Horizon Therapeutics Plc
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Investor Presentation Horizon Therapeutics plc November 2019 HorizonTherapeutics.com Forward-Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements related to Horizon’s full-year 2019 net sales and adjusted EBITDA guidance; expected financial performance and operating results in future periods, including potential growth in net sales of certain of Horizon’s medicines; expected impact of refinancing transactions; expected timing of clinical trials and regulatory submissions and decisions, including related to the Biologics License Application (BLA) for teprotumumab; potential market opportunity for and benefits of Horizon’s medicines and medicine candidates; and business and other statements that are not historical facts. These forward-looking statements are based on Horizon’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks that Horizon’s actual future financial and operating results may differ from its expectations or goals; Horizon’s ability to grow net sales from existing medicines; the availability of coverage and adequate reimbursement and pricing from government and third-party payers; risks relating to Horizon’s ability to successfully implement its business strategies; risks inherent in developing novel medicine candidates, such as teprotumumab, and existing medicines for new indications; risks associated with regulatory approvals; risks in the ability to recruit, train and retain qualified personnel; competition, including potential generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon operates and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Horizon’s filings and reports with the SEC. Horizon undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information. 2 Horizon A leading rare Delivering Generating disease biopharma innovative therapies high returns for company to patients shareholders 3 Advancing Our Unique Biopharma Model Our Foundation is Commercial Execution; The Future is Our Pipeline HORIZON: A Rare Disease Biopharma Company TRADITIONAL BIOTECH: • Conduct development program(s) 1 2 3 4 using R&D expertise • Obtain multiple financings with significant cash burn • If successful, either sell or hire marketing Establish commercial Build solid portfolio financial position expertise 2011-2016 Optimize growth Expand pipeline through trajectory through internal development, commercial expertise licensing and acquisitions 2017 and beyond 4 We Have Rapidly Evolved into a Company Focused on Rare Disease Medicines 2013: Net sales of $74 Million 2018: Net sales of $1.2 Billion 2 Medicines Diversified Portfolio; 6 for Rare Diseases Non-Rare Disease Medicines 5 Commercial Execution: One of Our Hallmark Strengths We Use a Three-Fold Approach to Optimize the Value of Our Medicines so More Patients Can Benefit We DEEPLY UNDERSTAND We BUILD THE RIGHT TEAM AND We EDUCATE PHYSICIANS the medicine, the disease and REQUIRED INFRASTRUCTURE through a highly experienced clinical the market dynamics to drive uptake, support our patients team, investing in clinical data that and optimize further opportunities improves their understanding of the disease and its treatment • KRYSTEXXA exemplifies how we optimize the value of our medicines: ⁻ Was an underperforming and undervalued asset when we acquired it in January 2016 ⁻ We transformed its growth trajectory, quadrupling its annual net sales and helping bring KRYSTEXXA to more patients living with uncontrolled gout(1) ⁻ We see continued growth opportunities for KRYSTEXXA and with continued strong execution are projecting peak annual U.S. net sales (1) Horizon estimate. (2) YOY: year over year.of >$750 million (1) Uncontrolled gout is chronic gout refractory (unresponsive) to conventional therapies. (2) Horizon estimate. 6 A Leading Rare Disease Biopharma Company Executing on Our Strategy Significant Progress in 2019 Expected Milestones in 2020 and Beyond • Building a robust pipeline of • Announced teprotumumab Phase 3 topline data: • Teprotumumab BLA decision and launch: rare disease medicines with – Primary endpoint achieved at 82.9% vs. – March 8, 2020 PDUFA date leading R&D capabilities placebo of 9.5% (p<0.001) • Teprotumumab long-term data • Maximizing the value of our – All secondary endpoints met (p≤0.001) medicines, particularly • KRYSTEXXA MIRROR and PROTECT study data KRYSTEXXA® • Initiated teprotumumab Expanded Access • Early stage gout candidates (HZN-003, HZN-007) Program move into clinical development • Submitted teprotumumab BLA; FDA granted • HemoShear lead candidate decision Priority Review • Advancing toward peak net sales expectations: • Initiated two KRYSTEXXA trials: – KRYSTEXXA: >$750M(2) – MIRROR immunomodulation trial – Teprotumumab: >$750M(2) – PROTECT trial in kidney transplant patients • Potential upside from future pipeline assets with uncontrolled gout • Expecting >25 percent full-year 2019 KRYSTEXXA net sales growth(1) BLA: Biologics License Application. MIRROR: Registrational, randomized, placebo-controlled 135-patient trial evaluating the use of KRYSTEXXA in combination with methotrexate to increase the response rate; with open-label, 14-patient pilot study. PROTECT: Clinical trial evaluating the effect of KRYSTEXXA on serum uric acid levels in kidney transplant patients with uncontrolled gout. (1) Horizon estimate. (2) Horizon estimate. Peak net sales estimate for U.S. only. Teprotumumab is an investigational candidate and its safety and efficacy have not been established. 7 Strong Financial Results and Strategic Execution • Q3 net sales increased 3 percent to $335.5M; adjusted EBITDA of $130.4M • Record quarterly Orphan and Rheumatology net sales of $250.4M, an increase of 14 percent, driven by KRYSTEXXA net sales growth of 42 percent; O&R segment represents approximately 75 percent of total company net sales Financial highlights • Maintained full-year net sales guidance of $1.28B to $1.30B; raised midpoint of full-year 2019 adjusted EBITDA guidance with new range between $465M to $475M; full-year 2019 KRYSTEXXA net sales growth expected to be >25 percent • Reduced gross debt by $575M in 2019 to better align with biopharma capital structure; net leverage of 1.1x at Sept. 30, 2019 • Granted Priority Review of teprotumumab for active thyroid eye disease (TED) by FDA in early September, with March 8, 2020 PDUFA date Executing on • Additional Phase 3 teprotumumab data demonstrated significantly reduced double vision and improved quality of life for our strategy patients with Active TED • Initiated PROTECT trial in October; evaluating KRYSTEXXA to improve management of uncontrolled gout for adults with a kidney transplant Net Leverage: Net debt to last-12-months adjusted EBITDA. PDUFA: Prescription Drug User Fee Act. PROTECT: Clinical trial evaluating the effect of KRYSTEXXA on serum uric acid levels in kidney transplant patients with uncontrolled gout. Teprotumumab is an investigational candidate and its safety and efficacy have not been established. Note: Adjusted EBITDA and net leverage are non-GAAP measures; see reconciliations at the end of the presentation for a reconciliation of GAAP to non-GAAP measures. 8 Combined Estimated Annual Peak Net Sales of KRYSTEXXA and Teprotumumab Alone Would Double FY18 Net Sales • Orphan and Rheumatology: durable base of rare disease medicines Teprotumumab • >25% net sales growth expected for KRYSTEXXA in 2019(1) >$750M(1) • Expect significant peak net sales potential for KRYSTEXXA and teprotumumab • KRYSTEXXA Potential upside with future pipeline assets >$750M(1) KRYSTEXXA 2013 2014 2015 2016 2017 2018 Orphan and Rheumatology Net Sales Teprotumumab is an investigational candidate and its safety and efficacy have not been established. Horizon cannot generate U.S. net sales of teprotumumab unless and until it obtains FDA approval. Note: Company full-year 2018 net sales were $1.21B. (1) Horizon estimate. 9 Have Evolved Our Capital Structure to Be in Line with Biopharma Peers Reduced Gross Debt by $575M in 2019; Net Leverage of 1.1x at Sept. 30, 2019 Strong Cash Balance and Net Debt Position Managing Debt and Leverage Efficiently $1,500M • Reduced gross debt by $575M while maintaining strong cash balance of $884M $1,000M – Gross Debt of $1.418B at Sept. 30, 2019 vs. $1.993B at Dec. 31, 2018 • July 2019 Senior Notes Offering: $600M of 5.5% Senior Notes due 2027; $500M $959M $884M $751M used proceeds along with cash to repay $625M of gross debt, reducing gross $509M debt by a further $25M $0M $534M • Net leverage ratio of 1.1x, down from 2.9x one year ago $500M $1,034M $1,269M $1,435M $1,000M Sept. 30, 2018 Sept. 30, 2019 Target $1,500M 12/31/2016 12/31/2017 12/31/2018 9/30/2019 Gross Leverage 4.9x 2.9x <3.0x Cash Net Debt Net Leverage 2.9x 1.1x <2.0x Gross Leverage: Gross debt to last-12-months adjusted EBITDA. Net Leverage: Net debt to last-12-months adjusted EBITDA. Note: Net debt and LTM adjusted EBITDA are non-GAAP measures; see reconciliation slides at the end of the presentation for a reconciliation of GAAP to non-GAAP measures. 10 KRYSTEXXA Our Flagship