% Combined oral 70,000 contraceptive 24% Vaginal ring 60,000 US$4.0b 50,000 69% Patch 40,000 30,000 MAT sales of key CHC products 20,000 US$960m 10,000 US$890m 20 19 M 0 9 9 9 20 19 0
Slide 11: NEXTSTELLIS (E4/DRSP) clinical trial results
NEXTSTELLIS™ (E4/DRSP) clinical trial results ● Phase 3 trials in over 3,600 women demonstrated contraceptive efficacy and safety - Included women with BMI 30-35 kg/m2 ● There was a neutral impact on lipids and glucose in these trials1 ● The women in these trials demonstrated good menstrual cycle co
Slide 12: NEXTSTELLIS (E4/DRSP) oral contraceptive update
NEXTSTELLIS™ (E4/DRSP) oral contraceptive update ● NDA accepted for filing with potential approval and launch 2QCY21 Regulatory ● TGA filing CY20 with potential approval 2HCY21 ● NEXTSTELLIS™ brand name received conditional acceptance from FDA ● Medical Science Liaison team in place for scientific e
Slide 13: Expanding dermatology and women's health portfolio and advance key pipeline products
Expanding dermatology and women’s health portfolio and advance key pipeline products ● Launched gCORDRAN®, gLOCOID® and gTRIANEX® in FY20 ● Licensed topical acne product which is pending at the FDA targeting addressable market of US$40m1 Dermatology ● Two high impact rare disease skin programs in de
Slide 14: Dermatology and women's health pipeline market potential
Dermatology and women’s health pipeline market potential Mkt size Product Indication Bx / Gx Phase II Phase III Filed Approved (US$m)1 Dermatology SUBA®-itraconazole BCCNS 300 Bx Lamellar Trifarotene 200 Bx ichthyosis Gx topical Acne 40 Gx Women’s health NEXTSTELLIS™ - US Contraception 4,000 Bx NEXT
Slide 15: Trifarotene, a retinoid for lamellar ichthyosis
Trifarotene, a Nove Trifarotene – a retinoid for lamellar ichthyosis Trifarotene, a Novel Retinoid, for Lamellar Ichth ● Lamellar ichthyosis is a rare dermatological disorder with high unmet medical need - Begins at birth and causes severe skin scaling ● Trifarotene, a retinoic acid receptor-y (RARy
Slide 16: Maximise SUBA-itraconazole franchise
Maximise SUBA®-itraconazole franchise ● TOLSURA® experienced solid growth across TOLSURA units COVID FY20 until the 4QFY20 / COVID-19 pandemic 404 351 345 ● Endemic mycoses study interim results to be presented at IDWeek in October 2020 Anti-fungal (TOLSURA®) ● New studies as treatment for 144 cocci
Slide 17: Accelerate contract service platform globally
Accelerate contract service platform globally Contract services historical sales (A$m) Key facts 120.0 ● 170+ analytical chemists and formulators 100.0 +1 3 % CAGR ● 100+ active clients 80.0 60.0 ● Support 14 of the top 20 global pharma companies1 40.0 ● >40 years of history in contract services in
Slide 18: Optimisation of cost base
Optimisation of cost base ● Reduced global workforce by approximately 10% across FY20 ● Discontinued unprofitable generic SKUs FY20 achievements ● Opex reduced by A$16m in FY20 versus pcp ● Streamlined generic R&D and reduced gross spend by A$15m in FY20 versus pcp ● Expected dermatology opex saving
Slide 19: FY20 segment and financial information
FY20 segment and financial information
Slide 20: Generic Products Division (GPD)
Generic Products Division (GPD) ● In USD terms, GPD reported revenue was Change A$million FY20 FY19 US$169.8m, down 26% on pcp impacted by FY20 v FY19 competition on key products - liothyronine, Reported revenue 253.0 320.8 (21%) dofetilide and butalbital Gross Profit 95.7 164.5 (42%) ● FY20 also im
Slide 21: Specialty Brands Division (SBD)
Specialty Brands Division (SBD) ● In USD terms, SBD revenue was US$52.9m, Change A$million FY20 FY19 down 19% on FY19 FY20 v FY19 ● DORYX®, FABIOR® and SORILUX® sales were Reported revenue 78.8 91.6 (14%) down on pcp impacted by COVID-19, tightened Gross Profit 65.4 79.8 (18%) managed care and new c
Slide 22: Metrics Contract Services (MCS)
Metrics Contract Services (MCS) ● In USD terms, MCS revenue was US$55.6m, Change A$million FY20 FY19 up 8% on pcp benefiting from new FY20 v FY19 development programs and manufacturing Reported revenue 82.8 72.2 15% revenues Gross Profit 39.4 35.5 11% ● Quotes US$ won increased 8% in FY20 versus FY1
Slide 23: Mayne Pharma International (MPI)
Mayne Pharma International (MPI) ● MPI performance was significantly stronger in Change A$million FY20 FY19 the 2HFY20 with sales up 20% on 1HFY20 FY20 v FY19 benefiting from positive impacts of COVID-19 Reported revenue 42.4 40.7 4% ● In Australia, specialty products UROREC® and Gross Profit 11.0 1
Slide 24: Significant reduction in R&D and operating expenses
Significant reduction in R&D and operating expenses R&D spend1 A$million FY20 FY19 Change ● Generic R&D spend reduced by ~50% yoy FY20 v FY19 ● >75% of R&D spend directed to key R&D expensed 24.8 28.5 (13%) therapeutic areas of dermatology, women’s R&D capitalised 11.0 21.8 (50%) health and infectio
Slide 25: Reported to underlying earnings attributable to members
Reported to underlying earnings attributable to members Reported Business Underlying Earn-out Drug pricing Gross-to-net Inventory A$million turnaround & Impairment INTI E4/DRSP FY20 reassessment Restructuring investigations adjustment adjustments FY20 Revenue 457.0 14.6 471.6 Gross profit 211.5 14.6
Slide 26: Consolidated balance sheet position
Consolidated balance sheet position Pre AASB16 ● Growth in intangibles and financial As at As at As at liabilities reflects inclusion of A$million 30 Jun 20 30 Jun 20 30 Jun 19 NEXTSTELLIS™ Cash 137.8 137.8 89.0 Inventory 94.0 94.0 100.3 - Unwind of the discount on the NEXTSTELLIS™ earnout liabiliti
Slide 27: Consolidated cash flow – EBITDA to cash reconciliation
Consolidated cash flow – EBITDA to cash reconciliation Full Year ending ● Cash flow working capital movements based on average A$million 30 Jun 20 30 Jun 19 AUD/USD exchange rate for the Reported EBITDA attributable to members1 80.3 111.6 period whereas the June balance Minority share of INTI EBITDA
Slide 28: Capital structure
Capital structure ● Company has A$138m of cash and A$200m of undrawn debt Net debt As at As at ● Dual currency debt facility A$million 30 Jun 20 30 Jun 19 Change - US$150m, 3 year bullet facility, matures December 2021 - US$200m, 5 year revolving facility, matures December Syndicated facility 344.4
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