Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs, will host an investor meeting today where for the first time it is providing full-year 2016 net sales and adjusted EBITDA guidance and outlining its long-range plan for its current portfolio of medicines. The Company's presentation will begin at 11:30 a.m. EST and will be available via webcast athttp://ir.horizon-pharma.com/events.cfm.
"Since our Company's inception, we have built a strong and diversified portfolio of medicines through best-in-class commercial execution and value-enhancing acquisitions that we expect will drive nearly $1 billion in net sales in 2016," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "As we look to the future, we believe our long-range plan has the potential to double net sales by 2020, led by our rapidly expanding orphan business. We expect to accelerate clinical development of ACTIMMUNE, with a specific focus on Friedreich's ataxia and cancer."
Key Business Highlights
- High-value, growing orphan business unit with current ACTIMMUNE and RAVICTI indications; significant growth opportunities with potential future indications
- ACTIMMUNE and RAVICTI U.S. sales are currently annualizing at a $265 million run rate based on third quarter 2015 net sales.
- Strong patent protection, including ACTIMMUNE through 2022 and RAVICTI through 2032 and additional long-term future growth opportunities:
- ACTIMMUNE is in Phase 3 clinical development for Friedreich's ataxia with data expected by the end of 2016 and a potential regulatory decision in 2017.
- ACTIMMUNE has potential in cancer with a Phase 1 dosing trial expected to initiate by year-end 2015:
- Fox Chase Cancer Center collaboration to study ACTIMMUNE in combination with PD-1/PD-L1 inhibitors in various forms of cancer, including advanced urothelial carcinoma (bladder cancer) and renal cell carcinoma.
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion in September recommending a centralized marketing authorization for RAVICTI for use as an adjunctive therapy for Urea Cycle Disorders (UCDs). A marketing authorization decision by the European Commission is expected by the end of 2015 with a commercial launch anticipated in 2017, if approved.
- Horizon's long-range plan anticipates its orphan business unit will represent approximately 60 percent of its total company net sales in 2020.
- Primary care and specialty business units provide strong foundation for future growth
- Horizon Pharma expects DUEXIS, VIMOVO, PENNSAID 2% and RAYOS to exceed $500 million in 2015 net sales and $800 million to $1 billion in 2020 net sales based on its long-range plan, driven by clinical differentiation and commercial execution, resulting in expected continued strong prescription growth.
- Since January 2014, Horizon's total prescription growth for its primary care and specialty medicines has increased 189 percent, while the average net realized price for these medicines has increased approximately 16 percent.
- DUEXIS, VIMOVO and PENNSAID 2% participate in the U.S. NSAID market, where 117 million prescriptions are written annually. The aggregate total prescription annual run rate for these three medicines is 1.5 million total prescriptions. This offers a significant opportunity for future growth.
Key Financial Highlights
- On November 6, 2015, the company reported third-quarter 2015 results with net sales of $226.5 million, up more than 200 percent versus third quarter 2014 and adjusted EBITDA of $131.1 million, up nearly 500 percent versus third quarter 2014. The company also significantly increased its full-year 2015 net sales guidance to $750 to $760 million and adjusted EBITDA guidance to $350 to $360 million.
- Providing first-time full-year 2016 net sales guidance of $950 to $975 million, which would represent more than 25 percent year-over-year growth at the midpoints of Horizon's 2015 and 2016 guidance ranges. (Street sees FY16 revenue of $884.7 million)
- Providing first-time full-year 2016 adjusted EBITDA guidance of $460 to $475 million, which would represent more than 30 percent year-over-year growth at the midpoints of Horizon's 2015 and 2016 guidance ranges.
- 2020 full-year net sales potential in long-range plan of more than $2 billion, which includes sales from ACTIMMUNE in Friedreich's ataxia, assuming approval for that indication.
- If ACTIMMUNE is approved in selected cancer indications, based on the Company's long-range plan, it could present an additional net sales potential of $300 to $500 million in 2020.